HN Logo
Prior Authorization Protocol
COPEGUSR, REBETOLR(ribavirin)


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:
    • 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

    • Prescribed by or in consultation with a gastroenterologist, hepatologist or infectious disease physician.

    AND

    • Chart note documentation and copies of lab results are required

    AND

    • One of the following clinical states to 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
        • Transient elastography (Fibroscan) score greater than or equal to 7.5 kPa
        • FibroSure (also known as FibroTest) score of greater than or equal to 0.48
        • APRI score greater than 0.7
        • FIB greater than 3.25
        • ARFI score of greater than 1.34 m/s
        • MRE score of greater than 3.20 kilopascals
        • HepaScore ≥0.55
        • FibroMeter ≥ 0.411
      • 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).
      • For treatment of CHC in patients with hepatocellular carcinoma with a life expectancy greater than 12 months meeting Milan criteria (awaiting liver transplantation): Milan criteria is defined as 1 lesion ≤5 cm, up to 3 lesions each of which are ≤3 cm, and no extrahepatic manifestations/no vascular invasion
      • 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) Fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest, and causes a substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities, that persists for more than 6 months]
      • Men who have sex with men with high-risk sexual practices
      • Patients with a current injectable substance abuse disorder and actively participating in treatment
      • Persons on long-term hemodialysis
      • Women of childbearing age who wish to get pregnant
      • HCV-infected health care workers who perform exposure-prone procedures
  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:
    • This section intentionally left blank
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    This field intentionally left blank.

    This field intentionally left blank.

    This field intentionally left blank.

    * 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.