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Prior Authorization Protocol
COPEGUSR, REBETOLR(ribavirin)

NATL
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Copegus:†For the treatment of chronic hepatitis C (CHC) virus infection in combination with Pegasys in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients coinfected with HIV
    • Rebetol:†Use in combination with interferon alfa-2b (pegulated and nonpegulated) for the treatment of CHC in patients 3 years of age and older with compensated liver disease.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of chronic hepatitis C (CHC) confirmed by detectable serum HCV RNA by quantitative assay
    AND
    • Member must meet prior authorization criteria for Harvoni, Olysio, Sovaldi, Technivie or Viekira Pak for combination use
  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

    ribavirin, Copegus, Rebetol

    The daily dose of administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen

    Coincide with duration of for Harvoni, Olysio, Sovaldi, Technivie or Viekira Pak authorization

  7. Product Availability:
    Copegus: 200 mg tablets
    Rebetol: 200 mg capsules, 40 mg/ml oral solution


  8. References:
    1. Rebetol [Prescribing Information] Whitehouse Station, NJ; Merck and Co;†November 2013.
    2. Copegus [Prescribing Information] South San Francisco, CA: Genentech USA Inc, February 2013.
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.