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Prior Authorization Protocol

COPEGUSR , REBETOLR (ribavirin)


HNMC

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:
    • Copegus: In combination with Pegasys for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha, and in adult CHC patients coinfected with HIV
    • Rebetol: In combination with interferon alfa-2b (pegylated and nonpegylated) 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. Genotype is required to determine length of approval.

    AND

    • Member must meet prior authorization criteria for Epclusa, Harvoni, Olysio, Sovaldi, Technivie, Zepatier or Viekira Pak for combination use

    AND

    • Patient is 18 years of age or older

    AND

    • Any of the following clinical states identify candidates for treatment:
      • Evidence of Stage 2 or greater hepatic fibrosis including one of the following: Liver biopsy confirming a METAVIR score F2 or greater OR Transient elastography (FibroscanR), score greater than or equal to 7.5 kPa; OR FibroSure (also known as FibroTestR) score of greater than or equal to 0.48; OR APRI score greater than 0.7; OR FIB greater than 3.25.
      • Evidence of extra-hepatic manifestation of hepatitis C virus, such as type 2 or 3 essential mixed cryoglobulinemia with end- organ manifestations (e.g. vasculitis), or kidney disease (e.g., proteinuria, nephrotic syndrome or membranoproliferative glomerulonephritis).
      • Persons with hepatocellular carcinoma with life expectancy greater than 12 months
      • Pre- and post-liver transplant, or other solid organ transplant
      • HIV-1 co-infection
      • Hepatitis B co-infection
      • Other coexistent liver disease (e.g. nonalcoholic steatohepatitis)
      • Type 2 diabetes mellitus (insulin resistant)
      • Porphyria cutanea tarda
      • Debilitating fatigue impacting quality of life (e.g., secondary to extra-hepatic manifestations and/or liver disease)
      • Men who have sex with men with high-risk sexual practices
      • Active injection drug users
      • Persons on long-term hemodialysis
      • Women of childbearing age who wish to get pregnant
      • HCV-infected health care workers who perform exposure-prone procedures

    Criteria for Reauthorization/Continuation of Therapy:

    • Initial authorization criteria have been met, and
    • Evidence of lack of adherence may result in denial of treatment reauthorization.
    • Missed medical appointments related to the hepatitis C virus may result in denial of treatment authorization.
  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 Epclusa, Harvoni, Olysio, Sovaldi, Technivie, Zepatier 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; January 2016.
    2. Copegus [Prescribing Information] South San Francisco, CA: Genentech USA Inc, August 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.
Draft Prepared:
Approved By Health Net National P&T: 18-NOV-15
Revised: 25-MAY-16 NN