CurrentEmblemHealthPolicy MG.MM.PH.374

Sunlenca (lenacapavir) subcutaneous solution

Coverage criteria and prior authorization requirements for Sunlenca (lenacapavir) subcutaneous solution and oral tablets for treatment-experienced adults with multidrug-resistant HIV-1. Applies to clinicians seeking authorization from EmblemHealth/ConnectiCare for members receiving this therapy.

Policy Summary

PayerEmblemHealth

PolicySunlenca (lenacapavir) subcutaneous solution

Policy CodePolicy MG.MM.PH.374

Change TypeAnnual review updates to renewal criteria and coding

Effective DateN/A

Next Review DateFeb 13, 2025

Key ActionSubmit prior authorization with clinical evidence of resistance and treatment history; initial approvals are for 6 months and renewals for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Renewal criteria were updated to add a note about 'improvement or stabilization of CD4 T-cell count'.

Procedure code J3490 was removed and J1961 was added; NDCs were updated.

6 monthsInitial authorization length

12 monthsRenewal authorization length

J1961HCPCS code

2+ agents from ≥3 classesRequired resistance pattern

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Coverage Criteria for Sunlenca (lenacapavir)

inv-01: Initial Therapy — ALL of the following are met

Covered when ALL of the following are met:

Initial approval criteria: i. Patient is > 18 years of age; ii. According to the prescriber, the patient is failing a current antiretroviral regimen for HIV; 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); iv. The medication will be taken in combination with an optimized antiviral background regimen including one or more other antiretroviral agents; v. The medication is prescribed by, or in consultation with, a physician who specializes in the treatment of HIV infection.

Examples of drug classes and example agents are listed in policy text.

Use of Sunlenca (lenacapavir) is limited to heavily treatment‑experienced adults with multidrug‑resistant HIV‑1 who are failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. The policy does not cover treatment‑naïve patients or patients without documented multidrug resistance.

This policy is not applicable to patients who do not meet the indication of being heavily treatment‑experienced with multidrug‑resistant HIV‑1 and who are not failing their current antiretroviral regimen because of resistance, intolerance, or safety concerns.

Applicable Codes

Applicable Procedure CodesHCPCSCovered

J1961

Injection, lenacapavir, 1 mg

Applicable NDCsNDC

61958-3002-01	Sunlenca (lencapavir) 309 mg/1 mL subcutaneous 1.5 mL
61958-3004-01	Sunlenca 463.5 mg/1.5 mL Solution

Applicable ICD-10 DiagnosesICD-10

B20

HIV

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approval will be for 6 months; renewal approvals for 12 months. Prescriptions must be from or in consultation with a physician who specializes in the treatment of HIV infection.

Initial authorization duration: 6 months
Renewal authorization duration: 12 months
Prescriber requirement: Specialist in HIV or documented consultation

Documentation Required

Background Regimen Requirement

The medication must be used in combination with an optimized antiviral background regimen. Requests must document the optimized background regimen (one or more other antiretroviral agents) that will be continued with therapy.

Background regimen required: one or more other antiretroviral agents
Must document that therapy will be taken in combination with an optimized antiviral background regimen

Key Definitions

inv-13: Indication definition — Sunlenca indicated for treatment-experienced adults with multidrug-resistant HIV-1 in combination therapy

Indication (age group)Heavily treatment-experienced adults with multidrug‑resistant HIV‑1

Clinical settingFor patients failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations

Therapy frameworkLenacapavir (Sunlenca) is indicated only in combination with other antiretroviral(s)

Treatment experience requirementNot indicated for treatment‑naïve patients — limited to treatment‑experienced individuals

Resistance requirementMultidrug‑resistant HIV‑1 (failure of current regimen attributed to resistance)

Background on Sunlenca (lenacapavir)

Sunlenca (lenacapavir), when used in combination with other antiretroviral agents, is indicated for the treatment of HIV‑1 infection in heavily treatment‑experienced adults with multidrug‑resistant HIV‑1 who are failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

Policy Revision History

2025-02-13annual_reviewLatest

Renewal criteria updated to add a note about 'improvement or stabilization of CD4 T-cell count'.

2024-01-03annual_review

Procedure code J3490 was removed, HCPCS code J1961 was added, and applicable NDCs were updated.

2023-02-09policy_creation