Sovaldi (sofosbuvir) — Blue Cross Blue Shield of Montana

Preferred products

• Epclusa (sofosbuvir/velpatasvir)
• Mavyret (glecaprevir/pibrentasvir)
• Zepatier (elbasvir/grazoprevir)

Initial criteria

• The patient has an intolerance or hypersensitivity to BOTH Epclusa and Mavyret OR the patient has an FDA labeled contraindication to BOTH Epclusa and Mavyret OR BOTH Epclusa and Mavyret are expected to be ineffective, cause significant barriers to adherence or worsen a comorbid condition, or cause harm OR BOTH Epclusa and Mavyret are not in the best interest of the patient based on medical necessity OR there is support for the use of the requested agent over BOTH Epclusa and Mavyret (e.g., the patient is currently taking the requested agent) [chart notes required]
• ONE of the following: (A) Treatment naïve OR (B) Previously treated with only peg-interferon and ribavirin OR (C) Adult diagnosed with hepatocellular carcinoma secondary to chronic hepatitis C genotype 1–4 OR (D) Adult with hepatitis C genotype 1–4 meeting specific treatment naive/experienced definitions and preferred-agent criteria exceptions
• If preferred agents apply, the patient has met one of the following: (A) Plan type exemption, (B) Previously treated with non-preferred agent in past 30 days, (C) Currently stable on non-preferred agent, (D) Inadequate response to ALL preferred agents, (E) Discontinued ALL preferred agents due to lack of efficacy or adverse event, (F) Intolerance or hypersensitivity to ALL preferred agents, (G) Contraindication to ALL preferred agents, (H) ALL preferred agents expected ineffective or unsafe, (I) ALL preferred agents not in the patient’s best medical interest, (J) Tried another drug in same class discontinued due to lack of efficacy or adverse event, or (K) Support for use of the requested non-preferred agent over preferred agent(s)
• The prescriber has screened for current or prior hepatitis B viral (HBV) infection AND will monitor for HBV flare-up or reactivation if positive
• Prescriber is a specialist in gastroenterology, hepatology, or infectious disease, or has consulted with one OR fulfills simplified HCV treatment criteria per AASLD guidelines (treatment naive, without or with compensated cirrhosis Child-Pugh A, meets simplified treatment qualifications)
• The patient does NOT have any FDA labeled contraindications to the requested agent
• The patient will use the requested agent in a regimen noted in Table 6 or 7 (FDA labeling)
• The requested length of therapy does NOT exceed FDA-labeled duration

Approval duration

6 months (BCBSIL and BCBSMT); otherwise up to duration of treatment per FDA labeling (≥12 weeks BCBSNM); 12 months for Ohio-specific criteria