Sunlenca RX Form

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RX.PA.082.CCH SUNLENCA (LENACAPAVIR) The purpose of this policy is to define the prior authorization process for Sunlenca (lenacapavir) for treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection and are failing their current antiretroviral regimen (due to resistance, intolerance, or safety considerations). DEFINITIONS

AIDS = Acquired Immunodeficiency Syndrome HIV = Human Immunodeficiency Virus INSTIs = Integrase strand transfer inhibitors NRTIs = Nucleoside and nucleotide reverse transcriptase inhibitors NNRTIs = Non-nucleoside reverse transcriptase inhibitors PIs = protease inhibitors

POLICY
It is the policy of the Health Plan to maintain a prior authorization process that promotes appropriate utilization of specific drugs with potential for misuse or limited indications. This process involves a review using Food and Drug Administration (FDA) criteria to make a determination of Medical Necessity, and approval by the Medical Policy Committee.

The drug, Sunlenca (lenacapavir), is subject to the prior authorization process.

PROCEDURE Initial Authorization Criteria: Must meet all the criteria listed below:

• Must be age 18 years or older • Must be prescribed by, or in consultation with, a provider who specializes in the treatment of HIV/AIDS • Must have a diagnosis of HIV-1 infection

SUNLENCA (LENACAPAVIR) POLICY NUMBER: RX.PA.082.CCH REVISION DATE: 01/2024 PAGE NUMBER: 2 of 3

Proprietary and Confidential Information of Evolent Health LLC
© 2024 Evolent Health LLC All Rights Reserved • Must be prescribed at a dose within the manufacturer’s dosing guidelines (based on diagnosis, weight, etc.) listed in the FDA approved labeling
• Must be given in combination with other antiretroviral medications • Must have documented treatment failure to the member’s current antiretroviral regimen (e.g., resistance, intolerance, safety considerations) • Must have documented resistance to at least TWO antiretroviral medications from at least THREE of the following drug classes: o INSTIs (e.g., cabotegravir, dolutegravir, elvitegravir, raltegravir) o NRTIs (e.g., abacavir, emtricitabine, lamivudine, stavudine, tenofovir, zidovudine) o NNRTIs (e.g., doravirine, efavirenz, etravirine, nevirapirine, ripivirine) o PIs (e.g., atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, saquinavir, tipranavir)

Limitations:

If the established criteria are not met, the request is referred to a Medical Director for review, if required for the plan and level of request.

Codes: CPT Codes / HCPCS Codes / ICD-10 Codes Code Brand Description J1961 Sunlenca Injection, lenacapavir, 1 mg

References:

1. Sunlenca [package insert]. Foster City, CA; Gilead Sciences, Inc; December 2022

2. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv.

   Length of Authorization (if above criteria met) Initial Authorization Indefinite Reauthorization N/A

SUNLENCA (LENACAPAVIR) POLICY NUMBER: RX.PA.082.CCH REVISION DATE: 01/2024 PAGE NUMBER: 3 of 3

Proprietary and Confidential Information of Evolent Health LLC
© 2024 Evolent Health LLC All Rights Reserved Revision History

DESCRIPTION OF REVIEW / REVISION DATE APPROVED New Policy 01/2024

Record Retention Records Retention for Evolent Health documents, regardless of medium, are provided within the Evolent Health records retention policy and as indicated in CORP.028.E Records Retention Policy and Procedure.

Disclaimer CountyCare medical payment and prior authorization policies do not constitute medical advice and are not intended to govern or otherwise influence the practice of medicine. The policies constitute only the reimbursement and coverage guidelines of CountyCare and its affiliated managed care entities. Coverage for services varies for individual members in accordance with the terms and conditions of applicable Certificates of Coverage, Summary Plan Descriptions, or contracts with governing regulatory agencies.

CountyCare reserves the right to review and update the medical payment and prior authorization guidelines in its sole discretion. Notice of such changes, if necessary, shall be provided in accordance with the terms and conditions of provider agreements and any applicable laws or regulations.

These policies are the proprietary information of Evolent Health. Any sale, copying, or dissemination of said policies is prohibited.