Pharmacy Prior Authorization Criteria

Mavyret (glecaprevir/pibrentasvir)

Indications for Prior Authorization

Mavyret (glecaprevir/pibrentasvir)

• For diagnosis of Chronic Hepatitis C (CHC)
  Indicated for the treatment of adult and pediatric patients 3 years and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A).

  Indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.

Criteria

Mavyret (glecaprevir/pibrentasvir)

Prior Authorization

Length of Approval: 8 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 2, 3, 4, 5, or 6; Treatment-Naïve; without Decompensated Cirrhosis

• Diagnosis of chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6
AND
• Patient is treatment-naive
AND
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

Mavyret (glecaprevir/pibrentasvir)

Prior Authorization

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1; Treatment-Experienced (Prior failure to an NS3/4A Protease Inhibitor); without Decompensated Cirrhosis

• Diagnosis of chronic hepatitis C genotype 1
AND
• Patient has experienced failure with a previous treatment regimen that included a HCV NS3/4A protease inhibitor [e.g., Incivek (telaprevir), Olysio (simeprevir), Victrelis (boceprevir)]
AND
• Patient has had no previous treatment experience with a treatment regimen that included an NS5A inhibitor (e.g., Daklinza [daclatasvir])
AND
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

Mavyret (glecaprevir/pibrentasvir)

Prior Authorization

Length of Approval: 16 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1; Treatment-Experienced (Prior failure to an NS5A Inhibitor); without Decompensated Cirrhosis

• Diagnosis of chronic hepatitis C genotype 1
AND
• Patient has experienced failure with a previous treatment regimen that included an NS5A inhibitor (e.g., Daklinza [daclatasvir])
AND
• Patient has had no previous treatment experience with a treatment regimen that included a HCV NS3/4A protease inhibitor [e.g., Incivek (telaprevir), Olysio (simeprevir), Victrelis (boceprevir)]
AND
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

Mavyret (glecaprevir/pibrentasvir)

Prior Authorization

Length of Approval: 16 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 3; Treatment-Experienced (Interferon- or Sovaldi-based Regimen); without Decompensated Cirrhosis

• Diagnosis of chronic hepatitis C genotype 3
AND
• Patient has experienced treatment failure with a previous treatment regimen that included interferon, peginterferon, ribavirin, and/or Sovaldi (sofosbuvir)
AND
• Patient has had no previous treatment experience with a treatment regimen that included a HCV NS3/4A protease inhibitor [e.g., Incivek (telaprevir), Olysio (simeprevir), Victrelis (boceprevir)] or an NS5A inhibitor (e.g., Daklinza [daclatasvir])
AND
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

Mavyret (glecaprevir/pibrentasvir)

Prior Authorization

Length of Approval: 8 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 2, 4, 5, or 6; Treatment-Experienced (Interferon-based Regimen); without Cirrhosis

• Diagnosis of chronic hepatitis C genotype 1, 2, 4, 5, or 6
AND
• Patient has experienced treatment failure with a previous interferon-based treatment regimen
AND
• Patient has had no previous treatment experience with a treatment regimen that included a HCV NS3/4A protease inhibitor [e.g., Incivek (telaprevir), Olysio (simeprevir), Victrelis (boceprevir)] or an NS5A inhibitor (e.g., Daklinza [daclatasvir])
AND
• Patient is without cirrhosis
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

Mavyret (glecaprevir/pibrentasvir)

Prior Authorization

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 2, 4, 5, or 6; Treatment-Experienced (Interferon-based Regimen); with Compensated Cirrhosis

• Diagnosis of chronic hepatitis C genotype 1, 2, 4, 5, or 6
AND
• Patient has experienced treatment failure with a previous interferon-based treatment regimen
AND
• Patient has had no previous treatment experience with a treatment regimen that included a HCV NS3/4A protease inhibitor [e.g., Incivek (telaprevir), Olysio (simeprevir), Victrelis (boceprevir)] or an NS5A inhibitor (e.g., Daklinza [daclatasvir])
AND
• Patient has compensated cirrhosis (e.g., Child-Pugh Class A)
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

Mavyret (glecaprevir/pibrentasvir)

Prior Authorization

Length of Approval: 16 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 2, 4, 5, or 6; Treatment-Experienced (Sovaldi-based regimen); without Decompensated Cirrhosis

• Diagnosis of chronic hepatitis C genotype 1, 2, 4, 5, or 6
AND
• Patient has experienced treatment failure with a previous treatment regimen that included Sovaldi (sofosbuvir)
AND
• Patient has had no previous treatment experience with an HCV NS3/4A protease inhibitor inclusive combination direct acting antiviral regimen (e.g., Zepatier [elbasvir/grazoprevir])
AND
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

Mavyret (glecaprevir/pibrentasvir)

Prior Authorization

Length of Approval: 16 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 2, 3, 4, 5, or 6; Treatment-Experienced (Prior failure of Mavyret); without Decompensated Cirrhosis

• Diagnosis of chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6
AND
• Patient has experienced treatment failure with Mavyret (glecaprevir/pibrentasvir) [2]
AND
• Used in combination with Sovaldi (sofosbuvir) and ribavirin [2]
AND
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

Mavyret (glecaprevir/pibrentasvir)

Prior Authorization

Length of Approval: 16 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 2, 3, 4, 5, or 6; Treatment-Experienced (Prior failure of Vosevi); without Decompensated Cirrhosis

• Diagnosis of chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6
AND
• Patient has experienced treatment failure with Vosevi (sofosbuvir/velpatasvir/voxilaprevir) [2]
AND
• Used in combination with Sovaldi (sofosbuvir) and ribavirin [2]
AND
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

Mavyret (glecaprevir/pibrentasvir)

Prior Authorization

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 2, 3, 4, 5, or 6 Post-Liver or Kidney Transplant; Treatment-Naive or Treatment-Experienced (Non-Direct-Acting Antiviral); without Decompensated Cirrhosis

• Diagnosis of chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6
AND
• Patient has had a liver or kidney transplant [2]
AND
• One of the following:
• Patient is treatment-naive
• Patient has previously received non-direct-acting antiviral treatment (e.g., peginterferon)
AND
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

Mavyret (glecaprevir/pibrentasvir)

Prior Authorization

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 2, 3, 4, 5, or 6; HCV-Uninfected Recipients of a Liver Transplant from HCV-Viremic Donors; without Decompensated Cirrhosis

• Both of the following [2]:
• Patient was not infected with HCV prior to receiving a liver transplant
• Patient received a liver transplant from a donor with a diagnosis of chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6
AND
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

Mavyret (glecaprevir/pibrentasvir)

Prior Authorization

Length of Approval: 8 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 2, 3, 4, 5, or 6; HCV-Uninfected Recipients of Non-Liver Organ Transplant from HCV-Viremic Donors; without Decompensated Cirrhosis; within First Week After Transplant

• Both of the following [2]:
• Patient was not infected with HCV prior to receiving a non-liver organ transplant
• Patient received a non-liver organ transplant from a donor with a diagnosis of chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6
AND
• Treatment initiation will occur no later than the first week after transplant
AND
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

Mavyret (glecaprevir/pibrentasvir)

Prior Authorization

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 2, 3, 4, 5, or 6; HCV-Uninfected Recipients of Non-Liver Organ Transplant from HCV-Viremic Donors; without Decompensated Cirrhosis; beyond First Week After Transplant

• Both of the following [2]:
• Patient was not infected with HCV prior to receiving a non-liver organ transplant
• Patient received a non-liver organ transplant from a donor with a diagnosis of chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6
AND
• Treatment initiation will occur beyond the first week after transplant
AND
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

P & T Revisions

2024-06-05, 2023-06-06, 2022-06-22, 2022-06-05, 2021-11-05, 2021-09-27, 2021-06-15, 2021-05-21, 2020-04-29, 2019-10-30

References

1. Mavyret Prescribing Information. Abbvie Inc. North Chicago, IL. October 2023.
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.

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Revision History

• 2024-06-05: Annual review - updated post-liver or kidney transplant section to specify treatment-naïve or non-DAA-experienced; addition of criteria for HCV-uninfected recipients of non-liver organ transplants from HCV-viremic donors
• 2023-06-06: Annual review - removed HIV coinfection criteria since the guidelines no longer list HIV as a contraindication to the simplified treatment approach; 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; added sections for HIV coinfection; added a section for prior failure of Mavyret; background updates
• 2021-11-05: Addition of oral pellet formulation
• 2021-09-27: Annual review; updated indication
• 2021-06-15: Annual review; updated indication
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2020-04-29: Annual review - no clinical changes; reference updates
• 2019-10-30: Combined criteria for treatment-naïve patients without cirrhosis and with compensated cirrhosis for an 8-week approval duration based on new FDA-approved criteria.

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