CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Medicaid_Cmp_Sunlenca_Rx_20250903

Policy governing Medicaid (and listed medical/commercial/Medicare scopes) coverage, prior authorization criteria, quantity limits, and billing codes for Sunlenca (lenacapavir) when used to treat HIV-1 in heavily treatment-experienced adults with multidrug-resistant infection.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedicaid_Cmp_Sunlenca_Rx_20250903

Policy CodePolicy N/A

Change TypeClarified (non-material review)

Effective DateJul 1, 2023

Next Review Date

Key ActionDocument resistance testing confirming resistance to at least two drugs in at least three classes and document that the background HAART is sensitive/susceptible; request prior authorization for initial (up to 6 months) and continuation (up to 12 months) per criteria.

SourceLink

POLICY UPDATE CHANGES

Reviewed dates listed as 3/23, 3/24, 9/25 indicating periodic review; no clinical policy statement changes noted in document.

1Covered FDA indication(s)

4Initial approval criteria count

2Continuation approval criteria count

2Formulation quantity limit items

Coverage stance: covered_with_criteria. Scope: Policy governs Medicaid (and listed medical/commercial/Medicare scopes) coverage, prior authorization criteria, quantity limits, and billing codes for Sunlenca (lenacapavir) when used to treat HIV-1 in heavily treatment-experienced adults with multidrug-resistant infection. Covered indication: FDA-approved indication — treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current regimen due to resistance, intolerance, or safety considerations. Not covered: All other indications are considered experimental/investigational and not medically necessary.

Effective date: 2023-07-01. Last review date: 2025-09-01.

Quick reference

Baseline viral load≥ 400 copies/mL

Initial authUp to 6 months

Continuation authUp to 12 months

Continuation Therapy Criteria

Continuation of Therapy

Authorization of 12 months may be granted when ALL of the following are met:

Clinical benefit: There is a clinical benefit demonstrated from Sunlenca therapy (e.g., reduction in viral load from baseline)
Increases in viral load from nadir or less-than-anticipated reduction should prompt resistance testing and optimization of background regimen.
Continued combination therapy: Sunlenca will continue to be taken in combination with an optimized antiviral background regimen including one or more other antiretroviral agents

Indications and Exclusions

Indications / Exclusions

Covered indication and exclusion statement:

Covered FDA indication: Covered: FDA-approved indication — treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current regimen due to resistance, intolerance, or safety considerations
Not covered: All other indications are considered experimental/investigational and not medically necessary

Provider Actions (Prior Authorization, Documentation, Billing)

Prior Authorization

Prior authorization required for Sunlenca

Prior authorization is required for Sunlenca (lenacapavir). Initial authorization may be granted for up to 6 months when initial criteria are met; continuation authorization may be granted for up to 12 months when continuation criteria are met. Providers must document resistance testing showing multi-drug resistance and that the background HAART regimen is susceptible per testing.

Affected billing code: J1961
Initial authorization: up to 6 months
Continuation authorization: up to 12 months

Documentation Required

Resistance testing documentation

Document resistance testing that confirms resistance to at least two drugs in at least three antiretroviral classes, and include documentation that the background HAART regimen is sensitive/susceptible based on resistance testing.

Billing Rule

Quantity limits and dosing/billing guidance

Quantity limits and dosing/billing guidance for Sunlenca:

Tablet pack limit: Sunlenca 300 mg tablets — 1 pack (4 or 5 tablets) per 365 days
Vial limit: Sunlenca 463.5 mg/1.5 mL single-dose vials — 3 mL per 6 months (26 weeks)
Injection maintenance dosing: 927 mg subcutaneous (2 x 1.5 mL injections) every 6 months (26 weeks) from last injection ±2 weeks
Oral bridging: If scheduled injection will be missed by >2 weeks, tablets may be used for oral bridging for up to 6 months (recommended 300 mg orally once every 7 days)
Billing code: J1961 applies for injection where applicable
Quantity limit exception requests may be reviewed on a case-by-case basis

Denial Risk

Coverage denial for non-FDA indications

Claims for uses other than the FDA-approved indication (treatment of heavily treatment-experienced adults with multidrug-resistant HIV-1 failing their current regimen) are considered experimental/investigational and not medically necessary, and may be denied.

Clinical Evidence & References

Reference: Sunlenca [package insert], Gilead Sciences, Inc.; October 2023. Accessed March 2024.

Policy note: Use is restricted to the FDA-approved indication described in the package insert; uses outside the approved indication are considered experimental/investigational and not medically necessary.

Background and Definitions

Background: Sunlenca (lenacapavir) is an HIV-1 capsid inhibitor indicated for heavily treatment-experienced adults with multidrug-resistant HIV-1 failing current regimens.

Prescriber requirement: This medication must be prescribed by or in consultation with an infectious disease specialist who specializes in the treatment of HIV infection.

Definitions: Heavily treatment-experienced multi-drug resistant disease — resistance to at least two drugs in at least three antiretroviral classes as confirmed by resistance testing. HAART — highly active antiretroviral therapy used in combination with Sunlenca, with background regimen sensitivity confirmed by testing.

Revision History

2023-07-01effective

Policy became effective 2023-07-01 (initial effective date). Reviewed entries later indicate periodic reviews but no material changes to policy criteria.

2024-03-23review

Periodic review noted (3/23); document indicates review but no material changes to clinical policy criteria.

2024-03-24review

Periodic review noted (3/24); document indicates review but no material changes to clinical policy criteria.

2025-09-01reviewLatest

Periodic review noted (9/25); document indicates review but no material changes to clinical policy criteria.