CurrentCignaPolicy N/A

Sunlenca (lenacapavir) Prior Authorization Policy — Treatment of Multidrug‑Resistant HIV-1

Prior authorization requirements for Sunlenca (lenacapavir tablets and subcutaneous injection) for treatment of multidrug-resistant HIV-1 in eligible adults, applicable to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicySunlenca (lenacapavir) Prior Authorization Policy — Treatment of Multidrug‑Resistant HIV-1

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateJan 7, 2026

Key ActionObtain prior authorization; initial approvals are granted for 6 months when all initial criteria are met and renewals for 1 year for responding patients.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA-approvedIndication

6 monthsInitial approval

1 yearRenewal

26 weeksDosing interval

PrEP / naïveNot covered

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FDA-Approved Indication — Treatment of HIV-1 infection

Covered when ONE of the following is met

FDA-Approved Indication: A) Initial Therapy: Approve for 6 months if ALL of the following are met

Initial Therapy criteria: i. Patient is ≥ 18 years of age; AND ii. According to the prescriber, the patient is failing a current antiretroviral regimen for HIV; AND iii. According to the prescriber, the patient has resistance to two or more agents from at least THREE antiviral classes (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase strand transfer inhibitors); AND iv. Sunlenca will be taken in combination with an optimized antiviral background regimen including one or more other antiretroviral agents; AND v. The medication is prescribed by or in consultation with a physician who specializes in the treatment of HIV infection

Examples of drug class agents are listed in policy.

Currently Receiving Sunlenca: B) Patient is Currently Receiving Sunlenca: Approve for 1 year if BOTH of the following are met

Continuation criteria: i. Sunlenca will continue in combination with an optimized antiviral background regimen including one or more other antiretroviral agents; AND ii. Patient has responded to a Sunlenca-containing regimen, as determined by the prescriber (examples: HIV RNA < 50 copies/mL, ≥ 0.5 log10 reduction from baseline, or improvement or stabilization of CD4 T-cell count).

Sunlenca (lenacapavir tablets and subcutaneous injection) is not medically necessary for Pre‑Exposure Prophylaxis (PrEP). The policy explicitly states Sunlenca is not approved for PrEP and lists PrEP as a condition not covered.

Sunlenca is also not medically necessary for use in treatment‑naïve patients; the agent is not approved for that indication and the policy identifies treatment‑naïve use as a condition that will not be covered.

Requests for Sunlenca for either PrEP or for treatment‑naïve HIV patients will be denied as not medically necessary. The document clarifies that Sunlenca is not approved for these uses (PrEP and treatment‑naïve therapy) and therefore are listed under conditions not covered.

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior Authorization is required. Initial approvals: 6 months when ALL initial criteria are met. Renewal approvals: 1 year for current users who meet continuation criteria.

Initial approvals: 6 months when ALL initial criteria met
Renewal approvals: 1 year for current users who meet continuation criteria

Step Therapy

No step therapy requirements are specified in this policy.

Documentation Required

Required Clinical Documentation

Prescriber must be a physician who specializes in the treatment of HIV infection or the medication must be prescribed in consultation with an HIV specialist. For initial therapy, documentation should support: patient age ≥ 18 years; failure of current antiretroviral regimen; resistance to two or more agents from at least three antiviral classes; plan to use Sunlenca in combination with an optimized antiviral background regimen. For continuation therapy, documentation should show the medication will continue with an optimized background regimen and that the patient has responded to a Sunlenca-containing regimen (examples: HIV RNA < 50 copies/mL, ≥ 0.5 log10 reduction in viral load, or improvement/stabilization of CD4 count).

Prescriber specialty: HIV specialist or consult required
Initial therapy documentation: age ≥ 18, failing current regimen, documented multi-class resistance, plan for optimized background regimen
Continuation therapy documentation: continued optimized regimen and documented response to Sunlenca

Denial Risk

Conditions Not Covered

Requests for Sunlenca for PrEP or for treatment‑naïve patients are considered not medically necessary and will be denied.

Pre‑Exposure Prophylaxis (PrEP) — Sunlenca is not approved for PrEP and is not covered
Treatment‑naïve patients — Sunlenca is not approved for use in treatment‑naïve patients and is not covered

Definitions

inv-09: Multidrug-resistant HIV-1

DefinitionHIV-1 infection in heavily treatment-experienced adults failing current antiretroviral regimens with documented resistance to two or more agents from at least three of the main antiretroviral classes (NRTI, NNRTI, PI, INSTI) and having limited active agents available for optimized background therapy.

Clinical contextIndication applies when patients are failing current regimen due to resistance, intolerance, or safety considerations and require combination therapy with other antiretrovirals.

Evidence basisPivotal Phase II/III trial enrolled patients with documented resistance to ≥2 agents from three of four main antiretroviral classes and limited active agents for optimized background therapy.

Treatment settingUsed in combination with an optimized antiviral background regimen that includes one or more other antiretroviral agents.

Dosing relevanceMaintenance dosing is given as subcutaneous injections every 26 weeks (Q6M) with oral tablet options for planned missed doses or restart strategies as described in dosing guidance.