Sofosbuvir/Velpatasvir — Blue Cross Blue Shield of Alabama

Preferred products

• Harvoni
• Ledipasvir/Sofosbuvir

Initial criteria

• The patient has a diagnosis of hepatitis C genotype 1, 2, 3, 4, 5, or 6
• The prescriber has provided the patient’s baseline HCV RNA level if the patient has genotype 1
• ONE of the following: the 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 the patient for current or prior hepatitis B infection and will monitor for HBV reactivation if positive
• The patient’s age is within FDA labeling for the requested indication OR there is support for use for the requested age
• Step therapy requirement: if preferred agents for the patient’s specific factors exist, one of the following must apply: (a) the requested agent is preferred, OR (b) patient treated with requested non-preferred agent in past 30 days, OR (c) patient intolerance or hypersensitivity to all preferred agents, OR (d) FDA labeled contraindication to all preferred agents, OR (e) appropriate clinical support for use of non-preferred agent
• ONE of the following: prescriber is a specialist (gastroenterologist, hepatologist, infectious disease) or has consulted with one OR (patient is treatment naive AND does not have cirrhosis or has compensated cirrhosis AND requested agent supported in AASLD guidelines for simplified treatment AND patient meets all AASLD simplified-treatment eligibility)
• Patients eligible for simplified treatment must: be adults with chronic HCV (any genotype, including HIV), no prior HCV treatment, and without cirrhosis or with compensated cirrhosis (Child-Pugh A) as established by diagnostic criteria; patients excluded if have prior HCV treatment, HB surface antigen positive, end-stage renal disease (eGFR<30), decompensated cirrhosis (Child-Pugh≥7), pregnancy, hepatocellular carcinoma, or prior liver transplantation
• The patient has no FDA labeled contraindications to the requested agent
• The requested regimen and duration align with FDA labeling or AASLD/IDSA guideline tables for decompensated cirrhosis

Approval duration

up to duration of treatment per Tables 1 or 2