Zepatier — CareFirst (Caremark)

Initial criteria

• Prescribed by or in consultation with a provider experienced in the management of hepatitis C virus infection
• Member age ≥ 12 years or weight ≥ 30 kg
• No decompensated cirrhosis/moderate or severe hepatic impairment (Child-Turcotte-Pugh class B or C)
• For Genotype 1a infection WITHOUT ribavirin: authorization up to 12 weeks total if no baseline NS5A resistance-associated substitutions (RASs)/polymorphisms (M28, Q30, L31, Y93) and member is treatment-naïve or failed prior PEG-IFN + RBV WITHOUT a protease inhibitor (boceprevir, simeprevir, telaprevir)
• For Genotype 1b infection WITHOUT ribavirin: authorization up to 12 weeks total if treatment-naïve or failed prior PEG-IFN + RBV WITHOUT a protease inhibitor
• For Genotype 4 infection WITHOUT ribavirin: authorization up to 12 weeks total if treatment-naïve
• For kidney transplant recipients: authorization up to 12 weeks total if genotype 1 or 4 WITHOUT baseline NS5A RASs/polymorphisms and treatment-naïve or not failed prior direct-acting antiviral
• For Genotype 1a infection WITH ribavirin: authorization up to 16 weeks total if baseline NS5A RASs/polymorphisms present and member is treatment-naïve or failed prior PEG-IFN + RBV with or without protease inhibitor; OR authorization up to 12 weeks if no baseline NS5A RASs/polymorphisms and failed prior PEG-IFN + RBV with protease inhibitor
• For Genotype 1b infection WITH ribavirin: authorization up to 12 weeks total if failed prior PEG-IFN + RBV with protease inhibitor
• For Genotype 4 infection WITH ribavirin: authorization up to 16 weeks total if failed prior PEG-IFN + RBV
• For HCV and HIV coinfection: authorization when criteria for HCV approval are met

Reauthorization criteria

• Continuation requests must meet all initial coverage criteria

Approval duration

Up to 12 or 16 weeks total depending on genotype and ribavirin use