Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: HIV prevention. 
Treatment: Apretude 600mg (milligrams) ER (extended release) suspension. 

The insurer denied: Apretude 600mg (milligrams) ER (extended release) suspension. 
The denial is overturned. 

The patient is an adult male who has been prescribed Apretude for human immunodeficiency virus (HIV) prevention. The patient has been on Truvada for human immunodeficiency virus prevention for the past 5 years. The request was denied on initial review. The Plan criteria were not met, and this was the reason for denial on prior review. 

The health plan should cover the proposed treatment. 

Apretude is a long-acting, injectable medication with a Food and Drug Administration (FDA) approved indication for at-risk adults to reduce the risk of sexually acquired human immunodeficiency virus-1 infection. The current guidelines of the Centers for Disease Control (CDC) titled "Preexposure Prophylaxis 
For The Prevention of HIV 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 dosing schedule." 
Apretude has been shown to be superior to Truvada for the prevention of 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 human immunodeficiency virus infection was three times higher in the group treated with Truvada versus those who received Apretude therapy (39 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. In 05/2020, a randomized trial (HPTN 083) comparing Cabotegravir long acting (CAB LA) given every eight weeks with daily oral tenofovir disoproxil fumarate/emtricitabine (TDF-FTC) in 4570 MSM and transgender women was stopped early since the study reached its efficacy endpoint, and there were fewer new infections in those who received Cabotegravir long acting (CAB LA) compared with tenofovir disoproxil fumarate/emtricitabine (TDF-FTC) (13 versus 39) (Reference 1). 
Apretude is Food and Drug Administration (FDA) indicated for preexposure prophylaxis (PrEP) in at-risk individuals to reduce the risk of sexually acquired human immunodeficiency virus (HIV)-1 infection. These individuals must have a negative human immunodeficiency virus (HIV-1) test prior to initiating therapy.
Apretude was found in two pivotal clinical trials, HPTN 083 and HPTN 084, to be superior to daily oral tenofovir/emtricitabine for human immunodeficiency virus (HIV) 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 demonstrated a 69% (HPTN 083) and 92% (HPTN 084) reduction in incident human immunodeficiency virus infection in study participants as compared to the tenofovir/emtricitabine. 

Apretude 600 milligrams (mg) / 3 milliliters (mL) (200 milligrams per milliliter) suspension, extended-release injection is given as an injection of 3 milliliters intramuscularly once a month for two months then every other month. This will allow the patient to avoid having to take medication daily and will likely lead to better compliance.
The injectable medication Apretude will allow the patient to avoid having to take the oral medication and will allow proper compliance with medication and serve the purpose of pre-exposure prophylaxis better. Switching to Apretude will allow a different dosing method of only requiring an injection every two months once therapy is established. This has the benefit of preventing missed doses and possible infection due to missed doses. Use of Apretude is medically appropriate in this patient.