In November 2020, the U.S. Department of Health and Human Services (HHS) posted a draft detailing its human immunodeficiency virus (HIV) National Strategic Plan for 2021 through 2025. Their vision? That the U.S. would be a place where new infections are prevented, every person knows their status and where high-quality care and treatment is available for those who need it free from stigma and discrimination1. With the huge breakthroughs that have been made since the HIV epidemic was first identified in 1981, this vision seems more achievable than ever. Through advocacy and research, HIV and the subsequent disease that follows if left untreated — acquired immunodeficiency syndrome (AIDS) — have changed from a hopeless diagnosis to a manageable and preventable disease.
Recently we have seen a lot of growth in the HIV prevention medication space. These medications, also known as pre-prophylaxis (PrEP), allow people to take a pill daily to reduce their risk of getting HIV. With more than 1.2 million Americans currently living with HIV2, these types of medications are crucial in helping stop the spread. Truvada® (Gilead), originally used in the treatment of HIV, was approved for use in PrEP by the Food and Drug Administration (FDA) in 2012. Taken daily, it was able to reduce the risk of transmission of HIV through sex by greater than 90% and from intravenous drug use by greater than 70%3. Last year, Gilead also received the PrEP indication approval for their other drug, Descovy®, and Teva Pharmaceuticals was able to release a generic for Truvada® providing even more robust options within this space. Looking at the pipeline, pharmaceutical companies are now looking to design longer term options for PrEP, such as implants, intravaginal rings and injections/infusions. Early data for the injectable cabotegravir has shown promising results and would only be administered every eight weeks compared to the daily requirements of existing therapies4.
With the increasing popularity of PrEP medication, the U.S. Preventive Services Task Force (USPSTF), made of independent experts that review services and medications, reviewed PrEP medications in 2019 and assigned them its highest grade A recommendation. This means the task force strongly recommends the offering of these services due to their substantial net benefit5. In combination with the Affordable Care Act (ACA), this requires clients to cover some form of PrEP medication at $0 cost share to the member6. Naturally, clients were required to reevaluate their benefit design, and many were concerned of the potential increases in costs with this change. Working with our pharmacy benefit managers (PBMs), we reviewed how each organization was handling the change to provide clients insight. Specifically, we looked at how each PBM was identifying which patients were using HIV medications for treatment versus prevention (which would have to be covered) and if they were including step therapies to guide members toward impending generics. Furthermore, we addressed the current reevaluation of HIV medications as specialty products. Traditionally, they were placed in the specialty bucket due to the sensitive disease state, importance of strict adherence and the complexity of multi-pill regimens. Over time, new medications were more effective, and combination pills reduced the pill burden. Still, the importance of adherence remains especially if using it for PrEP. From a contracting standpoint, this class is still highly brand-dominated, and many clients would continue to benefit from keeping HIV under the specialty bucket.
Moving into 2021, it will be interesting to review how spend within this class has changed. As with all preventive medications, the train of thought is that by covering more up front on the pharmacy side, it helps reduce the costs on the medical side by eliminating hospital and treatment costs for HIV-positive patients. As more PrEP options become available, we anticipate that HIV will continue to be an important topic to monitor this coming year.