Pharmacy Prior Authorization Criteria

Sunlenca (lenacapavir sodium)

Indications for Prior Authorization

Sunlenca (lenacapavir sodium)

• For diagnosis of Multidrug Resistant HIV-1 Infection
  Indicated in combination with other antiretroviral(s) for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

Criteria

Sunlenca

Prior Authorization

Length of Approval: 12 Month(s)

• All of the following:
• Diagnosis of HIV-1 infection
AND
• Both of the following:
• Patient is heavily treatment-experienced with multidrug resistance as confirmed by a resistance assay
AND
• Patient is failing their current antiretroviral regimen due to one of the following:
• Resistance
• Intolerance
• Safety considerations
AND
• Patient is currently taking, or will be prescribed, an active and optimized background antiretroviral therapy regimen
AND
• Prescribed by or in consultation with a clinician with HIV expertise
OR
• For continuation of prior therapy

P & T Revisions

2025-05-07, 2025-01-20, 2024-01-23, 2023-02-08

References

1. Sunlenca Prescribing Information. Gilead Sciences, Inc. Foster City, CA. November 2024.

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Revision History

• 2025-05-07: Addition of new formulation.
• 2025-01-20: 2025 annual review. No clinical changes.
• 2024-01-23: 2024 annual review. Updated criteria formatting with no change to clinical intent. Updated UM Characteristics and references.
• 2023-02-08: New program for Sunlenca.

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