CurrentNeighborhood Health Plan of Rhode IslandPolicy 4517-A

Cabenuva (cabotegravir + rilpivirine) long-acting injectable — coverage criteria

Covers clinical criteria and authorization requirements for Cabenuva as treatment for HIV-1 in adults and adolescents when approval criteria are met; includes initial pathways for switch or management of viremia, continuation criteria, required documentation, and exclusion/ NMN guidance.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCabenuva (cabotegravir + rilpivirine) long-acting injectable — coverage criteria

Policy CodePolicy 4517-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with a plasma HIV-1 RNA (viral load) within the last 6 months and supporting documentation to request up to 12 months of coverage when clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

<50suppression threshold

>=200virologic failure definition

>=35 kgmin adolescent weight

Coverage Criteria for Cabenuva

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Initial Therapy and Viremia Pathway

Authorization of 12 months may be granted for treatment of HIV-1 when either one of the following distinct pathways is met:

Main pathways: Either A (switch for virologically suppressed patients) OR B (management of viremia) must be met

A: Switch to Cabenuva for virologically suppressed patients: All of the following must be true: member is virologically suppressed on the current antiretroviral regimen with HIV-1 RNA <50 copies/mL; member is currently receiving a stable antiretroviral regimen; member has no history of treatment failure; member has no known or suspected resistance to cabotegravir or rilpivirine.HIV-1 RNA < 50 copies/mL

This pathway is intended to replace a current suppressive oral regimen.

B: Treatment for members with viremia: All of the following must be true: member is unable to achieve or maintain virologic suppression on oral ART despite intensive medication adherence support; member has high risk of disease progression (e.g., CD4 <200 cells/µL or history of AIDS-defining complications); prescriber attests that they have discussed the significant risk of resistance to certain drug classes (e.g., NNRTIs, INSTIs) if virologic failure occurs on the requested medication; member has no known or suspected resistance to cabotegravir or rilpivirine.

Documentation (laboratory results, chart notes) supporting high risk of disease progression and prior adherence interventions required.

Continuation Therapy

Continuation of therapy

Reauthorization criteria: Authorization may be renewed for 12 months if the member has not experienced virologic failure while on the requested drug.Virologic failure = two consecutive plasma HIV-1 RNA >= 200 copies/mL

If two consecutive viral loads >=200 copies/mL are documented, the member is considered to have experienced virologic failure and continuation is not supported.

All indications for Cabenuva other than the FDA‑approved indication and any compendial uses specified in this policy are considered experimental/investigational and are not eligible for coverage.

Use of Cabenuva for indications outside the FDA‑approved indication and compendial uses specified in this policy is not medically necessary and therefore will not be authorized.

Coding and Viral Load Thresholds

Covered medicationsNDC | mixedCovered

Cabenuva

cabotegravir extended-release injectable suspension and rilpivirine extended-release injectable suspension (brand and generic, all dosage forms and strengths)

Viral load thresholds

Thresholds for regimen switchPlasma HIV-1 RNA (viral load) < 50 copies/mL is required to switch to Cabenuva (member must be virologically suppressed on current regimen)

Definition of virologic failure for continuationTwo consecutive plasma HIV-1 RNA levels ≥ 200 copies/mL define virologic failure for reauthorization/continuation decisions

Authorization durationAuthorization may be granted for 12 months when clinical criteria are met

Prior Authorization and Provider Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization may be granted for up to 12 months when clinical criteria are met.

Authorization may be granted for 12 months when member meets clinical criteria.

Note

Clinical Prerequisites Before Switching to Cabenuva

Before switching to Cabenuva, ensure the member is virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known or suspected resistance to cabotegravir or rilpivirine.

Virologic suppression: HIV-1 RNA < 50 copies/mL on current regimen.
Member is on a stable antiretroviral regimen.
No history of treatment failure.
No known or suspected resistance to cabotegravir or rilpivirine.

Documentation Required

Required Documentation

Submit required documentation with initial requests to initiate authorization review.

Plasma HIV-1 RNA (viral load) within the last 6 months.
For members with viremia only: supporting laboratory results, chart notes, or medical record documentation demonstrating high risk of disease progression (e.g., CD4 count < 200 cells/µL, history of AIDS-defining complications).

Denial Risk

Triggers for Denial

Requests may be denied if the member does not meet the clinical eligibility requirements.

Member is not virologically suppressed (HIV-1 RNA ≥ 50 copies/mL) when switching to Cabenuva.
History of treatment failure.
Known or suspected resistance to cabotegravir or rilpivirine.
For continuation requests: member has experienced virologic failure while on the requested drug (defined as two consecutive plasma HIV-1 RNA ≥ 200 copies/mL).

Key Definitions

Virologic suppression

Virologic suppression definitionPlasma HIV-1 RNA (viral load) less than 50 copies per mL.

PopulationApplies to adults and adolescents ≥12 years and weighing ≥35 kg who are replacing a suppressive oral regimen

Clinical prerequisitesMember must be on a stable antiretroviral regimen with no history of treatment failure and no known or suspected resistance to cabotegravir or rilpivirine

Virologic failure (for continuation)

Virologic failure (continuation) definitionTwo consecutive plasma HIV-1 RNA (viral load) levels greater than or equal to 200 copies per mL.

Impact on reauthorizationAuthorization for continued treatment may not be granted if the member has experienced virologic failure as defined above

Authorization duration referenceReauthorization may be granted for 12 months if virologic failure has not occurred while on the requested drug