Ledipasvir/Sofosbuvir — Blue Cross Blue Shield of Texas

Initial criteria

• The patient has a diagnosis of hepatitis C genotype 1, 2, 3, 4, 5, or 6 AND
• If genotype 1, the prescriber has provided the patient’s subtype AND
• The patient is NOT treatment naive AND
• The patient has NOT been previously treated with the requested agent 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 for the requested agent OR (B) There is support for use of the requested agent for the patient’s age for the requested indication AND
• The prescriber has screened the patient for current or prior hepatitis B viral (HBV) infection AND
• If the screening for HBV was positive, the prescriber will monitor for HBV flare-up or reactivation during and after treatment AND
• If client has preferred agent(s) for the patient’s specific factors, then ONE of A–M conditions relating to preference, prior use, intolerance, contraindication, or medical necessity is met AND
• ONE of the following: (A) The prescriber is a specialist (gastroenterologist, hepatologist, infectious disease) or has consulted with one OR (B) The patient meets AASLD simplified treatment qualifications (treatment naive, no or compensated cirrhosis, etc.) AND
• The patient does NOT have any FDA labeled contraindications to the requested agent AND
• The patient meets all requirements and will use the requested agent in a regimen noted in Table 9 AND
• The requested length of therapy does NOT exceed the length of therapy noted in Table 9

Approval duration

6 months (BCBSIL and BCBSMT); up to duration of treatment per Table 9 for all other plans (≥12 weeks for BCBSNM)