Ampyra For patients age 18 or older who meet all of the following criteria: Prescribed by, or in consultation with a neurologist Patient is between 18 and 70 years old Documented diagnosis of multiple sclerosis with impaired walking ability Patient must not be Baseline 25-ft walking test between 8 and 45 seconds Patient must not have a history of seizures Patient must not have moderate to severe renal impairment (Crcl < 50 ml/min) Patient must be on disease modifying therapy for MS Initial Approval: 6 months Renewal: 1 year Requires: At least 20% improvement in timed walking speeds on 25-ft walk within 4 weeks) Antidementia Drugs donepezil 5mg,10mg, galantamine, -ER, Namenda, rivastigmine capsules For Patients who meet all of the following: Diagnosis of Alzheimer’s disease Potential causes for cognitive dysfunction. (eg, cerebrovascular disease, cobalamin [vitamin B-12] deficiency, syphilis, thyroid disease) has beeen ruled out. Cognitive assessment to evaluate for the presence of dementia; Mini-Mental Status Exam (MMSE) below 22 OR Mini-Cog score of ≤ 2 and abnormal CDT (clock drawing test) Age restriction: must be at least 18 years old Initial Approval: Indefinitely ARBs Benicar Edarbi For patients who meet the following: Prescribed by a cardiologist OR 2 fills of a first-line agent (or any combination of first-line agents) in the last 130 days OR Documented intolerance to formulary ARBs Age restriction Benicar – must be at 6 years old and weigh at least 20 kg Edarbi – must be at least 18 years old First-line Agents include: ACE inhibitors Formulary ARBs: Initial Approval: Indefinite - trial
In addition, for treatment of moderate to severe rheumatoid arthritis: Failure of, or contraindication/intolerance to all of the following: Methotrexate AND at least 1 other oral DMARD (sulfasalazine, hydroxychloroquine or leflunomide) for at least 3 months (in combination or each as monotherapy) At 2 of the following: Enbrel or Humira for three consecutive months Colony-Stimulating Factors (CSF) Neupogen, Neulasta Neumega Leukine For Patients who meet the following: Prescribed for a medically accepted indication/diagnosis Prescribed by hematologist and/or oncologist, or specialist per associated diagnosis/indication In addition, for Neupogen: Chemotherapy-induced neutropenia Chemotherapy regimen has approximately ≥ 20% risk of febrile neutropenia OR Member is at high-risk for neutropenic complications (e.g., age > 65, pre-existing neutropenia or tumor involvement in the bone marrow, infection, renal or liver impairment, other serious co-morbidities) Administered 24 – 72 hours after completion of chemotherapy Patient is not receiving concurrent chemotherapy and radiation therapy Treatment of neutropenia Severe chronic congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia HIV-induced or drug-induced neutropenia in immunosuppressed patients Patient has evidence of inadequate bone marrow reserve (e.g., recurrent fevers, splenomegaly, mucosal ulcers, abdominal pain) OR Patient is at high risk for the development of serious bacterial infection (e.g., primarily severe neutropenia, indwelling venous catheters, prior serious infections) OR Patient has a documented bacterial infection Initial Approval: Neupogen 14 day course per chemotherapy cycle Refills if indicated Neulasta 1 dose per 21 days Refills as indicated Neumega Up to 21 days’ supply Refills if number of cycles provided Leukine AML, bone marrow transplant: up to 42 days All other indications: 30 days Renewal: trial
Patient is receiving treatment with zidovudine at a dose < 4200 mg/week Patient meets both of the following: Endogenous erythropoietin levels < 500 mUnits/mL. Hemoglobin < 10 g/dL within the last two weeks Anemia associated with myelodysplastic syndrome (Epogen, Procrit) Patient meets all of the following: Hemoglobin < 10 g/dL within 2 weeks prior to initiating therapy Recent erythropoietin < 500 mU/mL Anemia due to Chemotherapy in Patients with Cancer (Epogen, Procrit, Aranesp) Patient is currently receiving chemotherapy Patient meets all of the following: Hemoglobin < 10 g/dL within the 2 prior to starting therapy Documentation to support anemia is due to concomitant myelosuppressive chemotherapy Diagnosis of non-myeloid malignancy (e.g., solid tumor) Patient has a minimum of 2 additional months of planned chemotherapy upon initiation of therapy Additional information may be required on a case-by-case basis to allow for adequate review. Renewal: 3 months Requires Hb < 11 g/dL within the last 2 weeks Follow up iron studies showing member has adequate iron to support erythropoiesis Forteo For Patients who meet all of the following: > 18 years of age Black box warning – due to the potential risk of osteosarcoma, Forteo should not be used in patients at increased baseline risk for osteosarcoma (e.g., Paget’s disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, or prior external beam or implant radiation therapy involving the skeleton). Forteo should only be prescribed for patients whom potential benefits outweigh potential risk. For the treatment of osteoporosis in men and women who meet the following criteria: Initial Approval: Osteoporosis – 2 years Hypoparathyroidism – 3 months (parathyroid hormone level, PTH – within 30 days) Renewal: 1 year
30 days for three months Renewal: 3 months Hyperlipidemia Medications Last reviewed: 6/15/15 Crestor Zetia Lovaza Vascepa Epanova Repatha Praluent Juxtapid Kynamro Crestor can be approved when the following criteria are met: Patient is at least 10 years old; AND Patient has failed to achieve LDL goal on a compliant regimen of maximum tolerated dose of atorvastatin; OR Patient requires a high intensity statin (i.e., diagnosis of familial hypercholesterolemia or high ASCVD risk per provider evaluation) AND patient had a trial and failure of atorvastatin requires step therapy: If member has filled 2 prescriptions for 2 different statins (specifically atorvastatin, simvastatin or Crestor) within the last 130-days, the prescription will automatically process at the pharmacy. Prior Authorization will be required for prescriptions that do not process automatically at the pharmacy. In those cases, Zetia will be authorized upon receipt of documentation to support the diagnosis of hyperlipidemia and failure of, or contraindication to atorvastatin, simvastatin, and Crestor. Non-formulary medications for hypertriglyceridemia (Lovaza, Vascepa, and Epanova) can be approved when the following criteria are met: Patient is at 18 years old Drug will be used as an add-on to lifestyle interventions to include diet and exercise Treatment of severe hypertriglyceridemia (triglyceride level greater than or equal to 500 mg/dL) Trial and failure of OTC fish oil and at least ONE other formulary medication such as fenofibrate, fenofibric acid, gemfibrozil, or niacin or contraindication to all formulary agents PCSK9 Inhibitors (Repatha and Praluent) can be approved when ALL of the following criteria are met: Lab results support an LDL ≥300 mg/dL (within the past 90 days) Initial Approval: PSCK9 inhibitors: 3 months Juxtapid, Kynamro: 3 months All others: 6 months Renewal: inhibitors: 6 months Juxtapid, Kynamro: 6 months All others: indefinite Renewals require improvement in fasting lipids and documentation of recommended safety monitoring parameters (such as liver enzymes)
supporting skeletal muscle related symptoms that resolved when statin therapy was discontinued; and documentation the member has been rechallenged at a lower dose or with a different statin. Idiopathic Pulmonary Fibrosis Agents Last reviewed: 06/16/15 Esbriet Ofev Non-formulary use of Esbriet or Ofev can be approved when the following are met: Diagnosis of mild to moderate idiopathic pulmonary fibrosis Confirmed by high resolution computed tomography (HRCT), lung biopsy, or bronchoscopy Interstitial lung disease cannot be attributed to another cause (i.e., rheumatoid arthritis, lupus, systemic sclerosis, asbestos exposure, or hypersensitivity pneumonitis) Forced vital capacity (FVC) between 50 and 80% predicted Documentation of baseline liver function tests (LFT’s) prior to initiating treatment Patient age must be 18 years or greater Patient is not a current smoker Prescribed by, or in consultation with, a pulmonologist Note: There is no conclusive evidence to support the use of any drugs to increase the survival of people with idiopathic pulmonary fibrosis. Initial Approval: 3 months Renewal: 6 months Criteria for renewal: Documentation of stable FVC (recommended to discontinue if there is a >10% decline in FVC over a 12 month period) Attestation that LFT’s are being monitored Increlex Last reviewed: 4/22/15 For patients that meet the following: Prescribed by or in consultation with pediatric endocrinologist Patient is ≥ 2 years old No evidence of epiphyseal closure No evidence of neoplastic disease Documentation supports a diagnosis of Severe, Primary IGF-1 deficiency Height standard deviation score less than or equal to −3 Basal IGF-1 standard deviation score less than or equal to −3 Normal or elevated growth hormone (GH) levels No evidence of secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of corticosteroids. OR Initial Approval: 6 months Renewal: 6 months if at least doubling of pretreatment growth velocity 1 year if growth velocity ≥ 2.5 cm/yr and epiphyses are open
Diagnosis of Type 2 diabetes Trial and failure of metformin in combination with Januvia or Byetta for at least 3 consecutive months OR Trial and failure of Janumet for at least 3 consecutive months Age restriction: must be at 18 years old Indefinite Long acting Opioids Oxycontin Butrans Patch Exalgo Oxymorphone ER Zohydro ER Xartemis XR Nucynta ER) STEP criteria for Oxymorphone ER: Treatment of chronic pain At least 18 years old Failed a minimum of 2 week trials of maximum tolerated doses of at least TWO formulary long-acting opioids (i.e., fentanyl patch, morphine sulfate ER, methadone) OR have contraindications to all formulary agents. Criteria for Oxycontin and other Non-Formulary Long-Acting Opioids: Treatment of malignant pain and pain due to sickle cell anemia (Oxycontin) OR Treatment of chronic non-malignant pain: At least 18 years old Failed a minimum of 2 week trials of maximum tolerated of at least THREE formulary long-acting agents (i.e., fentanyl patch, morphine sulfate ER, methadone, oxymorphone ER) one of which must be oxymorphone ER OR Contraindication to all formulary long-acting agents OR Treatment of diabetic peripheral neuropathy (Nucynta ER only): At least 18 years old Failed an adequate trial (at least 4 weeks at maximum tolerated doses) of duloxetine and tramadol and at least ONE additional formulary medication (i.e., gabapentin, amitriptyline, nortriptyline, or topical capsaicin) OR Contraindications to all formulary agents Initial Approval: 1 year Renewal: 1 year
Idiopathic hypersomnia: For patients age 16 years of age or older Trial and failure of 2 formulary stimulants (e.g., amphetamine/dextroamphetamine, methylphenidate) Diagnosis is supported by polysomnography and multiple sleep latency test. Multaq Multaq will be authorized when prescribed by, or in consultation with a cardiologist. If not prescribed by or in consultation with a cardiologist, the following must be met: Diagnosis is atrial fibrillation Patient has and failed amiodarone Age restriction: must be at 18 years old Initial Approval: Indefinite Multiple Sclerosis Avonex, Betaseron, Extavia, Copaxone, Gilenya, Novantrone, Gilenya, Tecfidera, Aubagio, mitoxantrone For patients who meet the following: Must be prescribed by a neurologist, or in consultation with a neurologist Must be 18 years of age or older In addition: Gilenya, Tecfidera, Aubagio: Failure of a compliant regimen of two formulary medications; such as, Avonex, Rebif, Betaseron, Extavia or Copaxone Mitoxantrone: Cumulative dose is less than 140 mg/m2 (if patient has received drug in the past) Failure of a compliant regimen of Avonex, Rebif, Betaseron, Extavia or Copaxone Failure of a complaint regimen of Tyasbri for 6 months Avonex, Betaseron, Extavia, Rebif, Copaxone, Gilenya, Tecfidera, Aubagio: Indefinite Mitoxantrone: 3 months Documentation to support that prior to each dose patient is: Assessed for cardiac signs and symptoms by history, physical examination and ECG. Quantitative reevaluation of LVEF
For Crohn’s Disease, all of the following: Trial and failure of a compliant regimen of oral corticosteroids (for moderate to severe CD) or intravenous corticosteroids (for severe and fulminant CD) for one month (or documented contraindication or intolerance to PO or IV corticosteroids); and Trial and failure of a compliant regimen of azathioprine or mercaptopurine for three consecutive months (or documented contraindication or intolerance to azathioprine or mercaptopurine); and Trial and failure of a compliant regimen of Humira OR Remicade for at least 3 months Additional Renewals: For Multiple Sclerosis: Approve for 6 months, up to 2 total, if patient is responding For Crohn’s Disease: If member is unable to taper off of steroids in the first 6-months, d/c natalizumab If patient has responded, approve for 6 months Velphoro For patients that meet all of the following: Diagnosis of hyperphosphatemia At least 18 years old Receiving dialysis Failed at least 2 formulary phosphate binding agents such as calcium acetate capsules or tablets, sevelamer carbonate (Renvela), or Renagel Initial Approval: 1 year Renewal: 1 year Weight Reduction Medications Xenical Belviq Bontril Didrex phentermine Tenuate Qsymia Contrave For patients who meet all of the following: BMI ≥ 30 kg/m2 (obese) OR BMI ≥ 27kg/m2 (overweight) and one of the following obesity-related chronic diseases and risk factors: Coronary heart disease Dyslipidemia: HDL <35mg/dl or LDL ≥ 160mg/dL, or Triglycerides ≥ 400mg/dl Controlled hypertension (less than> 140/90mm Hg) Type II diabetes mellitus Sleep apnea Initial Approval: 3 months Renewal: Xenical and Belviq: 3 months Requires documentation of a weight loss of at least 4 pounds per month All others: Treatment beyond 3 months is not
Weight is less than 150 kg (330 lbs) Allergic sensitization demonstrated by positive skin testing or in testing for IgE to an allergen that is present year round (a perennial allergen), such as dust mite, animal dander, cockroach, or molds Evidence of reversible disease (12% or greater improvement in FEV1 with at least a 200-ml increase or 20% or greater improvement in PEF as a result of a short-acting bronchodilator challenge Patient should be non-smoking or actively receiving smoking cessation treatment Patient has tried and failed conventional immunotherapy or immunotherapy is not indicated. (Immunotherapy has demonstrated efficacy against dust mites, animal dander, and pollens but not against molds and cockroach allergies). Asthma symptoms are not adequately controlled by high dose inhaled corticosteroids AND a long-acting beta agonist (LABA) for 6 months Inadequate control is defined as: Requirement for systemic corticosteroids (oral, parenteral) to treat asthma exacerbations OR Daily use of rescue medications (short-acting inhaled beta-2 agonists) OR 2 ED visits or 1 hospitalization for asthma in the last 12 months OR 2-3 unscheduled office visits with documentation of intensive care for acute asthma exacerbation OR Nighttime symptoms occurring more than once a week For the treatment of chronic urticaria: Symptoms continuously or intermittently present for at least 6 weeks. Prescribed by an allergist/immunologist or dermatologist 12 years of age or older Currently receiving H1 antihistamine therapy Failure of a 4 week, compliant of at least two high dose H1 antihistamines Chronic urticaria: 3 months Renewal: Asthma: 1 year Requires demonstration of clinical improvement (e.g., ↓ use of rescue medications or systemic corticosteroids, ↑ in FEV1 from pre-treatment baseline, ↓ in number of ED visits or hospitalizations) and compliance with asthma controller medications, and non-smoking status. Chronic urticaria: 6 months Requires demonstration of adequate symptom control (e.g., ↓ itching)