Harvoni (ledipasvir/sofosbuvir tablets and oral pellets − Gilead) — Cigna

Initial criteria

• Patient is ≥ 3 years of age; AND
• Patient meets ONE of the following (i, ii, or iii):
• i. Approve for 8 weeks if the patient meets ALL of the following (a, b, c, d, and e):
• a) Patient is treatment-naïve; AND
• b) Patient does not have cirrhosis; AND
• c) Patient does not have human immunodeficiency virus (HIV); AND
• d) Patient is not awaiting liver transplantation; AND
• e) Baseline HCV RNA is < 6 million IU/mL; OR
• ii. Approve for 12 weeks if the patient meets ONE of the following (a, b, or c):
• a) Patient is treatment-naïve AND does not meet criterion Bi above; OR
• Treatment-naïve includes patients with or without HIV who are treatment-naïve with compensated [Child-Pugh A] cirrhosis regardless of baseline HCV RNA, or treatment-naïve patients with or without HIV without cirrhosis and baseline HCV RNA ≥ 6 million IU/mL. This would also include treatment-naïve patients awaiting transplant with compensated [Child-Pugh A] cirrhosis regardless of baseline HCV RNA or treatment-naïve patients awaiting transplant without cirrhosis and baseline HCV RNA ≥ 6 million IU/mL.

Approval duration

8 weeks or 12 weeks