Please call the Customer Service number on the back of your BCBSM ID card if you have questions about your drug coverage or a drug claim.

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1 Medicare Plus Blue PPO Essential, Vitality, Signature and Assure Plus Comprehensive Formulary Prior Authorization / Step Therapy Program 2017 Plan Year (Updated ) BCBSM Medicare Plus Blue PPO Essential, Vitality, Signature and Assure monitors the use of certain medications to ensure our members receive the most appropriate and cost-effective drug therapy. Prior authorization (PA) for these drugs means that either clinical and/or administrative criteria must be met before coverage is provided. Drugs subject to step therapy (ST) may require previous treatment with one or more formulary drugs prior to coverage. Drugs that must meet clinical/administrative criteria are identified in the formulary list with (PA) or (ST). If drugs listed below have a (g) noted, the PA or ST criteria may also apply to the generic version of the drug. In some cases, the brand name drug is listed for reference and the generic drug is covered. Please refer to the Formulary to verify if your drugs are covered. Your physician can contact our pharmacy help desk to request prior authorization or step therapy for these drugs. The clinical criteria for authorization are based on current medical information and the recommendations of the Blues Pharmacy and Therapeutics Committee, a group of physicians, pharmacists and other experts. Please call the Customer Service number on the back of your BCBSM ID card if you have questions about your drug coverage or a drug claim. MEDICATION/ DRUG CLASS Abilify Maintena (aripiprazole) Coverage requires trial of oral aripiprazole. g = generic available Page 1 of 40 FORM ID#17093 Medicare Plus Blue SM is a PPO plan with a Medicare contract. Enrollment in Medicare Plus Blue depends on contract renewal. H9572_Ph_17PA_ST

2 Actemra Subcutaneous (tocilizumab) Coverage is provided for the diagnosis of Rheumatoid Arthritis. Requires trial and failure of one preferred TNF agent (adalimumab (Humira ) or etanercept (Enbrel )). Adempas (riociguat) Afinitor Disperz (everolimus) Alecensa (alectinib) Alpha-1 Proteinase Inhibitors Aralast NP Glassia Prolastin Zemaira Prescriber restrictions: Prescribing physician is a rheumatologist. Coverage duration: Lifetime Coverage requires documentation of medical diagnosis. Requires documentation of a congenital deficiency of alpha-1 antitrypsin, demonstrated by a homozygous phenotype of AAT, and must have symptomatic emphysema and serum levels of alpha-1 antitrypsin that are less than 80mg/dl and must have deteriorating pulmonary function, as demonstrated by a decline in the fev1 (less than 65% of predictive value). For reauthorization must provide serum levels of alpha-1 antitrypsin that are above threshold of 80mg/dl. Age restrictions: Patients 18 years of age or older Coverage duration: Initial approval is for 6 months. Reauthorization is for 1 year. g = generic Page 2 of 40 FORM ID#17093

3 Alunbrig (brigatinib) Amitiza (lubiprostone) Coverage is provided for diagnosis of chronic idiopathic constipation, constipationirritable bowel syndrome, or opioid induced constipation with chronic, non-cancer pain. Age restrictions: Patients 18 years of age or older. Ampyra (dalfampridine) Initial coverage is provided to improve walking distance in patients with a diagnosis of Multiple Sclerosis who have the ability to walk a timed 25 foot walk test. Initial requests require documentation of a 25 foot timed walk test. Renewal of therapy requires documentation that the member has shown an improvement in walking distance of a 25 foot timed walk test compared to pretreatment. Prescriber restrictions: Prescribing physician is a neurologist. Exclusion criteria: Patients with a history of seizure or moderate to severe renal impairment defined by a CrCl of 50ml/min or less. Coverage duration: Initial approval is for 3 months. Reauthorization is for 1 year. Anabolic Steroids Anadrol-50 (oxymetholone) Oxandrin (g) (oxandrolone) Oxandrin requires documentation that use is 1) For therapy to offset protein catabolism associated with prolonged use of corticosteroids. 2) For bone pain associated with osteoporosis. 3) As prophylactic therapy in patients with hereditary angioedema. g = generic Page 3 of 40 FORM ID#17093

4 Anticonvulsants Oxtellar XR (oxcarbazine) Anti-diabetic Injectable Agents Byetta (exenatide) Bydureon (exenatide) Victoza (liraglutide) Exclusion criteria: Coverage will not be provided if anabolic steroids are used to enhance athletic performance or for anti-aging purposes. Coverage requires trial or intolerance to at least 2 generic anticonvulsants. Coverage will be provided as adjunctive therapy to improve glycemic control in patients who have a diagnosis of type II diabetes mellitus and are currently taking or have tried and failed 1 of the following: metformin, a sulfonylurea, or a thiazolidinedione, or one of the following: a combination of metformin and a sulfonylurea or a combination of metformin and a thiazolidinedione. Documentation of HbA1c greater or equal to 7% will be required. Exclusion criteria: Coverage will not be provided for weight loss in patients with or without diabetes. Anti-diabetic agents Farxiga (dapagliflozin) Invokana (canagliflozin) Invokamet (canagliflozin + metformin) Xigduo XR (dapagliflozin + metformin) Antidepressants Trintellix (voritoxetine) Desvenlafaxine ER Fetzima (levomilnacipran) Fetzima titration pack (levominacipran) Viibryd (vilazodone HCl) Coverage requires trial or intolerance to at least 1 of the following: metformin, a sulfonylurea, pioglitazone or a DPP-4 inhibitor. Coverage requires trial of at least 2 formulary (non-high risk medication) generic antidepressants. g = generic Page 4 of 40 FORM ID#17093

5 Antipsychotic Agents 1 Latuda (lurasidone) Saphris (asenapine) Vraylar (cariprazine) Aristada (aripiprazole lauroxil) Arzerra (ofatumumab) Coverage requires that the member has had a trial of at least one generic antipsychotic agent. Coverage requires trial or intolerance to Abilify Maintena, aripiprazole, or aripiprazole ODT. Coverage duration: Lifetime This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Prescriber restrictions: Prescribing physician must be an oncologist. Aubagio (teriflunomide) Avonex (interferon beta-1a) g = generic Page 5 of 40 FORM ID#17093

6 Bavencio (avelumab) Beleodaq (belinostat) Berinert (C1 inhibitor, human) Coverage is provided for acute attacks of hereditary angioedema (HAE). Diagnosis of hereditary angioedema (HAE) must be established by an immunologist or hematologist. Age restrictions: 13 years of age and older. Betaseron (interferon beta-1b) Bosulif (bosutinib) Coverage duration: Lifetime Coverage requires diagnosis of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). Briviact (brivaracetam) Bystolic (nebivolol) Coverage duration: 1 year Requires the trial of at least 2 of the formulary cardioselective beta blockers. g = generic Page 6 of 40 FORM ID#17093

7 Cabometyx (cabozantinib) Campral (g) (acamprosate calcium) Coverage is provided for the maintenance of abstinence from alcohol in patients with alcohol dependence who have been abstinent at treatment initiation for at least 5 days post detoxification. Cayston (aztreonam) Coverage is provided for treatment to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. Cholbam (cholic acid) Cholesterol-Lowering Therapies 1: Livalo (pitavastatin) Chorionic Gonadotropins Coverage requires that the member has had a trial of at least one generic statin. Coverage will be provided based on documentation of diagnosis. g = generic Page 7 of 40 FORM ID#17093

8 Cometriq (cabozantinib s-malate) Coverage is provided for the diagnosis of progressive, metastatic medullary thyroid cancer. Plus patients already started on Cometriq for a covered use. Copaxone (glatiramer acetate) Cotellic (cobimetinib) Cryopyrin-Associated Periodic Syndromes (CAPS) Agents Arcalyst (rilonacept) Coverage will be provided based on documentation of diagnosis. Age restrictions: Arcalyst : Patients 12 years of age and older. Cyramza (ramucirumab) Coverage Duration: Lifetime. Daklinza (daclatasvir) Coverage duration: Criteria will be applied consistent with current AASLD/IDSA guidance. g = generic Page 8 of 40 FORM ID#17093

9 Darzalex (daratumumab) Coverage Duration: Lifetime. Duopa (carbidopa levodopa) This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Coverage requires verification that member has a feeding tube. Durable Medical Equipment (DME) Supply Drugs Various products This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Empliciti (elotuzumab) Coverage Duration: Lifetime. Epclusa (sofosbuvir/velpatasvir) Erivedge (vismodegib) Coverage Duration: Criteria will be applied consistent with current AASLD/IDSA guidance. Prescribers restrictions: Prescribing Physician is an Oncologist or Dermatologist g = generic Page 9 of 40 FORM ID#17093

10 Erythropoiesis Stimulating Agents Aranesp (darbepoetin), Epogen (epoetin alfa), Procrit (epoetin alfa) These drugs may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Exclusion criteria: Coverage is not provided in the following conditions: 1.) Anemia due to folate, vitamin b-12 and iron deficiencies, hemolyisis, bleeding, or bone marrow fibrosis, 2.) Anemia associated with treatment of acute and chronic myelogenous leukemias (CML, AML). Esbriet (pirfenidone) Coverage duration: 3 months. Estrogens Coverage for Oral Estrogen will be approved when used as part of a cancer treatment regimen. For all other uses, oral estrogen products will be approved if two of the following safer alternatives (SSRIs, venlafaxine ER, Premarin vaginal cream, Estrace vaginal creams, Estring or Femring Vaginal Rings, Vagifem vaginal tablets) have been tried and failed or are not appropriate or contraindicated. Age restrictions: Authorization is required for members 65 years of age and older g = generic Page 10 of 40 FORM ID#17093

11 Estrogen Combination Products Coverage for oral Estrogen/Progesterone combination products will be provided for moderate to severe abnormal vasomotor function if two of the following safer alternatives (SSRIs, venlafaxine ER, Premarin vaginal cream, Estrace vaginal creams, Estring or Femring Vaginal Rings, Vagifem vaginal tablets) have been tried and failed or are not appropriate or contraindicated. Oral Estrogen/Progesterone combination products will be approved for postmenopausal osteoporosis if two of the following safer alternatives (bisphosphonates, calcitonin, raloxifene, Forteo or Prolia) have been tried and failed or are not appropriate or contraindicated. Age restrictions: Authorization is required for members 65 years of age and older Evomela (melphalan) Extavia (interferon beta-1b) Farydak (panobinostat) Firazyr (icatibant acetate) Coverage duration: 1 year Coverage duration: 1 year Coverage duration: Lifetime Coverage is provided for acute attacks of hereditary angioedema (HAE). Diagnosis of hereditary angioedema (HAE) must be established by an immunologist or hematologist. Age restrictions: Patients 18 years of age or older. g = generic Page 11 of 40 FORM ID#17093

12 Gattex (teduglutide) Coverage requires a diagnosis of short bowel syndrome and dependence on parenteral support for 12 months or greater. Age restrictions: Patients 18 years of age and older. Gazyva (obinutuzumab) Coverage duration: 1 year Gilenya (fingolimod hydrochloride) Gilotrif (afatinib) Gralise (gabapentin) Coverage requires diagnosis of neuropathic pain associated with post-herpetic neuralgia. Requires trial and failure or intolerance to immediate release Neurontin (g). Growth Hormone (somatropin), Genotropin, Humatrope, Norditropin, Norditropin Nordiflex, Initial requests for human growth hormone in pediatric patients: 1) one of the following indications: growth hormone deficiency (GHD), Prader-Willi Syndrome (PWS), Turners Syndrome, chronic renal insufficiency (CRI). And 2.) Initiating g = generic Page 12 of 40 FORM ID#17093

13 Nutropin (all), Omnitrope, Saizen, Serostim therapy in children (male less than 16, female less than 15): initial height measurements less than 5th percentile for age (based on initial evaluation), abnormal growth velocity for at least 6 months, initial subnormal growth hormone test. Renewing treatment in children requires growth velocity of at least 2.5 cm/yr during first 6 months and at least 4.5 cm/yr for each succeeding 6 month period. May be continued until final height or epiphyseal closure is documented. Requests in adult patients: 1.) The diagnosis of growth hormone deficiency with hypopituitarism when one of the following criteria (a or b) are met: a. Two pituitary hormone deficiencies (other than growth hormone) requiring hormone replacement such as TSH, ACTH, gonadotropins and ADH and both of the following i and ii: i. At least one known cause for pituitary disease or a condition affecting pituitary function, including pituitary tumor, surgical damage, hypothalamic disease, irradiation, trauma or infiltrative disease (histoplasmosis, Sheehan Syndrome, autoimmune hypophysitis, or sarcoidoisis) is documented. And ii. One provocative stimulation less than 5 ng/ml. The insulin tolerance test is the preferred testing method, but other secretagogoues, such as arginine, GHRH, clonidine and l-dopa are acceptable. Or b. Three pituitary hormone deficiencies (other than growth hormone) requiring hormone replacement and an igf-1 level below 80 ng/ml. Coverage for serostim for the treatment of aids-related cachexia. Prescriber restrictions: Pediatric patients requires for all indications must be prescribed by a pediatric endocrinologist or pediatric nephrologist. Coverage duration: Pediatrics equals 1 year. Adults equals lifetime. Harvoni (ledipasvir/sofosbuvir) Hepatitis Vaccine Engerix-B, Recombivax HB Coverage duration: Criteria will be applied consistent with current AASLD/IDSA guidance. This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. g = generic Page 13 of 40 FORM ID#17093

14 Hetlioz (tasimelteon) Ibrance (palbociclib) Iclusig (ponatinib) Coverage requires diagnosis for which Iclusig is being used. Approved as a single agent for T315I-positive chronic myelogenous leukemia (CML). For non-t315ipositive CML, prior therapies tried must be reported to confirm resistance or intolerance to prior tyrosine kinase inhibitor therapy. For acute lymphoblastic leukemia (ALL), the Philadelphia chromosome (Ph) status of the leukemia must be reported. Approved as a single agent for T315I-positive Ph+ ALL. For non-t315ipositive Ph+ ALL, prior therapies must be reported to document resistance or intolerance to prior tyrosine kinase inhibitor therapy. All medically accepted indications not otherwise excluded from Part D, plus patients already started on Iclusig for a covered use. Idhifa (enasidenib) Ilaris (canakinumab) Requires documentation of the diagnosis. g = generic Page 14 of 40 FORM ID#17093

15 Imbruvica (ibrutinib) Imfinzi (durvalumab) Immune Thrombocytopenic Purpura (ITP) Agents Promacta (eltrombopag olamine) Coverage is provided for: 1.) Diagnosis of chronic immune thrombocytopenia (ITP) and persistent thrombocytopenia with inadequate response or patient must not be a candidate for corticosteroids, immunoglobulins or splenectomy, 2.) For the treatment of thrombocytopenia in patients with chronic hepatitis C, 3.) For the treatment of severe aplastic anemia in patients who have had insufficient response to immunosuppressive therapy. Documentation of a current platelet count less than 50,000 mcl is required. Renewal of therapy is provided in patients who meet all of the following criteria: recent platelet count between 30, ,000 mcl. Coverage duration: Initial request: 3 months. Renewal of therapy: 1 year. Immunosuppressive Therapy for an Organ Transplant Various products This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Increlex (mecasermin) Prescriber restrictions: Must be prescribed by a pediatric endocrinologist. g = generic Page 15 of 40 FORM ID#17093

16 Inlyta (axitinib) Coverage is provided for the treatment of Renal Cell Carcinoma (RCC) after failure with one prior systemic therapy. Exclusion criteria: Will not be covered for use in combination with other tyrosine kinase inhibitors such as sorafenib or sunitinib. Coverage duration: 12 months. Intravenous Immune Globulin (IVIG) Various products These drugs may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Requires documentation of medical condition. Invega Sustenna (paliperidone palmitate) Invega Trinza (paliperidone palmitate) Jakafi (ruxolitinib) Coverage requires the trial of oral paliperidone or oral risperidone. Initial request: patient must be at intermediate or high-risk, including primary myleofibrosis, post-polycthemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis. Also requires imaging tests documenting spleen enlargement and measurement. For renewal: patient must have experienced a 35% reduction in spleen volume or a 50% reduction in palpable spleen size. g = generic Page 16 of 40 FORM ID#17093

17 Documentation of diagnosis. CBC prior to initiation of therapy (platelet count greater than 100 x 10(9)/l). Prescriber restrictions: prescribing physician is an Oncologist or Hematologist. Jevtana (cabazitaxel) Coverage requires documentation of diagnosis. Coverage is provided for the treatment of patients, in combination with prednisone, with hormone-refractory metastatic prostate cancer previously treated with a docetaxel- containing treatment regimen. Juxtapid (lomitapide) Coverage is provided for treatment of homozygous familial hypercholesterolemia confirmed by genetic testing. Requires documentation of the diagnosis and trial and failure of Kynamro. g = generic Page 17 of 40 FORM ID#17093

18 Kalbitor (ecallantide) Coverage is provided for acute attacks of hereditary angioedema (HAE). Documentation of diagnosis confirmed by genetic testing or with the following laboratory findings: normal C1q levels with level below the limits of the laboratory's normal reference range for both C4 and C1INH (antigenic or function) is required. Diagnosis of hereditary angioedema (HAE) established by an immunologist or hematologist. Age restrictions: 16 years of age and older. Kalydeco TM (ivacaftor) Coverage is provided for the diagnosis of cystic fibrosis with confirmed G551D G1244E, G1349D, G178R, G551S, S1251N, S1255P,S549N,S549R OR R117H gene mutation. Kanuma (sebelipase alfa) Kisqali (ribociclib) Kisqali Femara Co-Pack (ribociclib & letrozole) g = generic Page 18 of 40 FORM ID#17093

19 Korlym (mifepristone) Coverage is provided for the diagnosis of hypercortisolism as a result of endogenous Cushing's Syndrome in patients with type 2 diabetes mellitus or glucose intolerance that have failed surgery or are not candidates for surgery. Documentation of diagnosis is required. Age restrictions: 18 years and older Kynamro (mipomersen sodium) Kyprolis (carfilzomib) Lartruvo (olaratumab) Lemtrada (alemtuzumab) Coverage is provided for a diagnosis of homozygous familial hypercholesterolemia. Age restrictions: 18 years of age and older Prescriber restrictions: Prescribing physician must be a neurologist. Coverage duration: Initial = 180 days, Renewal = 180 days Lenvima (lenvatinib) g = generic Page 19 of 40 FORM ID#17093

20 Lidoderm Patch (g) (lidocaine) Lonsurf (trifluridine and tipiracil) Lotronex (g) (alosetron hydrochloride) Coverage duration: Lifetime Coverage is provided for the diagnosis of severe diarrhea-predominant irritable bowel syndrome (IBS), and unresponsive to a trial of conventional IBS therapy such as Bentyl (g). Age restrictions: Patients 18 years of age and older. Lynparza TM (olaparib) Mavyret (glecaprevir/pibrentasvir) Coverage duration:. Lifetime. Coverage duration: Criteria will be applied consistent with current AASLD/IDSA guidance. Megestrol g = generic Page 20 of 40 FORM ID#17093

21 Mekinist TM (trametinib) Coverage is provided with documentation of BRAF mutation as detected using anfda-approved test. Prescriber restrictions: Prescribing physician must be an Oncologist. Coverage duration:. Lifetime. Miscellaneous Vaccine: BCG Live Vaccine, Hepatitis A Vaccine, Measles Virus Vaccine, Rabies Vaccine, Tetanus Toxoid Vaccine Various products Movantik TM (Naloxegol Oxalate) Approved under Medicare Part B if given to treat an injury or as a result of direct exposure to a disease or condition. Approved under Medicare Part D for prophylactic use. Coverage is provided for diagnosis of opioid induced chronic constipation with chronic, non-cancer pain. Member must be stable on opioid therapy for a minimum of 2 weeks. Age restrictions: Patients 18 years of age or older. Coverage duration: Initial=3 months Renewal=1 year g = generic Page 21 of 40 FORM ID#17093

22 Mozobil (plerixafor) Coverage is provided in combination with granulocyte colony stimulating factor (G CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-hodgkin s lymphoma (NHL) and multiple myeloma (MM). Requires documentation of diagnosis and of G-CSF prior to initiation of Mozobil for 4 days. Coverage duration: 1 month. Myalept (metreleptin) Coverage is provided for diagnosis of generalized lipodystrophy. Coverage is not provided for the following: general obesity, HIV-related lipodystrophy, partial lipodystrophy, metabolic disease (without concurrent generalized lipodystrophy) or liver disease. Renewal requires adherence to therapy and no signs or symptoms of pancreatic disease, lymphoma or events suggesting neutralizing antibody formation. Prescriber restrictions: Prescribing physician is an endocrinologist. Coverage duration: Initial = 3 months Renewal = 1 year Narcolepsy Agents Nuvigil (g) (armodafinil) Provigil (g) (modafanil) Coverage for modafanil requires a diagnosis of narcolepsy, obstructive sleep apnea, or shift work sleep disorder. Coverage of Nuvigil requires a diagnosis of narcolepsy, obstructive sleep apnea, or shift work disorder, and trial and failure of modafanil. g = generic Page 22 of 40 FORM ID#17093

23 Narcotic analgesics (fentanyl citrate) Abstral Fentora Lazanda Subsys Coverage is provided for breakthrough pain only in patients diagnosed with cancer currently receiving a long acting narcotic with documented tolerance to high dose narcotics. Documentation of medical diagnosis and tolerance to high dose narcotics is required. Natpara (parathyroid hormone, recombinant) Nerlynx (neratinib) Nexavar (sorafenib) Prescriber restrictions: must be prescribed by an Oncologist. Ninlaro (ixazomib) Nplate (romiplostim) Coverage duration: Lifetime Requires a diagnosis of chronic immune thrombocytopenia (ITP) and persistent thrombocytopenia. Documentation of platelet count less than 150,000 mcl for greater than or equal to 2 months and a current platelet count less than 30,000 mcl. Requires inadequate response or patient must not be a candidate for corticosteroids, immunoglobulins or splenectomy. g = generic Page 23 of 40 FORM ID#17093

24 Age restrictions: Patients 18 years of age or older. Prescriber restrictions: Must be prescribed by a Hematologist or in consultation with a hematologist. Coverage duration: 3 months. Nuplazid (pimavanserin) Odomzo (sonidegib) Ofev (nintedanib) Coverage duration: Lifetime Olysio (simeprevir) Age restrictions: 18 years of age and older. Coverage duration: Criteria will be applied consistent with current AASLD/IDSA guidance. Oral Anti-emetics Agents Various products This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. g = generic Page 24 of 40 FORM ID#17093

25 Oral Chemotherapeutic Agents Various products This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Orkambi (ivacaftor/lumacaftor) Orenitram ER (treprostinil diolamine) Coverage duration:. Lifetime. Coverage is provided for the diagnosis of pulmonary arterial hypertension. Requires trial and failure or contraindication to inhaled treprostinil and sildenafil. g = generic Page 25 of 40 FORM ID#17093

26 Osteoporosis Agents Forteo (teriparatide, rdna origin) Prolia (denosumab) Forteo - coverage requires diagnosis of: postmenopausal women with osteoporosis, glucocorticoid induced osteoporosis, or men with primary or hypogonadal osteoporosis, all of who are at high risk for fracture, and 1) have tried and failed, or have a documented intolerance to a bisphosphonate, and 2) requires documentation of a bone mineral density that is 2.5 standard deviations or more below the mean (t-score at or below -2.5). Prolia - Coverage is provided for: 1. The treatment of postmenopausal osteoporosis with a high risk of fracture. 2. To increase bone mass in men at risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. 3. To increase bone mass in women at high risk of fracture receiving adjuvant aromatase inhibitor therapy for nonmetastatic breast cancer. 4. To increase bone mass in men with osteoporosis at high risk of fracture. Requires trial and failure, or a documented intolerance, to a bisphosphonate. Exclusion criteria (Prolia only): Coverage is not provided if patient has preexisting hypocalcemia. Coverage duration: Forteo : 2 years, Prolia : Lifetime. Otezla (apremilast) Coverage is provided for the diagnosis of psoriatic arthritis when there has been trial and failure or contraindication to: 1. An oral DMARD and 2. A preferred biologic (Enbrel or Humira ). Coverage is also provided for the diagnosis of moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy. Parenteral Nutrition (Numerous ingredients may be reflected in various products) This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. g = generic Page 26 of 40 FORM ID#17093

27 Plegridy (peginterferon beta-1a) Pomalyst (pomalidomide) Coverage is provided if the patient has 1. Received at least two prior therapies including lenalidomide and a proteasome inhibitor and 2. Demonstrated disease progression on or within 60 days of completion of the last therapy. Procysbi (cysteamine bitartrate) Promethazine Promethazine will be approved when used as part of an analgesia regimen. Promethazine is approved for other uses if at least one safer alternative has been tried and failed unless the alternative is not appropriate or contraindicated. Alternatives for allergic conditions include a second generation antihistamine (e.g., cetirizine, desloratadine, loratadine, fexofenadine). Alternatives for sleep include low dose trazodone (25-50mg), rozerem or melatonin. For nausea or vomiting or motion sickness, alternatives include prochlorperazine, ondansetron or meclizine. Age restriction: Authorization is required for members age 65 years and older. Coverage duration: 1 year g = generic Page 27 of 40 FORM ID#17093

28 Pulmonary Arterial Hypertension (PAH) agents Adcirca (tadalafil), Letairis (ambrisentan), Opsumit (macitentan), Revatio (sildenafil citrate), Revatio IV (sildenafil citrate), Tracleer (bosentan) Adcirca and Revatio (oral): coverage is provided for a diagnosis of Pulmonary Arterial Hypertension (PAH). Coverage for Revatio or Adcirca is also provided if used in combination with bosentan (Tracleer ), epoprostenol (Flolan ), treprostinil (Remodulin ) or iloprost (Ventavis ) after monotherapy with one of these agents has been found to be inadequate in the treatment of the patients symptoms. Revatio IV: coverage is provided for the continued treatment of patients with Pulmonary Arterial Hypertension who are currently prescribed Revatio tablets but who are temporarily unable to take oral medication. Tracleer : coverage is provided for the diagnosis of Pulmonary Arterial Hypertension (PAH) in patients with world health organization (WHO) class II to IV symptoms. Letairis and Opsumit : coverage is provided for the diagnosis of Pulmonary Arterial Hypertension (PAH) in patients with WHO class II or III symptoms. Exclusion criteria: Coverage is not provided for sildenafil (Revatio ) and tadalafil (Adcirca ) in situations where patients are receiving nitrate therapy. Coverage duration: Injectable agents for 3 months. Oral agents for Lifetime. Radicava (edaravone) Ravicti (glycerol phenylbutyrate) Age restrictions: 2 years of age and older g = generic Page 28 of 40 FORM ID#17093

29 Rebif (interferon beta-1a) Relistor (methylnaltrexone) Requires 1.) a diagnosis of opioid induced constipation in members with advanced illness who are receiving palliative care when response to laxative therapy has not been sufficient or 2.) a diagnosis of opioid induced constipation in members with chronic non-cancer pain. A member must be stable on opioid therapy for greater than 2 weeks. Age restrictions: Patients 18 years of age or older. Exclusion criteria: Coverage is not provided for patients with known or suspected mechanical gastrointestinal obstruction. Coverage duration: 3 months. Renal Cell Carcinoma Agents Afinitor (everolimus) 5mg, 10mg Votrient (pazopanib) Exclusion Criteria: will not be covered in combination with Nexavar or Sutent. Prescriber restrictions: must be prescribed by an oncologist. Coverage duration: Initial and Renewal requests approve for 12 months. Renewal of therapy is provided in patients who meet all of the following criteria: confirmation that current medical necessity criteria are met and the medication is effective. g = generic Page 29 of 40 FORM ID#17093

30 Repatha (evolocumab) Member must receive Repatha with maximally tolerated statin therapy. If concomitant statin therapy is not used, member must have tried and failed at least 2 different statins or be intolerant to statin therapy. For a diagnosis of homozygous familial hypercholesterolemia, maximally tolerated concomitant treatment with ezetimibe and a bile acid sequestrant such as cholestyramine or colestipol is required unless contraindicated. Prescriber restrictions: Prescribing physician must be a cardiologist, endocrinologist, or board-certified lipidologist. Revlimid (lenalidomide) Rexulti (brexpiprazole) Risperdal Consta (risperidone) Rituxan (rituximab) Age restrictions: Patients 13 years of age and older. Coverage duration: Initial: 2 months. Renewal: 1 year. Renewal requires documentation of achieving an LDL level at or below patient specific goal. Prescriber restrictions: Must be prescribed by an oncologist or hematologist. Coverage duration: 1 year Coverage requires trial or intolerance to Abilify Maintena, aripiprazole, or aripiprazole ODT. Coverage requires the trial of oral risperidone. Rydapt (midostaurin) g = generic Page 30 of 40 FORM ID#17093

31 Rubraca (rucaparib) Samsca (tolvaptan) Coverage requires documentation that the member does not have underlying liver disease. Coverage duration: 1 month. Savella (milnacipran) Coverage is provided for the diagnosis of fibromyalgia characterized by pain in all 4 body quadrants. Sirturo (bedaquiline fumarate) Coverage is provided when used in combination with at least 3 other agents. Somavert (pegvisomant) Coverage is provided for patients diagnosed with acromegaly who have had an inadequate response to surgery or radiation therapy. Sovaldi (sofosbuvir) Age restriction: Patients 18 years of age and older. g = generic Page 31 of 40 FORM ID#17093

32 Sprycel (dasatinib) Stelara (ustekinumab) Coverage duration: Criteria will be applied consistent with current AASLD/IDSA guidance. Coverage duration: 1 year Coverage is provided for a diagnosis of moderate to severe plaque psoriasis or psoriatic arthritis, and requires the trial and failure or either Enbrel or Humira. Age restrictions: Patients 18 years of age or older. Strattera (atomoxetine) Strensiq (asfotase alfa) Coverage requires trial of either methylphenidate or dextroamphetamine/amphetamine. Sutent (sunitinib) Prescriber restrictions: Prescribing physician must be an Oncologist. Sylvant (siltuximab) g = generic Page 32 of 40 FORM ID#17093

33 Tafinlar (dabrafenib) Coverage is provided after confirmation of the presence of BRAF V600E or V600K mutation in tumor specimen Tagrisso (osimertinib) Tarceva (erlotinib) Targretin (bexarotene) Prescriber restrictions: Prescribing physician must be an oncologist Prescriber restrictions: must be prescribed by an Oncologist. Prescriber restrictions: must be prescribed by an Oncologist or Dermatologist Tasigna (nilotinib) Tecentriq (atezolizumab) Tecfidera (dimethyl fumarate) Coverage duration: 1 year g = generic Page 33 of 40 FORM ID#17093

34 Technivie (ombitasvir/paritaprevir/ritonavir) Testosterone Androderm (testosterone) Androgel (testosterone) Angrogel Pump Gel (testosterone) Testim (testosterone) Thalomid (thalidomide) TNF agents 2 and related products Kineret (anakinra) Orencia subcutaneous (atabacept) Simponi (golimumab) Coverage duration: Criteria will be applied consistent with current AASLD/IDSA guidance. Following criteria are used in reviewing Kineret : 1. Diagnosis of rheumatoid arthritis, when there has been treatment failure or contraindication to adalimumab (Humira ) or etanercept (Enbrel ). 2. Diagnosis of neonatal onset multi-system inflammatory disease (NOMID). Following criteria are used in reviewing Orencia : For diagnosis of psoriatic arthritis, rheumatoid arthritis or juvenile arthritis when there has been treatment failure or a contraindication to adalimumab (Humira ) or etanercept (Enbrel ). Following criteria are used in reviewing Simponi : 1. For the treatment of rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis when there has been treatment failure or a contraindication to both adalimumab (Humira ) and etanercept (Enbrel ). 2. For the diagnosis of moderately to severely active ulcerative colitis when there has been treatment failure or a contraindication to adalimumab (Humira ). g = generic Page 34 of 40 FORM ID#17093

35 TNF agents 3: Cimzia (certolizumab pegol) Coverage will be provided for the diagnosis of acute exacerbation of moderate to severe Crohn s disease when both of the following criteria are met: 1) treatment with adequate course of systemic corticosteroids has been ineffective, contraindicated, patient has been unable to taper, or is experiencing breakthrough disease while stabilized on an immunomodulatory medication for at least two months and, 2) patient has had previous trial and failure or contraindication to Humira. Coverage is provided for the diagnosis of moderate to severe rheumatoid arthritis when there has been the trial and failure or contraindication of adalimumab (Humira ) and etanercept (Enbrel ). Age restrictions: 18 years or older. Topical Non Steroidal Anti- Inflammatories Flector (diclofenac epolamine) Coverage duration: 1 month. Topiramate Torisel (temsirolimus) Prescriber restrictions: must be prescribed by an Oncologist. Treanda and Bendeka (bendamustine) g = generic Page 35 of 40 FORM ID#17093

36 Triptans 1 Maxalt (g), Maxalt MLT (g) (rizatriptan) Triptans 2 [Axert (g) (almotriptan), Frova (g) (frovatriptan), Zomig 5mg non-aerosol nasal spray, Relpax ] Tysabri (natalizumab) Coverage requires the trial of sumatriptan. Requires the trial of sumatriptan and rizatriptan. These drugs may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Coverage under Medicare Part D requires documentation of diagnosis. Coverage is provided for the following 1) Diagnosis of a relapsing-remitting forms of Multiple Sclerosis and has had a trial of Copaxone and at least one other interferon beta product unless contraindicated. 2) Diagnosis of Crohn s disease with an elevated baseline C-reactive protein (CRP) level and has had a trial and failure of Humira and either Simponi or Cimzia unless contraindicated. Documentation of C-reactive protein levels in patients with Crohn s. Coverage duration: Crohn s disease: 1 year; relapsing-remitting Multiple Sclerosis: 6 months. Uloric (febuxostat) Uptravi (selexipag) Vecamyl TM (mecamylamine) Coverage requires trial or contraindication with allopurinol. g = generic Page 36 of 40 FORM ID#17093

37 Venclexta (venetoclax) Viekira TM (ombitasvir, paritaprevir and ritonavir tabs; dasabuvir tabs) Vimizim TM (elosulfase alfa) Vytorin (simvastatin/ezetimibe) Xalkori (crizotinib) Zejula (niraparib) Xeljanz (tofacitnib citrate) Coverage duration: Criteria will be applied consistent with current AASLD/IDSA guidance. Coverage requires trial with simvastatin and Zetia or ezetimibe as individual agents when used concomitantly. Coverage requires the diagnosis of rheumatoid arthritis when there has been treatment failure or a contraindication to adalimumab (Humira) or etanercept (Enbrel). g = generic Page 37 of 40 FORM ID#17093

38 Xenazine (g) (tetrabenazine) Coverage requires a diagnosis of chorea associated with Huntington s disease. Documentation of the CYP2D6 genotype of the patient will be required for doses above 50mg per day. Exclusion criteria: Coverage will not be provided in the following situations, 1) Hepatic function impairment, 2) Actively suicidal or who have untreated or inadequately treated depression, 3) Taking monoamine oxidase inhibitors or Reserpine. Xgeva (denosumab) Xiaflex (collagenase clostridium histolyticum) Coverage is provided for the treatment of adult patients with Dupuytren's contracture with a palpable cord. Prescriber restrictions: Physician must have completed the Xiaflex Xperience training and their facility is currently enrolled as a healthcare site to receive Xiaflex orders. Age restrictions: 18 years and older. Coverage duration: 1 month. Xolair (omalizumab) g = generic Page 38 of 40 FORM ID#17093

39 Xtandi (enzalutamide) Xyrem (sodium oxybate) Yervoy (ipilimumab) Exclusion criteria: coverage is not provided for patients taking sedative hypnotics or in patients with succinic semialdehyde dehydrogenase deficiency Prescriber restrictions: must be prescribed by an Oncologist. Coverage duration:1 year. Yondelis (trabectedin) Zelboraf (vemurafenib) Coverage is provided for the diagnosis of unresectable or metastatic melanoma with BRAF V600E mutation as detected by a FDA-approved test. Exclusion criteria: Coverage will not be provided in combination with Yervoy. Zepatier (elbasvir/grazoprevir) Coverage duration: Coverage duration will be determined based on currently approved treatment guidelines. g = generic Page 39 of 40 FORM ID#17093

40 Zolinza (vorinostat) Zonisamide Zurampic (lesinurad) Zydelig (idelalisib) Zykadia (ceritinib) Zytiga (abiraterone) Coverage duration: 1 year g = generic Page 40 of 40 FORM ID#17093

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