CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sunlenca (lenacapavir) — Coverage Criteria

Policy governs clinical coverage criteria, prescribing requirements, dosing, quantity limits, and billing for Sunlenca (lenacapavir) for treatment of heavily treatment-experienced adults with multidrug-resistant HIV-1 for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySunlenca (lenacapavir) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization and document resistance testing showing resistance to at least two drugs in at least three antiretroviral classes plus baseline viral load ≥400 copies/mL.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization duration

12 mocontinuation authorization duration

≥400 cp/mLbaseline viral load required

3 mL/6 moinjectable vial limit

J1961billing code

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Coverage Criteria for Sunlenca (lenacapavir)

Initial Therapy

Authorization of 6 months may be granted for treatment of HIV-1 when ALL of the following are met:

Initial Approval Requirements: A. Patient has heavily treated multi-drug resistant disease, confirmed by resistance testing, to at least two drugs in at least three classes; AND B. Patient has a baseline viral load >= 400 copies/mL; AND C. Patient is failing on their current antiretroviral regimen for at least 2 months; AND D. Sunlenca will be used in combination with highly active antiretroviral therapy (HAART) for which, via resistance testing, the patient's disease is known to be sensitive/susceptible; AND E. Medicare members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements.

See policy for class examples (NRTI, NNRTI, PI, INSTI).

Continuation Therapy

Authorization of 12 months may be granted for members continuing with Sunlenca therapy when ALL of the following are met:

Continuation Approval Requirements: A. There is a clinical benefit demonstrated from Sunlenca therapy (e.g., reduction in viral load from baseline); AND B. Sunlenca will continue to be taken in combination with an optimized antiviral background regimen including one or more other antiretroviral agents.

Increases in viral load from nadir or less than anticipated reduction should prompt resistance testing and optimization of the background regimen.

Dosing and Quantity Limits

Dosing schedules and quantity limits that affect coverage and authorization:

Dosing Options: Initiation Option 1: Day 1: 927 mg subcutaneous (2 x 1.5 mL injections) AND 600 mg orally (2 x 300 mg tablets); Day 2: 600 mg orally (2 x 300 mg tablets). Initiation Option 2: Day 1: 600 mg orally (2 x 300 mg tablets); Day 2: 600 mg orally (2 x 300 mg tablets); Day 8: 300 mg orally (1 x 300 mg tablet); Day 15: 927 mg subcutaneous (2 x 1.5 mL injections). Maintenance: 927 mg subcutaneous every 6 months (26 weeks) +/- 2 weeks. If a scheduled injection will be missed by >2 weeks, oral bridging with 300 mg once weekly may be used for up to 6 months.

Quantity limits: Sunlenca 300 mg tablets — 1 pack (4 or 5 tablets) per 365 days; injectable vials (463.5 mg/1.5 mL) — 3 mL per 6 months (26 weeks).

Not Medically Necessary

Experimental/Not Medically Necessary: All indications other than the FDA-approved indication (heavily treatment-experienced adults with multidrug resistant HIV-1 failing current regimen due to resistance, intolerance, or safety considerations) are considered experimental/investigational and not medically necessary.

Use of Sunlenca (lenacapavir) for indications other than the FDA-approved population of heavily treatment-experienced adults with multidrug-resistant HIV-1 who are failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations is considered experimental/investigational and is not covered.

All other indications for Sunlenca (lenacapavir) beyond the FDA-approved indication described above are considered experimental/investigational and not medically necessary.

Billing and Coding

Billing code for lenacapavir injectionHCPCSCovered

J1961

injection, lenacapavir, 1mg

inv-08: Baseline viral load — >= 400 copies/mL

Baseline viral load requirement>= 400 copies/mL

Context in initial approvalRequired as one of five initial approval criteria for 6-month authorization

Supporting actionsUse baseline viral load measurement to document failure of current regimen for >= 2 months

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial approvals are granted for 6 months when all initial criteria are met. Continuation authorizations require documentation of ongoing clinical benefit and meeting continuation criteria.

Initial approval duration: 6 months
Continuation: documentation of ongoing clinical benefit required

Step Therapy

Step Therapy Exception for Medicare

Medicare members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements.

Documentation Required

Background

Sunlenca (lenacapavir) is an HIV-1 capsid inhibitor indicated, in combination with other antiretrovirals, 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.

Definitions and Clinical Terms

inv-15: Heavily treatment-experienced multi-drug resistant disease

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

Classes referencedExamples include NRTI, NNRTI, PI, and INSTI (see policy for class-specific examples)

DocumentationRequires resistance testing results to confirm multi-class resistance for initial authorization

inv-16: Clinical benefit for continuation

Clinical benefit standardDemonstrated reduction in viral load from baseline or continued virologic suppression while on Sunlenca plus optimized background regimen.

Continuation authorization durationAuthorization of 12 months may be granted when clinical benefit is demonstrated

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySunlenca (lenacapavir) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization and document resistance testing showing resistance to at least two drugs in at least three antiretroviral classes plus baseline viral load ≥400 copies/mL.

SourceLink

On This Page

Required Documentation

Documentation must include resistance testing confirming resistance to at least two drugs in at least three classes, baseline viral load, evidence of failure on the current regimen for ≥2 months, and a plan for concomitant HAART demonstrating susceptibility by resistance testing.

Resistance testing showing resistance to ≥2 drugs in ≥3 classes
Baseline viral load ≥ 400 copies/mL
Evidence of treatment failure on current regimen for ≥ 2 months
Plan showing Sunlenca will be used in combination with HAART to which virus is susceptible per resistance testing

Denial Risk

Experimental / Investigational Uses

All other indications are considered experimental/investigational and not medically necessary.

Denial Risk

Failure to Meet Initial Approval Criteria

If the patient does not meet the initial approval criteria for heavily treatment-experienced multidrug-resistant HIV-1 (i.e., resistance to at least two drugs in at least three classes, baseline viral load ≥ 400 copies/mL, failing current regimen ≥2 months, and planned use in combination with HAART shown to be susceptible by resistance testing), the request will be denied as not meeting medical necessity. Providers may submit additional clinical rationale and supporting documentation for reconsideration or appeal.

Denial condition: failure to meet any of the initial approval criteria listed under IV. Criteria for Initial Approval
Appeal: submit additional clinical rationale and supporting documentation for reconsideration

Action on suboptimal responseIncreases in viral load from nadir or less-than-anticipated reduction should prompt resistance testing and background regimen optimization