Pharmacy Prior Authorization Criteria

Epclusa (sofosbuvir/velpatasvir) - PA, NF

Indications for Prior Authorization

Epclusa (sofosbuvir and 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: 12 Week(s)
For diagnosis of Chronic Hepatitis C (without decompensation) - Genotype 1, 2, 3, 4, 5, or 6

Diagnosis of chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6

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

Prescribed by or in consultation with one of the following:

Hepatologist
Gastroenterologist
Infectious disease specialist
HIV specialist

Brand sofosbuvir/velpatasvir

Prior Authorization

Length of Approval: 12 Week(s)
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

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

Prescribed by or in consultation with one of the following:

Hepatologist
Gastroenterologist
Infectious disease specialist
HIV specialist

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)

For continuation of prior brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Non Formulary

Length of Approval: 12 Week(s)
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

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

Prescribed by or in consultation with one of the following:

Hepatologist
Gastroenterologist
Infectious disease specialist
HIV specialist

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)

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: 12 Week(s)
For diagnosis of Chronic Hepatitis C (without decompensation) - Genotype 2, 3

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 does NOT have decompensated liver disease (Child-Pugh Class B or C)

AND

Prescribed by or in consultation with one of the following:

Hepatologist
Gastroenterologist
Infectious disease specialist
HIV specialist

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)

For continuation of prior brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Non Formulary

Length of Approval: 12 Week(s)
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

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

Prescribed by or in consultation with one of the following:

Hepatologist
Gastroenterologist
Infectious disease specialist
HIV specialist

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)

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: 12 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 2, 3, 4, 5, or 6 - Patients with Decompensated Liver Disease - Epclusa plus ribavirin

Diagnosis of chronic hepatitis C virus genotype 1, 2, 3, 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
HIV specialist

Brand sofosbuvir/velpatasvir

Prior Authorization

Length of Approval: 12 Week(s)
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
HIV specialist

AND

One of the following:

Trial and failure or intolerance to ONE of the following:

Brand Epclusa
Brand Harvoni (ledipasvir/sofosbuvir)

For continuation of prior brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Non Formulary

Length of Approval: 12 Week(s)
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
HIV 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)

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: 12 Week(s)
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
HIV specialist

AND

One of the following:

Trial and failure or intolerance to Brand Epclusa

For continuation of prior brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Non Formulary

Length of Approval: 12 Week(s)
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
HIV 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

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: 24 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 2, 3, 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, 2, 3, 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

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
HIV specialist

Brand sofosbuvir/velpatasvir

Prior Authorization

Length of Approval: 24 Week(s)
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

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
HIV specialist

AND

One of the following:

Trial and failure or intolerance to ONE of the following:

Brand Epclusa
Brand Harvoni (ledipasvir/sofosbuvir)

For continuation of prior brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Non Formulary

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

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
HIV 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)

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: 24 Week(s)
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

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
HIV specialist

AND

One of the following:

Trial and failure or intolerance to Brand Epclusa

For continuation of prior brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Non Formulary

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

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
HIV 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

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

Guideline ID
GL-148002
Formulary
EHB
Effective date
Aug 1, 2024
P&T approval date
Jun 22, 2016

P & T Revisions

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

Epclusa Prescribing Information. Gilead Science, Inc. Foster City, CA. April 2022.
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

2024-06-19: 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

Epclusa (sofosbuvir/velpatasvir) - PA, NF

Indications for Prior Authorization

Epclusa (sofosbuvir and velpatasvir)

Criteria

Epclusa*

Brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Epclusa*

Brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Epclusa*

Brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

Brand sofosbuvir/velpatasvir

P & T Revisions

References

Revision History

Provider Tools