Pharmacy Prior Authorization Criteria

Bixlenvo (bictegravir and lenacapavir) - PA. NF

Indications for Prior Authorization

Bixlenvo (bictegravir and lenacapavir)

• For diagnosis of Treatment of HIV-1 Infection
  Indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of Bixlenvo.

Bixlenvo Sunleca Starter Pack (bictegravir and lenacapavir tablets; lenacapavir tablets)

• For diagnosis of Treatment of HIV-1 Infection
  Indicated for the initiation of Bixlenvo, a complete regimen for the treatment of HIV-1 infection, in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of Bixlenvo

Criteria

Bixlenvo

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Treatment of HIV-1 Infection

• All of the following:
• Diagnosis of HIV-1 infection
AND
• Patient is currently virologically suppressed (i.e., HIV-1 RNA less than 50 copies/mL) on a stable, uninterrupted oral antiretroviral regimen for at least 6 months [A]
AND
• Requested medication will not be used in combination with another drug therapy (e.g., Biktarvy, Dovato) for the treatment of HIV infection
AND
• Patient has no known or suspected resistance to bictegravir or lenacapavir
AND
• Prescribed by or in consultation with a clinician with HIV expertise
OR
• For continuation of prior therapy

Bixlenvo

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Treatment of HIV-1 Infection

• Submission of medical records (e.g., chart notes) or paid claims confirming continuation of prior therapy, defined as no more than a 45 days gap in therapy
OR
• All of the following:
• Submission of medical records (e.g., chart notes) confirming diagnosis of HIV-1 infection
AND
• Submission of medical records (e.g., chart notes) confirming patient is currently virologically suppressed (i.e., HIV-1 RNA less than 50 copies/mL) on a stable, uninterrupted oral antiretroviral regimen for at least 6 months [A]
AND
• Submission of medical records (e.g., chart notes) or absence of paid claims confirming requested medication will not be used in combination with another drug therapy (e.g., Biktarvy, Dovato) for the treatment of HIV infection
AND
• Submission of medical records (e.g., chart notes) confirming patient has no known or suspected resistance to bictegravir or lenacapavir
AND
• Prescribed by or in consultation with a clinician with HIV expertise

P & T Revisions

2026-10-23

References

1. Bixlenvo Prescribing Information. Gilead Sciences, Inc. Foster City, CA . August 2026.
2. Bixlenvo Sunlenca Starter Pack Prescribing Information. Gilead Sciences, Inc. Foster City, CA . August 2026.

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End Notes

1. In clinical studies, participants must have been suppressed on their baseline regimen for at least 6 months prior to trial entry. [1]

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Revision History

• 2026-10-23: New PA guideline

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