Formulary additions . . . . . .1

ISS U E 1
u Formulary Additions . . . . .
u National Medicare Part D
Formulary . . . . . . . . . . . . . .
u Floostock Additions . . . . . .
u KPGA Approved Compounds .
u Clinical Updates . . . . . . . .
u Medications Reviewed At
VOLUME 7
F E B R U A RY 2 0 1 3
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2
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3
P&T, But Not Added To The
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Formulary . . . . . . . . . . . . 4
Formulary
Update
Formulary Additions
Orencia (abatacept) 125 mg/ml injection is
currently available on the National Medicare
Part D (MPD) Formulary as Tier 5, specialty,
and was added to the Commercial Formulary
effective February 21, 2013. Orencia is a selective
T cell co-stimulation modulator FDA approved for the
treatment of moderate to severe rheumatoid arthritis.
Orencia was previously only available as an intravenous (IV) infusion, but is not
available as a subcutaneous injection for patient self administration. Outpatient
administration carries a convenience for patients and can spare infusion clinic
visits and related costs. Commercial members will pay their brand co-pay for
subcutaneous Orencia. Since Orencia is Tier 5, Specialty, on the National MPD
Formulary, MPD members will pay a 25% co-insurance for the subcutaneous
Orencia.
Complera (rilpivirine/emtricitabine/tenofovir)
25/200/300 mg tablets are currently available on the
National MPD Formulary as Tier 5, specialty, and were
added to the Commercial Formulary effective February
21, 2013. Complera is a fixed combination antiretroviral
agent FDA approved for the treatment of HIV-1 infection in
adults. It is a combination of two nucleoside/nucleotide reverse
transcriptase inhibitors (emtricitabine & tenofovir) and a nonnuceloside reverse transcriptase inhibitor (rilpivirine).
A P U B L I C AT I O N O F T H E G E O R G I A
PHARMACY AND THERAPEUTICS (P&T)
C O M M I T T E E . The Formulary Update contains
information regarding formulary additions,
deletions, exclusions, brief descriptions of
products, and current drug related news. It also
lists items to be discussed at upcoming P&T
meetings. Please refer to the web site http://
kpnet.kp.org:81/ga/healthcare/formularies.html or
providers.kp.org for the full KP GA Drug Formulary.
If you have Lexi-Comp PDA access to the KPGA
Online Formulary, remember to sync your device
for the most current information.
EpiPen & EpiPen Jr (epinephrine) are currently
available on the National MPD Formulary as Tier
3, brand, and were added to the Commercial
Formulary effective February 21, 2013. EpiPen and
Epipen Jr are epinephrine authoinjectors FDA approved
for the treatment of Type 1 allergic reactions. In December
2010, EpiPen and EpiPen Jr were removed from the
formulary and replaced with epinephrine autoinjector
(generic Adrenaclick); however, that product has been
discontinued by the manufacturer. EpiPen and EpiPen Jr will be available to
members for their brand co-payment.
Kaiser Permanente Georgia
1
Formulary Additions, Continued
Carbamazepine (Tegretol-XR) 200 mg & 400 mg extendedrelease tablets are currently available on the National
MPD Formulary as Tier 2, generic, and were added to
the Commercial Formulary effective February 21, 2013.
U pcoming
F ormulary
D ecisions
Carbamazine ER (Tegretol XR) tablet is an anticonvulsant FDA approved
for partial seizures with complex symptomatology (psychomotor,
temporal lobe), generalized tonic-clonic seizures (grand mal), mixed
seizure patterns, trigeminal neuralgia, glossopharyngeal neuralgia. Due to a contract
change, carmabazpine ER tablet is now more cost effective than carbamazpine ER capsule
(Carbatrol).
National Medicare Part D Formulary
Kaiser Permanente has a National Medicare Part D (MPD) Formulary. Each regional P&T
Committee reviews drugs and decides on tier status. The National Medicare Part D
Pharmacy and Therapeutics Committee is charged with reconciling regional differences in
MPD Formulary recommendations through consensus building in order to maintain one
National MPD Formulary for Kaiser Permanente.
National MPD Formulary Tier changes are listed below with their
corresponding effective date:
Medication Name
Tier
Effective Date
ProAir HFA (with counter)
Tier 3
02/05/2013
Lumigan (bimatoprost) 0.1% ophth drops
Tier 3
02/05/2013
Gattex (teduglutide) 5 mg inj
Tier 5
02/05/2013
Juxtapid (lomitapide) 5 mg, 10 mg, & 20 mg
capsules
Tier 5
02/05/2013
Signifor (pasireotide) 0.3 mg/ml, 0.6 mg/ml, &
0.9 mg/ml inj
Tier 5
02/05/2013
Tier 1 = Value Generic
Tier 3 = Brand
Tier 5 = Specialty
Tier 2 = Generic Tier 4 = Non-Preferred Brand Tier 6 = Injectable Part D Vaccine
An important aspect of the
formulary process is the
involvement of all practitioners.
So that each of you has an
opportunity to participate in the
process, upcoming P&T agenda
items are listed below. Please
contact your P&T Committee
representative or your clinical
service chief by March 15, 2013
if you wish to comment on
any of the medications, class
reviews, or other agenda items
under consideration. To make
formulary addition requests,
you must submit a Formulary
Additions/Deletions Form and
Conflict of Interest Form to Drug
Information Services or call (404)
949-5331.
Formulary Reviews
(April 2013):
• Formulary status of the
following medications will be
reviewed: Azelastine
Medication Class Reviews
Medical Office Floorstock Additions
The medications below will be added to the electronic floorstock ordering forms on the
intranet:
Androgen/Anabolic Agents
Antidiabetic Agents
Antiemetic Agents
Antineoplastic Agents
Department Name
Medication Added
Corticosteroids
Pain Management
Gentamicin 2 mg/ml vial
Pediatrics
MenHibrix
Dietary Management
Agents
Digestive Aids
Gastrointestinal Agents,
Misc
New KPGA Approved Compounds
Only medications on the List of Approved Compounds may be prepared at Kaiser
Permanente Pharmacies. The Approved list of Compounds and recipes are posted on the
intranet under Healthcare Delivery/Pharmaceutical Services/Compounds.
The medication listed below was added to the List of Approved Compounds:
• Testosterone 2% in velvachol topical cream
2 Kaiser Permanente Georgia
Gout Agents
Ophthalmic Agents
Pharmaceutical Adjuvants
Thyroid Agents
Q uestions and
C oncerns ?
If you have any questions or
concerns, please contact any of
the following P&T Committee
members and designated
alternates:
P&T Chair:
Daniel Lee, MD, FACS
Physician Program Director of Pharmacy
P&T Committee Members:
Seeme Ahmad, MD*
Behavioral Health
Debbi Baker, PharmD, BCPS
Clinical Pharmacy
Gary Beals, RPh
Director of Pharmacy
Karen Bolden, RN, BSN
Clinical Services
Deborah Burzotta, PharmD
Pharmacy Operations
Alyssa Dayton, MD
Obstetrics and Gynecology
Carole Gardner, MD
Elder Care
Patrice Gaspard, MD
Pediatrics
Marcus Griffith, MD*
Behavioral Health
Donald Hanchett, MD
Ambulatory Medicine
David Jones, MD
Pediatrics
Felecia Martin, PharmD
Pharmacy/Geriatrics
Susan Moon, MD
Hospitalist
LaJune Oliver, MD
Ambulatory Medicine
Designated Alternates:
Jacqueline Anglade, MD
Obstetrics and Gynecology
Lesia Jackson, RN
Clinical Services
*Attend alternating meetings
Clinical Updates
MedSafety Alert: Zolpidem Containing Products:
Drug Safety Communication - FDA Requires Lower
Recommended Doses. FDA is notifying the public of new
information about zolpidem, a widely prescribed insomnia
drug. FDA recommends that the bedtime dose be lowered
because new data show that blood levels in some patients
may be high enough the morning after use to impair activities
that require alertness, including driving. This announcement
focuses on zolpidem products approved for bedtime use, which are marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist. Zolpidem is a
sedative-hypnotic (sleep) medicine used in adults for the treatment of insomnia.
FDA is also reminding the public that all drugs taken for insomnia can impair driving and
activities that require alertness the morning after use. Drowsiness is already listed as a common side effect in the drug labels of all insomnia drugs, along with warnings that patients
may still feel drowsy the day after taking these products. Patients who take insomnia drugs
can experience impairment of mental alertness the morning after use, even if they feel fully
awake.
For zolpidem products, data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs (Ambien CR and generics). Women
appear to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men. Because use of lower doses of zolpidem will result in lower blood
levels in the morning, FDA is requiring the manufacturers of Ambien, Ambien CR, Edluar,
and Zolpimist to lower the recommended dose.
FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia
drugs, including over-the-counter (OTC) drugs available without a prescription.
Recommendations: FDA urges health care professionals to caution all patients (men and
women) who use these products about the risks of next-morning impairment for activities
that require complete mental alertness, including driving.
• The recommended dose of zolpidem for women should be lowered from 10 mg to 5
mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg
to 6.25 mg for extended-release products (Ambien CR).
• For zolpidem and other insomnia drugs, prescribe the lowest dose that treats the patient’s symptoms.
• Inform patients that impairment from sleep drugs can be present despite feeling fully
awake.
• The recommended doses of Intermezzo, a lower dose zolpidem product approved for
middle-of-the-night awakenings, are not changing. At the time of Intermezzo’s approval
in November 2011, the label already recommended a lower dosage for women than for
men.
High Risk Medication Alert: Nonbenzodiazepine
Hypnotics in the Elderly. While the new FDA warning
applies to zolpidem for all age groups, the American Geriatrics Society 2012 Beers Criteria Update Expert Panel has
recently added ALL non-benzodiazepine sedative hypnotics
to the Beers List. This means zolpidem (Ambien), eszopiclone (Lunesta), and zaleplon (Sonata) are considered High
Risk Medications in the Elderly. If a patient age 65 or older
receives any one or combination of these drugs for >90 days per calendar year, HEDIS and
CMS quality metrics are negatively affected. All patients seeking treatment for insomnia
should be educated on good sleep hygiene practices as well as undergo assessment and
treatment for underlying conditions such as anxiety, depression or pain. If medical treatment is required, melatonin 3 mg (OTC) or trazodone 25 mg (titrated to 150-200 mg nightly
as needed) are considered safer options for elderly patients. Melatonin and trazodone
should be administered 1 hour before bedtime. If a non-benzodiazepine sedative hypnotic
is required after adequate trials of first line therapies, consider using the lowest possible
dose for the shortest possible duration (<10 days). KPHC tools and patient communication
tools are currently under development to support prescribers in addressing patients with
insomnia.
Kaiser Permanente Georgia
3
Clinical Updates, Continued
MedSafety Alert: Eliquis (apixaban): Drug Warning - Potential
Risk of Thrombotic Events. The FDA has determined that a Risk
A dditional
C linical A lerts
Evaluation and Mitigation Strategy (REMS) is necessary to ensure that
the benefits of Eliquis outweigh the potential risks in patients with nonvalvular atrial fibrillation including: Increased risk of thrombotic events,
including stroke, when discontinuing Eliquis without an adequate
alternative anticoagulant. Eliquis is non-formulary on the KPGA Commercial Formulary and Tier 4, Non-Preferred Brand, on the National
MPD Formulary.
Eliquis has an apparent half-life of 12 hours during repeat dosing; therefore, the anticoagulant effect of Eliquis is present when the drug is taken and for at least a day after discontinuation. Discontinuing Eliquis in the absence of adequate alternative anticoagulation
increases the risk of thrombotic events. An increased rate of stroke was observed during the
transition from Eliquis to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If Eliquis must be discontinued for a reason other than pathological bleeding, consider
coverage with another anticoagulant.
When converting from or to Eliquis (per manufacturer package insert)
• Switching from warfarin to Eliquis: Warfarin should be discontinued and Eliquis
started when the international normalized ratio (INR) is below 2.0.
• Switching from Eliquis to warfarin: Eliquis affects INR, so that INR measurements
during coadministration with warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue Eliquis and
begin both a parenteral anticoagulant and warfarin at the time the next dose of Eliquis
would have been taken, discontinuing the parenteral anticoagulant when INR research
an acceptable range.
• Switching between Eliquis and anticoagulants other than warfarin: Discontinue one
being taken and begin the other at the next scheduled dose.
Directives from Manufacturer:
• Advise patients to take Eliquis only as directed and not to discontinue Eliquis without
first speaking to a health care provider.
• To report all suspected adverse events associated with the use of Eliquis, please contact: Bristol-Myers Squibb at 1-800-721-5072 and/or FDA Medwatch Program at 1-800FDA-1088 or www.fda.gov/medwatch
Medications Reviewed, but Not Added to the Formulary
• Rotigotine (Neupro) 1 mg, 2 mg, & 3 mg transdermal patch, not added to the Commercial
Formulary, decision pending for the National MPD Formulary
• Estradiol valerate & dienogest (Natazia) tablet, not added to the Commercial Formulary,
decision pending for the National MPD Formulary
• Mirabegron (Mybetriq) 25 mg & 50 mg extended release tablets, not added to the
Commercial Formulary, decision pending for the National MPD Formulary
• Fluticasone & azelastin (Dymista) 0.1%-0.37% nasal suspension, not added to the
Commercial Formulary, decision pending for the National MPD Formulary
• Fluorometholone (FML) 0.1% ophthalmic ointment, not added to the Commercial
Formulary
• Denosumab (Prolia) 60 mg/ml injection, decision pending for the National MPD formulary
• Pregabalin (Lyrica) 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, & 300 mg capsules &
20 mg/ml oral solution, decision pending for the National MPD Formulary
4 Kaiser Permanente Georgia
Samsca (tolvaptan): Drug
Warning - Potential Risk of
Liver Injury
http://www.fda.gov/Safety/
MedWatch/SafetyInformation/