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Sovaldi (sofosbuvir) — Blue Cross Blue Shield of Montana

hepatitis C genotype 3

Preferred products

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

Initial criteria

  • 1. The patient has a diagnosis of hepatitis C genotype 1, 2, 3, 4, 5, or 6 AND
  • 2. ONE of the following:
  • A. The patient is treatment naive OR
  • B. The patient was previously treated with ONLY peginterferon and ribavirin with or without an HCV protease inhibitor OR
  • C. The patient has decompensated cirrhosis AND
  • 3. 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 [medical records required] AND
  • 4. The prescriber has screened the patient for current or prior hepatitis B viral (HBV) infection AND
  • 5. If the screening for HBV was positive, the prescriber will monitor for HBV flare-up or reactivation during and after treatment AND
  • 6. If the client has preferred agent(s) for the patient’s specific factors (e.g., age, genotype, cirrhosis, treatment history), 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 stable on the requested non-preferred agent [chart notes required] OR
  • E. The patient has tried and had an inadequate response to ALL preferred agents [chart notes required] OR
  • F. ALL preferred agents were discontinued due to lack of efficacy/effectiveness/adverse event [chart notes required] OR
  • G. The patient has an intolerance or hypersensitivity to ALL preferred agents [chart notes required] OR
  • H. The patient has an FDA-labeled contraindication to ALL preferred agents [chart notes required] OR
  • I. ALL preferred agents are expected to be ineffective or not in the patient’s best interest [chart notes required] OR
  • J. There is clinical support for the use of the requested non-preferred agent over the preferred agent(s) AND
  • 7. ONE of the following:
  • A. The prescriber is a specialist in the area of the patient’s diagnosis (gastroenterologist, hepatologist, or infectious disease), or has consulted with such specialist OR
  • B. ALL of the following:
  • 1. The patient is treatment naive AND
  • 2. The patient does NOT have cirrhosis or has compensated cirrhosis AND
  • 3. The requested agent is supported in AASLD guidelines for simplified treatment AND
  • 4. The patient meets all qualifications for AASLD guidelines simplified treatment (per eligibility/exclusion tables) 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 in a treatment regimen noted in Table 1 (FDA labeling) or Table 2 (AASLD/IDSA guidelines for decompensated cirrhosis) AND
  • 10. The requested length of therapy does NOT exceed the length of therapy noted in Table 1 or 2 for the patient’s treatment regimen

Approval duration

6 months