Sovaldi (sofosbuvir) — Blue Cross Blue Shield of Texas

Initial criteria

• The patient meets all criteria above for hepatitis C DAA use including specialist involvement or consultation, HBV screening and monitoring if positive, and absence of FDA labeled contraindications
• The requested agent and regimen are consistent with Tables 6 and 7 (FDA labeling): appropriate genotype, treatment-naive or treatment-experienced status, presence or absence of cirrhosis, interferon eligibility status, and specific duration requirements
• Treatment-naive or treatment-experienced patients must follow approved combinations (e.g., Sovaldi + peg-interferon alfa + ribavirin for genotype 1 or 4, 12 weeks; Sovaldi + ribavirin 24 weeks if interferon-ineligible; Sovaldi + ribavirin 12 or 24 weeks for genotypes 2 or 3 as applicable; Sovaldi + ribavirin up to 48 weeks for transplant candidates)
• Pediatric patients age ≥ 3 years may receive Sovaldi + ribavirin per labeling for genotypes 2 or 3 for 12–24 weeks
• For members residing in Ohio (Fully Insured or HIM Shop), additional coverage may be approved if patient has another FDA labeled indication, compendia-supported indication, or at least two peer-reviewed journal articles support use as generally safe and effective

Approval duration

6 months (BCBSIL/BCBSMT); otherwise up to labeled treatment duration per FDA (at least 12 weeks for BCBSNM); 12 months for Ohio exceptions