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

Preferred products

• Harvoni (ledipasvir/sofosbuvir)
• Ledipasvir/Sofosbuvir

Initial criteria

• The patient has a diagnosis of hepatitis C genotype 1, 2, 3, 4, 5, or 6 AND
• 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
• 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 OR (B) There is support for the use at the patient’s age [medical records required] AND
• The prescriber has screened the patient for current or prior hepatitis B viral (HBV) infection AND
• If HBV screening was positive, the prescriber will monitor for HBV flare-up or reactivation during and after HCV treatment AND
• If the client has preferred agent(s) for the patient’s specific factors (e.g., age, genotype, cirrhosis status, treatment status), then ONE of the following: (A) Request meets plan-specific member category OR (B) Requested agent is a preferred agent OR (C) Patient was treated with requested non-preferred agent in past 30 days OR (D) Patient is currently stable on requested non-preferred agent [chart notes required] OR (E) 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 or adverse event [chart notes required] OR (G) Patient has intolerance or hypersensitivity to ALL preferred agents [chart notes required] OR (H) Patient has an FDA labeled contraindication to ALL preferred agents [chart notes required] OR (I) ALL preferred agents expected to be ineffective or cause adherence or health issues [chart notes required] OR (J) ALL preferred agents not in best interest of patient based on medical necessity [chart notes required] OR (K) Patient tried another drug in the same class and discontinued due to lack of efficacy or adverse event [chart notes required] OR (L) Clinical support exists for use of the non-preferred agent over preferred agents AND
• ONE of the following: (A) Prescriber is a specialist (gastroenterologist, hepatologist, or infectious disease) or has consulted with one OR (B) ALL of the following: patient is treatment naive, without cirrhosis or with compensated cirrhosis, requested agent supported in AASLD guidelines for simplified treatment, and patient meets all simplified treatment qualifications AND
• The patient does NOT have FDA labeled contraindications to the requested agent AND
• 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
• The requested length of therapy does NOT exceed the duration noted in Table 1 or Table 2

Approval duration

6 months (BCBSIL and BCBSMT); ≥12 weeks (BCBSNM); up to duration of treatment as per Tables 1 or 2 for others