Zepatier (grazoprevir/elbasvir) — Medica

Initial criteria

• Patient is ≥ 12 years of age OR patient weighs ≥ 30 kg
• Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician
• Approve for 12 weeks if patient is treatment‑naïve OR previously treated with pegylated interferon + ribavirin only AND patient does NOT have a baseline NS5A polymorphism at amino acid positions 28, 30, 31, or 93
• OR Approve for 12 weeks if patient previously treated with pegylated interferon + ribavirin + HCV protease inhibitor AND medication prescribed in combination with ribavirin
• OR Approve for 16 weeks if patient is treatment‑naïve OR previously treated with pegylated interferon + ribavirin only AND has baseline NS5A polymorphism at amino acid positions 28, 30, 31, or 93 AND medication prescribed in combination with ribavirin

Reauthorization criteria

• Patient is currently receiving Zepatier for an approved indication and approval period sufficient to complete total recommended course

Approval duration

12 or 16 weeks depending on genotype 1a subtype and prior therapy