CurrentCentenePolicy CP.PHAR.573

Cabotegravir (Apretude), Cabotegravir/Rilpivirine (Cabenuva) (PDF)

Defines medical necessity criteria, approval durations, dosing limits, and prescribing requirements for Apretude (HIV PrEP) and Cabenuva (HIV-1 treatment) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyCabotegravir (Apretude), Cabotegravir/Rilpivirine (Cabenuva) (PDF)

Policy CodePolicy CP.PHAR.573

Change TypeRevisions to approval durations, indications, contraindications, and coding updates

Effective DateMar 1, 2022

Next Review Date

Key ActionProvider must submit office chart notes, lab results or other clinical information supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

1Q 2026 annual review: extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

1Q 2025 annual review: revised FDA approved indication language for Apretude; added Apretude contraindication for UGT enzyme inducing drugs; updated panel recommendation wording; removed redirection to generic Truvada for PrEP.

For PrEP indication, modified Commercial approval duration from 12 months to 6 months or to the member's renewal date.

Added disclaimer that medical management techniques beyond step therapy are not allowed for members in Nevada per SB 439.

Updated HCPCS code for cabotegravir and annual reference updates (1Q2023, 1Q2024 reviews noted no significant changes).

2Covered Indications (HIV treatment, PrEP)

12+Minimum age (years) for Cabenuva

Minimum weight for both products

50 copies/mLViral load threshold for Cabenuva eligibility

Coverage Summary

This policy (CP.PHAR.573) documents that cabotegravir products are covered with criteria (covered_with_criteria) for specified indications. Scope includes medical necessity criteria, approval durations, dosing limits, and prescribing requirements for Apretude (PrEP) and Cabenuva (HIV-1 treatment) across Commercial, HIM, and Medicaid lines of business. Key policy dates: Effective 03.01.22 and Last reviewed 02.26 (see policy header). The policy aligns with current FDA-approved indications and HHS guidance as described in the background and appendices.

Thresholds and key stats

Age threshold≥ 12 years (Cabenuva)

Weight threshold≥ 35 kg (Apretude and Cabenuva)

Virologic suppression requirementHIV-1 RNA < 50 copies/mL for ≥ 3 months (required for Cabenuva)

Documentation of stable ARTAdherence to a stable oral antiretroviral regimen for ≥ 3 months required prior to Cabenuva

Approval duration (maintenance)Medicaid/HIM: 12 months; Commercial: 6 months or to member renewal date

Initial Therapy Criteria

A. HIV-1 Infection (Initiation - Cabenuva)

Must meet ALL:

ALL of the following

Request is for Cabenuva
Diagnosis of HIV-1 infection
Prescribed by or in consultation with an infectious disease or HIV specialist
Age ≥ 12 years
Member weighs ≥ 35 kg

Continuation / Maintenance Criteria

A. HIV-1 Infection (Continuation/Maintenance - Cabenuva)

Must meet ALL:

ALL of the following

Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Cabenuva for a covered indication and has received this medication for at least 30 days
Request is for Cabenuva
Member is responding positively to therapy
If request is for a dose increase, new dose does not exceed (a, b, or c)
- a:

Other Indications and Exclusions

C. Other diagnoses/indications

Must meet ONE of the following:

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, refer to the no coverage criteria policy or non-formulary policy for the relevant line of business (CP.CPA.190, HIM.PA.33, CP.PMN.255; or CP.CPA.190, HIM.PA.103, CP.PMN.16 respectively).
If the requested use is NOT specifically listed under section III AND criterion above does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Requests for uses that are not FDA-approved and not listed in the policy require documentation consistent with the off-label use policies; non-FDA approved indications are not authorized unless there is sufficient documentation of efficacy and safety per the off-label use policies (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid). Providers must submit office chart notes, lab results, or other clinical information supporting that the member meets approval criteria; the policy explicitly states that requests for non‑FDA indications require sufficient documentation of efficacy and safety and that otherwise coverage is not authorized (denial risk). Continuation and initiation requests are reviewed against the policy criteria and require the supporting documentation described in provider actions.

Applicable Codes

HCPCS injections (informational)HCPCS

J0741	Injection, cabotegravir and rilpivirine, 2 mg/3 mg
J0739	Injection, cabotegravir, 1 mg

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required for initiation/continuation

Requests for Apretude or Cabenuva require review against the policy criteria and supporting documentation; continuation requests must include documentation of at least 30 days prior Centene benefit use or evidence the member has been receiving the medication and is responding.

Documentation Required

Submit supporting documentation

Provider must submit office chart notes, laboratory results, or other clinical information that support the member has met all approval criteria for the requested medication.

Clinical Evidence & References

Evidence referenced in this policy includes: Apretude Prescribing Information — Updated April 2025 (Apretude PI); Cabenuva Prescribing Information — Updated June 2025 (Cabenuva PI); and US Department of Health and Human Services antiretroviral guidelines (panel recommendations referenced, updated 2025). The policy notes that panel recommendations were referenced in guidance for Cabenuva use.

Background

Cabotegravir is an integrase strand transfer inhibitor (INSTI) available as the long‑acting injectable Apretude for HIV pre‑exposure prophylaxis (PrEP) and as the co‑packaged product Cabenuva (cabotegravir + rilpivirine) for HIV‑1 treatment. Cabenuva is intended to replace a current antiretroviral regimen in virologically suppressed patients without known or suspected resistance. This description and the dosing/administration details are aligned with FDA prescribing information and HHS guideline recommendations referenced in the policy.

Definitions

PrEP (definition)Pre-exposure prophylaxis to reduce risk of sexually acquired HIV-1 infection

Virologic suppression (definition)HIV-1 RNA < 50 copies/mL

Revision History

07.18.22material (policy change)

For PrEP indication, modified Commercial approval duration from 12 months to 6 months or to the member's renewal date, whichever is longer.

10.26.22non-material (coding/reference)

1Q 2023 annual review: no significant changes; updated HCPCS code for cabotegravir; references reviewed and updated.

06.04.24non-material (state restriction added)

Added disclaimer that medical management techniques, including quantity management, beyond step therapy is not allowed for members in Nevada per SB 439.

Policy Summary

PayerCentene

PolicyCabotegravir (Apretude), Cabotegravir/Rilpivirine (Cabenuva) (PDF)

Policy CodePolicy CP.PHAR.573

Change TypeRevisions to approval durations, indications, contraindications, and coding updates

Effective DateMar 1, 2022

Next Review Date

Key ActionProvider must submit office chart notes, lab results or other clinical information supporting that member has met all approval criteria.

SourceLink

On This Page

Documentation of adherence to a stable oral antiretroviral regimen for HIV-1 for ≥ 3 months

Documentation of sustained virologic suppression as evidenced by HIV-1 RNA viral load < 50 copies/mL for ≥ 3 months

Member has no history of treatment failure (see Appendix D)

Member has no known or suspected resistance to either cabotegravir or rilpivirine

Dose does not exceed (a or b)

a: Monthly schedule: 600 mg cabotegravir and 900 mg rilpivirine (1 kit of 2 vials) initiation dose, followed by 400 mg cabotegravir and 600 mg rilpivirine (1 kit of 2 vials) every month thereafter. (A initiation dose may be repeated if member misses more than 2 monthly scheduled continuation injections)
b: Every 2-month schedule: 600 mg cabotegravir and 900 mg rilpivirine (1 kit of 2 vials) 1 month apart for 2 consecutive months (initial dose), followed by 600 mg cabotegravir and 900 mg rilpivirine (1 kit of 2 vials) every 2 months thereafter.

B. Pre-exposure HIV Prophylaxis (Initiation - Apretude)

Must meet ALL:

ALL of the following

Request is for Apretude
Member is HIV-negative and has no signs or symptoms of acute HIV infection
Member is considered at high risk and meets ONE of
- a: Engaging in sexual activity with an HIV-1 infected partner
- b
  - i: Inconsistent or no condom use
  - ii: Diagnosis of sexually transmitted infections in the past 6 months
  - iii: Exchange of sex for commodities
  - iv: Incarceration
  - v: Not in a monogamous partnership
  - vi: Partner of unknown HIV status with any of the preceding risk factors
- c: Use of illicit injection drugs
Member weighs ≥ 35 kg
Dose does not exceed a 600 mg intramuscular injection given 1 month apart for 2 consecutive months (initial dose), followed by single 600 mg intramuscular injection given every 2 months thereafter.

400 mg cabotegravir and 600 mg rilpivirine (1 kit of 2 vials) every month

b: 600 mg cabotegravir and 900 mg rilpivirine (1 kit of 2 vials) every 2 months

c: If member has missed injections (> 2 injections if on monthly schedule or just one injection if on every 2-month schedule) as evidenced by claims history; provider attestation that member remains an appropriate candidate for therapy; and follow recommended dosing schedule for missed injections

B. Pre-exposure HIV Prophylaxis (Continuation/Maintenance - Apretude)

Must meet ALL:

ALL of the following

Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Apretude for a covered indication and has received this medication for at least 30 days
Request is for Apretude
Member is responding positively to therapy
If request is for a dose increase, new dose does not exceed a single 600 mg intramuscular injection given every 2 months.

Documentation Required

Specialist prescribing requirement (Cabenuva)

Cabenuva must be prescribed by or in consultation with an infectious disease or HIV specialist as a requirement for approval.

Documentation Required

Adherence and viral suppression documentation (Cabenuva)

For Cabenuva initiation and continuation, document adherence to a stable oral antiretroviral regimen for ≥ 3 months and sustained virologic suppression defined as HIV-1 RNA < 50 copies/mL for ≥ 3 months to meet eligibility criteria.

Billing Rule

Dose limits and scheduling

Providers must follow the specified initiation and continuation dosing schedules (monthly and every‑2‑month regimens) and not exceed the listed maximum dosing regimens; affected HCPCS codes include J0741 and J0739.

Denial Risk

Denial risk for non-FDA or unsupported off-label uses

Non‑FDA approved indications not addressed in this policy require sufficient documentation of efficacy and safety per the applicable off‑label use policies; otherwise coverage is not authorized and requests may be denied.

07.24.24material (policy change)

For PrEP indication, added generic Truvada redirection to allow bypass if member has history of non-adherence to oral PrEP therapy.

11.08.24material (clinical/contraindication updates)

1Q 2025 annual review: revised FDA approved indication language for Apretude to align with prescribing information; added Apretude contraindication for UGT enzyme inducing drugs in Appendix C; updated panel recommendation wording for Cabenuva and, per USPSTF PrEP recommendation, removed redirection to generic Truvada; references reviewed and updated.

10.23.25material (approval duration extension)Latest

1Q 2026 annual review: extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.