Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Syphilis. 

Treatment: APRETUDE 600 mg (milligrams) ER (extended release) SUS (suspension).

The insurer denied coverage for APRETUDE 600 mg ER SUS.

The denial is upheld.

 
At issue is the request for a formulary exception for APRETUDE 600 mg ER SUS for prevention of human immunodeficiency viruses (HIV) infection.

Renal and bone safety issues have been documented with the formulary drug(s). Neither TRUVADA nor DESCOVY should be used in those with an estimated glomerular filtration rate (eGFR) < (less than) 30. According to clinical trials, overall safety of APRETUDE was similar to that of the formulary drug (TRUVADA), except for injection site reactions leading to discontinuation, which occurred more frequently in those who received APRETUDE.

There's no documentation provided to suggest lack of efficacy.

A randomized trial (HPTN 083) comparing the requested drug given every eight weeks versus daily oral TRUVADA showed there were fewer new HIV infections in those who received APRETUDE compared with TRUVADA. There is no head-to-head comparison between APRETUDE and DESCOVY.

On December 20, 2021, the Food and Drug Administration (FDA) approved APRETUDE (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. 

Currently, there are two alternative pill options for HIV PrEP: TRUVADA (tenofovir disoproxil fumarate (TDF) coformulated with emtricitabine-FTC) and DESCOVY (tenofovir alafenamide (TAF) coformulated with emtricitabine-FTC). Both are effective options that require high levels of adherence to be effective and certain high-risk individuals and groups may be less likely to adhere to daily pills. 

The safety and efficacy of Apretude to reduce the risk of acquiring HIV were evaluated in two randomized, double-blind trials that compared Apretude to Truvada, a once daily oral medication for HIV PrEP. Trial 1 included HIV-uninfected men and transgender women who have sex with men and have high-risk behavior for HIV infection. Trial 2 included uninfected cisgender women at risk of acquiring HIV. The trial measured the rate of HIV infections among trial participants taking daily cabotegravir followed by Apretude injections every two months compared to daily oral Truvada. The trial showed participants who took Apretude had 69% less risk of getting infected with HIV when compared to participants who took Truvada.

TDF has been associated with acute and chronic kidney disease in patients with HIV, and the safety of this agent has not been examined in patients without HIV who have an eGFR (estimated glomerular filtration rate) <60.  By contrast, DESCOVY is safe in those with an eGFR > (greater than) 30.

Neither TRUVADA nor DESCOVY should be used in those with an eGFR <30.
According to limited medical records from the appeal letter, the patient's GFR has been "slightly decreasing" since being on PrEP. There's no quantified documentation of the patient's actual GFR provided. It is also unclear which oral HIV PrEP alternatives are used by the patient.  

Based on above findings, the patient does not meet criteria for APRETUDE.  

The formulary drugs are not expected to cause adverse effects. 

The formulary drugs were not tried.

The formulary drug is not expected to be ineffective.

The non formulary drug is not expected to be more effective that the formulary alternatives.

The carrier's denial of Request for Formulary Exception for Apretude 600 milligram (mg) ER SUS is upheld.