- NHS Ealing Clinical Commissioning Group

Transcription

North West London Collaboration of
Clinical Commissioning Groups
Planned Procedures with a Threshold
Version 3
April 2013
Help and advice
The IFR Service is available to provide help and answer any questions you might have. Further details and all
related documentation to the IFR service can be found at www.northwestlondon.nhs.uk/ifr
Email: [email protected]
Phone number for borough staff and clinical stakeholders: 020 3350 4242
Phone number for patients and carers: 0203 350 4123
Page 1 of 1
Abdominoplasty / Apronectomy
Policy
NHS NWL CCGs will not routinely fund abdominoplasty or apronectomy surgery because they are considered
t o b e cosmetic p ro c e d u re s . However, funding could be c o n s i de re d where the following criteria are met:
1)
The patient is 18 or over at the time of application
AND
2)
The patient has BMI of 18-27 kg/m2 and stable for at least two years
OR
The patient has lost at least 50% of their original excess weight and maintained their weight for at
least two years
AND
3)
The patient is suffering from severe functional problems, e.g.
o
o
Difficulties with activities of daily living (e.g. walking & dressing)
Recurrent skin infection in the skin fold that recurs or fails to respond despite
appropriate medical therapy for at least 6 months
Please provide supporting evidence for the above.
Where the criteria are not met, funding may be considered via the IFR route if there are any exceptional reasons.
This policy does not apply to belt lipectomy. Funding for this procedure is not routinely available and will be
considered via IFR only. See the cosmetics policy.
This policy does not apply where the abdominoplasty/abdominal wall repair is required in conjunction with other
medically necessary procedures such as complex hernia repair.
These polices have been approved by the eight Clinical Commissioning Groups in North West London (Brent
CCG, Central London CCG, Ealing CCG, Hammersmith and Fulham CCG, Harrow CCG, Hillingdon CCG,
Hounslow CCG and West London CCG). Production of the policies and management of appeals is coordinated on behalf of the CCGs by North West London Commissioning Support Unit.
NHS NWL CCGs Planned Procedures with a Threshold Policy. Version 3 (April 2013)
Is this the latest version? Check here: http://www.northwestlondon.nhs.uk
Background
Abdominoplasty or a “tummy tuck" is used to make the abdomen firm. The surgery involves the removal of
excess skin and fat from the middle and lower abdomen in order to tighten the muscle and fascia of the
abdominal wall. An Apronectomy or mini tummy tuck is less radical than the abdominoplasty.
This type of surgery is usually sought by patients with loose tissues after pregnancy or individuals with sagging
after major weight loss particularly following bariatric surgery. Excessive abdominal skin folds may occur
following weight loss in obese patients and these can cause significant functional difficulties for patients –
difficulties walking, dressing, and problems with skin infections. Abdominoplasty is a beneficial procedure for
these patients. It is important that patients undergoing abdominoplasty/apronectomy have achieved and
maintained a stable weight so that the risks of obesity recurring are reduced.
References
Patient information leaf et:
http://www.nhs.uk/conditions/cosmetic-surgery/pages/introduction.aspx
References:
Mammaplasty and Abdominoplasty. Dafydd, Juma, Meyers, Shokrollahi (2009) The Contribution of
Breast and Abdominal Pannus Weight to Body Mass Index Implications for Rationing of Reduction
Annals of Plastic Surgery.
Adenoidectomy in Children
Policy
Adenoidectomy is of limited clinical effectiveness when performed as a single procedure and will not be routinely unded
Adenoidectomy for other indications will only be considered via the IFR route in exceptional cases.
Backgroun
Adenoidectomy1 is an operation to remove the adenoids. Adenoids are removed in order to improve breathing in
children especially while they sleep, and reduce frequency of attacks of acute otitis media with effusion (OME).
Evidence Base
The evidence for adenoidectomy supports surgery only if performed in conjunction with grommets insertion and
the child meets the grommet referral criteria1. This is because adenoidectomy on its own is of unknown
effectiveness.1 NICE guidance1 does not recommend adjuvant adenoidectomy in the absence of persistent
and/or frequen upper respiratory tract symptoms. Adenoidectomy does not reduce the incidence of oti is media.1
Reference
1.
2.
3.
4.
5.
http://www.entuk.org/patient_info/throat/adenoid (accessed October 2010)
Lous J, Burton MJ, Felding J, Ovesen T, Rovers M, Williamson I. Grommets (ventilation tubes) for hearing
loss associated with otitis media w th effusion in children. Cochrane Database of Systematic Reviews
2005
Oomen k et al (2005) Effect of adenotonsillectomy on middle ear status in children Laryngoscope
Apr;115(4):731-4
NICE Clinical Guidance CG60 (February 2008)
Oomen k et al (2005) Effect of adenotonsillectomy on middle ear status in children Laryngoscope
Apr;115(4):731-4
NHS NW London CCGs Planned Procedures with a Threshold Policy. Version 3 (April 2013)
Benign Lesions and lumps
Benign skin lesions
Policy
Within scope of policy - complete PPwT form
(examples)
Benign pigmented moles
Comedones
Corn/callouses
Lipomata
Milia
Molluscum contagiosum
Mucoid cysts
Sebaceous cysts (epidermoid or pilar cysts)
Seborrhoeic keratoses (basal cell papillomata)
Skin tags including anal tags
Spider naevus
Warts
Not within scope (please refer via cancer pathway)
Malignant lesions
Lesions with malignant potential e.g., actinic keratoses
Refer to related PPWT policies:
Chalazia
Ganglion
Benign lesions that are requested to be removed for cosmetic reasons only e.g. portwine stain or
xanthelasma are not funded unless there are exceptional clinical circumstances.
Benign lesions
NHS NWL CCGs will fund the appropriate investigation and removal of any lesion or lump if any of the following
criteria are met:
causing obstruction of orifice or movement
causing functional limitation e.g. lesion catching on clothing
impairing vision, hearing or smell (but only if there has been no response to non-surgical
subject to repeated infection or bleeding
it is a sinus, fistula or fissure
Mucoid cyst
causing disturbance of nail growth
tendency to discharge
Removal of warts
Viral warts will only be eligible for removal if the following criteria are met: where painful, persistent or
extensive warts (particularly in immuno-suppressed patients).
Lipomata
lipoma(-ta) of any size causing symptoms or demonstrable functional impairment
larger than 5 cm
deep-seated
the lump is rapidly growing or abnormally located (e.g. sub-fascial, submuscular,
patients with multiple subcutaneous lipomata may need a biopsy to exclude neurofibromatosis.
NHS NWL CCGs Planned Procedures with a Threshold Policy. Version 3(April 2013)
Background
Specific background comments for some of these benign skin conditions are given in the table below.
Lesion
Lipomata
(basal cell
papillomata)
Background and/or therapy
A population-based case series (n=428) comparing patients with
lipoma to those with sarcoma, found that the solitary lipoma:
sarcoma ratio decreased as size of mass increased. [Rydholm 1997].
Thigh and deep seated lipomas were also more likely to be
sarcomas. Patients with multiple subcutaneous lipomata may need a
biopsy to exclude neurofibromatosis.
Medical Care
Ammonium lactate and alpha hydroxy acids have been reported to
reduce the height of seborrheic keratoses. Superficial lesions can be
treated by carefully applying pure trichloroacetic acid and repeating if
the full thickness is not removed on the first treatment.
Topical treatment with tazarotene cream 0.1% applied twice daily for
16 weeks caused clinical improvement in seborrheic keratoses in 7
of 15 patients.
Surgical Care
A variety of techniques may be used to treat seborrheic
keratoses. They include cryotherapy with carbon dioxide (dry ice)
liquid nitrogen, electrodesiccation, electrodesiccation and curettage,
curettage alone,
or excision using a scalpel, or a laser
or dermabrasion surgery. Some of these techniques destroy the
lesion without providing a specimen for
No consultations are needed, unless the sudden appearance of
multiple pruritic seborrheic keratoses occurs (known as the LeserTrélat sign).
Background (continued)
Spider naevus
(telangiectasia)
Management
Usually no treatment is required and many will fade spontaneously or
resolve as the underlying condition improves. Spider naevi may be
treated with laser therapy or electrodessication if desired for cosmetic
reasons.
Prognosis
This benign lesion tends to resolve spontaneously but may take a
number of years to do so. If
liver disease, they may
resolve if the liver disease improves.
eMedicine also has a chapter on spider nevus and they suggest
electrodesiccation and laser treatment. They also highlight that
treating the possible underlying cause should help.
Viral warts
Viral warts are usually of aesthetic significance only and
surgical removal is not routinely funded by the CCGs. Most
viral warts will clear spontaneously or following application of
topical treatments so should normally be treated in primary
care.. Painful, persistent or extensive warts (particularly in
immuno-suppressed patient) may need specialist assessment
by a GPwSI or a Dermatologist. For a small proportion
surgical removal (cryotherapy, cautery, laser or excision)
may be appropriate. However, treatment of viral warts on the
eyelid is problematic and these should be referred for
consideration of treatment. There are no restrictions on
treatment of genital warts.
References
Patient Information:
Breast Augmentation
Policy
NHS NWL CCGs will not fund breast augmentation surgery for cosmetic purposes. Funding could be considered via the
IFR route in exceptional clinical circumstances.
This policy does not apply to post mastectomy or lumpectomy reconstruction, which is routinely funded.
Background
Breast augmentation, or augmentation mammoplasty, involves increasing the size or improving the shape of a
woman’s breasts (or breast) by inserting a breast implan
is the most commonly performed cosmetic procedure
performed on women in the UK. When this is done as a purely cosmetic procedure the aim is to reduce a woman’s
dissatisfaction with the size, shape or appearance of her breasts. Breast augmentation may also be deemed
medically necessary (rather than cosmetic) after a mastectomy or lumpectomy that results in significant deformity
i.e.: mastectomy or lumpectomy for treatment of or prophylaxis for, breast cancer and mastectomy or lumpectomy
performed for chronic severe fibrocystic breast disease, also known as cystic mastitis, unresponsive to medical
therapy. Procedures include mastopexy (breast lift), insertion of breast prostheses, the use of tissue expanders, or
reconstruction with transverse rectus abdominis myocutaneous flap, deep inferior epigastric perforator lap or
similar procedure and associated nipple and areolar reconstruction and tattooing o the nipple area.
Breast augmentation commonly has a high rate of patient satisfaction (rates of 90% and more have been reported in
the literature) with evidence of improvements in body-image and self- esteem. There is no evidence that healthrelated quality of life improves after breast augmentation
Some patients will benefit from counselling and psychological therapies
References
1. Aesthetic (Cosmetic) Surgery and other related procedures Evidence Based Framework for Decision Making.
NHS Leeds Cosmetic Framework September 2008.
2. Murphy, Beckstrand and Sarwer 2009 Annals of Plastic Surgery. A prospective, multi-centre study of
psychosocial outcomes after augmentation with natrelle silicone-filled breast implants
Benign skin lesions
Breast Prosthesis Removal or Replacement
Policy
NHS NWL CCGs will fund breast implant removal where the following criteria are me
Indications for removal (any of the following)
o
o
o
o
And
Rupture of silicone-filled gel.
Implants complicated by recurrent infections.
Extrusion of implant through skin.
Implants with Baker Class IV contracture*.
The patient is 18 or over at the time of application.
Removal of both implants where asymmetry is an issue will be funded
Where the above criteria are met re-implantation with a new prosthesis will only be considered where original
implants were funded by the NHS for non-cosmetic purposes. Additional cosmetic surgery (e.g. mastopexy or
bigger implants) should not be done at the same time as the re-implantation and will not be funded.
If the patient does not meet policy but has exceptional circumstances to be considered an IFR form can be
submitted.
Hounslow CCG and West London CCG). Production of the policies and management of appeals is co-ordinated
on behalf of the CCGs by North West London Commissioning Support Unit.
Background
Women who have undergone breast augmentation procedures can rarely go through heir entire lives with
the same prostheses (implants). The survival time of implants varies depending on individual circumstances but
removal is often necessary at some point or various reasons. Some prostheses breakdown over time and
complications may develop.
The US Food and Drug Administration (FDA) advise that ruptured silicone implants should be removed
since the health risks of extruded silicone are not known. The FDA caution that asymptomatic rupture may be
present in up to 4% of women with silicone implants, and recommend regular screening for asymptomatic
ruptures.
Rupture of silicone implants can be subdivided into two categories, intra- and extracapsular. After implantation,
a reactive fibrous capsule is formed around the implant. If the extruded silicone is contained by this fibrous
capsule the rupture is termed intracapsular. If the silicone gel is extruded beyond the capsule, the rupture is
termed extracapsular. Extracapsular silicone can induce granulomatous reaction and can occasionally migrate
to the axillary lymph nodes, producing a lymphadenopathy, which can mimic cancer. Clinically, extracapsular
ruptures are often associated with a change in size and consistency of the breast Extracapsular ruptures can
usually be identified on mammography or other imaging studies. Research by the Department of Health
concluded that there is no evidence of long term harm associated with the use of silicone gel implants.
Nevertheless, an intracapsular rupture can evolve to an extracapsular rupture and the FDA indicated that
rup ured implants, whether intracapsular or extracapsular, should be explanted
*Baker’s Classification Grade
Grade I (Absent)
The breast is soft with no
palpable capsule and looks
natural.
Grade II (Minimal)
The breast is a little firm with a
palpable capsule but looks
normal.
Grade III (Moderate)
The breast is firm with an easily
palpated capsule and is visually
abnormal.
Grade IV (Severe)
The breast is hard, cold,
painful, and markedly
distorted.
References
Patient information eaflet
http://www.cks.nhs uk/patient_in ormation_leaflet/breast_implants
References
1. Aesthetic (Cosmetic) Surgery and other related procedures Evidence Based Framework for
Decision
Making. NHS Leeds Cosmetic Framework September 2008
2. FDA News release, November 2006 FDA Approves Silicone Gel-Filled Breast Implants After InDepth
Evaluation.
3. Baker JL, Bartels RJ, Douglas WM. Closed compression techniques for rupturing a contracted capsule
around a breast implant. Plast Reconstr Surg 1976;58:137-41.
Breast Reduction (Reduction Mammoplasty)
Policy
NHS NWL CCGs will not routinely fund breast reduction for cosmetic purposes. However, funding will be
considered for functional purposes where the following criteria are me
1.
Patients with breast hyperplasia/hypertrophy
2.
The patient should be 18 or over at the time of application.
3.
BMI equal to or below 30 for at least two years.
4.
Patient is symptomatic – with at least TWO of the following for at least one year( and documented evidence
of GP visits for these problems) : evidence to be submitted
o
o
o
o
o
5.
Pain in the neck
Pain in the upper back
Pain in the shoulders
Painful kyphosis documented by X-rays.
Pain / discomfort / ulceration from bra straps cutting into shoulders
Pain symptoms persist as documented by the physician despite a 6-month trial of therapeutic measures
including all of the following: with evidence submitted
o
o
o
Supportive devices (e.g., proper bra/support bra fitted by a trained bra er, wide bra straps).
Analgesic / non-steroidal anti-inflammatory drugs (NSAIDs) interventions.
Physical therapy / exercises / posturing manoeuvres.
Chronic intertrigo, eczema or dermatitis alone will not be considered as grounds for his procedure unless all of
the above are met and the patient has failed to respond to 6 months of conservative reatment.
Where criteria are not met funding will be considered via an IFR application
Background
Female breast reduction, also known as reduction mammoplasty, is a surgical operation o reduce the weight
and volume of the breasts. During the procedure, fat, glandular tissue and skin are removed from the
breasts, which are then reshaped and the nipples repositioned. This is a commonly performed procedure with
almost 4000 cases per year carried out by the NHS in England.
Breast size is determined by genes, hormones, body frame and weight. For most women, breast size is
proportionate to the body, but for some, the breasts are particularly large. When breasts grow to be unusually
large (gigantomastia) in young women at puberty, this is termed virginal hyperplasia or virginal hypertrophy.
This condition is thought to be caused by a particular sensitivity to female sex hormones. Large breasts can
cause physical symptoms such as discomfort, backache, neck pain or skin irritations. Large breasts can also
cause psychological distress. Common complaints from women with large breasts include unwanted attention,
not being able to wear fashionable clothes and finding it difficult to take part in active spor s
Breasts are particularly sensitive to the hormone oestrogen. They can grow particularly large during adolescence
or later in life following the menopause or because of the use of hormone replacement therapy (HRT). Some
women also develop a noticeable asymmetry (difference in size or shape) between their breasts. The goal of
medically necessary breast reduction surgery is to relieve symptoms of pain and disability related to excessive
breast weigh
References
Patient information:
http://www.nhs.uk/conditions/Breast-reduction/Pages/Introduction.aspx
References
Aesthetic (Cosmetic) Surgery and other related procedures Evidence Based Framework for Decision Making.
Shah, Al-Ajam, Stott and King. Obesity in mammoplasty: A study of complica ions following breast reduction.
(2010) Journal of Plastic, Reconstructive and Aesthetic Surgery
Carpal Tunnel Syndrome Surgery
Policy
Referral for carpal tunnel surgery will be considered if the following criteria are me
Patient has acute, severe symptoms that persist after conservative therapy with either local
corticosteroid injection and/or nocturnal splinting (with dates supplied)
Mild to moderate symptoms persist for at least 4 months after conserva ive therapy with either
local corticosteroid injection (if appropriate) and/or nocturnal splinting (used for at least 8 weeks).
There is neurological deficit e.g. sensory blunting, muscle wasting or weakness of thenar
abduc ion.
Severe symptoms significantly interfere with daily ac ivi ies
These polices have been approved by the eight Clinical Commissioning Groups in North West London
(Brent CCG, Central London CCG, Ealing CCG, Hammersmith and Fulham CCG, Harrow CCG, Hillingdon
CCG, Hounslow CCG and West London CCG). Production of the policies and management of appeals is coordinated on behalf of the CCGs by North West London Commissioning Support Unit.
Background
Carpal tunnel syndrome causes pain, numbness and tingling in the hand and orearm.
entrapment of the median nerve in the wris
is due to
Ev dence Base
The benefits of conservative therapy are seen early after treatment and then decrease while the
benefits of surgery take longer to be fully realised. Local corticosteroid injection for carpal tunnel
syndrome provides greater clinical improvement in symptoms one month after injection compared to
placebo but significant symptom relief beyond one month has not been demonstrated.
Current evidence shows significant short-term benefit from oral s eroids, splinting, ultrasound, yoga
and carpal bone mobilisation. Other non-surgical treatments do not produce significant benefit.
Surgical treatment of carpal tunnel syndrome relieves symptoms significantly be er than splinting
both in the short and long term. Further research is needed to discover whether this conclusion applies
to people with mild symptoms and whether surgical treatment is better than steroid injec ion
There is no strong evidence supporting the need for replacement of standard open carpal tunnel
release by existing alternative surgical procedures for the treatment o carpal tunnel syndrome. The
pooled estimate indicated that a significant proportion of medically treated people required surgery
while the risk of re-operation in the surgically treated people is low
References
Patient information eaflet
http://www.nhs.uk/conditions/carpal-tunnel-syndrome/Pages/Whatisit.aspx
References
Verdugo RJ, Salinas RA, Castillo JL, Cea JG. Surgical versus non-surgical treatment for carpal
tunnel syndrome. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No. CD001552.
DOI: 10 1002/14651858.CD001552.pub2.
Scholten RJPM, Mink van der Molen A, Uitdehaag BMJ, Bouter LM, de Ve HCW.Surgical
treatment options for carpal tunnel syndrome. Cochrane Database of Systematic
Reviews 2007, Issue 4. Art. No. CD003905. DO 10.1002/14651858.CD003905.pub3
O'Connor D, Marshall SC, Massy-Westropp N. Non-surgical treatment (other than steroid
injection) for carpal tunnel syndrome. Cochrane Database of Systematic Reviews 2003, Issue 1.
Art. No.: CD003219. DOI: 10.1002/14651858.CD003219
Marshall SC, Tardif G, Ashworth NL. Local corticosteroid injection for carpal tunnel syndrome.
Cochrane Database of Systematic Reviews 2007, Issue 2 Art. No.: CD001554. DOI:
10 1002/14651858.CD001554.pub2.
Cataract Surgery
Policy
NHS North West London CCGs will fund cataract surgery for either or both eyes if the following
thresholds are met:
1. Cataract surgery to be considered for patients with a best corrected visual acuity of 6/9 (LogMAR 0.18)
or worse in the affected eye(s).
AND
2.
Have impairment in lifestyle such as significant effect on activities of daily living, leisure activities,
and risk of falls
OR THRESHOLD 3 ALONE
3.
Surgery is indicated for management of ocular comorbidities e g management of glaucoma OR in
diabetes where the view of the retina is obscured in retina screening
Revision cataract surgery is not in scope of this policy
Where the criteria are not met, funding may be considered via the IFR route if there are exceptional reasons.
Background
Cataracts are cloudy patches or areas in the eye lens that are very common in the elderly population and cataract
surgery is a fast, safe and effective treatment.1 Referral depends on reduced visual acuity, impairment of activities
of daily living and a willingness to have surgery. Impairment of activities of daily living may include the following:
The patient is at significant risk of falls
he patient’s vision is substantially affecting their ability to work
The patient’s vision is substantially affecting their ability to undertake leisure activities such as reading,
recognising faces or watching television
Although there is significant improvement in vision from mono- to binocular vision (35% o cataract operations
are in the second eye), there is debate around whether second cataract surgery is cost effective.1 There is also
debate around whether cataract surgery in both eyes should occur simultaneously. The risk of bilateral intraocular complications is generally perceived to be too important to warrant simultaneous treatment and if second
surgery occurs it is usually delayed after the first opera ion.1
As such, there is no agreed guidance for second eye cataract operations – is i cost-effective and should it be
carried out simultaneously? This document summarises the risks, benefits and cost-effectiveness for first and
second eye cataract surgery, including immediately sequential cataract surgery (ISCS), and offers guidelines
for clinicians and commissioners.
First Eye Cataract Surgery
First eye cataract surgery is recommended by NICE and the Department of Health2 Surgery can involve either
accommodating or non-accommodating intraocular lenses as they both improve visual acuity. Compared with
monofocal lenses, multifocal lenses reduce dependence on spectacles (OR 0.17 – 0.12, 0.24) but do increase
the risk of halos and glares (OR 3.55 – 2.11, 5.96). Key efficacy outcomes from surgery are spectacle
independence, uncorrected near and distance vision, pos operative refractive error, contrast sensitivity and
quality of life. Referral should not be based only on the presence of the cataract but also on the presence of
reduced visual acuity impairment of lifestyle and willingness to have surgery.
Second Eye Cataract Surgery
The Royal College of Ophthalmologists released guidance on cataract surgery in 2004 stating that second eye
surgery is warranted given the significant gains in visual function and quality of life compared with single surgery
alone.3,4 Multiple randomised studies have shown improved clinical and functional benefit from surgery
in he second eye, in terms of visual acuity, contrast sensitivity, stereoacuity, and visual disability however
second surgery does not improve the risk of falling in the elderly.4,5,6,14
At the population level, maximum utility is obtained from increasing access to irst eye surgery in the first
instance. However where first surgery rates are high then second-eye surgeries should be performed to
maximise quality of life to as many as possible.7,8
Cost-benefit of Second Cataract Surgery
Modelled cos -benefit analysis has shown that second eye surgery yields an additional 0.92 QALYs over a 12
year life expectancy, with each additional QALY gained costing between $2045 to $3649 2001). Compared with
first eye surgery ($2023 per QALY) this is only slightly less cost-efficient and represents good costeffectiveness when compared with o her procedures. However, these estimates may not be generalisable to
the UK because they are based on US studies where healthcare costs and systems are different from the NHS
Immediate Sequential Cataract Surgery (ISCS)
Simultaneous surgery in both eyes results in improved visual function9 compared to single eye surgery,
however this is not a long-lasting effect and its value is mostly to avoid suboptimal vision while waiting for
second-eye surgery. Simultaneous bilateral surgery minimises the use of local and general anaesthesia,
ensures only one-s ep visual rehabilitation is required, leads to fewer hospital visits, and a more efficient use of
hospital time, shorter waiting lists and less demand on hospital services. Including all surgical costs, delayed
second-eye surgery is 14% more expensive than ISCS. ISCS leads to 15-30% greater efficiency in the
numbers of eyes that can be operated on per day, given that the second operation adds only 12 minutes on
average to the operating time compared to delayed surgery. 3,10,11,12
Theoretically, there is no risk arising from ISCS additional to that from monocular cataract surgery itself. The
perceived threat of binocular complications occurring simultaneously underpins the concern around
simultaneous bilateral surgery. However, evidence suggests that the risk of bilateral complications in ISCS
(which includes catastrophic and non-catastrophic complications) compares favourably to unilateral surgery
complica ion rates Smith and Liu (2001). In general, the risk of a complication in the second eye is he same as
in the first eye. The chance of complications occurring in both eyes is the same as in the unilateral operations
of two consecutive patients. The principal exclusion criteria or ISCS should be for patients that have specific
underlying co-morbidities or experiences with previous cataract surgery that indicate an increased risk of postoperative complications.
References
Patient information leaf et
http://www.nhs.uk/conditions/Cataract-surgery/Pages/Introduction.aspx
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
NHS Executive. Action on Cataracts Good Practice Guidance. 2000
NICE 2007 Interventional Procedure Guidance: implantation of multifocal (non- accommodative)
intraocular lenses during cataract surgery
Smith GT and Liu CSC 2001 – Is it time for a new attitude to ‘simultaneous’ bilateral cataract
surgery?
British Journal of Ophthalmology 85:1489-1496
Royal College of Ophthalmologists 2004 - Cataract surgery guidelines.
Foss AJ, Harwood RH, Osborn F 2006 – Falls and health status in elderly women following second
eye cataract surgery: a randomised controlled trial Age and Aging 3591):66-71Castells X, Cornas
M,
Alonso J et al 2006 – In a randomised trial, cataract surgery in both eyes increased benefits
compared to surgery in one eye only. Journal o Clinical Epidemiology 59(2):201-7
Lundstrom M and Wendel E 2004 – Modelling utility of second-eye cataract surgery. International
Journal of Technology Assessment in Health Care. 20(3):361-7
Busbee BG, Brown MM, Brown GC et al 2003 – Cost-utility analysis of cataract surgery in the
second eye. Ophthalmology 110(12):2310-7
Laidlaw DA, Harrad RA, Hopper CD et al 1998 – Randomised trial of effectiveness of second eye
cataract surgery. Lancet 352(9132):925-9
Javitt JC, Steinberg EP, Sharkey P et al 1995 – Cataract surgery in one eye or bo h a billion dollar
per year issue. Ophthalmology 102(11):1583-93
Nassiri N, Nassiri N and Sadeghi Yarandi SH et al 2009 – Immediate vs delayed sequential
cataract surgery: a comparative study. Eye 23(1):89-95
Lunstrom M, Albrecht S, Nilsson M 2006 – Benefit to patients of bilateral same-day cataract
extraction: randomised clinical study. Journal of Cataract and Re ractive Surgery. 32(5):826-30
Lundstrom M, Albrecht S and Roos P 2009 – Immediate vs delayed sequential bilateral cataract
surgery: an analysis of costs and patient value. Ac a Opthalmologica 87(1):33-8
Javitt JC, Bremner HM, Curbow B et al 1993 – Outcomes of cataract surgery improvement in
visual acuity and subjective visual function after surgery in the first, scond and both eyes. Archives
of Ophthalmology 111: 686-91
Chalazia
Policy
Surgical excision of chalazia will only be funded where the following criteria
1.
Conservative treatment has been tried for at least six months
AND
2.
Interferes with vision
OR
Is causing persistent inflammation and pain
CCG, Central London CCG, Ealing CCG, Hammersmith and Fulham CCG, Harrow CCG, Hillingdon CCG, Hounslow
CCG and West London CCG). Production of the policies and management of appeals is co-ordinated on behalf
of the CCGs by North West London Commissioning Support Unit.
Background
Chalazia (meibomian cysts) are benign lesions of the eye lid that will normally resolve within 6 months.
Mainstay of treatment is regular (four times daily) application of heat compressions. Surgical treatment is rarely
indicated.
Chronic Fatigue Syndrome
Policy
Patients with CFS/ME should be referred to the North West London sector service provided at Hillingdon Hospital in
line with NICE criteria ( http://www.cnwl.nhs.uk/hillingdon_adult_CFSMEService.html)
In-patient treatment for CFS at other centres will not be routinely funded except in exceptional circumstances.
Background
Chronic fatigue syndrome (CFS – often known as ME) is relatively common, with a population prevalence of 0.2 –
0.4%. It is characterised by debilitating fatigue that has persisted for four months in an adult and three months in a
child or young person. Diagnoses are often difficult and by exclusion, with symptoms ranging from fatigue malaise,
sleep disturbance and headaches to difficulty with concentration and muscle pain. As a result, clinical management
can be difficult and requires a patient-centred, multi-disciplinary approach.
NICE guidelines on management of CFS recommend that patients should be referred to specialist CFS/ME care
based on their needs, the ype duration, complexity of their symptoms and the presence of co-morbidities. Re erral
should be offered within 6 months of presentation for people with mild CFS, within 3-4 months for those with
moderate symptoms and immediately if symptoms are severe Patients should be managed holistically with a
combination of cognitive behavioural therapy and graded exercise +/- pharmacological therapy for symptom
con rol
be ineffective
activity management programmes such as adaptive pacing have been shown to
References
Link to Patient information leaflet on CFS ME
http://www.nhs.uk/conditions/Chronic- a igue-syndrome Pages/Introduction.aspx
References
1. National Institute for Health and Clinical Excellence (2007) Chronic fatigue syndrome/myalgic encephalomyelitis (or
encephalopathy): diagnosis and management of CFS/ME in adults and children. Clinical guideline 53
http://guidance.nice.org.uk/CG53
2. White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, et al (2011) Comparison of adaptive pacing
therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue
syndrome (PACE): a randomised trial. The Lancet, 377: 823-836
NHS NW London Planned Procedures with a Threshold Policy. Version 3 (April 2013)
Cosmetic Surgery Policy
NHS NWL CCGs will not fund procedures done for cosmetic reasons. Funding may be considered
through the Individual Funding Request (IFR) route in exceptional clinical circumstances.
This policy covers all procedures done for cosmetic reasons. Examples include: (list is not exhaustive)
CCG, Hounslow CCG and West London CCG). Production of the policies and management of appeals is
co-ordinated on behalf of the CCGs by North West London Commissioning Support Unit.
Skin procedures
1
2
3
4
5
6
7
Procedure
Refashioning of scars and keloids
Skin graft for Scars
Skin Resurfacing, including for acne scarring
Light or laser therapy for aesthetic reasons
Procedures for tattoo removals
Procedures to correct rhinophyma
Procedures for removal of benign skin lesions
Surgery for removal of chalazia
Funding Route
IFR only
IFR only
IFR only
IFR only
IFR only
IFR only
Complete PPwT or IFR where
thresholds are not met
Breast Procedures
1
2
3
Procedure
Breast Augmentation
Mastopexy
Breast reduction
4
5
6
Surgical treatment for Gynaecomastia
Nipple Inversion Procedures
Breast Prosthesis Removal and Replacement
7
Revision Mammoplasty
Funding Route
IFR only
IFR only
IFR only
IFR only
IFR only
General Cosmetic procedures
1
2
3
4
5
6
7
8
9
Procedure
Face and brow lift
Blepharoplasty
Rhinoplasty
Pinnaplasty
Earlobe Repair
Liposuction
Body contouring including Thigh lift, buttock lift, arm lift
Belt lipectomy
Abdominoplasty
10
11
Hair Grafting
Hair depilation for hirsuitism
12
13
Labiaplasty
Varicose veins procedures
14
Plastic operations on the umbilicus
Funding Route
IFR only
IFR only
IFR only
IFR only
IFR only
IFR only
IFR only
IFR only
IFR only
IFR only
IFR only
Refashioning of Scars and Keloids
Policy
NHS NWL CCGs will not fund surgery to re-fashion scars because this is considered as a cosmetic procedure.
However, funding could be considered through the Individual Funding Request (IFR) route in exceptional
circumstances.
Background
A scar is a patch or line of tissue that remains after a wound has healed and may look or feel different from the
area around it. Scars are a natural part of the healing process and can happen both inside and outside the body.
Visible scars sometimes form after the skin has been broken. When a wound occurs and there is a break in some
of the tissue in the body, collagen builds up at the place where the tissue is broken, eventually helping to close it.
New collagen continues to form and then break down in the site of the wound for years afterwards. The scar
gradually becomes smoother and softer. Scars on the skin can take up to two years to fade, but after this time it is
unlikely that they will fade any more. Certain areas of the body are more likely to have scars than others. The knees
and shoulders often have more visible scars, perhaps because they need to move and stretch a lot during the healing
process. Darker skin is more likely to scar.
Sometimes abnormal scars develop, for example:
•
A hypertrophic scar is a red, raised scar that may form when healing goes on for too long. When these scars
cover a large area, they can restrict movement because scar tissue is not as flexible or sensitive as the
original skin. Hypertrophic scarring is more common in fair skin and tends to follow surgery and burn injuries.
•
A keloid scar is an overgrowth of tissue when too much collagen is produced at the site of the wound and the
scar continues to grow after the wound has healed. This type of scar may push into the normal skin or hang
off the skin in a saggy lump. Keloid scarring is more common in darker skin and occurs after trivial injuries
such as insect bites, ear piercing and vaccination.
Scars occurring on some sites of the body, such as the lower face, neck and upper arms are more likely to develop
abnormally. Scarring, particularly when it involves the face, can have a psychological effect. People with scars can
become depressed because they feel that they are being stared at, and this may mean they do not want to go out or
see a lot of people. Scars only need to be treated if a patient feels uncomfortable with the way they look, or if they
are painful or restrict movement in someway. Scars cannot be removed completely, but in many cases it is
possible to make them less visible.
The type of treatment recommended depends on the particular scar. Factors that will affect the type of treatment
include the size, location and character of the scar, as well as the aim of the treatment (to reduce to appearance or
to minimise a physical problem that the scar is causing). Severe acne scars are sometimes removed using laser
resurfacing, when the top layer of the skin is gently removed using lasers.
Sometimes surgery is used to improve the appearance of scars. This is known as scar revision.
More conservative therapies for scars where surgery is not considered appropriate include:
•
•
•
•
•
Make-up: Both men and women can use camouflage make-up to cover up scars, on the face or elsewhere.
Vitamin E: Creams or supplements containing vitamin E may speed up the healing process, leaving less visible
scars afterwards.
Silicone gel sheets: Soft, self-adhesive silicon gel sheeting is designed to be used in reducing the visibility of
existing scars by flattening and softening them, as well as for preventing formation of scars. However, a recent
Cochrane review found insufficient evidence for whether silicon gel sheeting helps prevent scarring or is
effective in treating existing hypertrophic and keloid scars.
Medications: Drugs such as potassium aminobenzoate or steroid injections help to break down scar tissue.
These are often used to treat conditions such as scleroderma that can cause extensive scarring and
hardening of the skin.
Massage and steroid injections
Skin Resurfacing Procedures
(dermabrasion, dermaroller, chemical peels)
Policy
NHS NWL CCGs will not fund skin resurfacing procedures (including dermabrasion, microdermabrasion, dermaroller,
chemical peels and laser) because they are cosmetic in nature.
Light and Laser Therapy for Aesthetic Reasons
Policy
Light or laser therapy for aesthetic reasons will not be funded. Funding may be considered for funding in
exceptional circumstances via the IFR route.
References
Haedersdal M, Togsverd-Bo K, Wulf HC. Evidence-based review of lasers, light sources and photodynamic
therapy in the treatment of acne vulgaris. J Eur Acad Dermatol Venereol. 2008a Mar;22(3):267-78. Epub 2008 Jan
23.
NICE IP ELT - Interventional procedures overview of intralesional photocoagulation of subcutaneous congenital
vascular disorders http://www.nice.org.uk/nicemedia/live/11065/30837/30837.pdf
Shakespeare Peter G., Hambleton Joan and Carruth John A. S. Skin surface temperatures during argon
and
tunable dye laser therapy of port wine stains Lasers in Medical Science. Volume 6, Number 1, 29 34, DOI:
10.1007/BF02042643
Rhinophyma
Policy
NHS NWL CCGs will not fund cosmetic correction of rhinophyma. Funding could be considered in individual patients
with exceptional circumstances through the IFR route.
Background
Rhinophyma is a descriptive term for a large, bulbous, ruddy appearance of the nose caused by hypertrophy of
the sebaceous glands and surrounding connective tissue. It is thought to be the end stage of chronic rosacea and
affects predominately men. There is no known medical treatment but multiple surgical techniques have been used to
improve the cosmetic appearance of the nose.
Modalities of surgical treatment include dermabrasion, freehand scalpel shave, cryosurgery, electrocautery, excision,
closure with local flaps and laser resection.
Evidence Base
The outcomes for the different surgical techniques used for treatment of rhinophyma generally report a good cosmetic
outcome. However complications like scarring and bleeding are also reported. The studies in this evidence have
small numbers and are followed up for only short periods. For this reason, the results should be used cautiously
because the studies are of low quality of evidence.
References
Lim SW, Lim SW, Bekhor P Rhinophyma: Carbon dioxide laser with computerized scanner is still an outstanding
treatment. Australasian Journal of Dermatology, November 2009, vol./is. 50/4(289-93), 0004-8380;1440-0960 (2009
Nov)
Madan V, Ferguson JE, August PJ Carbon dioxide laser treatment of rhinophyma: a review of 124 patients.
British Journal of Dermatology, October 2009, vol./is. 161/4(814-8), 0007-0963;1365-2133 2009 Oct)
Vural E, Royer MC, Kokoska MS Sculpting resection of rhinophyma using the Shaw scalpel. Archives of Facial
Plastic Surgery, July 2009, vol./is. 11/4(263-6), 1521- 2491;1538-3660 (2009 Jul-Aug)
Cravo M, Miguel Canelas M, Carlos Cardoso J, Vieira R, Figueiredo A Combined carbon dioxide laser
and
bipolar electrocoagulation: another option to treat rhinophyma. Journal of Dermatological Treatment, 2009, vol./is.
20/3(146-8), 0954-6634;1471-1753 (2009)
Taghizadeh R, Mackay SP, Gilbert PM Treatment of rhinophyma with the Versajet Hydrosurgery System. Journal
of Plastic, Reconstructive & Aesthetic Surgery: JPRAS, 2008, vol./is. 61/3(330-3), 1748-6815 (2008)
Karim Ali M, Streitmann MJ Excision of rhinophyma with the carbon dioxide laser: a ten-year experience. Annals of
Otology, Rhinology & Laryngology, November 1997, vol./is. 106/11(952-5), 0003-4894;0003 4894 (1997 Nov)
Gjuric M, Rettinger G. Comparison of carbon dioxide laser and electrosurgery in the treatment of rhinophyma.
Rhinology, March 1993, vol./is. 31/1(37-9), 0300-0729;0300-0729 (1993)
Benign Lesions
Policy
NHS NWL CCGs will fund the appropriate investigation and removal of any lesion or lump if the criteria in the PPwT
policy are met. Benign lesions that are requested to be removed for cosmetic reasons will only be considered via the
IFR route if there are exceptional clinical circumstances.
Surgery for the removal of Chalazia
Policy
NHS NWL CCGs will fund the appropriate removal of Chalazia if the criteria in the PPwT policy are met. (Please
refer to Chalazia policy). Surgery for the removal of Chalazia for cosmetic reasons will only be considered via the
Tattoo Removal
Policy
NHS NWL CCGs will not routinely fund laser tattoo removal unless in exceptional circumstances via the individual
funding request. The following situations might be considered exceptional:
The tattoo was applied under duress, or traumatic circumstances
Background
Before lasers became popular for tattoo removal starting in the late 1980s, removal involved the use of one or more of these
often painful, often scar-inducing surgeries such as dermabrasion, cryosurgery or excision. Although the procedures above are
still used in certain cases today, lasers have become the standard treatment for tattoo removal because they offer a bloodless,
low risk, effective alternative with minimal side effects. Each procedure is done on an outpatient basis in a single or series of
visits. Patients may or may not require topical or local anesthesia.
The type of laser used to remove a tattoo depends on the tattoo's pigment colours. (Yellow and
are the hardest colours to
remove; blue and black are the easiest.)The three lasers developed specifically for use in tattoo removal use a technique known
as Q- switching, which refers to the laser's short, high-energy pulses. The Q-switched Nd: YAG is the newest system in this
class of lasers and is particularly advanced in the removal of red, blue and black inks.
Evidence Base
There are no references to tattoo removal procedures from SIGN, Trip or Cochrane. Most dermatologic surgeons caution that
complete tattoo removal is not possible. Tattoos are meant to be permanent, so removing them is difficult. Few surgeons
guarantee complete removal. However, there are various methods of tattoo removal which have been shown to be effective.
References
Patient information leaflet
http://health.howstuffworks.com/skin-care/beauty/skin-and-lifestyle/tattoo-removal.htm
References
Beauchamp 2008 - Use of class 3b and class 4 lasers and intense pulsed light sources for cosmetic procedures
in
non-medical settings [2008-09] - ID:11878/11883- Report prepared by Sylvie Beauchamp, Alicia Framarin and
Jean- Marie R. Lance, Montreal: AETMIS, 2008 2008_04_res_en.pdf | English summary | 133,1 KB.
http://www.aetmis.gouv.qc.ca/site/download.php?f=735e2c6a01a8002f9b8da150e893e5b3&countonly=1
Http://www.crd.york.ac.uk/CRDWeb/ShowRecord.asp?ID=32008100095
Ealing ITPP - Individual Treatment Panel Policy 2008
HSW – http://health.howstuffworks.com/skin-care/beauty/skin-and-lifestyle/tattoo- removal3.htm
HSW2 - http://health.howstuffworks.com/skin-care/beauty/skin-and-lifestyle/tattoo- removal2.htm
NHS Plan - The NHS Plan: a plan for investment, a plan for reform.
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyA ndGuidance/DH_4002960
NHS NW London CCGs Planned Procedures with a Threshold Policy Version 3 (April 2013)
References Continued
NICE
Board
Appendix
September
2000
Board
Appendix
B
The
National
Plan.
http://www.nice.org.uk/aboutnice/whoweare/board/boardmeetings/2000/20thseptember2000/september_2000_
board_appendix_b_the_national_plan.jsp
NICE TW - Quality and productivity: NICE activities- Report of technical workshop held on
Sept 25, 1990
in London.
NICE TW2 - The Threshold and the Appraisal Committee- NICE Threshold Technical Workshop 20 April 2009.
NHS NW London CCGs Planned Procedures with a Threshold Policy Version 3 (April 2013)
Breast Augmentation
Policy
NHS NWL CCGs will not fund breast augmentation surgery for cosmetic purposes. Funding could be considered via the
IFR route in exceptional clinical circumstances.
This policy does not apply to post mastectomy or lumpectomy reconstruction, which is routinely funded.
Background
Breast augmentation, or augmentation mammoplasty, involves increasing the size or improving the shape of a
woman’s breasts (or breast) by inserting a breast implan
is the most commonly performed cosmetic procedure
performed on women in the UK. When this is done as a purely cosmetic procedure the aim is to reduce a woman’s
dissatisfaction with the size, shape or appearance of her breasts. Breast augmentation may also be deemed
medically necessary (rather than cosmetic) after a mastectomy or lumpectomy that results in significant deformity
i.e.: mastectomy or lumpectomy for treatment of or prophylaxis for, breast cancer and mastectomy or lumpectomy
performed for chronic severe fibrocystic breast disease, also known as cystic mastitis, unresponsive to medical
therapy. Procedures include mastopexy (breast lift), insertion of breast prostheses, the use of tissue expanders, or
reconstruction with transverse rectus abdominis myocutaneous flap, deep inferior epigastric perforator lap or
similar procedure and associated nipple and areolar reconstruction and tattooing o the nipple area.
Breast augmentation commonly has a high rate of patient satisfaction (rates of 90% and more have been reported in
the literature) with evidence of improvements in body-image and self- esteem. There is no evidence that healthrelated quality of life improves after breast augmentation
Some patients will benefit from counselling and psychological therapies
References
1. Aesthetic (Cosmetic) Surgery and other related procedures Evidence Based Framework for Decision Making.
2. Murphy, Beckstrand and Sarwer 2009 Annals of Plastic Surgery. A prospective, multi-centre study of
psychosocial outcomes after augmentation with natrelle silicone-filled breast implants
Benign skin lesions
Breast Lift (Mastopexy)
Policy
NHS NWL CCGs will not fund mastopexy. Funding could be considered via the IFR route in exceptional clinical
circumstances.
This policy does not apply to post mastectomy or lumpectomy reconstruction which is routinely funded.
Background
Breast ptosis is inevitable in most women due to a combination of maturity, gravity and pregnancy/lactation.
Mastopexy, or a breast lift, involves the relocation of the nipple and shaping the breast. Breast uplift surgery
involves removing skin from underneath the breast or from around the areola (the area of dark tissue
surrounding the nipple). The skin and tissue of the breast is tightened and the nipple is moved to a higher
position to give a more youthful and firm appearance. A breast enlargement or reduction procedure may be
done at the same time.
References
References:
1.
2.
3.
4.
5.
6.
7.
Lim SW, Lim SW, Bekhor P Rhinophyma: Carbon dioxide laser wi h computerized scanner is still an
outstanding treatment. Australasian Journal of Dermatology, November 2009, vol./is. 50/4(289-93),
0004-8380;1440-0960 (2009 Nov)
Madan V, Ferguson JE, August PJ Carbon dioxide laser treatment of rhinophyma: a review of 124
patients. British Journal of Dermatology, October 2009, vo is. 161/4(814-8), 0007-0963;1365-2133
2009 Oct)
Vural E, Royer MC, Kokoska MS Sculpting resection of rhinophyma using he Shaw scalpel. Archives of
Facial Plastic Surgery, July 2009, vo is. 11/4(263-6), 1521- 2491;1538-3660 (2009 Jul-Aug)
Cravo M, Miguel Canelas M, Carlos Cardoso J, Vieira R, Figueiredo A Combined carbon dioxide laser
and bipolar electrocoagulation: another option to treat rhinophyma. Journal of Dermatological Treatment,
2009, vo is. 20/3(146-8), 0954-6634;1471-1753 (2009)
Taghizadeh R, Mackay SP, Gilbert PM Treatment of rhinophyma with the Versajet Hydrosurgery
System. Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS, 2008, vol./is. 61/3(330-3),
1748-6815 (2008)
Karim Ali M, Streitmann MJ Excision of rhinophyma with the carbon dioxide laser: a ten-year experience.
Annals of Otology, Rhinology & Laryngology, November 1997, vol./is. 106/11(952-5), 0003-4894;0003
4894 (1997 Nov)
Gjuric M, Rettinger G. Comparison of carbon dioxide laser and electrosurgery in the treatment of
rhinophyma. Rhinology, March 1993, vol./is. 31/1(37-9) 0300-0729;0300-0729 (1993)
Breast Reduction
Policy
NHS NWL C C G s will not fund breast reduction for cosmetic purposes. Funding is available for functional
reasons if the criteria in the PPwT policy are met. Funding could be considered via the IFR route in exceptional
clinical circumstances.
Gynaecomastia (Enlarged Male Breasts)
Policy
NHS NWL CCGs will not routinely fund gynaecomastia surgery because it is considered as a cosmetic procedure.
Funding could be considered via the IFR route in exceptional clinical circumstances.
Background
Gynaecomastia is a benign condition of the male breast. In most cases a thorough history and physical examination,
along with laboratory investigations, should help to exclude breast malignancy and any serious underlying endocrine
or systemic disease, as well as to identify pseudogynaecomastia. Careful clinical observation may then be all that is
necessary, because gynaecomastia often resolves spontaneously, especially in the case of adolescence, with
regard to pubertal gynaecomastia.
There is a lack of consensus as to the non-surgical management of gynaecomastia. Because gynaecomastia is
usually caused by an imbalance of androgenic and estrogenic effects on the breast, medical therapy may include
anti- oestrogens, such as tamoxifen (unlicensed indication), androgens or aromatase inhibitors. However, although
idiopathic gynaecomastia is highly prevalent, there is no proven medical therapy for this condition and the quality of
the medical research for pharmaceutical agents is very poor.
Psychological support may be important in relation to reassurance, especially in view of the social pressure on
young men around body image and so-called “man boobs”.
Gynaecomastia may have an extrinsic cause in up to 39% of cases. Of the suspected idiopathic cases, some will
be found to have an important aetiology, such as testicular carcinoma. Selected endocrinological investigation is
therefore important to address such aetology.
There are at least 69 drugs that are known to be associated with gynaecomastia. Patients who are on medication
that may cause gynaecomastia may not always be able to have that medication stopped, for example: antiandrogens as a monotherapy for prostate cancer. Furthermore, withdrawal of the medication may not always be
associated with resolution of the gynaecomastia.
References
Al-Allak A, Govindarajulu S, Shere M et al. Gynaecomastia: A decade of experience. The Surgeon 2011; 9:255-258
Godwin Y Gynaecomastia: considerations and challenges in treating male patients with varying body
Habitus. Eur J Plast Surg 2012; 35:55–64
MacLean GM, Smith B, Umeh H. UK National survey of Gynaecomastia management. European Journal of Surgical
Oncology 2012;38(5)434,
Rahmani, MB.Turton P, Shaaban A, Dall B. Overview of Gynecomastia in the Modern Era and the Leeds
Gynaecomastia Investigation Algorithm. The Breast Journal, 2011; 17(3):246–255
Yazici M Sahin M. Bolu E Evaluation of breast enlargement in young males and factors associated with gynecomastia
and pseudogynecomastia. Ir J Med Sci 2010; 179:575–583
El Gawad, A., Pritchard-Jones, R. The diagnosis and management of gynaecomastia. NHS Evidence - surgery
anaesthesia, perioperative and critical care, NHS Evidence [published June 2009]
Correction of Inverted Nipple
Policy
Surgical correction of nipple inversion will not be funded it is considered as a cosmetic procedure. Funding could
be considered via the IFR route in exceptional clinical circumstances.
Background
The term inverted nipple refers to a nipple that is tucked into the breast instead of sticking out or being flat. It
can be unilateral or bilateral. It may cause functional and psychological disturbance. Nipple inversion may occur
as a result of an underlying breast malignancy and it is essential that this be excluded.
Breast Prosthesis Removal and Replacement
Policy
NHS NWL CCGs will fund breast prosthesis removal and replacement if the criteria in the PPwT policy are met.
Requests that do not meet the policy will only be considered via the IFR route if there are exceptional clinical
circumstances.
Revision Mammoplasty
Policy
NHS NWL CCGs will not fund revision mammoplasty as it is considered a cosmetic procedure. Requests will only be
considered via the IFR route if there are exceptional clinical circumstances.
Related policy: Breast Prosthesis Removal and Replacement
Background
The term mammoplasty refers to breast reduction or augmentation procedures. Revision mammoplasty may be
indicated if desired results are not achieved or as a result of problems with implants.
Face Lift and Brow Lift
Policy
NHS NWL CCGs will not fund face or brow lift for cosmetic reasons. Requests for cosmetic reasons will only be
Blepharoplasty
Policy
NHS NWL CCGs will not fund blepharoplasty for cosmetic reasons. Requests for cosmetic reasons will only be
Rhinoplasty
Policy
NHS NWL CCGs will not fund rhinoplasty procedures for cosmetic reasons. Requests will only be considered via the
This policy excludes manipulation of fractured nasal bones following trauma.
References
Litner J.A., Rotenberg B.W., Dennis M., Adamson P.A., Impact of cosmetic facial surgery on satisfaction with
appearance and quality of life, Archives of Facial Plastic Surgery,March 2008, vol./is. 10/2(79-83), 15212491;1538-3660 (March/April 2008)
R J Honigman, K A Philips, D J Castle , Review of Psychosocial outcomes for Patients seeking cosmetic surgery,
Centre for Reviews and Dissemination, 2009
Kosowski T.R., McCarthy C., Reavey P.L., Scott A.M., Wilkins E.G., Cano S.J., Klassen A.F., Carr N., Cordeiro
P.G., Pusic A.L. A systematic review of patient-reported outcome measures after facial cosmetic surgery and/or
nonsurgical facial rejuvenation Citation: Plastic and Reconstructive Surgery, June 2009, vol./is. 123/6(18191827), 0032-1052 (June 2009)
Pearson A, Wiechula R, Jordan Z and Henstridge V, Policy Related to rhinoplasty in publicly funded elective
surgery programs: a systematic review, International Journal of Evidence-Based Healthcare , June 2009
Pinnaplasty
Policy
NHS NWL CCGs will fund pinnaplasty only in exceptional circumstances through the individual funding request
(IFR) route for children less than 19 years with prominent ears where the child, rather than parents alone, expresses
concern.
Background
Background
Otoplasty (pinnaplasty) is a procedure designed to realign the normal anatomical features of the ear (pinna) into a
more aesthetically pleasing form for people with prominent ears. There are different techniques available to effect this
change.
Evidence Base
The evidence shows that different surgical techniques employed in pinnaplasty produce positive outcomes1,
Pinnaplasty (otoplasty) is an effective procedure in alleviating psychosocial distress in the vast majority of children
that undergo the operation on the NHS for children with prominent ears 1,
The NHS Modernization Agency instituted an ‘Action on Plastic Surgery’, guide which justifies the use of surgery for
pinnaplasty because “prominent ears may lead to significant psychosocial dysfunction for children and adolescents and
impact on the education of young children as a result of teasing and truancy”.
References
Olivier B, Mohammad H, Christian A, Akram R Retrospective study of the long-term results of otoplasty using a modified
Mustarde (cartilage-sparing) technique., Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhinolaryngologie et de chirurgie cervico-faciale, June 2009, vol./is. 38/3(340-7), 1916-0216 (2009 Jun)
Leclere FM, Petropoulos I, Mordon S, Laser-assisted cartilage reshaping (LACR) for treating
protrusions: a clinical
study in 24 patients, Aesthetic Plastic Surgery, April 2010, vol./is. 34/2(141-6), 0364-216X;1432-5241 (2010 Apr)
Cooper-Hobson G, Jaffe W , Otoplasty using a modified anterior scoring technique: standardized measurements of longterm results, Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS, February 2009, vol./is. 62/2(190-4), 18780539 (2009 Feb)
Gasques JA, Pereira de Godoy JM, Cruz EM , Psychosocial effects of otoplasty in children with prominent ears,
Aesthetic Plastic Surgery, November 2008, vol./is. 32/6(910-4), 0364-216X;1432-5241 (2008 Nov)
External ear lobe repairs
Policy
NHS NWL CCGs will not fund procedures to correct external ear lobe deformities for cosmetic reasons. Requests will
only be considered via the IFR route if there are exceptional clinical circumstances.
Background
NHS NWL CCGs will not fund procedures to correct external ear lobe deformities for cosmetic reasons. Requests will
only be considered via the IFR route if there are exceptional clinical circumstances.
Torn earlobes, or cleft ear lobes, may be classified as either a complete or partial cleft. Acquired clefts or splitting
of the earlobes commonly occur from prolonged traction of heavy earrings. In rare cases, it can also occur from
pressure necrosis from the clip-on earring, as well as from intentional and unintentional trauma. These clefts are most
commonly incomplete; however, complete clefts are also common. Bleeding is minimal, and the defect edges heal with
little scar formation except when keloids occur.
References
Reiter D, Alford EL. Torn earlobe: a new approach to management with a review of 68 cases. Ann Otol Rhinol
Laryngol. 1994 Nov;103(11):879-84.
Fearon J, Cuadros CL. Cleft earlobe repair. Annals of Plastic Surgery, Mar 1990, vol./is. 24/3(252-7), 01487043;0148-7043 (1990 Mar)
Vujevich Goldberg LH,Obagi S. Repair of partial and complete earlobe clefts: a review of 21 methods. Journal of
Drugs in Dermatology: JDD, Jul 2007, vol./is. 6/7(695-9), 1545-9616;1545-9616 (2007 Jul)
Liposuction
Policy
NHS NWL CCGs will not fund liposuction surgery for cosmetic reasons. Requests will only be considered via the
Related policy: Inpatient & surgical treatments for Lymphoedema and Lipoedema policy.
Background
Liposuction also known as liposculpture or suction-assisted lipectomy is a treatment to remove body fat. It is carried
out for aesthetic reasons on areas of the body where deposits of fat tend to collect, such as the buttocks, hips, thighs
and abdomen. Other popular areas for liposuction are under the chin, neck, upper arms, breasts, knees, calves or
ankles.
Body Contouring including Thigh Lift, Buttock Lift
and Arm Lift, Excision of Redundant Skin or Fat
Policy
NHS NWL CCGs will not fund body contouring procedures for cosmetic reasons. Requests will only be considered
via the IFR route if there are exceptional clinical circumstances.
Related policy: Abdominoplasty policy
Belt Lipectomy
Policy
NHS NWL CCGs will not fund Belt Lipectomy. Funding may be considered for funding in exceptional
circumstances via the IFR route.
Abdominoplasty / Apronectomy
Polic
y
NHS NWL C C G s will not fund abdominoplasty or belt lipectomy for cosmetic purposes. Funding is available for
abdominoplasty procedures where there are functional problems present. Please refer to the abdominoplasty PPwT
policy. Funding could be considered via the IFR route in exceptional clinical circumstances where thresholds are not
met.
Hair Grafting
Policy
NHS NWL CCGs will not fund hair grafting. Requests will only be considered via the IFR route if there are
exceptional clinical circumstances.
Hair Depilation for Hirsutism
Polic
y
NHS NWL C C G s will not fund hair depilation for hirsutism for cosmetic purposes. Please refer to the PPWT policy
for funding thresholds. Where thresholds are not met, funding could be considered via the IFR route in exceptional
Labiaplasty
Policy
NHS NWL C C G s will not fund labiaplasty procedures. Requests will only be considered via the IFR route if there are
exceptional clinical circumstances.
This policy does not relate to reversal of female genital mutilation which is routinely funded
References
Bramwell R, Morland C, Garden AS Expectations and experience of labial reduction: a qualitative study.
BJOG An International Journal of Obstetrics and Gynaecology 2007;114:1493-1499.
Lloyd J, Crouch NS, Minto CL, Creighton SM Female genital appearance: ‘normality’ ‘unfolds’ BJOG An
International Journal of Obstetrics and Gynaecology 2005;112:643-646
Liao LM, Michala L, Creighton SM Labial surgery for well women: a review of the literature. BJOG An
international Journal of Obstetrics and Gynaecology 2010;117: 20-25
Liao LM, Michala L, Creighton SM. Requests for cosmetic genitoplasty: how should healthcare providers
respond? BMJ 2007; 334: 1090
Goodman MP, Placik OJ, Benson RH et al, A large multicentre outcome study of female genital plastic
surgery. Journal of Sexual Medicine 2010;7:1565-77
Solanki NS, Tejero-Trujeque R, Stevens-King A, Malata CM Aesthetic and Functional reduction of the labia
minora using the Maas AND Hage technique. Journal of Plastic Reconstructive and Aesthetic Surgery
2010;63: 1181-1185
Varicose Veins
Policy
NHS NWL C C G s will not fund varicose vein procedures for cosmetic purposes. Funding is
available for varicose vein procedures where there are functional problems present via the PPWT route.
If the thresholds are not met funding will only be considered via the IFR route if there are exceptional
Plastic operations on the umbilicus
Policy
NHS NWL C C G s will not fund plastic operations on the umbilicus. Requests will only be considered via the
Male Circumcision
Policy
This policy does not apply to
Suspected penile malignancy. Use the 2 week cancer referral pathway (do not fill in a PPwT form)
Traumatic foreskin injury where it cannot be salvaged.
Circumcision may only be funded for medical reasons
Balanitis xerotica obliterans
Recurrent balanitis or balanoposthitis
Adult phimosis or phimosis in children with spraying, ballooning and/or recurrent infec ion
Paraphimosis
Dermatological disorders unresponsive to treatment, such as lichen planus or eczema
Painful intercourse
Recurrent febrile UTI’s with an abnormal urinary tract.
Applications for other indications must proceed through the IFR route.
Background
Male circumcision is defined as the surgical removal of all or part of the foreskin of the penis. may be done for
medical reasons, but is often done for cultural or religious reasons. Male circumcision is generally assumed to be
lawful provided that: “it is performed competently; it is believed to be in the child’s best interests; and there is valid
consent.” [BMA, 2006] The General Medical Council advises that doctors must "have the necessary skills and
experience both to perform the operation and use appropriate measures, including anaesthesia, to minimise pain
and discomfort
Although circumcision for non-medical reasons is generally not thought to be of benefit, there is strong evidence that
male circumcision reduces the acquisition of HIV by heterosexual men, in areas of high HIV prevalence. [Siegfried
et al, 2009
When performing a circumcision, adequate pain relief should be given. [Brady-Fryer et al, 2004] Common risks of
surgical circumcision include bleeding (1.5%), local sepsis (8.5%), oozing (36%), discomfort > 7 days (26%), mental
scabbing or stenosis, removal of too much or too little skin, urethral injury, amputation of the glans and inclusion
cyst. [BAPS, 2007]. Furthermore, long-term psychological trauma and decreased sexual pleasure have also been
reported
References
Patient information
http://www.nhs.uk/conditions/Circumcision/Pages/Introduction.aspx
References
Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database of Systematic
Reviews 2004, Issue 3. Art. No.: CD004217. DOI:10.1002/14651858.CD004217.pub2.
British Medical Association. The law and ethics of male circumcision: guidance for doc ors. London: BMA,
2006
Siegfried N, Muller M, Deeks JJ, Volmink J. Male circumcision for prevention o heterosexual acquisition of
HIV in men. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No.: CD003362. DOI:
10 1002/14651858.CD003362.pub2.
Statement from the British Association of Paediatric Urologists on behalf of the British Association of
Paediatric Surgeons and The Association of Paediatric Anaesthetists 2007. Management of Foreskin
Conditions. Date accessed: 21 10 10. http://www.baps.org.uk documents Circumcision_2007
Statement from the British Association of Paediatric Surgeons, The Royal College of Nursing, The Royal
College of Paediatrics and Child Health, The Royal College of Surgeons of England and The Royal College
of Anaesthetists. “Statement on Male Circumcision”. 2001
Complementary and Alternative Therapies
Policy
NHS NWL CCGs will fund the following complimentary / alternative therapies in exceptional circumstances
only via the IFR route because of some evidence of clinical benefit in selected conditions:
Acupuncture
For non-surgical management of joint pain as part of pathway which may lead to joint replacement.
In non-acute lumbar pain not warranting surgical referral.
In chronic pain conditions (and only when therapy is accompanied by continued symptomatic
improvement i.e. not maintenance)
In selected patients with migraine headache
In selected cases of nausea of pregnancy
In some cases with postoperative and chemotherapy-induced nausea and vomiting; or
In selected cases of postoperative dental pain; or
Temporomandibular disorders (TMD)
Sub-acute and chronic low back pain of more than six weeks duration
Osteopathy
Children with spastic cerebral palsy
In the treatment of paediatric dysfunctional voiding
Adults with Lumber or Cervical pain not warranting surgical referral being treated as part
of an integrated MSK Package.
Some adults with large joint pain as part of a care pathway that may lead to joint replacement.
Biofeedback, for:
Chronic constipation (biofeedback is the primary treatment option for patients with dyssynergic
defecation)
Irritable bowel syndrome
Levator ani syndrome.
Migraine and tension headaches (muscle, thermal or skin biofeedback);
Neuromuscular rehabilitation of stroke and traumatic brain injury (TBI) (policy does not cover
neuromuscular electrical stimulators)
Raynaud's disease
Refractory severe subjective tinnitus
Temporomandibular joint (TMJ) syndrome
Urinary incontinence
Electrical stimulation
As an adjunct or as an alternative to the use of drugs either in the treatment of acute postoperative pain in the first 30 days after surgery, or for certain types of chronic, intractable
pain not adequately responsive to other methods of treatment including, as appropriate, physical
therapy and pharmacotherapy.
A physician evaluated trial lasting between 1 and 2 months should determine if treatment is to
continue.
Selected use in palliative care
Mistletoe in cervical cancer
Meditation and Tai Chi in selected elderly patients with optimally treated heart failure – evidence
of reduction in sympathetic activity (SIGN 95)
Hypnotherapy
Severe chronic insomnia
IBS
Manipulation and Stretching
Selected cases of osteoarthritis of the hip as an adjunct to core treatment
Sub-acute and chronic low back pain of more than six weeks duration
Acute low back pain of less than six weeks
Mobilisation of the neck
Policy Continued
NHS NWL CCGs will NOT routinely fund the following therapies because of lack of sufficient evidence
of effectiveness:*
Homeopathy
Aromatherapy
Herbal remedies
Clinical ecology
Active release technique
Acupressure
Alexander technique
AMMA therapy
Antineoplastons -- see CPB 240 - Antineoplaston Therapy and Sodium
Phenylbutyrate
Antineoplastons -- see CPB 240 - Antineoplaston Therapy and Sodium Phenylbutyrate
Apitherapy
Applied kinesiology
Art therapy
Autogenous lymphocytic factor
Auto urine therapy
Bioenergetic therapy
Biofield Cancell (Entelev) cancer therapy
Bioidentical hormones
Brain integration therapy
Carbon dioxide therapy
Cellular therapy
Chelation therapy for Atherosclerosis -- see CPB 234 - Chelation Therapy
Chiropractic services
Chung Moo Doe therapy
Coley's toxin
Colonic irrigation
Clinical ecology
Active release technique
Acupressure
Alexander technique
AMMA therapy
Conceptual mind-body techniques
Craniosacral therapy
Cupping
Dance/Movement therapy
Digital myography
Ear Candling
Egoscue method
Electrodiagnosis according to Voll (EAV)
Equestrian therapy -- see CPB 151 - Hippotherapy
Essential Metabolics Analysis (EMA)
Essiac
Feldenkrais method of exercise therapy (also known as awareness through movement)
Flower essence
Fresh cell therapy
Functional intracellular analysis (also known as essential metabolic analysis, intracellular
micronutrient analysis, leukocyte nutrient analysis, as well as micronutrient testing).
Gemstone therapy
Gerson therapy
Glyconutrients
Graston technique
Greek cancer cure
Guided imagery
Hair analysis - see CPB 300 - Hair Analysis
Hako-Med machine (electromedical horizontal therapy)
Hellerwork
Policy Continued
Hoxsey method
Human placental tissue
Hydrolysate injections
Humor therapy
Hydrazine sulfate
Hypnosis
Hyperoxygen therapy
Immunoaugmentive therapy
Infratronic Qi-Gong machine
Insulin potentiation therapy
Inversion therapy
Iridology
Iscador
Juvent platform for dynamic motion therapy
Kelley/Gonzales therapy
Laetrile
Live blood cell analysis
Macrobiotic diet
Magnet therapy
MEDEK therapy
Meditation/transcendental meditation
Megavitamin therapy (also known as orthomolecular medicine)
Meridian therapy
Mesotherapy
Moxibustion (except for fetal breech presentation) - see CPB 135 - Acupuncture
MTH-68 vaccine
Music therapy
Myotherapy
Neural therapy
Ozone therapy
Pfrimmer deep muscle therapy
Polarity therapy
(Poon's) Chinese blood cleaning
Primal therapy
Psychodrama
Purging
Qigong longevity exercises
Ream's testing
Reflexology (zone therapy)
Reflex Therapy
Reiki
Remedial massage
Revici's guided chemotherapy
Rife therapy/Rife machine
Rolfing (structural integration)
Rubenfeld synergy method (RSM)
714-X (for cancer)
Sarapin injections
Shark cartilage products
Telomere testing
Therapeutic Eurythmy-movement therapy
Therapeutic touch
Thought field therapy (TFT) (Callahan Techniques Training)
BackgroundTrager approach
Visceral manipulation therapy
Whitcomb technique
Wurn technique/clear passage therapy
ƒ
Yoga
*Adapted from the AETNA Complementary and Alternative Medicine Policy
Background
Complimentary therapies are seen by an increasing number of people (with increasing requests for
treatment) as a more holistic and ‘natural’ approach to dealing with a variety of complaints. Attractions
include the comparably longer interaction time with the practitioner and the belief that such therapies will
work, affecting a complex mix of factors impacting on health. However there is much uncertainty about
benefit/effectiveness, evidence of complications for some therapies and considerable grounds to
suspect other adverse effects may occur. Since conventional medicine also aspires to a holistic
approach, this means that some alternative therapies should be considered where evidence exists.
The types of complimentary therapies covered under this policy include Homoeopathy, Acupuncture,
Osteopathy, Biofeedback, Hypnotherapy, Chiropractic Therapy, Massage, Reflexology, Clinical Ecology,
Aromatherapy, Herbal Remedies, Chinese medicines, Psychotherapy and Meditation. This list is not
exhaustive and other treatments not listed here but that are considered ‘alternative’ or ‘complimentary’
therapies will be considered in the same way.
Some procedures may be available through services in hospices and hospitals as part of a palliative
care package; these are usually through charitable services and not part of commissioned services.
Some patients may also be treated as part of an integrated conventional and complimentary service for
a specific condition where these are commissioned, although exceptionality would need to be
demonstrated.
Evidence Base
The House of Commons Science and Technology Committee enquiry into the provision of homeopathic
services within the NHS in 2009 recommended that homeopathic treatments should not be routinely
available within the NHS.1 The committee report included a robust review of the evidence base for a
variety of homeopathic treatments but found no evidence of effectiveness for any condition from
published RCTs and systematic reviews. A previous report commissioned by the Association of
Directors of Public Health in 20072 and more recent reviews by AETNA3 are all consistent in confirming
the lack of sufficient evidence of effectiveness of homeopathic treatments despite many years of
research and hundreds of studies.
There is some evidence of clinical benefit for some complimentary therapies such as acupuncture,
osteopathy, biofeedback and hypnotherapy for certain conditions. For example, NICE recommends
Acupuncture for up to ten sessions for the treatment of sub-acute and chronic low back pain of more than
six weeks duration. NICE also suggests that manipulation and stretching should be considered as an
adjunct to core treatment for osteoarthritis of the hip, sub-acute and chronic low back pain of more than
six weeks duration, acute low back pain of less than six weeks duration and mobilisation of the neck.4,5,6,7
This has been summarised in a matrix in the appendix. A table of complementary therapies categorised
according to areas where some evidence of benefit exist (adapted from the AETNA Complementary and
Alternative Medicine Policy) is also included in the appendix.
Acupuncture, osteopathy and chiropractic may already be routinely provided within the NHS in North
West London as part of an integrated pathway within musculoskeletal or chronic pain services as an
adjunct to other treatments.
Gut directed Biofeedback is routinely commissioned as a specialist service.
References
Link to Patient information
http://www.nhs.uk/Search/Pages/Results.aspx?q=alternative+therapy
References
1.
2.
3.
4.
5.
Evidence Check 2: Homeopathy. House of Commons Science and Technology Committee Report.
2009-10. http://www.publications.parliament.uk/pa/cm200910/cmselect/cmsctech/45/45.pdf
Association of Public Health Report on the evidence for homeopathy (unpublished commissioned
Report on the evidence for Homeopathy)
AETNA Clinical Policy Bulletin 0388. Complimentary and Alternative Medicine. Last review date
05/04/2010. http://www.aetna.com/cpb/medical/data/300_399/0388.html
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE (2009), Clinical Guideline 88,
Early management of persistent non-specific low back pain, Shekelle et al , (1992), Spinal
Manipulation for Low Back Pain, Annals of internal Medicine, 117 (7), pp 590-598
Waddell G et al, (1999) Low Back Pain Evidence Review, London: Royal College of General
Practitioners
Dilatation and Curettage (D&C)
This should be read along with “Hysterectomy for Menorrhagia” & Hysteroscopy policy
Policy
Recommendations
The use of D & C in the non pregnant uterus will not be routinely funded.
D&C will not be specifically funded for the following indications.
Investigation and/or treatment of menorrhagia (HMB) – NICE CG no 44
Investigation of dysfunctional uterine bleeding (DUB) or post-menopausal bleeding (PMB)
Treatment of irregular periods
Treatment of endometrial hyperplasia
Removing unwanted tissue, endometrial polyps or benign tumours from the womb
Hysteroscopy and biopsy when indicated are now the procedures of choice. (Please see Hysteroscopy
policy)
ERPC and evacuation of molar pregnancies are routinely funded and not covered by this Policy.
Funding for any other indication that does not meet the PPwT criteria should be applied for via the IFR
route
Background
Dilatation and curettage (D&C) is a procedure performed under general anaesthetic in which the lining of the
uterus (the endometrium) is blindly biopsied (diagnostic) or removed (therapeutic) by scraping with a sharp metal
instrument (curette) in a systematic ashion.
Diagnos s
Historically, D&C was the traditional diagnostic technique for obtaining endometrial samples for pathological
examination (detecting his ological abnormalities), e.g.in investigation of
menorrhagia/heavy
menstrual
bleeding (HMB), dysfunctional uterine bleeding1 (DUB), or postmenopausal bleeding (PMB). However, as the
technique is ‘blind’, the operator cannot assess whe her lesions have been missed. In several small case series,
where patients had a D&C immediately prior to hysterectomy for PMB, endometrial lesions were overlooked in up to
10% of the instances in which D&C was the only procedure used 1. One study evaluating he completeness of
endometrial sampling by D&C showed that in 60% of patients less than half he cavity was curetted 1.
Ultrasound is the recommended first-line investigation to detect s ruc ural abnormalities in investigation of HMB or
PMB 2 . Hysteroscopy (allows direct visualisation of the uterine cavity) should be used as a diagnostic tool only
when ultrasound results are inconclusive 2. Neither saline infusion sonography nor MRI should be used as a firs line diagnostic tool 2. To detect histological abnormalities in HMB (i.e. to exclude endometrial cancer or atypical
endometrial hyperplasia), endometrial sampling or hysteroscopy with directed biopsy (curettage) have superseded
D&C for obtaining endometrial tissue. Indications for an endometrial biopsy/sampling in investigation of HMB
include persistent inter-menstrual bleeding, and in women aged ≥45 years - treatment failure or ineffective
treatment 2. D&C is no longer recommended as a diagnostic tool for HMB 2.
Treatment
D&C has also been used historically for treatment purposes, e.g. where first line (medical) therapy has
been ineffective in management of menorrhagia/ heavy menstrual bleeding (HMB), irregular periods or
endometrial hyperplasia; or for evacuation of retained products of conception, removal of molar pregnancy
(gestational trophoblastic disease), removal of unwanted tissue, endometrial polyps or benign umours from the
womb
Limited evidence is available on the use of therapeutic D&C for HMB, but the one study that was identified
showed that any effect was temporary 2. Given the limited evidence, the NICE recommendation – that
D&C should not be used as a therapeutic reatment for HMB – was based on clinical experience 2. While
medical treatment op ions remain first-line, surgical treatment options for HMB and DUB include
endometrial ablation methods that preserve the uterus but ‘ablate’ (remove) the lining (these have
superseded D&C); and hysterectomy (the definitive treatment, which results in high satisfaction rates but with
potential surgical morbidity) 2-4. The f i r s t g e n e r a t i o n gold standard hysteroscopic ablative techniques include
laser, transcervical resection of he endometrium and rollerball 5. Where dilatation is required for nonnd
hysteroscopic (‘blind’) (2 generation) ablative procedures, NICE recommend that hysteroscopy should be
used immediately prior to the procedure to ensure correct placement of the device 2.
Evacuation of retained products of conception (ERPC) after incomplete miscarriage or delivery has been
recommended treatment in order to reduce potential complications like blood loss and infection 6. Surgical
evacuation has been considered the most effective method of ensuring complete evacuation, by D&C (sharp
me al curettage) historically, or by vacuum aspiration/suction curettage. A 2001 Cochrane review of trials 7
found that vacuum aspiration/suction curettage was safe, quick and easy to perform, and less painful than
D&C, and in most developed countries vacuum aspiration has replaced D&C for surgical evacuation of the
uterus in management o incomplete miscarriage5 . A 2006 Cochrane review6 , and the large randomized
controlled MIST trial8 also suggest however, that non-surgical treatments including expectant (watchful
waiting) and medical management are reasonable alternatives to routine surgical uterine evacuation
depending on the clinical situation and the pa ient s desires9.
Gestational trophoblastic disease encompasses a range of pregnancy-related disorders, consisting of the
premalignant disorders of complete and partial hydatidiform mole, and the malignant disorders of invasive
mole, choriocarcinoma, and the rare placental-site trophoblastic tumour10 . Suction/vacuum curettage (rather
than sharp metal curettage/D&C) is the preferred method of evacuation irrespective of uterine size in patien s
with suspected hydatidiform mole who want to preserve fertility. In raoperative ultrasonography can reduce
the risk of uterine perforation1 0 . Hysterectomy is rarely recommended but might be considered for women
who do not want further children or have life-threatening haemorrhage10. Hysteroscopy and biopsy (curettage)
is the preferred technique to detect polyps and other benign lesions, and allows targeted removal.
References
Patient nformation
D&C: http://www.nhs uk/conditions/dilatation-and-curettage-(dc) Pages ntroduction.aspx (NHS Choices)
Menorrhagia:
http://www.nhs.uk/conditions/periods-heavy (NHS Choices)
References
1. Investigation of Post-Menopausal Bleeding. SIGN Publication No 61; 2002
2. National Institute for Health and Clinical Excellence. Heavy menstrual bleeding. Clinical guideline 44. 2007.
References (continued)
3.
4.
5.
6.
7.
8.
9.
10.
Apgar BS, Kaufman AH, George-Nwogu U, Kittendorf A. Treatment of menorrhagia. Am Fam
Physician. 2007 Jun 15;75(12):1813-9.
Duckitt K, Collins S. Menorrhagia. Clin Evid (Online). 2008; 2008.
Lethaby A, Hickey M, Garry R, Penninx J. Endometrial resection / ablation techniques for heavy
menstrual bleeding. Cochrane Database Syst Rev. 2009(4):CD001501
Nanda K, Peloggia A, Grimes D, Lopez L, Nanda G. Expectant care versus surgical treatment for
miscarriage. Cochrane Database Syst Rev. 2006(2):CD003518.
Forna F, Gulmezoglu AM. Surgical procedures to evacuate incomplete abortion. Cochrane
Database Syst Rev. 2001(1):CD001993.
Trinder J, Brocklehurst P, Porter R, Read M, Vyas S, Smith L. Managemen of miscarriage:
expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST)
trial). BMJ. 2006 May 27;332(7552):1235-40.
Chen BA, Creinin MD. Contemporary management of early pregnancy failure. Clin Obstet
Gynecol. 2007 Mar;50(1):67-88.
Seckl MJ, Sebire NJ, Berkowitz RS. Gestational trophoblastic disease. Lancet. 2010 Jul 28.
Dupuytren’s Disease/Contracture
Policy
NHS NWL CCGs will fund surgery for patients with
o
Flexion deformity >30 at the MCPJoint or PIPJoint.
OR
Rapidly progressive disease
OR
Contracture interferes with lifestyle and/or occupation
Requests that do not fulfil the above criteria or requests for clostridial collagenase injections will be considered via
the IFR route only
Background
Dupuytren’s Disease (DD) is characterised by skin changes in the palms of the hand (the development of pits,
nodules and cords) due to thickening of the palmar fascia (tissue plane under the skin of the palm). This may
progress to cause fixed flexion of the fingers.
DD can be classified into:
Mild (no functional impairment, contractures < 30oat metacarpophalangeal joints (MCPJ, knuckles)
o
Moderate (notable functional impairment and 30-60o fixed flexion at the MCPJ and <30 at the proximal
interphalangeal joint (PIPJ, small finger joint)
Severe (fixed flexion > 60o at the MCPJ and >30o at the PIPJ) (from British Society of Surgery of the Hand (BSSH)
http://www.bssh.ac.uk/education/referralguidelines/dupuytrens_disease.pdf
Treatment
Spontaneous resolution does not occur. Patients may be managed with observation if the contractures
themselves are not functionally limiting. Nodules, in general, do not require treatment (BSSH).
Conservative and “Non-operative” Treatment
Direct injection of clostridial collagenase into nodules and cords has been shown to cause lysis and rupture of
digital cords, releasing contractures (Badalamente 2000) Percutaneous needle fasciotomy (PNF) is used to relieve
contracture in the elderly or frail or as a temporising measure. PNF may be performed on an outpatient basis by an
appropriately trained specialist. In 2004, the NICE published guidance stating that percutaneous fasciotomy was
safe and effective (www.nice.org.uk/ip177overview). However, this technique does carry the risk of adverse events
and recurrence.
Operative/Surgical Treatment
Surgery remains the mainstay of treatment. Techniques include: limited fasciectomy (most widely used); radical
fasciectomy (fallen out of favour); dermofasciectomy (use of skin grafts which may reduce disease recurrence but
not its extension); amputation (in severe cases) and joint fusion. A recent retrospective audit undertaken by the
BSSH (British Society for Surgery of the Hand) (Dias and Braybrook 2006) indicated that surgery for Dupuytren’s
disease is successful in achieving full or almost full correction in 75% of cases. Complication rates, including early
recurrence were high at 46%.
There is limited evidence on safety and efficacy for radiation therapy for the treatment of early DD, however a review
of
the
evidence
does
not
raise
serious
concerns.
The
2010
NICE
guidance
(http://www.nice.org.uk/nicemedia/live/12353/51717/51717.pdf) suggested that radiation therapy can be used if
special arrangements for clinical governance, consent and audit or research are made.
Indications for Surgery
Indications for surgery depend on the patient’s requirement for hand function, the patient’s age, the severity of the
contracture, and the joint or joints involved.
BSSH recommendations for surgery
(http://www.bssh.ac.uk/education/referralguidelines/dupuytrens_disease.pdf) are contractures > 30o at the MCPJ
and any contracture at the PIPJ.
Medscape,(http://emedicine.medscape.com/article/1285422-overview) (American focussed guidelines) states:
metacarpophalangeal (MCPJ) flexion contracture of 30° or more is an accepted criterion for surgical correction
(Hueston 1982 Schneider 1991). They also agree PIP flexion contracture of any degree constitutes an indication
for operation due to higher risk of persisting deformity (Smith 1991, Andrew 1991).
References
Patient Information Leaflet:
http://www.nhs.uk/conditions/Dupuytrens-contracture/Pages/Introduction.aspx
http://www.dupuytren-online.info/index.html
http://www.patient.co.uk/health/Dupuytren's-Contracture.htm
References:
1.
2.
3.
4.
5.
6.
7.
8.
The majority of the information and references were taken from the BSSH guidelines on Dupuytren’s
Disease: http://www.bssh.ac.uk/education/referralguidelines/dupuytrens_disease.pdf
Dupuytrens Contracture. In; Medscape emedicine: http://emedicine.medscape.com/article/1285422overview
Dias JJ, Braybrooke J. Dupuytren's contracture: an audit of the outcomes of surgery.J Hand Surg [Br]. 2006
Oct;31(5):514-21. Epub 2006 Jul 11.
Badalamente MA, Hurst LC. Enzyme injection as nonsurgical treatment of Dupuytren's disease. J Hand Surg
[Am] 2000: 25;629-636.Surgery[Am].Volume 33, Issue 7, September 2008,1208-1210. BEST 1
Hueston JT .The table top test. The Hand. 1982, 14; 100-103
Schneider LH. The open palm technique. Hand Clin. Nov 1991;7(4):723-8; discussion 729.
Smith AC. Diagnosis and indications for surgical treatment. Hand Clin. Nov 1991;7(4):635-42; discussion
643.
Andrew JG. Contracture of the proximal interphalangeal joint in Dupuytren's disease. J Hand Surg Br. Nov
1991;16(4):446-8.
Reversal of Female Sterilisation
Policy
Reversal of female sterilisation will only be funded under exceptional individual circumstances such as:
Death of only child (biological or adopted) from current relationship or any previous relationship
Background
Female sterilisation is considered a permanent form of contraception. The operation involves cutting, sealing,
or blocking, the fallopian tubes. This prevents the eggs from reaching the uterus (womb) where they could
become fertilised, resulting in pregnancy. Female sterilisation can be reversed, but it is a very difficult process
that involves removing the blocked part of the fallopian tube and re-joining the ends. There is no guarantee
that the patient would become fertile again. The success rates of female sterilisation reversal depend on
factors such as age, and the method that was used in the original operation. For example, if the tubes were
clipped, rather than tied, a successful reversal is more likely. The current success rate of sterilisation reversal
is between 50-60% 1. It is not normally available on the NHS.
The reversal of sterilisation is a surgical procedure that involves the reconstruction of the fallopian tubes.
The sterilisation procedure is available on NHS and couples seeking sterilisation should be fully advised and
counselled (in accordance with RCOG guidelines) that the procedure is intended to be permanent.
References
Patient Information Leaflet
http://www.nhs.uk/chq/Pages/1996.aspx?CategoryID=117&SubCategoryID=116
1.
2.
3.
Royal College of Obstetricians and Gynaecologists. Guideline summary - Male and Female
Sterilisation, RCOG 1998.
Prabha S; Burnett LC;Hill R. Reversal of sterilisation at Glasgow Royal Infirmary. Journal of Family
Planning and Reproductive Health Care 2002; 29: 32–33
National Public Health Service. Health Policy Advice – 3. Reversal of sterilisation & reversal of
vasectomy. NPHS 2004. Available at:
Functional Electrical Stimulation
Policy
NHS NWL C C G will fund functional electrical stimulation (FES) for drop foot of central neurological origin only.
Patients should have been assessed by a multidisciplinary team specialising in rehabilitation prior to referral to FES.
NHS NWL C C G will not fund FES for u p p e r l i m b s o r f o o t d r o p d u e t o lower motor neurone
diseases (such as motor neurone disease, polio, Guillain–Barre syndrome, peripheral neuropathy, traumatic injury
etc.).
There is a lack of evidence for FES for shoulder pain, shoulder subluxation or reaching or grasping and so FES will
not be funded for these indications.
Patients who are already receiving treatment will only be considered for on going funding if the following criteria
apply:
Documented history of tripping, falling, or gait problems;
Patient has a full range of ankle dorsal flexion/good calf tone/absence of severe spasticity and lower limb
oedema.
All referrals for the indication above should be sent to the Ealing FES service, ENable Service Manager, Ealing and
Harrow Community Services, Clayponds Hospital, W5 4RN, Tel: 020 8568 0679, Mobile: 07908 205483.
Email: Contact [email protected] or [email protected] for further information regarding the FES service, or
referrals may be sent to [email protected]
Referrals to any other centre for patients who meet the criteria will be for CCGs to consider as non-contracted activity
and funding will be dependent on the CCG.
These polices have been approved by the eight Clinical Commissioning Groups in North West London (Brent CCG,
Central London CCG, Ealing CCG, Hammersmith and Fulham CCG, Harrow CCG, Hillingdon CCG, Hounslow CCG
and West London CCG). Production of the policies and management of appeals is co-ordinated on behalf of the
CCGs by North West London Commissioning Support Unit.
Background
Functional electrical stimulation (FES) is the procedure by which electrical impulses (either through the skin or via
implanted electrodes) are used to stimulate muscle contractions that mimic normal voluntary muscle contractions. FES
is used where muscles have been paralysed by upper motor neurone lesions (UMN) (e.g. stroke, cerebral palsy,
multiple sclerosis or spinal cord injury) with the aim of improving muscle function.
Current therapies for muscle weakness secondary to UMN include physiotherapy, orthosis, medical therapies such as
muscle relaxants or botulinum toxin type A injections. Surgery is reserved for refractory cases. FES is not suitable for
lower motor neurone conditions (such as Motor Neurone Disease, Polio, Guillain-Barre disease, peripheral neuropathy
and traumatic injury) as it requires an intact peripheral nerve through which to conduct.
Evidence Base
Current evidence (NICE IPG 278, 2009)1 on the safety and efficacy (in terms of improving gait) of functional
electrical stimulation (FES) for drop foot of central neurological origin appears adequate to support the use of this
procedure provided that normal arrangements are in place for clinical governance, consent and audit. There have
been a number of trials and several recent systematic reviews into the effectiveness of FES in limb dysfunction.
However, most of the available evidence come from small studies with short intervention period and substantial
methodological weaknesses. The cost per QALY of FES for foot drop of central neurological origin is approximately
£19,238 (with a cost per QALY in the first year of £52,337, and of £10,964 in subsequent years).2, 3
References
Patient Information Leaflet:
http://www.nice.org.uk/nicemedia/live/11932/42904/42904.doc
1.
2.
3.
National Institute for Health and Clinical Excellence. Functional Electrical Stimulation for drop foot of central
neurological origin. NICE IPG278 2009. Available at
http://guidance.nice.org.uk/IPG278NHS Purchasing and Supply Agency, Centre for Evidence-based
Purchasing.Economic report: Functional Electrical Stimulation for drop foot of central neurological origin.
CEP10012 2010. Available at: www.cep.doh.gov.uk
Koyuncu E. Nakipoglu-Yuzer GF. Dogan A. Ozgirgin N. The effectiveness of functional electrical
stimulation for the treatment of shoulder subluxation and shoulder pain in hemiplegic patients:
A randomized controlled trial. Disability & Rehabilitation. 32(7):560-6, 2010.
4. Mangold S. Schuster C. Keller T. Zimmermann-Schlatter A. Ettlin T. Motor training of upper
extremity with functional electrical stimulation in early stroke rehabilitation. Neurorehabilitation
& Neural Repair. 23(2):184-90, 2009 Feb.
5. Okafor UA. Akinbo SR. Sokunbi OG. Okanlawon AO. Noronha CC. Comparison of electrical
stimulation and conventional physiotherapy in functional rehabilitation in Erb's palsy. Nigerian
Quarterly Journal of Hospital Medicine. 18(4):202-5, 2008 Oct-Dec.
6. Hara Y. Ogawa S. Tsujiuchi K. Muraoka Y. A home-based rehabilitation program for the
hemiplegic upper extremity by power-assisted functional electrical stimulation. Disability &
Rehabilitation. 30(4):296-304, 2008.
7. Kapadia NM. Zivanovic V. Furlan JC. Craven BC. McGillivray C. Popovic MR. Functional
electrical stimulation therapy for grasping in traumatic incomplete spinal cord injury:
randomized control trial. Artificial Organs. 35(3):212-6, 2011 Mar.
8. Weber DJ. Skidmore ER. Niyonkuru C. Chang CL. Huber LM. Munin MC. Cyclic functional
electrical stimulation does not enhance gains in hand grasp function when used as an adjunct
to onabotulinumtoxinA and task practice. Archives of Physical Medicine & Rehabilitation.
91(5):679-86, 2010 May.
9. Chan MK. Tong RK. Chung KY. Bilateral upper limb training with functional electric
stimulation in patients with chronic stroke. Neuro-rehabilitation & Neural Repair. 23(4):35765, 2009 May.
10. Thrasher TA. Zivanovic V. McIlroy W. Popovic MR. Rehabilitation of reaching and grasping
function in severe hemiplegic patients using functional electrical stimulation therapy. Neurorehabilitation & Neural Repair. 22(6):706-14, 2008 Nov-Dec.
11. Popovic MR. Thrasher TA. Adams ME. Takes V. Zivanovic V. Tonack MI. Functional
electrical therapy: retraining grasping in spinal cord injury Spinal Cord. 44(3):143-51, 2006
Mar.Price CIM, Pandyan AD. Electrical stimulation for preventing and treating post-stroke
shoulder pain. Cochrane Database of Systematic Reviews 2000, Issue 4. Art. No.:
CD001698. DOI: 10.1002/14651858.CD001698
Ganglions
Policy
Surgery for ganglia will only be funded in adults for the following indication:
The ganglion is very painful and restricts work and hobbies.
For mucoid cysts, please refer to the policy on Benign Lesions.
Background
A ganglion is a benign, mucin-filled cyst that forms around joints or tendons. They normally occur around the
hands, wrists and fingers. Most are symptom free, but occasionally they can give pain weakness, mobility
disorders or pressure neuropathy. Untreated approximately 50% resolve in adults, while up to 79% resolve
spontaneously in children.
Recurrence rates after surgery vary, but can be up to 30-40%. Complications of surgical excision include scar
sensitivity, joint stiffness and distal numbness. Side effects of surgery are pain and discolouring of the skin.
References
http://www.nhs.uk/conditions/Excisionofganglion/Pages/Introduction.aspx
References:
FD Burke et al. Primary care referral protocol for wrist ganglia Postgrad Med J 2003 79:329-331
Grommets in Children (with or without
Adenoidectomy)
Policy
NHS NWL CCG will fund grommets (with or without adenoidectomy) for children who meet the following
criteria:Otitis media with effusion has persisted, following a period of watchful waiting, for three months from
diagnosis in primary care;
AND
The child suffers from at least one of the ollowing
o
o
o
o
at least 5 recurrences of acute otitis media in a year
evidence of delay in speech development educational or behavioural problems attributable to
persistent hearing impairment
with hearing loss of at least 25dB, particularly in the lower ones
a second, relevant health problem, e.g. Down’s syndrome, cleft palate
Background
Grommets are small tubes that are put inside children's ears to help drain away sticky luid that is trapped
there and to aid their hearing. Acute otitis media is one of the most common infectious diseases in
childhood. Recurrent acute otitis media is defined for the purposes of this review as either three or more
acute infections of the middle ear cleft in a six-month period, or at least five episodes in a year. Otitis media
with effusion (OME) is common in children with a peak incidence from about 2 to 6 years of age. Most
cases resolve spontaneously. Bilateral hearing loss (>=25 dB) is the major concern in children with
persistent (>=3 months) OME
Ev dence Base
There is evidence that ventilation tube insertion reduces the frequency of episodes o recurrent acute otitis
media and the proportion of children with symptoms of ear disease within the first six months after insertion.
Ventilation tube insertion is also associated with an improvement in the mean hearing levels with both
unilateral and bilateral tubes in the first 6 months of follow-up. However, this effect diminishes with time and
the benefits of gromme s in children in the long run appear small compared with myringotomy or non-surgical
treatments 1,1 that grommets improved hearing at up to 2 years, but not at 5 years compared with no
gromme s Grommets did not significantly improve cognition, language comprehension or expression
compared wi h no grommets; although relatively insensitive outcomes may have been used
Adverse effects on the tympanic membrane such as otorrhoea, focal atrophy or retraction of the tympanic
membrane and tympanosclerosis are common after grommet insertion.1 Therefore, an initial period of
watchful waiting seems to be an appropriate management strategy for most children with OME
NICE clinical guidance recommends that healthcare professionals should consider surgical intervention in
children with persistent bilateral OME with a hearing loss less than 25–30 dBHL where the impact of the hearing
loss on a child’s developmental, social or educational status is judged to be significant. Tube ventilation and
hearing aids is also recommended in children with Down’s syndrome and cleft lip who have hearing loss. The
Scottish Intercollegiate Guidelines Network (SIGN) recommends watchful waiting for children under three years
of age with persistent bilateral otitis media with effusion and hearing loss of =<25 dB, but no speech and
language, development or behavioural problems to be safely managed with watchful waiting. However, referral
should be considered for children with persistent bilateral otitis media with effusion who are over three years of
age or who have speech and language, developmental or behavioural problems.
There is some evidence that bilateral ventilation tube insertion plus adenoidectomy results in a reduction in the
time spent with effusion, time spent with abnormal hearing, and in the number of surgical re-treatments at 2
years of follow-up. Combined grommets and adenoidectomy improves hearing more than adenoidectomy alone
at up to 12 months, but there are no significant difference between treatments at 2-5 years.
References
References
Lous J, Burton MJ, Felding JU, Ovesen T, Rovers MM, Williamson I, 2005, Grommets for hearing loss
associated with otitis media with effusion. Cochrane Systematic Review , 2005
NICE Clinical Guidance 60, Surgical Management Of OME, by the
Collaborating Centre for
Women’s and Children’s Health
McDonald Stephen, Langton Hewer Claire D, Nunez Desmond A, 2008, Grommet (ventilation
tubes) for recurrent acute otitis media in children. Cochrane Systematic Review
Gynaecomastia (Enlarged Male Breasts)
Policy
NHS NWL CCGs will not routinely fund gynaecomastia surgery because it is considered as a cosmetic
procedure. Requests may be considered only in exceptional circumstances via the submission of an Individual
Funding Request (IFR) form
Background
Gynaecomastia is a benign condition of the male breast. In most cases a thorough history and physical
examination, along with laboratory investigations, should help to exclude breast malignancy and any serious
underlying endocrine or systemic disease, as well as to identify pseudogynaecomastia. Careful clinical
observation may then be all that is necessary, because gynaecomastia often resolves spontaneously,
especially in the case of adolescence, with regard to pubertal gynaecomastia.
There is a lack of consensus as to the non-surgical management of gynaecomastia. Because
gynaecomastia is usually caused by an imbalance of androgenic and estrogenic effects on the breast,
medical therapy may include anti- oestrogens, such as tamoxifen (unlicensed indication), androgens or
aromatase inhibitors. However, although idiopathic gynaecomastia is highly prevalent, there is no proven
medical therapy for this condition and the quality of the medical research for pharmaceutical agents is very
poor.
Psychological support may be important in relation to reassurance, especially in view of the social pressure
on young men around body image and so-called “man boobs”.
Gynaecomastia may have an extrinsic cause in up to 39% of cases. Of the suspected idiopathic cases,
some will be found to have an important aetiology, such as testicular carcinoma. Selected endocrinological
investigation is therefore important to address such aetiology.
There are at least 69 drugs that are known to be associated with gynaecomastia. Patients who are on
medication that may cause gynaecomastia may not always be able to have that medication stopped, for
example: anti-androgens as a monotherapy for prostate cancer. Furthermore, withdrawal of the medication
may not always be associated with resolution of the gynaecomastia.
References
1.
2.
3.
4.
5.
6.
7.
8.
Aesthetic (Cosmetic) Surgery and other related procedures Evidence Based Framework for
Decision Making. NHS Leeds Cosmetic Framework September 2008.
South East London Exceptional Treatments Commissioning Policy. March 2009
Al-Allak A, Govindarajulu S, Shere M et al. Gynaecomastia: A decade of experience. The
Surgeon 2011; 9:255-258
Godwin Y, Gynaecomastia: considerations and challenges in treating male patients with varying
body Habitus. Eur J Plast Surg 2012; 35:55–64
MacLean GM, Smith B, Umeh H. UK National survey of Gynaecomastia management.
European. Journal of Surgical Oncology 2012;38(5)434,
Rahmani, MB.Turton P, Shaaban A, Dall B. Overview of Gynecomastia in the Modern Era and
the Leeds Gynaecomastia Investigation Algorithm. The Breast Journal, 2011; 17(3):246–255
Yazici M Sahin M. Bolu E Evaluation of breast enlargement in young males and factors
associated with gynecomastia and pseudogynecomastia. Ir J Med Sci 2010; 179:575–583
El Gawad, A., Pritchard-Jones, R. The diagnosis and management of gynaecomastia. NHS
Evidence - surgery, anaesthesia, perioperative and critical care, NHS Evidence [published June
2009]
Haemorrhoids
Policy
This policy does not apply to
Referrals for suspected cancer and acute, profuse rectal bleeding
Haemorrhoidectomy will be funded for
Patients with first or second degree haemorrhoids who do not respond to conservative
treatment (e.g. lifestyle changes and pharmacological treatment) and other techniques
(e.g. rubber band ligation, sclerotherapy, or infra-red photocoagulation)
Patients with third or fourth-degree haemorrhoids that are either too large for other measures
or have not responded to them.
Background
Evidence Base
Haemorrhoids are common with estimates of between 4 and 25% of the UK population being affected.
Haemorrhoids are a benign, mostly self-limiting condition that can cause bleeding, discomfort and pain. The
aetiology is unknown but a number of risk factors are known, such as increasing age, pregnancy and childbirth,
chronic constipation, chronic diarrhoea and a family history. The haemorrhoids are graded according to their size,
location and protrusion from the anus. It is usually the Grade 4 haemorrhoids, which protrude from the anus, and
remain outside that require treatment.
There are a number of treatments, both surgical and non-surgical. A “treatment ladder” is recommended whereby
less invasive treatments are used first. The treatments are designed to relieve symptoms rather than altering the
pathology. The non-surgical treatments include dietary changes, such as eating a high fibre diet, creams,
ointments and suppositories. Cold compresses or sitting a bath of warm water can also help to ease the pain. The
more invasive treatments include banding, sclerotherapy, infrared coagulation and surgical options such as
haemorrhoidectomy and stapling. [Chand et al, 2008] [NICE TA, 2007]
Haemorrhoidectomy is necessary when clots repeatedly form in external haemorrhoids, ligation fails to treat
internal haemorrhoids, the protruding haemorrhoid cannot be reduced, or there is persistent bleeding. [Brisinda G,
2000] A Cochrane systematic review confirms the long-term efficacy of excisional haemorrhoidectomy for patients
who failed after repeated RBL or grade III haemorrhoids. Compared to rubber band ligation, excisional
haemorrhoidectomy leads to increased pain, higher complications and more time off work, patient satisfaction
appears to be similar. [Shanmugam V et al, 2005]
Classification of haemorrhoids [Goligher et al, 1984]
Grade 1
Grade 2
Grade 3
Grade 4
Normal appearance. Bleeding but not prolapsing
Bleeding and prolapsing, but will reduce spontaneously
Bleeding and prolapsing, but requires manual reduction
Bleeding and permanently prolapsed
References
References
1.
2.
3.
4.
Brisinda G. How to treat haemorrhoids. BMJ. 2000; 321: 582-583
Chand M, Nash FG, Dabbas N. The management of haemorrhoids. Br J Hosp Med.2008; 69 (1): 35-40
Goligher J, Duthie H, Nixon H. Surgery of the anus, rectum and colon 5. 1984. Balliere Tindall.
Shanmugam V, Campbell KL, Loudon MA, Rabindranath KS, Steele RJC, Thaha MA. Rubber band
ligation versus excisional haemorrhoidectomy for haemorrhoids. Cochrane Database of Systematic
Reviews 2005, Issue 1. Art. No.: CD005034. DOI:10.1002/14651858.CD005034.pub2.
Hair Depilation for Hirsutism
Policy
NHS NWL CCGs will fund facial hair depilation only when the following criteria are met:
Facial
There is an existing endocrine medical condition and severe f acial hirsutism
Ferriman Gallwey Score of 3 or more per area requested
Medical treatments such as hormone suppression therapy has been tried for at least one year and failed.
Patients with a BMI>30 should be in a weight reduction programme and should
at least 5% of their
body weight.
Peri Anal
Removal of excess hairs in the peri anal area will only be funded as part of treatment for pilonidal sinuses.
Other Area
Have undergone reconstructive surgery leading to abnormally located hair- bearing skin
Laser treatment for excess hair (hirsutism) will only be funded for 6 treatment sessions and only at NHS
commissioned services.
Hair depilation for sites other than the above is not routinely funded and may be available via the IFR route under
exceptional circumstances.
CCG and West London CCG). Production of the policies and management of appeals is co-ordinated on behalf of
the CCGs by North West London Commissioning Support Unit.
Background
Hirsutism is excessive hair growth in women in areas of the body where only
to develop coarse hair,
primarily on the face and neck area.1 Unwanted and excessive hair growth is a common problem and
considerable amounts of time and money are spent on hair removal. It affects about 5-10% of women, and is
often quoted as a cause of emotional distress. Possible underlying causes
Ovarian Syndrome
(PCOS), (a condition of unknown cause characterised by reduced fertility, ovarian cysts and increased androgen
production), other rare hormone disorders and some forms of medication. Traditional treatments include shaving,
waxing and plucking. Most endocrine causes of hirsutism respond to hormone suppression therapy with a
contraceptive pill containing an anti-androgen or an anti-androgen alone.7 Hirsutism also improves with weight loss.8
Hair depilation (for the management of hypertrichosis – code L68) involves permanent removal/reduction of hair
from face, neck, legs, armpits and other areas of body usually for cosmetic reasons. It is usually achieved by
electrolysis or laser therapy. Although evidence on the use of laser in hirsutism is currently limited, it is
advised that laser treatment should not be used by dark-skinned women and there is evidence that it is less
effective with blond, red or white hair. Light-skinned women with dark hair get the best results from laser treatment
and the benefits are greater for large areas of hair. Most types of laser hair removal are considered safe if performed
properly, but recent studies suggest other skin structures can be adversely affected by laser irradiation and the longterm consequences of this are yet unknown. Hair re-growth is common, hence the need for repeated treatments.
The benefits of using laser treatment can include:
•
•
•
Minimal pain experienced
Improved appearance
Improved satisfaction with results from patients
Common side effects include pigmentary changes, occasional blistering and rare scarring, along with other
untoward effects were observed. These included: de- novo growth of hair outside the area treated by laser,
potentiation of co-existing vellus hair in the treatment area, induction or aggravation of acne, rosacea-like rash,
premature greyness of hair, tunnelling of hair under the skin, prolonged diffuse redness and oedema of the face,
focal hypopigmentation of the lip, angular cheilitis, allergic reaction to the cooling gas, and inflammatory and
pigmentary changes of pre-existing nevi.1. It has been noted that burning and sequelae, leukotrichia,
paradoxical hypertrichosis and folliculitis are four major side effects of the use of Lumina IPL system and
Vasculight-SR multi-functional laser and IPL system when used to treat hair removal in hirsute patients.1 In
addition pain, skin redness, swelling, burned hairs and pigmentary changes were infrequently reported adverse
effects.1
The Steer report found no evidence to compare effects of different laser techniques. Case series evidence
suggests that after laser depilation, hair growth is reduced for a period of weeks to months, but that multiple
treatments may be required to achieve complete hair loss.
Acceptable indications for Intervention
For those patients who:
Have undergone reconstructive surgery leading to abnormally located hair- bearing skin
Have a proven underlying endocrine disturbance resulting in severe hirsutism
(e.g. polycystic ovary syndrome)
Are undergoing treatment for pilonidal sinuses to reduce recurrence
Figure illustrating how to score severity of hirsutism using The Ferriman Gallwey score.
References
http://www.nhs.uk/conditions/hirsutism/Pages/introduction.aspx
http://www.patient.co.uk/health/Polycystic-Ovary-Syndrome.htm
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
Azziz R, Carmina E and Sawaya M. (2000): Idiopathic Hirsutism. The Endocrine Society, Endocrine
Reviews 21 (4): 347-362
Rasheed AI. Uncommonly reported side effects of hair removal by long pulsed-alexandrite laser.
Journal of Cosmetic Dermatology, December 2009, vol./is. 8/4(267-74), 1473- 2130;1473-2165 (2009
Dec)
Haedersdal M, Gøtzsche PC. Laser and photoepilation for unwanted hair grow h Cochrane Database
of Systematic Reviews 2006, Issue 4. Art. No.: CD004684. DOI:10.1002/14651858. CD004684. pub2.
Radmanesh M, Azar-Beig M, Abtahian A, Naderi AH. Burning, paradoxical hypertrichosis, leukotrichia
and folliculitis are four major complications of intense pulsed light hair removal therapy Journal of
Dermatological Treatment, 2008, vo is. 19/6(360-3), 0954-6634;1471- 1753 (2008)
Haedersdal M, Gøtzsche PC. Laser and photoepilation for unwanted hair grow h Cochrane Database
of Systematic Reviews 2006, Issue 4. Art. No.: CD004684. DOI:10.1002/14651858. CD004684. pub2.
Ferriman D, Gallwey JD: Clinical assessment of body hair growth in women. Journal o Clinical
Endocrinology 1961; 21 1440-1447
Carmina, E, Anti-androgens for the treatment of hirsutism, Expert Opin Investig Drugs, 2002, 11(3):35763
Bernasconi D et al, The impact of obesity on hormonal parameters in hirsute and nonhirsute women,
Metabolism, 1996, 45(1):72-5
American Association of Clinical Endocrinologists medical guidelines for clinical practice for the
diagnosis and treatment of hyperandrogenic disorders https://www.aace.com/files/hyper-androgenism2001.pdf
Hernias in Adults
Policy
NHS NWL CCG will fund surgery for hernia only in patients who meet the following criteria:
History of incarceration, or real difficulty in reducing the hernia
Inguino-scrotal hernia
Progressive increase in size of hernia (month-on-month)
Pain or discomfort significantly interfering with activities of daily living
Presence of Work related issues e.g. missed work/unable to work/on light duties due to hernia
Patients with suspected femoral hernias (including all women presenting with a groin hernia)
NHS NWL CCG will not fund surgery for the following:
Small, asymptomatic hernias
Minimally symptomatic hernias
Large, wide necked hernias unless there is demonstrable evidence that it is causing significant
symptoms
Background
An asymptomatic inguinal hernia has been defined as an inguinal hernia without pain or discomfort for the
patient, and a minimally symptomatic hernia as an inguinal hernia with complaints that do not interfere with
normal daily activities. There is increasing evidence that not all symptomatic or minimally symptomatic hernias
will progress to complication or a state that will require surgical intervention, and many clinicians now agree
that watchful waiting is a treatment option. In a few cases the risk of surgery may outweigh the benefit.
Evidence base
The European Hernia Society (EHS)1 produced guidelines for the treatment of inguinal hernia in adult
patients in 2009. Evidence from a good quality RCT in 2006 that compared elective surgery to watchful
waiting supports a watchful waiting strategy.2,3 The EHS 2009 made the following recommendations:
A watchful waiting strategy in minimally symptomatic or asymptomatic inguinal hernia in men
Urgent surgery for strangulated hernias
Routine surgery for symptomatic inguinal hernias
Exclude a femoral hernia in women presenting with hernia in the groin
References
Links to Patient Information Leaflets
http://www.cks.nhs.uk/patient_information_leaflet/hernia
References
1.
2.
3.
4.
Simons MP, Aufenacker T. European Hernia Society guidelines on the treatment on inguinal hernia in
adult patients. Hernia 2009; 13:343-403
Fitzgibbons RJ, Giobbe-Hurder A. Watchful waiting vs. Repar of Inguinal Hernia in Minimally
Symptomatic Men. JAMA 2006; 295:285292
O’Dwyer PJ, Norrie J. Observation or Operation for Patients with an Asymptomatic Inguinal hernia. Ann
Surg 2006; 244:167-173
Regional/PCT Funding Policies reviewed:
a. Bedfordshire and Hertfordshire Priorities forum statement
b. Thames Valley Priorities Committees (Oxfordshire PCTs)
c. West Essex PCT
d. Herfordshire PCT Derbyshire County PCT
e. West Sussex PCT
f. Outer North East London (ONEL)
Hip Replacement (Total)
Policy
Referral criteria for Total Hip Replacements (THR) should be based on the level of pain and
functional impairment suffered by the patient. NHS NWL CCGs will fund THR for patients who fulfil
the following criteria;
1.
Or
Patient complains of severe joint pain AND functional limitation, despite the use of nonsurgical treatments such as adequate doses of NSAID analgesia, weight control treatments
and physical therapies.
2. Patient complains of mild to moderate joint pain AND has severe functional limitation,
despite the use of non-surgical treatments such as adequate doses of NSAID analgesia,
weight control treatments and physical therapies.
Background
Total hip replacement (THR) is a common intervention carried out in the NHS. The most frequent indication
for this is degenerative osteoarthritis in adults. Osteoarthritis of the hip is common in the older age groups in
the UK, with approximately 210,000 people thought to have moderate to severe osteoarthritis1. The aim of a
THR is to relieve pain and improve function. This operation can be very successful for the appropriate
patients, with less than 10% of people who undergo these operations needing revision surgery.
Prior to referral for THR, non-surgical treatments, as specified in Figure 1, should be offered for all patients
and the management of any underlying medical conditions should be optimised. This should include
communication of the risks and benefits of all treatment options, taking into account the individual patient’s
comorbidities 2,3. Where appropriate, patients should be encouraged to reduce their BMI to <30 prior to
surgery4. Referral decisions should not be made on the basis of hip radiography as this is thought to be
unreliable1.
Cemented vs Cementless procedures
Hip replacement techniques can broadly be split into those that use cement and those that do not.
Traditionally cement has been used to fix the prosthesis in place, but cementless prostheses that allow the
bone to grow into the implant, are becoming more popular. In 2004 cemented hip replacements made up
approximately half of the total while cementless accounted for a fifth. Cementless hip replacements have
increased from 22% of all replacements in 2005 to 41% total replacements in 2011 across England and
Wales.
The 2010 National Hip Fracture database report14 showed that the proportion of cemented procedures
being done in NWL acute trusts varies considerably, ranging from 30-92%5. Clinically there are advantages
and disadvantage to both techniques6,7. A meta-analysis comparing both procedures has shown them to
have equivalent revision rates, though analysis of the newer studies may indicate better survival in
uncemented hip replacements.8
At present it is not possible to make robust comparisons of outcomes for cemented vs cementless hip
replacements7.
NICE is due to update its guidance on prosthesis for hip replacements next year but its Technology
Appraisal in 2000 recommended that cemented hip replacements should be performed over cementless9.
This is supported by SIGN 200910, and the recent 2010 National Hip Fracture Database analysis report14.
SIGN 2009 recommended that cementless procedures could be considered in patients with
cardiorespiratory complications, particularly in frail older patients10. The difference in cost of the procedures
is mostly that of the prosthesis, with cementless prostheses being more expensive. The limited costeffectiveness research has shown both procedures to have a similar cost- effectiveness due to differences
11
in revision rates .
Figure 1: Targeting treatment: a summary of available treatments
Definitions of pain and functional limitation levels:
Pain level
Mild
Pain interferes minimally on an intermittent basis with usual
daily activities
Not related to rest or sleep
Pain controlled by one or more of the following; NSAIDs with no or
tolerable side effects, aspirin at regular doses, paracetamol
Moderate
Pain occurs daily with movement and interferes with usual daily activities.
Vigorous activities cannot be performed
Severe
Pain is constant and interferes with most activities of daily living
Pain at rest or interferes with sleep
Pain not controlled, even by narcotic analgesics
Functional limitations
Minor
Functional capacity adequate to conduct normal activities and self care
Walking capacity of more than one hour
No aids needed
Moderate
Functional capacity adequate to perform only a few or none of the
normal activities and self care
Walking capacity of about one half hour
Aids such as a cane are needed
Largely or wholly incapacitated
Walking capacity of less than half hour or unable to walk or
bedridden
Aids such as a cane, a walker or a wheelchair are required
Severe
References
Patient information leaflet:
1.
National Collaborating Centre for Chronic Conditions. Royal College of Physicians of London
2008.Osteoarthritis, National clinical guideline for care and management in adults.
2. NICE 2008 clinical guideline 59 Osteoarthritis: the care and management of osteoarthritis in adults
3. British Orthopaedic Association Primary Total Hip Replacement: A Guide to Good Practice 2006.
4. Busato A, Roder C, Herren S, Eggli S. Influence of high BMI on functional outcome after total hip
arthroplasty. Obesity Surgery. 2008; 18: 595-600
5. National Joint Registry Annual report 2012
6. Huo MH, Osier CJ. Is Cement Still a Fixation Option for Total Hip Arthroplasty? The Journal of
Arthroplasty. Vol. 23 No. 7 Suppl. 1 2008
References (continued)
7.
8.
9.
10.
11.
12.
13.
14.
Dheerendra S, Khan W, Saeed MZ, Goddard N. Recent developments in total hip
replacements:cementation, articulation, minimal-invasion and navigation. Journal of Perioperative Practice.
2010; 20 (4):133
Morshed S, Bozic KJ, Ries MD, Malchau H, Colford Jr JM. Comparison of cemented and uncemented
fixation in total hip replacement A meta-analysis Acta Orthopaedica 2007; 78 (3): 315–326 315
Guidance on the Selection of Prostheses for Primary Total Hip Replacement NICE 2000 TA
SIGN 2009. Management of hip fracture in older people. National clinical guideline111
Marinelli M, Soccetti A, Panfoli N, de Palma L. Cost-effectiveness of cemented versus cementless
tota hip arthroplasty. A Markov decision analysis based on implant cost Journal of Orthopaedics and
Traumatology. 2008;9(1): 23-8
2010/11 South West London Effective Commissioning Initiative. May 2010
NHS ONEL PoLCE Policy Document. April 2010.
The National Hip Fracture Database Analysis Report. 2010.
Hyperbaric Oxygen Therapy
Policy
The funding criteria: The list below is based on the best available evidence of effectiveness from the report
mentioned above.
HBOT will be funded for the following conditions:
1.
2.
Diabetic Lower Extremity Ulcers where the conditions listed below are met.
Radiation-induced Proctitis
HBOT for diabetic lower extremity ulcers will only be funded if the patient meets all of the following
conditions:
Type I or II diabetes mellitus
Wounds/Ulcers classified as Wagner grade III only.
History of failed standard wound therapy for at least 30 days for a Wagner Grade 3
Wound/Ulcer i.e. failure of objective evidence of any improvement
The Wagner classification system of wounds is defined as follows:
Grade 0 - no open lesion;
Grade 1 - superficial ulcer without penetration to deeper layers; Grade 2=ulcer penetrates to tendon, bone or
joint;
Grade 3 - lesion has penetrated deeper than grade 2 and there is abscess, osteomyelitis, pyarthrosis, plantar
space abscess, or infection of the tendon and tendon sheaths;
Grade 4 - wet or dry gangrene in the toes or forefoot;
Grade 5 - gangrene involves the whole foot or such a percentage that no local procedures are possible and
amputation (at least at the below the knee level) is indicated.
Standard wound therapy protocols will include the use of all of the following:
Objective evaluation of ischaemia
Assessment and correction of vascular abnormalities Optimisation of nutritional status and glucose control
Exclusion of the presence of osteomyelitis
Performing sharp debridement
Provision of moist wound healing
Provision of essential offloading of the wound
Regular follow-up assessment
For HBOT to continue at 30 day intervals, re-evaluation must show continued progression to healing.
Background
Hyperbaric Oxygen Therapy (HBOT) has been used for a number of years in the NHS for a variety of
conditions, not all of which are supported by evidence of clinical effectiveness or of cost effectiveness. NHS
Quality Scotland published a comprehensive review of the evidence for HBOT in April 2008
(http://www.nhshealthquality.org/nhsqis/4208.html). The only indication for which there was a body of costeffective evidence was diabetic foot ulcer. There is sufficient evidence for the use of HBOT in radiation
induced proctitis. HBOT use in decompression illness and carbon monoxide poisoning is supported by a
good theoretical basis, long-standing use and clinical consensus, despite a lack of RCT evidence. It would
be difficult to justify further trials in these treatment areas.
For many conditions there may be some evidence of effectiveness but this had been derived from case
series or clinical trials that were poorly conducted or reported, and therefore cannot not be considered
robust.
References
The clinical and cost effectiveness of hyperbaric oxygen therapy. HTA programme: HTA systematic review 2
– May 2008. NHS Quality Improvement Scotland.
Hyperhidrosis treatment with Botulinum
Toxin for Axillary Hyperhidrosis
Policy
In accordance with the licensing, treatment with Botulinum Toxin A will only be funded for the management of
severe (HDSS score of 3 or 4) axillary hyperhidrosis, provided first-line treatment (topical therapy) and/or
iontophoresis have failed or are contraindicated.
Background
Hyperhidrosis (ICD-10 Code: R61) refers to excessive/enhanced sweating beyond that which is required to
return body temperature to normal1 . It can be generalised or focal, primary or secondary. Primary focal
hyperhidrosis is the most common type 2 , is idiopathic, and develops in previously healthy people. It typically affec s
the axillae, palms, soles of feet (plantar) and face (craniofacial) 2-5, areas principally involved in emotional sweating
2
. It is thought to affect >2.5% of the population5 . It usually has its onset in childhood or adolescence4, but can
occur at any age. Palmar and plantar hyperhidrosis may be present at birth.
Secondary generalised hyperhidrosis involves the entire body, and is due to an underlying condition, most often an
infectious, endocrine or neurological disorder; or may be simply drug-induced4 . It develops due to dysfunction
of the central or peripheral nervous system2 . Secondary focal hyperhidrosis involves specific areas of the body,
but is also caused by an underlying condition (e.g. neurological disorders, intrathoracic neoplasms, or
compensatory hyperhidrosis).
The Hyperhidrosis Disease Severity Scale (HDSS) (http://www.sweathelp.org/pdf/HDSS.pdf) provides a
qualitative measure of he severity of the patient’s condition, and allows tailoring of treatment6 . A score of 1 or 2
indicates mild or moderate hyperhidrosis. A score of 3 or 4 indicates severe hyperhidrosis. A one- point
improvement in HDSS score post-treatment has been associated with a 50% reduction in sweat production and a 2point improvement with an 80% reduction6.
Recommended treatment approaches
Type
First-line
Mild
palmar,
plantar
hyperhidrosis
(HDSS
treatments
aluminium chloridebased (AC) &
Consider
any
underlying anxiety,
be
Severe
palmar,
plantar
hyperhidrosis
(HDSS
or
–
AC
Consider
any
underlying anxiety,
be
3
Second-line
(BTX-A)**
*
BTX-A
Local
(axillary)
should
failure
ETS
all
indication only
for
axillary
hyperhidros
but
exists
benefit
treatment
palmar
plantar
hyperhidrosis
statements
sugges
first-line
–
AC
Consider
any
underlying anxiety,
be
Treatment
underlying
medications^
BTX-A**
medications
these
indication
statements
sugges
first-line
BTX-A
these
§ based on Guidelines for the primary care treatment and referral of
hyperhidrosis (9), an
evidence-based review (22), US and Canadian
consensus statements (6, 8), and
internet-based guidelines
Evidence base for treatment
Secondary hyperhidrosis
Management of secondary generalised or focal hyperhidrosis should be directed at looking for an
underlying cause, and managing that appropriately7. Oral anti- cholinergics may also be used8,9
Primary focal hyperhidrosis
Various medical, surgical and electrical therapies exist for primary focal hyperhidrosis. However, for many, the
efficacy is short-term or they are associated with unacceptable side effects1 . A step-by-step approach is
recommended for treatment. Local treatment options with few and minor side effec s should be tried first2,7,9
First-line treatment (primary care)
20% aluminium chloride (AC) hexahydrate in alcohol solution e.g. aluminium salts in OTC anti-perspirants2,3,7,9
Consider treating any underlying anxiety, which may be an exacerbating factor7
If that fails – refer to dermatologist/ secondary care9
Secondary care treatment options
Modified topical herapy:
o emollients, topical corticosteroids, different strengths of aluminium salts (up to 50%), and topical
glutaraldehyde or formaldehyde
o topical glycopyrrolate (an antimuscarinic agent) can be prepared by special order manufacturers,
and may be useful for primary craniofacial hyperhidrosis
o efficacy and tolerability vary widely10.
Lontophoresis 2,3,7
o The sites of hyperhidrosis (hands, feet) are immersed in warm water (or a wet contact pad may
be applied e.g. for the axillae) through which a weak electric current is passed
o In more severe cases of hyperhidrosis affecting plantar and palmar areas, glycopyrronium bromide
(an antimuscarinic agent) as a 0 05% solution can be added to the water 11, but adverse effects
are common
o Some people seem to gain considerable symptom relief. Most report an improvement after 6-10
sessions. Maintenance treatment is usually required at 1-4-week in ervals.
Botulinum toxin A (BTX-A) (Botox®)
o BTX-A blocks neuromuscular transmission by binding to acceptor sites on motor or sympathetic
nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. When
injected intradermally, BTX-A produces temporary chemical denervation of the sweat gland
resulting in local reduction in sweating 12
o BTX-A is the best-studied treatment to date for focal hyperhidrosis, and local intradermal
injections of BTX-A have been used since 1996 as a minimally invasive treatment for focal
hyperhidrosis, with numerous studies documenting safety, efficacy, effectiveness, and extremely
high levels of patient satisfaction, especially when other treatment options have proven ineffec ive
o It is only licensed for the treatment of severe axillary hyperhidrosis tha is inadequately
managed by /unresponsive to topical agents 11,13,14
o Effectiveness: BTX-A effectively treats axillary hyperhidrosis 1,5,10,13-16. In a 52-week, multicentre,
double-blind study comparing BTX-A with placebo for treatment of severe primary axillary
hyperhidrosis, published in 2007 (15), a 2- point improvement on the 4-point HDSS was reported
in 75% of subjects in the 75- U and 50-U BTX-A groups and in 25% of the placebo group (p
<0.001). In a single- centre, randomised, parallel, open-label, 12-week study10 which compared the
efficacy and safety of BTX-A with 20% AC for the treatment of primary focal axillary
hyperhidrosis, 92% of subjects in the BTX-A group (n=25) achieved treatment response at week 4,
compared with 33% of the subjects in the AC group
o Duration of effectiveness: effectiveness is of limited duration, and repetitive treatments are
necessary. In a 52-week, multicentre, double-blind study comparing BTX-A with placebo for
treatment of severe primary axillary hyperhidrosis, published in 2007 (15), the median duration of
effect was 197 days, 205 days, and 96 days in the 75-U BTX-A, 50-U BTX-A, and placebo
groups, respectively1 5 . An audit by Moffat et al in 2008 17, which aimed to determine trea ment
durability by active follow-up of patients over 24 months, suggests that patien s experience a
gradual return of symptoms between 6 and 24 months. A minority do not require re-treatment at
this time17
o Other anatomic sites: while BTX-A is also used routinely off-label or other anatomic sites5 , the
procedure may be more difficult and painful at these sites 7. It has been shown to be effective for
treatment of primary palmar hyperhidrosis 1,7,16,18. It may also be helpful for gustatory sweating16,
and plantar, and craniofacial hyperhidrosis7. Other indications (forehead sweating, truncal
sweating) are only anecdotally reported 16
o Paediatric patients: while the product information states that safe y and effectiveness of
BTX-A have not been established for the treatment of hyperhidrosis in paediatric patients
under age 181 2 , there is some evidence to suggest the efficacy of BTX-A in primary palmar
hyperhidrosis in children 7 , 1 9 , with a mean duration of effect of 7 months in one study of nine
patients19
o Safety: BTX-A is reported to be well-tolerated 5,10,13,16 including in children 19. The most frequently
reported adverse events (3-10% of adult patients) following injection of Botox® in double-blind
studies included injection site pain and haemorrhage, non-axillary
sweating
(compensatory
sweating), infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and
anxiety 12
o Patient satisfaction: BTX-A is reported to produce high levels of patient satisfac ion 5,10,15,16
o Cost-effectiveness: the cost-effectiveness of BTX-A compared to o her treatments has yet to be
established 20,21
2,3,7
Surgery
o Local surgery (axillary; resection of sweat glands) and endoscopic thoracic sympathectomy (ETS)
should only be considered if other treatment options have failed or have not been tolerated6;
complications may be permanent and significant
o ETS involves video-assisted laparoscopic division of the sympathetic chain over the neck of the
ribs under general anaesthesia, usually by a vascular surgeon. It is mainly indicated as a last resort
for severe palmar, axillary and sometimes craniofacial hyperhidrosis. Lumbar sympathectomy is no
used for plantar hyperhidrosis because of the risk of sexual dysfunction.
Oral medication
o Oral anti-muscarinics, such as glycopyrronium bromide (which needs o be imported7 and
oxybutinin, may be used, but their use is limited by adverse effects; other options include:
clonidine, diltiazem, benzodiazepines
o Systemic therapies are mainly used in treatment of generalised hyperhidrosis
References
Patient information
British Association of Dermatologists: Hyperhidrosis. See: http://www.bad.org uk/si e/829/de ault.aspx
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
Bhidayasiri R, Truong DD. Evidence for effectiveness of botulinum toxin for hyperhidrosis. J Neural
Transm. 2008;115(4):641-5.
Schlereth T, Dieterich M, Birklein F. Hyperhidrosis--causes and trea men of enhanced sweating.
Dtsch Arztebl Int. 2009 Jan;106(3):32-7.
Grunfeld A, Murray CA, Solish N. Botulinum toxin for hyperhidrosis: a review. Am J Clin Dermatol.
2009 10(2):87-102
Stolman LP. Hyperhidrosis: medical and surgical treatment. Eplasty. 2008;8 e22
Murray CA, Cohen JL, Solish N. Treatment of focal hyperhidrosis. J Cutan Med Surg. 2007 MarApr;11(2):67-77
Solish N, Bertucci V, Dansereau A, Hong HC, Lynde C, Lupin M, et al. A comprehensive approach
to the recognition, diagnosis, and severi y-based treatment of focal hyperhidrosis:
recommendations of the Canadian Hyperhidrosis Advisory Committee. Dermatol Surg. 2007
Aug;33(8):908-23
National Institute for Health and Clinical Excellence. NHS Clinical Knowledge Summaries.
Hyperhidrosis. 2010 [updated 2010; cited 2010 12 August]; Available rom
http://www.cks.nhs.uk hyperhidrosis/management/scenario_hyperhidrosis#358004006
Hornberger J, Grimes K, Naumann M, Glaser DA, Lowe NJ, Naver H, e al. Recognition, diagnosis,
and treatment of primary focal hyperhidrosis. J Am Acad Dermatol. 2004 Aug;51(2):274-86.
Lowe NJ, Cliff S, Halford J. Guidelines for the primary care treatment and referral of focal
hyperhidrosis. eGuidelines. 2003 Feb 19:373-7
Flanagan KH, King R, Glaser DA. Botulinum toxin type a versus topical 20% aluminum chloride for
the treatment of moderate to severe primary focal axillary hyperhidrosis. J Drugs Dermatol. 2008
Mar;7(3):221-7
British Medical Association and Royal Pharmaceutical Society of Grea Britain. BNF no.59.
Pharmaceutical Press; 2010.
Allergan. Botox (onabotulinumtoxinA) prescribing information. 2010 [updated 2010 June; cited 2010
11 August ]; Available rom http://www.allergan.com/assets/pdf/botox_pi.pdf, also from
http://www.allergan.com products/medical_derma ology/bo ox htm
Absar MS, Onwudike M. Efficacy of botulinum toxin type A in he treatment of focal axillary
hyperhidrosis. Dermatol Surg. 2008 Jun;34(6):751-5.
Naumann M, Lowe NJ. Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis:
randomised, parallel group, double blind, placebo controlled trial. BMJ. 2001 Sep 15;323(7313):5969
Lowe NJ, Glaser DA, Eadie N, Daggett S, Kowalski JW, Lai PY. Botulinum toxin type A in the
treatment of primary axillary hyperhidrosis: a 52-week multicenter double- blind, randomized,
placebo-controlled study of efficacy and safety. J Am Acad Dermatol. 2007 Apr;56(4):604-11
Naumann M. Evidence-based medicine: botulinum toxin in ocal hyperhidrosis. J Neurol. 2001
Apr;248 Suppl 1:31-3.
Moffat CE, Hayes WG, Nyamekye IK. Durability of botulinum toxin reatment for axillary
hyperhidrosis. Eur J Vasc Endovasc Surg. 2009 Aug;38(2):188-91.
Benohanian A. What stands in the way of treating palmar hyperhidrosis as effectively as axillary
hyperhidrosis with botulinum toxin type A. Dermatol Online J.2009;15(4):12
Coutinho dos Santos LH, Gomes AM, Giraldi S, Abagge KT, Marinoni LP. Palmhyperhidrosis: longterm follow-up of nine children and adolescents treated with bo ulinum toxin type A. Pediatr Dermatol.
2009 Jul-Aug;26(4):439-44.
NHS North West London Primary Care Trusts. NWL Evidence-Based Policy to nform
Commissioning Decisions on ‘Interventions Not Normally Funded (INNF)' 2009.
NHS Kent & Medway. NHS Kent & Medway List of Low Priority Procedures and Other Procedures
with Restrictions or Thresholds. March 2010.
DTB. Treatments for excessive armpit sweating. Drug & Therapeutics Bulletin 2005;43(10):77-80
International Hyperhidrosis Society. Hyperhidrosis Treatments. 2010 updated 2010; cited 2010 11
August ]; Available from http: www.sweathelp.org/English/PFF_Treatment_Overview asp
Hysterectomy for Menorrhagia
Policy
Referral for hysterectomy should be considered only if the following criteria are met:
There has been a prior unsuccessful trial with a levonorgestrel intrauterine system, unless medically
contraindicated.
AND
•
At least two of the following treatments have failed, are not appropriate or are contra-indicated in line with
the NICE guidelines:
Non-steroidal anti-inflammatory agents
Tranexamic acid
Injected progesterones
Combined oral contraceptives
AND
Endometrial ablation has been tried (unless patient has fibroids > 3cm or the uterus is bigger than a 10
week pregnancy)
Women who have contraindications or ethical reasons for not trying LNG-IUS must try two or more
of the second line treatments and failed. These include:
a.
b.
c.
d.
e.
3 cycles of traxanemic acid or NSAID treatment
3 cycles of alternative hormonal contraceptive treatment in line with NICE guidelines (NICE CG44)
Endometrial ablation
Uterine Artery Embolisation (for fibroids under 3cm)
Myomectomy (for fibroids over 3cms)
Background
Menorrhagia, or heavy menstrual bleeding, can be defined as blood loss of greater than 80ml per menstual
cycle [Warner et al.] or excessive menstrual blood loss which interferes with a woman’s physical, social,
emotional/material quality of life. [NICE 2007]
Hysterectomy is the most effective treatment for menorrhagia but compared to other treatments, it is not
thought to produce a significantly improved quality of life. [Marjoribanks et al., Clarke] Hysterectomy should
not be used as a first-line treatment solely for menorrhagia as it is a major surgical procedure with
associated complications (the risk of serious complications is about 10% [Brown et al.]). It should only be
considered when the fully informed patient requests the procedure, wishes for amenorrheoa and to no
longer retain her uterus and fertility. The risks and complications of the procedure should be explained.
[NICE 2007]
Medical treatment options include oral medication and a hormone-releasing intrauterine system. An
alternative surgical option is uterine resection or ablation, which both are effective and have high
satisfaction rates. [Lethaby] In women with menorrhagia alone, with uterus no bigger than a 10-week
pregnancy, endometrial ablation is considered preferable to hysterectomy [NICE 2007].
References
http://www.cks.nhs.uk/patient_information_leaflet/hysterectomy
460214
•
and
http://www.cks.nhs.uk/menorrhagia#-
References
•
Brown JS, Sawaya G, Thom DH, Grady D. Hysterectomy and urinary incontinence: a systematic
review. Lancet. 2000 ; 356: 535-9
•
Clarke J. Treatment of heavy menstrual bleeding. BMJ 2010; 341: 353
•
Lethaby A, Shepperd S, Farquhar C, Cooke I. Endometrial resection and ablation versus
hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 1999,
Issue 2. Art. No.: CD000329.
DOI:10.1002/14651858.CD000329
•
Marjoribanks J, Lethaby A, Farquhar C. Surgery versus medical therapy for heavy menstrual
bleeding. Cochrane Database of Systematic Reviews 2006, Issue 2. Art. No.: CD003855. DOI:
10.1002/14651858.CD003855.pub2.National Institute for Health & Clinical Excellence (NICE) CG44
Heavy
menstrual bleeding, Jan 2007
•
2010/11 South West London Effective Commissioning Initiative. May 2010
•
Warner PE, Critchley HO, Lumsden MA, Campbell-Brown M, Douglas A, Murray GD.
Menorrhagia I: measured blood loss, clinical features, and outcome in women with heavy periods: a
survey with follow-up data. Am J Obstet Gynecol. 2004 May;190(5):1216-23.
Hysteroscopy for diagnostic purposes
Policy
NHS NWL CCG will fund Hysteroscopy for Diagnostic purposes where ultrasound scan has been insufficient to
make a diagnosis.
This policy does not apply for hysteroscopy for suspected cancer (including PMB) or hysterosalpingograms for
the diagnosis of subfertility or operative/therapeutic purposes.
Background
A hysteroscopy is a procedure used to examine the inside of the uterus (womb). It is done using a
hysteroscope, a narrow tube with a telescope at the end. Images are sent to a computer to
close-up of
the womb. There are two types of hysteroscopy, and the procedure can
with or without a local
anaesthetic. A diagnostic hysteroscopy is used to look for abnormalities in the womb and find the cause of any
symptoms. These can include: heavy or irregular periods, pelvic pain, unusual vaginal discharge, repeated
miscarriage and infertility. Operative hysteroscopy is when it involves an additional procedure such as a biopsy
or treatment. The common types of operative hysteroscopy include the removal of polyps, division of uterine
adhesions, scars and septum, endometrial resection, resection of sub mucous fibroids, and removal of missing
IUCDs.
Evidence
There is strong evidence that hysteroscopy is safe and accurate in diagnosing endometrial cancer women with
abnormal uterine bleeding, but diagnostic accuracy for endometrial hyperplasia is only moderate (Clark et al,
2003).Sonohysterography, hysteroscopy and transvaginal ultrasonography TVUS are all effective in detecting
submucous fibroids, but hysteroscopy is associated with unacceptable pain in 3.6% of women (Farquhar et al,
2005). Both sonohysterography and hysteroscopy are effective in the investigation of women with dysfunctional
uterine bleeding (DUB), but Sonohysterography is more cost-effective (Evans,2004). Transvaginal ultrasonography
(TVUS) is an effective diagnostic tool for the identification of structural pathology in women with heavy menstrual
bleeding (Farquhar et al.
Ultrasound is the recommended first-line investigation to detect structural abnormalities in investigation of HMB or
PMB . Hysteroscopy (allows direct visualisation of the uterine cavity) should be used as a diagnostic tool only when
ultrasound results are inconclusive . Neither saline infusion sonography nor MRI should be used as a first-line
diagnostic tool . To detect histological abnormalities in HMB (i.e. to exclude endometrial cancer or atypical
endometrial hyperplasia), endometrial sampling or hysteroscopy with directed biopsy (curettage) have superseded
D&C for obtaining endometrial tissue. Indications for an endometrial biopsy/sampling in investigation of HMB
include persistent inter-menstrual bleeding, and in women aged ≥45 years - treatment failure or ineffective
treatment . D&C is no longer recommended as a diagnostic tool for HMB .
Limited evidence is available on the use of therapeutic D&C for HMB, but the one study that was identified showed
that any effect was temporary . Given the limited evidence, the NICE recommendation – that D&C should not be
used as a therapeutic treatment for HMB – was based on clinical experience . While medical treatment options
remain first-line, surgical treatment options for HMB and DUB include endometrial ablation methods that preserve
the uterus but ‘ablate’ (remove) the lining (these have superseded D&C); and hysterectomy (the definitive
treatment, which results in high satisfaction rates but with potential surgical morbidity). The first generation gold
standard hysteroscopic ablative techniques include laser, transcervical resection of the endometrium and rollerball.
Where dilatation is required for non- hysteroscopic (‘blind’) (2nd generation) ablative procedures, NICE recommend
that hysteroscopy should be used immediately prior to the procedure to ensure correct placement of the device .
Hysteroscopy and biopsy (curettage) is the preferred technique to detect polyps and other benign lesions, and
allows targeted removal.
References
http://www.patient.co.uk/health/Hysteroscopy.htm
References
1.
2.
3.
4.
5.
6.
7.
Evans K D. A cost utility analysis of sonohysterography compared with hysteroscopic evaluation for
dysfunctional uterine bleeding NHS Economic Evaluation Database (NHS EED). 30 September 2004
Farquhar C, Ekeroma A, Furness S, Arroll B. 31 October 2005. A systematic review of transvaginal
ultrasonography, sonohysterography and hysteroscopy for the investigation of abnormal uterine
bleeding in
premenopausal women. Acta Obstetricia et Gynecologica Scandinavica 2003; 82(6):
493-504
Clark T J, Voit D, Gupta J K, Hyde C, Song F, Khan K S. 31 March 2003 Database
of
Reviews of Effects (DARE) Produced by the Centre for Reviews and Dissemination. Copyright ©
2008 University of York
National Institute for Health and Clinical Excellence. Heavy menstrual bleeding. Clinical guideline
44. 2007.
Apgar BS, Kaufman AH, George-Nwogu U, Kittendorf A. Treatment of menorrhagia. Am Fam
Physician. 2007 Jun 15;75(12):1813-9.
Duckitt K, Collins S. Menorrhagia. Clin Evid (Online). 2008; 2008.
Lethaby A, Hickey M, Garry R, Penninx J. Endometrial resection / ablation techniques for heavy
menstrual bleeding. Cochrane Database Syst Rev. 2009(4):CD001501.
IVF
Funding Criteria
Guiding principles
Explanation
The welfare of the child
Evidence in support of improved treatment outcome
(higher chances of success)
Equity of access to services and choice of provider for
those meeting the eligibility criteria.
The Constraints on NHS Resources. Clauses 226 to
230 of the NHS Act 2006 deal with the financial duties
of Health Bodies. It is a duty to ensure that annual
expenditure does not exceed annual allowance (as set
out in accordance with the provisions of the NHS Act).
Definition of a treatment cycle
A cycle of IVF/ICSI includes ovarian stimulation, egg
recovery, fertilisation and single fresh embryo transfer. This
includes the provision for further transfer of one frozen
embryo where the initial procedure does not result in a viable
pregnancy and the subsequent storage of embryo. A frozen
cycle is one which starts when a cryopreserved embryo is
removed from storage in order to be thawed and then
transferred.
Eligibility criteria
Couples will only be referred for assisted conception if they
meet the eligibility criteria below and when all appropriate
tests and investigations have been successfully completed in
primary and secondary care in line with NICE guidelines.
See appendix for list of investigations.
1. Registration status
Must be registered with a GP on the medical list of one of
the 8 CCGs in NW London or if not registered reside in a
NWL borough.
2. Compliance criteria
The referring clinician must ensure that patients are aware
of the implications of IVF or ICSI treatment and the
commitments required before making a referral for assisted
conception. Those where compliance to IVF treatment is
deemed to be a problem must be referred for counselling in
the first instance.
3. Duration of infertility
Couples who have not conceived after one year of
unprotected sexual intercourse should be offered
investigations in primary and secondary care as appropriate
and referred for Assisted Conception if they meet other IVF
access criteria and have been trying to conceive without
success for at least 2 years. Investigation after 6 months may
be indicated if maternal age is approaching the maternal age
referral criterion.
4. Cause of infertility
Couples with diagnosed or known cause of infertility that
precludes natural conception do not need to wait for one year
before referral for AC. This includes couples who cannot
achieve full sexual intercourse due to disability.
Couples in whom one or both partners have been voluntarily
sterilised will not be eligible for IVF treatment under this
policy.
5. Age of the female
IVF treatment will be funded for couples where the female
partner at least 23 years and not yet reached their 40th
birthday by the time the treatment commences (defined as
the start of the stimulating phase of the IVF cycle). It is the
responsibility of service providers to ensure that eligible
couples have commenced the woman’s frozen treatment
before her 40th birthday.
6. Welfare of the child
The referrer/provider should ensure that the HFEA code of
ethics is followed.
Details can be found at
http://www.hfea.gov.uk/index.html
7. Children from
relationship
previous
8. Life style factors
Neither partner should have any living children (including
adopted children) from current or previous relationships.
The couple’s health and social circumstances should pose no
significant risk to conception, pregnancy or the resultant child.
Obesity and smoking reduce fertility and increase risks to
mother and baby during pregnancy.
The woman must have a body mass index (BMI) of between
19 and 30 at the commencement of treatment. Women who
are overweight or underweight will be offered referral to
dieticians in order to improve their BMI before referral to AC.
Women with a BMI less than 19 and greater than 30 will not
be funded.
Couples who smoke must be referred to smoking cessation
service to support their efforts in stopping smoking. NHS
NWL CCG will not fund IVF treatment until both partners have
stopped smoking for six months. This information should be
included in the referral letter to the tertiary provider. Referral
for smoking cessation prior to referral will be the responsibility
of the GP/hospital consultant. NHS NWL CCG recommends
that households are encouraged to be smoke free.
9. Number of cycles to be funded
NHS NWL CCG will fund 1 Full cycle of IVF or ICSI at the
current accredited providers across NWL - Hammersmith,
UCLH, Guys and St Thomas’ and Chelsea and Westminster.
The Full IVF cycle will consist of one fresh cycle and one
frozen embryo transfer cycle. One treatment cycle will ideally
be followed by the other, but a successful fresh cycle (in
terms of a live birth) would make the couple ineligible for a
frozen cycle. Similarly a spontaneous conception while on the
waiting list will make the couple ineligible for further IVF
treatment. NHS NWL CCG will not fund IVF where a patient
has received any previous Full IVF or ICSI treatment cycle
funded by the NHS. NHS NWL CCG will not fund IVF
treatment where a woman has a history of 3 or more previous
privately funded fresh cycles. Where a woman has previously
privately funded one or two cycles, NHS NWL CCG will still
fund one full cycle or only one fresh cycle as appropriate
under this policy, until a maximum of three fresh cycles has
been completed after which the chance of success decreases
substantially.
10. Frozen Embryos
NHS NWL CCG will fund the freezing and transfer of embryos
or preferably embryos as part of its multiple births
minimisation policy.
Embryo freezing and storage will be funded for a maximum of
12 months for eligible women. (Or the female partner’s 40th
birthday if this is sooner) so that couples have the option to
use stored embryos at a later stage if they choose to do so.
Couples who do not use up their frozen embryos by 12
months will be responsible for subsequent annual storage
charges, but NHS NWL CCG will pay for the embryo transfer
costs where eligible.
Where a woman has frozen embryos or embryos from a
previous cycle of IVF treatment, NHS NWL CCG will only
fund one cycle of frozen embryo transfer per one fresh cycle.
The transfer of frozen embryos in this situation is less
invasive, less stressful and does not involve another risk of
unnecessary ovarian stimulation.
11. Frozen cycles
The transfer of frozen embryos will constitute a cycle for the
purpose of establishing entitlement to NHS funding under this
policy.
If a couple has had frozen embryos transferred as part of
earlier self-funded treatment the frozen cycles will not be
counted as previous cycles when assessing eligibility for NHS
funded IVF.
Frozen embryos must be transferred before the patient
reaches their 40th birthday.
Where couples have previously self funded and frozen
embryos exist, the couple must implant one or two of the
previously frozen embryos,
rather than
undergo
ovarian stimulation, egg retrieval and fertilisation again.
12. Abandoned cycles
Abandoned
cycles following
known clinical
complications of assisted conception treatment will not
constitute a cycle for the purpose of establishing entitlement
to NHS funding. Providers may only charge for the cycle if it
reached the stimulating stage when treatment is stopped.
13. Number of embryos to be
transferred
In order to comply with the HFEA’s multiple births
minimisation strategy as outlined in the document ‘One Child
at a Time’, NHS NWL CCG will require its IVF and assisted
conception provider units to adhere with the following
guidance;
If female partner is less than 37 years and having first fresh
cycle, provider units should transfer one embryo NHS NWL
CCG will fund embryo transfers and freezing in order to
support this single embryo transfer strategy.
If the female partner is more than 37 years, provider units can
transfer up to 2 embryos in the first fresh cycle.
Where the female is undergoing a frozen cycle for all age
groups, only one embryo (or 2 embryos where the quality of
frozen embryos are judged to be poor) could be transferred.
NHS NWL CCG will leave this judgement to clinicians.
14. Gamete and Embryo storage
The CCGs will fund sperm banking for post-pubertal males
under the age of 55 years who have not yet completed their
family, and are about to undergo treatment which is likely to
result in long-term subfertility. In accordance with HFEA
guidance, gametes can be stored for up to 50 years.
NHS NWL CCG will fund gamete storage for the first 12
months but subsequent annual storage charges will be the
responsibility of the individual patient.
Subsequent assisted conception procedures using the sperm
will not be funded unless the other IVF eligibility criteria set
out in this policy are met. Ovarian stimulation and embryo
cryopreservation will be made available to women who are
about to undergo treatment likely to cause infertility, provided
they are in a stable relationship and wish to pursue this
option.
Oocyte (egg) preservation and ovarian tissue preservation
are still experimental treatments, and will not be funded.
However, the evidence will be kept under review.
The procedures recommended by the Royal College of
Physicians and the Royal College of Radiologists should be
followed before commencing chemotherapy or radiotherapy
likely to affect fertility, or management of post-treatment
fertility problems. Retrieval and storage of sperm, eggs or
embryos should also be in accordance with HFEA guidelines.
15. Intra Uterine Insemination
(IUI)
Intra Uterine Insemination (IUI) for unexplained infertility is
part of the care pathway leading to IVF/ICSI. Therefore
previous treatment with IUI will not preclude access to NHS
funded IVF treatment.
16. Egg Donation
NHS NWL CCG will fund IVF using donated eggs from UK
clinics licensed by the HFEA (but not from clinics abroad) for
women with premature ovarian failure due to a pathological or
iatrogenic cause or in order to avoid the transmission of
inherited disorders to a child where the couple meet the
relevant eligibility criteria. Egg donation outside of these
criteria will not be funded.
17. Sperm Donation
NHS NWL CCG will not fund donor sperm but will fund the
associated IUI/IVF/ICSI treatment in line with the criteria in
this policy providing the sperm meet the criteria laid down by
the treating provider unit. Patients wishing to access donor
sperm treatments must make their own arrangements but are
advised to check with the treating provider unit to ensure
compliance with HFEA guidelines before accessing donated
sperm.
18. Surgical sperm retrieval
Surgical
sperm retrieval will
be
funded in
appropriately selected patients, provided that the
azoospermia is not the result of a sterilisation procedure.
19. Surrogacy
IVF using a surrogate mother will not be funded by NHS NWL
CCG.
20. Sperm Washing
NHS NWL CCG will fund sperm washing for IUI/IVF/ICSI in
infertile couples where the male partner is HIV positive and
the female partner is HIV negative.
Where there are no fertility problems, NHS NWL CCG will
fund sperm washing and up to 3 cycles of IUI in couples
where the male partner is HIV positive and the female partner
is HIV negative, subject to other IVF clinical criteria being
met, in order to prevent the transmission of HIV to an unborn
child.
The attending Consultant in Genito Urinary Medicine or
Infectious Diseases will be required to provide written
confirmation of the suitability of the couple for NHS funding.
21. Same sex couples and women
not in a partnership
The main aim of this policy is to assist couples with medical
or physical limits to their fertility. Applying the infertility policy
to same sex couples requires some flexibility from those
seeking treatment and the clinical team referring or treating
the couple to ensure that the over-arching aim of this policy is
met.
Women in same sex relationships and women not in a
partnership should have access to professional experts in
reproductive medicine to obtain advice on the options
available to them.
Same sex female couples will not have access to initial
investigations for IVF without some medical evidence of six
unsuccessful cycles of IUI or donor sperm use and no
resultant pregnancy. Same sex male couples will not be able
to access fertility treatment within their relationship but may
be eligible for some assistance if there is a medical infertility
issue as would be available for couples using a surrogate
(e.g. women born without a uterus but have normal ovaries,
premature menopause, Cancer of the ovaries, uterus etc.).
Applications from women not in a partnership will be
considered in line with HFEA Guidance and Code of Practice
and the Human Rights of the individual.
NHS NWL CCG will fund assisted conception treatment for
same sex couples who demonstrate evidence of clinical
infertility as would be required for couples in heterosexual
relationships. (This is normally defined as failure to conceive
after regular unprotected sexual intercourse for 2 years or
where there is already known or established anatomic
cause(s) of infertility, but for the purposes of this policy,
couples could start investigations in primary care after 1 year
of unexplained infertility).
Same sex couples will be expected to have undertaken all
necessary fertility tests to exclude possible causes of
treatable infertility such as anovulation and tubal blockage in
the first instance.
Where fertility tests show no obvious cause of infertility, same
sex couples will be required to provide evidence of failure to
conceive after 6 cycles of self funded donor IUI before they
become eligible for NHS funded IVF or other assisted
conception treatment.
In the case of women in same sex couples in which only one
partner is sub fertile, clinicians should discuss the possibility
of the other partner receiving treatment before proceeding to
interventions involving the sub fertile partner.
21 Continued
NHS NWL CCG will not fund donor sperm, so same sex
couples have to fund this element themselves, for either IUI
or IVF.
All couples will have to be in a stable relationship for at least
2 years before eligibility for NHS funded IVF or other assisted
conception treatment.
22. Provider units
Because NHS NWL CCG is committed to improving choice
for couples and commissions for better treatment outcomes, it
will commission IVF and other tertiary assisted conception
treatments from the current providers across NWL –
Hammersmith, UCLH (NHS wing), Chelsea and Westminster
and Guys and St Thomas’.
The IVF provider units are expected to meet nationally agreed
waiting times for
all fertility treatments and to comply
with the NHS NWL CCG access criteria.
Where no existing arrangements are in place (such as IVF
units outside London), the provider units must gain funding
approval from NHS NWL CCG before accepting a referral.
All drug costs should be met by the tertiary unit as part of the
commissioned service and must not be prescribed by a GP.
Providers are expected to use the most clinically and cost
effective drugs available.
To avoid the clinical risks associated with multiple births,
tertiary units must have a strategy in place to comply with the
HFEA’s multiple births minimisation strategy as outlined in the
document ‘One Child at a Time’ published by
HFEA.(www.oneatatime.org.uk/36.htm)
Where a consultant has assessed a patient and
established that the likelihood of success is less than 10%
(due to FSH levels or other valid clinical reasons such
as previous poor response), the clinician may decide not to
continue with IVF/ICSI treatment even if the patient meets
the access criteria set out in this policy. In these cases, NHS
NWL CCG will be guided by the clinician's view.
23. Specific provider unit
responsibilities
•
Confirm that any referred patient is registered with a
GP in NWL or respective CCG catchment area.
•
Check that the couple meets the eligibility criteria
stated in this policy.
•
Have up to date patient information leaflets including
information on treatment outcomes for patients.
Develop their own clinical criteria for success and discuss
implications with patients before starting treatment. For
example a woman with an FSH level > 12 have a
significantly reduced chance of success using her own
eggs, and such patients should be counselled on the
option of donor eggs in order to maximise their outcomes.
•
Check that BMI and smoking status comply with CCG
policy, in addition to excluding problem drinking or
alcoholic addiction through usual enquiries with the
patient’s GP.
•
Provide NHS NWL CCG with timely monitoring and
audit data as listed below.
Ensure all information exchanges with NHS NWL CCG or
the CCG comply with Caldecott standards for
confidentiality and the requirements of the HFEA Act.
24. Monitoring and Audit
NHS NWL CCG will require assisted conception units to
provide yearly returns on their activity levels with emphasis on
the following:
•
The number of couples treated
•
Age profile of patients treated
•
The conception rate per cycle
•
Live birth rate per cycle
•
Multiple birth rate per cycle
•
Waiting times for routine IVF treatment.
These polices have been approved by the eight
Commissioning
Groups treatments
in North West
• Clinical
Numbers
of
abandoned
withLondon
reasons
(Brent CCG, Central London CCG, Ealing CCG,
Hammersmith
and
Fulham
CCG,
Harrow
CCG,
Hillingdon
for
abandonment.
CCG, Hounslow CCG and West London CCG. Production
of the policies and management of appeals is
•
number
of couples receiving
where the
co-ordinated on behalf of the CCGs by North West The
London
Commissioning
Support treatment
Unit.
cause of infertility has been explained (& the causes
identified).
•
The number of couples receiving treatment where the
cause of infertility has not been explained.
•
Number of women undergoing laparoscopic
salpingectomy prior to IVF treatment in women with
hydrosalpinges.
Appendix 1
Investigations to be done
Is age of female partner less than 40 ?(Please be aware that
the stimulation phase of IVF must start before the patient turns
40)
Menstrual history
Social history
partners
of
Sexual history
Predisposing factors
both
Insert Response
LMP
Cycle
Menorrhagia
Female Smoking status
Female Alcohol intake
Male Smoking Status
Male Alcohol intake
Frequency
Duration of trying
Dyspareunia
PCOS
PID/STIs
Tubal Surgery
Erectile Dysfunction
History of scrotal lumps/surgery
BMI of female patient ( ≥ 30 will exclude from treatment)
Smear result
Preconception
investigations done in Rubella Status
primary care
Chlamydia screening
Mid luteal Progesterone
Day 2-5 LH/FSH in irregular
cycle
FBC
TFT
Prolactin
Semen Analysis
Hospital Investigations
HSG or hysteroscopy findings
Vaginal US
Laparoscopy
Direct access for
GPs to be arranged
Knee arthroscopy
Policy
Referral for knee arthroscopy should be considered only in the following situations:
Removal of loose body
A clear history of mechanical locking in a patient with osteoarthritis.
Meniscal surgery (repair or resection)
Ligament reconstruction/ repair (including lateral release)
Synovectomy or synovial biopsy
Suspected chondral lesion
Use of knee arthroscopy as a diagnostic tool will only be funded in the following
situations:
Patients with medial knee pain where the Plica syndrome is suspected.
When Chondromalacia patellae is suspected
Arthroscopy will not be funded for the following indications:
As part of treatment for osteoarthritis.
Use of knee arthroscopy as a primary diagnostic tool
Intractable knee pain which may benefit from arthroscopic treatment may be funded under exceptional
circumstances.
Background
Arthroscopy uses a fibreoptic telescope to perform washout and debridement of the knee joint.
Washout removes debris in the joint, while debridement removes damaged cartilage or bone. Other
than a
of infection and venous thromboembolism arthroscopy is thought to be a safe
procedure.
References
Patient information leaflet:
http://www.cks.nhs.uk/patient_information_leaflet/arthroscopy/introduction#460280000
References:
1. N.I.C.E. Interventional Procedure Guidance IPG230- Arthroscopic knee washout, with or without
debridement, for the treatment of osteoarthritis (August 2007)
2. NICE 2008 clinical guideline 59 Osteoarthritis: the care and management of osteoarthritis in adults
3. Laupattarakasem W, Laopaiboon M, Laupattarakasem P, Sumananont C. Arthroscopic
debridement for knee osteoarthritis. Cochrane Database of Systematic Reviews 2008, Issue 1.
Art. No.: CD005118. DOI: 10.1002/14651858.CD005118.pub2.
4. NHS ONEL PoLCE Policy Document. April 2010
5. NHS West Essex Surgical Thresholds. November 2009
Knee Replacement
Policy
Funding for total or partial knee replacement surgery is available if the following criteria are met
1. Patients with BMI <40
AND
2. Patient complains of moderate joint pain AND moderate to severe functional limitations that has a
substantial impact on quality of life, despite the use of non-surgical treatments such as adequate doses of
NSAID analgesia, weight control treatments and physical therapies.
AND
3. Has radiological features of severe disease;
OR
4. Has radiological features of moderate disease with limited mobility or instability of the knee joint
Patients not meeting the above criteria can be referred via the IFR route where there are exceptional
circumstances present.
Background
Total knee replacement can be performed for a number of conditions, but it is most often for osteoarthritis of
the knee. Osteoarthritis of the knee presents with joint pain, deformity, stiffness, a reduced range of
movement and sometimes giving way.
Complications for knee replacement can be severe for a small number so it should only be considered when
other treatments have failed. Non-surgical management includes medications for pain and inflammation,
weight reduction in patients who are obese with patient-specific exercise programmes, walking aids, cushionsoled footwear. Corticosteroids may also be injected into the knee joint to relieve inflammation. If these
therapies are insufficient, a partial or total knee replacement may be necessary.1,2,3,4
The usual indications for a knee replacement are pain and disability with accompanying radiological changes.
Occasionally knee replacements are done to manage a progressive deformity/instability. Any comorbidities,
including obesity should be managed to their optimum level prior to referral.5 All treatment options with risks
and benefits should be offered to the patient. Patients who meet the criteria below before having knee
replacement surgery are thought to have greater quality of life improvements.6
Definitions of pain and functional limitation levels:
Pain level
Mild
Pain interferes minimally on an intermittent basis with usual
daily activities
Moderate
Pain occurs daily with movement and interferes with usual daily activities.
Vigorous activities cannot be performed
Severe
Pain is constant and interferes with most activities of daily living
Pain at rest or interferes with sleep
Pain not controlled, even by narcotic analgesics
Functional limitations
Minor
Functional capacity adequate to conduct normal activities and self care
Walking capacity of more than one hour
No aids needed
Moderate
Functional capacity adequate to perform only a few or none of the
normal activities and self care
Walking capacity of about one half hour
Aids such as a cane are needed
Largely or wholly incapacitated
Walking capacity of less than half hour or unable to walk or
bedridden
Aids such as a cane, a walker or a wheelchair are required
Severe
Variable
Mobility and Stability
Preserved mobility and
stable joint
Definition
Limited mobility and /or
stable joint
Limited mobility is equivalent to a range of movement less than 0 to 90 .
Unstable or lax is equivalent to the presence of slackness of more than
5mm in the extended joint.
Radiology
Slight
Moderate
Severe
Preserved mobility is equivalent to minimum range of movement from 0 to 90 .
Stable or not lax is equivalent to an absence of slackness of more than 5mm
in the extended joint.
Ahlback grade 1.
Ahlback grade II and III.
Ahlback grade IV and V.
References
References:
1. NICE Referral Advice. A guide to appropriate referral from general to specialist services. 2001
2. The National Collaborating Centre for Chronic Conditions. Royal College of Physicians of
London 2008. Osteoarthritis, National clinical guideline for care and management in adults.
3. NICE 2008 clinical guideline 59 Osteoarthritis: the care and management of osteoarthritis in
adults
4. NICE Mini-incision surgery for total knee replacement. May 2010
5. British Orthopaedic Association Total Knee Replacement; A Guide to Best Practice. 1999
6. Quintana JM, Escobar A, Arostegui I, Bilbao A, Azkarate J, Goenaga I and Arenaza J. Health
related quality of life and appropriateness of knee or hip joint replacement
7. Escobar A, Quintana JM, Arostehui I, Azkarate J, Güenaga, Arenaza JC, Garai I.Development of
explicit criteria for total knee replacement. International Journal of Technology Assessment in
Healthcare, 2003; 19: 57-70.
Inpatient & surgical treatments for
Lymphoedema and Lipoedema
Policy
NHS NWL CCGs will fund combined decongestion therapy and other conservative physical therapies for
patients with severe lipoedema or lymphoedema. Obese patients with lipoedema should first be assessed in an
appropriate service.
Inpatient treatment and other forms of treatment such as surgical intervention for patients with severe lipoedema or
lymphoedema or treatment at centres not commissioned by the NHS will only be considered in exceptional
circumstances through the IFR route.
Background
Lymphoedema is a medical condition in which excessive fluid (or 'lymph') is accumulated in the tissues as a result of
impaired lymphatic drainage. Although it is not life-threatening it can be very distressing and can become a major
physical and social problem. Lipoedema is the accumulation of adipose tissue in the lower limbs which is often
bilateral, symmetrical and often develops in a “chaps-style” fashion, namely starting from the hips down to the
ankles. It affects women more than men, with a prevalence of up to 11% in women. The aetiology is unknown and it
can be progressive. At late stages it can present as oedematous-fibrosclerotic panniculitis, elephantiasis and
immobility. Management is generally as with lymphoedema.
There is no known cure for lymphoedema and lipoedema. Various treatment strategies have been suggested for the
management of both conditions. These aim to reduce the volume of the affected limb, retain or restore function and
provide cosmesis to improve an individual’s health outcomes and quality of life. Manual lymphatic decompression is
often used but not recommended as first line treatment for obese patients with lipoedema.
NICE provides guidance for liposuction to treat lymphoedema. Lymphoedema is the abnormal accumulation of lymph
fluid in body tissues that results from an impaired lymphatic system. It most commonly affects the arms and legs.
It can limit mobility and cause recurrent infection, pain, disfigurement and distress. Secondary lymphoedema
results from damage to the lymphatic system or removal of lymph nodes by surgery, radiation, infection or
injury, while primary lymphoedema
congenital inadequacy of the lymphatic system.
In the UK, the most common type of chronic lymphoedema is secondary lymphoedema of the arm following breast
cancer. Liposuction for chronic lymphoedema involves the surgical removal of excess subcutaneous fat tissue
through several small incisions. It can be performed under general or regional anaesthesia. Cannulas connected
to a vacuum pump are inserted into small incisions and lymphoedematous fat tissue is removed by vacuum
aspiration.
Evidence base
The NICE palliative care guidance recommends the provision of lymphoedema services as part of the range of
rehabilitation services that should be available through cancer networks. Summary of literature evidence for current
management strategies are given below:
The long-term use of low-stretch elastic garments or compression bandaging is effective in reducing
and/or controlling limb swelling and may be an essential component of combination physical therapies.
Favourable outcomes have been described for complex physical therapy; however, some of the evidence is
inconsistent and further trial evidence is required to define an optimal strategy.
Current evidence regarding the use of drug therapy is inconclusive.
Surgical procedures may be indicated in select patients with lipoedema or lymphoedema who have not
responded to physical therapy.
References
Report to the Australian Health Ministers’ Advisory Council; Review of current practices and future directions in the
diagnosis, prevention and treatment of lymphoedema in Australia. Commonwealth of Australia 2006. Available at:
http://www.ag.gov.au/cca
1.
2.
3.
4.
Kligman L, Wong R K, Johnston M, Laetsch N S. The treatment of lymphedema related to
cancer: a
systematic review and evidence summary. Supportive Care in Cancer 2004 12:421.
Badger C, Preston N, Seers K, Mortimer P. Physical therapies for reducing and controlling lymphoedema of the
limbs. Cochrane Database of Systematic Reviews 2004, Issue 4. Art. No.: CD003141. DOI:
10.1002/14651858.CD003141.pub2.
National Institute for Health and Clinical Excellence. Guidance on Cancer Services. Improving Supportive and
Palliative Care for Adults with Cancer The Manual 2004
Corradino campisi. Lipoedema; in lymphatic surgery, lymphology and micro surgery.
http://www.chirurgiadeilinfatici.it/en Lipoedema Accessed 5 Nov 2010.
Magnetic Resonance guided Focused
Ultrasound (MRgFUS) for uterine fibroids
Policy
NHS NWL CCGs will not fund magnetic resonance guided ultrasound (MRgFUS) treatment for uterine
fibroids for the purposes of fertility preservation because of lack of evidence of effectiveness.
NHS NWL CCGs will not routinely fund MRgFUS treatment for symptomatic relief except in exceptional
circumstances via the individual funding request (IFR) route.
Background
Uterine fibroids are benign tumours of smooth muscle cells and fibrous connective tissue that develop within
the walls of the uterus. They occur in approximately one third of women. In many cases they are
asymptomatic, but they can cause abnormal uterine bleeding,
the bladder or bowel and a feeling
of pelvic pressure or pain.
Treatment depends on whether the fibroids are symptomatic, and on the woman’s desire to become
pregnant. Treatment will rarely be required after the menopause (because of natural shrinkage of the fibroid
in response to hormonal changes). Asymptomatic fibroids (often
incidentally) require no treatment
other than monitoring. Symptomatic fibroids can be removed surgically by either hysterectomy (which can be
laparoscopic or abdominal and either total or partial) or myomectomy (open surgical removal of just the
fibroid with conservation of the uterus). Uterine artery embolisation (a type of non-surgical treatment which
blocks off the uterine arteries causing the fibroids to shrink) may also be a treatment option for some women.
Magnetic Resonance-guided Focused Ultrasound (MRgFUS) treatment is a minimally invasive technique
designed to reduce the symptoms of fibroids. Low power ultrasound is used to target the fibroid. It is then
heated with high power ultrasound which destroys the fibroid tissue.
Evidence base
The pivotal study ‘Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids’1
established the safety and efficacy of the procedure and resulted in MRgFUS receiving FDA approval in
the United States. However, the evidence currently available is
arm treatment trials with small
patient groups and does not compare this treatment with other treatment options. There have not yet been
any randomised controlled trials
procedure with other existing procedures or treatments.
The 2007 NICE interventional procedure guidance (IPG)2 found that the evidence on safety is adequate to
support use of this procedure provided that normal arrangements are in place for clinical governance and audit.
NICE recommends that the procedure should only be carried out by clinicians with specific training in this
technique and patient selection to be done by a multidisciplinary team including a gynaecologist and an
appropriate imaging specialist. Patients should be informed that their symptoms may not be relieved or that they
may return and further treatment may be needed. NICE also found that the evidence on efficacy for MRI-guided
FUS was adequate for treatment of uterine fibroids in the short term, although further treatment may be required
and there may be risks of skin burns. Effect on subsequent pregnancy is uncertain (evidence based on one nonrandomised comparative study and case-series studies).
The BlueCross BlueShield Association Technology Evaluation Centre undertook a comprehensive review of
the effectiveness of MRgFUS in 2005 and concluded that MRI-guided focused ultrasound for uterine fibroids
did not meet the TEC criteria. The TEC assessment noted that durability of MRI-guided ultrasound is a
major concern because a substantially greater proportion of women undergo other (or repeat) procedures
after MRI-guided ultrasound compared to either UAE or myomectomy. The TEC assessment also found that
available data suggest that fibroid
with MRI-guided ultrasound is much lower than with
comparison procedures.
embolization appears to produce a more profound improvement in
symptom severity scores than MRI-guided ultrasound. For fertility preservation, myomectomy was considered as
the treatment of choice (TEC BCBSA, 2005)3
References
1.
2.
3.
Stewart EA, Rabinovici J, Tempany CM, Inbar Y, Regan L, Gostout B, Hesley G, Kim HS, Hengst S,
Gedroyc WM. Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids.Fertil
Steril. 2006 Jan;85(1):22-9.
National Institute for Health and Clinical Excellence, Magnetic resonance image guided transcutaneous
focused ultrasound for uterine fibroids 23 November 2011 - Publication type: Full Guidance,
Blue Cross Blue Shield Association. Magnetic resonance-guided focused ultrasound therapy
symptomatic uterine fibroids. Blue Cross Blue Shield Association (BCBS), 2005; TEC Assessment 20(10):
22
Reversal of Male Sterilisation
Policy
Reversal of male sterilisation (vasectomy) will not be funded except in exceptional circumstances such as:
Death of only child (biological or adopted) from current relationship or any previous relationship
Background
Reversal of male sterilisation is a surgical procedure that involves the reconstruction of the
Sterilisation procedure is available on the NHS and couples seeking sterilisation should
fully advised and
permanent. A vasectomy
counselled (in accordance with RCOG guidelines) that the procedure is intended
can be reversed, but reversals are not usually successful.
References
Link to Patient Information Leaflet
References
1. Royal College of Obstetricians and Gynaecologists. Guideline summary - Male and Female
Sterilisation, RCOG 1998.
Open MRI
Policy
NHS NWL CCGs will fund Open MRI of greater than 0.5T as an alternative to conventional MRI in the
following circumstances:
Patients who suffer from claustrophobia where an oral, prescription sedative has not been effective
(GPs are expected to support Extended Scope Practitioners (ESPs) in prescription of sedatives in this
situation)
In patients who are obese and therefore cannot fit comfortably in a conventional MRI
Background
MRI is a widely used diagnostic imaging technology and is particularly useful in detecting soft tissue damage
and disease. The patient undergoing imaging is placed in a gradient magnetic field delivering radiofrequency
pulses to the patient and processing the resulting electromagnetic signals emitted from the region being
examined (CADTH)1 . The standard (closed/high-field) method
requires the patient to be in a supine or
recumbent position.
The orientation of standard MRI requires the patient to be horizontal and stationary. For
most scanners, the patient examination table is positioned in a long, narrow tube. Some patients may experience
claustrophobic reactions which might be effectively controlled by sedation or anaesthesia. Obese individuals may
b e u n a b l e t o fit into the tube. Open MRIs in which patients lie, sit or stand between two plates overcome these
difficulties. They are also used for intraoperative imaging or image-guided interventions where easy access to the
patient is required1.
The technology
The quality of MRI images is partly dependent on the field strength of the magnet which is measured in Tesla (T).
Above 1T is considered high field strength. Closed MRIs have magnet field strengths of >1.5 tesla whereas open
MRIs have medium strength magnets of 0.5-1.0T. The lower field strength of open MRIs results in poorer
quality images in comparison to closed MRIs, with lower signal-to-noise ratios and more motion artefacts. The
length of time required to obtain an image is also longer.
Generally low field strength is below 0.5T, mid-field strength is 0.5 T, up to 0.9 T or 1 T;
strength is
at/and or above 1 T. 1 High-field s t r e n g t h devices are usually closed-bore magnets due to the fact that the
stronger magnetic fields (1–3 T) require more robust shielding and gradient structure to maintain field
homogeneity. The open magnet’s field strength usually varies from 0.2–1.0 T.
Evidence Base
MRI studies reported in the literature are generally based on intermediate or high-field MRI. There is insufficient
evidence in the published peer-reviewed literature to support the use of low-field strength MRI for any diagnostic
indication2 . The Washington State Health Technology Assessment on standing, weight-bearing, positional, or
upright MRI in 20063 concluded that there is insufficient evidence for the diagnostic accuracy or diagnostic utility
of standard MRI for these situations. Open MRI (i.e., extremity, upright, and positional) allows for imaging
without the patient being placed within an enclosed space. Open-design MRI has become the standard of care
when conventional design is contraindicated. Specifically, this includes patients with pulmonary and/or
cerebrovascular disease as well as patients who would require sedation for a conventional MRI such as severely
claustrophobic or paediatric patients.
A review on the impact of obesity on medical imaging4 suggested an industry weight and maximum aperture
diameter for closed (cylindrical bore) MRI’s as;
Wt – 350 lb (159kg) and Aperture diameter of 60cm (minus 15-18cm for table thickness.
References
1. CADTH. Open Magnetic Resonance Scanner. Issue 92. November 2006
2. CIGNA. Magnetic Resonance Imaging- low field. CIGNA coverage policy 0444
3. Washington State Department of Labor and Industries, Office of the Medical Director. Standing, weightbearing,
positional or upright MRI. Health Technology
.
Washington State Department of Labor
and
Industries; May 31 2006
4. Upport, et al; Impact of obesity on Radiology. Radiologic clinics of North America. 2007: 45(2);231-246
Pain Management Programmes
Policy
NHS NWL CCGs will fund outpatient pain management programmes (of at least 25-30 hours) for those meeting
the following criteria (Grade B recommendation): Inclusion criteria:
1.
2.
3.
Clinical staff from the pain management programme has assessed the patien and agreed that they would
benefit from the programme;
The patient has chronic non-malignant pain of least 3 months duration, which is causing significant disability
and/or distress, and a negative impact on quality o life. Patients satisfying these criteria do not have to wait until
other trea ments have failed before referral to PMP.
The patient is able to communicate in the language in which the PMP is conducted (a trained independent
interpreter may facilitate successful participation);
Exclusion criteria
1.
2.
3.
The patient has a limited life expectancy or rapidly deteriorating disease or condition;
The patient has active psychological or psychiatric problems which require urgent attention, or which preclude the
use of cognitive and behavioural methods in a group (including severe cognitive impairment); (3) The patient has
current primary drug or alcohol problems;
The patient has severe disability or significant medical condition such that the basic requirements of attending
treatment exceed the patient’s current capacity.
Background
Chronic pain is continuous, long-term pain of more than 12 weeks or after the ime that healing would have been
thought to have occurred in pain after trauma or surgery (British Pain Society). There are several different
treatments available or chronic pain, including pain management programmes
A pain management programme (PMP) is a psychologically-based rehabilitative treatment for people with chronic
pain which remains unresolved by other treatments currently available (British Pain Society). It is delivered in a
group setting by a multidisciplinary team, either on an outpatient or inpatient basis
There is good evidence that PMPs improve pain and function compared o non- multidisciplinary treatments (Flor
1992, Thomson 2002, Guzman 2002, British Pain Society). A systematic review of ten trials found strong evidence
for improved function, good evidence for decreased pain, but contradictory evidence for improved return to work
(Guzman 2002). There is some evidence for reduced demand on healthcare after participation in PMPs, including
reduced use of analgesics, reduced consultations, and reduced surgical interventions (Flor 1992, Turk 2001,
Gatchel 2006).
Although both outpatient programmes of at least 25-30 hours are effective, more intensive inpatient programmes
produce better outcomes (Bendix 1995, Williams 1996, Guzmán 2002, British Pain Society). This difference was
maintained at one year in one randomised controlled trial (Williams 1996). Less intensive outpatient programmes
did not improve pain, function or work readiness when compared with non-multidisciplinary outpatient therapy or
usual care (Guzmán 2002). However, inpatient programmes are four times as expensive as outpatient programmes
(Bedfordshire & Hertfordshire policy).
National and regional guidelines recommend PMPs for lower back pain (NICE CG88, Airaksinen 2006). Clinical
guidelines recommend assessment by one or more members of the PMP clinical staff before acceptance onto a
PMP, in order to gauge potential benefit (British Pain Society). Common exclusion criteria include: a limited life
expectancy or rapidly progressive disorder; active psychiatric problems or drug/alcohol misuse; inability to speak
or write in the language used by the PMP; or severe disability which would preclude attendance in the PMP
(British Pain Society, comparative policies)
Background
Summary
Pain management programmes are effective in improving pain and unction in chronic pain, and can lead to
return to work (level 1a)
Pain management programmes can reduce healthcare costs for these patients (level 1b)
Inpatient programmes produce better outcomes than outpatient programmes, but are much more expensive
(level 1b)
Patients who meet certain criteria are more likely to benefit from these programmes (level 5)
Reference
s
1.
Airaksinen O, Brox JI, Cedrashi C, Hildebrandt J, Klaber-Moffet J, Kovacs F, et al, on behalf of the
COST B13 Working Group on Guidelines for Chronic Low Back Pain. European guidelines for the
management of chronic nonspecific low back pain. Eur Spine J 2006;15 s192-300.
2. Bendix AF, Bendix T, Ostenfeld S, Bush E, Andersen. Active treatment programs for patients with
chronic low back pain: a prospective, randomized, observer-blinded study. European Spine Journal 1995,
4 (3): 148-52
3. British Pain Society. Recommended guidelines for Pain Management Programmes for adults: A
consensus statement prepared on behalf of the British Pain Society. April 2007
4. Flor H, Fydrich T, Turk DC. Efficacy of multidisciplinary pain treatment centers: a meta- analytic review.
Pain. 1992;49(2):221-30.
5. Gatchel R.J. Okifuji A. Evidence-based scientific data documenting the reatmen and costeffectiveness of comprehensive pain programs for chronic nonmalignant pain. Journal of Pain 2006; 7: 77998.
6. Guzmán J, Esmail R, Karjalainen K, Malmivaara A, Irvin E, Bombardier C. Multidisciplinary biopsycho-social rehabilitation for chronic low back pain. Cochrane Database Syst Rev. 2002;(1):CD000963.
7. NICE Clinical Guidance CG88 - Early management of persistent non-specific low back pain. National
Institute for Clinical Excellence, May 2009.
8. Thomsen A, Sorensen J, Sjogren P, et al. Chronic non-malignant pain patients and health economic
consequences. Eur J Pain 2002 6:341
9. Turk DC. Clinical effectiveness and cost-effectiveness of treatments for patients with chronic pain. Clin J
Pain 2002 18(6):355-65.
10. Williams A.C.de C., Richardson P.H., Nicholas M.K., Pither C., Harding V.R., Ridout K.L., Ralphs J.A.,
Richardson I.H., Justins D.M., Chamberlain J.H. Inpatient vs outpatient pain management: results of a
randomised controlled trial. Pain 1996; 66 13–22
Comparative policies
Kent & Medway List of Low Priority Procedures policy
o Residential Pain Management Programmes are not rou inely funded
NHS Berkshire Priorities Policy:
o Funding for inpatient pain management programmes for chronic pain should be low priority on the
basis of lack of evidence of clinical and cost effectiveness compared to other multi-disciplinary
interventions
Bedfordshire and Hertfordshire Priorities s atement:
o Inpatient programmes may support more significant improvement, but are four times as
expensive as outpatient programmes
Outer North East London Procedures of Limited Clinical Effectiveness (PoLCE) policy:
o Inclusion & exclusion criteria
Penile Implants
Policy
NHS NWL CCG will not fund penile implants as first or second-line treatment for erectile dysfunction
(Grade C recommendation).
Possible exceptions to this policy are patients with severe structural disease such as:
Peyronie’s disease
pos -priapism
complex penile mal ormations
Background
This is a surgical intervention to improve male erectile dysfunction (ED). ED is the persistent inability to attain and
maintain an erection sufficient to permit satis actory sexual performance. ED is highly prevalent, and 5–20% of
men have moderate to severe ED1. First-line therapy is either oral phosphodiesterase inhibitors or vacuum
erection devices combined with risk factor modifications. If these are not e ec ive, second-line therapy includes
intracavernous injections or intraurethral medication. Penile implants are usually third-line therapy for patients
who fail to respond to or are unable to continue with medical therapy or vacuum devices2.
Two types of penile implants (PI) exist: malleable and inflatable. The malleable version uses semi-rigid rods
that keep the penis fairly rigid all the time, but allow it o be bent down when an erection isn’t needed. The other
type is a hydraulic sys em comprising a fluid-filled reservoir in the abdomen, a pump placed in the scrotum and
two inflatable cylinders. The prosthesis is activated by squeezing the pump which transfers fluid from the reservoir
to the cylinders, causing the penis to become rigid. Patients must be medically fit for surgery and accept
potential complications of infection and mechanical failure which may require re- operation2
Evidence Base
Although older devices have had technical problems, the latest generation o three-piece inflatable devices have
low rates of complications and mechanical ailure 3-5. A health technology assessment from Spain put prosthesis
survival rate at five years at 78%-91% and the complication rate as 3%-8%6.Several studies have also reported
high patient satisfaction levels after penile implants, including with regard to intercourse ability and confidence,
and device rigidity and func ion1,5 6 However, no systematic reviews or randomised controlled trials were
available.
PI has the highest initial cost of all the treatments for ED2,7. First and second-line treatments are considerably
cheaper and have proven efficacy2,7. A Canadian cost-utility study assessed the cost of various ED treatments and
their utilities in patients with spinal cord injury7. The incremental cost-utility ratios for PI compared to sildenafil (a
phosphodiesterase inhibitor) and vacuum erection devices were CAN $63,412 and CAN $178,626 per qualityadjusted life year, respectively. Therefore firs and second-line treatments are more likely to be cost-effective in
patients with ED than P Several guidelines including the British Society for Sexual Health concur that the
management of ED should be staged, with PI as a last-stage treatment for those in which previous treatments
have failed1,2,4,6 or those with severe structural disease such as Peyronie’s disease, post-priapism or complex
penile malformations2,6
Summary
Low failure and complication rates (level 2b)
High patient satisfaction outcomes (level 2b)
Less cost-effective than first and second-line treatments (level 2b)
References
References:
1. European Association of Urology 2010: Guidelines on Male Sexual Dysfunction: Erectile dysfunction
and premature ejaculation. Available at: www.uroweb.org
2. British Society for Sexual Health 2007. Guidelines on the management o erectile dysfunction.
Available at: www.bssm.org uk
3. Wilson SK, MA Cleves, JR Delk, 2nd, Comparison of mechanical reliability o original and enhanced
Mentor Alpha I penile prosthesis. J Urol 1999;162:715-718.
4. American Urological Association 2006. Management of erectile dysfunction: an update. Available at:
www auane org
5. Safety and efficacy outcome of mentor alpha-1 inflatable penile prosthesis implantation for impotence
treatment. Goldstein I, L Newman, N Baum, M Brooks, L Chaikin, KGoldberg, A McBride, RJ Krane, J
Urol 1997;157:833-839
6. Penile prosthesis implantation in the treatment of erectile dysfunc ion (HTA report). Santiago de
ComPostela: Galician Agency or HealthTechnology Assessment (AVALIA-T) 2005: 111
7. Erectile dysfunction in spinal cord injury: a cost-utility analysis. N Mittman, C Craven, M Gordon, et al. J
Rehabil Med 2005; 37: 358–364
8. Comparative policies (other NHS organisations):
NHS Kent & Medway: Not routinely funded
NHS Devon: Not routinely funded
NHS Western Cheshire: Not routinely unded
NHS North Lincolnshire: Treatment will not routinely be approved except for patients with impotence
of organic cause, or for those who have failed to respond to or are unable to continue with medical
treatmen or external
Polysomnography
Policy
Full polysomnography (with electroencephalogram EEG, electro-oculogram EOG and electromyogram EMG sleep
staging) is NOT needed to diagnose the majority of cases of obstructive sleep apnoea/hypnoea syndrome (OSA/H).
In those with high and moderate pretest probability respiratory polygraphy (a cardiorespiratory sleep study) is
adequate.1,2
Full polysomnography is reserved for those with:
a)
suspected sleep disordered breathing (OSA/H) in whom a cardiorespiratory sleep study has not produced a
clear diagnosis,
b)
if an intrinsic sleep disorder is suspected e.g. narcolepsy, REM sleep behaviour disorder in which
EEG/EOG/EMG sleep staging is required to make the diagnosis
c)
to assess response to therapy/monitor progress in some conditions
d) to investigate failure to respond to therapies such as continuous positive airway pressure (CPAP)
and non-invasive ventilation ( NIV) providing adequate control of respiratory events and adherence to therapy has
been confirmed.
Background
Adults (>16 years) services
Full polysomnography is indicated:
In patients with symptoms of obstructive sleep apnoea/hypnoea syndrome such as excessive daytime
somnolence or nocturnal choking in whom a cardiorespiratory sleep study has not established a diagnosis.
In patients with hypersomnolence and features associated with narcolepsy -e.g. cataplexy, sleep paralysis,
hypnogogic hallucinations (combined with multiple sleep latency tests, MSLT).
In patients with features of parasomnias such as REM sleep behavior disorder (e.g. acting out dreams, hitting
partner/ bedside objects)
In patients with limb movement disorders in which a diagnosis cannot be made on a clinical history and
cardiopulmonary sleep study alone.
In the differential diagnosis of circadian sleep disorders such as delayed sleep phase syndrome and
advanced sleep phase syndrome (usually together with actigraphy)
In cases of persistent hypersomnolence (>3 months) or cyclical hypersomnolence which are not explained by
other causes.
NHS NWL CCGs Planned Procedures with a Threshold Policy. Version 3 (Feb 2013)
In nocturnal movement disorders, nocturnal fits or if repetitive stereotypic movements occur during sleep (full
montage EEG monitoring and neurology opinion may be required).
In patients with confirmed obstructive sleep apnoea/hyponoea syndrome who fail to respond to CPAP therapy
despite evidence of control of apnoea and hyponoeas, and evidence of adherence to treatment.
In patients receiving ventilatory support e.g. non-invasive ventilation (NIV) for nocturnal hypoventilation in
whom symptom control is not achieved despite evidence of control of hypoventilation, adherence to therapy
and use of information downloaded from device on leak, respiratory events mask fit etc. from device.
In suspected parasomnias such as sleep walking, sleep terrors in which diagnosis cannot be made of history
alone.
In some cases of insomnia to exclude other diagnoses which may be contributing to poor sleep quality.
To assess response to medical therapeutic interventions such as use of: modafinil for narcolepsy, e.g.
clonazepam for REM sleep behavior disorder, antiparkinsonian medication such as L-dopa or ropinirole for
restless limb syndrome, melatonin for circadian disorder and use of antiepileptic therapy for simple or
complex fit disorders.
Paediatric services
Full polysomnography is indicated:
In children with symptoms of obstructive sleep apnoea/hyponoea syndrome (symptoms and signs may
include somnolence or hyperactivity, witnessed apnoeas, snoring and failure to thrive) in whom a
cardiorespiratory sleep study (respiratory polygraphy) has not achieved a diagnosis. This includes children
with adenotonsillar hypertrophy, or those with syndromes such as Prader Willi syndrome, Down syndrome,
mucopolysaccharidoses or craniofacial disorders.
If the diagnosis or narcolepsy is suspected.
To confirm the diagnosis of congenital central hypoventilation syndromes (CO2 monitoring also required).
To confirm central apneas and other complex sleep disorders in which occurrence in NREM or REM sleep is
important to know for further management.
In infants in who sleep disordered breathing is suspected or who have had an apparent life threatening
episode (ALTE), and in whom diagnosis is not clear using a cardiorespiratory sleep study.
In patients with cyclical or episodic hypersomnolence and features suggestive of Kleine Levin syndrome.
As part of the diagnostic work-up of a child with a undiagnosed neurological/neuromuscular disorder in which
it may clarify the component of central control of breathing disorder and peripheral weakness of respiratory
muscles.
Full polysomnography may be indicated to titrate device therapy e.g. CPAP or NIV in children with complex
sleep disorders or in obstructive sleep apnoea/hyponoea if symptomatic control cannot be achieved using
cardiorespiratory titration, and information downloaded from device.
Full polysomnography may be indicated to assess the response to medical therapy in children with
narcolepsy, complex sleep disorders, nocturnal epilepsy, insomnia, circadian disorders.
References
1.
2.
SIGN guidelines for Obstructive Sleep Apnoea. Scottish Intercollegiate Guidelines network 2003.
Service Specification for sleep apnoea and CPAP provision. British Thoracic Society 2008
NHS NWL CCGs Planned Procedures with a Threshold Policy. Version 3 (Feb 2013)
Septorhinoplasty
Policy
NHS NWL CCGs will not fund Septorhinoplasty procedures for cosmetic reasons
Septorhinoplasty procedures will be funded for functional reasons where:
1. Patient has a deviated septum causing significant and persistent nasal blockage
2. A septoplasty alone will not improve functional impairment
3. Septorhinoplasty is not being performed for cosmetic reasons .
For all other indications – please apply via the IFR route etc .
Background
Septorhinoplasty is a surgical procedure to correct a deformity of the nasal septum as well as the bony deformity of the pyramid
of the nose.
References
1.
2.
3.
Aetna. Clinical Policy Bulletin: Septorhinoplasty and Rhinoplasty (2011)
http://www.aetna.com/cpb/medical/data/1_99/0005.html
Nease CJ, Deal RC. Septoplasty in conjunction with cosmetic rhinoplasty. Oral and Maxillofacial surgery
clinics of North America, 2012; 24 (1), 49-58,
Phillips PS, Stow N, Timperley DG, Sacks R, Srubiski A, Harvey RJ, Marcells GN. Functional and
cosmetic outcomes of external approach septoplasty. Americal Journal of Rhinology and Allergy. 2011;
25(5) 351-357
Laser Surgery for Short Sight
Policy
NHS NWL CCGs will not fund laser eye surgery for the correction of Myopia, only in exceptional circumstances
via the Individual Funding Request (IFR) route.
Background
Short sight or myopia (ICD-10 Code: H52.1) is a condition where distant objects appear blurred. Refractive
errors are usually corrected by wearing spectacles or contact lenses, and these treatments are currently not
available on the NHS. Both have limitations and contact lens wear is associated with an increased risk of sightthreatening corneal infection. Surgical treatments have been developed o permanently improve refraction by reshaping the cornea. In laser (photore rac ive) surgery, corneal re-shaping is achieved using excimer laser
ablation. Excimer laser techniques include photorefractive keratectomy (PRK), laser epithelial
keratomileusis (LASEK) and laser in situ keratomileusis (LASIK).
Evidence Base
Current evidence suggests that laser surgery for the correction of myopia is safe and efficacious for use in
appropriately selected patients.1,2 Several reviews have concluded that the three techniques appear to be equally
effec ive in achieving the predicted refractive outcome in myopia. 2 - 4 There is some risk for permanent side
effects associated with the surgical procedures, although these are rare.2,4
Laser surgery is more effective at lower levels of myopia. 2 , 4 An alternative technique for higher levels is
phakic intraocular lenses (IOL). A Cochrane review suggested that phakic IOLs are safer than laser surgical
correction for moderate o high myopia and preferred by patients.5
The safety and efficacy of laser surgery should be considered against the more common methods of correction:
spectacles and contact lenses. Unfortuna ely there was no evidence directly comparing the risk profile and/or
cos -e ectiveness of surgery with spectacles and contact lenses.6
Summary:
There is strong evidence (level 1A) that laser surgery is safe and effective in selected patients with
myopia.
Phakic IOLs are safer than laser surgery in higher levels of myopia (level 1A).
There is no evidence directly comparing the risk profile and/or cost-effectiveness of laser surgery to the
alternatives of spectacles and/or contact lenses.
References
Patient information
http://www.nhs.uk/Conditions/Short-sightedness/Pages/Introduction.aspx
1.
2.
3.
4.
5.
National Institute for Health and Clinical Excellence.
Pho orefractive (laser) surgery for the
correction of refractive errors. London: NICE; 2006. Available at: http://www.nice.org.uk/IPG164
[Accessed 19th Sept 2007
Murray A, Jones L, Milne A et al. A systematic review of the safety and efficacy of elective photorefractive
surgery for the correction of refractive error.
Aberdeen: University of Aberdeen; 2005.
Shortt AJ, Allan BDS. Photorefractive keratectomy (PRK) versus laser-assisted in-situ keratomileusis
(LASIK) for myopia. Cochrane Database of Systematic Reviews 2006, Issue 2. Art. No.: CD005135.
DOI:10.1002/14651858.CD005135.pub2.
Swedish Council on Technology Assessment in Health Care. Laser eye surgery for the correction of
refractive errors - early assessment briefs (Alert).Swedish Council on Technology Assessment in
Health Care (SBU). SBU Alert report no. 2007-04. 2007
Barsam A, Allan BDS. Excimer laser refractive surgery versus phakic intraocular lenses for the
correction of moderate to high myopia Cochrane Database of Systematic Reviews 2010, Issue
5.Art.No.:CD007679. DOI:10.1002/14651858.CD007679.pub2.
Temporomandibular Joint Retainers and
Appliances
Policy
NHS NWL CCGs will not fund TMJ appliances unless in exceptional cases.
situations might be considered exceptional:
For example, the following
Patient has unsuccessfully tried alternative, cheaper treatments including: analgesics, muscle relaxants,
stress reduction and self-massage, soft diet
Background
Malfunction of the temporomandibular joint (TMJ) which lies between the base of the skull and the lower jaw is an
important oral health problem and reduces the quality of life of sufferers due to pain, muscle spasms and difficulties
in moving the joint. In 2007 approximately 1 in 1000 people in England were diagnosed with TMJ by a GP2,
although more will present to a dentist. It is estimated that around 1 in 6 people suffer from some sort of TMJ
disorder, onset is most common between 20 and 50 and approximately 2/3 of sufferers are women. The prognosis
for TMJ is generally good as both groups in RCTs tend to improve with time, regardless of type of treatment
physical therapy, stress reduction, massage, occlusal splints) or placebo3, however “no
specific therapies have proven to be uniformly effective but conservative treatments provide at least as much
symptomatic relief as invasive treatments, with less risk of harm6”.
Evidence base
Occlusal splits, also known as the Tanner appliance, the Fox appliance, the Michigan splint, or the centric relation
appliance are the subject of two systematic reviews. A Cochrane systematic review found weak evidence that hard
stabilization splints (the most common type of occlusal splint) reduce pain severity in people with myofascial pain,
but that they are no more effective
other active treatments. Conversely, a subsequent systematic
review found more convincing evidence that hard stabilization appliances (splints) reduce pain in people with
temporomandibular disorders compared with a non-occluding appliance, but did not demonstrate that hard
stabilization appliances reduce pain more than no treatment3, possibly due to underpowered studies. No economic
evaluations or cost benefit analysis of treatment have been found (NHS Evidence, NICE, Bandolier, EMBASE,
HMIC, MEDLINE).
References
http://www.tmj.org/site/
References:
1. Guo C, Shi Z, Revington P. Arthrocentesis and lavage for treating temporomandibular joint disorders.
Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.: CD004973. DOI:
10.1002/14651858.CD004973.pub2.
2. Birmingham Research Unit (2007) Weekly returns service: annual prevalence report 2007. Royal
College of General Practitioners
3. http://www.cks.nhs.uk/tmj_disorders Accessed 19/10/10
4. Al-Ani, M.Z., Davies, S.J., Gray, R.J.M. et al. (2004) Stabilisation splint therapy for temporomandibular
pain dysfunction syndrome (Cochrane Review). Issue 1. John Wiley & Sons, Ltd.
5. Fricton, J., Look, J.O., Wright, E. et al. (2010) Systematic review and meta-analysis of randomized
controlled trials evaluation intraoral orthopaedic appliances for temporomandibular disorders. Journal of
Orofacial Pain 24(3), 237-254.
6. American Association for Dental Research – Policy Statement (2010) – Temporomandibular Joint
Disorders (adopted 1996, revised 2010)
7. Truelove E., Huggins K.H., Mancl L., Dworkin S.F. (2006) The efficacy of traditional, low- cost and nonsplint
therapies for temporomandibular disorder: A randomized controlled trial Journal of the American Dental
Association, 137/8(1099-1107)
Link to further sources of evidence:
http://www.aadronline.org/i4a/pages/index.cfm?pageid=3465#TMD Accessed 19/10/10
http://expertpages.com/news/valuation_diagnosis_treatment_tmj.htm Accessed 21/10/10
Tonsillectomy (with or without Adenoidectomy)
Policy
Suspected or confirmed malignancy – this is an absolute indication to refer. Please use the
two week cancer referral form.
Referral criteria
Referral for tonsillectomy should be considered for the following indications.
Tonsillectomy in Adults:
o
o
o
Recurrent severe sore throat in adults where Group A Streptococcal infection is suspected.
Two or more quinsys (peri-tonsillar abscesses)
Co-existing complications such as neck abscess or tonsillar enlargement causing upper
airway obstruction.
Tonsillectomy in Children:
o
Recurrent acute sore throat in children where the following conditions are met.
o sore throats are due to acute tonsillitis
o the episodes of sore throat are disabling and prevent normal functioning
seven or more well documented, clinically significant, adequately treated sore throats in
the preceding year
o five or more such episodes in each of the preceding two years
o three or more such episodes in each of the preceding three years
Two or more quinsys (peri-tonsillar abscesses)
Co-existing complications such as neck abscess or tonsillar enlargement causing upper
airway obstruction.
Failure to thrive where recurrent tonsillitis is considered a contributory factor.
Sleep apnoea. Tonsillectomy will be considered where one or more of
apply:
o A positive sleep study
o Demonstrable significant impact on quality of life
o A strong clinical history suggestive of sleep apnoea
o
o
o
o
o
* Adapted from SIGN Guidelines 2010 ; ONEL, and Kent & Medway Policy Documents
Background
Tonsillectomy is the surgical removal of the tonsils usually after recurrent episodes of tonsillitis.
Evidence Base
Tonsillectomy offers relatively small clinical-benefit. In the year after the operation the number of days not
attending school is reduced by approximately 2.8 days. The mortality risk of tonsillectomy
1:8000
and 1:35 000 cases.
The quality of the evidence for tonsillectomy in children is poor, but it suggests that surgery may be
beneficial in selected cases. In adults, evidence from a small randomized controlled trial with a short
follow up time of only 3 months suggested that tonsillectomy may benefit people with recurrent
infection. A six-month period of watchful waiting by an ENT surgeon is recommended
tonsillectomy to establish firmly the pattern of symptoms and allow the patient to consider fully the
implications of the operation. Once a decision is made for tonsillectomy, this should be performed as soon
as possible, to maximise the period of benefit before natural resolution of symptoms might occur. Watchful
waiting is more appropriate than tonsillectomy for children with mild sore throats.
References
.
Scottish Intercollegiate Guidelines Network. 117 Management of sore throat and indications for
tonsillectomy. ISBN 978 1 905813 62 9. Published April 2010
Burton MJ, Glasziou PP. Tonsillectomy or adeno-tonsillectomy versus
for
chronic/recurrent acute tonsillitis. Cochrane Database of Systematic Reviews 2009, Issue 1
Lim J, McKean MC. Adenotonsillectomy for obstructive sleep apnoea in children. Cochrane
Database of Systematic Reviews 2009, Issue 2. Art. No.: CD003136.
DOI:10.1002/14651858.CD003136.pub2.http://www.cks.nhs.uk/sore_throat_acute/evidence/supportin
g_evidence/tonsillectomy#-327542 Date accessed = 6/7/10
Trigger Finger / Tenosynovitis
Policy
Surgery for trigger finger will be funded in patients who have functional limitation affecting lifestyle or
occupation and meet one of the following criteria:
Failure to respond to conservative treatment, including at least 2 corticosteroid injections with
dates.
Who have a fixed flexion deformity that cannot be corrected
Patients for whom corticosteroid treatment is not suitable such as multiple digits affected.
Background
Trigger finger (stenosing tenosynovitis) is a disease of the tendons of the hand leading to triggering (locking)
of affected fingers, dysfunction and pain. Trigger finger usually affects the thumb, middle or ring finger, and
may develop on both hands. In most cases the underlying cause is unknown, but could be linked to
diabetes or inflammatory conditions, e.g., rheumatoid arthritis.
The symptoms may include stiffness and clicking when the finger is moved, especially first thing in the
morning; and a bump (nodule) or tenderness at the base of the affected finger in the palm. If the condition
worsens, the finger may get stuck in a bent position, then suddenly pop straight. Eventually, it may not
fully straighten and become ‘locked’.
In most cases, trigger finger is a nuisance rather than a serious condition. However, if left untreated, the
finger or thumb may actually become closed in a bent position or, less likely, in a straightened position,
which can cause difficulties in performing everyday tasks.
Treatment:
Patients managed in primary care may benefit from advice and conservative treatment that includes: rest from
activities that aggravate the condition (if that is an option for the patient) the use of ice packs to reduce
swelling exercising/massaging the affected finger(s) to relieve pain placing the affected finger(s) in warm
water for 5-10 minutes, especially in the morning NSAIDs to reduce pain and inflammation wearing a splint
at night if finger(s) bend and lock during the night and are painful to straighten in the morning for appropriate
patients, corticosteroid injection (with lidocaine) in the area of tendon sheath thickening
Spontaneous recovery may occur with time. (Schofield, 993).
Steroid Injection is an effective therapy for trigger finger and thumb. Success rates for a single injection of
steroid vary between 49-78% (Fleisch 2007, Peters-Veluthamaningal 2008). A second injection is often
(50%) successful if the first has no, or only temporary, effect (Akhtar 2007, Ring 2008). Steroid
injections have few complications (Baumgarten 2008, Peters-Veluthamaningal 2008) and are safely given in
the primary care setting (Peters-Veluthamaningal 2008).
Surgical release is an effective treatment with a high success rate, low complication rate and short
recovery period (3-4 weeks). It is usually done on a day case basis under local anaesthetic and provides
a permanent “cure” when performed by appropriately trained surgeons.
Surgery (trigger finger release) is indicated:
after failed conservative treatment
for recurrent triggering after 1-2 injections of steroid
if there are severe symptoms at presentation
in populations who are unlikely to benefit from steroid injections (for example a diabetic with
many digits affected and severe symptoms)
References
Patient Information:
http://www.nhs.uk/conditions/Trigger-finger/Pages/Introduction.aspx
References:
1.
2.
3.
4.
5.
6.
Schofield CB, Citron ND.The natural history of adult trigger thumb. J Hand Surg [Br].1993
Apr;18(2):247-8.
Fleisch SB, Spindler KP, Lee DH. Corticosteroid injections in the treatment of trigger finger: a level I and
II systematic review. J Am Acad Orthop Surg. 2007 Mar;15(3):166-71. Review.
Peters-Veluthamaningal C, Winters JC, Groenier KH, Jong BM. Corticosteroid injections effective
for trigger finger in adults in general practice: a double-blinded randomised placebo controlled trial.
Ann Rheum Dis. 2008 Sep;67(9):1262-6. Epub 2008 Jan 7.
Akhtar S, Burke FD. Study to outline the efficacy and illustrate techniques for steroid injection for trigger
finger and thumb. Postgrad Med J. 2006 Nov;82(973):763-6. Review.
Ring D, Lozano-Calderón S, Shin R, Bastian P, Mudgal C, Jupiter J. A prospective randomized
controlled trial of injection of dexamethasone versus triamcinolone for idiopathic trigger finger. J Hand
Surg [Am]. 2008 Apr;33(4):516-22; discussion 523-4.
Baumgarten KM. Current treatment of trigger digits in patients with diabetes mellitus. J Hand Surg [Am].
2008 Jul-Aug;33(6):980-1. Review.
Uterovaginal Prolapse
Policy
NHS NWL CCGs will only fund surgical interventions for Uterovaginal Prolapse in the following circumstances:1) In cases of mild to moderate symptomatic cystoceles where trial of a pessary has failed.
2) In cases of mild to moderate symptomatic rectoceles.
3) In severe cases of prolapse or procedentia
Initially, patients should be assessed and managed conservatively in primary care.
1.
2.
3.
Watchful waiting, with observation for the development of new symptoms or complications
Appropriate if the prolapse is minimal (Stage I)2, or asymp omatic
Conservative treatment options
2.1 Lifestyle modification
Treatment of conditions that increase intra-abdominal pressure: constipation, chronic cough,
overweight/obesity; reduction of heavy lifting (while POP has been associated with these factors, he role of
lifestyle modification in prevention/treatment has not been investigated)1 .
2.2. Pelvic floor muscle exercises
Role in managing prolapse unclear; probably not useful if the prolapse ex ends to or beyond the vaginal
introitus.
Cochrane review 2006: concluded evidence was insufficient (from 3 randomised trials) to judge the value
of conservative management of POP, & that further trials were needed7
The pilot study for the Pelvic Organ Prolapse Physiotherapy (POPPY) multi-centre trial suggested that
pelvic floor muscle training delivered by a physiotherapist to symptomatic Stage I or II POP women in
an outpatient setting may reduce the severity of prolapse12
2.3. Local (vaginal) oestrogen creams
Cochrane review 2010: limited evidence from RCTs regarding use of oestrogens to reduce or prevent the
symptoms of prolapse; need for rigorous RCTs with long- term follow-up to assess oestrogen
preparations, particularly as an adjunctive treatment for women using pessaries, and be ore & after
prolapse surgery4
Use of local oestrogen in conjunction with pelvic floor muscle training before surgery may reduce the
incidence of post-operative cystitis within 4 weeks after surgery4
Oral raloxifene may reduce the need for POP surgery in women >60 years although this cannot be
taken as an indication for practice4
Vaginal pessary insertion
Cochrane review 2004: no RCTs of pessary use in women with prolapse13; there is no consensus on
the use of different types of device, the indications, nor the patterns of replacement & follow-up care1 3 ;
evidence or pessary selection and management is incomplete so trial and error, expert opinion, and
experience remain the best guides for use and management o he pessary14
Although not supported by definitive evidence, current opinion is that pessaries are effective1 & should
be considered before surgery in women who have symptomatic prolapse15; they can be attempted in all
POP cases irrespective of stage15,16
o for short-term relief before surgery, or in the long-term if surgery is not wan ed or recommended14
o to predict surgical outcomes14 or unmask occult urodynamic stress incontinence before
surgery, as part of the investigation of con inent women with POP (so that the decision to
perform a concomitant continence procedure along with pelvic reconstruction can then be
individually tailored)
Risk factors for unsuccessful fitting include: short vaginal length <6 cm and wide introitus >4
fingerbreadths1 6 ; local oestrogens may play a role in successful fitting17
Failure to retain the pessary has been associated with increasing parity and previous
hysterectomy1 8 ; and discontinuation with history of hysterectomy or prolapse surgery, and stress
incontinence19;
Follow-up: no clear consensus on how often to follow up1 ; after 3 months & then every 6 months, if
there are no complications, has been suggested1;
Complications tend to occur in women who are not regularly followed up1; self- care of pessary is also
important to minimise adverse events16; however, many patients find insertion & removal of most pessary
ypes challenging20
Policy (continued)
4. Surgery
Assessed as effective, but with a close risk/benefit in mild cases; a combination of procedures may be
required and reoperation is required in 29% of cases1
Types of repair surgery vary depending on type of POP & associated symptoms, whether the woman
is sexually active & her fitness for surgery
4.1. Reconstructive surgery (abdominal or vaginal approach)
2010 Cochrane review of surgical management of POP: found 40 RCTs with a variety of types of
POP5
o There was not enough evidence on most types of common prolapse surgery nor about the use
of mesh or grafts in vaginal prolapse surgery
o Impact of POP surgery on bowel, bladder & sexual function can be unpredictable
& may make symptoms worse or result in new symptoms, such as leakage of
urine (unmask occult SI) or problems with intercourse5
o Uterine/vaginal vault prolapse: abdominal sacral colpopexy may be better than vaginal
sacrospinous colpopexy – it was associated with a lower rate of recurrent vault prolapse and
dyspareunia; these benefits must be balanced against a longer operating time, longer time to
return to activities of daily living and increased cost of the abdominal approach5
o Posterior vaginal wall prolapse/ rectocele: posterior vaginal wall repair may be better than
transanal repair in terms of recurrence of prolapse (limited evidence)5
o Value of the addition of a continence procedure to a prolapse repair operation in women who
are dry before operation remains to be assessed5
Use of mesh/graft inlays (biological or synthe ic):
o 2010 Cochrane review5 : use of mesh or grafts at the time of anterior vaginal wall repair
reduces the risk of recurrent anterior wall prolapse on examination; however, evidence of
benefit to the woman, including symptoms and quality of life improvement, is lacking for the
use of grafts over native tissue repairs5
o 2008 NICE guidance2 1 : surgical repair of vaginal wall prolapse using mesh
4.2 Obliterative Surgery
Corrects POP by moving the pelvic viscera back into the pelvis & closing o the vaginal canal;
vaginal intercourse is no longer possible1
Clinical scenarios where surgery
will not be routinely funded
Asymptomatic pelvic organ prolapse
Mild pelvic organ prolapse (unless
combined with urinary/faecal
incontinence)
Clinical scenarios where referral for
specialist assessment is necessary to
determine suitability for surgery
Failure of pessary
Women with symptomatic prolapse (including
those combined with ure hral sphincter
incompetence or faecal incontinence)
Prolapse combined with urethral sphincter
incompetence/ urinary incontinence or faecal
incontinence
Women with moderate to severe prolapse who
want definitive treatmen
Recommendations
Initially, patients should be assessed and managed conservatively in primary care
All patients should have a trial of ring pessary, including suitable candidates for surgery, as part of the
investigation of continent women with prolapse; he decision to perform a concomitant continence
procedure along with pelvic reconstruction can then be individually tailored
Patient information
http://www.nhs.uk/conditions/Prolapse-of-the-uterus/Pages/Introduction.aspx
Background
Pelvic organ prolapse (POP) (genitourinary prolapse) refers to abnormal descent/ herniation of one or more of the pelvic
organs as a result of failure of ligamentous and fascial supports, resulting in the protrusion of the organ beyond its normal
anatomical confines. Prolapse can occur in the anterior (urethrocele, cystocele, cystourethrocele), middle/apical (uterine,
vaginal vault (pos -hys erectomy), enterocele), or posterior (rectocele) compartment of the pelvis1. POP development is
multifactorial2,3, with vaginal child birth, advancing age, and increasing body-mass index (BMI) the most consistent risk
factors3
Diagnosis is usually clinical and based on history and pelvic (speculum) examination to establish the compartments
affected (classification of the prolapse) and define he extent of the prolapse (grading of severity/degree)2.
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
Patient UK. Genitourinary Prolapse. 2010 [updated 2010 31 August; cited 2010 28 October ]; Available from:
ht p www.pa ient.co.uk doctor Genitourinary-Prolapse.htm
Doshani A, Teo RE, Mayne CJ, Tincello DG. Uterine prolapse. BMJ. 2007 Oc 20;335(7624):819-23.
Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet. 2007 Mar 24;369(9566):1027-38.
Ismail SI, Bain C, Hagen S. Oestrogens for treatment or prevention of pelvic organ prolapse in postmenopausal women. Cochrane
Database Syst Rev 2010(9):CD007063.
Maher C, Feiner B, Baessler K, Adams EJ, Hagen S, Glazener CM Surgical management of pelvic organ prolapse in women.
Cochrane Database Syst Rev 2010(4):CD004014.
Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity
and gravidity. Am J Obstet Gynecol.2002 Jun 186(6):1160-6
Hagen S, Stark D, Maher C, Adams E. Conservative management of pelvic organ prolapse in women. Cochrane Database Syst
Rev. 2006(4) CD003882.
Handa VL, Garrett E, Hendrix S, Gold E, Robbins J. Progression and remission of pelvic organ prolapse: a longitudinal study of
menopausal women. Am J Obstet Gynecol.2004 Jan 190(1):27-32
Hall AF, Theofrastous JP, Cundiff GW, Harris RL, Hamilton LF, Swift SE, e al. Interobserver and intraobserver reliability of the
proposed International Continence Society, Society of Gynecologic Surgeons, and American Urogynecologic Society pelvic organ
prolapse classification system. Am J Obstet Gynecol. 1996 Dec;175(6):1467-70; discussion 70-1.
Radley SC, Jha S. The benefits of an internet pelvic floor questionnaire. Continence UK. 2007;1(1).
Jones GL, Radley SC, Lumb J, Farkas A. Responsiveness of the elec ronic Personal Assessment Questionnaire-Pelvic Floor
(ePAQ-PF). Int Urogynecol J Pelvic Floor Dysfunct. 2009 Feb 3.
Hagen S, Stark D, Glazener C, Sinclair L, Ramsay I. A randomized controlled trial of pelvic floor muscle training for stages I and II
pelvic organ prolapse. In Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1) 45-51
Adams E, Thomson A, Maher C, Hagen S. Mechanical devices for pelvic organ prolapse in women. Cochrane Database Syst Rev.
2004(2) CD004010.
Atnip SD. Pessary use and management for pelvic organ prolapse. Obste Gynecol Clin North Am. 2009 Sep;36(3):541-63
Kuncharapu I, Majeroni BA, Johnson DW. Pelvic organ prolapse. Am Fam Physician. 2010 May 1 81(9):1111-7
Manchana T. Ring pessary for all pelvic organ prolapse. Arch Gynecol Obstet. 2010 Sep 17
Hanson LA, Schulz JA, Flood CG, Cooley B, Tam F. Vaginal pessaries in managing women with pelvic organ prolapse and urinary
incontinence: pa ient characteristics and factors contributing to success. Int Urogynecol J Pelvic Floor Dysfunct. 2006
Feb 17(2):155-9
Fernando RJ, Thakar R, Sultan AH, Shah SM, Jones PW. Effect of vaginal pessaries on symptoms associated with pelvic organ
prolapse. Obstet Gynecol. 2006 Jul;108(1) 93-9.
Friedman S, Sandhu KS, Wang C, Mikhail MS, Banks E. Factors influencing long- term pessary use. Int Urogynecol J Pelvic Floor
Dysfunct. 2010 Jun;21(6):673-8
Jones KA, Harmanli O. Pessary use in pelvic organ prolapse and urinary incontinence. Rev Obstet Gynecol. 2010 Winter;3(1):3-9
National Institute for Health and Clinical Excellence
Varicose Veins
Policy
NHS NWL CCGs will only fund invasive procedures for varicose vein surgery if at least one of the
following criteria are
History of bleeding from a varicosity and at risk of bleeding again
Ulcer which is progressive and/or painful despite treatment
Recurrent superficial thrombophlebitis.
Progressive skin changes e.g. pigmentation, eczema, lipodermatosclerosis or atrophie blanche
Venous skin problems
If the patient’s quality of life is severely affected for example, inability to stand for long periods of time, affecting life
and/or occupation. ALL of the below must apply
o There is evidence that symptoms severely affect quality of life with respect to physical functioning
o There has been a documented unsuccessful 6 month trial of conservative management, for relief of
the symptoms severely affecting quality of life
o Symptoms are disease-specific and cannot be attributed to co-morbidities or other disease/disability
affecting the lower limb(s) concerned,
Patients who do not meet these criteria should be offered conservative therapy in primary care, which includes:
Compression stockings
Exercise
Daily elevation several times a day
This policy will be reviewed once final NICE guidance is published. Revised policy is expected to be in
September 2013.
(Brent CCG, Central London CCG, Ealing CCG, Hammersmith and Fulham CCG, Harrow CCG, Hillingdon CCG,
Background
Varicose veins (ICD-10 Code:183) are dilated superficial veins in the leg caused by incompetent venous valves.
In the UK varicose veins occur in around 15–20% of adults. Although treatment for varicose veins is generally
effective recurrence is estimated at around 50% within five years. An evidence based classification of varicose
veins (CEAP, 2004) is given below to assist clinicians in assessing the severity of varicose veins. There is mixed
evidence as to the relative effectiveness of sclerotherapy or surgery, therefore specific surgical options for
individual patients should be left to clinical decision. Whilst symptom severity generally corresponds to disease
severity, there is also evidence of severe limitations on quality of life in some patients with lower level disease
C0
C1
C2
C3
C4
C5
C6
No visible or palpable signs of venous disease
Telangiectasies or reticular veins
Varicose veins; diameter >3mm
Oedema
Changes in skin and subcutaneous tissue: pigmentation, eczema,
lipodermatosclerosis or atrophie blanche
Healed venous ulcer
Active venous ulcer
References
http://www.cks.nhs.uk/patient_information_leaflet/Varicose_Veins
References
Simpson, S. & Roderick, P. in Stevens, A., Raftery, J., Mant, J. & Simpson, S. (eds) Health Care Needs
Assessment First Series, Volume 1, Second Edition “Varicose Veins & Venous Ulcers” (2004)
N.I.C.E. Referral Advice: a guide to appropriate referral from general practice to specialist services 2001
N.I.C.E. Interventional Procedures guidance IPG8 (September 2003)
N.I.C.E. Interventional Procedures guidance IPG52 (March 2004)
Campbell B. Clinical Review - Varicose veins and their management. BMJ 2006;333:287-292
Bradbury A, Evans C, Allan P et al. What are the symptoms of varicose veins? Edinburgh vein study
cross
sectional
population
survey.
BMJ
1999;318:353-356
(6
February)
http://www.cks.nhs.uk/varicose_veins#-341091 Date accessed = 6/7/10
Rigby KA, Palfreyman SSJ, Beverley C, Michaels JA. Surgery versus sclerotherapy for the treatment of
varicose veins. Cochrane Database of Systematic Reviews 2004, Issue 4. Art. No.: CD004980. DOI:
10.1002/14651858.CD004980.
Eklof B, Rutherfors RB, Bergan JJ et al. Revision of the CEAP Classification for chronic venous
disorders: Consensus Statement. J Vas Surg 2004; 40; 1248 – 52
Nesbitt C, Wilson WRW, Lees TA and Stansby G. Interpretation of patient-reported outcome measures
for varicose vein surgery. Phlebology 2012; 27: 173-178.
Carradice D, Mekako IA, Mazari FAK et al. Randomized clinical trial of endovenous laser ablation
compared with conventional surgery for great saphenous varicose veins. British Journal of Surgery
2011; 98: 501–510
Conway, AM, Nordon IM, Hinchliffe RJ et al Patient-reported symptoms are independent of disease
severity in patients with primary varicose veins. Vascular 2011; 19(5);262–268.Venous Forum of the
Royal Society of Medicine. Recommendations for the referral and treatment of patients with lower limb
chronic insufficiency including varicose veins. Phlebology 2011;26:91–3
Darvall KA, Bate GR, Adam, DJ Bradbury AW. Generic Health-related Quality of Life is Significantly
Worse in Varicose Vein Patients with Lower Limb Symptoms Independent of Ceap Clinical Grade.
European Journal of Vascular and Endovascular Surgery 2012; 44;) 341-344

- NHS Ealing Clinical Commissioning Group

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