Pharmacy Prior Authorization Criteria

Harvoni (ledipasvir/sofosbuvir) - PA, NF

Indications for Prior Authorization

Harvoni (ledipasvir/sofosbuvir)

• 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, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis; - Genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin; - Genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin

Criteria

Harvoni*, Brand ledipasvir/sofosbuvir

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

Prior Authorization

Length of Approval: 8 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1 - Treatment Naive without Cirrhosis - Pre-Treatment HCV RNA less than 6 Million IU/mL

• Diagnosis of chronic hepatitis C genotype 1
AND
• Patient is without cirrhosis
AND
• Patient is treatment-naive
AND
• Pre-treatment HCV RNA less than 6 million IU/mL
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
• One of the following (applies to brand ledipasvir/sofosbuvir only):
• 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 ledipasvir/sofosbuvir

Brand ledipasvir/sofosbuvir

Non Formulary

Length of Approval: 8 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1 - Treatment Naive without Cirrhosis - Pre-Treatment HCV RNA less than 6 Million IU/mL

• Submission of medical records (e.g., chart notes, laboratory values) documenting diagnosis of chronic hepatitis C genotype 1
AND
• Patient is without cirrhosis
AND
• Patient is treatment-naive
AND
• Submission of medical records documenting pre-treatment HCV RNA less than 6 million IU/mL
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
• 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

Harvoni*, Brand ledipasvir/sofosbuvir

*Approve brand Harvoni 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 - Treatment Naive without Cirrhosis - Pre-Treatment HCV RNA greater than or equal to 6 Million IU/mL

• Diagnosis of chronic hepatitis C genotype 1
AND
• Patient is without cirrhosis
AND
• Patient is treatment-naive
AND
• Pre-treatment HCV RNA greater than or equal to 6 million IU/mL
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
• One of the following (applies to brand ledipasvir/sofosbuvir only):
• 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 ledipasvir/sofosbuvir

Brand ledipasvir/sofosbuvir

Non Formulary

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1 - Treatment Naive without Cirrhosis - Pre-Treatment HCV RNA greater than or equal to 6 Million IU/mL

• Submission of medical records (e.g., chart notes, laboratory values) documenting diagnosis of chronic hepatitis C genotype 1
AND
• Patient is without cirrhosis
AND
• Patient is treatment-naive
AND
• Submission of medical records documenting pre-treatment HCV RNA greater than or equal to 6 million IU/mL
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
• 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

Harvoni*, Brand ledipasvir/sofosbuvir

*Approve brand Harvoni 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, 4, 5, or 6 - Treatment-Naive or PegIFN/RBV-experienced or PegIFN/RBV/protease inhibitor-experienced (No Decompensated Cirrhosis)

• Diagnosis of chronic hepatitis C genotype 1, 4, 5, or 6
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
• 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., Sovaldi [sofosbuvir])
AND
• One of the following (applies to brand ledipasvir/sofosbuvir only):
• 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 ledipasvir/sofosbuvir

Brand ledipasvir/sofosbuvir

Non Formulary

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 4, 5, or 6 - Treatment-Naive or PegIFN/RBV-experienced or PegIFN/RBV/protease inhibitor-experienced (No Decompensated Cirrhosis)

• Submission of medical records (e.g., chart notes, laboratory values) documenting diagnosis of chronic hepatitis C genotype 1, 4, 5, or 6
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
• 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., Sovaldi [sofosbuvir])
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

Harvoni*, Brand ledipasvir/sofosbuvir

*Approve brand Harvoni 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, 4, 5, or 6 – Post-Liver Transplant

• Diagnosis of chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6
AND
• Patient is a liver transplant recipient
AND
• One of the following:
• Patient is without cirrhosis or has compensated cirrhosis (Child-Pugh Class A)
OR
• Both of the following:
• Patient has decompensated cirrhosis (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 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
• One of the following (applies to brand ledipasvir/sofosbuvir only):
• 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 ledipasvir/sofosbuvir

Brand ledipasvir/sofosbuvir

Non Formulary

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 4, 5, or 6 – Post-Liver Transplant

• Submission of medical records (e.g., chart notes, laboratory values) documenting diagnosis of chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6
AND
• Patient is a liver transplant recipient
AND
• One of the following:
• Patient is without cirrhosis or has compensated cirrhosis (Child-Pugh Class A)
OR
• Both of the following:
• Patient has decompensated cirrhosis (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 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
• 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

Harvoni*, Brand ledipasvir/sofosbuvir

*Approve brand Harvoni 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, 4, 5, or 6 – Decompensated Cirrhosis - Ribavirin Eligible

• Diagnosis of chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6
AND
• Patient has decompensated cirrhosis (e.g., Child-Pugh Class B or C)
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
• One of the following (applies to brand ledipasvir/sofosbuvir only):
• Trial and failure, contraindication, or intolerance to ONE of the following:
• Brand Epclusa (sofosbuvir/velpatasvir)
• Brand Harvoni (ledipasvir/sofosbuvir)
OR
• For continuation of prior brand ledipasvir/sofosbuvir

Brand ledipasvir/sofosbuvir

Non Formulary

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 4, 5, or 6 – Decompensated Cirrhosis - Ribavirin Eligible

• Submission of medical records (e.g., chart notes, laboratory values) documenting diagnosis of chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6
AND
• Submission of medical records (e.g., chart notes, laboratory values) documenting that the patient has decompensated cirrhosis (e.g., Child-Pugh Class B or C)
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
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to ONE of the following:
• Brand Epclusa (sofosbuvir/velpatasvir)
• 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

Harvoni*, Brand ledipasvir/sofosbuvir

*Approve brand Harvoni 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, 4, 5, or 6 – Decompensated Cirrhosis; Ribavirin Ineligible OR Prior Sovaldi or NS5A-Based Treatment Failure

• Diagnosis of chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6
AND
• Patient has decompensated cirrhosis (e.g., Child-Pugh Class B or C)
AND
• One of the following:
• Patient is ribavirin 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 therapy
• 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
• One of the following (applies to brand ledipasvir/sofosbuvir only):
• Trial and failure, contraindication, or intolerance to ONE of the following:
• Brand Epclusa (sofosbuvir/velpatasvir)
• Brand Harvoni (ledipasvir/sofosbuvir)
OR
• For continuation of prior brand ledipasvir/sofosbuvir

Brand ledipasvir/sofosbuvir

Non Formulary

Length of Approval: 24 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 4, 5, or 6 – Decompensated Cirrhosis; Ribavirin Ineligible OR Prior Sovaldi or NS5A-Based Treatment Failure

• Submission of medical records (e.g., chart notes, laboratory values) documenting diagnosis of chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6
AND
• Submission of medical records (e.g., chart notes, laboratory values) documenting that the patient has decompensated cirrhosis (e.g., Child-Pugh Class B or C)
AND
• One of the following:
• Patient is ribavirin 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 therapy
• 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
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to ONE of the following:
• Brand Epclusa (sofosbuvir/velpatasvir)
• 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

P & T Revisions

2024-06-05, 2023-06-06, 2022-08-23, 2022-06-29, 2022-06-22, 2022-06-08, 2022-01-04, 2021-06-08, 2021-05-25, 2021-01-07, 2020-07-30, 2020-06-09, 2020-04-29, 2019-10-30

References

1. Harvoni Prescribing Information. Gilead Sciences, Inc. Foster City, CA. March 2020.
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 - added continuation of therapy to the steps in the decompensated criteria sections for consistency throughout the guideline; background updates
• 2023-06-06: Annual review - no criteria changes; background updates
• 2022-08-23: Background update
• 2022-06-29: Removed submission of medical records verbiage from prior auth criteria.
• 2022-06-22: Updated guideline effective date to 7/1/22 to align with UM optimization updates. No other updates made to guideline.
• 2022-06-08: Annual review - Removed submission of medical records requirement; added prior failure of pegylated interferon/ribavirin with or without a protease inhibitor based on the label; background updates
• 2022-01-04: Addition of NF criteria for ledipasvir/sofosbuvir
• 2021-06-08: Annual review
• 2021-05-25: Addition of EHB formulary. No changes to criteria
• 2021-01-07: Removal of separate embedded steps based on age; Addition of verbiage defining contraindication (e.g., safety concerns, not indicated for patient's age/weight).
• 2020-07-30: For consistency with other sections, removed continuation of therapy in the decompensated criteria sections since patients currently receiving ledipasvir/sofosbuvir may continue therapy with brand Harvoni.
• 2020-06-09: Addition of pellet formulations
• 2020-04-29: Adjusted embedded steps to account for the approval of Epclusa for select pediatric patients; Annual review - added Epclusa as a step option for liver transplant patients to align with clinical guidelines; Removed Olysio as an example of a direct acting antiviral; updated references
• 2019-10-30: Updated indication and corresponding criteria to allow for patients 3 years and older, and added new pediatric tablet formulation.

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