CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lenacapavir (Sunlenca) coverage criteria for heavily treatment‑experienced, multidrug‑resistant HIV‑1

Coverage policy for Sunlenca (lenacapavir) for treatment of HIV‑1 in heavily treatment‑experienced adults with multidrug‑resistant infection; governs prescribers and prior authorization/benefit limits for Neighborhood Health Plan of Rhode Island members under listed medical/pharmacy scopes.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLenacapavir (Sunlenca) coverage criteria for heavily treatment‑experienced, multidrug‑resistant HIV‑1

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization; initial approvals are for 6 months and continuation approvals for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization duration

12 mocontinuation authorization duration

J1961billing HCPCS code

1 pack/yrtablet quantity limit

Every 6 momaintenance injection schedule

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Coverage Criteria for Lenacapavir (Sunlenca)

Initial Approval

Covered when ALL of the following are met:

Initial approval for 6 months: A. Patient has heavily treatment‑experienced, multidrug‑resistant disease, confirmed by resistance to at least two drugs in at least three antiretroviral classes; B. Baseline plasma HIV‑1 RNA ≥ 400 copies/mL; C. Patient has been on their current antiretroviral regimen for at least 2 months and is failing that regimen; D. Lenacapavir will be used in combination with highly active antiretroviral therapy (HAART) for which resistance testing shows the patient's virus is known to be susceptible6 months

Authorization of 6 months may be granted

Continuation Therapy

Covered when ALL of the following are met:

Continuation/renewal for 12 months: A. Demonstrated clinical benefit from lenacapavir (Sunlenca) therapy (e.g., reduction in viral load from baseline); B. Lenacapavir will continue to be taken in combination with an optimized antiviral background regimen including one or more other antiretroviral agents12 months

Authorization of 12 months may be granted

Coverage for Sunlenca (lenacapavir) is limited to the indication and criteria specified in this policy. Requests that meet the documented criteria for treatment of heavily treatment‑experienced adults with multidrug‑resistant HIV‑1 may be approved per the stated authorization periods. All other uses, including treatment of populations or indications not explicitly listed, are not covered under this policy and are considered experimental/investigational.

Use of Sunlenca for any indication other than treatment of heavily treatment‑experienced, multidrug‑resistant HIV‑1 is considered experimental/investigational and not medically necessary. Such requests are subject to denial.

Coding and Billing

Billing HCPCS CodesHCPCSCovered

J1961

injection, lenacapavir, 1mg

inv-06: Baseline viral load — baseline plasma HIV-1 RNA threshold/value

Baseline plasma HIV-1 RNA threshold≥ 400 copies/mL

PurposeRequired for initial approval of lenacapavir (Sunlenca) for treatment of HIV-1

Authorization implicationMeets one of the required criteria for a 6-month initial authorization when combined with other listed criteria

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Requests for Sunlenca (lenacapavir) require prior authorization. Approval, when criteria are met for initial therapy, is for up to 6 months; for continuation therapy, approval may be granted for up to 12 months.

Prior authorization is required before drug dispensation.
Initial approval duration: up to 6 months when all initial criteria are met.
Continuation approval duration: up to 12 months when continuation criteria are met.

Prior Authorization

Combination Therapy Requirement

Combination Therapy Requirement: Sunlenca must be used in combination with an optimized background regimen (HAART). The background regimen should include one or more other antiretroviral agents and, per resistance testing, the regimen should contain agents to which the virus is known to be susceptible.

Sunlenca is not to be used as monotherapy; must be given with an optimized HAART background regimen.
Continuation approvals require ongoing use with an optimized antiviral background including one or more other antiretroviral agents.

Background

Sunlenca (lenacapavir) is a capsid inhibitor indicated, in combination with other antiretroviral agents, for the treatment of HIV‑1 infection in heavily treatment‑experienced adults with multidrug‑resistant HIV‑1. Use is intended for patients whose current antiretroviral regimen is failing because of resistance, intolerance, or other considerations and who require an optimized background regimen alongside lenacapavir.

Key Definitions

inv-12: Heavily treatment-experienced, multidrug-resistant disease — definition (resistance to ≥2 drugs in ≥3 classes)

DefinitionResistance to at least two drugs in at least three antiretroviral classes, confirmed by resistance testing

Clinical roleCharacterizes the heavily treatment-experienced, multidrug-resistant population eligible for lenacapavir under this policy

DocumentationResistance testing must demonstrate the specified multi-class resistance to support prior authorization

inv-13: Baseline viral load threshold — Baseline plasma HIV-1 RNA ≥ 400 copies/mL

Threshold valueBaseline plasma HIV-1 RNA ≥ 400 copies/mL

ApplicationRequired as part of initial approval criteria for lenacapavir (Sunlenca)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLenacapavir (Sunlenca) coverage criteria for heavily treatment‑experienced, multidrug‑resistant HIV‑1

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization; initial approvals are for 6 months and continuation approvals for 12 months when criteria are met.

SourceLink

On This Page

If viral load increases or expected response is not achieved, prompt resistance testing and optimization of the background regimen are required.

Denial Risk

Indication-related Denial Risk

Indication-related Denial Risk: Requests falling outside the specified heavily treatment-experienced, multidrug-resistant HIV-1 population or lacking required supporting documentation may be denied.

Requests for indications other than treatment of heavily treatment-experienced adults with multidrug-resistant HIV-1 are considered experimental/investigational and may be denied.
Lack of documentation of resistance to at least two drugs in at least three classes, baseline viral load ≥ 400 copies/mL, evidence of treatment failure on current regimen, or absence of resistance testing demonstrating susceptibility to the background regimen increases denial risk.

Documentation Required

Required Clinical Documentation

Required Clinical Documentation: Include resistance testing results, baseline viral load, documentation of current antiretroviral regimen and duration (≥ 2 months), and evidence of treatment failure on the current regimen.

Document resistance to at least two drugs in at least three classes.
Provide baseline viral load (≥ 400 copies/mL) at time of request.
Confirm patient has been on current antiretroviral regimen for at least 2 months and is failing that regimen.
Provide resistance testing demonstrating the virus is susceptible to the proposed background agents.

Authorization effectContributes to eligibility for a 6-month initial authorization when all criteria are met