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

Preferred products

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

Initial criteria

• Patient is treatment naive OR previously treated only with peginterferon and ribavirin with or without an HCV protease inhibitor
• If patient has FDA approved indication, patient’s age is within FDA labeling for the requested indication OR there is support for agent use for that age and indication
• Prescriber has screened patient for current or prior hepatitis B infection
• If HBV screening positive, prescriber will monitor for HBV flare-up or reactivation during and after treatment
• If client has preferred agent(s) for the patient’s factors (e.g., age, genotype, cirrhosis status, treatment-naive/treatment-experienced), then ONE of the following holds: 1. Request is for BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR 2. Patient has been treated with the requested non-preferred agent in the past 30 days OR 3. Patient is currently stable on the requested agent OR 4. Patient has tried and had inadequate response to ALL preferred agent(s) OR 5. ALL preferred agent(s) were discontinued due to lack of efficacy/effectiveness/adverse events OR 6. Patient has intolerance/hypersensitivity to ALL preferred agent(s) OR 7. Patient has FDA labeled contraindication to ALL preferred agent(s) OR 8. ALL preferred agent(s) expected to be ineffective or cause adherence barrier/ worsen comorbidity/adverse reaction/physical or mental harm OR 9. ALL preferred agent(s) not in best interest based on medical necessity OR 10. Patient tried another drug in same class or mechanism as ALL preferred agents and it was discontinued due to poor efficacy/adverse event OR 11. There is support for use of requested non-preferred agent over preferred agent(s)
• Prescriber is a hepatology/gastroenterology/infectious disease specialist or has consulted one OR ALL of: - Patient is treatment-naive - Patient has no cirrhosis or compensated cirrhosis - Requested agent is supported in AASLD guidelines for simplified treatment - Patient meets AASLD simplified treatment eligibility (HBsAg negative, not pregnant, no HCC, no prior liver transplant; if with compensated cirrhosis, also no decompensation, eGFR ≥30 mL/min/m²)
• Patient does not have any FDA labeled contraindications to requested agent
• Patient will use requested agent as per FDA labeling (Table 10) and requested therapy length does not exceed labeled duration

Approval duration

6 months (BCBSIL, BCBSMT) or up to treatment duration per FDA labeling (min 12 weeks for BCBSNM); 12 months for Ohio Fully Insured or HIM Shop plans