Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: HIV (human immunodeficiency virus) pre-exposure prophylaxis
Treatment: Formulary exception for Apretude 600mg ER (extended release) Suspension
The insurer denied: Formulary exception for Apretude 600mg ER (extended release) Suspension
The denial is overturned.

The patient is an adult female. She is on Descovy for HIV (human immunodeficiency virus) pre-exposure prophylaxis. The treating physician has ordered Apretude for HIV (human
immunodeficiency virus) pre-exposure prophylaxis (switching from Descovy to Apretude). The request was denied coverage by the health plan. The denial is being appealed.

The health plan should cover the Formulary exception for Apretude.

The formulary drug is not expected to be as effective as the requested non-formulary drug. Apretude is a long-acting, injectable medication with an FDA (United States Food and Drug
Administration)-approved indication for at-risk adults to reduce the risk of sexually acquired HIV-1 (human immunodeficiency virus) infection. The current guidelines of the Centers for Disease Control (CDC) titled "Preexposure Prophylaxis For The
Prevention of HIV [human immunodeficiency virus] Infection In the United States - 2021 Update" (Reference 4) supports the use of Apretude injections, noting that "Cabotegravir injections may be especially appropriate for patients... who prefer injections every 2 months to an oral PrEP [pre-exposure prophylaxis] dosing schedule." This document is available via the official website for HIV (human immunodeficiency virus) information of the National Institutes of Health (hivinfo.nih.gov) via the links for Guidelines and PrEP (pre-exposure prophylaxis). (6)
Apretude has been shown to be superior to Truvada for the prevention of HIV (human immunodeficiency virus) infection among men who have sex with men (MSM), as documented in the phase 2b-3 study by Landovitz et al., as published in The New England Journal of Medicine. Very remarkably, in this study the incidence of HIV (human immunodeficiency virus) infection was 3 times higher in the group treated with Truvada versus those who received Apretude therapy (39 HIV [human immunodeficiency virus] infections versus 13 respectively), this trial was stopped early due to efficacy on review. Cabotegravir, an integrase inhibitor that is available in a long-acting injectable formulation (CAB LA), for use as PrEP (pre-exposure prophylaxis). 
In May 2020, a randomized trial (HPTN 083) comparing CAB LA (Cabotegravir long acting) given every eight weeks with daily oral TDF-FTC (tenofovir disoproxil fumarate-emtricitabine) in 4570 MSM (men who have sex with men) and transgender women was stopped early since the study reached its efficacy endpoint, and there were fewer new infections in those who received CAB LA (Cabotegravir long acting) compared with TDF-FTC (tenofovir disoproxil fumarate-emtricitabine) (13 versus 39) (Reference 1).
Apretude was found in two pivotal clinical trials, HPTN 083 (7) and HPTN 084 (8), to be superior to daily oral tenofovir/emtricitabine for HIV (human immunodeficiency
virus) prevention among cisgender men and transgender women who have sex with men (HPTN 083) and cisgender women (HPTN 084). Further, this long-acting injectable for PrEP (pre-exposure prophylaxis) demonstrated a 69% (HPTN 083) and 92% (HPTN 084) reduction in incident HIV (human immunodeficiency virus) infection in study participants as compared to the tenofovir/emtricitabine. Use of Apretude is medically appropriate in this patient.