Pharmacy Prior Authorization Criteria

Epclusa (sofosbuvir/velpatasvir) - PA, NF

Indications for Prior Authorization

Epclusa (sofosbuvir/velpatasvir)

• For diagnosis of Chronic Hepatitis C (CHC)
  Indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis, and with decompensated cirrhosis for use in combination with ribavirin.

Criteria

Epclusa*

*Approve brand Epclusa at NDC level (i.e., closed NDC) if criteria are met.

Prior Authorization

Length of Approval: 16 Weeks [A]
For diagnosis of Chronic Hepatitis C (without decompensation)

• Diagnosis of chronic hepatitis C
AND
• One of the following:
• Patient is treatment-naive
OR
• Both of the following:
• Patient has prior failure to treatment with peginterferon alfa plus ribavirin with or without an HCV NS3/4A protease inhibitor (e.g., boceprevir, simeprevir, or telaprevir)
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• Liver transplant specialist
AND
• Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
AND
• Patient does NOT have decompensated liver disease (Child-Pugh Class B or C)

Brand sofosbuvir/velpatasvir

Prior Authorization

Length of Approval: 16 Weeks [A]
For diagnosis of Chronic Hepatitis C (without decompensation) - Genotype 1, 4, 5, or 6

• Diagnosis of chronic hepatitis C virus genotype 1, 4, 5, or 6
AND
• One of the following:
• Patient is treatment-naive
OR
• Both of the following:
• Patient has prior failure to treatment with peginterferon alfa plus ribavirin with or without an HCV NS3/4A protease inhibitor (e.g., boceprevir, simeprevir, or telaprevir)
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• Liver transplant specialist
AND
• Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
AND
• Patient does NOT have decompensated liver disease (Child-Pugh Class B or C)
AND
• One of the following:
• Both of the following:
• Trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to ONE of the following:
• Brand Epclusa (sofosbuvir/velpatasvir)
• Brand Harvoni (ledipasvir/sofosbuvir)
AND
• Trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to Mavyret (glecaprevir/pibrentasvir)
OR
• For continuation of prior brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Non Formulary

Length of Approval: 16 Weeks [A]
For diagnosis of Chronic Hepatitis C (without decompensation) - Genotype 1, 4, 5, or 6

• Submission of medical records (e.g., chart notes, laboratory values) documenting a diagnosis of chronic hepatitis C virus genotype 1, 4, 5, or 6
AND
• One of the following:
• Patient is treatment-naive
OR
• Both of the following:
• Patient has prior failure to treatment with peginterferon alfa plus ribavirin with or without an HCV NS3/4A protease inhibitor (e.g., boceprevir, simeprevir, or telaprevir)
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• Liver transplant specialist
AND
• Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
AND
• Patient does NOT have decompensated liver disease (Child-Pugh Class B or C)
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to ONE of the following:
• Brand Epclusa (sofosbuvir/velpatasvir)
• Brand Harvoni (ledipasvir/sofosbuvir)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to Mavyret (glecaprevir/pibrentasvir)
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy

Brand sofosbuvir/velpatasvir

Prior Authorization

Length of Approval: 16 Weeks [A]
For diagnosis of Chronic Hepatitis C (without decompensation) - Genotype 2, 3

• Diagnosis of chronic hepatitis C virus genotype 2 or 3
AND
• One of the following:
• Patient is treatment-naive
OR
• Both of the following:
• Patient has prior failure to treatment with peginterferon alfa plus ribavirin with or without an HCV NS3/4A protease inhibitor (e.g., boceprevir, simeprevir, or telaprevir)
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• Liver transplant specialist
AND
• Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
AND
• Patient does NOT have decompensated liver disease (Child-Pugh Class B or C)
AND
• One of the following:
• Trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to BOTH of the following:
• Brand Epclusa (sofosbuvir/velpatasvir)
• Mavyret (glecaprevir/pibrentasvir)
OR
• For continuation of prior brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Non Formulary

Length of Approval: 16 Weeks [A]
For diagnosis of Chronic Hepatitis C (without decompensation) - Genotype 2, 3

• Submission of medical records (e.g., chart notes, laboratory values) documenting a diagnosis of chronic hepatitis C virus genotype 2 or 3
AND
• One of the following:
• Patient is treatment-naive
OR
• Both of the following:
• Patient has prior failure to treatment with peginterferon alfa plus ribavirin with or without an HCV NS3/4A protease inhibitor (e.g., boceprevir, simeprevir, or telaprevir)
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• Liver transplant specialist
AND
• Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
AND
• Patient does not have decompensated liver disease (e.g., Child-Pugh Class B or C)
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to BOTH of the following:
• Brand Epclusa (sofosbuvir/velpatasvir)
• Mavyret (glecaprevir/pibrentasvir)
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy

Epclusa*

*Approve brand Epclusa at NDC level (i.e., closed NDC) if criteria are met.

Prior Authorization

Length of Approval: 16 Weeks [A]
For diagnosis of Chronic Hepatitis C - Patients with Decompensated Liver Disease - Epclusa plus ribavirin

• Diagnosis of chronic hepatitis C
AND
• Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
AND
• Both of the following:
• Patient has decompensated liver disease (Child-Pugh Class B or C)
• Used in combination with ribavirin
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• Liver transplant specialist

Brand sofosbuvir/velpatasvir

Prior Authorization

Length of Approval: 16 Weeks [A]
For diagnosis of Chronic Hepatitis C - Genotype 1, 4, 5, or 6 - Patients with Decompensated Liver Disease - Epclusa plus ribavirin

• Diagnosis of chronic hepatitis C virus genotype 1, 4, 5, or 6
AND
• Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
AND
• Both of the following:
• Patient has decompensated liver disease (Child-Pugh Class B or C)
• Used in combination with ribavirin
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• Liver transplant specialist
AND
• One of the following:
• Trial and failure or intolerance to ONE of the following:
• Brand Epclusa
• Brand Harvoni (ledipasvir/sofosbuvir)
OR
• For continuation of prior brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Non Formulary

Length of Approval: 16 Weeks [A]
For diagnosis of Chronic Hepatitis C - Genotype 1, 4, 5, or 6 - Patients with Decompensated Liver Disease - Epclusa plus ribavirin

• Submission of medical records (e.g., chart notes, laboratory values) documenting a diagnosis of chronic hepatitis C virus genotype 1, 4, 5, or 6
AND
• Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
AND
• Both of the following:
• Patient has decompensated liver disease (Child-Pugh Class B or C)
• Used in combination with ribavirin
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• Liver transplant specialist
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure or intolerance to ONE of the following:
• Brand Epclusa
• Brand Harvoni (ledipasvir/sofosbuvir)
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy

Brand sofosbuvir/velpatasvir

Prior Authorization

Length of Approval: 16 Weeks [A]
For diagnosis of Chronic Hepatitis C - Genotype 2, 3 - Patients with Decompensated Liver Disease - Epclusa plus ribavirin

• Diagnosis of chronic hepatitis C virus genotype 2 or 3
AND
• Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
AND
• Both of the following:
• Patient has decompensated liver disease (Child-Pugh Class B or C)
• Used in combination with ribavirin
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• Liver transplant specialist
AND
• One of the following:
• Trial and failure or intolerance to Brand Epclusa
OR
• For continuation of prior brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Non Formulary

Length of Approval: 16 Weeks [A]
For diagnosis of Chronic Hepatitis C - Genotype 2, 3 - Patients with Decompensated Liver Disease - Epclusa plus ribavirin

• Submission of medical records (e.g., chart notes, laboratory values) documenting a diagnosis of chronic hepatitis C virus genotype 2 or 3
AND
• Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
AND
• Both of the following:
• Patient has decompensated liver disease (Child-Pugh Class B or C)
• Used in combination with ribavirin
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• Liver transplant specialist
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure or intolerance to Brand Epclusa
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy

Epclusa*

*Approve brand Epclusa at NDC level (i.e., closed NDC) if criteria are met.

Prior Authorization

Length of Approval: 28 Weeks [A]
For diagnosis of Chronic Hepatitis C - Patients with Decompensated Liver Disease - Ribavirin Intolerance/Ineligible OR Prior Sofosbuvir or NS5A-based Treatment Failure

• Diagnosis of chronic hepatitis C
AND
• Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
AND
• Patient has decompensated liver disease (Child-Pugh Class B or C)
AND
• One of the following:
• Patient is ribavirin intolerant or ineligible
OR
• Both of the following:
• Prior failure (defined as viral relapse, breakthrough while on therapy, or non-responder therapy) to Sovaldi or NS5A-based treatment
AND
• Used in combination with ribavirin
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• Liver transplant specialist

Brand sofosbuvir/velpatasvir

Prior Authorization

Length of Approval: 28 Weeks [A]
For diagnosis of Chronic Hepatitis C - Genotype 1, 4, 5, or 6 - Patients with Decompensated Liver Disease - Ribavirin Intolerance/Ineligible OR Prior Sofosbuvir or NS5A-based Treatment Failure

• Diagnosis of chronic hepatitis C virus genotype 1, 4, 5, or 6
AND
• Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
AND
• Patient has decompensated liver disease (Child-Pugh Class B or C)
AND
• One of the following:
• Patient is ribavirin intolerant or ineligible
OR
• Both of the following:
• Prior failure (defined as viral relapse, breakthrough while on therapy, or non-responder therapy) to Sovaldi or NS5A-based treatment
AND
• Used in combination with ribavirin
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• Liver transplant specialist
AND
• One of the following:
• Trial and failure or intolerance to ONE of the following:
• Brand Epclusa
• Brand Harvoni (ledipasvir/sofosbuvir)
OR
• For continuation of prior brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Non Formulary

Length of Approval: 28 Weeks [A]
For diagnosis of Chronic Hepatitis C - Genotype 1, 4, 5, or 6 - Patients with Decompensated Liver Disease - Ribavirin Intolerance/Ineligible OR Prior Sofosbuvir or NS5A-based Treatment Failure

• Submission of medical records (e.g., chart notes, laboratory values) documenting a diagnosis of chronic hepatitis C virus genotype 1, 4, 5, or 6
AND
• Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
AND
• Patient has decompensated liver disease (Child-Pugh Class B or C)
AND
• One of the following:
• Patient is ribavirin intolerant or ineligible
OR
• Both of the following:
• Prior failure (defined as viral relapse, breakthrough while on therapy, or non-responder therapy) to Sovaldi or NS5A-based treatment
AND
• Used in combination with ribavirin
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• Liver transplant specialist
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure or intolerance to ONE of the following:
• Brand Epclusa
• Brand Harvoni (ledipasvir/sofosbuvir)
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy

Brand sofosbuvir/velpatasvir

Prior Authorization

Length of Approval: 28 Weeks [A]
For diagnosis of Chronic Hepatitis C - Genotype 2, 3 - Patients with Decompensated Liver Disease - Ribavirin Intolerance/Ineligible OR Prior Sofosbuvir or NS5A-based Treatment Failure

• Diagnosis of chronic hepatitis C virus genotype 2 or 3
AND
• Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
AND
• Patient has decompensated liver disease (Child-Pugh Class B or C)
AND
• One of the following:
• Patient is ribavirin intolerant or ineligible
OR
• Both of the following:
• Prior failure (defined as viral relapse, breakthrough while on therapy, or non-responder therapy) to Sovaldi or NS5A-based treatment
AND
• Used in combination with ribavirin
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• Liver transplant specialist
AND
• One of the following:
• Trial and failure or intolerance to Brand Epclusa
OR
• For continuation of prior brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Non Formulary

Length of Approval: 28 Weeks [A]
For diagnosis of Chronic Hepatitis C - Genotype 2, 3 - Patients with Decompensated Liver Disease - Ribavirin Intolerance/Ineligible OR Prior Sofosbuvir or NS5A-based Treatment Failure

• Submission of medical records (e.g., chart notes, laboratory values) documenting a diagnosis of chronic hepatitis C virus genotype 2 or 3
AND
• Not used in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir)]
AND
• Patient has decompensated liver disease (Child-Pugh Class B or C)
AND
• One of the following:
• Patient is ribavirin intolerant or ineligible
OR
• Both of the following:
• Prior failure (defined as viral relapse, breakthrough while on therapy, or non-responder therapy) to Sovaldi or NS5A-based treatment
AND
• Used in combination with ribavirin
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist
• Liver transplant specialist
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure or intolerance to Brand Epclusa
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy

P & T Revisions

2025-07-17, 2024-06-19, 2023-06-06, 2022-08-23, 2022-07-25, 2022-06-22, 2022-06-08, 2022-01-04, 2021-11-05, 2021-06-15, 2021-05-19, 2020-12-03, 2020-04-29

References

1. Epclusa Prescribing Information. Gilead Science, Inc. Foster City, CA. April 2022.
2. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Recommendations for Testing, Managing, and Treating Hepatitis C. December 2023. http://www.hcvguidelines.org/full-report-view. Accessed June 25, 2025.

---

End Notes

1. The approval length has been extended by 4 weeks from the treatment duration to allow patients additional time to complete the treatment course.

---

Revision History

• 2025-07-17: Annual review - extended the authorization durations by an additional 4 weeks; removed genotype from brand Epclusa criteria sections where all 6 genotypes were included; removed prescriber requirement from uncomplicated, treatment-naive criteria; removed HIV specialist and added liver transplant specialist; background updates
• 2024-06-19: Annual review - Added continuation of therapy to select embedded steps for consistency throughout the guideline; background updates
• 2023-06-06: Annual review - no criteria changes; background updates
• 2022-08-23: Background update
• 2022-07-25: Updated guideline effective date to 7/1/22 to align with UM optimization updates.
• 2022-06-22: Updated guideline effective date to 7/1/22 to align with UM optimization updates.
• 2022-06-08: Annual review - Removed submission of medical records requirement from the PA criteria; background updates
• 2022-01-04: Addition of NF criteria sections for sofosbuvir/velpatasvir
• 2021-11-05: Addition of new oral pellet formulations
• 2021-06-15: Annual review; updated indication
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2020-12-03: Addition of GPI for the 200 mg/50 mg tablets. Addition of verbiage defining contraindication (e.g., safety concerns, not indicated for patient's age/weight).
• 2020-04-29: Updated indication to include pediatric approval. Annual review - Removed Olysio as an example of a direct acting antiviral; added Child-Pugh classes; background and reference updates

---