Harvoni (ledipasvir/sofosbuvir) — Medica

Initial criteria

• age ≥ 3 years
• Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician
• Approve for 8 weeks if ALL: patient is treatment-naïve AND has no cirrhosis AND does not have HIV AND is not awaiting liver transplantation AND baseline HCV RNA < 6 million IU/mL
• Approve for 12 weeks if ONE: (a) patient is treatment-naïve but does not meet 8-week criteria OR (b) patient has previously been treated for HCV and does not have cirrhosis OR (c) treatment-naïve or previously treated with decompensated cirrhosis (Child-Pugh B or C), ribavirin-eligible, and used with ribavirin
• Approve for 24 weeks if ONE: (a) previously treated with compensated cirrhosis (Child-Pugh A) OR (b) treatment-naïve or previously treated with decompensated cirrhosis (Child-Pugh B or C), ribavirin-ineligible

Approval duration

8, 12, or 24 weeks (based on criteria met)