Washington has run out of funding for its HIV prevention assistance program and its future remains uncertain — despite growing demand.
The state Department of Health's program, known as the pre-exposure prophylaxis drug assistance program (PrEP DAP), covers nearly all out-of-pocket expenses for Washingtonians who take HIV prevention medicine, usually a once-a-day pill, or their related lab or doctor visits. It has existed for eight years, but because of a sudden increase in pharmacy costs and changes to health insurance coverage this summer, program leader Elizabeth Crutsinger-Perry said she's been forced to close it to new enrollment.
The program is using extra state funding that had been allocated to general HIV prevention efforts to keep its doors open, but will likely close Dec. 1 unless another funding source is established before then.
Crutsinger-Perry hopes she can find new sources of funding and work with pharmacies toward a solution.
"This is not the news I wanted to deliver to my peers and partners," Crutsinger-Perry said. " ... But I don't see it as coming to an end — I see it as evolving."
Program leaders started becoming aware of some changes in June — a month before the state's fiscal year began — when drug costs were creeping up much higher than expected.
"Before we could figure out a plan, drug costs increased very quickly," Crutsinger-Perry said. "Within less than the first three months and before the end of September, we spent all the money we had allotted for the whole year. That has never happened before."
After generic versions of PrEP drugs started becoming available in recent years, health officials assumed the drug would be low-cost to patients, particularly those without health insurance.
But while many pharmacies charged the state fairly low costs on monthly medication (about $50 or less per patient), some billed the program over $1,300 per patient for some reason, leading to a "rapid depletion of program funds," Crutsinger-Perry said.
"The generic drug is being priced differently depending on some factors in the drug-pricing world that I need to understand a bit more," Crutsinger-Perry said. "And we're now working with our partners to set some limits about what we're able to pay."
In addition, the federal government last year announced almost all health insurers must cover PrEP costs with no cost sharing. The requirement came after the U.S. Preventive Services Task Force granted the HIV prevention pill an "A" rating in 2019, which, under the Affordable Care Act, means the service should be covered by nearly all insurers.
"We expected to see insurance plans pick up those costs and we'd be paying very little," she said. But that has not happened.
Reimbursement changes to some pharmacies' patient assistance programs, which are quite common, also had an impact, causing some patients, particularly those uninsured, to lose access and seek out the state's PrEP DAP.
As a result, the number of uninsured patients using PrEP DAP grew nearly nine times in 2022, Crutsinger-Perry said.
"We didn't anticipate all those changes that happened quite quickly, so unfortunately we're now having to react to this a little bit too late," she said.
The state introduced PrEP DAP in April 2014, when it became the first program of its kind in the United States. Since then, it's grown to benefit about 2,500 people a year in Washington, though Crutsinger-Perry noted that number doesn't include the many others in the state who are on PrEP outside of the program.
Anyone, regardless of insurance status, can apply to the program with a doctor's or pharmacist's PrEP prescription. Once enrolled, the program will cover the patient's portion of drug costs and doctor/lab visits.
The program's budget is about $1.3 million per year, which is allocated by the state Legislature from its general fund.
"I still believe we can innovate," Crutsinger-Perry said. "We're going to need some time. ... If I can extend the program to the end of June, we'd start new with fresh general state fund dollars in July."
The vast majority of PrEP DAP patients are male and live in King County, according to state data.
Dr. Matthew Golden, who leads King County's sexual health clinic, said that while he has some concerns about the future of the state program, many patients will still be able to continue their medications through Ready, Set, PrEP, a nationwide program run by the U.S. Department of Health and Human Services, and other pharmacy drug assistance programs.
"We do just have to make sure we know how people's labs are being taken care of," he said. "The challenge with PrEP DAP going away is paying for labs and seeing a medical provider."
In King County and throughout the state, public health teams continue to work on upping HIV prevention strategies. While slightly less than 50% of King County residents most at risk of contracting HIV are on PrEP, the goal is to reach at least 70%, Golden sad.
Short-term steps for the state program remain up in the air this week. And while Crutsinger-Perry said she hopes to meet with pharmacies and partners in the next few weeks to come up with a new plan for the re-imagined program, it could take longer to find extra funding.
Regardless, she said, her big-picture goals for the program haven't changed.
"To give individuals who have suffered fear and stigma and the despair of expecting that becoming HIV-positive is just going to be a thing that happens in my life, to give them an option to take a more proactive approach in a way that still honors their sex life and humanity, is a life-changing and cause-changing part of our history," Crutsinger-Perry said. "I believe our role in making that medication a possibility is really important and not one we take lightly."