Pharmacy Prior Authorization Criteria

Vosevi (sofosbuvir/velpatasvir/voxilaprevir)

Indications for Prior Authorization

Vosevi (sofosbuvir/velpatasvir/voxilaprevir)

• For diagnosis of Chronic Hepatitis C (CHC)
  Indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have: • Genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor. • Genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. (Additional benefit of Vosevi over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor.)

Criteria

Vosevi (sofosbuvir/velpatasvir/voxilaprevir)

Prior Authorization

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 2, 3, 4, 5, or 6; without Decompensated Cirrhosis; Prior Relapser to NS5A-Based Regimen

• Diagnosis of chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6
AND
• Patient is a previous relapser to an NS5A-based regimen (e.g., Daklinza [daclatasvir]; Epclusa [sofosbuvir/velpatasvir]; Harvoni [ledipasvir/sofosbuvir]; Mavyret [glecaprevir/pibrentasvir]; Technivie [ombitasvir/paritaprevir/ritonavir]; Viekira [ombitasvir/paritaprevir/ritonavir & dasabuvir]; Zepatier [elbasvir/grazoprevir])
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

Vosevi (sofosbuvir/velpatasvir/voxilaprevir)

Prior Authorization

Length of Approval: 12 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1a or 3; without Decompensated Cirrhosis; Prior Relapser to Sofosbuvir-Based Regimen without an NS5A Inhibitor

• Diagnosis of chronic hepatitis C genotype 1a or 3
AND
• Patient is a previous relapser to a sofosbuvir-based regimen without an NS5A inhibitor
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

Vosevi (sofosbuvir/velpatasvir/voxilaprevir)

Prior Authorization

Length of Approval: 24 Week(s)
For diagnosis of Chronic Hepatitis C - Genotype 1, 2, 3, 4, 5, or 6; without Decompensated Cirrhosis; Prior Failure to Vosevi

• Diagnosis of chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6
AND
• Patient had a prior treatment failure with Vosevi (sofosbuvir/velpatasvir/voxilaprevir) [2]
AND
• Used in combination with ribavirin [2]
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., Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir)]

P & T Revisions

2024-06-02, 2023-06-06, 2022-06-22, 2022-06-05, 2021-06-08, 2020-04-29

References

1. Vosevi Prescribing Information. Gilead Sciences, Inc. Foster City, CA. November 2019.
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 clinical 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
• 2021-06-08: Annual review
• 2020-04-29: Annual review - no clinical changes; reference updates

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