On Nov. 20, 2018, the U.S. Preventive Services Task Force (USPSTF) released a draft recommendation that could transform HIV-1 pre-exposure prophylaxis (PrEP) scale-up in the United States. While a promising first step, it is six years late. Until now, the federal government has failed to take serious action to ensure access to PrEP. While the USPSTF recommendation will have significant public health benefits, we still need a coordinated national PrEP program combined with affordable drugs to systematically address the myriad barriers to uptake and implementation. Anything less is an insult to the nearly 200,000 Americans who have been newly diagnosed with HIV since PrEP's FDA approval in 2012.
The USPSTF is an independent panel of experts in disease prevention that is funded, staffed, and appointed by the U.S. Department of Health and Human Services (HHS). The panel's meta-analysis of Truvada (FTC/tenofovir disoproxil fumarate or TDF/FTC) PrEP's efficacy earned a grade "A" recommendation -- a full-throated endorsement of PrEP's effectiveness in preventing HIV. Under the Affordable Care Act, all private insurers are required to cover grade "A" or "B" services or products with no out-of-pocket costs to the patient. In other words, no more copays, deductibles, or coinsurance costs for PrEP users.
This draft recommendation represents one of the first concrete federal efforts to enable PrEP use in the U.S. As of now, there is no national requirement that insurance companies cover PrEP, leaving some unable to access the drug or associated clinical care despite being insured. If the recommendation prevails, it will force all private insurers to cover TDF/FTC PrEP for high-risk individuals, including sexually active men who have sex with men (MSM), transgender people, people who inject drugs, and serodiscordant heterosexual couples. Second, by prohibiting cost-sharing for PrEP, such as copays and deductibles, the USPSTF rating will reduce financial barriers, which currently can cost up to $7,500 annually for the drug alone, even with Gilead's copay assistance program.
While these two changes will undoubtedly benefit countless Americans, this recommendation does nothing to help uninsured people, many of whom are vulnerable to HIV infection. The American South has the lowest PrEP utilization rate and the highest rate of new HIV infections across the country; however, the USPSTF recommendation will have the least impact here, as the region also has the largest percentage of uninsured people. This perpetuates a pattern in PrEP implementation: The people who need it most often face the most barriers to accessing it.
In October, the U.S. Centers for Disease Control and Prevention released a report indicating that in 2016, just over 78,000 individuals in the country were actively on PrEP -- only 7% of the population who would benefit from the drug. Furthermore, Black and Hispanic populations face higher rates of new HIV infection, lower rates of insurance, and access PrEP at dramatically lower rates than white populations. While the USPSTF recommendation may alleviate some existing disparities, it will do nothing to address disparities caused by lack of insurance.
Even for insured people, the recommendation does not remove barriers created by insurance companies. Anyone who has tried to access PrEP via their commercial health insurer has navigated the labyrinth of prior authorizations, mail-order pharmacy requirements, and refill restrictions that work to dissuade individuals from protecting themselves from HIV infection.
The reason behind the multitudinous barriers established by insurance providers ties back to the core problem in PrEP implementation in this country: price. Gilead Sciences charges over $1,600 a month for a drug that costs less than $6 a month to manufacture. Despite this egregious markup, all of the research used to develop TDF/FTC as PrEP was funded by the American taxpayer and charitable foundations, not Gilead. As a result, insurance companies work to systemically prevent people from accessing PrEP because of the outrageous cost that Gilead forces onto the American health care system. This recommendation is the first time USPSTF is prohibiting insurance companies from utilizing cost-sharing for a drug that is not yet available generically. The only way to scale PrEP on the population level is either introducing generic drugs into the market or forcing Gilead to lower the price.
Related: HIV Activists Launch #BreakThePatent Campaign and National Plan for Generics and Lower-Cost Truvada for HIV Prevention in the U.S.
Currently, the U.S. health care system spends approximately $2 billion for Truvada PrEP for less than 10% of the people who need it. If generic drugs were available, for the same cost, we could supply free TDF/FTC PrEP to all 1.2 million Americans who would benefit from it, while paying for their clinical care. Even then, we would still have half a billion dollars left over to address other barriers to accessing PrEP, including education, stigma, and transportation.
We know making PrEP universally accessible works. Starting in 2016, New South Wales, Australia began offering a generic TDF/FTC PrEP and associated clinical care for free to all high-risk MSM. Within a year, the number of acute HIV diagnoses dropped by nearly a third among MSM, an unprecedented reduction in infections. Without generic drugs, this program would not have been possible.
The lagging PrEP scale-up in the United States represents a national tragedy. Despite funding its development and approving it more than six years ago, the U.S. is still failing to get PrEP to the people who need it most. The USPSTF recommendation is helpful, but long overdue. The key to successfully implementing PrEP on a national scale is twofold: First, affordable drugs and associated clinical care must be available to everyone, whether through generics or otherwise; and second, governments must take a proactive role in ensuring that all barriers to PrEP use are effectively mitigated. Our government has the resources and ability to dramatically slow the spread of this deadly pathogen, and yet 40,000 Americans have died from AIDS since PrEP's FDA approval (from data we were able to analyze from CDC.).
We've had the science to fight this epidemic for years, but not the will. The debate is over. Now is the time for action.
Christian Urrutia and James Krellenstein are co-founders of The PrEP4All Collaboration and the #BreakThePatent movement. For more information, please visit www.breakthepatent.org.