Harvoni (ledipasvir/sofosbuvir) — Blue Cross Blue Shield of Montana

Preferred products

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

Initial criteria

• Patient has a diagnosis of hepatitis C genotype 1, 2, 3, 4, 5, or 6 AND
• If the patient has an FDA labeled indication, ONE of the following: A. Patient’s age is within FDA labeling for the requested indication OR B. There is support for use in patient’s age for the requested indication AND
• Prescriber has screened the patient for current or prior hepatitis B viral (HBV) infection AND
• If HBV screening positive, prescriber will monitor for HBV flare-up or reactivation during and after treatment AND
• If client has preferred agents for the patient’s specific factors, ONE of the following: A. Request is for BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR B. Requested agent is preferred for patient’s factors OR C. Patient has been treated with the non-preferred agent in the past 30 days OR D. Patient is currently being treated and stable on the non-preferred agent [chart notes required] OR E. Patient has tried and had inadequate response to ALL preferred agents [chart notes required] OR F. Preferred agents discontinued due to lack of efficacy or adverse event [chart notes required] OR G. Patient has intolerance or hypersensitivity to ALL preferred agents [chart notes required] OR H. Patient has FDA labeled contraindication to ALL preferred agents [chart notes required] OR I. Preferred agents expected to be ineffective or cause adherence barrier, worsen comorbid condition, or cause functional harm [chart notes required] OR J. Preferred agents not in best interest of patient based on medical necessity [chart notes required] OR K. Patient has tried another drug in the same class as all preferred agents and discontinued due to lack of efficacy or adverse event [chart notes required] OR L. Prescriber provides clinical information supporting use of non-preferred agent AND
• ONE of the following: A. Prescriber is a specialist (e.g., gastroenterologist, hepatologist, or infectious disease) or has consulted with a specialist OR B. ALL of the following: 1. Patient is treatment naive 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 AASLD guidelines simplified treatment
• Patient has not been previously treated with the requested agent AND
• Patient does NOT have any FDA labeled contraindications to the requested agent AND
• Patient meets all requirements and will use the agent in a regimen noted in Table 5 (FDA labeling) AND
• Requested length of therapy does not exceed Table 5 duration

Approval duration

6 months (BCBSIL and BCBSMT) or per FDA Table 5; at least 12 weeks for BCBSNM