Skip to main content
Shop Plans Learn more about our coverage options including health, Medicare, dental and vision options for you, your family or your employees. Get Started Individual & Family Medicare Employer Vision Dental International Travel Find Care FAQ Blog Members Stay on top of your health care with helpful member resources. Members Home Medicare Health Dental Vision Find Care Member Knowledge Center Member Forms Medicare Forms Library Make a Payment Federal Employees Student Blue Healthy Blue Providers Access tools, policies and the latest information to help you care for our members. Providers Home Network Participation Networks & Programs Claims, Appeals & Inquiries Prior Authorization Services & CPT codes Prescription Drug Search Policies, Guidelines & Codes Provider News Provider FAQ Contact Us Employers Learn about our coverage options for small and large employers, and access tools and resources for your group. Employers Home Shop Employer Plans Employer Portal Support Member Forms & Resources Find Care Blog Agents Access the tools you need: rate quotes, applications, forms, the latest industry news, marketing materials and more. Agents Home Agent Services Check Eligibility Find Care Member Forms & Resources Medicare Forms Library
Contact Us
Log In
I am ... Please select A member A provider An employer An agent
Log in to Agent Services
Log in to Employer Services Register for Employer Services I'm registered but need portal access
Username Forgot username? Continue to Log In Register for Blue Connect Need help? Learn how to log in.
Log in to Blue e Register for Blue e Log in to Dental Blue
Back
Harvoni, ledipasvir/sofosbuvir Prior Authorization Criteria - Medicare Part D

Utilization Management Policy

Last Review: 01/01/2024
Prior Authorization Criteria for Approval

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:

        A. The requested medication is the preferred medication: Harvoni

OR

        B. The requested medication is the non-preferred medication: ledipasvir/sofosbuvir AND ONE of the following:

            i. There is evidence of a claim that the patient has been treated with the requested medication within the past 90 days

OR

            ii. The prescriber states the patient has been treated with the requested medication within the past 90 days

OR

            iii. The patient has an FDA labeled contraindication or hypersensitivity to TWO preferred medications (Epclusa and Harvoni) for supported genotypes

OR

            iv. 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.