Pharmacy Prior Authorization Criteria

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

Patient has prior failure to peginterferon alfa plus ribavirin treatment

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)

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)

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

Patient has prior failure to peginterferon alfa plus ribavirin treatment

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)

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)

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)

For continuation of prior Zepatier (elbasvir/grazoprevir) therapy

Guideline ID
GL-147981
Formulary
EHB
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

References

Zepatier Prescribing Information. Merck Sharp & Dohme Corp. Whitehouse Station, NJ. December 2021.
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.

Revision History

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

Zepatier (elbasvir/grazoprevir)

Indications for Prior Authorization

Zepatier (elbasvir/grazoprevir)

Criteria

Zepatier

Zepatier

Zepatier

Zepatier

Zepatier

P & T Revisions

References

Revision History

Provider Tools