Prior Authorization Criteria for Approval

Mavyret will be approved when ALL of the following are met:

1. ONE of the following:
   1. The patient has a diagnosis of hepatitis C confirmed by serological markers
      OR
   2. The patient is a hepatitis C virus (HCV) - uninfected solid organ transplant recipient AND BOTH of the following:
      1. The patient received an HCV - viremic donor organ
         AND
      2. The requested medication is being used for prophylaxis
         AND
2. The prescriber has screened the patient for current or prior hepatitis B viral (HBV) infection and if positive, will monitor the patient for HBV flare-up or reactivation during and after treatment with the requested medication
   AND
3. The requested medication will be used in a treatment regimen and length of therapy that is supported in FDA approved labeling or AASLD/IDSA guidelines for the patient’s diagnosis and genotype
   AND
4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist, hepatologist, or infectious disease) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND
5. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND
6. The requested dose is within FDA labeled dosing or supported in AASLD/IDSA guideline dosing for the requested indication

Length of Approval: 8-16 weeks based on FDA approved labeling or supported in AASLD/IDSA guidelines: https://www.hcvguidelines.org/