Vosevi — Blue Cross Blue Shield of Alabama

Initial criteria

• The patient has an FDA labeled diagnosis for the requested agent AND the requested agent is FDA labeled for treatment of the patient's genotype
• If the patient has an FDA labeled indication, one of the following: • The patient’s age is within FDA labeling for the requested indication • OR there is support for the use of the requested agent for the patient’s age for the requested indication
• If FDA labeling for the requested agent requires patients are tested for hepatitis B viral (HBV) infection prior to starting treatment, BOTH of the following must apply: • The prescriber has screened the patient for current or prior HBV • AND if screening was positive, the prescriber will monitor the patient for HBV flare-up or reactivation during and after treatment
• The patient does not have any FDA labeled contraindications to the requested agent
• One of the following: • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist, hepatologist, infectious disease) or has consulted such specialist • OR all of the following: patient is treatment naive, does not have cirrhosis or has compensated cirrhosis, the requested agent is supported in AASLD guidelines for simplified treatment, and the patient meets AASLD simplified treatment qualifications
• If the client has preferred agent(s) for the patient’s specific factors (e.g., age, genotype, cirrhosis status, treatment status, previous treatment), one of the following must apply: • The requested agent is a preferred agent • OR the patient has been treated with the requested non-preferred agent in the past 30 days • OR the patient has intolerance or hypersensitivity to all preferred agents • OR the patient has an FDA labeled contraindication to all preferred agents • OR there is clinical information supporting the use of the requested non-preferred agent over preferred agent(s)
• The patient meets all requirements and will use the requested agent in a treatment regimen noted in Table 11 (FDA labeling)
• The requested length of therapy does not exceed the duration noted in Table 11

Approval duration

up to treatment duration per FDA labeling (Table 11)