WHA

Zepatier (elbasvir/grazoprevir)

Indications for Prior Authorization

Zepatier (elbasvir/grazoprevir)
  • For diagnosis of Chronic Hepatitis C (CHC)
    Indicated with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg.

Criteria

Zepatier

*NS5A resistance-associated polymorphisms at amino acid positions 28, 30, 31, or 93.

Prior Authorization

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1a: treatment-naïve or PegIFN/RBV-experienced or PegIFN/RBV/protease inhibitor-experienced WITHOUT baseline NS5A polymorphisms*

  • Diagnosis of chronic hepatitis C genotype 1a
    • AND
  • One of the following:
    • Patient is 12 years of age or older
    • Patient weight is at least 30 kg
    AND
  • One of the following:
    • Patient is treatment-naive
      • OR
    • Patient has prior failure to peginterferon alfa plus ribavirin treatment
      • OR
    • Both of the following:
      • Patient has prior failure to treatment with peginterferon alfa plus ribavirin plus a HCV NS3/4A protease inhibitor (e.g., boceprevir, simeprevir, or telaprevir)
      • Used in combination with ribavirin
    AND
  • Both of the following: [1, A]
    • Patient has been tested for the presence of NS5A resistance-associated polymorphisms
      • AND
    • Patient is without baseline NS5A resistance-associated polymorphisms (i.e., polymorphisms at amino acid positions 28, 30, 31, or 93)
    AND
  • Prescribed by or in consultation with one of the following:
    • Hepatologist
    • Gastroenterologist
    • Infectious disease specialist
    • HIV specialist certified through the American Academy of HIV Medicine
    AND
  • Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
    • AND
  • Patient does not have moderate to severe hepatic impairment (e.g., Child-Pugh Class B or C) [B]
    • AND
  • One of the following:
    • Both of the following:
      • Trial and failure, intolerance, or contraindication to ONE of the following:
        • Epclusa (sofosbuvir/velpatasvir)
        • Harvoni (ledipasvir/sofosbuvir)
        AND
      • Trial and failure, contraindication, or intolerance to Mavyret (glecaprevir/pibrentasvir)
      OR
    • For continuation of prior Zepatier (elbasvir/grazoprevir) therapy
Zepatier

*NS5A resistance-associated polymorphisms at amino acid positions 28, 30, 31, or 93.

Prior Authorization

Length of Approval: 16 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1a: treatment-naïve or PegIFN/RBV-experienced or PegIFN/RBV/protease inhibitor-experienced WITH baseline NS5A polymorphisms*

  • Diagnosis of chronic hepatitis C genotype 1a
    • AND
  • One of the following:
    • Patient is 12 years of age or older
    • Patient weight is at least 30 kg
    AND
  • One of the following:
    • Patient is treatment-naive
    • Patient has prior failure to peginterferon alfa plus ribavirin treatment
    • Patient has prior failure to treatment with peginterferon alfa plus ribavirin plus a HCV NS3/4A protease inhibitor (e.g., boceprevir, simeprevir, or telaprevir)
    AND
  • Both of the following: [1, A]
    • Patient has been tested for the presence of NS5A resistance-associated polymorphisms
      • AND
    • Patient has baseline NS5A resistance-associated polymorphisms (i.e., polymorphisms at amino acid positions 28, 30, 31, or 93)
    AND
  • Used in combination with ribavirin
    • AND
  • Prescribed by or in consultation with one of the following:
    • Hepatologist
    • Gastroenterologist
    • Infectious disease specialist
    • HIV specialist certified through the American Academy of HIV Medicine
    AND
  • Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
    • AND
  • Patient does not have moderate to severe hepatic impairment (e.g., Child-Pugh Class B or C) [B]
    • AND
  • One of the following:
    • Both of the following:
      • Trial and failure, intolerance, or contraindication to ONE of the following:
        • Epclusa (sofosbuvir/velpatasvir)
        • Harvoni (ledipasvir/sofosbuvir)
        AND
      • Trial and failure, contraindication, or intolerance to Mavyret (glecaprevir/pibrentasvir)
      OR
    • For continuation of prior Zepatier (elbasvir/grazoprevir) therapy
Zepatier

Prior Authorization

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1b: treatment-naïve or PegIFN/RBV-experienced or PegIFN/RBV/protease inhibitor-experienced

  • Diagnosis of chronic hepatitis C genotype 1b
    • AND
  • One of the following:
    • Patient is 12 years of age or older
    • Patient weight is at least 30 kg
    AND
  • One of the following:
    • Patient is treatment-naive
      • OR
    • Patient has prior failure to peginterferon alfa plus ribavirin treatment
      • OR
    • Both of the following:
      • Patient has prior failure to treatment with peginterferon alfa plus ribavirin plus a HCV NS3/4A protease inhibitor (e.g., boceprevir, simeprevir, or telaprevir)
      • Used in combination with ribavirin
    AND
  • Prescribed by or in consultation with one of the following:
    • Hepatologist
    • Gastroenterologist
    • Infectious disease specialist
    • HIV specialist certified through the American Academy of HIV Medicine
    AND
  • Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
    • AND
  • Patient does not have moderate to severe hepatic impairment (e.g., Child-Pugh Class B or C) [B]
    • AND
  • One of the following:
    • Both of the following:
      • Trial and failure, intolerance, or contraindication to ONE of the following:
        • Epclusa (sofosbuvir/velpatasvir)
        • Harvoni (ledipasvir/sofosbuvir)
        AND
      • Trial and failure, contraindication, or intolerance to Mavyret (glecaprevir/pibrentasvir)
      OR
    • For continuation of prior Zepatier (elbasvir/grazoprevir) therapy
Zepatier

Prior Authorization

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 4: Treatment-naive

  • Diagnosis of chronic hepatitis C genotype 4
    • AND
  • One of the following:
    • Patient is 12 years of age or older
    • Patient weight is at least 30 kg
    AND
  • Patient is treatment-naive
    • AND
  • Prescribed by or in consultation with one of the following:
    • Hepatologist
    • Gastroenterologist
    • Infectious disease specialist
    • HIV specialist certified through the American Academy of HIV Medicine
    AND
  • Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
    • AND
  • Patient does not have moderate to severe hepatic impairment (e.g., Child-Pugh Class B or C) [B]
    • AND
  • One of the following:
    • Both of the following:
      • Trial and failure, intolerance, or contraindication to ONE of the following:
        • Epclusa (sofosbuvir/velpatasvir)
        • Harvoni (ledipasvir/sofosbuvir)
        AND
      • Trial and failure, contraindication, or intolerance to Mavyret (glecaprevir/pibrentasvir)
      OR
    • For continuation of prior Zepatier (elbasvir/grazoprevir) therapy
Zepatier

Prior Authorization

Length of Approval: 16 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 4: PegIFN/RBV-experienced

  • Diagnosis of chronic hepatitis C genotype 4
    • AND
  • One of the following:
    • Patient is 12 years of age or older
    • Patient weight is at least 30 kg
    AND
  • Patient has prior failure to peginterferon alfa plus ribavirin treatment
    • AND
  • Used in combination with ribavirin
    • AND
  • Prescribed by or in consultation with one of the following:
    • Hepatologist
    • Gastroenterologist
    • Infectious disease specialist
    • HIV specialist certified through the American Academy of HIV Medicine
    AND
  • Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
    • AND
  • Patient does not have moderate to severe hepatic impairment (e.g., Child-Pugh Class B or C) [B]
    • AND
  • One of the following:
    • Both of the following:
      • Trial and failure, intolerance, or contraindication to ONE of the following:
        • Epclusa (sofosbuvir/velpatasvir)
        • Harvoni (ledipasvir/sofosbuvir)
        AND
      • Trial and failure, contraindication, or intolerance to Mavyret (glecaprevir/pibrentasvir)
      OR
    • For continuation of prior Zepatier (elbasvir/grazoprevir) therapy

  • Guideline ID
    GL-147981

  • Formulary
    Premium

  • Effective date
    Aug 1, 2024

  • P&T approval date
    Nov 18, 2015

P & T Revisions

2024-06-02, 2023-06-06, 2022-06-22, 2022-06-05, 2022-02-03, 2021-06-08, 2021-05-26, 2021-05-25, 2020-04-29

  1. Zepatier Prescribing Information. Merck Sharp & Dohme Corp. Whitehouse Station, NJ. December 2021.
  2. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Recommendations for Testing, Managing, and Treating Hepatitis C. October 2022. http://www.hcvguidelines.org/full-report-view. Accessed May 13, 2024.
  1. Testing patients with HCV genotype 1a infection for the presence of virus with NS5A resistance-associated polymorphisms is recommended prior to initiation of treatment with Zepatier to determine dosage regimen and duration. In subjects receiving Zepatier for 12 weeks, sustained virologic response (SVR12) rates were lower in genotype 1a-infected patients with one or more baseline NS5A resistance-associated polymorphisms at amino acid positions 28, 30, 31, or 93. [1]
  2. Zepatier is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) due to the expected significantly increased grazoprevir plasma concentration and the increased risk of alanine aminotransferase (ALT) elevations. [1]
  • 2024-06-02: Annual review - no criteria changes; background updates
  • 2023-06-06: Annual review - no criteria changes; background updates
  • 2022-06-22: Updated guideline effective date to 7/1/22 to align with UM optimization updates. No other updates made to guideline.
  • 2022-06-05: Annual review - Removed submission of medical records requirement; background updates
  • 2022-02-03: Updated indication and criteria with new pediatric age criteria
  • 2021-06-08: Annual review
  • 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
  • 2020-04-29: Annual review - Removed Olysio as an example of a direct acting antiviral; reference updates