Harvoni, ledipasvir/sofosbuvir Prior Authorization Criteria - Medicare Part D

The following products are included in this PA program (formulary specific):

Enhanced and MAPD formularies: Harvoni, ledipasvir/sofosbuvir

Basic formulary: Harvoni

Harvoni and ledipasvir/sofosbuvir will be approved when ALL of the following are met: 

1. The patient has a diagnosis of hepatitis C confirmed by serological markers 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 
7. ONE of the following: 
   1. The requested medication is the preferred medication: Harvoni OR 
   2. The requested medication is the non-preferred medication: ledipasvir/sofosbuvir AND ONE of the following:
      1. There is evidence of a claim that the patient has been treated with the requested medication within the past 90 days OR
      2. The prescriber states the patient has been treated with the requested medication within the past 90 days OR
      3. The patient has an FDA labeled contraindication or hypersensitivity to TWO preferred medications (Epclusa and Harvoni) for supported genotypes OR
      4. The prescriber has provided information based on FDA approved labeling or AASLD/IDSA guidelines supporting the use of the non-preferred medication for the patient’s diagnosis and genotype over TWO preferred medications (Epclusa and Harvoni) for supported genotypes

Length of Approval: 8 - 24 weeks as determined by FDA labeling or supported in AASLD/IDSA guidelines: https://www.hcvguidelines.org/