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Prior Authorization Protocol

STRENSIQTM (asfotase alfa)


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:
    • For use in the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP)
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of perinatal/infantile-onset hypophosphatasia (HPP) or juvenile-onset HPP
  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:
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  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
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    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Strensiq

    6 mg/kg/week administered SC as either:

    2 mg/kg TIW
    or
    1 mg/kg six times per week

    For perinatal/infantile-onset HPP, the dose may be increased for lack of efficacy (e.g., no improvement in respiratory status, growth, or radiographic findings) up to 9 mg/kg/week administered SC as 3 mg/kg TIW.

    Length of Benefit

  7. Product Availability:

    Single-use vials: 18 mg/0.45 mL, 28 mg/0.7 mL, 40 mg/mL, 80 mg/0.8 mL

  8. References:

    1. Strensiq [Prescribing Information]. Cheshire, CT: Alexion Pharmaceuticals, Inc.; October 2015.

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.