Abstract
Background
Concerns about the actual and perceived costs of pre-exposure prophylaxis (PrEP) continue to be a major barrier to uptake among gay, bisexual and men who have sex with men (GBMSM) in the United States.
Methods
We conducted semi-structured interviews with 25 GBMSM who presented for routine health care at a STD clinic in the northeastern United States. The cohort included GBMSM who were or were not currently taking PrEP and represented varied health care coverage and financial resources. We used a structured coding scheme to analyze transcripts and identify themes relevant to cost factors.
Results
Participants shared their perspectives about PrEP and their experiences with accessing and paying for PrEP. Our findings suggest that health care coverage or financial assistance were essential to PrEP access but were not easily accessible to all people and did not always cover all costs. Therefore, paying for PrEP had to be balanced with other life expenses. Participants had multiple sources for information about PrEP cost and assistance from clinic and pharmacy staff helped reduce burden and resolve difficulties.
Conclusion
Addressing gaps in health care coverage, providing financial support, and improving the enrollment process in a financial assistance program may improve PrEP uptake.
Introduction
In the United States (US), gay, bisexual, and other men who have sex with men (GBMSM) experience the greatest burden of HIV, accounting for 68% of new diagnoses. 1 Pre-exposure prophylaxis (PrEP) is a daily oral medication that is highly effective at preventing HIV infection and recommended by the Centers for Disease Control and Prevention. 2 More than 227,000 individuals used PrEP in 2019, 3 only a quarter of those who were clinically indicated for PrEP. 4 Within these data are significant inequalities by race and ethnicity. White men receive 66% of PrEP prescriptions compared to a combined 25% for Black and Latino men, who experience higher risk for HIV. 4 Concerns about actual and perceived costs of PrEP influence acceptance, interest, and continuation of PrEP in GBMSM.5–10 Studies with young Black GBMSM in Atlanta, Georgia, 11 young Black and Hispanic/Latino GBMSM in Los Angeles, 12 and HIV-discordant GBMSM couples in Los Angeles 13 demonstrated cost as a barrier to uptake and retention. The full financial cost of PrEP is prohibitive for most people without at least some health insurance coverage or financial assistance. There are currently two name-brand formulations of PrEP on the market, Truvada (tenofovir disoproxil fumarate and emtricitabine, TDF/FTC), which costs up to $24,000 per year; 14 and Descovy (emtricitabine and tenofovir alafenamide, TAF/FTC), which costs up to $20,000 per year. 15 Currently, out-of-pocket costs for insured patients are around $94 per month, varying by region. 14 A generic formulation of TDF/FTC was introduced in October 2020 at a lower cost of around $8600 per year, 15 potentially making it more affordable.
The complexities of the health insurance system in the US, uneven policy coverage, varying out-of-pocket costs, and other factors that impact access to PrEP need further study to address barriers to uptake. 16 Health insurance plans with copays (fixed dollar amount per visit or prescription), co-insurance (percentage of costs that must be paid out-of-pocket), and deductibles (total amount that must be paid before insurance coverage begins) each represent cost structures that have differing impact on ability or willingness to pay costs associated with PrEP. 17 The goal of this study was to gain insight into the real-world impact of PrEP-related costs, including insurance coverage, financial assistance, and out-of-pocket costs on PrEP use.
Methods
Data presented here were collected during the first of a two-phase study examining perspectives of GBMSM on the impact of cost on PrEP uptake. The first phase consisted of semi-structured interviews with GBMSM who presented for routine care at the Sexually Transmitted Infections Clinic at The Miriam Hospital between August 2019 and December 2020. The second phase, consisted of a survey of a diverse sample of GBMSM administered through a dating app. Clinic staff screened patients for eligibility for interviews. Inclusion criteria for the study were: (1) Assigned male at birth; (2) Identified as male; (3) English or Spanish-speaking; (4) HIV-negative based on self-report; and (5) 18 years old or older. Men currently taking PrEP, those who had taken PrEP in the past, and those who were not currently taking PrEP were included. All interviews were conducted in English.
Trained staff interviewed participants in private rooms or via telephone using a semi-structured interview guide with open-ended questions. The guide was created using a structured coding scheme developed at the beginning of the project. Participants were asked about their knowledge of PrEP and any previous experiences with PrEP; their knowledge of their insurance coverage and any experiences with insurance, including gaps or difficulties with coverage; and their ability and willingness to pay out of pocket costs for PrEP. Participants who were currently using PrEP were asked about actual costs of PrEP. Those who had previously used PrEP were asked to recall costs, and participants who had never used PrEP were asked about the perceived costs of PrEP. Interviews lasted approximately an hour and all participants received a $50 gift card. In addition, demographic information was obtained, and participants completed the HIV Incidence Risk Index MSM (HIRI-MSM), 18 a ten-point assessment used as an objective measure of HIV risk for HIV negative men who have sex with men (MSM). A score of 10 or higher indicates perceiving oneself at moderate-to-high HIV risk. Data collection was stopped when no new data emerged. The study was approved by the Institutional Review Board at The Miriam Hospital.
Each interview was audio recorded, transcribed without identifying information, and reviewed for errors. Transcripts were analyzed with Dedoose software 19 using the previously developed structured coding scheme. Four members of the research team coded 5 transcripts, meeting twice to compare results and resolve discrepancies through discussion. Once finalized, the remaining 20 transcripts were coded individually by members of the team, meeting periodically to compare results for consistency. Coders wrote memos summarizing key findings.
Results
Demographics, GBMSM (N = 25), Phase 1 study conducted 2020–2021.
Health insurance and out-of-pocket costs
Insured participants received private insurance through an employer, coverage from a parent’s plan (if under age 26), or the Affordable Care Act (ACA) health insurance exchange; or public insurance including Medicare and Medicaid. Most participants said that their health care plans provided some coverage for PrEP, but individual plans varied widely. Copayments for the medication, lab tests, and provider visits varied. Copayments for medications ranged from $2 to $70, with a typical copayment of approximately $20. Copayments for provider visits ranged from $20 to $150, depending on the type of provider (i.e. primary care provider or specialist) and whether or not the provider was in network. Some participants had insurance plans with deductibles ranging from $250 to $5000 or coinsurance (cost sharing).
For some participants, their insurance covered most of the costs and was not a barrier to paying for a PrEP prescription.
I was under the assumption that [insurance company] might have said, “Oh, we need to do an extra this,” or put some sort of extra barrier for me to have this prescription, but surprisingly nothing happened. I was nervous before picking it up, so I called the pharmacy and asked them if it was going be much with the insurance, and they told me they didn’t know until I actually picked it up. I picked it up, and it came back as zero dollars. (Age 26, public insurance, on PrEP)
Several others, however, encountered high unanticipated costs.
The copays, I think, for specialist visits were maybe $25 or $60, something like that, whereas the bloodwork came in, I think it was around $300 at times. (Age 48, private insurance, on PrEP)
For some participants, PrEP was not covered under their plan. One person hoped that their insurance would cover the generic form of Truvada when it was released onto the market.
I would have to look for the generic and see if there’s enough coverage there that I could afford the copay, if there’s any. (Age 81, public insurance, not on PrEP)
Interruptions in coverage affected some when they changed jobs, their employer switched plans, or life circumstances required changes to their health insurance.
When I got laid off, my company covers my health insurance for three months … I've only had a gap for two weeks … [but] I had to get my medication, couldn't get it because I was uninsured. (Age 31, private insurance, on PrEP)
Similarly, one participant described stopping PrEP while he worked out issues with coverage.
The reason why I'm not taking it now is because of my insurance issues, so I had to get cut off because of that. I had to straighten it out. (Age 28, public insurance, formerly on PrEP)
For people without insurance or financial assistance, taking PrEP would not be feasible. Participants estimated that PrEP would cost thousands of dollars per month without coverage, which would be out of reach for most people.
Well, I believe the out-of-pocket price for PrEP, it’s running like $2,500, and, obviously, it’s going to be a problem for anybody who has no insurance, including myself. (Age 30, uninsured, on PrEP, receiving financial assistance)
I do want to take PrEP, but I don’t have any insurance. I don’t want to spend that much of money—I know that it’s something good, but I really can’t right now. (Age 24, uninsured, not on PrEP)
Mixed views about financial assistance
Gilead Sciences, Inc., the manufacturer of Truvada and Descovy for PrEP, offers financial assistance to people who are uninsured or underinsured to pay for the entire cost of the medication. The application requires the disclosure of financial documents about personal income, including tax returns, and approval for the prescription from their provider. Among our sample, three were enrolled in the financial assistance program and described an easy enrollment process, facilitated by clinic staff.
It was an easy process.[PHARMACY LIAISON] was great. . . He called me back. I think it was four days later to tell me that it had been approved
Some participants who were not enrolled said that they would be wary of sharing their financial information because they felt it was unnecessary, invasive, and stigmatizing.
I believe that’s on the line of invasion of privacy because why does me having access to medication to take so that I can afford it, rather than the difference between a medication that would be prescribed for any other reason? We wouldn’t ask someone for a W2 for a high blood pressure medication, and it seems it’s wrong, so why would something that I’m taking to prevent contracting HIV need documentation to prove my financial status?” (Age 23, uninsured, not on PrEP)
Other expenses
Regardless of insurance status or PrEP status, participants set limits for what they were willing to pay for PrEP and associated clinical care. Several were not willing to pay more than their current co-payments for medications, usually $20–40, while others estimated an upper limit before they would feel it was no longer affordable. This amount ranged from $10 to $200 per month.
I view it as a monthly-basis-type thing, so about—just over $50 a month for that would still be fine. I could still afford that, like I said, as long as there was no change in my finances. (Age 29, private insurance, not on PrEP)
I guess you would have to take into account the visits, all the tests—the routine testing and everything like that. To me, thinking of my past experience with health insurance, a clinic visit is a copay of $20, which seems like, Okay, I can do that. Then the lab testing, maybe another $20 bucks. I’m like, Um, okay. That makes sense. Then you have the prescription, your $50 per month of pills. You only have to get that lab and the visit every, what, three months or something. (Age 23, uninsured, not on PrEP)
Other costs, such as household expenses or paying for other health care would take precedence over PrEP. Furthermore, as a prophylactic, participants did not see PrEP as medically necessary, especially where there are other more affordable and accessible safeguards against HIV.
There’s too much stuff that you have to pay for where this preventative medicine is just going not be a necessity. That's $100 you could have put down towards your light bill or paying off your credit card ... There are so many more useful places that it could go in the sense of, you could just not have sex. (Age 29, private insurance, formerly on PrEP)
Almost all participants said that low cost or free PrEP would be an incentive to take it. For some, it would increase the likelihood that they would.
That would influence me and others more to use it because it's free. Now, it's more affordable, so you can't really have an excuse not to use it. (Age 28, public insurance, formerly on PrEP)
Sources for information about cost
Participants had access to multiple sources for information regarding coverage and costs, including their primary care or PrEP providers, people they know, clinics, pharmacists, or their insurance company. Some also suggested looking online to get the best price if PrEP was too expensive even with coverage.
Actually, CVS has a good website, and you can look up the cost of any kind of drug on there ... Obviously, you can get [PrEP] online, which is actually, I guess, a lot cheaper. (Age 58, private insurance, on PrEP)
One participant received assistance from their health care provider, saving them the effort of finding out costs themselves or at the pharmacy.
I was also fortunate enough that my provider ran my insurance before and told me how much it would be, so that was very helpful. (Age 23, private insurance, on PrEP)
Other people who took PrEP were a potential resource.
Well, I know some people that is on PrEP, so I would talk to them to know how it works and how much they take and how they get the medication. Where did they go? What kind of doctors and physicians they go? (Age 24, uninsured, not on PrEP)
Discussion
In this qualitative exploration of cost factors that affect uptake and adherence to PrEP, we identified several themes that describe real-world experiences with paying for PrEP among GBMSM in the US Northeastern. As in previous studies, our participants said that PrEP is costly and unaffordable without health insurance,5,9,10 and that cost and varying insurance coverage are sometimes significant barriers to PrEP uptake.8,13,20,21 Our sample included individuals who had sufficient coverage as well as those who encountered gaps in coverage, underinsurance, high copayments or deductibles, or lack of insurance. This uneven distribution of coverage seriously impacts some individuals’ access to PrEP and continuation of care. Furthermore, Black and Hispanic/Latino GBMSM have lower rates of insurance and delays in initiation increase risk of HIV transmission.22,23 Even when the medication is covered by insurance, other medical expenses, including copayments, deductibles, and lab costs, may be burdensome, 24 especially among Black and Hispanic/Latino GBMSM.22,23 The amount of routine out-of-pocket costs that participants were willing to pay varied, and some who were not currently taking PrEP predicted that basic life expenses would prevent them from affording PrEP. Under these circumstances, some questioned the value of a prophylactic medication when there are behavioral alternatives such as condoms or abstinence. In addition, some participants described short-term gaps during which PrEP was not covered, suggesting that financial assistance may be necessary when insurance plans change or when there is a gap in insurance coverage to ensure continuity in taking PrEP.
Our participants said that offering PrEP for free would relieve financial burden and be an incentive to take PrEP. Other studies have also shown there is less interest in PrEP when there is a cost9,25 and greater interest when PrEP is free. 26 Among young Black GBMSM in the Southern US, Crosby et al. 5 found 60% acceptability if PrEP were provided for free, and 19% acceptability for a cost of $100 or less per month. Galindo et al. 27 emphasized the necessity for costs to be absorbed or subsidized by private insurance companies, federal and local government programs, and/or pharmaceutical companies to make PrEP accessible. 28
The patient assistance program offered by Gilead Sciences, Inc. provides free PrEP to eligible individuals, who are usually uninsured or underinsured. Enrolling in the program requires submitting personal financial information, including tax documents. Among our sample, some participants worked with clinic staff to enroll and described it as an easy process. Others, however, questioned the need for such personal information and said they would not be willing to provide it to enroll. Making eligibility criteria clearer, explaining the need for financial documents, and assuring protection of that information could ease some people’s concerns and remove this barrier. For some individuals with insurance, Gilead Sciences, Inc. also provides coupons to cover the copayment. As Ard and Walensky 29 comment, navigating financial assistance “requires time, expertise, and person power; when these are underfunded and in short supply, PrEP uptake suffers” (p. 844). These programs may not be well known or understood by clinicians, pharmacists, or patients. Clinics should be familiar with and able to help, especially for financially vulnerable patients.
Finally, most participants said they would contact their provider, a pharmacy, or their insurance company or search the internet to find out their co-pay or cost. Participants in this study were recruited from a sexually transmitted infections clinic. They had easy access to information and knowledgeable providers, and staff who were familiar with procedures to obtain PrEP and able to take the time and effort to resolve issues. Others with fewer resources may be deterred by extra effort and may be lost to PrEP care following an initial health care visit. Having clear information about cost and getting issues resolved before visiting the pharmacy would ease the burden on the patient and smooth the process.
In summary, our findings suggest that feasibility of affording PrEP was contingent on how much an insurance plan paid for PrEP, receiving financial assistance if eligible, and manageable out-of-pocket costs. For many individuals, reductions in costs would undoubtedly facilitate an increase in PrEP uptake and retention. Other facilitators include providing clear information about pricing and insurance coverage, assistance obtaining information about their insurance plan’s coverage, and assistance with enrolling in financial assistance programs.
The strengths of our study should be considered in the context of its limitations. The demographics of our study skew towards White GBMSM with health insurance and higher educational attainment, a group who are not as affected by HIV and have higher PrEP uptake than Black and Hispanic/Latino GBMSM. This factor may limit the contribution of the study results to interventions and strategies that reduce racial/ethnic disparities in HIV transmission. Inclusive interventions will need to be culturally competent and take these added burdens for into account. Our sample was recruited from among patients at a sexually transmitted infections clinic clinic with a dedicated PrEP program and providers with a high level of knowledge about PrEP. Clinical practices and provider knowledge may not be the same as other health care settings where patients are prescribed PrEP, including primary care settings. 30 While our sample included both people who were insured and not insured, experiences with insurance outside of this region may have yielded different results and expectations for PrEP costs. Rhode Island is a Medicaid expansion state, making health insurance coverage available to most residents while there are greater inequities in states without Medicaid expansion. Our study took place on the precipice of the release of a generic version of TDF/FTC in October 2020. The impact on access to PrEP is still unclear. Overall, this study enhances the understanding of GBMSM’s experiences with encountering and negotiating the costs associated with PrEP.
Footnotes
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the National Institute of Mental Health (5R21MH118019-02 and K01MH116817).
