Pharmacy Prior Authorization Criteria

Sovaldi (sofosbuvir)

Indications for Prior Authorization

Sovaldi (sofosbuvir)

• For diagnosis of Chronic Hepatitis C (CHC)
  ADULT PATIENTS: Indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen. - Genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis for use in combination with pegylated interferon and ribavirin. - Genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin. PEDIATRIC PATIENTS: Indicated for the treatment of chronic HCV genotype 2 or 3 infection in pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.

Criteria

Sovaldi

Prior Authorization

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C (without decompensation) - Genotype 1 or 4 - Sovaldi Plus Peginterferon Plus Ribavirin

• Diagnosis of chronic hepatitis C genotype 1 or 4
AND
• Used in combination with peginterferon alfa and 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
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)
AND
• Patient has not experienced failure with a previous treatment regimen that includes Sovaldi
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)
OR
• For continuation of prior Sovaldi (sofosbuvir) therapy

Sovaldi

Prior Authorization

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C (without decompensation) - Genotype 2 - Sovaldi Plus Ribavirin

• Diagnosis of chronic hepatitis C genotype 2 infection
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
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)
AND
• Patient has not experienced failure with a previous treatment regimen that includes Sovaldi
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:
• Epclusa (sofosbuvir/velpatasvir)
• Mavyret (glecaprevir/pibrentasvir)
OR
• For continuation of prior Sovaldi (sofosbuvir) therapy

Sovaldi

Prior Authorization

Length of Approval: 24 Week(s)
For diagnosis of Chronic Hepatitis C (without decompensation) - Genotype 3 - Sovaldi Plus Ribavirin

• Diagnosis of chronic hepatitis C genotype 3 infection
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
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)
AND
• Patient has not experienced failure with a previous treatment regimen that includes Sovaldi
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:
• Epclusa (sofosbuvir/velpatasvir)
• Mavyret (glecaprevir/pibrentasvir)
OR
• For continuation of prior Sovaldi (sofosbuvir) therapy

Sovaldi

Prior Authorization

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

• 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 Mavyret (glecaprevir/pibrentasvir) and ribavirin [2]
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
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)

Sovaldi

Prior Authorization

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

• 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 Mavyret (glecaprevir/pibrentasvir) and ribavirin [2]
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
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)

P & T Revisions

2024-06-02, 2023-06-06, 2022-06-22, 2022-06-05, 2021-09-27, 2021-06-08, 2021-05-26, 2021-05-25, 2021-01-07, 2020-06-09, 2020-04-29, 2019-10-30

References

1. Sovaldi 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

• 2024-06-02: 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; added a section for prior failure of Mavyret; background updates
• 2021-09-27: Annual review
• 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
• 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).
• 2020-06-09: Added pellet formulations
• 2020-04-29: Adjusted embedded steps for GT 2 and 3 to account for the approval of Epclusa for select pediatric patients. Annual review - background and reference updates
• 2019-10-30: Expanded indication: treatment of chronic HCV genotype 2 or 3 infection in adults and pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis for use in combination with ribavirin. (Previously approved for this indication in pediatric patients 12 years of age and older or weighing at least 35 kg.) Criteria updated accordingly.

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