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Prior Authorization Protocol
OTREXUPTM, RASUVO (methotrexate) injection


NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy
    • Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of severe, active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis or severe, recalcitrant, disabling psoriasis
    AND
    • Failure or clinically significant adverse effects to generic methotrexate injection
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • Otrexup and Rasuvo are not indicated for the treatment of neoplastic diseases
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    methotrexate Injection

    Varies

    Varies

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Otrexup, Rasuvo (methotrexate)

    RA, pJIA, psoriasis
    7.5 to 25 mg SC once weekly
    NATL: Length of benefit

    HNCA: 6 month or to member's renewal period, whichever is longer
  7. Product Availability:
    Otrexup: Autoinjector that administers a single 0.4 mL dose: 10 mg/0.4 mL methotrexate, 15 mg/0.4 mL methotrexate, 20 mg/0.4 mL methotrexate, 25 mg/0.4 mL methotrexate
    Rasuvo: Preservative-free sterile solution for a single subcutaneous injection, 7.5 mg per 0.15 mL, 10 mg per 0.20 mL, 12.5 mg per 0.25 mL, 15 mg per 0.30 mL, 17.5 mg per 0.35 mL, 20 mg per 0.40 mL, 22.5 mg per 0.45 mL, 25 mg per 0.50 mL, 27.5 mg per 0.55 mL, 30 mg per 0.60 mL
  8. References:
    1. Otrexup [package insert]. Ewing, NJ : Antares Pharma, Inc. November 2014.
    2. Rasuvo [package insert]. Chicago, IL : Medac Pharma, Inc. November 2014.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.