BCN Custom Select Prior Authorization and Step

Transcription

Blue Care Network
Custom Select Drug List
Prior Authorization and Step Therapy Guidelines
January 2015
Blue Care Network’s Custom Select Prior Approval and Step Therapy Guidelines help ensure that safe,
high-quality cost-effective drugs are prescribed prior to the use of more expensive agents that may not
have proven value over current preferred medications. Our prior authorization and step-therapy criteria
are based on current medical information and have been approved by the BCBSM/BCN Pharmacy
and Therapeutics Committee. These guidelines apply to all BCN members whose prescription benefit
includes the BCBSM/BCN Custom Select Drug List.
PRIOR APPROVAL (PA): Drugs requiring PA are covered only if the member meets specific criteria.
STEP THERAPY (ST): Drugs subject to ST require previous treatment with one or more preferred
agents prior to coverage.
OTHER UTILIZATION MANAGEMENT TOOLS:
• Quantity Limits (QL) and mandatory generic dispensing are applied to all BCN marketplace
drug riders.
• Specialty drugs <s> are limited to a maximum 30-day supply per fill and are available through
Walgreens Specialty Pharmacy and most retail pharmacies. Some specialty drugs are limited
to a 15-day supply for all fills and members will pay half of their copayment.
Please visit us online at BCBSM.com/RxInfo for more information.
This information applies to members with a BCN Custom Select drug benefit. Criteria for BCN
AdvantageSM members can be viewed on our Web site: bcbsm.com.
(g)=generic available Anti-Infectives
Antifungals Approval duration: up to 3 months
Nonpreferred:
Lamisil® Granules
Requires documentation that the member has experienced treatment failure of or intolerance to
at least three months of treatment with griseofulvin (Grifulvin V(g)) suspension.
Antituberculars
Preferred:
Sirturo™ (bedaquiline)
Antivirals
Preferred:
IncivekTM (telaprevir),
OlysioTM (simeprevir),
SovaldiTM (sofosbuvir),
Approval duration: up to 6 months
Approved for members > 18 years old with pulmonary multi-drug resistant tuberculosis (MDRTB).
Incivek: Requires a diagnosis of Hepatitis C genotype 1. Members taking Incivek must be
receiving triple therapy along with a peg interferon and ribavirin for the appropriate duration of
the treatment.
Approval duration: Initial approval: up to 6 weeks. Renewal: up to 6 weeks if viral load is 1000 IU/
mL or less at treatment week 4.
Olysio: Requires a diagnosis of chronic Hepatitis C genotype 1, with compensated
liver disease. Members taking Olysio must be receiving combination therapy along with a
peginterferon alfa and ribavirin for the appropriate duration of the treatment and receive NS3
Q80K viral ploymorphism testing if genotype 1a.
Sovaldi: Requires a diagnosis of chronic Hepatitis C, with compensated liver disease.
Members taking Sovaldi must be receiving combination therapy with peginterferon alfa and
ribavirin for genotypes 1 and 4 and ribavirin for genotypes 2 and 3, for the appropriate duration of
the treatment.
Cont. on next page...
Blue Care Network - Custom Select Drug List Prior Authorization and Step-Therapy Guidelines
Page 1
Anti-Infectives (cont.)
Antivirals (cont.)
Preferred:
VictrelisTM (boceprevir)
Preferred:
Victrelis: Requires a diagnosis of Hepatitis C genotype 1, and treatment failure of or
intolerance to Incivek. Members taking Victrelis must be receiving triple therapy along with a peg
interferon and ribavirin for the appropriate duration of the treatment.
Approval duration: Initial and renewal approval durations depend on the member’s viral loads at
all futility points and treatment duration as indicated in the prescribing information.
Quinolones Approval duration: up to 1 month
Preferred:
Approved only for uncomplicated urinary tract infection (cystitis). Alternatives include Cipro(g)
Cipro® XR(g) (ciprofloxacin-extended 100-250mg BID x 3 days and Bactrim DS®(g) BID x 3-5 days.
release)
Antineoplastics & Immunosuppressants
Alkylating Agents
Approval duration: up to 1 year
Nonpreferred:
Approved for members with a diagnosis of Stage 1A or 1B Mycosis Fungoides type cutaneous
ValchlorTM
T-cell lymphoma and requires previous treatment with at least two skin-directed therapies:
1. Topical carmustine or topical retinoid
AND
2. Phototherapy or total skin electron beam therapy.
Antimetabolites
Nonpreferred:
Requires a diagnosis of acute lymphoblastic leukemia (ALL) when used as part of a combination
PurixanTM
chemotherapy regimen and in situations where the member is unable to swallow oral solids.
Hormonal Agents Approval duration: up to 1 year
Preferred:
Preferred agents:
Arimidex® (g) (anastrozole),
PA required for males: Approved only for ER-positive breast cancer treatment.
Aromasin® (g) (exemestane),
Evista(g), Tamoxifen: $0 copay for female members who meet criteria: diagnosis of
Evista® (g) (raloxifene),
primary prevention for breast cancer, age 35 years or older, documented risk factors showing the
Femara® (g) (letrozole),
member is high risk for developing breast cancer and no history of breast cancer nor personal or
Tamoxifen(g) (tamoxifen),
family history of venous thromboembolic events.
Xtandi® (enzalutamide),
Approval duration: up to 5 years
Zytiga® (abiraterone acetate)
Xtandi, Zytiga: Approved for FDA indication, or requires documentation of enrollment in a
Phase II-IV investigative study approved by an appropriate IRB. Trial or failure of a preferred
therapy may be required before coverage will be authorized.
Nonpreferred
Soltamox®
Immunomodulators Preferred:
Arcalyst™ (rilonacept)
Nonpreferred:
Pomalyst®,
Revlimid®
Nonpreferred agents:
Soltamox: $0 copay for female members who meet criteria: diagnosis of primary prevention
for breast cancer, age 35 years or older, documented risk factors showing the member is high
risk for developing breast cancer and no history of breast cancer nor personal or family history
of venous thromboembolic events. Documentation that the member is unable to swallow tablets/
capsules must also be provided.
Preferred agents:
Approved for the treatment of cryopyrin-associated periodic syndrome in members ≥12 years of
age.
Inital approval: 3 months
Approved for FDA indication or requires documentation of enrollment in a Phase II-IV
investigative study approved by an appropriate Investigational Review Board (IRB.) Trial or
failure of a preferred therapy may be required before coverage will authorized.
Blue Care Network - Custom Select Drug List Prior Authorization and Step Therapy Guidelines
Page 2
Antineoplastics & Immunosuppressants (cont.)
Kinase Inhibitors & Molecular Target Inhibitors (cont.)
Preferred:
Approved for FDA indication, or requires documentation of enrollment in a Phase II-IV
Afinitor, Disperz® (everolimus),
investigative study approved by an appropriate IRB. Trial or failure of a preferred therapy may be
Bosulif® (bosutinib),
required before coverage will be authorized.
Caprelsa® (vandetanib),
Jakafi: Initial approval 6 months
Cometriq™ (cabozantinib s-malate),
Gilotrif™ (afatinib dimaleate),
Iclusig® (ponatinib),
Imbruvica™ (ibrutinib),
Inlyta® (axitinib),
Jakafi® (ruxolitinib),
Mekinist® (trametinib),
Nexavar® (sorafenib),
Sprycel® (dasatinib),
Stivarga® (regorafenib),
Sutent® (sunitinib),
Tafinlar® (dabrafenib),
Tarceva® (erlotinib),
Tasigna® (nilotinib),
Tykerb® (lapatinib),
Votrient® (pazopanib),
Xalkori® (crizotinib),
Xtandi® (enzalutamide),
Zelboraf® (vemurafenib),
Zydelig™ (idelalisib),
Zykadia™ (ceritinib)
Miscellaneous Antineoplastic Agents
Preferred:
Preferred agents:
Erivedge™ (vismodegib),
Approved for FDA indication, or requires documentation of enrollment in a Phase II-IV
Hycamtin® (topotecan),
investigative study approved by an appropriate IRB. Trial or failure of a preferred therapy may be
Zolinza® (vorinostat)
required before coverage will be authorized.
Erivedge: Initial approval 6 months
Nonpreferred:
Targretin®
Approved for cutaneous T-cell lymphoma (CTCL) where the member has experienced failure of
or intolerance to at least one systemic therapy.
Cardiovascular, Hypertension, Cholesterol
Alpha-adrenergic Agents
Preferred:
Approved for the treatment of hypertension and sweating episodes in members with
dibenzyline
pheochromocytoma.
Angiotensin II Receptor Blockers (ARBS)
Preferred:
Preferred agents:
Atacand® (g) (candesartan), HCT(g); Requires documentation that the member has experienced intolerance to a generic ARB
Benicar® (olmesartan medoxomil),
(Avapro(g), Avalide(g), Cozaar(g), Hyzaar(g), or Teveten 600mg(g)).
HCT;
Exforge(g), HCT(g); Twynsta: Requires successful treatment of at least three months
Diovan®(g) (valsartan),
of therapy with the individual agents contained in the requested medication at the prescribed
Diovan HCT(g) (valsartan/hctz),
dosage.
Exforge®(g) (amlodipine/valsartan),
Exforge HCT(g) (amlodipine/
valsartan/hctz)
Micardis® (g) (telmisartan),
Micardis HCT (g) (telmisartan/hctz);
Twynsta® (g) (telmisartan/amlodipine)
Page 3
Cardiovascular, Hypertension, Cholesterol (cont.)
Angiotensin II Receptor Blockers (ARBS) (cont.)
Nonpreferred:
Azor®, Edarbi®, Edarbyclor®, Teveten® Edarbi, Edarbyclor, Teveten HCT: Requires documentation that the member has
HCT;
experienced treatment failure of or intolerance to two of the following preferred ARB’s: Atacand
TribenzorTM
(g), HCT (g); Avapro (g), Avalide (g), Cozaar(g), Diovan(g), HCT (g); Exforge(g),
Hyzaar(g), AND Benicar, HCT.
Azor, Tribenzor: Requires successful treatment of at least three months of therapy with the
individual agents contained in the requested medication at the prescribed dosage.
Beta Blockers
Nonpreferred:
Bystolic: Requires documentation that the member has experienced treatment failure of or
Bystolic®
intolerance to at least two unique preferred cardioselective beta blockers, such as betaxolol,
atenolol, acebutolol, metoprolol, or bisoprolol.
Cardiovascular Treatment
Nonpreferred:
Ranexa®
both a beta-blocker and a maintenance nitrate given around-the-clock. The member must have
no history of or high risk for cancer.
Cholesterol-Lowering Agents Approval duration: up to 10 years
Preferred:
Preferred agents:
Kynamro (mipomersen sodium)®,
Kynamro: Requires documentation that the member has homozygous familial
Lovaza® (g) (omega-3 acid ethyl
hypercholesterolemia (HoFH) and is receiving optimal adjunctive treatment with other therapies
esters),
including a low-fat diet and other oral lipid lowering treatments. Approval Duration: up to 1 year.
Trilipix® (g) (fenofibric acid)
Lovaza(g): Requires documentation that the member has experienced treatment failure of or
intolerance to three of the following: Lopid(g), an OTC Omega-3 fatty acid at a dose of at least 3/
grams/day, and a generic fenofibrate (i.e. Antara(g), Lofibra(g), or Tricor(g)) AND triglyceride levels
> 500mg/dl.
Trilipix(g): Requires documentation that the member has experienced treatment failure to a
generic fenofibrate (i.e. Antara(g), Lofibra(g), or Tricor(g)) AND Lopid(g). An explanation why Trilipix(g)
is expected to work when another generic fenofibrate and fibric acid have not must also be submitted
to the plan. Concomitant use of a statin does not satisfy criteria.
Nonpreferred:
Crestor®, Livalo®, Vytorin®
Requires documentation that the member has experienced failure of or intolerance to two generic
statins one of which must be high dose (>40mg) Lipitor(g).
Miscellaneous Antihypertensives Approval duration: up to 10 years
Nonpreferred:
Amturnide, Tekamlo: Requires successful treatment of at least three months of therapy
Amturnide®,
with the individual agents contained in the requested medication at the prescribed dosage.
TekamloTM,
Tekturna, HCT: Approved for the treatment of hypertension AND requires documentation
Tekturna®, HCT
that the member has experienced treatment failure of or intolerance to ALL of the following drug
classes: diuretics, beta-blockers, ACE inhibitors, and angiotensin II receptor blockers (ARBS).
Page 4
Central Nervous System
Anticonvulsants
Nonpreferred:
Lyrica®,
Onfi®
Lyrica: Requires documentation that the member has at least one of the three listed diagnoses:
• Seizure disorder: Requires that the member is being treated concurrently with other
anticonvulsants
• Neuropathic pain: When associated with either diabetic peripheral neuropathy or postherpetic neuralgia or spinal cord injury AND the member has experienced treatment failure of or
intolerance to:
o Members ≥ 65 years of age: gabapentin 1200 mg per day
o Members < 65 years: gabapentin 1200 mg per day AND a tricyclic antidepressant.
• Fibromyalgia: Requires documentation to show that the member has experienced
intolerance to gabapentin or inadequate relief from gabapentin 1200 mg per day AND treatment
failure of or intolerance to at least three of the following: a tricyclic antidepressant, an SSRI, an
SNRI, cyclobenzaprine or tramadol.
Additional criteria:
•Approved dosage is limited to < 300 mg per day for initial treatment and will not exceed 600
mg per day if 300 mg/day is tolerated.
Onfi: Approved for members age 2 and older for adjunctive treatment of seizures associated
with Lennox-Gastaut syndrome where the member has experinced treatment failure of or
intolerance to at least two generic anticonvulsants, one of which is Klonopin(g).
Antidepressants
Preferred:
Preferred agents:
Luvox CR® (g) (fluvoxamine maleate) Requires documentation that the member has experienced treatment failure of or intolerance to
at least three generic antidepressants AND documentation that continued use of Luvox(g) will
adversely affect the member’s mental health.
Nonpreferred:
AplenzinTM, Desvenlafaxine fumarate
ER, Pexeva®, Savella®, ViibrydTM
Cont. next page...
Antipsychotics Preferred:
Abilify®(aripiprazole), Fazaclo®
(clozapine) (g)
Nonpreferred:
Abilify® Discmelt, Fanapt®, Fazaclo,
Latuda®, Saphris®
Cont. on next page
Aplenzin: Requires documentation that the member has experienced treatment failure of or
intolerance to at least three generic antidepressants one of which is Wellbutrin SR/XL(g); AND
documentation that continued use of Wellbutrin SR/XL(g) will adversely affect the member’s
mental health.
Desvenlafaxine fumarate ER: Requires documentation that the member has
experienced treatment failure of or intolerance to at least two generic antidepressants, one of
which is Effexor(g), XR(g); AND documentation that continued use of Effexor(g) or Effexor
XR(g) will adversely affect the member’s mental health.
Pexeva: Requires documentation that the member has experienced treatment failure of or
intolerance to at least two generic antidepressants one of which is Paxil(g); AND documentation
that continued use of Paxil(g) will adversely affect the member’s mental health.
Savella: Approved for treatment of fibromyalgia AND requires documentation that the member
has experienced intolerance to gabapentin or inadequate relief from gabapentin 1200 mg per day
and treatment failure of or intolerance to at least three of the following: a tricyclic antidepressant,
an SSRI, an SNRI, cyclobenzaprine, or tramadol.
Viibryd: Requires documentation that the member has experienced treatment failure of or
intolerance to at least three generic antidepressants.
Preferred agent(s):
Requires treatment failure of or intolerance to one of the following 2nd generation preferred
antipsychotics: Geodon(g), Risperdal(g), Seroquel(g), Zyprexa(g).
Nonpreferred agent(s):
Abilify Discmelt: Requires treatment failure of or intolerance to one of the following 2nd
generation preferred antipsychotics: Geodon(g), Risperdal(g), Seroquel(g), Zyprexa(g).
Fanapt, Fazaclo 150, 200mg, Latuda, Saphris: Requires treatment failure of or
intolerance to one of the following 2nd generation antipsychotics: Geodon(g), Risperdal(g),
Seroquel(g), Zyprexa(g) AND Abilify.
Page 5
Central Nervous System (Cont.)
Antipsychotics (Cont.)
Nonpreferred:
Nonpreferred agent(s):
Invega®
Invega: Requires documentation that the member has experienced treatment failure of or
intolerance Risperdal(g) AND Abilify. Maximum dose of Invega is limited to 12 mg per day.
CNS Stimulants Approval duration: up to 5 years
Preferred:
Preferred agents:
Procentra™ (dextroamphetamine),
Procentra: Requires documentation that the member has experienced treatment failure of or
Provigil® (modafinil) (g)
intolerance to both Metadate CD and Adderall XR; both of which may be sprinkled on food.
Provigil(g): Approved only for members with narcolepsy or obstructive sleep apnea. Shiftwork sleep disorder is not covered since treatment is not medically necessary.
Nonpreferred:
Nuvigil®
Strattera™
Migraine Therapy Preferred:
Amerge® (g) (naratriptan),
Zomig®, ZMT® (g) (zolmitriptan)
Nuvigil: Approved for treatment of narcolepsy or obstructive sleep apnea and requires
documentation that the member has experienced treatment failure of or intolerance to
Provigil(g). Coverage is not provided for shift-work sleep disorder.
Strattera: Approvable when stimulants are contraindicated by medical history OR the following
criteria by age:
•For BCN members age 5 to 20: Requires documentation that the member has
experienced treatment failure of or intolerance to both a methylphenidate (such as Ritalin(g) or
Concerta(g)) AND an amphetamine (such as Adderall(g)).
•For BCN members age 21 and older: Requires documentation that the member
has experienced treatment failure of or intolerance to either a methylphenidate OR an
amphetamine.
Note: The use of Strattera in members ≤ 4 years of age is not recommended or supported by
literature.
Preferred agents:
Amerge(g): Requires documentation that the member has experienced treatment failure of or
intolerance to Imitrex(g).
Zomig, ZMT(g): Requires documentation that the member has experienced treatment failure
of or intolerance to Imitrex(g) and Maxalt, MLT(g).
Nonpreferred:
Axert®, Frova®, Relpax®, Zomig nasal
spray
Miscellaneous CNS Preferred:
Kapvay® (clonidine hcl) (g),
Nuedexta® (dextromethorphan/
quinidine)
Requires documentation that the member has experienced failure of or intolerance to both
Imitrex(g) and Maxalt(g), MLT(g).
Preferred agents:
Kapvay(g): Approved for treatment of ADHD and requires documentation that the member
has experienced treatment failure of or intolerance to all of the following: a methylphenidate
(such as Ritalin(g) or Concerta(g)), an amphetamine (such as Adderall(g)), Tenex(g) and
Catapres(g).
Nuedexta: Requires documentation that the member has a diagnosis of pseudobulbar affect.
Nonpreferred:
Xyrem®
Approved for members with a confirmed diagnosis of narcolepsy with cataplexy. For members
with a confirmed diagnosis of narcolepsy with excessive day time sleepiness, requires
documentation that the member has experienced treatment failure of or intolerance to either
methylphenidate or amphetamine AND Provigil(g).
Page 6
Narcotics Approval duration: up to 1 year
Preferred:
Preferred agents:
Actiq® (fentanyl citrate) (g),
Actiq(g): Approved for the treatment of breakthrough cancer pain in members that are tolerant
ExalgoTM (hydromorphone) (g),
of high dose narcotics and are currently receiving a long-acting narcotic. The member must also
have experienced treatment failure of or intolerance to the use of other oral immediate-release
narcotics for the management of breakthrough pain.
Exalgo(g): Coverage is provided for the management of moderate to severe pain in opioid
tolerant members requiring continuous around the clock analgesia AND requires treatment
failure of or intolerance to ALL of the following long-acting preferred agents: methadone,
Oramorph(g), or MS Contin(g), and Duragesic(g).
Nonpreferred:
Nucynta®, ER; Oxycontin®
Nucynta: Requires documentation that the member has experienced treatment failure of or
intolerance to Ultram(g), ER(g); or Ultracet(g) AND two preferred immediate-release narcotics.
If use is to exceed 30 days, Nucynta must be used in combination with a long-acting narcotic,
such as methadone, Oramorph(g) or MS Contin(g), and Duragesic(g).
Approval Duration: 30 days
Nucynta ER:
• Moderate to severe chronic pain: Requires documentation that the member has
experienced treatment failure of or intolerance to Ultram ER(g) AND two of the following
preferred long-acting agents: Oramorph(g) or MS Contin(g), Duragesic(g) and methadone.
• Post-herpetic neuralgia or diabetic peripheral neuropathy: If the member
is > 65 years old, requires treatment failure of or intolerance to gabapentin 1200 mg per day,
Cymbalta(g). If the member is < 65 years old, requires treatment failure of or intolerance to
gabapentin 1200 mg per day and a tricyclic antidepressant, and Cymbalta(g).
Oxycontin: Requires documentation that the member has experienced treatment failure of
or intolerance to 2 dose titrations to doses of 400mg/day of Oramorph(g) or MS Contin(g) AND
100mcg per application of Duragesic(g).
Narcotic/Analgesic Combinations
Preferred:
Fioricet 50/300/40mg(g): Requires documentation that the member has experienced
Fioricet® (butalbital/apap/caffeine)
treatment failure of or intolerance to Esgic(g) (50/325/40mg), documentation as to why Fioricet
50/300/40mg (g),
50/300/40mg is expected to work when Esgic(g) did not AND a completed MedWatch form has
Fioricet Codeine (butalbital/apap/
been submitted to the FDA and to the plan to documenting the adverse effect or quality issue
caffeine/codeine) (g)
with Esgic(g).
Fioricet Codeine 50/300/30mg(g): Requires documentation that the member
has experienced treatment failure of or intolerance to Fioricet/Codeine(g) (50/325/30mg),
documentation as to why Fioricet/Codeine(g) (50/300/30mg) is expected to work when Fioricet/
Codeine(g) (50/300/30mg) did not and a completed MedWatch form has been submitted to the
FDA and to the plan documenting the adverse effect or quality issue with Fioricet/Codeine(g)
(50/325/30mg).
Narcotic Mixed Agonist/Antagonist
Nonpreferred:
Coverage is provided for a diagnosis of moderate to severe chronic pain AND documentation
Butrans®
that the member has experienced treatment failure of or intolerance to ALL of the following:
methadone, Duragesic(g) and MS Contin(g) or Oramorph SR(g).
Sedatives/Hypnotics Approval duration: up to 1 year
Preferred:
Preferred agents:
Ambien CR® (g) (zolpidem),
an adequate trial of both Ambien®(g) and Sonata®(g).
Coverage is not provided in combination with other sedatives.
Nonpreferred:
Hetlioz®,
Rozerem®
Hetlioz: Approved for the treatment of Non- 24-Hour Sleep-Wake Disorder in completely blind
members ≥ 18 years of age who have experienced treatment failure of or intolerance to both
Rozerem®(g) and OTC melatonin.
Page 7
Sedatives/Hypnotics (cont.)
Nonpreferred:
Rozerem®
Rozerem: Requires documentation that the member has been diagnosed with middle of the
night waking and experienced treatment failure of or intolerance to Ambien(g) AND Sonata(g).
Coverage is not provided in combination with other sedatives.
Skeletal Muscle Relaxants
Preferred:
Skelaxin(g), Soma(g): Requires documentation that the member has experienced
Skelaxin® (g) (metaxalone),
treatment failure of or intolerance to at least 3 of the following: Flexeril(g), Norflex(g), Parafon
Soma® (g) (carisoprolol)
Forte(g), Robaxin(g).
Zanaflex capsules (g) (tizanadine)
Zanaflex capsules(g): Requires treatment failure of or intolerance to ALL of the following:
baclofen, Flexeril(g) and Zanaflex tablets(g).
Dermatology
Acne Treatment Approval duration: up to 1 year
®
Nonpreferred:
Requires treatment failure of or intolerance to Retin-A (g).
Veltin™ gel
Antipsoriatic/Antiseborrheic Approval duration: up to 1 years
Preferred:
Preferred agent:
Taclonex®(g) (calcipotriene/
Requires documentation that the member has experienced treatment failure of or intolerance
betamethasone dipropionate)
to at least 30 days of treatment with the combination of a very high potency corticosteroid
[Diprolene ointment(g), Temovate(g), Psorcon(g)] AND Dovonex(g)].
Nonpreferred:
Stelara®,
Taclonex Scalp
Miscellaneous
Nonpreferred:
Stelara: Approved for members > 18 years of agefor the treatment of plaque psoriasis and
psoriatic arthritis who have experienced treatment failure of or intolerance to either Humira or
Enbrel.
Taclonex scalp: Requires documentation that the member has experienced treatment failure
of or intolerance to at least 30 days of treatment with the combination of a very high potency
corticosteroid [Diprolene ointment(g), Temovate(g), Psorcon(g)] AND Dovonex(g)].
Preferred:
Solaraze® (g) (diclofenac sodium)
Preferred agents:
Approved for actinic keratosis when the member has experienced treatment failure of or
intolerance to 3 different treatment courses using cryotherapy and two formulary agents such as
(Efudex(g), Aldara(g) and Retin-A(g)).
Nonpreferred:
Picato®, Protopic®
Picato: Approved for actinic keratosis when the member has experienced treatment failure of
or intolerance to 3 different treatment courses using cryotherapy and two formulary agents such
as (Efudex(g), Aldara(g) and Retin-A(g)).
Protopic: Approved for members ≥ 2 years of age with a diagnosis of atopic dermatitis or
eczema and documentation that the member has experienced treatment failure of or intolerance
to Elidel®. For members ages 2 to 15, only the 0.03% strength may be used.
Requires documentation that the member has a diagnosis of lower extremity diabetic neuropathic
ulcers that have an adequate blood supply and extend into the subcutaneous tissue or beyond
(must be a full thickness – for example, Stage III to the muscle or Stage IV to the bone).
Members must be participating in a comprehensive wound care program which includes
treatment such as surgical removal of tissue, pressure relief (for example, non-weight bearing),
and infection control.
Wound & Burn Therapy Nonpreferred:
Regranex®
Page 8
Diagnostics & Other Miscellaneous
Diagnostic & Other Miscellaneous
Preferred:
Preferred agents:
Kuvan®, packet (sapropterin
Kuvan: Requires documentation that the member has a diagnosis of phenylketonuria (PKU)
dihydrochloride),
and will be following a phenylalanine-restricted diet in conjunction with Kuvan.
Xenazine® (tetrabenazine)
Xenazine: Requires documentation that the member has a diagnosis of chorea associated
with Huntington’s disease. Approval duration: up to 10 years
Nonpreferred:
Exjade®, Ferriprox®, Firazyr®,
Ruconest®
Endocrinology
Androgens Preferred:
Androderm® (testosterone),
Androgel® (testosterone),
Androxy™ (g) (fluoxymesterone),
Delatestryl® (g) (testosterone
enanthate)
Exjade: Approved for members ≥ 2 years of age with a diagnosis of chronic iron overload
due to blood transfusions (transfusional hemosiderosis) or transfusional iron overload due to
thalssemia syndromes and documentation that the member has experienced treatment failure of
or intolerance to Desferal®(g).
Ferriprox: Requires treatment failure of or intolerance to Desferal(g) and Exjade for members
with transfusional iron overload.
Firazyr, Ruconest: Approved for for members ≥ 18 years of age with a confirmed diagnosis
of type 1 or type 2 hereditary angioedema (HAE) for the treatment of acute attacks, or short-term
prophylaxis in members who meet clinical criteria.
Preferred agents:
Approved for testosterone replacement therapy in males with two morning testosterone levels
below the normal range (i.e. 300 ng/dL) and two or more signs or symptoms specific to android
deficiency.
Nonpreferred:
Methitest™
Approved for testosterone replacement therapy in males with two morning testosterone levels
below the normal range (i.e. 300 ng/dL) and two or more signs or symptoms specific to android
deficiency who have experienced treatment failure of or intolerance to Androgel and Androderm.
Growth Hormone & Related Products
Preferred:
Genotropin® (somatropin),
Nutropin® AQ, Nuspin (somatropin)
Preferred agents:
Children (<18 years of age): Requires a diagnosis of growth hormone deficiency, growth
failure secondary to chronic renal failure/insufficiency who have not received a renal transplant,
growth failure in children small for gestational age or with intrauterine growth retardation, Turner’s
Syndrome, Noonan’s Syndrome, Prader-Willi Syndrome, SHOX deficiency, or for treatment of
severe burns covering >40% of the total body surface area. The member’s current height and
weight must be provided. The member must also have open epiphyses.
Initial treatment: For growth hormone deficiency, test results confirming diagnosis must be
provided. The member’s height must be below the 5th percentile, and confirmed open epiphyses.
To continue: The member must achieve a growth velocity of > 4.5 cm/year while receiving
therapy over the past year. Treatment may continue until final height or epiphyseal closure has
been documented.
Adults (≥18 years of age): Approved for treatment of growth hormone deficiency, AIDS
wasting cachexia, Turner’s Syndrome and Short Bowel Syndrome (SBS). The diagnosis of
growth hormone deficiency must be made by an endocrinologist or a nephrologist, and must be
based on two growth hormone stimulation tests, three or more pituitary hormone deficiencies with
an IGF-1 below 80ng/ml OR one growth hormone and at least one pituitary hormone deficiency
OR one GH stimulation test or subnormal IGF-1 level AND any of the following: defined CNS
pathology, history of irradiation/surgery/trauma, multiple pituitary hormone deficiency or a genetic
defect affecting the growth hormone axis.
Approval duration: up to 10 years (exception SBS 1 month)
Page 9
Endocrinology
Growth Hormone & Related Products (cont.) Approval duration: up to 1 year
Nonpreferred agents: Also requires documentation that the member has experienced
treatment failure of or intolerance to preferred agents.
Increlex: Approved for treatment of severe IGF-1 deficiency, growth hormone gene deletion,
and Laron’s syndrome in members < 18 years of age with open epiphyses, and height below
the 3rd percentile. Member must have a normal or elevated growth hormone level with an
IGF-1 level 3 or more standard deviations below normal. The prescriber must be a pediatric
endocrinologist.
Approval duration: Initial approval is granted for 1 year and renewal can be obtained if member
has clinical response with therapy, as demonstrated by an annual growth velocity of ≥ 2.5 cm
Non-Insulin Hypoglycemic Agents Approval duration: up to 10 years
Preferred:
Bydureon, Pen; Victoza: Approved for members with a diagnosis of type 2 diabetes with a
BydureonTM, Pen; Victoza®
Hgb A1c > 7%, who have experienced treatment failure of or intolerance to one of the following:
metformin, a sulfonylurea, or a thiazolidinedione (TZD).
Nonpreferred:
Humatrope®, Increlex™, Norditropin®,
Flexpro®; Omnitrope®, Saizen® ,
Serostim®, Tev-Tropin®, Zorbtive™
Nonpreferred:
Actoplus MET® XR, Avandamet®,
Avandaryl®, Avandia®, Byetta®,
Cycloset®, InvokametTM, InvokanaTM,
Prandimet®, Tradjenta™, Symlin®,
Symlinpen®
Miscellaneous
Preferred:
Carbaglu® (carglumic acid),
Korlym™ (mifepristone),
Signifor® (pasireotide)
Nonpreferred:
Actoplus MET XR, Avandamet, Avandaryl, Invokamet, Prandimet: Requires
documentation that the member has experienced successful treatment with at least three months
of therapy with the individual agents that are in the combination product.
Avandia: Requires documentation that the member has had treatment failure of or intolerance
to both Glucophage(g) and Actos(g).
Byetta: Approved for members with a diagnosis of type 2 diabetes.
• If Hgb A1c < 9%: treatment failure of or intolerance to two oral antidiabetic agents, one of
which is metformin, and two injectable antidiabetic agents Bydureon, And Victoza.
• If Hgb A1c > 9%: treatment failure of or intolerance to two oral antidiabetic agents, one of
which is metformin, AND insulin therapy, AND two injectable antidiabetic agents Bydureon,
And Victoza.
Cycloset: Requires documentation that the member has experienced treatment failure of or
intolerance to the use of three of the following: metformin, basal insulin, a sulfonylurea and a
thiazolidinedione (TZD).
Invokana: Requires documentation that the member has experienced treatment failure of or
intolerance to three of the following: metformin, a sulfonylurea, Actos(g) and a preferred DPP-4
inhibitor, AND adequate renal function
Tradjenta: Requires documentation that the member has experienced treatment failure of or
intolerance to three of the following: metformin,basal insulin, a sulfonylurea, and a TZD, AND a
preferrred DPP-4 Inhibitor.
Symlin, Symlinpen: Approved for members ≥ 18 years of age for the treatment of type 1
or 2 diabetes who are receiving mealtime insulin therapy and have not achieved desired glucose
goal despite good compliance with optimal insulin therapy.
Preferred agents:
Carbaglu: Approved for a diagnosis of hyperammonemia due to a deficiency of the hepatic
enzyme N-acetylglutamate synthase (NAGS) as confirmed by enzyme or DNA mutation analysis.
Korlym: Approved for members > 18 and requires documentation of:
a) A diagnosis of hypercortisolism as a result of endogenous Cushing’s syndrome
b) Failure of or intolerance to ketoconazole or Lysodren®, unless contraindicated or not
tolerated.
b) Diagnosis of type II diabetes mellitus or glucose intolerance
c) Surgical treatment has been ineffective or are not candidates for surgery
d) Failure to achieve blood glucose control with maximally titrated therapy including at least 3
months of insulin.
Note: Also requires enrollment in REMS program
Page 10
Endocrinology (Cont.)
Miscellaneous (cont.)
Preferred:
Signifor® (pasireotide)
Nonpreferred:
Myalept™, Ravicti™, Zavesca®
Preferred agents:
Signifor: Approved for members > 18 years who meet the following criteria:
a) Hypercortisolism as a result of endogenous Cushing’s syndrome.
b) Surgical treatment has been ineffective or are not candidates for surgery.
c) Treatment failure of or intolerance to Nizoral(g) or Lysodren.
Inital approval length up to 3 months, renewal up to 6 months
Myalept:Requires a diagnosis of generalized lipodystrophy in members optimally treated with
insulin and a statin.
Ravicti: Approved for the treatment of any chronic Urea Cycle Disorder (except for NAGS
deficiency) with treatment failure of or intolerance to Buphenyl®.
Zavesca: Approved for members > 18 years of age for the treatment of Type 1 Gaucher’s
disease with treatment failure of or intolerance to enzyme replacement therapy, such as
Cerezyme.
Gastrointestinal Agents
Antiemetics Approval duration: up to 1 year
Nonpreferred:
Sancuso®
oral Kytril(g) AND Zofran(g), ODT(g).
Antidiarrheals and Antispasmodics
Nonpreferred:
Fulyzaq: Approved for members with HIV/AIDS who are currently on antiretroviral therapy for
FulyzaqTM
the treatment of symtomatic relief of non-infectious diarrhea.
Miscellaneous Gastrointestinal Agents Approval duration: up to 1 year
Preferred:
Relistor® (methylnaltrexone)
Preferred agent:
Approved for the treatment of opioid-induced constipation in members with advanced illness
who are receiving palliative care and requires documentation that the member has experienced
inadequate response to at least 3 of the following laxatives: bulk laxatives (polycarbophil,
psyllium, methylcellulose), saline laxatives (milk of magnesia/magnesium hydroxide), osmotic
laxatives (Miralax(g)) or stimulants (Dulcolax(g), Senna(g)).
Nonpreferred:
Amitiza®, Cimzia®, Gattex®, GiazoTM,
LiznessTM
Amitiza, Linzess: Approved for the treatment of chronic idiopathic constipation (fewer than
3 bowel movements/week) or constipation predominant IBS in female members 18 to 65 years
of age who have tried and failed ALL of the following: dietary advice, trial of bulk laxatives, stool
softeners, and a short course of stimulant laxatives and are NOT taking medications causing
constipation. A total of 12 weeks can be approved, with renewal, only if improvement in bowel
frequency is seen with initial trial. Amitiza: Also covered for opioid induced constipation - when
have tried and failed ALL of the following: dietary advice, trial of bulk laxatives, stool softeners,
and a short course of stimulant laxatives AND is currently on opioid therapy causing the
constipation.
Cimzia: Approved for the treatment of Crohn’s disease in members ≥ 18 years of age whom
have experienced treatment failure of or intolerance to Humira.
Gattex: Approved for members > 18 years of age with a diagnosis of Short Bowel Syndrome
(SBS) AND dependence on parenteral support > 12 months.
18 years of age who have experienced treatment failure of or intolerance to Colazal(g) AND
Azulfidine(g).
Lotronex: Approved for the treatment of severe, diarrhea-predominant irritable bowel
syndrome in women at least 18 years of age who have failed to respond to conventional
antidiarrheal therapy including one OTC product (loperamide, bismuth subsalicylate) and one
prescription agent (Lomotil(g)).
Page 11
Gastrointestinal Agents (Cont.)
Miscellaneous Gastrointestinal Agents (cont.)
Nonpreferred:
Lotronex®, Simponi®, Xifaxan 550®
Proton Pump Inhibitors Preferred:
Aciphex® (g) (rabeprazole),
Prevacid®(g) capsule (lansoprazole)
Immunology & Hematology
Hematopoietic Agents
Preferred:
Procrit® (epoetin alfa),
Promacta® (eltrombopag)
Nonpreferred:
Aranesp®, Epogen®
Interferons and MS Therapy
Preferred:
GilenyaTM (fingolimod hydrochloride),
Infergen (interferon alfacon-1),
Intron-A® (interferon alfa-2B),
Tecfidera® (dimethyl fumarate)
Cont. next page...
Lotronex: Approved for the treatment of severe, diarrhea-predominant irritable bowel
syndrome in women at least 18 years of age who have failed to respond to conventional
antidiarrheal therapy including one OTC product (loperamide, bismuth subsalicylate) and one
prescription agent (Lomotil(g)).
Simponi: Approved for the treatment of ulcerative colitis in members > 18 years of age whom
have experienced treatment failure of or intolerance to Humira. Approval duration: up to 10 years
Xifaxan 550: Requires diagnosis of hepatic encephalopathy AND documentation that the
member has had treatment failure of or intolerance to lactulose.
Aciphex(g): Requires documentation that the member has experienced failure of or
intolerance to Prilosec® OTC(g) or Prilosec(g), Protonix(g) AND Prevacid(g) or Prevacid
Solutab.
Prevacid(g): Requires documentation that the member has experienced failure of or
intolerance to Prilosec® OTC(g) or Prilosec(g) AND Protonix(g).
Preferred agents:
Procrit: Requires documentation that the member has anemia secondary to one of the
following conditions: chronic renal failure, chronic renal insufficiency, HIV infection, HIV therapy,
chemotherapy, myelodysplasia, or chronic hepatitis C therapy, OR prophylaxis prior to surgery
to reduce need for allogenic blood transfusions. A Hgb level of less than 10 g/dL is required
for initial therapy. For continued coverage the member’s Hgb level must be less than 12 g/dL.
Duration of approval is dependent on the indication.
Approval duration: Initial approval up to 6 months to 1 year
Promacta: Approved for treatment of thrombocytopenia with chronic immune
thrombocytopenic purpura or chronic hepatitis C infection associated thrombocytopenia, in
members who have had an inadequate response to, intolerance to, or are not candidates for
standard first-line treatments such as corticosteroids, immunoglobulins or splenectomy . Also
approved for members diagnosed with severe aplastic anemia who have not responded to
immunosuppressive therapy.
Approval duration: inital up to 6 months. Continued coverage is dependent on platelet count and
indication.
Also requires documentation that the member has experienced failure of or intolerance to
preferred epoetin alfa (Procrit).
Approval duration: up to 6 months to 1 year
Preferred agents:
Gilenya, Tecfidera: Approved for members 18 and older who have a diagnosis of a
relapsing form of multiple sclerosis.
Infergen: Approved for the treatment of Hepatitis B.
Intron-A: Approved for the treatment of Hepatitis B, condyloma acuminate, essential
thrombocythemia, hairy cell leukemia, Kaposi’s sarcoma, malignant melanoma, multiple
myeloma, non-Hodgkin’s lymphoma, Philadelphia chromosome (Ph) positive chronic phase
myelogenous leukemia (CML), and renal cell carcinoma.
Page 12
Immunology & Hematology (Cont.)
Interferons and MS Therapy (cont.)
Preferred:
Preferred agents:
GilenyaTM (fingolimod hydrochloride), Peg-Intron, Pegasys: Approved for the treatment of Hepatitis B and Hepatitis C. For
Infergen (interferon alfacon-1),
hepatitis C, approved for members naïve to pegylated interferon therapy only. Genotype,
Intron-A® (interferon alfa-2B),
HIV status, previous therapy and duration must also be provided. The member must receive
Pegasys® (peginterferon alfa 2-A),
peglylated interferon in combination with ribavirin unless contraindicated.
Peg-Intron® (peginterferon alfa-2B),
Approval duration: dependent on indication
Rebetrol (g) (ribavirin),
Rebetrol: Approved for the treatment of Hepatitis C. Genotype, HIV status, previous therapy
Tecfidera® (dimethyl fumarate)
and duration must also be provided. Approval duration: up to 1 year
Nonpreferred:
AmpyraTM ,
AubagioTM,
Betaseron®,
SyaltronTM
Ampyra: Initial treatment: Requires a diagnosis of multiple sclerosis and documentation
of difficulty walking resulting in significant limitations of instrumental activities of daily living. Also
requires two timed 25-foot walk (T25FW) measurements that must be within 10% variability and
demonstrates that the member is able to walk 25 feet in 8-45 seconds, and where the member
is receiving concurrent disease-modifying therapy. To continue: Requires documentation of
improvement in walking speed by at least 20% as assessed by the T25FW AND that limitations
of instrumental activities of daily living have improved as a result of increased walking speed.
Coverage thereafter will be provided if there is documentation that the member has maintained
or experienced improved walking speed from the previous measurement, and where the member
is receiving concurrent disease-modifying therapy.
Approval duration: initial approval is 6 months, renewal up to 12 months
Aubagio: Approved for members 18 and older who have a diagnosis of a relapsing form of
multiple sclerosis, where the member has experienced treatement failure of or intolerance to an
interferon beta product (for example, Avonex®, Extavia® or Rebif®), Copaxone®, Tecfidera, AND
Gilenya. Treatment failure is defined as documented relapse or the presence of new and/or
newly enlarged MRI lesions in the previous year.
Betaseron: Requires documentation that the member has experienced failure of or
intolerance to Extavia®.
Sylatron: Approved for the treatment of melanoma in situations where the member has
microscopic or gross nodal involvement within 84 days of definitive surgical resection, including
complete lymphadenectomy.
Lifestyle Modification Products
Smoking Cessation Approval duration: up to 6 months
Preferred:
Requires treatment failure of or intolerance to one of the following: nicotine gum, lozenge, patch
Chantix® (varenicline)
or Zyban(g) for $0 copayment.
Nonpreferred:
Nicotrol®, NS
Obstetrics and Gynecology
Contraceptives Nonpreferred:
Nuvaring®
Infertility treatment Preferred:
Clomid® (clomiphene),
Gonal-F®, -RFF, Redi-Ject (follitropin
alfa, recomb), Ovidrel® (HCG alfa,
recomb), Novarel®/Pregnyl®/Profasi®
(gonadotropin, chorionic, human),
Cont. next page...
Requires treatment failure of or intolerance to 2 generic contraceptives for $0 copayment.
Preferred agents:
Coverage is provided for most BCN female members with an infertility benefit and also in
accordance with generally accepted medical practice. BCN does not provide coverage for
infertility drugs to be used as part of assisted reproductive technology treatment, such as invitro fertilization (IVF), zygote in vitro fertilization transfer (ZIFT), gamete in vitro fertilization
transfer (GIFT). Authorization will be provided for one year. Additional coverage will be based
on documentation that the member is being treated according to accepted medical practice.
Requests are not considered for men.
Page 13
Obstetrics and Gynecology
Infertility treatment Approval duration: up to 1 year
Nonpreferred:
Nonpreferred agents: Also requires treatment failure of or intolerance to Gonal-F,-RFF,
Follistim® AQ
Redi-Ject.
Opthalmic Agents
Miscellaneous
Preferred:
Approved for members with a diagnosis of cystanosis who are also taking oral cysteamine.
Cystaran™ (cysteamine)
Respiratory Cough & Cold
Antihistamines and Combinations Approval duration: up to 10 years
Preferred:
Xyzal® (g) (levocetirizine)
OTC loratadine and OTC cetirizine.
Cystic Fibrosis Agents Approval duration: up to 6 months
Preferred:
Preferred agent:
Kalydeco™ (ivacaftor)
Approved for FDA indication, only when genetic testing has been submitted to the plan to
document the specific gene mutation.
Initial approval duration: 1 year, up to 5 years for continuation
Nonpreferred:
Cayston®
Inhaled Beta-Agonists Nonpreferred:
Brovana®, Perforomist™
Miscellaneous Nonpreferred:
DalirespTM
Cayston: Coverage is provided for the treatment of pseudomonas aeruginosa infection in
members with cystic fibrosis.
both Serevent® and Foradil®.
Daliresp: Requires documentation that the member has a diagnosis of severe chronic
obstructive pulmonary disorder (COPD) associated with chronic bronchitis and a history of
exacerbations despite therapy with a long acting beta agonist, an anticholinergic and a preferred
inhaled steroid.
Pulmonary Arterial Hypertension
Preferred:
Preferred agents:
Letairis™ (ambrisentan),
Approved for the treatment of pulmonary arterial hypertension (PAH), (WHO Group 1). Revatio
Revatio®(g), Revatio suspension
suspension: also requires documentation that the member is unable to swallow tablets/
(sildenafil), Tracleer® (bosentan),
capsules.
TyvasoTM (treprostinil), Ventavis®
(iloprost)
Nonpreferred:
Adcirca®, Adempas®, Opsumit®
Adcirca, Opsumit: Approved for the treatment of PAH (WHO Group 1) with functional class
II or III and requires documentation that the member has experienced treatment failure of or
intolerance to Revatio(g).
Adempas:
• Approved for the treatment of PAH (WHO Group 1) and requires treatment failure of or
intolerance to Revatio(g)
• Requires a diagnosis of chronic thromboembolic pulmonary hypertension (WHO Group 4) in
members who are ineligible or refractory to surgical treatment.
Rheumatology & Musculoskeletal
Gout Therapy Approval duration: up to 10 years
Page 14
Preferred:
Preferred: Approved for the treatment of gout and requires treatment failure of or intolerance
Uloric® (febuxostat)
to Allopurinol(g). Uloric 80mg: also requires treatment failure or or intolerance to 40mg.
Rheumatology & Musculoskeletal (Cont.)
Miscellaneous Rheumatologic Agents Approval duration: up to 10 years
Nonpreferred:
Actemra, Kineret, Orencia SC, Xeljanz: Requires FDA-approved indication in
Actemra®, Cimzia®, Kineret®, Orencia® situations where the member has experienced treatment failure of or intolerance to Enbrel OR
SC, Otezla®, SimponiTM, Xeljanz®
Humira.
Cimzia, Otezla, Simponi: Requires FDA-approved indication in situations where the
member has experienced treatment failure of or intolerance to Enbrel and Humira.
Osteoporosis/Bone Resorption Inhibitors Approval duration: up to 10 years
Preferred:
Preferred agents:
Actonel® (risedronate) (g),
Actonel(g): Requires documentation that the member has experienced treatment failure of or
Boniva® (ibandronate) (g)
intolerance to Fosamax(g) and Boniva(g).
Boniva(g): Requires documentation that the member has experienced treatment failure of or
intolerance to Fosamax(g).
Nonpreferred:
AtelviaTM, ForteoTM
Atelvia: Requires documentation that the member has experienced treatment failure of or
intolerance to three preferred alternatives Actonel(g), Boniva(g), Fosamax(g).
Forteo: Approved for the treatment of osteoporosis (T-score < -2.5) AND requires
documentation that the member has a contraindication to or experienced treatment failure after
24 months of treatment or intolerance to a preferred bisphosphonate.
Urology
Bladder Control
Nonpreferred:
Myrbetriq®
BPH Treatment Preferred:
JalynTM (dutasteride/tamsulosin)
Approved when the member has experience treatment failure of or intolerance to at least 2 of the
following generics (Detrol(g), LA(g); Ditropan(g), XL(g); Sanctura(g), XR(g)).
Requires successful treatment of at least one month of therapy of either an alpha blocker,
5-alpha-reductase inhibitor or Jayln.
Page 15

BCN Custom Select Prior Authorization and Step

Transcription

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