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Medicare Plus Blue Group PPO Assure Prior Authorization / Step Therapy Program 2015 Plan Year

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Medicare Plus Blue Group PPO Assure Prior Authorization / Step Therapy Program 2015 Plan Year BCBSM Medicare Plus Blue PPO Assure and Prescription Blue PDP Option B monitors the use of certain medications
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Medicare Plus Blue Group PPO Assure Prior Authorization / Step Therapy Program 2015 Plan Year BCBSM Medicare Plus Blue PPO Assure and Prescription Blue PDP Option B 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 Acthar HP (corticotropin) Page 1 of 40 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 )). Prescriber restrictions: Prescribing physician is a rheumatologist. Adempas (riociguat) Coverage is provided for: 1. The diagnosis of persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH)(WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class. 2. The diagnosis of pulmonary hypertension (PAH)(WHO Group 1) and has tried and failed or has intolerance to a PDE5 inhibitor. Requires documentation of medical diagnosis. ADHD Agents Intuniv (guanfacine extended release) Kapvay (clonidine) Advicor (lovastatin/extended release niacin) Coverage requires trial or contraindication of either Ritalin (g) or Adderall (g). Coverage requires at least 1 month of previous treatment with lovastatin and either Niacor or niacin extended release as individual agents when used concomitantly. Afinitor Disperz (everolimus) Page 2 of 40 Alpha-1 Proteinase Inhibitors Aralast NP Glassia Prolastin Zemaira 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. Amitiza (lubiprostone) Coverage is provided for diagnosis of chronic idiopathic constipation, constipationirritable bowel syndrome, or opioid induced constipation with chronic, non-cancer pain. Ampyra (dalfampridine) Age restrictions: Patients 18 years of age or older. 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. Page 3 of 40 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. Anadrol-50 requires documentation of: 1) HIV associated wasting. 2) Prophylactic therapy for hereditary angioedema.3) Clinically diagnosed anemia. Exclusion criteria: Coverage will not be provided if anabolic steroids are used to enhance athletic performance or for anti-aging purposes. Anticonvulsants Oxtellar XR (oxcarbazine) Anti-diabetic Injectable Agents Bydureon (exenatide) Byetta (exenatide) Victoza (liraglutide) 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. Page 4 of 40 Anti-diabetic agents Farxiga (dapagliflozin) Invokana (canagliflozin) Invokamet (canagliflozin/metformin HCl) Xigduo XR (dapagliflozin/metformin HCl extended-release) Antidepressants Brintellix (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. Antipsychotic Agents 1 Latuda (lurasidone) Saphris (asenapine) Arzerra (ofatumumab) Coverage requires that the member has had a trial of at least one generic antipsychotic agent. 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 is provided for 1. The diagnosis of Chronic Lymphocytic Leukemia (CLL) in patients who are refractory to fludarabine and alemtuzumab therapy or 2. In combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is inappropriate. Prescriber restrictions: Prescribing physician must be an oncologist. Page 5 of 40 Aubagio (teriflunomide) Coverage requires the trial and failure of either glatiramer or an interferon beta product. Prescriber restrictions: Must be prescribed by a neurologist. Beleodaq (belinostat) Berinert (C1 inhibitor, human) 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: 13 years of age and older. Betaseron (interferon beta-1b) Bisphosphonates 1: Actonel (risedronate) Atelvia (risedronate) Coverage requires the trial of Extavia. Coverage requires the trial of a generic bisphosphonate or Fosamax Plus D. Page 6 of 40 Bystolic (nebivolol) MEDICATION/ DRUG CLASS Requires the trial of at least 2 of the formulary cardioselective beta blockers. Campral (acamprosate calcium) Coverage is provided for maintenance of abstinence from alcohol in patients with alcohol dependence that have been abstinent at treatment initiation for at least 5 days post detoxification. Requires the patient to be enrolled in a comprehensive alcohol management program which includes psychosocial support, such as a 12-step facilitation, social skills training or a cognitive-behavioral therapy program. Cayston (aztreonam) Coverage is provided for treatment to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. Chenodal (chenodiol) Coverage requires the trial and failure or intolerance of ursodiol. Patient is not a candidate for surgery. Exclusion criteria: History of hepatocellular disease. Women who are or may become pregnant. Coverage duration: 2 years. Page 7 of 40 Cholesterol-Lowering Therapies 1: Altoprev (lovastatin), Crestor (rosuvastatin), Lescol XL (fluvastatin), 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. 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. Cosentyx (secukinumab) Requires diagnosis of moderate to severe plaque psoriasis and requires trial and failure of Enbrel or Humira Age restrictions: 18 years of age and older. 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. Page 8 of 40 Cyclobenzaprine. Coverage will be provided when used for fibromyalagia. Coverage is approved if at least two safer alternatives (gabapentin, pregabalin, duloxetine, nortriptyline, tramadol, tizandine or baclofen) have been tried and failed or are not appropriate or contraindicated. For all other indications, at least one safer alternative (tizanidine or baclofen) should be tried and failed or determined not appropriate or contraindicated for the intended use. Age restrictions: Authorization is required for members 65 years of age and older Coverage Duration: 1 year. Cyramza (ramucirumab) All FDA-approved indications not otherwise excluded from part D. Coverage Duration: Lifetime. Daklinza (daclatasvir dihydrochloride) All FDA-approved indications not otherwise excluded from part D. Coverage Duration: Up to 24 weeks, depending on genotype and established treatment guidelines. Digoxin Coverage will be provided with documentation of medical diagnosis. All FDA-approved indications not otherwise excluded from part D. Age restrictions: For members age 65 and older, digoxin 250 mcg and mcg will only be covered for a diagnosis of atrial fibrillation. For members under age 65, Page 9 of 40 digoxin 250 mcg and mcg will be covered for both atrial fibrillation and heart failure. Use in heart failure for ages 65 and older, without a co-morbid diagnosis of atrial fibrillation, will not be authorized due to the American Geriatric Society's classification of high risk in the elderly for this diagnosis. Coverage Duration: 1 year. 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. Erivedge (vismodegib) Erythropoiesis Stimulating Agents Aranesp (darbepoetin), Epogen (epoetin alfa), Procrit (epoetin alfa) Prescribers restrictions: Prescribing Physician is an Oncologist or Dermatologist 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, and requires hemoglobin less than 13 mg/dl for prophylactic use during some major surgeries for Page 10 of 40 Epogen and hemoglobin less than 12 mg/dl for remaining covered uses. Exclusion criteria: Coverage is not provided in the following conditions: i). Anemia due to folate, vitamin b-12, and iron deficiencies, hemolysis, bleeding, or bone marrow fibrosis, ii). Anemia associated with treatment of acute and chronic myelogenous leukemias (CML, AML). Coverage duration: 3 months. Esbriet (pirfenidone) 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. All FDA-approved indications not otherwise excluded from part D. Age restrictions: Authorization is required for members 65 years of age and older Farydak (panobinostat) Page 11 of 40 Firazyr (icatibant acetate) 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: 18 years of age and older. Fulyzaq (crofelemer) Coverage requires documentation of diagnosis, Prescriber must confirm the diarrhea is non-infectious and that it is related to antiviral therapy. Gamastan S/D Gattex (teduglutide) Initial requests: require a diagnosis of short bowel syndrome and dependence on parenteral support for 12 months or greater. Renewal requests: patients must demonstrate at least a 20% reduction in parenteral fluid volume from baseline. Age restrictions: 18 years of age and older. Coverage duration: Initial and renewal: 1 year. Page 12 of 40 Gazyva (obinutuzumab) 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, Nutropin (all), Omnitrope, Saizen, Serostim, Tev-Tropin, Zorbtive 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 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. Page 13 of 40 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 aidsrelated cachexia. All FDA approved indications not otherwise excluded from Part D. 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: New therapy with or without cirrhosis, therapy experienced without cirrhosis = 12 weeks. Therapy experienced with cirrhosis = 24 weeks. 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. Hetlioz (tasimelteon) High risk drugs Megace (megesterol acetate) High risk tricyclic antidepressants Zaleplon Cyproheptadine Diphenhydramine Thioridazine For all members age 65 and older the following criteria apply: megace (megesterol) is approved if at least one of the suggested alternatives (mirtazapine, oxandrolone, or dronabinol) have been tried and failed or are not appropriate or contraindicated for the intended use. High risk tricyclic antidepressants are approved if patient has a history of use. For patients initiating therapy, the high risk tricyclic antidepressant is approved if at least one of the suggested alternatives (nortriptyline, desipramine, citalopram, escitalopram, miratzapine, sertraline, venlafaxine) with less sedation and fewer anticholinergic effects have been tried and failed or are not appropriate or Page 14 of 40 contraindicated for the intended use. Zaleplon is approved if at least one of the suggested alternatives, (low dose trazodone (25-50mg) or rozerem), has been tried and failed or is not appropriate or contraindicated for the intended use. Cyproheptadine and diphenhydramine are approved if at least one suggested alternative such as a second generation antihistamine (e.g., cetirizine, desloratadine, loratadine, fexofenadine) or low dose trazodone (25-50mg) or rozerem, if using for sleep, have been tried and failed or are not appropriate or contraindicated for the intended use. Thioridizine is covered for patients who have a history of use. For patients initiating therapy, thioridizine is covered if patient has a failure of or intolerance to at least one other safer alternative antipsychotic such as abilify or seroquel. All FDA approved indications not otherwise excluded from Part D. Age restrictions: Authorization is required for formulary high risk medications for members 65 years of age and older. Coverage duration: Zaleplon: Approved for 90 days. All other high risk medications: Approved for 1 year. Ibrance (palbociclib) Page 15 of 40 Iclusig (ponatinib) MEDICATION/ DRUG CLASS Coverage is provided for the diagnosis of chronic myelogenous leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy. Prior therapies tried must be reported to confirm resistance or intolerance. Coverage is provided for adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy. For acute lymphoblastic leukemia (ALL), the Philadelphia chromosome (Ph) status of the leukemia must be reported. Prior therapies must be reported to confirm resistance or intolerance. All FDA approved indications not otherwise excluded from Part D, and patients already started on Iclusig for a Covered Use. Ilaris (canakinumab) Imbruvica (ibrutinib) Requires documentation of the diagnosis. All F
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