Cabenuva (cabotegravir and rilpivirine)

POLICY NUMBER

L.5.01.582

Cabenuva (cabotegravir and rilpivirine)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

For persons with HIV who have a stably suppressed plasma viral load (eg, HIV RNA below the limit of detection for at least 6 to 12 months) on antiretroviral therapy (ART), the patient and clinician may consider switching the ART regimen because of factors such as side effects or pill burden. In this setting, the goal is to maintain virologic suppression while improving the patient's quality of life and reducing the risk of short- or long-term toxicity. This is distinct from the situation of virologic failure, in which a salvage regimen must be crafted because of poor adherence and virologic rebound, with or without drug resistance.

Cabenuva (cabotegravir and rilpivirine), a long-acting injectable formulation consisting of an integrase strand-transfer inhibitor (INSTI) and a nonnucleoside reverse-transcriptase inhibitor (NNRTI), 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 per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

POLICY

Cabenuva (cabotegravir and rilpivirine) is considered not medically necessary for the treatment of human immunodeficiency virus as there are other alternatives covered by the Plan.

Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

POLICY HISTORY

08/17/2021: New policy added.

09/29/2021: Code Reference section updated to add new HCPCS code J0741, effective 10/01/2021.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants. Code Reference section updated to remove deleted HCPCS code C9077.

12/16/2024: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Cabenuva (cabotegravir and rilpivirine). Policy statements unchanged. Sources updated.

12/02/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Sources updated.

SOURCE(S)

1. Cabenuva prescribing information. ViiV Healthcare Company. June 2025. Last accessed September 2025.

2. Swindells S, Andrade-Villaneuva JF, Richmond GJ, et al. Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression. N Engl J Med. 2020; 382;12:1112-1123.

3. Wood BR. Switching antiretroviral therapy for adults with HIV-1 and a suppressed viral load. In: UpToDate, Connor RF (Ed), Wolters Kluwer. Accessed September 2025. https://www.uptodate.com/contents/switching-antiretroviral-therapy-for-adults-with-hiv-1-and-a-suppressed-viral-load

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Not Medically Necessary Codes

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