Sovaldi (sofosbuvir) — Blue Cross Blue Shield of New Mexico

Preferred products

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

Initial criteria

• 1. The patient has a diagnosis of hepatitis C genotype 1, 2, 3, 4, 5, or 6 AND
• 2. If the patient has an FDA labeled indication, then ONE of the following: (A) The patient’s age is within FDA labeling for the requested indication for the requested agent OR (B) There is support for the use of the requested agent for the patient’s age for the requested indication AND
• 3. The prescriber has screened the patient for current or prior hepatitis B viral (HBV) infection AND
• 4. If the screening for HBV was positive for current or prior HBV infection, the prescriber will monitor the patient for HBV flare-up or reactivation during and after treatment with the requested agent AND
• 5. If the client has preferred agent(s) for the patient’s specific factors, then ONE of the following: (A) The request is for a BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR (B) The requested agent is a preferred agent for the patient’s specific factors OR (C) The patient has been treated with the requested non-preferred agent in the past 30 days OR (D) The patient is currently being treated with the requested non-preferred agent and stable [chart notes required] OR (E) The patient has tried and had inadequate response to ALL preferred agents [chart notes required] OR (F) ALL preferred agents discontinued due to lack of efficacy/effectiveness/adverse event [chart notes required] OR (G) The patient has intolerance/hypersensitivity to ALL preferred agents [chart notes required] OR (H) The patient has FDA labeled contraindication to ALL preferred agents [chart notes required] OR (I) ALL preferred agents expected to be ineffective or cause significant barrier/harms [chart notes required] OR (J) ALL preferred agents not in best interest based on medical necessity [chart notes required] OR (K) The patient has tried another prescription drug in same class as ALL preferred agents and discontinued due to lack of efficacy/effectiveness/adverse event [chart notes required] OR (L) The prescriber provides clinical support for use of requested non-preferred agent over preferred agents AND
• 6. ONE of the following: (A) The prescriber is a specialist in gastroenterology, hepatology, or infectious disease, or has consulted with one 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 supported in AASLD guidelines for simplified treatment AND (4) Patient meets all AASLD guideline simplified treatment criteria
• 7. The patient has not been previously treated with the requested agent AND
• 8. The patient does NOT have any FDA-labeled contraindications to the requested agent AND
• 9. The patient meets all requirements and will use the requested agent within a treatment regimen per FDA labeling Table 5 AND
• 10. The requested length of therapy does not exceed the FDA-labeled regimen duration
• Additional criteria for members residing in Ohio (Fully Insured or HIM Shop): (1) The member resides in Ohio AND (2) Plan is Fully Insured or HIM Shop (SG) AND BOTH (A) The patient does not have any FDA contraindications AND (B) ONE of: another FDA labeled indication OR indication supported in compendia OR two peer-reviewed journal articles demonstrating safety and efficacy (journals required)
• Sovaldi pediatric criteria: (1) Pediatric hepatocellular carcinoma secondary to chronic HCV genotype 2 or 3 OR (2) Pediatric hepatitis C genotype 2 or 3 meeting age/FDA labeling criteria AND step therapy exceptions as outlined (BCBS IL membership categories, stabilization on non-preferred agent, etc.)

Approval duration

BCBSIL/BCBSMT:6 months; BCBSNM:≥12 weeks; Other plans:duration per FDA labeling; Ohio plans:12 months