The high court found that members of a task force that determines what preventive drugs must be covered can be removed at will by HHS Secretary Robert F. Kennedy Jr.
The Supreme Court of the United States has ruled in favor of the Department of Health and Human Services in a case that could have upended insurance coverage for HIV PrEP drugs like those manufactured by Gilead.
In a 6-3 decision, SCOTUS ruled in Kennedy v. Braidwood that the appointment of the U.S. Preventive Services Task Force (USPSTF), which makes decisions on what preventive drugs must be covered by insurance under the Affordable Care Act, was constitutional. The high court found that members of the task force can be removed at will by the HHS Secretary, in this case Robert F. Kennedy Jr. The recommendations can also be reviewed by the secretary before they are made final.
Analysts had predicted that the decision was an overhang for Gilead but did not see it meaningfully impacting PrEP coverage. GSK also manufactures PrEP drugs via its joint HIV venture with Pfizer and Shionogi called ViiV Healthcare. Insurers are already incentivized to cover PrEP rather than pay for more expensive HIV drugs later on, according to Jefferies. A single HIV patient costs the health system about $1.2 million, according to experts that the Jefferies analysts spoke with.
While the court case is now resolved, BMO Capital Markets noted a “double-edged sword”: Kennedy will now have the final say in deciding what is necessary for preventive health, while also being cleared to remove members of the panel at will. Kennedy has come under fire for removing all 17 members of the CDC’s highly influential Advisory Committee on Immunization Practices and replacing them with known vaccine skeptics.
Under his leadership, HHS has withdrawn funding for HIV care by eliminating programs aimed at prevention. The agency closed the Office of Infectious Disease and HIV/AIDS Policy, while other related offices were significantly cut down.
The matter was brought against the government by a group of insurance providers who challenged the Affordable Care Act’s requirement that they cover preventive medicines, such as HIV drugs that are recommended by the USPSTF. The case specifically challenged the task force, arguing that the panel is illegally appointed and therefore its recommendations should be void. The plaintiffs asserted that the panel should be appointed by the president and confirmed by the Senate. Currently, the panel is selected by the HHS secretary.
An appeals court ruled in favor of the providers, but the matter was taken to the Supreme Court.
If the high court had ruled in favor of the plaintiffs, the requirement of insurance coverage for the medications could have been removed from all providers, not just the ones who brought the case.
The USPSTF recommended Gilead’s Descovy and ViiV Healthcare’s Apretude for PrEP in 2023, requiring that they be covered with zero co-pay starting this year. Even prior to that decision, commercial payers were covering the drugs but could require a co-pay.
The panel has not yet recommended Gilead’s newest PrEP offering, lenacapavir, which was approved on June 18 to be marketed as Yeztugo for PrEP. Such a decision may take years, judging by the previous timeline for Descovy and Apretude.
