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Mavyret — Medica

Genotype 4 chronic hepatitis C virus, pediatric (≥ 3 years and < 18 years)

Preferred products

  • Epclusa (brand only)
  • Harvoni (brand only)
  • Zepatier
  • Vosevi

Initial criteria

  • Patient meets the Hepatitis C – Mavyret PA for PSM Policy criteria applicable to genotype and condition
  • Genotype-specific criteria:
  • Genotype 3, adult: if treatment-naïve → not approved; otherwise, patient meets Mavyret PA for PSM and either previously treated with pegylated interferon/ribavirin and failed Epclusa (SVR not achieved) OR previously treated with Sovaldi + ribavirin ± pegylated interferon and failed Vosevi (SVR not achieved) [documentation required]
  • Genotype 4, adult: if treatment-naïve → not approved; otherwise, patient meets Mavyret PA for PSM and either previously treated with pegylated interferon/ribavirin and failed Epclusa, Harvoni, or Zepatier (SVR not achieved) OR previously treated with Sovaldi + ribavirin ± interferon [documentation required]
  • Genotype 4, pediatric: if treatment-naïve → not approved; otherwise, patient meets Mavyret PA for PSM and either previously treated with pegylated interferon/ribavirin and failed Epclusa or Harvoni (SVR not achieved) OR previously treated with Sovaldi + ribavirin ± interferon [documentation required]
  • Genotype 5 or 6: if treatment-naïve → not approved; otherwise, patient meets Mavyret PA for PSM and either previously treated with pegylated interferon/ribavirin and failed Epclusa or Harvoni (SVR not achieved) OR previously treated with Sovaldi + ribavirin ± interferon [documentation required]
  • Genotype 1 with renal impairment, adult: if treatment-naïve → not approved; otherwise, patient meets Mavyret PA for PSM and either previously treated with pegylated interferon/ribavirin, Incivek, Olysio, or Victrelis and failed Zepatier (SVR not achieved) OR previously treated with Sovaldi + ribavirin ± interferon, Sovaldi + Olysio, Daklinza, Epclusa, Harvoni, or Zepatier [documentation required]
  • Genotype 4 with renal impairment, adult: if treatment-naïve → not approved; otherwise, patient meets Mavyret PA for PSM and either previously treated with pegylated interferon/ribavirin and failed Zepatier (SVR not achieved) OR previously treated with Sovaldi + ribavirin ± interferon [documentation required]
  • Genotype 1 or 4 with renal impairment, pediatric; Genotype 2, 3, 5, 6 with renal impairment; Genotype 1–6 kidney transplant; Genotype 2 or 3 post-liver transplant; Genotype 1, 4, 5, 6 post-liver transplant pediatric; or Genotype 1–6 liver transplant recipient: approve if patient meets Mavyret PA for PSM Policy criteria
  • Genotype 1, 4, 5, or 6 recurrent HCV post-liver transplant, adult: patient meets Mavyret PA for PSM Policy criteria AND has completed therapy with Harvoni and did not achieve SVR [documentation required]
  • Genotype unknown/undetermined, no cirrhosis: not approved; with compensated cirrhosis: approve per Mavyret PA for PSM Policy criteria

Approval duration

as specified in the Hepatitis C – Mavyret PA for PSM Policy