The U.S. Preventive Services Task Force (USPSTF) issued their final recommendation for PrEP in JAMA today, recommending "that clinicians offer pre-exposure prophylaxis (PrEP) with effective antiretroviral therapy to persons who are at high risk of HIV acquisition." Due to a key provision in the Affordable Care Act (ACA), this means that payers (private insurers and public programs like Medicaid) will have to offer PrEP to patients who want it, with no out-of-pocket cost to the patient for the prescription, labs or any of their doctor visits.
"The inclusion of PrEP as an A-rated recommendation by the USPSTF is an enormous victory for PrEP implementation in the United States," said Demetre Daskalakis, M.D., M.P.H., deputy commissioner of the division of disease control at the New York City Department of Health and Mental Hygiene. "Removing the often onerous copays will simplify access and address the gaps experienced by individuals with insurance plans that carry high copays."
The USPSTF is an independent panel of experts in disease prevention who volunteer to review evidence of the effectiveness of preventive services, and develop recommendations for the best preventive interventions for a range of illnesses or conditions using an A-to-D grading scale. In November 2018, USPSTF released its draft recommendation with an "A" grade for PrEP, inviting public comment for a five-week period. According to the ACA, insurers must cover, without cost-sharing, current USPSTF-recommended services that have garnered an "A" or "B" rating.
Krisczar Bungay, MD, a primary care physician in New York City who has many patients who use PrEP (as well as those on antiretroviral therapy to treat HIV) was encouraged by the recommendations, especially because it is worded carefully to allow for an interpretation that future PrEP drugs will also fall under the recommendation, once approved.
"They were smart to use PrEP as a general field rather than Truvada since more meds are coming up," he said. "That means insurance companies can choose to have preferred drugs for PrEP as long as they are covering a medication for PrEP."
Now that the recommendations are finalized, the details will be in the implementation process for public and private payers. TheBodyPRO reached out to several private health insurance companies to comment on how this recommendation would impact their bottom line, since they will soon no longer be able to recoup some of their costs through copays for the drug or doctor visits. None returned our emails for comment by the time of publication.
Several health departments nationwide have established PrEP Drug Access Programs (or PrEP-DAPs) to assist people who want PrEP but cannot pay the out-of-pocket costs. How will removal of the cost of labs and visits impact these public health programs?
"While PrEP-DAPs established by many health departments in the U.S. frequently rely on Gilead's copay assistance program to cover cost sharing for Truvada [FTC/tenofovir disoproxil fumarate, TDF/FTC], manufacturer copay assistance won't likely be available for generic versions of TDF/FTC once they become available," said Tim Horn, director of medication access and pricing at NASTAD. "PrEP-DAPs also stand to benefit from the elimination of deductibles and copays on lab tests and provider visits associated with accessing PrEP."
Still, the current retail price remains high. Even when costs for labs and provider visits are eliminated, questions remain as to whether this measure will be enough to ease the strain the cost of the drug itself is placing on the budgets of health departments working to improve PrEP access to uninsured and underinsured patients.
"Addressing the baseline cost of the medication approved as PrEP should be next on the horizon," said Daskalakis. "This would further empower public health authorities and other agencies to reallocate resources spent on pharmaceuticals to programming that brings people who should consider PrEP into preventive care."
While the cost of care for PrEP does influence the policies that payers set for prior authorization and the use of specialty pharmacies, it does not address all the challenges of expanding PrEP access to all those who could benefit from its protection. One of the major questions the USPSTF attempts to address is how providers should decide which patients have behavioral risk factors for PrEP. The recommendation names people who should be considered for PrEP, including men who have sex with men (and with men and women), "high-risk" heterosexuals, transgender people, people who inject drugs, and sex workers. Within each of these populations, they name people who are having sex with partners who are living with HIV or are of unknown status, and people who have had a sexually transmitted infection in the last six months, as likely PrEP candidates.
But even the USPSTF recommendation acknowledges the lack of evidence, noting: "Although the USPSTF found no well-validated, accurate tools to assess risk of HIV acquisition, epidemiologic data, Centers for Disease Control and Prevention (CDC) guidelines, and enrollment criteria for clinical trials provide guidance on detecting persons who may be at high risk."
But some recent studies have shown that the current clinical guidelines may miss scores of people who would benefit from PrEP, but do not neatly fit into any of these categories. A 2018 study that reviewed several clinical guidelines for PrEP eligibility with young black men who have sex with men (BMSM) stated: "Overall, our findings were consistent with other studies demonstrating that BMSM were less likely to meet indications for PrEP compared to other racial groups, despite their acute risk for HIV acquisition."
Danielle Campbell, M.P.H., chair of the U.S. Women and PrEP Working Group, responded with similar concerns about how the USPSTF recommendations for screening for risk factors would miss many black and Latinx women.
"Overwhelmingly, women respond and ask why they would need to take a pill to prevent HIV when they only have one sexual partner," she said. "For women, our perception of risk isn't always neat, and these statements [from women] place perception of risk squarely on its head."
Horn believes that the opportunity to grapple with questions of how to best implement these recommendations is now.
"The USPSTF recommendation will likely be operationalized by private insurers starting with the 2021 plan year," he said. "Making sure that plans are maximizing coverage for all of the services recommended by the CDC, without stigmatizing PrEP eligibility determinations, is now the priority."