ModifiedHealth NetPolicy CP PHAR.622

Clinical Policy: Lenacapavir (Sunlenca, Yeztugo)

Policy governs medical necessity and prior authorization criteria for lenacapavir products (Sunlenca for treatment of multidrug-resistant HIV-1 and Yeztugo for HIV PrEP), specifying required documentation, prescriber qualifications, dosing, and approval durations.

Policy Summary

PayerHealth Net

PolicyLenacapavir (Sunlenca, Yeztugo) coverage criteria

Policy CodePolicy CP PHAR.622

Change TypeMaterial update — added Yeztugo (PrEP), HCPCS codes, and revised continued approval wording

Effective DateJun 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with clinical documentation (chart notes, labs, resistance testing) and the appropriate HCPCS/J-code to support indication and dosing.

SourceLink

POLICY UPDATE CHANGES

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

Revised continued approval duration for Commercial to align with standard injectable agent approach.

Added HCPCS codes J0738 and J0752 (and referenced J1961, J8499) for lenacapavir products.

2FDA indications

J0738,J0752,J1961,J8499HCPCS codes referenced

927 mgMaintenance dose

6 monthsTypical approval duration

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Coverage Criteria for Lenacapavir Products

Initial Therapy (Sunlenca)

Sunlenca (HIV-1 treatment) Covered when ALL of the following are met

Sunlenca initial therapy criteria: Request is for Sunlenca; prescribed by or in consultation with an infectious disease or HIV specialist; diagnosis of multidrug‑resistant HIV‑1; age > 18 years; documentation of resistance to >= 2 antiretroviral medications from >= 3 of the 4 main classes (NRTI, NNRTI, PI, INSTI) unless clinically significant adverse effects or contraindications; failure of prior regimens as specified in the medical record unless contraindicated; prescribed concurrently with additional active antiretroviral agents if available; dosing does not exceed labeled initiation and maintenance regimens; maintenance injections 927 mg SC every 6 months (26 weeks) from the date of the last injection + 2 weeks.age>18

Approval duration: Commercial 6 months; Medicaid/HIM 12 months

Continuation Therapy (Sunlenca)

Sunlenca continuation (members already receiving therapy) Covered when ALL of the following are met

Sunlenca continuation criteria: Currently receiving Sunlenca via the benefit, or documentation supports member has received Sunlenca for >= 30 days; request is for Sunlenca; member is responding positively to therapy; if request is for a dose increase, the new dose does not exceed labeled initiation or maintenance dosing limits; maintenance injections 927 mg SC every 6 months (26 weeks) from the date of the last injection + 2 weeks.

Initial and Continuation Therapy (Yeztugo)

Yeztugo (PrEP) Covered when ALL of the following are met

Yeztugo initial PrEP criteria: Request is for Yeztugo; member is HIV‑negative with no signs or symptoms of acute HIV infection; member is at high risk for acquiring HIV (examples include sexual activity with an HIV‑infected partner, inconsistent or no condom use, recent STI, exchange of sex for commodities, incarceration, not in a mutually monogamous partnership with a partner known to be HIV‑negative, or injection drug use); member weighs >= 35 kg; Yeztugo is not prescribed concurrently with any other antiretroviral medications including other PrEP agents; dosing follows initiation and continuation regimens with oral bridging allowed if injection is delayed.

Oral bridging for Yeztugo continuation: If a scheduled 6‑month injection is anticipated to be delayed by >2 weeks, interim dosing of 300 mg PO (1 x 300 mg tablet) once every 7 days for up to 6 months may be used until injections resume; the continuation injection should be resumed within 7 days after the last oral dose; if >28 weeks have elapsed since the last injection and no interim tablets were taken, reinitiate with the initiation dosing schedule.

Product-specific dosing and timing criteria

Coverage is tied to specific dosing regimens for each product and appropriate use (Sunlenca for HIV‑1 treatment; Yeztugo for HIV‑1 PrEP).

Sunlenca initiation and maintenance: Initiation options include oral loading and/or an initial SC injection per the labeled regimens; maintenance dosing is 927 mg SC (2 x 1.5 mL injections) every 6 months (26 weeks) from the date of the last injection + 2 weeks. If a maintenance injection is missed by more than 28 weeks and it is clinically appropriate to continue, initiation doses may be repeated per the product labeling.dose and timing per regimen

If maintenance injection is delayed, follow product labeling for interim dosing or reinitiation.

Yeztugo initiation and continuation for PrEP: Initiation includes 927 mg SC (2 x 1.5 mL injections) plus oral 600 mg on Day 1 and Day 2 per the initiation options; continuation dosing is 927 mg SC every 6 months (26 weeks). If a scheduled 6‑month injection is anticipated to be delayed by >2 weeks, interim oral dosing (300 mg PO once every 7 days for up to 6 months) may be used until injections resume; the continuation injection should be resumed within 7 days after the last oral dose. If >28 weeks have elapsed since the last injection and no interim oral doses were taken, reinitiate with the initiation schedule.timing windows (2 weeks, 28 weeks)

Coverage for indications that are not FDA‑approved and are not specifically addressed in this policy is not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (see CP.PMN.53 for Medicaid or other evidence of coverage documents).

Certain billing codes for lenacapavir products are designated for HIV pre‑exposure prophylaxis (PrEP) only. Specifically, J0738 (injection, lenacapavir) and J0752 (oral, lenacapavir, 300 mg) are described in this policy as intended only for use as HIV PrEP and must be used accordingly to reflect the indication on the claim.

Use of lenacapavir for indications that are not FDA‑approved and not covered by this policy will be considered not medically necessary unless the request includes adequate off‑label justification and documentation that meets the insurer's off‑label use requirements.

Do not bill PrEP‑designated HCPCS codes when lenacapavir is being used to treat HIV infection, and conversely do not bill treatment codes when the product is being used for PrEP. Using a PrEP‑only code (e.g., J0738, J0752) for treatment or a treatment code for PrEP may result in inappropriate coding and coverage denial; coding must accurately reflect the clinical indication and supporting documentation.

Product Codes and Billing Guidance

Product availability / NDCsNDC

NDC not listed

No NDC codes provided in this document part

Referenced HCPCS/J-codesHCPCS

J8499	Prescription drug, oral, non chemotherapeutic, nos.
J1961	Injection, lenacapavir; 1 mg.
J0738	Injection, lenacapavir, 1 mg, FDA approved prescription, only for use as HIV pre-exposure prophylaxis (not for use as treatment for HIV).
J0752	Oral, lenacapavir, 300 mg, FDA approved prescription, only for use as HIV preexposure prophylaxis (not for use as treatment for HIV).

Minimum body weight for Yeztugo

Minimum body weight>= 35 kg

PopulationMembers who are HIV-negative and meet PrEP high-risk criteria

RelevanceRequired for Yeztugo initiation and continuation dosing

Injection interval

Maintenance injection intervalEvery 6 months (26 weeks) from the date of the last injection (+ 2 weeks allowance)

Interim dosing windowIf scheduled injection is delayed by >2 weeks, oral bridging may be used (see routing) until injection resumes

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Sunlenca and Yeztugo. Prescribers must be an infectious disease or HIV specialist or consult with one when requesting Sunlenca for treatment of multidrug‑resistant HIV‑1. Submit a prior authorization request that includes the correct HCPCS/J‑codes for the product and formulation billed.

Prior authorization required for Sunlenca (treatment) and Yeztugo (PrEP).
Prescriber qualification: Sunlenca requests must be prescribed by or in consultation with an infectious disease or HIV specialist.
Providers must submit the appropriate HCPCS/J‑code(s) that correspond to the administered product and route when requesting prior authorization (see Coding Implications).

Documentation Required

Dosing and Administration Documentation

Ensure dosing, administration and product identity are documented in the chart notes submitted with the authorization request. Documentation should clearly state the dosing regimen used (initiation and maintenance schedules), dates of injections and oral doses, route of administration (SC vs PO), and the specific product name (Sunlenca vs Yeztugo).

Clinical Background

Lenacapavir is an HIV‑1 capsid inhibitor available in branded formulations for distinct indications: Sunlenca for treatment of HIV‑1 (including heavily treatment‑experienced, multidrug‑resistant infection) and Yeztugo for pre‑exposure prophylaxis (PrEP). Both products include a subcutaneous injection regimen with a maintenance dose of 927 mg SC every 6 months (26 weeks); a 300 mg tablet formulation is also available for oral dosing and interim "oral bridging" when injections are delayed.

Definitions and Terminology

PrEP definition

DefinitionPrEP (pre-exposure prophylaxis): use of antiretroviral medication to reduce risk of sexually acquired HIV-1 infection

Yeztugo indicationLenacapavir (Yeztugo) indicated for HIV-1 PrEP in HIV-negative persons at high risk

Prerequisite testingMember must be HIV-negative with no signs or symptoms of acute infection prior to initiation

ARV classes

Major ARV classes listedINSTI, NRTI, NNRTI, PI

Use in policyClasses are referenced for resistance criteria required for Sunlenca (treatment) eligibility

Abbreviations key