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Prior Authorization Protocol
TECHNIVIE (ombitasvir-ritonavir-paritaprevir)

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:
    • For use in combination with ribavirin for treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of hepatitis C virus (HCV) genotype 4 infection confirmed by detectable serum HCV RNA by quantitative assay. Baseline viral load by quantitative assay including genotype and treatment status of patient (treatment naive or treatment-experienced) are required.
    AND
    • The patient is 18 years or older
    AND
    • Failure or clinically significant adverse event to Zepatier (grazoprevir/elbasvir)
    AND
    • Must be used in combination with ribavirin (RBV)
    AND
    • Any of the following clinical states identify candidates for treatment:
      • Evidence of Stage 2 or greater hepatic fibrosis defined by 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
      • 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.
    • Patients who have failed to respond to previous protease inhibitor (Olysio, Victrelis, Viekira Pak) based therapy.
    • Patients with decompensated cirrhosis (Child-Pugh Class B or C).
  4. General Information:
    • Technivie has not been studied in patients with HCV genotypes other than genotype 4.
    • Technivie is contraindicated in patients with severe hepatic impairment (Child-Pugh C) due to potential risk of toxicity. Technivie is not recommended for use in patients with moderate hepatic impairment (Child-Pugh class B).
    • In the SYNERGY trial, 21 patients (40% treatment experienced and 43% with advanced fibrosisF3 or F4 Metavir) with genotype 4 CHC began 12 weeks of treatment with Harvoni. One patient withdrew consent after taking the first dose. All 20 of the remaining patients achieved SVR-12. In a second trial, 21 /22 (95%) of treatment naove patients achieved SVR-12.
    • The American Association for the Study of Liver Disease (AASLD) recommendations for treatment of genotype 4 HCV infection includes treatment with Harvoni for 12 weeks including Harvoni in combination with RBV for patients with infection in the HCV infection in the allograft and cirrhosis.
    • The combination of Sovaldi (sofosbuvir) plus pegylated interferon and ribavirin produced SVR-12 in 27/28 (96%) patients with CHC genotype 4 infection.
    • In a phase II study, patients with HCV genotype 4 infection received daily Sovaldi plus weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg]) for 12 weeks or 24 weeks; among treatment-naive patients SVR12 rates were 84% (21/25) and 92% (22/24), respectively. The PHOTON-2 trial, an open-label study of HIV/HCV-coinfected patients, included 31 treatment-naive patients with HCV genotype 4 infection who received daily Sovaldi plus weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg]) for 24 weeks. In this study, 84% of patients (26/31) achieved SVR12.
    • Viekira Pak and Technivie are contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C).
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Zepatier

    Genotype 4:
    Treatment-naive
    One tablet PO QD

    12 weeks

    Zepatier + ribavirin

    Genotype 4:
    PegIFN/RBV-experienced
    One tablet PO QD plus BID ribavirin

    16 weeks

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

    Technivie

    Two tablets PO QD plus weight based ribavirin

    12 weeks

  7. Product Availability:

    Technivie Tablets containing paritaprevir 75 mg, ritonavir 50 mg, ombitasvir 12.5 mg

  8. References:
    1. Technivie [Prescribing Information]. North Chicago, IL: Abbvie Pharmaceuticals Corp; July 2015.
    2. Hezode C, Asselah T, Reddy KR et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naove and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-1): a randomized, open label trial. The Lancet June 20, 2015; 385;9986:2502-2509.
    3. American Association for the Study of Liver Disease Recommendations for Testing, Managing, and Treating Hepatitis C; October 2015. (accessed at: http://www.hcvguidelines.org).
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.