ModifiedmhnPolicy CP.PHAR.622

Lenacapavir (Sunlenca, Yeztugo)

Medical policy governing prior authorization, coverage criteria, and continued use for lenacapavir (Sunlenca for treatment and Yeztugo for PrEP) for members under the payer's lines of business listed.

Policy Summary

Payermhn

PolicyLenacapavir (Sunlenca, Yeztugo)

Policy CodePolicy CP.PHAR.622

Change TypeAdded PrEP brand + extended approval durations

Effective Date06.01.23

Next Review Date

Key ActionObtain prior authorization with documentation (chart notes, labs) showing member meets all approval criteria before initiating Sunlenca or Yeztugo.

SourceLink

POLICY UPDATE CHANGES

Added newly approved brand Yeztugo and corresponding HIV-1 PrEP criteria.

For HIV-1 infection, extended initial approval duration from 7 months to 12 months for maintenance medication and extended Commercial continued approval duration from 6 months to '6 months or to the member's renewal date, whichever is longer'.

Added ICHRA line of business.

Added step therapy bypass for Illinois HIM per IL HB 5395.

2indications covered

12 moMedicaid/HIM approval

6 moCommercial approval

≥18min age (Sunlenca)

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≥35 kgmin weight (Yeztugo)

J1961,J0738,J0752,J8499codes referenced

Coverage Criteria

Initial Therapy — Sunlenca (HIV-1 Infection)

Covered when ALL of the following are met:

ALL of the following

Request is for Sunlenca;
Diagnosis of multidrug resistant HIV-1 infection;
Prescribed by or in consultation with an infectious disease or HIV specialist;
Age ≥ 18 years;
Documentation of resistance to at least 2 antiretroviral medications from at least 3 of the 4 main classes (NRTI, NNRTI, PI, INSTI), unless clinically significant adverse effects are experienced or all are contraindicated;
If CCR5 tropic, failure of maraviroc (Selzentry®), unless contraindicated, clinically significant adverse effects are experienced or member is resistant; Note: For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395;
Current (within the past 30 days) HIV ribonucleic acid viral load of ≥ 200 copies/mL;
Prescribed concurrently with additional antiretroviral agents to which member is susceptible, if available;
Dose does not exceed one of the following (a, b, or c): - a. Initiation Option 1 (i and ii): - i. Day 1: 927 mg by subcutaneous injection (2 x 1.5 mL injections) and 600 mg orally (2 x 300 mg tablets); - ii. Day 2: 600 mg orally (2 x 300 mg tablets); - b. Initiation Option 2 (i-iv): - i. Day 1: 600 mg orally (2 x 300 mg tablets); - ii. Day 2: 600 mg orally (2 x 300 mg tablets); - iii. Day 8: 300 mg orally (1 x 300 mg tablet); - iv. Day 15: 927 mg by subcutaneous injection (2 x 1.5 mL injections); - c. Maintenance: 927 mg by subcutaneous injection (2 x 1.5 mL injections) every 6 months (26 weeks) from the date of the last injection ± 2 weeks. Note: The initiation doses may be repeated if the member misses a scheduled maintenance dose by more than 28 weeks, and it is clinically appropriate to continue Sunlenca.

Initial Therapy — Yeztugo (PrEP)

Covered when ALL of the following are met:

ALL of the following

Request is for Yeztugo;
Member is HIV-negative and has no signs or symptoms of acute HIV infection;
Member is considered at high risk for acquiring HIV and meets one of the following: - a. Engaging in sexual activity with an HIV-1 infected partner; - b. Engaging in sexual activity and one or more of the following: inconsistent or no condom use; diagnosis of sexually transmitted infections in the past 6 months; exchange of sex for commodities; incarceration; not in a monogamous partnership; partner of unknown HIV status with any of the preceding risk factors; - c. Use of illicit injection drugs;
Member weighs ≥ 35 kg;
Yeztugo is not prescribed concurrently with any other antiretroviral medications, including other agents for PrEP (e.g., Apretude®, Descovy®, emtricitabine/tenofovir disoproxil fumarate);

Coding and Billing

Referenced HCPCS / CodingHCPCS

J8499	Prescription drug, oral, non-chemotherapeutic, NOS
J1961	Injection, lenacapavir, 1 mg
J0738	Injection, lenacapavir, 1 mg; FDA-approved only for HIV pre-exposure prophylaxis (PrEP), not for treatment
J0752	Oral, lenacapavir, 300 mg; FDA-approved only for HIV pre-exposure prophylaxis (PrEP), not for treatment

Prior Authorization

Prior Authorization Required

Prior authorization is required for lenacapavir products when coverage criteria in this policy apply. Providers must obtain prior authorization before billing. Submit clinical documentation that supports medical necessity as described in the policy (diagnosis, prior therapy history, rationale for use, and any laboratory or resistance testing results when applicable).

Prior authorization must be obtained prior to claim submission for covered members.
Include clinical justification: diagnosis, prior therapy trials and failures, and any relevant lab/resistance data.

Prior Authorization

Prior Authorization and Coding Updates

Notify payer of any coding updates or changes in drug formulation or administration route that could affect claim submission. If using miscellaneous or nonspecific codes (e.g., J8499), attach detailed documentation including drug name, strength, quantity, NDC when available, and clinical indication to avoid denials.

Providers should update prior authorization requests when there are coding changes affecting the requested service.
When billing with J8499 include drug name, strength, NDC, and clinical indication on the claim and in supporting documentation.

Provider Actions / Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Sunlenca (treatment) and Yeztugo (PrEP); approval requires submission of documentation demonstrating that all applicable clinical approval criteria are met.

Requests must meet the policy's listed clinical criteria for Sunlenca or Yeztugo (diagnosis, age/weight, lab results, dosing limits, specialist involvement, etc.).

Note

PA and coding updates; provider notification

The policy and prior authorization requirements have been updated over time and now reference multiple HCPCS codes for lenacapavir formulations; providers should follow the plan's PA process for the specific lenacapavir formulation requested.

Policy history notes addition of HCPCS codes (J1961, J0738, J0752) and other coding updates — follow current PA submission instructions.

Step Therapy

Background

Lenacapavir is an HIV‑1 capsid inhibitor available as Sunlenca (for treatment of multidrug‑resistant HIV‑1 in heavily treatment‑experienced adults) and as Yeztugo (for HIV pre‑exposure prophylaxis). Sunlenca is intended to be used in combination with other antiretroviral agents when resistance, intolerance, or safety concerns limit standard regimens. Yeztugo is approved for PrEP to reduce the risk of sexually acquired HIV‑1 and requires confirmation of HIV‑negative status prior to initiation; Yeztugo is authorized for at‑risk adolescents and adults meeting the product weight threshold.

Definitions

Lenacapavir / Sunlenca / Yeztugo — key value summary

MechanismHIV-1 capsid inhibitor (lenacapavir).

Brand namesSunlenca (treatment), Yeztugo (PrEP).

Approved treatment indicationSunlenca: treatment of multidrug‑resistant HIV‑1 in heavily treatment‑experienced adults, used in combination with other antiretrovirals when current regimen is failing due to resistance, intolerance, or safety issues.

Approved PrEP indicationYeztugo: pre‑exposure prophylaxis to reduce risk of sexually acquired HIV‑1 in adults and adolescents weighing ≥35 kg; requires a negative HIV‑1 test prior to initiation.

Population/age/weight limitsSunlenca: adults (≥18 years) for treatment; Yeztugo: adults and adolescents weighing ≥35 kg for PrEP.

Policy Summary

Payermhn

PolicyLenacapavir (Sunlenca, Yeztugo)

Policy CodePolicy CP.PHAR.622

Change TypeAdded PrEP brand + extended approval durations

Effective Date06.01.23

Next Review Date

Key ActionObtain prior authorization with documentation (chart notes, labs) showing member meets all approval criteria before initiating Sunlenca or Yeztugo.

SourceLink

On This Page

Dose does not exceed the following (a and b): - a. Initiation: - i. Day 1: 927 mg by subcutaneous injection (2 x 1.5 mL injections) and 600 mg orally (2 x 300 mg tablets); - ii. Day 2: 600 mg orally (2 x 300 mg tablets); - b. Continuation (i or ii): - i. 927 mg by subcutaneous injection (2 x 1.5 mL injections) every 6 months (26 weeks) from the date of the last injection ± 2 weeks; - ii. All of the following: 1) 300 mg orally (1 x 300 mg tablet) every 7 days for up to 6 months; 2) Documentation that the scheduled 6-month injection is anticipated to be delayed by more than 2 weeks; 3) Attestation that tablets will be used only on an interim basis. Note: The initiation doses may be repeated if the member misses a scheduled continuation dose by more than 28 weeks and Yeztugo tablets have not been taken.

Documentation Required

Required Documentation

Maintain and provide upon request all medical records supporting the service: signed physician orders, medication administration records, progress notes, documentation of prior therapies, lab results, and prior authorization approval letter. Failure to supply required documentation may result in claim denial or retrospective recoupment.

Required documentation: signed orders, MARs, clinician notes, prior therapy history, lab/resistance reports, and prior authorization approval.
Keep documentation on file and submit with claims or appeals as requested.

Billing Rule

Coding Documentation

For claim submission, use the most specific HCPCS code applicable. Coding guidance for this policy includes: J1961 (Injection, lenacapavir, 1 mg), J0738 (Injection, lenacapavir, 1 mg — FDA-approved for PrEP only), J0752 (Oral, lenacapavir, 300 mg — FDA-approved for PrEP only), and J8499 (Prescription drug, oral, non-chemotherapeutic, NOS) when no specific code exists. When using J8499, include NDC, quantity, strength, and clinical indication in the claim documentation.

Bill J1961 for injectable lenacapavir per 1 mg unit when applicable.
Do not use J0738 or J0752 for HIV treatment — these are FDA-labeled for PrEP only; verify clinical indication.
Use J8499 only when no specific HCPCS is available and include detailed supporting documentation.

Step Therapy

State-Specific Step Therapy Rules

State-specific step therapy or prior authorization override rules may apply. Providers must follow applicable state regulations where the member resides — including any mandated exceptions to step therapy or expedited override processes. Check state-specific requirements and include documentation to support any requested exception.

Follow state-mandated step therapy exception and override procedures applicable to the member's residence.
Include supporting documentation for any exception request (e.g., intolerance, contraindication, or clinical rationale).

Step Therapy

Step Therapy Changes

Step therapy requirements and changes: if the policy requires trial and failure of preferred agents before lenacapavir is authorized, document prior use, dates, doses, and reasons for discontinuation (inefficacy, adverse effects, contraindication). When step therapy policies are updated, providers must submit revised clinical evidence to the prior authorization reviewer to support continuation of therapy or exception requests.

Document trials of preferred agents with dates, doses, and reason for discontinuation.
When step therapy rules change, update prior authorization requests with current clinical evidence and rationale for exception if applicable.

Nevada restrictions on medical management

For members in Nevada, medical management techniques beyond step therapy (including quantity management) are not allowed; follow state-specific restrictions when requesting authorization.

Do not apply additional medical management techniques beyond step therapy for Nevada-member requests.

Step Therapy

Step therapy bypass and updates (Illinois HIM)

Step therapy rules were modified to add a bypass for Illinois HIM members per IL HB 5395 and other adjustments (for example, removal of a Fuzeon failure requirement); apply these exceptions where applicable.

Illinois HIM: step therapy requirements noted in the Sunlenca criteria do not apply as of 1/1/2026 per IL HB 5395.

Documentation Required

Submit chart notes, labs, and clinical information

When submitting a PA, include supporting clinical documentation such as office chart notes, laboratory results, and other clinical information that demonstrate the member meets all approval criteria.

Examples: HIV RNA viral load results, resistance testing, specialist consultation notes, weight for Yeztugo, HIV test results for PrEP eligibility.

Documentation Required

Must submit documentation demonstrating all approval criteria are met

Provider must submit documentation (e.g., chart notes, lab results, other clinical information) showing the member meets every applicable approval criterion; absence of required documentation may result in denial of the request.

If documentation demonstrating criteria (for example, HIV RNA ≥ 200 copies/mL for Sunlenca or a negative HIV test for Yeztugo) is not provided, the PA may be denied.

Denial Risk

Contraindications that may trigger denial

Prescribing Sunlenca when the member is receiving concomitant strong CYP3A inducers, or prescribing Yeztugo when the member's HIV-1 status is unknown or positive, are contraindications and may lead to denial.

Sunlenca contraindication: concomitant strong CYP3A inducers.
Yeztugo contraindication: unknown or positive HIV-1 status (requires documented negative HIV test before initiation).

integrase strand transfer inhibitors (INSTI) definition

DefinitionINSTI = integrase strand transfer inhibitors.

ContextINSTIs are listed in the policy appendix as one of the main antiretroviral classes referenced for resistance assessment (NRTI, NNRTI, PI, INSTI).

Relevance to criteriaResistance to antiretrovirals from multiple classes including INSTIs is part of Sunlenca initial therapy eligibility.

pre-exposure prophylaxis (PrEP) definition

DefinitionPrEP = pre‑exposure prophylaxis.

PurposePharmacologic prevention to reduce risk of sexually acquired HIV‑1 in at‑risk individuals prior to exposure.

Policy implicationYeztugo is approved and covered as a PrEP agent for adults and adolescents ≥35 kg who are HIV‑negative at initiation and at high risk for acquisition.