Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Apretude (cabotegravir) and Cabenuva (cabotegravir/rilpivirine) require prior authorization.

2)    Cabenuva is used to treat human immunodeficiency virus type-1 (HIV-1) infection.

3)    Apretude is used for pre-exposure HIV prophylaxis.

4)    Both Apretude and Cabenuva are covered under the medical benefit.

Cabenuva (capotegravir/rilpivirin)

Cabenuva is considered medically necessary when the following criteria are met:

1)    Diagnosis of HIV-1 infection;

2)    Prescribed by or in consultation with an infectious disease or HIV specialist;

3)    Age  12 years;

4)    Member weighs > 35 kg;

5)    Documentation of adherence to a stable oral antiretroviral regimen for HIV-1 for > 3 months;

6)    Documentation of sustained virologic suppression as evidenced by HIV RNA viral load < 50 copies/mL for > 3 months;

7)    Member has no history of treatment failure as defined by the Department of Health and Human Services Antiretroviral Guidelines;

8)    Member has no known or suspected resistance to either cabotegravir or rilpivirine;

9)    Doses does not exceed (a or b):

a.    Monthly schedule: 600mg cabotegravir and 900mg rilpivirine (1 kit of 2 vials) initiation dose*, followed by 400mg cabotegravir and 600mg ripilvirine (1 kit of 2 vials) every month thereafter;

·         An initiation dose may be repeated if member misses more than 2 monthly scheduled continutation injections.

b.    Every 2- monbth schedule; 600mg cabotegravir and 900mg rilpivirine (1 kit of 2 vials) 1 month apart for 2 consecutive months (initial dose), followed by 600mg cabotegravir and 900mg ripilvirine (1 kit of 2 vials) every 2 months thereafter.

Approval Duration: 6 months

Continuation of Therapy for Cabenuva

1)    Member is responding positively to therapy;

2)    Dose does not exceed (a, b, or c):

a.    400mg cabotegravir and 600mg ripilvirine (1 kit of 2 vials) every month;

b.    600mg cabotegravir and 900mg ripilvirine (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, both the following i or ii):

                                          i.    Provider attestation that member remains an appropriate candidate for therapy;

                                        ii.    Follow recommended dosing schedule for missed injections.

Approval Duration: 12 months

Apretude (cabotegravir)

1)    Member is HIV-1 negative and has no signs or symptoms of acute HIV infection;

2)    Member is considered at high risk for acquiring HIV and meets one of the following (a, b, or c):

a.    Engaging in sexual activity with an HIV-1 injected partner;

b.    Engaging in sexual activity and one or more of the following:

                                          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;

3)    Member weighs > 35 kg;

4)    Member must instead use emtricitabine/tenofiovir disoproxil fumarate (generic Truvada), unless contraindicated, clinically significant adverse effects are experienced, or member has bone/renal co-morbidities or risk factors;

5)    Dose does not exceed 600mg IM given 1 month apart for 2 consecutive months (initial dose), followed by single 600mg IM given every 2 months thereafter.

Approval duration: 12 months

Continuation of Apretude therapy

1)    Member is responding positively to therapy;

2)    If request is for a dose increase, new does not exceed a single 600mg IM injection given every 2 months.

Approval Duration: 12 months

Codes Used In This BI:

1)    J0739 – Injection, cabotegravir, 1mg

2)    J0741 – Injection, cabotegravir and rilpivirine, 2mg/3mg

1)    Apretude Prescribing Information. Research Triangle Park, NC: ViiV Healthcare; December 2021.

2)    Cabenuva Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline; March 2022.

3)    Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services. August 16, 2021 last update.

4)    Centers for Disease Control and Prevention. U.S. Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States – 2021 update. 2021.