Glassman: How Trump can meet his goal of ending AIDS

On election night, Donald Trump said he would “govern by a simple motto: promises made, promises kept.” One important promise goes back to his 2019 State of the Union Address, when he made “a commitment to eliminate the HIV epidemic in the United States within 10 years” by launching the federal Ending the HIV Epidemic Initiative.

With 32,000 new infections (kff.org) annually in the U.S., and 1.2 million Americans living with HIV, the epidemic isn’t over. But after he takes office, President Trump will shortly have a new, highly effective preventative therapy to help achieve his goal. Still, he’ll need an accelerated federal effort to ensure that Americans who need PrEP are able to get it.

By mid- to late-2025, it’s likely the Food & Drug Administration will approve lenacapavir for HIV prevention, a twice-yearly injectable pre-exposure prophylaxis (PrEP) medicine that reduces the risk of acquiring the HIV virus that leads to AIDS. While daily PrEP pills have been available since 2012, adherence can be a challenge for some people. But lenacapavir requires just two shots a year.

“It’s rare for scientists to get a standing ovation for presenting their data,” reported Science magazine in July. But that’s what happened when a researcher told the AIDS 2024 conference in Munich about the results of the lenacapavir trial. “The audience stood up and clapped for almost one minute.”

The trial, involving more than 5,000 women, found the twice-yearly injections provided 100% protection against HIV. “That’s it. We finally have a tool that can end this epidemic,” said Chris Beyrer, director of the Duke Global Health Institute.

But the new drug can’t do it alone. Twelve years after the first PrEP drug was approved, only “36% of the 1.2 million people who could benefit from PrEP were prescribed it,” the Centers for Disease Control and Prevention reports.

There are too many barriers to PrEP access. A study in the journal Advances in Therapy, by Kenneth H. Mayer of the Harvard Center for AIDS Research and two colleagues, “found that many individuals at risk had not heard of PrEP…. Even among healthcare providers themselves, some were not aware of PrEP or how it should be used…. In a study of 53 family physicians, 71% had no/limited knowledge of PrEP treatment guidelines.”

In addition, stigma around HIV deters some people from getting tested or seeking HIV prevention services. And finding a nearby PrEP provider can be difficult, especially for rural and low-income Americans.

How to encourage more PrEP use? Better education is part of the answer. So is additional spending on PrEP “navigators,” who can help people access the medicine. “Delivery system innovation,” concluded Georgetown University’s O’Neill Institute for National and Global Health Law, “needs to match research progress.”

Despite misleading statements from some activists, the cost of PrEP drugs is not the issue. Only 8% of Americans lack insurance, and the U.S. Department of Health and Human Services makes it clear that “under the Affordable Care Act, PrEP is free under almost all health insurance plans.” PrEP is also free under Medicare and Medicaid. State governments, as well as drug manufacturers, provide financial help to the uninsured, often reducing the cost of PrEP medicines to zero.

A study published in 2023 by Robert A. Bonacci and four colleagues at the Centers for Disease Control and Prevention found that just 4% of the 1.2 million Americans with PrEP needs had uncovered costs and that was for PrEP clinical care and not PrEP medications.

One welcome development is recent guidance from the Centers for Medicare and Medicaid Services (CMS) that eliminates utilization management practices for PrEP. These are techniques like step therapy and prior authorization that insurers and their pharmacy benefit managers use to delay or discourage the use of medicines preferred by physician prescribers. We need more policies like this.

To unlock the full potential of PrEP, more federal funding is required to support healthcare provider education, community awareness and outreach, patient navigation, and out-of-pocket costs for PrEP clinical visits and laboratory tests.

Stronger efforts are also needed from federal and state insurance regulators to make sure that health plans are providing not just PrEP medicines but also related clinical and laboratory services at no cost to individuals. The initiative that President Trump launched in 2019 — and Joe Biden continued — needs sustained support and funding if we’re going to take advantage of lenacapavir and other innovations and meet the once-and-future president’s worthy goal.

James K. Glassman, a former Under Secretary of State and chairman of Strategic Health Diplomacy, is an advisor to health care non-profits and corporations.

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