Health Choice Arizona Medication Prior Authorization Criteria October
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Health Choice Arizona Medication Prior Authorization Criteria October 1, 2019 1 Brand Name Generic Name ACCRUFER ferric malitol CRITERIA FOR COVERAGE/NON-COVERAGE ACCRUFER (ferric malitol) will be considered for coverage under the pharmacy benefit program when the following criteria are met: 4 week trial and failure of, or contraindication to all formulary iron supplements (ferrous sulfate oral tablet 325 [65 Fe] mg) AND Iron deficiency after the 4 weeks for treatment above as demonstrated by o Males: hemoglobin <11 g/dL or ferritin <8 μg/L o Females: hemoglobin <10 g/dL or ferritin <8 μg/L Maximum quantity: two 30mg tablets twice daily Approval duration: 24 weeks Continuation criteria: Continued iron deficiency as demonstrated by o Males: hemoglobin <11 g/dL or ferritin <8 μg/L o Females: hemoglobin <10 g/dL or ferritin <8 μg/L Re-approval duration: 12 weeks 2 Non Formulary Brand Name Generic Name ACTEMRA toclizumab CRITERIA FOR COVERAGE/NON‐COVERAGE Actemra is an interleukin-6 (IL-6) receptor antagonist indicated for the self-administered subcutaneous injection treatment of: Adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease Modifying Anti-Rheumatic Drugs (DMARDs). • Adult patients with giant cell arteritis (GCA). • Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Other indications such as systemic juvenile idiopathic arthritis (SJIA) and cytokine release syndrome (CRS) are FDA approved for administration of Actemra by intravenous infusion. Actemra will be considered for coverage under the pharmacy benefit program when the following criteria are met: 1. Rheumatoid Arthritis a. Prescribed by or in consultation with a rheumatologist. b. Age ≥ 18 years. c. Documentation submitted member has no latent or active tuberculosis infection. d. Documented diagnosis of moderate to severe rheumatoid arthritis (RA) and one or more of the following: i. Clinical Disease Activity Index (CDAI) > 10.0 ii. Disease Activity Score 28 (DAS) ≥ 3.2 iii. Simplified Disease Activity Index (SDAI) > 11.0 e. Trial and failure of one of the following therapies unless intolerant or contraindicated: i. Methotrexate for ≥ 3 consecutive months ii. If documented intolerance or known contraindication to MTX, then one of the following disease-modifying antirheumatic agent for ≥ 3 consecutive months Hydroxychloroquine Sulfasalazine Leflunomide f. Prescribed concomitantly with MTX or another agent if intolerance or contraindication to MTX; Note: Per 2015 ACR (American College of Rheumatology) Treatment Guidelines for rheumatoid arthritis biologic therapy should be used in combination with 3 methotrexate, when possible, due to superior efficacy of this combination over biologic monotherapy. g. Member has documented trial and failure per prescription claims history and chart notes or documented contraindication to, or intolerance of both Humira (adalimumab) and Enbrel (etanercept). h. Recent lab documentation submitted of hepatic function, absolute neutrophil count (ANC), and platelet count. i. Requested dose and dosing interval is consistent with the FDA labeled recommended dosing for Actemra and with the current weight (within 30 days) of the member. j. Documentation Actemra will be administered by subcutaneous self-injection by the member. 2. Giant Cell Arteritis a. Prescribed by or in consultation with a rheumatologist. b. Age ≥ 18 years. c. Documentation submitted member has no latent or active tuberculosis infection. d. Documented diagnosis of giant cell arteritis. e. Documented trial and failure of, or contraindication to or intolerance of, at least one of the following: i. Glucocorticoids (e.g., prednisone, methylprednisolone) ii. Methotrexate f. Recent lab documentation submitted of hepatic function, absolute neutrophil count (ANC), and platelet count. g. Documentation Actemra will be administered by subcutaneous self-injection by the member. 3. Polyarticular juvenile idiopathic arthritis a. Prescribed by or in consultation with a rheumatologist. b. Age of member is ≥ 2 years old. c. Documentation submitted member has no latent or active tuberculosis infection. d. Diagnosis of moderate to severe arthritis with at least five swollen joints and at least three joints with limitation of motion. e. Trial and failure of one of the following therapies unless intolerant or contraindicated i. Methotrexate for at least 30 days ii. Oral NSAID for at least 30 days iii. Oral corticosteroid for at least 14 days f. Member has documented trial and failure per prescription claims history and chart notes or documented contraindication to, or intolerance of both Humira (adalimumab) and Enbrel (etanercept). g. Requested dose and dosing interval is consistent with the FDA labeled recommended dosing for Actemra and with the current weight (within 30 days) of the member. h. Recent lab documentation submitted of hepatic function, absolute neutrophil count (ANC), and platelet count. i. Documentation Actemra will be administered by subcutaneous self-injection by the member. 4 Approval Length: Three months initially then up to 12 months thereafter based on clinical response. Quantity Limits: Up to four prefilled syringes per 30 days based on diagnosis. Continuation Criteria: Rheumatoid arthritis – Documentation submitted supporting continued positive clinical response is occurring or stabilization of disease with improvement from pre-treatment baseline parameters by a result of at least one of the following disease activity measurements listed below. Clinical Disease Activity Index (CDAI) < 10.0 Disease Activity Score 28 (DAS) ≤ 3.2 Simplified Disease Activity Index (SDAI) < 11.0 Giant cell arteritis – Documentation submitted supporting continued positive clinical response is occurring or stabilization of disease with improvement from pre-treatment baseline parameters including both of the following: Normalization of erythrocyte sedimentation rate to < 30 mm/hour for women and < 23 mm/hour for men. Normalization of C-reactive protein to < 1 mg/dL. Polyarticular juvenile idiopathic arthritis – Documentation submitted supporting member has achieved and is maintaining a 30% improvement in number of joints with active arthritis and the number of joints with limitation of movement. For all diagnoses: If member is transitioning to the subcutaneous injection formulation from intravenous infusion then all initial pharmacy benefit criteria must be met in full. Exclusions: 1. Concomitant use with other biologic DMARD medications (oral and injectable). 2. Alcohol use is not considered a supported clinical reason for avoidance of methotrexate. 3. The following is a list of acceptable contraindications for the use of methotrexate: Pregnancy Actively breast-feeding Anemia, thrombocytopenia, leukopenia, or bone marrow hypoplasia Immunodeficiency syndrome Hepatitis B or C infection Liver enzymes that are persistently elevated Alcoholism or alcoholic liver disease stated as a diagnosis documented by the provider **If all criteria met and approval is granted, medication will only be dispensed by a defined specialty pharmacy vendor at the discretion of Steward Health Choice** References: 1. Actemra prescribing information. South San Francisco, CA. Genentech, Inc. Rev May 2018. 2. Singh J, Saag KG, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care & Research. 2015. 3. Lovell DJ, Ruperto N, et al. Adalimumab with or without Methotrexate in Juvenile Rheumatoid Arthritis. N Engl J Med;359:810-820 Aug 2018. 5 4. Ringold S, Weiss P, et al. 2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis. Arthritis & Rheumatism. Vol 65(10);Oct 2013,2499-2512. 5. Mukhtyar C, Guillevin L, et al. EULAR recommendations for the management of large vessel vasculitis. Ann Rheum Dis. 2009 Mar; 68(3):318-23. Criteria effective: 10/01/2018; Last reviewed April 2019 6 Brand Name Generic Name ACTIMMUNE Interferon gamma-1b CRITERIA FOR COVERAGE/NONCOVERAGE ACTIMMUNE/Interferon gamma-1b will be considered for coverage under the pharmacy benefit program when the following criteria are met: Member must meet the following criteria for initial authorization: 1. The member must be clinically diagnosed with one of the following conditions: a. Chronic Granulomatous Disease (CGD): Actimmune is being used to reduce the frequency and severity of serious infections associated with CGD. b. Malignant osteopetrosis (severe): Actimmune is being used to delay time to disease progression. Criteria for continuation: 1. For Chronic Granulomatous Disease: documentation has been provided that the member has had a positive response to treatment defined as a reduction in frequency and severity of serious infections. 2. For Malignant osteopetrosis: documentation has been provided that the member‘s disease progression has been slowed. Approval will be granted for 6 months (if no improvement within 6 months discontinue treatment) References 1. Micromedex/DRUGDEXatwww.microdexsolutions.com. 2. Facts&ComparisonseAnswersathttp://online.factsandcomparisons.com. Criteria last updated: 2/2019 7 Criteria Name ADHD Medications in Children < 6 years old CRITERIA FOR COVERAGE/NONCOVERAGE ADHD medications will be considered for initial coverage under the pharmacy benefit program when the following criteria are met: 1. The requesting clinician has documented that the child has a diagnosis