Sovaldi (sofosbuvir) — Blue Cross Blue Shield of Kansas

Preferred products

• Epclusa (sofosbuvir/velpatasvir)
• Harvoni (ledipasvir/sofosbuvir)
• Ledipasvir/Sofosbuvir
• Mavyret (glecaprevir/pibrentasvir)
• Vosevi (sofosbuvir/velpatasvir/voxilaprevir)
• Zepatier (elbasvir/grazoprevir)

Initial criteria

• ONE of the following:
• A. Pediatric patient with hepatocellular carcinoma secondary to chronic hepatitis C genotype 2 or 3 AND if FDA labeled indication: ONE of the following:
• 1. Age is within FDA labeling for the requested agent for the requested indication OR
• 2. There is support for use of the requested agent for the patient’s age for the requested indication
• OR
• B. Pediatric patient with hepatitis C genotype 2 or 3 AND ALL of the following:
• 1. If patient has FDA labeled indication, ONE of the following:
• A. Age is within FDA labeling OR
• B. There is support for using the requested agent for the patient’s age for the requested indication AND
• 2. ONE of the following:
• A. Intolerance or hypersensitivity to BOTH Epclusa and Mavyret OR
• B. FDA labeled contraindication to BOTH Epclusa and Mavyret OR
• C. Support for use of requested agent over BOTH Epclusa and Mavyret (e.g., currently taking the requested agent) AND
• 3. ONE of the following:
• A. Treatment naïve OR
• B. Previously treated only with peg-interferon and ribavirin
• OR
• C. Adult with hepatocellular carcinoma secondary to chronic hepatitis C genotype 1, 2, 3, or 4
• OR
• D. Adult with hepatitis C genotype 1, 2, 3, or 4 AND BOTH of the following:
• 1. ONE of the following:
• A. Treatment naïve OR
• B. Previously treated only with peg-interferon and ribavirin AND
• 2. If the client has preferred agent(s) for the patient’s specific factors (age, genotype, cirrhosis status, treatment naïve vs experienced, previous treatment), ONE of the following:
• A. Patient treated with requested non-preferred agent in the past 30 days OR
• B. Intolerance or hypersensitivity to ALL preferred agents OR
• C. FDA labeled contraindication to ALL preferred agents OR
• D. Support for use of requested non-preferred agent over preferred agent(s)
• AND
• Prescriber has screened patient for current or prior hepatitis B infection AND if positive, will monitor for HBV flare-up/reactivation during and after therapy
• AND
• ONE of the following:
• A. Prescriber is a specialist (gastroenterologist, hepatologist, infectious disease) or has consulted with a specialist OR
• B. ALL of the following:
• 1. Patient is treatment naïve AND
• 2. Patient does NOT have cirrhosis or has compensated cirrhosis AND
• 3. Requested agent is supported in AASLD guidelines for simplified treatment AND
• 4. Patient meets all qualifications for simplified treatment (infected with any genotype, not previously treated, without cirrhosis or with compensated cirrhosis per criteria, and exclusions as listed)
• AND
• No FDA labeled contraindications to the requested agent
• AND
• Patient meets all regimen requirements in Table 6 or 7 (FDA labeling) AND requested duration does not exceed FDA labeling

Approval duration

up to duration of treatment per FDA labeling (Table 6 or 7)