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). Approval duration: up to 3 months 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) Approval duration: up to 3 months 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 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 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. Approval duration: up to 5 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 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. Blue Care Network - Custom Select Drug List Prior Authorization and Step Therapy Guidelines Page 2 Antineoplastics & Immunosuppressants (cont.) Kinase Inhibitors & Molecular Target Inhibitors (cont.) 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 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 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 Zolinza® (vorinostat) required before coverage will be authorized. Erivedge: Initial approval 6 months Nonpreferred: Targretin® Nonpreferred agents: 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) Approval duration: up to 10 years 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) Cont. on next page... Blue Care Network - Custom Select Drug List Prior Authorization and Step-Therapy Guidelines Page 3 Cardiovascular, Hypertension, Cholesterol (cont.) Angiotensin II Receptor Blockers (ARBS) (cont.) Approval duration: up to 10 years Nonpreferred: Nonpreferred agents: 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 Approval duration: up to 10 years 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: Requires documentation that the member has experienced treatment failure of or intolerance to 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® Nonpreferred agents: 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). Blue Care Network - Custom Select Drug List Prior Authorization and Step Therapy Guidelines Page 4 Central Nervous System Anticonvulsants Nonpreferred: Lyrica®, Onfi® Approval duration: up to 10 years 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 Approval duration: up to 10 years 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 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. 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. Approval duration: up to 10 years 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. Blue Care Network - Custom Select Drug List Prior Authorization and Step-Therapy Guidelines Page 5 Central Nervous System (Cont.) Antipsychotics (Cont.) Approval duration: up to 10 years 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. Approval duration: up to 10 years Nonpreferred: Nuvigil® Strattera™ 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 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. 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). Nonpreferred: Axert®, Frova®, Relpax®, Zomig nasal spray Miscellaneous CNS Preferred: Kapvay® (clonidine hcl) (g), Nuedexta® (dextromethorphan/ quinidine) Nonpreferred agents: Requires documentation that the member has experienced failure of or intolerance to both Imitrex(g) and Maxalt(g), MLT(g). Approval duration: up to 1 year 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). Approval duration: up to 5 years Nuedexta: Requires documentation that the member has a diagnosis of pseudobulbar affect. Nonpreferred: Xyrem® Nonpreferred agents: 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). Blue Care Network - Custom Select Drug List Prior Authorization and Step Therapy Guidelines Page 6 Central Nervous System (Cont.) 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® Nonpreferred agents: 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 Approval duration: up to 1 year 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 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). Sedatives/Hypnotics Approval duration: up to 1 year Preferred: Preferred agents: 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). Coverage is not provided in combination with other sedatives. Nonpreferred: Hetlioz®, Rozerem® Nonpreferred agents: 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. Blue Care Network - Custom Select Drug List Prior Authorization and Step-Therapy Guidelines Page 7 Central Nervous System (Cont.) Sedatives/Hypnotics (cont.) Approval duration: up to 1 year Nonpreferred: Nonpreferred agents: 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 Approval duration: up to 1 year 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. 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)]. Approval duration: up to 1 year 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® 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 (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. Approval duration: up to 5 months 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® Blue Care Network - Custom Select Drug List Prior Authorization and Step Therapy Guidelines Page 8 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) 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 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™ Nonpreferred 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 who have experienced treatment failure of or intolerance to Androgel and Androderm. Growth Hormone & Related Products Approval duration: up to 1 year Preferred: Genotropin® (somatropin), Nutropin® AQ, Nuspin (somatropin) Cont. on next page... 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) Blue Care Network - Custom Select Drug List Prior Authorization and Step-Therapy Guidelines 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) Cont. on next page... 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. Approval duration: up to 10 years 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. 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 Blue Care Network - Custom Select Drug List Prior Authorization and Step Therapy Guidelines Page 10 Endocrinology (Cont.) Miscellaneous (cont.) Preferred: Signifor® (pasireotide) Nonpreferred: Myalept™, Ravicti™, Zavesca® Approval duration: up to 10 years 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 Nonpreferred agents: 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: Requires documentation that the member has experienced treatment failure of or intolerance to Sancuso® oral Kytril(g) AND Zofran(g), ODT(g). Antidiarrheals and Antispasmodics Approval duration: up to 1 year 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 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 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). Approval duration: up to 10 years 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)). Blue Care Network - Custom Select Drug List Prior Authorization and Step-Therapy Guidelines 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... Approval duration: up to 1 year Nonpreferred agents: 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. Approval duration: up to 10 years Approval duration: up to 5 years 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). Approval duration: up to 1 year 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. 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 Approval duration: up 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. Blue Care Network - Custom Select Drug List Prior Authorization and Step Therapy Guidelines Page 12 Immunology & Hematology (Cont.) Interferons and MS Therapy (cont.) Approval duration: up to 1 year 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 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 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®. 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 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... Approval duration: up to 10 years Requires treatment failure of or intolerance to 2 generic contraceptives for $0 copayment. Approval duration: up to 1 year 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. Blue Care Network - Custom Select Drug List Prior Authorization and Step-Therapy Guidelines 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 Approval duration: up to 1 year 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: Requires documentation that the member has experienced treatment failure of or intolerance to 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 Nonpreferred agents: Cayston: Coverage is provided for the treatment of pseudomonas aeruginosa infection in members with cystic fibrosis. Approval duration: up to 6 months Approval duration: up to 10 years Requires documentation that the member has experienced treatment failure of or intolerance to 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. Approval duration: up to 1 year Pulmonary Arterial Hypertension Approval duration: up to 10 years 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® 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. Rheumatology & Musculoskeletal Gout Therapy Approval duration: up to 10 years Blue Care Network - Custom Select Drug List Prior Authorization and Step Therapy Guidelines 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 Nonpreferred agents: 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. Approval duration: up to 2 years Urology Bladder Control Nonpreferred: Myrbetriq® BPH Treatment Preferred: 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 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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