Ledipasvir/Sofosbuvir — Blue Cross Blue Shield of Alabama
hepatitis C genotype 1, 4, 5, or 6 including HCV/HIV co-infection
Preferred products
- Epclusa
- Mavyret
Initial criteria
- The patient has a diagnosis of hepatitis C genotype 1, 4, 5, or 6
- The prescriber has provided the patient’s baseline HCV RNA level if patient has genotype 1
- ONE of the following: patient is treatment naive OR previously treated with peg-interferon and ribavirin with or without an HCV protease inhibitor OR has decompensated cirrhosis
- The prescriber has screened for HBV and will monitor if positive
- The patient’s age is within FDA labeling or supported for the indication
- Step therapy requirement: one of the following must apply if preferred agents for specific factors exist — requested agent preferred OR patient treated with non-preferred agent in past 30 days OR intolerance/hypersensitivity to all preferred OR contraindication to all preferred OR supported clinical rationale
- ONE of the following: prescriber is a specialist or has consulted with one OR (patient is treatment naive, no or compensated cirrhosis, requested agent supported in AASLD simplified treatment and meets AASLD simplified eligibility)
- The patient has no FDA-labeled contraindications
- The patient will use regimen and therapy duration consistent with Table 3 (FDA labeling) or Table 4 (AASLD guidelines)
- Treatment durations per FDA/AASLD tables (8–24 weeks) apply depending on viral load, previous therapy, cirrhosis status, ribavirin eligibility, and transplant status
Approval duration
up to duration of treatment per Tables 3 or 4