ModifiedAnthemPolicy CC-0291

Apretude (cabotegravir extended-release injectable suspension)

Defines medical necessity criteria, continuation criteria, quantity limits, and coding guidance for Apretude (cabotegravir extended-release injectable suspension) when provided under the medical benefit for HIV pre-exposure prophylaxis (PrEP). Applies to at-risk adults and adolescents weighing 9 kg.

Policy Summary

PayerAnthem

PolicyApretude (cabotegravir extended-release injectable suspension)

Policy CodePolicy CC-0291

Change TypeClinical criteria and coding added; exclusion for combination use added

Effective DateOct 24, 2025

Next Review Date

Key ActionPrior authorization is required and providers must document a negative HIV test performed within one week prior to initiation and prior to each subsequent injection.

SourceLink

POLICY UPDATE CHANGES

May not be used in combination with other agents for HIV criteria was added.

Clinical criteria and quantity limit for Apretude added.

1HCPCS drug code added

2ICD-10 codes listed

1Vial limit per 2 months

Coverage Summary

Scope summary: Defines medical necessity criteria, continuation criteria, quantity limits, and coding guidance for Apretude (cabotegravir extended-release injectable suspension) when provided under the medical benefit for HIV pre-exposure prophylaxis (PrEP). Applies to at-risk adults and adolescents weighing ≥35 kg.

FDA indication summary from evidence: Approved for HIV PrEP in at-risk adults and adolescents ≥35 kg; administered by a healthcare provider as a gluteal intramuscular injection once every 2 months. Black box warning: risk of drug resistance if used in undiagnosed HIV infection; individuals must be tested for HIV prior to initiating Apretude and with each subsequent injection.

Key thresholds

Weight>= 35 kg

HIV testing timingHIV test immediately (within one week) prior to initiating therapy and within one week prior to each injection

Vial limit per 2 monthsLimit = 1 vial (600 mg/3 mL) per 2 months; may approve one additional vial during the first two months of initiation or when re-initiating after missed doses

Initial Therapy Criteria

Initial requests - Medical necessity criteria

Initial requests for Apretude may be approved if ALL of the following are met:

Weight: Individual weighs at least 35 kg>= 35 kg
Indication: Individual is using for pre-exposure prophylaxis (PrEP) of human immunodeficiency (HIV) infection
HIV testing prior to initiation: Individual will undergo HIV testing immediately (within one week) prior to initiating therapy to verify HIV negative statusHIV test immediately (within one week) prior to initiating therapy
Black box warning: risk of drug resistance if used in undiagnosed HIV infection; must verify negative status prior to initiation.

Continuation Therapy Criteria

Continuation requests - Medical necessity criteria

Continuation requests for Apretude may be approved if ALL of the following are met:

Indication: Individual is using for pre-exposure prophylaxis (PrEP) of human immunodeficiency (HIV) infection
HIV testing prior to each injection: Individual is undergoing HIV testing immediately (within one week) prior to each Apretude injection to verify HIV negative statusHIV test within one week prior to each injection
Per policy must test prior to each subsequent injection; black box warning applies.

Not Approved / Exclusions

Not approved (exclusions)

Apretude may not be approved for the following (any one applies):

HIV status: Individual who is HIV positive or whose HIV status is unknown
Claims may be denied if HIV positive or status unknown.
Combination use: Use in combination with another agent for HIV treatment or prophylaxis
Policy revision: may not be used in combination with other HIV agents (added 9/8/2025).
Other indications: When the above criteria are not met and for all other indications

Black box warning: Risk of drug resistance when Apretude is used in individuals with undiagnosed HIV infection. Drug‑resistant HIV variants have been identified with use of Apretude in individuals with undiagnosed HIV infection.

Testing requirement: Individuals must be tested for HIV infection prior to initiating Apretude and with each subsequent injection (HIV testing immediately, within one week, prior to initiating therapy and prior to each injection for continuation).

Policy change (9/8/2025): Prohibition on combination use with other HIV agents was added — Apretude may not be used in combination with another agent for HIV treatment or prophylaxis.

Applicable Codes

HCPCS - drug administration/code for medicationHCPCSCovered

J0739

Injection, cabotegravir, 1 mg, FDA approved prescription, only for use as HIV pre-exposure prophylaxis (not for use as treatment for HIV) [Apretude]

ICD-10 Diagnosis codes (informational)ICD-10

Z11.4	Encounter for screening for human immunodeficiency virus [HIV]
Z29.81	Encounter for HIV pre-exposure prophylaxis

Provider Actions

Prior Authorization

Prior authorization requirement

Prior authorization is required for medical-benefit coverage review. Initial and continuation requests must meet the clinical criteria, including documented weight (≥35 kg) and HIV testing immediately (within one week) prior to initiating therapy and prior to each injection to verify HIV-negative status.

Affected code: J0739

Documentation Required

HIV testing documentation

Provider must document a negative HIV test performed immediately (within one week) prior to initiating Apretude and a negative HIV test within one week prior to each subsequent injection.

Denial Risk

Denial if HIV positive/unknown

Claims may be denied if the individual is HIV positive or if HIV status is unknown at initiation or prior to injections; Apretude is not approved for individuals who are HIV positive or whose HIV status is unknown.

Billing Rule

Quantity limit per dosing period

Quantity limit = 1 vial (600 mg/3 mL) per 2 months. For initiation of therapy or when re-initiating after missed doses, one additional vial may be approved in the first two months.

J0739

Clinical Evidence & Safety

Evidence:

FDA approval / indication: Approved for HIV pre-exposure prophylaxis (PrEP) in at-risk adults and adolescents weighing at least 35 kg.

Black box warning: Risk of drug resistance when used in individuals with undiagnosed HIV infection; individuals must be tested for HIV prior to initiating Apretude and with each subsequent injection. Drug-resistant HIV variants have been identified with use of Apretude in individuals with undiagnosed HIV infection.

Background

Background: Apretude (cabotegravir extended-release injectable suspension) is an integrase strand-transfer inhibitor (INSTI) formulated for intramuscular administration. Route and dosing: administered by a healthcare provider as a gluteal intramuscular injection once every 2 months (600 mg/3 mL vial; quantity limit = 1 vial per 2 months with possible approval of one additional vial at initiation or when re-initiating after missed doses).

Scope of policy: Addresses medical-benefit coverage for Apretude for HIV pre-exposure prophylaxis (PrEP), including medical necessity and continuation criteria, required HIV testing, quantity limits, and coding guidance for use in at-risk adults and adolescents weighing ≥35 kg.

Revision History

2025-08-15annual review

Annual review added new clinical criteria and a quantity limit for Apretude; coding reviewed and HCPCS J0739 and ICD-10-CM Z11.4, Z29.81 were added.

2025-09-08select reviewLatest

Select review added prohibition on use in combination with other agents for HIV (may not be used in combination with other agents for HIV criteria added).