HIV prevention doesn't need to put a hole in your wallet. For Washington state residents who want access to pre-exposure prophylaxis (PrEP) for HIV prevention, the cost of Truvada can potentially be zero dollars thanks to the state's PrEP Drug Assistance Program (PrEP DAP). As of April 2014, the Washington State Department of Health has been actively enrolling those seeking assistance in paying for Truvada, the only FDA-approved medication for PrEP. It is the first, and currently the only, state-funded drug assistance program for PrEP in the United States.
Washington's PrEP DAP is modeled off of the AIDS Drug Assistance Program (ADAP), which is funded by grants given to each state from the federal government under the Ryan White HIV/AIDS Treatment Extension Act of 2009, known as the Ryan White CARE Act. All 50 states, the District of Columbia, Puerto Rico, Guam, the U.S. Virgin Islands and other U.S. territories are eligible for ADAP funding. According to the Washington State Department of Health's website, in order to access PrEP DAP, a person needs to:
- Be HIV negative.
- Live in Washington state.
- Meet one of the following risk factors:
- Have a known HIV-positive partner or partners, or
- Be a gay or bisexual man who lives in an area of high HIV prevalence, has been diagnosed with a sexually transmitted infection (STI) in the past year, has been exposed to a sexually transmitted infection (STI), has had 10 or more sexual partners in the past year, has used meth in the last year, or has had condomless sex in the past year.
Washington state residents are required to fill out the application with the help of a medical provider.
One eligibility criterion that is noticeably absent from the above list is income.
"We didn't want to curtail interest in the program too early," said Dave Kern of the Washington State Department of Health's Infectious Disease Prevention Program. Those looking to receive assistance do not need to submit financial documents, according to Kern.
According to Kern, the program has received 70 applications and currently has 45 active enrollees. Of the remaining 25 applicants, 11 were denied enrollment because they were either currently on Medicaid or were Medicaid-eligible. "What we find is that the coverage that Medicaid provides individuals who are interested in PrEP is better than the coverage that we can provide," he said. "Rather than just covering the costs associated with Truvada, which is what PrEP DAP is able to support, Medicaid is able to cover the costs of drugs, medical visits and labs." The remaining 14 applications are still being processed, Kern noted.
Washington's PrEP DAP currently covers the full cost of Truvada for those who are uninsured; it covers copays and deductibles for those who have health insurance. Truvada, manufactured by Gilead Sciences, currently costs around $1300 for one month's prescription. However, Kern seemed very optimistic about the ability of the state's PrEP DAP to cover potential enrollees. "We've committed around $2 million each year for PrEP DAP," he said.
He added, "Based on very early and conservative calculations, we estimated we can cover about 200 people at a cost of $2 million. In that initial calculation, we assumed that about half would need full coverage for Truvada, but what we're seeing in the program is that less than 20% actually need full paid coverage. Two hundred is the number we set in calculation before the program started. In practice, we will likely be able to enroll more than 200 -- somewhere around 250."
For the Washington State Department of Health, the PrEP DAP rollout strategy, according to Kern, has been one of "soft touch and a low-threshold release, meaning we didn't do a lot of marketing and media for one primary reason, and that was because we wanted to spend 2014 really building infrastructure should people want to get on PrEP and use the PrEP DAP program."
According to Kern, the state's initial rollout involved a low-key dinner party. "We worked with a physician in Seattle to convene a dinner of 10 to 12 clinicians primarily from the Seattle area who were already prescribing PrEP or were interested to discuss what they were currently doing, or any questions they might have." Invitees to this dinner were primarily infectious disease doctors or doctors that had a large gay and bisexual male clientele.
PrEP DAP Is a First Option for Some, Backup for Others
Evan Peterson, a 32-year-old Seattle-based author and college professor, accesses the pill through PrEP DAP and can corroborate Kern's strategy narrative. "I had not heard about Washington [PrEP] DAP until my doctor told me," he said, adding that the program is "still something that a lot of people don't even realize exists."
Peterson began to take PrEP and to access PrEP DAP, simultaneously, about two months ago. He described the registration process as quick and "fairly involved, but not terribly rigorous." Since beginning PrEP, Peterson has experienced a marked shift in his own attitudes around sex and HIV. "I feel really safe on PrEP. I'm glad it exists," he said.
When Peterson was contemplating going on PrEP, he was unsure of what the copay would be on his insurance. When choosing whether to access PrEP DAP, Peterson thus did so partly as an activist: He "wanted to show the health department that there is a demand for the PrEP DAP program," he said.
The need for financial assistance in order to access HIV prevention is a factor for more people than just Peterson. Roger Klorese, a 58-year-old PrEP user in a serodiscordant couple, is considering enrolling in Washington's PrEP DAP in order to keep his options open during an ongoing job search.
Klorese has been on PrEP since August 2012, only a month after it was first approved by the FDA. He first accessed PrEP through employer insurance, and now accesses the pill through a combination of COBRA benefits and Gilead's copay assistance program while he searches for a new job. For Klorese, who accesses PrEP and whose partner has to access his HIV meds, concerns about insurance coverage are often at the forefront of his mind. "Fundamentally, the whole idea that how good your health care is [must be] part of the decision making process for a job is just so broken," he said.
He added, "With my partner being HIV positive, and with some companies putting Truvada for PrEP and some of the therapeutic drugs up in very high tiers on some of their lower plans, this preserves my option to take a job with a startup that doesn't have great insurance, or a great prescription plan." The possibility of enrolling in PrEP DAP "takes one more boulder out of the road," he said.
Who Gets a Piece of the Prevention Pie?
Klorese and Peterson are just two examples of people who may benefit from signing up for PrEP DAP. Though the guidelines explicitly target gay and bisexual men, the list of enrollees currently includes two cisgender women. "For the infectious disease doctors, it's fair to assume that they do work with serodiscordant couples, and as a result that's why I believe we've seen at least the two women who have signed up for PrEP DAP at this point," said Kern.
He added, "We have not up to this point screened anybody out based on what they have selected as eligibility criteria. We do believe that it's open and flexible enough that should there be a woman who, for example, is involved in sex work, she could certainly meet one of the criteria and be part of the program. But there hasn't been active outreach to providers of that population up to this point."
The Future of PrEP DAP
In order to ensure that PrEP DAP continues to be a part of Washington's prevention landscape for people of all genders, the state's Department of Health has made a commitment to do an evaluation of the program at six months in order to reexamine how many people it can cover. One of the Department of Health's priorities for 2015 is "understanding the payer environment as it relates to Truvada," according to Kern. For him, that means getting a deeper understanding of Gilead's assistance programs and where major health insurance carriers have placed Truvada on their formularies.
While the program is looking into several factors that determine how much someone will pay for Truvada, advocacy efforts to reduce the price of Truvada are not currently on its radar, Kern said -- unless other departments move toward that goal first. "If there were a national coalition of health department programs that were advocating for more reasonable pricing for the drug, that's something we would take into consideration," he said.
Unfortunately, the likelihood of any change in the price of Truvada is "very low," according to David Evans, the Director of Research Advocacy at Project Inform in San Francisco. According to Evans, Truvada is a unique case because it is used for both treatment and prevention.
Also, Evans said, there has only been one case of an across-the-board reduction in price for a brand-name HIV drug in the U.S.: In September of 1989, the Burroughs Wellcome Company cut the price of Retrovir (zidovudine, AZT), which at the time was the only approved HIV antiretroviral, by 20 percent in the wake of community outrage. However, Evans points out that a host of factors surrounding Retrovir made it a much different ball game. For instance, compared to Truvada, "[Retrovir] was used less frequently and at a much lower dose," said Evans.
According to Evans, we shouldn't expect any price relief for Truvada until 2021, when its patent expires. (The patents for the individual drugs that combined make up Truvada, tenofovir and emtricitabine, expire in 2017 and 2021, respectively.)
Amidst quandaries of drug prices, money woes and opportunities for access, it may very well seem that the AIDS epidemic's earliest specters still haunt efforts to prevent the spread of HIV. However, Washington state's PrEP DAP success story is based in large part on long-standing support from governors, legislators, academics, researchers and major community stakeholders, according to Kern. For those wishing to replicate its success, the key may lie in the same communal approach, rooted in cooperation, communication, symbiosis and a shared sense of need.