Blue Care Network
Custom Drug List
Prior Authorization and Step Therapy Guidelines
January 2015
Blue Care Network’s 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 BCBSM/
BCN Custom 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 commercial 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.
• Most BCN members do not have coverage for nonpreferred drugs. Requests for coverage of
nonpreferred drugs are considered when the member meets BCN’s criteria and the member
has tried and failed to respond to an adequate trial of the available preferred agents, or the
available preferred agents would pose unnecessary risk to the member.
Please visit us online at BCBSM.com/RxInfo for more information.
This information applies to members with a BCN commercial drug benefit. Criteria for BCN
AdvantageSM members can be viewed on our web site: bcbsm.com.
(g)=generic available ANTI-INFECTIVES
Approval duration: up to 3 months
Antifungals Nonpreferred:
Lamisil® Granules, OnmelTM
Antituberculars
Preferred:
Sirturo™ (bedaquiline)
Antivirals
Preferred:
OlysioTM (simeprevir)
Cont. on next page...
Lamisil: 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.
Onmel: Requires a diagnosis of onychomycosis, treatment failure of or intolerance to
Sporanox(g) and either Lamisil(g) or griseofulvin AND a credible reason why Onmel is expected
to work when Sporanox(g) has not.
Approval duration: up to 6 months
Approved for members > 18 years old with pulmonary multi-drug resistant tuberculosis (MDRTB).
Approval duration: up to 6 months
Preferred agents:
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.
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ANTI-INFECTIVES (cont.)
Anti-Virals (cont.)
Preferred:
SovaldiTM (sofosbuvir),
VictrelisTM (boceprevir)
Quinolones Preferred:
Cipro® XR(g) (ciprofloxacin ER)
Tetracyclines
Preferred:
Adoxa®(g) (doxycyline
monohydrate),
Doryx®(g) (doxycyline hyclate),
Doxycycline 150mg tablet(g)
(doxycyline hyclate),
Solodyn®(g) (minocycline)
Approval duration: up to 6 months
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.
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.
*Note: 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.
Approval duration: up to 1 month
Approved only for uncomplicated urinary tract infection (cystitis). Alternatives include Cipro(g)
100-250mg BID x 3 days and Bactrim DS®(g) BID x 3-5 days.
Approval duration: up to 1 year
Preferred agents*:
Adoxa(g): Requires documentation that the member has experienced treatment failure of or
intolerance to generic doxycycline monohydrate (Monodox (g)).
Doryx(g), Doxycycline 150mg tablet: Requires documentation that the member has
experienced treatment failure of or intolerance to generic immediate release doxycycline hyclate
(Doxycline 20mg (g), Vibramycin (g)).
Solodyn(g): Requires documentation that the member has experienced treatment failure of or
intolerance to generic minocycline immediate release (Minocin (g), Dynacin (g)).
Nonpreferred:
Acticlate®, Doryx 200mg, Doxycycline
IR-DR, Oracea®, Solodyn 55, 65, 80,
105, 115mg
Nonpreferred agents*:
Doxycycline IR-DR, Oracea: Requires documentation that the member has experienced
treatment failure of or intolerance to generic doxycycline monohydrate (Monodox (g)).
Acticlate, Doryx: Requires documentation that the member has experienced treatment
failure of or intolerance to generic immediate release doxycycline hyclate (Doxycline 20mg (g),
Vibramycin (g)).
Solodyn 55, 65, 80, 105, 115mg: Requires documentation that the member has
experienced treatment failure of or intolerance to generic minocycline immediate release
(Minocin (g), Dynacin (g)).
*Approved if above criteria are met, and a copy of the completed MedWatch form (that has been
submitted to the FDA) has been submitted to the plan to document an adverse effect of quality
issue to a preferred agent.
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
Approval duration: up to 1 year
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 5 years
Preferred:
Preferred agents:
Arimidex® (g) (anastrozole),
Arimidex(g), Aromasin(g), Femara(g): PA required for males: Approved only for ERAromasin® (g) (exemestane),
positive breast cancer treatment.
Evista® (g) (raloxifene)
Evista(g), Tamoxifen: $0 copay for female members who meet criteria: diagnosis of
Femara® (g) (letrozole),
primary prevention for breast cancer, age 35 years or older, documented risk factors showing the
Tamoxifen (g) (tamoxifen)
member is high risk for developing breast cancer and no history of breast cancer nor personal or
Cont. next page...
family history of venous thromboembolic events.
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ANTINEOPLASTICS & IMMUNOSUPPRESSANTS (cont.)
Hormonal Agents (cont.)
Approval duration: up to 5 year
Preferred:
Preferred agents:
Xtandi® (enzalutamide)
Xtandi: 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. Approval duration: up to 10 years
Nonpreferred
Soltamox®,
Zytiga®
Immunomodulators Preferred:
Arcalyst™ (rilonacept)
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.
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. Approval duration: up to 10 years
Approval duration: up to 1 year
Preferred agents:
Approved for the treatment of cryopyrin-associated periodic syndrome in members ≥12 years of
age.
Inital approval: 3 months
Nonpreferred:
Pomalyst®,
Revlimid®
Nonpreferred agents:
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.
Kinase Inhibitors & Molecular Target Inhibitors
Approval duration: up to 1 year
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)
Iclusig® (ponatinib),
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),
Zelboraf® (vemurafenib)
ZydeligTM (Idelalisib),
Zykadia™ (ceritinib)
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ANTINEOPLASTICS & IMMUNOSUPPRESSANTS (Cont.)
Miscellaneous Antineoplastic Agents (cont.)
Approval duration: up to 1 year
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
Imbruvica™ (ibrutinib),
required before coverage will be authorized.
Zolinza® (vorinostat)
Erivedge: Initial approval 6 months
Nonpreferred:
Targretin®
Nonpreferred agents:
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 during the preoperative phase in members who have experienced
treatment failure to a preferred selective alpha1-adrenergic receptor blocker (i.e Cardura(g)) in
combination with a preferred calcium channel blocker (i.e. Norvasc(g)).
Angiotensin II Receptor Blockers (ARBS)
Approval duration: up to 10 years
Preferred:
Preferred agents:
Atacand® (g) (candesartan), Atacand Requires documentation that the member has experienced intolerance to a preferred generic
HCT(g) (candesartan/hctz); Benicar® ARB (Avapro(g), Avalide(g), Cozaar(g), Hyzaar(g), or Teveten 600mg(g)).
(olmesartan medoxomil), Benicar
Exforge(g), HCT(g); Twynsta: Requires successful treatment of at least three months
HCT (olmesartan medoxomil/hctz);
of therapy with the individual agents contained in the requested medication at the prescribed
Diovan®(g) (valsartan), Diovan
dosage.
HCT(g) (valsartan/hctz), Exforge®(g)
(amlodipine/valsartan),
Exforge HCT(g) (amlodipine/
valsartan/hctz); Micardis® (g)
(telmisartan), Micardis HCT(g)
(telmisartan/hctz); Twynsta® (g)
(telmisartan/amlodipine)
Nonpreferred:
Nonpreferred agents:
Azor®, Edarbi®, Edarbyclor®, Teveten® Azor, Tribenzor: Requires successful treatment of at least three months of therapy with the
HCT, TribenzorTM
individual agents contained in the requested medication at the prescribed dosage.
Edarbi, Edarbyclor, Teveten HCT: Requires documentation that the member has
experienced treatment failure of or intolerance to two of the following preferred ARBs: Atacand
(g), HCT (g); Avapro (g), Avalide (g), Cozaar(g), Diovan HCT (g), Hyzaar(g), AND Benicar,
HCT.
Beta Blockers
Approval duration: up to 10 years
Nonpreferred:
Bystolic: Requires documentation that the member has experienced treatment failure of or
Bystolic® , Coreg CR™
intolerance to at least two unique preferred cardioselective beta blockers, such as betaxolol,
atenolol, acebutolol, metoprolol, or bisoprolol.
Coreg CR: Requires documentation that the member experienced treatment failure of or
intolerance to both carvedilol immediate-release (Coreg(g)) AND metoprolol succinate (Toprol
XL(g)).
Cardiovascular Treatment
Approval duration: up to 10 years
Nonpreferred:
Northera: Approved for adult with symptomatic neurogenic orthostatic hypotension in
Northera®, Ranexa®
situations where the member has experienced treatment failure of or intolerance to midodrine
AND fludrocortisone.
Ranexa: Requires documentation that the member has experienced treatment failure of
or intolerance to both a beta-blocker and a maintenance nitrate given around-the-clock. The
member must have no history of or high risk for cancer.
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CARDIOVASCULAR, HYPERTENSION, CHOLESTEROL (Cont.)
Cardiovascular Treatment (cont.)
Approval duration: up to 10 years
Vecamyl: Requires diagnosis of moderately severe to severe primary hypertension or
uncomplicated cases of malignant hypertension in members who have experienced treatment
failure of or intolerance to three antihypertensive drug combinations.
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.
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)). Also requires
triglyceride levels > 500mg/dl.
Trilipix(g): Requires documentation that the member has experienced treatment failure of
or intolerance 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:
Vecamyl®
Nonpreferred:
Advicor®, Altoprev®, Crestor®,
Juxtapid™, Liptruzet®, Livalo®,
Vascepa™, Vytorin®
Nonpreferred agents:
Advicor, Simcor: Requires successful treatment of at least three months of therapy with the
individual agents contained in the requested medication at the prescribed dosage.
Altoprev, Crestor, Liptruzet, 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).
Juxtapid: Requires documentation that the member has homozygous familial
hypercholesterolemia (HoFH) and is receiving optimal adjunctive treatment with other therapies
including a low-fat diet and other oral lipid lowering treatments, and has experienced treatment
failure of or intolerance to Kynamro.
Vascepa: Requires documentation that the member has experienced treatment failure of or
intolerance to ALL of the following: Lopid(g), an OTC Omega 3 fatty acid at a dose of at least 3
grams/day, a generic fenofibrate (i.e. Antara(g), Lofibra(g), or Tricor(g)) AND Lovaza(g). Also
requires triglyceride levels > 500mg/dl.
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).
CENTRAL NERVOUS SYSTEM
Anticonvulsants
Approval duration: up to 10 years
Nonpreferred:
Aptiom: Approved for members > 18 years of age as adjunctive therapy in the treatment of
Aptiom®,
partial-onset seizures who have experienced treatment failure of or intolerance to at least 2
GraliseTM
generic formulary alternatives one of which must be Tegretol(g).
Gralise: Requires documentation that the member has:
• Diagnosis of neuropathic pain associated with post-herpetic neuralgia AND the member has
Cont. next page...
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.
• An explanation why gabepentin extended release is expected to work if gabepentin immediate
release has not.
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CENTRAL NERVOUS SYSTEM (Cont.)
Anticonvulsants (cont.)
Approval duration: up to 10 years
Nonpreferred:
Lyrica: Requires documentation that the member has at least one of the three listed diagnoses:
Lyrica®,
• Seizure disorder: Requires that the member is being treated concurrently with other
Onfi®,
anticonvulsants
QudexyTM XR,
• Neuropathic pain: When associated with either diabetic peripheral neuropathy or postTopiramate ER,
herpetic neuralgia or spinal cord injury AND the member has experienced treatment failure of or
Trokendi XRTM
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).
Qudexy XR: Approved for treatment of seizure disorders and requires treatment failure of or
intolerance to at least 2 generic formulary alternatives, one of which must be Topamax®(g), and
an explanation why topiramate extended release is expected to work if Topamax(g) immediate
release has not. Documentation that the member is unable to swallow tablets/capsules must also
be provided.
Topiramate ER, Trokendi XR: Requires documentation that the member has experienced
treatment failure of or intolerance to at least two generic preferred alternatives for the treatment
of partial-onset seizures, one of which must be Topamax(g), and an explanation why topiramate
extended release is expected to work if Topamax(g) immediate release has not.
Antidepressants Approval duration: up to 10 years
Preferred:
Preferred agents:
Luvox CR® (g) (fluvoxamine maleate) Luvox CR(g): 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, Brintellix®,
Desvenlafaxine ER, Desvenlafaxine
fumarate, FetzimaTM, Khedezla®,
OleptroTM, Pexeva®, Pristiq®,
Savella®, ViibrydTM
Nonpreferred agents:
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.
Brintellix, Viibryd: Requires documentation that the member has experienced treatment
failure of or intolerance to at least three generic antidepressants.
Desvenlafaxine ER, Desvenlafaxine Fumarate, Khedezla, Pristiq: 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.
Oleptro: Approved for major depressive disorder in members who have experienced treatment
failure of or intolerance to at least three preferred antidepressants one of which is Desyrel®(g)
AND documentation that continued use of Desyrel(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 treatment failure of or intolerance gabapentin 1200 mg per day and
at least three of the following: a tricyclic antidepressant, an SSRI, an SNRI, cyclobenzaprine, or
tramadol.
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CENTRAL NERVOUS SYSTEM (Cont.)
Antipsychotics Preferred:
Abilify®, Discmelt, solution
(aripiprazole), Fazaclo®(g)
(clozapine)
Approval duration: up to 10 years
Preferred agents:
Requires treatment failure of or intolerance to one of the following 2nd generation preferred
antipsychotics: Geodon(g), Risperdal(g), Seroquel(g), Zyprexa(g).
Nonpreferred:
Nonpreferred agents:
Fanapt®, Fazaclo®, Invega®, Latuda®, Fanapt, Fazaclo 150, 200mg, Latuda, Saphris: Requires treatment failure of or
Saphris®, Seroquel XR®
intolerance to one of the following 2nd generation antipsychotics: Geodon(g), Risperdal(g),
Seroquel(g), Zyprexa(g) AND Abilify.
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.
Seroquel XR: Requires documentation that the member has experienced treatment failure of
or intolerance to Seroquel(g) and Abilify.
CNS Stimulants Approval duration: up to 5 years
Preferred:
Preferred agents:
Adderall XR® (g) (amphet asp/
Adderall XR(g): Requires documentation that the member has experienced treatment failure
amphet/d-amphet),
of or intolerance to brand name Adderall XR.
Procentra™ (dextroamphetamine),
Procentra: Requires documentation that the member has experienced treatment failure of or
Provigil® (g) (modafinil)
intolerance to both Metadate CD(g) 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.
Approval duration: up to 10 years
Nonpreferred:
Nuvigil®, Quillivant XRTM, Strattera™,
Vyvanse™
Migraine Therapy Preferred:
Amerge® (g) (naratriptan),
Zomig®, ZMT® (g) (zolmitriptan)
Nonpreferred agents:
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.
Approval duration: up to 10 years
Quillivant XR: Approved for members ≥ 6 years of age who have been diagnosed with ADHD
and have experienced treatment failure of or intolerance to both a methylphenidate (such as
Ritalin(g) or Concerta(g)) AND an amphetamine (such as Adderall(g)), one of which must be a
generic long acting formulation, OR physician provides documentation that the member cannot
swallow tablets/capsules and has tried and failed one of the agents that can be opened and
sprinkled on apple sauce (e.g. Metadate CD(g) and Adderall XR). Approval duration: up to 1
year.
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.
Vyvanse: 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)).
Approval duration: up to 10 years
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).
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CENTRAL NERVOUS SYSTEM (Cont.)
Migraine Therapy (cont.)
Approval duration: up to 10 years
Nonpreferred:
Nonpreferred agents:
Alsuma®, Axert®, Frova®, Relpax®,
Alsuma, Axert, Frova, Relpax, Zomig nasal spray: Requires documentation that
Sumavel® Dosepro® , Treximet® ,
the member has experienced failure of or intolerance to both Imitrex(g) and Maxalt(g), MLT(g).
Zomig nasal spray
Sumavel Dosepro: Requires treatment failure of or intolerance to Imitrex injection and
Maxalt (g), MLT(g).
Treximet: Requires documentation that the member has experienced treatment failure of or
intolerance to a combination of Imitrex(g) with naproxen.
Miscellaneous CNS Approval duration: up to 1 year
Preferred:
Preferred agents:
Aricept® 23mg (g) (donepezil hcl),
Aricept 23mg: Requires documentation of a progressive-type dementia AND requires
Intuniv® (g) (guanfacine),
successful treatment with Aricept 10mg(g) for three months.
Kapvay® (g) (clonidine hcl),
Approval duration: up to 10 years
Nuedexta® (dextromethorphan/
Intuniv(g), Kapvay(g): Approved for treatment of ADHD and requires documentation
quinidine)
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).
Approval duration: up to 5 years
Nuedexta: Requires documentation that the member has a diagnosis of pseudobulbar affect.
Nonpreferred:
Namenda XR™, Xyrem®
Narcotics Preferred:
Actiq® (g) (fentanyl citrate),
ExalgoTM (g) (hydromorphone),
Opana® (g) (oxymorphone),
Opana ER(g) (oxymorphone)
Nonpreferred:
AbstralTM, Fentora®, Lazanda®,
SubsysTM
Cont. next page...
Nonpreferred agents:
Namenda XR: Approved for moderate to severe Alzheimer’s disease in members whom have
experienced treatment failure of or intolerance to Aricept(g).
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).
Approval duration: up to 1 year
Preferred agents:
Actiq(g): Approved for the treatment of breakthrough cancer pain in members that are tolerant
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).
Opana(g): Requires documentation that the member has experienced treatment failure of or
intolerance to Roxanol(g) or MSIR(g).
Opana ER(g): 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).
Nonpreferred agents:
Abstral, Fentora, Lazanda, Subsys: Approved for the treatment of breakthrough
cancer pain in members that are tolerant of high dose narcotics and who are currently receiving a
long-acting narcotic. The member must also have experienced treatment failure of or intolerance
to the use of Actiq(g) and other oral immediate-release narcotics for the management of
breakthrough pain. Lazanda,Subsys: also require treatment failure of or intolerance to a
buccal fentanyl product.
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CENTRAL NERVOUS SYSTEM (Cont.)
Narcotics (cont.)
Approval duration: up to 1 year
Nonpreferred:
Nonpreferred agents:
AbstralTM, Fentora®, Lazanda®,
Nucynta: Requires documentation that the member has experienced treatment failure of or
Nucynta®, ER; Oxycodone hcl ER,
intolerance to Ultram(g), ER(g); or Ultracet(g) AND two preferred immediate-release narcotics.
Oxycontin®, SubsysTM
If use is to exceed 30 days, Nucynta must be used in combination with a long-acting narcotic,
Zohydro ERTM
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, and
Cymbalta(g). If the member is < 65 years old, requires treatment failure of or intolerance to
gabapentin 1200 mg per day, a tricyclic antidepressant, and Cymbalta(g).
Oxycodone, 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).
Zohydro ER: Approved for the treatment of moderate to severe chronic pain requiring
around-the-clock, long-term opioid treatment and requires treatment failure of or intolerance to
an adequate trial with at least 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
Approval duration: up to 1 year
Preferred:
Preferred agents:
Fioricet® 50/300/40mg (g),
Fioricet 50/300/40mg(g): Requires documentation that the member has experienced
(butalbital/apap/caffeine)
treatment failure of or intolerance to Esgic(g) (50/325/40mg), documentation as to why Fioricet
Fioricet Codeine 50/300/30mg (g)
50/300/40mg is expected to work when Esgic(g) did not AND a completed MedWatch form has
(butalbital/apap/caffeine/codeine)
been submitted to the FDA and to the plan to documenting the adverse effect or quality issue
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).
Nonpreferred:
Xartemis XRTM
Nonpreferred:
Xartemis XR: Requires documentation that the member has experienced treatment failure
of or intolerance to 3 generic short acting opiod products one of which must be Percocet(g)
AND documentation as to why Xartemis XR is expected to work when the immediate-release
formulation has not.
Narcotic Mixed Agonist/Antagonist
Approval duration: up to 1 year
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).
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CENTRAL NERVOUS SYSTEM (Cont.)
Non-Steroidal Anti-Inflammatory Drugs Approval duration: up to 10 years
Preferred:
Preferred agent:
Arthrotec® (g) (diclofenac/
Arthrotec(g): Approved for members >60 years of age; or is receiving chronic treatment with
misoprostol), Celebrex®(g)
anticoagulants, antiplatelets or corticosteroids; (≥ 60 days duration), or has a history of or current
(celecoxib), PennsaidTM (g)
diagnosis of peptic ulcer disease, clinically significant gastrointestinal bleeding, and/or alcoholism.
(diclofenac sodium)
Celebrex(g):
• Approved for members >60 years of age: who are not at high risk for
cardiovascular events, and do not have a previous history of stroke, myocardial infarction (MI),
coronary heart disease or blood clots and must not be receiving concomitant anticoagulant
or an antiplatelet therapy. The member must experience treatment failure of or intolernace to
Mobic(g) or Lodine(g).
• Approved for members ≤ 60 years of age: who are receiving chronic treatment
with oral corticosteroids (≥ 60 days duration) or have a history of or current diagnosis of
peptic ulcer disease, clinically significant gastrointestinal bleeding, and/or alcoholism AND
experience treatment failure of or intolerance to Mobic(g) or Lodine(g). The member must not
be receiving concomitant anticoagulant or antiplatelet therapy AND have no previous history or
evidence of cardiovascular and thromboembolic disease. Note: Lodine®(g) is more selective
than Celebrex for the COX-2 enzyme.
Pennsaid(g): Requires documentation of treatment failure or intolerance to Voltaren(g)/
XR(g) tablets, an OTC topical analgesic (Myoflex OR Aspercreme).
Approval duration: up to 3 months
Nonpreferred:
Flector® Patch, Pennsaid 2%,
VimovoTM, Voltaren® Gel
Nonpreferred agents:
Flector Patch: Approved only for the treatment of acute sprains AND requires treatment
failure of or intolerance to Voltaren(g)/XR(g) tablets AND an OTC topical analgesic (Myoflex OR
Aspercreme).
Approval duration: up to 1 month
Pennsaid 2%: Requires documentation of treatment failure or intolerance to Voltaren(g)/
XR(g) tablets, OTC topical analgesic (Myoflex OR Aspercreme) and Pennsaid 1.5%(g).
Approval duration: up to 3 months
Vimovo: Requires documentation that the member has had treatment failure of or intolerance
to ALL generic formulary proton pump inhibitors, one of which is at a twice-daily high-dose,
regimen, AND meets any one of the following criteria:
• Greater than 60 years of age
• Receiving anticoagulant or antiplatelet therapy
• Receiving chronic treatment with oral corticosteroids (>60 days duration)
• A history or peptic ulcer disease, clinically significant gastrointestinal bleeding, and/or
alcoholism.
Voltaren Gel: Requires documentation of treatment failure or intolerance to Voltaren(g)/
XR(g) tablets AND an OTC topical analgesic (Myoflex OR Aspercreme).
Approval duration: up to 3 months
Parkinson’s Disease and Related Disorders Approval duration: up to 10 years
Nonpreferred:
Horizant:
HorizantTM , Mirapex ER®
Restless Legs Syndrome (RLS): Requires treatment failure or intolerance to Requip(g),
XL(g); Mirapex(g) and Neurontin(g), and an explanation why gabepentin extended release is
expected to work if Neurontin(g) release has not.
Cont. next page...
Post-herpetic neuralgia
• If 65 or older: requires treatment failure of or intolerance to Neurontin(g) 1200 mg per day.
• If under 65 years old: requires treatment failure of or intolerance to Neurontin(g) 1200 mg per
day and a tricyclic antidepressant.
Mirapex ER: Requires a diagnosis of Parkinson’s Disease and treatment failure or intolerance
to Mirapex IR(g) AND documentation that the continued use of Mirapex IR(g) will adversely
affect the member’s condition.
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CENTRAL NERVOUS SYSTEM (Cont.)
Parkinson’s Disease and Related Disorders (cont.)
Approval duration: up to 10 years
Nonpreferred:
Neupro: Requires a diagnosis of Parkinson’s disease or restless leg syndrome and treatment
Neupro®
failure of or intolerance to Mirapex(g), ER AND Requip(g), XL(g).
• Restless leg syndrome: also requires treatment failure of or intolerance to
Neurontin(g).
Sedatives/Hypnotics Approval duration: up to 1 year
Preferred:
Preferred agent:
Ambien CR® (g) (zolpidem)
Requires documentation that the member has experienced treatment failure of or intolerance to
an adequate trial of both Ambien®(g) and Sonata®(g).
Nonpreferred:
EdluarTM, Hetlioz®, Intermezzo®,
Rozerem®, SilenorTM, ZolpiMistTM
Skeletal Muscle Relaxants
Preferred:
Skelaxin®(g) (metaxalone)
Zanaflex capsules(g) (tizanadine)
DERMATOLOGY
Acne Treatment Nonpreferred:
Veltin™ gel, Ziana® gel
Nonpreferred agents:
Edluar, Intermezzo: Requires documentation that the member has experienced treatment
failure of or intolerance to Ambien CR(g) and Sonata(g). Coverage is not provided in
combination with other sedatives.
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.
Rozerem, ZolpiMist: Requires documentation that the member has experienced treatment
failure of or intolerance to Ambien(g) AND Sonata(g).
Silenor: Requires documentation that the member has experienced treatment failure of or
intolerance to doxepin IR®(g), Ambien(g), Sonata(g) AND Desyrel®(g).
Approval duration: up to 1 year
Skelaxin(g): Requires treatment failure of or intolerance to at least three of the following:
Flexeril(g), Norflex(g), Parafon Forte(g), Robaxin(g).
Zanaflex capsules(g): Requires treatment failure of or intolerance to ALL of the following:
baclofen, Flexeril(g) and Zanaflex tablets(g).
Approval duration: up to 1 year
Requires documentation of medical necessity to identify why individual agents [Cleocin-T®(g)
plus Retin-A®(g)] cannot be used in combination.
Antipsoriatic/Antiseborrheic Approval duration: up to 1 year
Preferred:
Preferred:
Taclonex®(g) (calcipotriene/
Taclonex(g): Requires documentation that the member has experienced treatment failure
betamethasone dipropionate)
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).
Nonpreferred:
Otrexup®,
Rasuvo™,
Stelara®,
Taclonex Scalp
Nonpreferred agents:
Otrexup, Rasuvo: Requires documentation that the member has a diagnosis of severe
and active rheumatoid arthritis, pJIA, or severe psoriasis, and has experienced treatment failure
or or intolerance to both oral and intramuscular methotrexate. Also an explanation as to why
subcutaneous methotrexate is expected to work when the other formulations have not must be
submitted to the plan.
Approval duration: up to 10 years
Stelara: Approved for members > 18 years of age for the treatment of plaque psoriasis and
psoriatic arthritis who have experienced treatment failure of or intolerance to either Humira or
Enbrel.
Approval duration: up to 10 years
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).
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DERMATOLOGY (Cont.)
Miscellaneous
Preferred:
Protopic® (g) (tacrolimus),
Solaraze® (g) (diclofenac sodium)
Approval duration: up to 1 year
Preferred agents:
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.
Solaraze: 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 Aldara(g), Efudex(g) and Retin-A(g)).
Nonpreferred:
Picato®
Nonpreferred agents:
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 Aldara(g), Efudex(g) and Retin-A(g)).
Wound & Burn Therapy Approval duration: up to 5 months
Nonpreferred:
Requires documentation that the member has a diagnosis of lower extremity diabetic neuropathic
Regranex®
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.
DIAGNOSTICS & OTHER MISCELLANEOUS
Diagnostic & Other Miscellaneous
Approval duration: up to 1 year
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),
Depo®-Testosterone (g)
(methyltestosterone)
Nonpreferred:
Android®, Axiron®, Fortesta™,
Methitest™, Natesto™, Striant®,
Testim®, Testosterone, Testred®,
Vogelxo®
Nonpreferred agents:
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.
Approval duration: up to 1 year
Preferred:
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:
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.
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ENDOCRINOLOGY (Cont.)
Growth Hormone & Related Products
Preferred:
Genotropin® (somatropin),
Nutropin® AQ, Nuspin (somatropin)
Approval duration: up to 1 year
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)
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:
Preferred agents:
BydureonTM (exenatide),
Bydureon, Victoza: Approved for members with a diagnosis of type 2 diabetes with a Hgb
Victoza® (liraglutide)
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:
Avandamet®, Avandaryl®, Avandia®,
Byetta®, Cycloset®, InvokametTM,
Jentadueto™, Kazano®, Oseni®,
Prandimet®, Tanzeum™, Trulicity®,
Xigduo XRTM
Cont. on next page...
Nonpreferred agents:
Avandamet, Avandaryl, Invokamet, Jentadueto, Kazano, Oseni, Prandimet
Xigduo XR: 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, Tanzeum, Trulicity: Approved for members with a diagnosis of type 2 diabetes.
• If Hgb A1c < 9%: treatment failure of or intolerance to all of the following: two oral antidiabetic
agents, one of which is metformin, Bydureon and Victoza.
• If Hgb A1c > 9%: treatment failure of or intolerance to all of the following: two oral antidiabetic
agents, one of which is metformin, insulin therapy, 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
TZD.
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ENDOCRINOLOGY (Cont.)
Non-Insulin Hypoglycemic Agents (cont.)
Approval duration: up to 10 years
Nonpreferred:
Nonpreferred:
Farxiga®, InvokanaTM, Jardiance®,
Farxiga, Invokana, Jardiance: Requires documentation that the member has
Nesina®, Tradjenta™, Symlin®,
experienced treatment failure of or intolerance to three of the following: metformin, a
Symlinpen®
sulfonylurea, Actos(g) and a preferred DPP-4 inhibitor.
Nesina, 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.
Osteoporosis/Hormonal Treatment
Approval duration: up to 1 year
Nonpreferred:
Duavee: Approved for the prevention of postmenopausal osteoporosis in female members
Duavee™
who have a higher risk of osteoporosis and have tried and failed at least 2 preferred oral
bisphosponates (Actonel(g), Fosamax(g), Boniva(g)).
Miscellaneous
Approval duration: up to 10 years
Preferred:
Preferred agents:
Carbaglu® (carglumic acid),
Carbaglu: Approved for a diagnosis of hyperammonemia due to a deficiency of the hepatic
Korlym™ (mifepristone),
enzyme N-acetylglutamate synthase (NAGS) as confirmed by enzyme or DNA mutation analysis.
Signifor® (pasireotide)
Approval duration: up to 3 months
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. Approval duration: inital up to 6 months.
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.
Approval duration: up to 1 year
Nonpreferred:
Duavee®, Egrifta®, Myalept™,
Procysbi®, Ravicti™
Cont. next page...
Nonpreferred agents:
Duavee: Approved for female members in the treatment of moderate to severe vasomotor
symptoms associated with menopause and requires treatment failure of or intolerance to at least
3 of the following: an SSRI, an SNRI, estrogen/progesterone combination, beta-blocker and
Neurontin(g).
Egrifta: Approved for members > 18 years of age for the reduction of excess abdominal fat
in HIV-associated lipodystrophy, receiving antiretroviral therapy, with gender-specific measures
when other weight loss efforts have been ineffective and there is functional impairment in
activities of daily living. Renewal coverage is provided for the reduction of excess abdominal fat
in HIV-associated lipodystrophy when clinical documentation is provided indicating a decrease in
waist circumference and continuation of functional impairment in activities of daily living.
Approval duration: Initial approval length up to 6 months, renewal up to 1 year.
Myalept: Requires a diagnosis of generalized lipodystrophy in members optimally treated with
insulin and a statin.
Procysbi: Diagnosis of nephropathic cystinosis and documentation that the member has
experienced treatment failure or intolerance to cysteamine IR (Cystagon®) and an explanation as
to why the extended release formulation would work if the immediate release has not.
Ravicti: Approved for the treatment of any chronic Urea Cycle Disorder (except for NAGS
deficiency) with treatment failure of or intolerance to Buphenyl®.
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ENDOCRINOLOGY (Cont.)
Miscellaneous (cont.)
Nonpreferred:
Zavesca®
Approval duration: up to 10 years
Nonpreferred agents:
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:
Diclegis: Requires treatment failure of or intolerance to pyridoxine OTC and doxylamine
Diclegis®, Sancuso®, Zuplenz®
OTC in combination and Zofran(g) and an explanation must be provided as to why Diclegis is
expected to work when the individual agents have not.
Approval duration: up to 9 months
Sancuso, Zuplenz: Requires documentation that the member has experienced treatment
failure of or intolerance to oral Kytril(g) AND Zofran(g), ODT(g).
Miscellaneous Gastrointestinal Agents Approval duration: up to 1 year
Preferred:
Preferred agent:
Relistor® (methylnaltrexone)
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®, ChenodalTM, Cimzia®,
FulyzaqTM, Gattex®, LiznessTM,
Lotronex®, Simponi®, Uceris™, Uceris
Foam, Xifaxan 550®
Nonpreferred agents:
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.
Approval duration: up to 10 years
Fulyzaq: Approved for members with HIV/AIDS who are currently on antiretroviral therapy for
the treatment of symtomatic relief of non-infectious diarrhea.
Gattex: Approved for members > 18 years of age with a diagnosis of Short Bowel Syndrome
(SBS) AND dependence on parenteral support > 12 months.
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
Uceris: Approved for the treatment of active, mild to moderate ulcerative colitis with a trial and
failure or intolerance to an oral 5-ASA AND two oral, locally active corticosteroids one of which is
Entocort EC™(g).
Uceris Foam: Approved for active mild to moderate distal ulcerative colitis in situations where
the member has experienced treatment failure of or
intolerance to a preferred corticosteroid enema/foam AND a generic rectal mesalamine.
Xifaxan 550: Requires diagnosis of hepatic encephalopathy AND documentation that the
member has had treatment failure of or intolerance to lactulose.
Approval duration: up to 10 years
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GASTROINTESTINAL AGENTS (Cont.)
Proton Pump Inhibitors Preferred:
Aciphex® (g) (rabeprazole),
Prevacid®(g) capsule (lansoprazole),
Prevacid SolutabTM,
Zegerid® (Rx Only) (g) capsule
(omeprazole/sodium bicarbonate)
Approval duration: up to 5 years
Preferred agents:
Aciphex(g), Zegerid(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), Solutab: Requires documentation that the member has experienced failure of
or intolerance to Prilosec® OTC(g) or Prilosec(g) AND Protonix(g).
Nonpreferred:
Aciphex® Sprinkles; DexilantTM,
Esomeprazole StrontiumTM, Nexium®,
packet; Prilosec suspension, Protonix
suspension, Zegerid Packet,
VimovoTM
Nonpreferred agents:
Aciphex Sprinkles; Zegerid Packet: Requires documentation that the member has
experienced treatment failure of or intolerance to Prilosec OTC or Prilosec(g), Protonix(g) AND
Prevacid(g) or Prevacid Solutab.
Dexilant, Esomeprazole Strontium, Nexium: Requires documentation that the
member has experienced treatment failure or intolerance to all BCN preferred alternatives:
Aciphex(g), Prilosec OTC or Prilosec(g), Protonix(g), AND Prevacid(g), one of which is at a
twice daily, high dose regimen.
Prilosec suspension, Protonix suspension: Requires documentation that the
member has experienced treatment failure of or intolerance to Prevacid Solutab.
Vimovo: Requires documentation that the member has had treatment failure of or intolerance
to Aciphex(g), Prilosec(g), Protonix(g) and Prevacid(g) AND meets any one of the following
criteria:
•Greater than 60 years of age
•Receiving anticoagulant or antiplatelet therapy
•Receiving chronic treatment with oral corticosteroids (>= 60 days duration)
•A history of peptic ulcer disease, clinically significant gastrointestinal bleeding, and/or
alcoholism.
Approval duration: up to 10 years
IMMUNOLOGY & HEMATOLOGY
Hematopoietic Agents
Approval duration: up to 1 year
Preferred:
Preferred agents:
Procrit® (epoetin alfa),
Procrit: Requires documentation that the member has anemia secondary to one of the
Promacta® (eltrombopag)
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.
Nonpreferred:
Aranesp®, Epogen®
Nonpreferred agents:
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
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GASTROINTESTINAL AGENTS (Cont.)
Interferons and MS Therapy
Approval duration: up to 1 year
Preferred:
Preferred agents:
Gilenya® (fingolimod hcl),
Gilenya, Tecfidera: Approved for members 18 and older who have a diagnosis of a
InfergenTM (interferon alfacon-1),
relapsing form of multiple sclerosis.
Intron-A® (interferon alfa-2B),
Infergen: Approved for the treatment of Hepatitis B.
Pegasys® (peginterferon alfa 2-A),
Intron-A: Approved for the treatment of Hepatitis B, condyloma acuminate, essential
Peg-Intron® (peginterferon alfa-2B),
thrombocythemia, hairy cell leukemia, Kaposi’s sarcoma, malignant melanoma, multiple
Rebetrol(g) (ribavirin),
myeloma, non-Hodgkin’s lymphoma, Philadelphia chromosome (Ph) positive chronic phase
Tecfidera® (dimethyl fumarate)
myelogenous leukemia (CML), and renal cell carcinoma.
Peg-Intron, Pegasys: Approved for the treatment of Hepatitis B and Hepatitis C. For
hepatitis C, approved for members naïve to pegylated interferon therapy only. Genotype,
HIV status, previous therapy and duration must also be provided. The member must receive
peglylated interferon in combination with ribavirin unless contraindicated.
Approval duration: dependent on indication
Rebetrol: Approved for the treatment of Hepatitis C. Genotype, HIV status, previous therapy
and duration must also be provided. Approval duration: up to 1 year
Nonpreferred:
AmpyraTM ,
AubagioTM,
Betaseron®,
SylatronTM
Nonpreferred agents:
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 on current 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
within the first 2 months of therapy. 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 on current 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 all
of the following: a interferon beta product (for example, Avonex®, Extavia® or Rebif®), Copaxone®,
Gilenya and Tecfidera. 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®.
Approval duration: up to 10 years
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
Impotence Approval duration: up to 1 year
Preferred:
For men under the age of 18, and for women: not covered
Caverject® (alprostadil), Cialis®
For men 18 to 34 years old: requires a diagnosis of erectile dysfunction (ED) secondary to a
(tadalafil), Muse® (alprostadil),
medical condition (including but not limited to multiple sclerosis, spinal cord injury, Parkinson’s
Viagra® (sildenafil citrate)
disease, radiation for prostate or bladder cancer). The member must not be using nitrates
concomitantly and avoid use of alpha blockers with oral ED agents. Maximum of 6 doses per 28
days.
Nonpreferred:
For men over the age of 34: requires a diagnosis of ED.
Edex®, Levitra®, Staxyn®, StendraTM
Cialis, Levitra, Staxyn Stendra, Viagra: Also requires treatment failure of or
intolerance to Revatio®(g).
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LIFESTYLE MODIFICATION PRODUCTS (Cont.)
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
Weight Loss Products Preferred:
phentermine and related products
Bontril® PDM(g) (phendimetrazine
tartrate), Didrex(g) (benzphetamine
hcl), diethylpropion
Approval duration: up to 1 year
Preferred agents:
Requires verification that the member’s Body Mass Index (BMI) is ≥ 30 kg/m2 or > 27 kg/m2 with
one or more of the following risk factors: hypertension, congestive heart failure, coronary artery
disease, diabetes or dyslipidemia. Maximum benefit is 12 months of treatment per lifetime.
Nonpreferred:
Belviq®, QsymiaTM, SuprenzaTM ODT,
Xenical®
Nonpreferred agents*:
Requires verification that the member’s Body Mass Index (BMI) is ≥ 30 kg/m2 or > 27 kg/m2 with
one or more of the following risk factors: hypertension, congestive heart failure, coronary artery
disease, diabetes or dyslipidemia. Qsymia: also requires documentation that the member has
experienced treatment failure or or intolerance to generic phentermine.
Suprenza ODT: also requires documentation that the member has experienced treatment
failure or or intolerance to generic phentermine AND a credible explanation as to why use of
orally disintegrating tablets are expected to work if tablets or capsules have not.
*Maximum benefit is 12 months of treatment per lifetime; 24 months of treatment per lifetime for
Xenical.
MISCELLANEOUS Approval duration: up to 6 months
Compounds
Coverage criteria include all the below:
• The compound is medically necessary for the member’s condition
• The compound contains only FDA-approved drugs.
• There are no appropriate FDA-approved commercial formulations of the compound available.
U6W’s (bulk powders) are not covered.
OBSTETRICS AND GYNECOLOGY
Contraceptives Approval duration: up to 1 year
Nonpreferred:
Requires treatment failure of or intolerance to 2 generic contraceptives for $0 copayment.
Nuvaring®
Infertility treatment Approval duration: up to 1 year
Preferred:
Preferred agents:
Bravelle® (urofollitropin),
Coverage is provided for most BCN female members with an infertility benefit and also in
Cetrotide® (cetrorelix acetate),
accordance with generally accepted medical practice. BCN does not provide coverage for
Crinone® (progesterone, micronized), infertility drugs to be used as part of assisted reproductive technology treatment, such as inEndometrin® (progesterone,
vitro fertilization (IVF), zygote in vitro fertilization transfer (ZIFT), gamete in vitro fertilization
micronized), FertinexTM
transfer (GIFT). Authorization will be provided for one year. Additional coverage will be based
(urofollitropin),
on documentation that the member is being treated according to accepted medical practice.
Ganirelix acetate® (ganirelix acetate), Requests are not considered for men.
Gonal-F®, RFF, Redi-ject (follitropin
alfa, recomb), Ovidrel® (HCG
alfa, recomb), Novarel®/Pregnyl®
(gonadotropin, chorionic, human)
Nonpreferred:
Follistim® AQ, Luveris®, Menopur®
Miscellaneous
Nonpreferred:
BrisdelleTM
Nonpreferred agents: Also requires treatment failure of or intolerance to Gonal-F, -RFF,
Redi-ject for Follistim AQ and Luveris.
Approval duration: up to 10 years
Requires treatment failure of or intolerance Paxil(g) and Effexor(g) and an explanation as to
why Brisdelle is expected to work when Paxil(g) has not.
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OPHTHALMIC AGENTS
Miscellaneous
Approval duration: up to 1 year
Preferred:
Approved for members with a diagnosis of cystanosis who are also taking oral cysteamine.
Cystaran™ (cysteamine)
OTIC & NASAL PREPARATIONS
Intranasal Steroids Approval duration: up to 10 years
Preferred:
Requires documentation that the member has experienced treatment failure of or intolerance to
Rhinocort Aqua® (g) (budesonide)
Flonase(g) or Nasalide(g)/Nasarel(g) AND Nasacort AQ(g).
Nonpreferred:
Beconase AQ®, Dymista™, Nasonex®,
Omnaris™, Qnasl®,
Veramyst™, Zetonna™
Nonpreferred agents:
Requires documentation that the member has experienced treatment failure of or intolerance to
Flonase(g) or Nasalide(g)/Nasarel(g) AND Nasacort AQ(g).
Dymista: requires documentation that the member has experienced treatment failure of or
intolerance to two generic nasal steroids AND a trial with the individual agents in combination
(azelastine and fluticasone) for at least three months.
RESPIRATORY COUGH & COLD
Antihistamines and Combinations Approval duration: up to 10 years
Preferred:
Requires documentation that the member has experienced treatment failure of or intolerance to
Clarinex®(g) (desloratadine),
OTC loratadine and OTC cetirizine.
Xyzal® (g) (levocetirizine)
Nonpreferred:
Clarinex-D®, Clarinex Syrup,
Semprex-D®
Cystic Fibrosis Agents Preferred:
Kalydeco™ (ivacaftor)
Nonpreferred:
Bethkis®,
Cayston®
Inhaled Beta-Agonists Nonpreferred:
Brovana®, Perforomist™
Miscellaneous Nonpreferred:
DalirespTM
Grastek®,
Oralair®,
Ragwitek®,
Approval duration: up to 6 months
Preferred agent:
Approved for FDA indication, only when genetic testing has been submitted to the plan to
document the specific gene mutation.
Approval duration: up to 1 year
Nonpreferred agents:
Bethkis: Requires a diagnosis of cystic fibrosis in members who experienced treatment
failure of or intolerance to generic tobramycin and a credible explanation provided as to why the
requested product is expected to work when the generic has not.
Cayston: Coverage is provided for the treatment of pneumonia in members with cystic fibrosis.
Approval duration: up to 10 years
Requires documentation that the member has experienced treatment failure of or intolerance to
both Serevent® and Foradil®.
Approval duration: up to 1 year
Nonpreferred agents:
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.
Grastek, Oralair and Ragwitek: Approved for the treatment of allergic rhinitis with or
without conjunctivitis with confirmed sensitivity to at least one allergen contained in the requested
agent, in members who have experienced treatment failure of or intolerance to all of the following
classes: an intranasal
corticosteroid, an antihistamine and a leukotriene inhibitor
Approval duration: up to 3 years
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RESPIRATORY COUGH & COLD (Cont.)
Pulmonary Arterial Hypertension
Approval duration: up to 10 years
Preferred:
Preferred agents:
Letairis™ (ambrisentan), Revatio(g), Approved for the treatment of pulmonary arterial hypertension (PAH), (WHO Group 1).
Revatio suspension (sildenafil);
Revatio suspension: also requires documentation that the member is unable to swallow
Tracleer® (bosentan), TyvasoTM
tablets/capsules.
(treprostinil), Ventavis® (iloprost)
Nonpreferred:
Adcirca®, Adempas®,
Orenitram®, Opsumit ®
Nonpreferred agents:
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.
Orenitram: Approved for the treatment of PAH (WHO Group 1), functional class II - III and
requires documentation that the member has experienced treatment failure of or intolerance to
Revatio(g) and Tyvaso.
RHEUMATOLOGY & MUSCULOSKELETAL
Gout Therapy Approval duration: up to 10 years
Preferred:
Approved for the treatment of gout and requires treatment failure of or intolerance to
Uloric® (febuxostat)
Allopurinol(g). 80mg also requires treatment failure or or intolerance to 40mg.
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®, Otrexup, RasuvoTM,
Humira.
RayosTM, SimponiTM, Xeljanz®
Cimzia, Otezla**, Simponi: Requires FDA-approved indication in situations where the
member has experienced treatment failure of or intolerance to Enbrel and Humira.
Otrexup, Rasuvo: Requires documentation that the member has been diagnosed with
of one of the following diseases: severe and active rheumatoid arthritis, pJIA, or severe
psoriasis, and has experienced treatment failure of or intolerance to both oral and intramuscular
methotrexate, and an explanation as to why subcutaneous methotrexate is expected to work
when the other formulations have not.
Rayos: Approved for the diagnosis of rheumatoid arthritis and documentation of trial or
intolerance of two generic oral corticosteroids, one of which must be prednisone immediaterelease and an explanation why delayed release is expected to work if prednisone immediate
release has not.
Osteoporosis/Bone Resorption Inhibitors Approval duration: up to 10 years
Preferred:
Preferred agents:
Actonel®(g) (risedronate),
Actonel(g): Requires documentation that the member has experienced treatment failure of or
Boniva®(g) (ibandronate)
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, BinostoTM, Fosamax D™,
ForteoTM
Nonpreferred agents:
Atelvia, Binosto, Fosamax D: 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.
Approval duration: up to 2 years
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UROLOGY
Bladder Control
Nonpreferred:
Myrbetriq®
BPH Treatment Preferred:
Cialis® (tadalafil), JalynTM
(dutasteride/tamsulosin)
Approval duration: up to 10 years
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)).
Approval duration: up to 10 years
Cialis: Approved for BPH when the member has experience treatment failure of or intolerance
to both an alpha blocker, AND a 5-alpha reductase inhibitor, and that the member has an IPSS
score > 13.
Jalyn: Requires successful treatment of at least one month of therapy of either an alpha
blocker, 5-alpha-reductase inhibitor or Jayln.
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