Coverage Decisions for Drugs

Direct-acting Antivirals for Hepatitis C


Coverage decision

The department or insurer covers direct-acting antivirals for Hepatitis C with prior authorization when the condition is accepted and all coverage criteria below are met. In addition, coverage is limited to FDA indications and dosing recommendations. The FDA has approved the following direct-acting antivirals:

Product Description
Epclusa® Sofosbuvir/velpatasvir* for decompensated cirrhosis
Daklinza® Daclatasvir
Harvoni® Ledipasvir/sofosbuvir
Mavyret® Glecaprevir/pibrentasvir*
Olysio® Simeprevir
Sovaldi® Sofosbuvir
Technivie® Ombitasvir/paritaprevir/ritonavir
Viekira Pak/XR® Ombitasvir/paritaprevir/ritonavir/dasabuvir
Vosevi® Sofosbuvir/velpatasvir/voxilaprevir* for FDA-approved indications
Zepatier® Grazoprevir/Elbasvir/

*Preferred agents in this drug class effective January 1, 2018.

 

Criteria for Coverage

  1. Patient has chronic hepatitis C infection as defined by:
  • A liver fibrosis score ≥ F1 and a detectable and quantifiable HCV RNA (> 15 international units/ml) test within the last 12 months; OR
  • A liver fibrosis score < F1; AND
    • A positive (reactive) HCV antibody test that is at least 6 months old; and a detectable and quantifiable HCA RNA (> 15 international units/ml) 6 months after date of positive HCV antibody test; OR
    • Two detectable and quantifiable HCV RNA (> 15 international units/ml) tests at least 6 months apart; AND
  1. Prescriber is:
  • A specialist in one of the following areas:

    Exceptions may be made for other specialties or non-specialist providers who work in coordination with an organized system of care, have received training in hepatitis C diagnosis, staging and treatment protocols, and have ready access to specialists that treat.
    • Gastroenterologist
    • Hepatologist
    • HIV
    • Infectious disease; OR
  • Prescriber is participating with Project ECHO or consulting with one of the specialists listed above (requires consultation note or documentation of phone call); AND
  1. Required documentation and lab tests:
  • HCV antibody test administered at least 6 months before request for treatment
  • HCV genotype
  • HCV RNA viral load
  • Laboratory tests (e.g. APRI score or FibroSure) to determine liver fibrosis staging are required to ensure the appropriate treatment regimen is used (e.g. patients with cirrhosis require longer treatment). Liver staging test results must be less than 2 years old;
    • For patients with cirrhosis, there must be documentation of patients’ status: compensated, currently decompensated, or has had previous episodes of decompensation.
  1. Patients with the following conditions are not eligible for HCV treatment until the condition is resolved:
  • Taking medications that are contraindicated or have a severe drug interaction with the prescribed HCV treatment
  • Are pregnant or planning on becoming pregnant
  • Have severe end organ disease and are not eligible for transplant (e.g. heart, lung, kidney)
  • Have decompensated liver disease with CPT >12 or MELD > 20
  • Have a clinically significant illness or any other major medical disorder that may interfere with patients’ ability to complete a course of treatment
  • Primary treating clinician’s judgement that HCV treatment would not achieve long term clinical benefit (e.g. patients with multisystem organ failure or receiving palliative care; have significant pulmonary or cardiac disease; and have malignancy outside of the liver not meeting oncologic criteria for cure)
  • Have a MELD < 20 and one of the following:
    • Cardiopulmonary disease that cannot be corrected and is a prohibitive risk for surgery
    • Malignancy outside the liver not meeting oncologic criteria for cure
    • Hepatocellular carcinoma with metastatic spread
    • Intrahepatic cholangiocarcinoma
    • Hemangiosarcoma
    • Uncontrolled sepsis 
  1. Retreatment:
  • Re-treatment after failure of an interferon-based treatment will be approved based on AASLD guidelines unless listed in the exceptions section.
  • Re-treatment after failure of an all-DAA regimen: All cases will be considered individually
  • Must provide documentation of prior treatment regimen including length, response and date of treatment:
  • Lab reports documenting the presence or absence of resistant mutations
  • Re-treatment cannot be with a regimen containing a drug that patients have failed or relapsed on:
    • Patients who failed a regimen containing an NS3/4A protease inhibitor (boceprevir, telaprevir, simeprevir or paritaprevir) should not be re-treated with a regimen containing one of these agents. Ledipasvir/sofosbuvir may be suitable for retreatment in such cases unless contraindicated.

 

Quantity and Dispensing Limits

Approved antiviral regimens may be limited to 7 days or 14 days supply with the initial dispensing and up to 28 days for ongoing treatment.

For more information:

Washington Health Care Authority (HCA): Hepatitis C Treatment Policy
Prior Authorization Form
Contact information.

 

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