Uninsured Americans can now access free pre-exposure prophylaxis (PrEP) medication through the federal government, albeit with qualifications and some possible financial barriers. And the program applimes to all residents of the United States regardless of citizenship status.
In announcing Ready, Set, PrEP on Tuesday, Dec. 3, the U.S. Department of Health and Human Services (HHS) said medications for PrEP -- both Descovy (emtricitabine/tenofovir alafenamide) and Truvada (emtricitabine//tenofovir disoproxil fumarate) -- will be available at no cost to people without prescription drug insurance coverage. This marks the first time the federal government is supplying PrEP to patients not enrolled in Medicaid, the Veterans Health Administration, or any other federal health program.
"Ready, Set, PrEP is a historic expansion of access to HIV prevention medication and a major step forward in President Trump's plan to end the HIV epidemic in America," HHS Secretary Alex Azar said in a press release.
HHS has set up a new website, GetYourPrEP.com, and it will take applications there or at a toll-free phone number, (855) 447-8410. There are qualifications: People must test negative for HIV, have a valid prescription for the medication, and not have prescription drug coverage. There is no income requirement to qualify. Anyone residing in the United States are able to access this free progam, according to an HHS spokesperson.
HHS's Health Resources and Services Administration has a health center program that will support Ready, Set, PrEP by working closely with health care professionals at more than 12,000 service sites and 1,400 health centers nationwide, the department said. Three major drug store chains -- CVS Health, Walgreens, and Rite Aid -- have donated their prescribing services for the program, and they will have the medications available no later than March 30 of next year.
The federal government will pay drugmaker Gilead Sciences $200 per bottle to cover the cost of moving donated drugs from factories through the supply chain to patients, HHS says. In the announcement Tuesday, HHS suggests that Gilead, which has the monopoly on the only approved PrEP medications, Truvada and Descovy, is making good on its agreement, through a partnership with HHS and the Centers for Disease Control and Prevention, to donate 2.4 million bottles of Truvada to 200,000 uninsured people each year for 11 years.
In an email, Mia Heck, a spokesperson from HHS, told TheBody that the goal is to reach and enroll as many qualified individuals as possible, and that HHS anticipates that 4,250 individuals will access PrEP by March 30, 2020, and up to 10,000 individuals in the first year.
But does this mean that Ready, Set, PrEP will allow a person without insurance to ask for PrEP at a pharmacy, and obtain it on the spot, completely free of charge? Not necessarily. While HIV/AIDS and PrEP advocates say the program a positive step in expanding access to PrEP, they point out that it won't cover everything, and they say the success of the program will depend on how it's implemented.
An essential part of PrEP care requires quarterly lab tests. In addressing the overall cost, Heck confirmed that while Ready, Set, PrEP covers 100% of the cost of the medications, it does not cover the cost of clinic visits and lab tests people need to obtain before accessing PrEP medications. "Those costs may vary based on a person's income," Heck wrote. "These services are available at low or no cost from many health care providers, including at federally qualified health centers that serve people who lack insurance or are ineligible for Medicaid."
Azar has said that some of those costs are covered by public clinics, and that his department is seeking nearly $300 million to defray PrEP-related costs in about 50 high-risk areas.
But for those who don't live near a public clinic, costs for health care providers and testing could be barriers to PrEP access, advocates say. These costs can run up to more than $1,000 annually, according to a recent study by the PrEP4All Collaboration.
James Krellenstein, a co-founder of the PrEP4All Collaboration, said he's concerned that by not covering wraparound costs of PrEP, HHS is "poised to repeat the errors" of Gilead's own patient assistance program, which donated free PrEP to qualified uninsured individuals on a smaller scale.
"The medication assistance program did not cover lab costs or associated clinical care," Krellenstein said. "As a result, people who access PrEP through the medication assistance program were found to have a statistically significant lower rate of PrEP initiation and a longer time between PrEP prescription and initiation. We don't see why [Ready, Set, PrEP] would not be repeating the same errors."
Krellenstein continued, "It is striking to note that if the $6 million HHS plans on paying Gilead to distribute their 'donation' was instead spent on paying for PrEP patients' lab costs, HHS could cover 6,000 PrEP patients' lab costs for an entire year."
Shannon Weber, M.S.W., founder and director of PleasePrEPMe.org, said that it's exciting that the federal government is getting involved with distributing PrEP meds at no cost, but that the program will present a "learning opportunity."
"Implementation will be on a state-by-state level, which may exacerbate inequities," she said, noting that many states, some of which have the highest rates of new HIV infections, also have not opted in to Medicaid expansion.