Pharmacy Prior Authorization Criteria

Lenacapavir Products

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.

Yeztugo (lenacapavir)

• For diagnosis of HIV-1 Pre-Exposure Prophylaxis
  Indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo.

Criteria

Sunlenca*

For initial authorization request, approve through 12/31/2039 For reauthorization request, bypass criteria review and approve through 12/31/2039 *If patient meets criteria above, please approve at NDC level.

Prior Authorization

Length of Approval: When approved; no reauthorization required
For diagnosis of Treatment of HIV-1 Infection

• 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

Yeztugo*

*If patient meets criteria above, please approve at NDC level.

Prior Authorization, Non-Formulary

Length of Approval: 12 Month(s)
For diagnosis of HIV-1 Pre-Exposure Prophylaxis

• All of the following:
• Requested drug is being used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection
AND
• Patient's weight is greater than or equal to 35 kg
AND
• Provider attests that the patient has a negative HIV-1 test prior to the initiation of Yeztugo [A]
AND
• Provider attests that the patient has been informed about the need for the required testing, adherence, and every 6-month injection dosing schedule with Yeztugo [B]
OR
• For continuation of prior therapy

P & T Revisions

1970-01-01, 2025-11-13, 2025-05-23, 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.
2. Yeztugo Prescribing Information. Gilead Sciences, Inc. Foster City, CA. June 2025.

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End Notes

1. Screen all individuals for HIV-1 infection prior to initiating Yeztugo, prior to each subsequent injection of Yeztugo, and additionally as clinically appropriate, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. When screening for HIV-1 infection prior to initiating Yeztugo, if an antigen/antibody-specific test is used and provides negative results, then such negative results should be confirmed using an RNA-specific assay, even if the results of the RNA-assay are available after Yeztugo initiation. [2]
2. Prior to starting Yeztugo, healthcare providers should select individuals who agree to the required testing and every 6 month injection dosing schedule, and counsel individuals about the importance of adherence to scheduled Yeztugo dosing visits to help reduce the risk of acquiring HIV-1 infection and development of resistance [2]

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Revision History

• 2025-11-13: New UM Criteria for Yeztugo
• 2025-05-23: Removing reauthorization requirement as part of extended reauthorization program
• 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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