Ledipasvir/Sofosbuvir — Blue Cross Blue Shield of Texas

Preferred products

• Epclusa (sofosbuvir/velpatasvir)
• Mavyret (glecaprevir/pibrentasvir)

Initial criteria

• Prescriber will monitor the patient for HBV flare-up or reactivation during and after treatment if screening for HBV was positive for current or prior HBV infection
• Patient has an FDA labeled indication for the requested agent or there is support for use based on the patient's age and indication
• If client has preferred agents for patient’s specific factors (e.g., age, genotype, cirrhosis status, treatment naive vs treatment experienced, previous treatment), then ONE of the following applies: request is for a BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR the requested agent is a preferred agent OR patient has been treated with the requested non-preferred agent in past 30 days OR patient is currently stable on non-preferred agent OR inadequate response to all preferred agents OR discontinuation of all preferred agents due to lack of efficacy/effectiveness/adverse event OR intolerance/hypersensitivity to all preferred agents OR FDA labeled contraindication to all preferred agents OR all preferred agents expected to be ineffective or cause significant barrier/adverse reaction/functional harm OR all preferred agents not in the best interest of the patient based on medical necessity OR patient has tried another drug in the same pharmacologic class as all preferred agents and discontinued due to lack of efficacy or adverse event OR there is support for the use of the requested non-preferred agent over preferred agents
• Prescriber is a specialist in gastroenterology, hepatology, or infectious disease, or has consulted with such specialist OR patient meets all AASLD simplified treatment criteria (treatment naive, no or compensated cirrhosis, supported in guidelines, qualifies per simplified HCV treatment tables)
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Patient meets all treatment regimen requirements in Table 3 (FDA labeling) or Table 4 (AASLD/IDSA guidelines for decompensated cirrhosis)
• Requested length of therapy does NOT exceed duration in Table 3 or 4

Approval duration

6 months (BCBSIL, BCBSMT) or up to treatment duration as per Table 3/4 (≥12 weeks for BCBSNM)