CurrentNeighborhood Health Plan of Rhode IslandPolicy 4517-A

Cabenuva (cabotegravir + rilpivirine) — long‑acting injectable for HIV-1

Defines coverage and prior authorization criteria for Cabenuva as a complete antiretroviral regimen for treatment of HIV-1 in eligible adolescents and adults, and describes documentation and reauthorization requirements for members of the plan.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCabenuva (cabotegravir + rilpivirine) — long‑acting injectable for HIV-1

Policy CodePolicy 4517-A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a plasma HIV-1 RNA (viral load) measured within the last 6 months with initial prior authorization requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauth duration (initial/cont)

<50 cp/mLvirologic suppression required

>=200 x2virologic failure definition

>=12 yrs & >=35 kgmin age/weight

Coverage Criteria for Cabenuva

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Covered when ALL of the following are met:

ALL of the following

Diagnosis of human immunodeficiency virus type 1 (HIV-1) infection.
Member is currently receiving a stable antiretroviral regimen.
Member is virologically suppressed on the current antiretroviral regimen with HIV-1 RNA (viral load) < 50 copies/mL.
Member has no history of treatment failure.
Member has no known or suspected resistance to either cabotegravir or rilpivirine.
For initial requests, documentation of a plasma HIV-1 RNA level (viral load) within the last 6 months must be submitted.

Covered for continuation when ALL of the following are met:

ALL of the following

Request is for reauthorization of Cabenuva for treatment of HIV-1 infection.
Member has not experienced virologic failure while on Cabenuva, defined as two consecutive plasma HIV-1 RNA levels ≥ 200 copies/mL.
Authorization may be granted for up to 12 months when continuation criteria are met.

FDA-Approved Indication: Cabenuva is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

All other indications are considered experimental/investigational and not medically necessary.

Viral Load Thresholds and Coding Notes

Viral load thresholds — initiation and virologic failure thresholds

Initiation thresholdHIV-1 RNA (viral load) < 50 copies/mL for initiation (virologic suppression on current regimen)

Virologic failure thresholdVirologic failure = HIV-1 RNA >= 200 copies/mL on two consecutive measurements

Authorization durationAuthorization of 12 months may be granted when initiation criteria are met

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior authorization — duration

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

Duration: up to 12 months

Prior Authorization

Requirement to be on stable regimen prior to switch

Member must be replacing their current antiretroviral regimen and be virologically suppressed on a stable regimen prior to switching to this therapy.

Must be replacing current regimen
Virologically suppressed: HIV-1 RNA < 50 copies/mL
Member currently receiving a stable antiretroviral regimen
No history of treatment failure

Documentation Required

Required documentation for initial requests

Submit plasma HIV‑1 RNA (viral load) measured within the last 6 months for initial prior authorization requests.

Initial request: plasma HIV‑1 RNA within last 6 months

Denial Risk

Common denial triggers

Denial may occur if the member is not virologically suppressed, has a history of treatment failure, or has known/suspected resistance to cabotegravir or rilpivirine; other non-covered indications are considered experimental/investigational.

Not virologically suppressed (HIV‑1 RNA ≥ 50 copies/mL)
History of treatment failure
Known or suspected resistance to cabotegravir or rilpivirine
Use for indications other than FDA‑approved replacement of a stable regimen is experimental/investigational

Background on Cabenuva

Cabenuva is a long-acting injectable combination of cabotegravir and rilpivirine indicated as a complete antiretroviral regimen for treatment of HIV-1 infection. The FDA-approved indication permits replacement of a patient’s current oral antiretroviral regimen for adolescents and adults who are at least 12 years old and weigh at least 35 kg, provided they are virologically suppressed with an HIV-1 RNA of less than 50 copies/mL on a stable regimen, have no history of treatment failure, and have no known or suspected resistance to either cabotegravir or rilpivirine.

Definitions

Virologic failure definition — two consecutive HIV-1 RNA >= 200 copies/mL while on requested drug

DefinitionTwo consecutive plasma HIV-1 RNA levels (viral loads) greater than or equal to 200 copies per mL while on the requested drug

Context for continuationMember must not have experienced virologic failure (as defined) to qualify for 12-month reauthorization

Use in decision-makingTwo consecutive >=200 copies/mL indicates treatment failure and guides discontinuation/denial of continuation