CurrentAvMedPolicy N/A

Sunlenca (lenacapavir) prior authorization for multidrug-resistant HIV-1

Defines prior authorization, clinical criteria, dosing, and documentation requirements for Sunlenca (lenacapavir) use in members with multidrug-resistant HIV-1; applies to providers prescribing this medication for AvMed members.

Policy Summary

PayerAvMed

PolicySunlenca (lenacapavir) prior authorization for multidrug-resistant HIV-1

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateOct 31, 2025

Key ActionSubmit medical prior authorization form with prescriber signature and required clinical documentation including genotype/phenotype results and recent viral load.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12 & ≥35 kgage/weight eligibility

>400 cp/mLvirologic failure threshold

927 mg q26wmaintenance dosing

3 mL/184dquantity limit

2 optionsinduction options

Coverage Criteria for Sunlenca (lenacapavir)

Initial Approval for Multidrug-Resistant HIV-1

Covered when ALL of the following are met

Population: Member is ≥ 12 years of age and weighing ≥ 35 kg, or an adult aged ≥ 18 years.age/weight per policy

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Prescriber: Prescribed by, or in consultation with, an infectious disease specialist or specialist in HIV treatment.

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Resistance: Documented multidrug-resistant HIV-1 with resistance to at least TWO (2) antiretroviral medications from ≥ 3 of the 4 main antiretroviral drug classes (NRTI/NNRTI, protease inhibitors, entry inhibitors including CCR5 antagonists, integrase inhibitor); submit genotype/phenotype resistance testing results.

Policy Summary

PayerAvMed

PolicySunlenca (lenacapavir) prior authorization for multidrug-resistant HIV-1

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateOct 31, 2025

Key ActionSubmit medical prior authorization form with prescriber signature and required clinical documentation including genotype/phenotype results and recent viral load.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Dosing Regimen

Induction/Initiation Regimens
- Initiation Option 1: Day 1: 927 mg subcutaneous (2 × 1.5 mL injections) AND 600 mg orally (2 × 300 mg tablets); Day 2: 600 mg orally (2 × 300 mg tablets).
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- Initiation Option 2: Day 1: 600 mg orally (2 × 300 mg tablets); Day 2: 600 mg orally (2 × 300 mg tablets); Day 8: 300 mg orally (1 × 300 mg tablet); Day 15: 927 mg subcutaneous (2 × 1.5 mL injections).
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Maintenance Dosing: Maintenance dose: 927 mg by subcutaneous injection (2 × 1.5 mL injections) every 6 months (26 weeks) from the date of the last injection ± 2 weeks; quantity limit 3 mL per 184 days.maintenance dosing per policy
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Coding and Dosing

Covered HCPCSHCPCSCovered

J1961

Sunlenca (lenacapavir)

inv-04: Weight — >= 35 kg for ages ≥ 12 years

Age/weight eligibilityMember is ≥ 12 years and weighing ≥ 35 kg, or an adult aged ≥ 18 years.

Weight threshold value>= 35 kg for ages ≥ 12 years.

Documentation requiredDate weight obtained must be provided on request form.

Quantity noteMaintenance dosing and quantity limit apply only after induction (see dosing); maintenance: 927 mg SC every 26 weeks.

inv-05: Viral load — > 400 copies/mL

Virologic failure thresholdCurrent virologic failure defined as viral load greater than 400 copies/mL prior to treatment initiation.

Required lab timingMost recent viral load must be submitted and obtained within 4-8 weeks prior to initiating therapy.

Field on formRequest form includes a 'Current Viral Load' field to report copies/mL.

Use for approval decisionViral load > 400 copies/mL is a required criterion for coverage approval.

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required for Sunlenca (J1961)

Sunlenca (lenacapavir) (J1961) requires prior authorization using the medical prior authorization/step-edit form with the prescribing physician's signature and supporting clinical documentation for approval.

Drug requested listed as Sunlenca (lenacapavir) (J1961) on the PA form
Prescribing physician must sign and clearly print name (preprinted stamps not valid)

Step Therapy

Samples do not meet step-edit/preauthorization

Use of sample medication to initiate therapy does not meet step-edit/preauthorization criteria; the source of prior therapies will be verified via pharmacy paid claims or submitted chart notes.

If medication was started with a sample, that does not satisfy step/PA requirements
Previous therapies will be verified through pharmacy claims or chart notes

Documentation Required

Required documentation and prescriber signature

Submit the completed medical prior authorization form with the prescriber signature and include member demographics, diagnosis/ICD code, weight (and date obtained) if applicable, genotype/phenotype resistance test results, current viral load (lab within 4–8 weeks), documentation of an optimized background regimen, and the selected induction/maintenance dosing schedule.

Prescriber signature required; preprinted stamps are not valid
Weight and date weight obtained (if applicable)
Genotype/phenotype resistance testing results
Current viral load with most recent labwork (within 4–8 weeks)
Documentation of optimized background antiretroviral regimen and chosen initiation/maintenance dosing

Denial Risk

Incomplete or illegible requests may delay/deny authorization

Authorization can be delayed if information on the request is incomplete, incorrect, or illegible; ensure member and prescriber contact information (including phone and fax) are complete and legible to avoid delays.

Incomplete or illegible requests may delay authorization
Ensure phone and fax numbers on the form are correct

Denial Risk

Missing clinical documentation may result in denial

Requests lacking required clinical documentation may be denied — include genotype/phenotype resistance testing, current viral load within 4–8 weeks, documentation of an optimized background regimen, and the selected induction/maintenance dosing regimen.

Genotype/phenotype resistance test results must be submitted
Current viral load lab result (within 4–8 weeks) required
Documentation confirming use with an optimized background regimen
Selected initiation option and maintenance dosing schedule must be provided

Definitions

inv-12: Multidrug resistant HIV-1 — Member has documented resistance to at least two antiretroviral medications from three or more of the four main antiretroviral drug class...

DefinitionMember has documented multidrug resistant HIV-1 infection with resistance to at least TWO antiretroviral medications from ≥ 3 of the 4 main antiretroviral drug classes.

Classes enumeratedNucleoside/Non-nucleoside Reverse Transcriptase Inhibitors (NRTI/NNRTI), Protease Inhibitors, Entry Inhibitors (including CCR5 antagonists), Integrase Inhibitors.

Evidence requiredMust submit genotype/phenotype resistance testing results to document resistance.

Role in criteriaDocumented multidrug resistance is a mandatory coverage criterion for Sunlenca approval.

inv-13: Current virologic failure — Viral load greater than 400 copies/mL prior to treatment initiation with most recent labwork submitted (within 4-8 weeks).

Current virologic failure definitionMember is experiencing current virologic failure defined as having a viral load greater than 400 copies/mL before treatment initiation.

Lab submission requirementMember's current viral load must be submitted with the request; most recent labwork within 4-8 weeks is required.

Form captureThe request form includes a 'Current Viral Load' field to record copies/mL prior to initiating therapy.

Link to coverage decisionPresence of current virologic failure (>400 copies/mL) is required for approval and must accompany other criteria.

OpenPayer

Sunlenca (lenacapavir) prior authorization for multidrug-resistant HIV-1

Coverage Criteria for Sunlenca (lenacapavir)

Coding and Dosing

Provider Requirements and Prior Authorization

Background

Definitions