July 31, 2018 – The Fair Pricing Coalition (FPC) today commended Gilead Sciences for recent improvements to its Advancing Access program for Truvada (tenofovir disoproxil fumarate/emtrictabine) as pre-exposure prophylaxis (PrEP). In a July 24, 2018, letter to advocates, Gilead announced that its copay assistance maximum would be increased from $4,800 to $7,200 a year. This change goes into effect September 1. Additionally, beginning July 1, people vulnerable to HIV who qualify for the Advancing Access Medication Assistance Program (MAP) – which provides free drug to uninsured or underinsured individuals who meet annual income criteria – will remain eligible for 12 months instead of six months.
“For at least two years, the FPC – independently and as part of a coalition of community leaders concerned about Truvada pricing and access – have been pushing Gilead to make these long-overdue changes,” said Tim Horn, Chair of ad hoc coalition of HIV and hepatitis C virus activists. “We have documented cases where individuals with health insurance acquired HIV because they could no longer afford the out-of-pocket costs associated with taking Truvada after meeting the current copay assistance maximum allowance. And we’re pleased that people in need of free Truvada for PrEP through the MAP can count on access for 12 months, as opposed to having to reapply every six months.”
Despite the FPC’s repeated requests going back to the time of the launch of Truvada for PrEP, which would have allowed for a more detailed look at the financial need of those seeking the medication, Gilead refused to make public the methodology by which it arrived at its support levels. This forced the FPC and its colleagues in the community to gather information independently to document the support programs’ shortfalls and their consequences.
In a related matter, the Gilead announcement does not address the lingering concern expressed by advocates about the application of co-pay accumulators by commercial health insurance plans. In short, these co-pay accumulators may prevent copay assistance from being applied toward members’ deductible requirements, which can be very high, particularly for those on Bronze or Silver Affordable Care Act Marketplace plans with lower premiums.
“Copay accumulators are unacceptable barriers to essential medications,” said John Peller of the FPC. “They are a crude tactic by commercial insurers to deal with runaway prescription drug prices. While we appreciate that they are meant to drive patients to use cheaper generic drugs, there is no evidence-based generic alternative to Truvada for PrEP. People vulnerable to HIV are being caught in the middle of a war between insurance companies and drug manufacturers. We need a truce, which must begin with manufacturers – including Gilead – offering the discounts and rebates necessary for insurers to do away with this unfair and dangerous practice.”
Separately, Gilead has also announced that patient representatives from health care facilities can sign Advancing Access assistance program applications from adolescents that need PrEP. The FDA approved PrEP for adolescents earlier in 2018.
“We are glad to see Gilead recognize that not all youth will be able to get a parent or guardian’s signature to access programs that make PrEP affordable,” said Horn. “Homophobia and transphobia remain pervasive threats to sexual health in the U.S., particularly among queer youth. This program change should help improve access to Truvada for PrEP among vulnerable adolescents. The need for awareness of this access mechanism is critical and we encourage Gilead to do everything possible to inform health care providers, community leaders, and adolescents in need.”
According to figures released at the recent International Conference on AIDS held in Amsterdam, as of 2016 only about 7 percent of the 1.1 million people most at risk of acquiring HIV in the United States are accessing Truvada for PrEP. Among African American and Latino/a gay, bisexual and other men who have sex with men and transgender and cisgender women of color, PrEP uptake has been even less robust.
“The FPC has discussed many times with Gilead the multiple barriers to PrEP uptake, with the ever-escalating cost of Truvada not the least of those factors,” said Horn. “In this case, we are pleased with the expansion of support for those who need PrEP, all the while dismayed that such programs are even necessary.”