Seeking to blunt criticism of its pricing, Gilead Sciences (GILD) is donating enough of its HIV prevention pill to cover as many as 200,000 patients over the next 11 years. The donation will cover both the existing Truvada pill, which has been the subject of battles with AIDS activists, and still another drug the company hopes will also win regulatory approval to prevent the virus.
The move was hailed by the Trump administration, which announced plans to end HIV in the U.S. by 2030, but has also been criticized by activists for not taking steps to reduce the cost of Truvada. The pill, which is also sometimes referred to as PrEP, costs about $1,675 a month, or $20,000 a year, but has been climbing steadily since it was first introduced in 2004 for treating HIV.
“The majority of Americans who are at risk and who could protect themselves with PrEP are still not receiving the medication. This agreement will help close that gap substantially and deliver on President Trump’s promise to end the HIV epidemic in America,” Alex Azar, the Health and Human Services Secretary, said in a statement.
The donation comes at a fraught time for Gilead, which has faced sustain criticism by some AIDS activists over Truvada. Since the pill was approved in the U.S. seven years ago for preventing HIV, the company has been under pressure to lower the price because activists argued the cost was a barrier to access, thwarting public health goals of eradicating the virus.
The drug maker, meanwhile, sued several erstwhile generic rivals for patent litigation. Those lawsuits were settled in 2014, although the terms were never disclosed and lower-cost versions of Truvada were not expected until 2021, when the patent on a key component is due to expire. The patent on another component expired last year. However, Teva Pharmaceuticals (TEVA) plans to sell a generic in September 2020.
Reactions to the move from the AIDS community, however, were mixed.
“This is a very significant development that will go a long way in helping prevent HIV,” said Carl Schmid of the AIDS Institute and co-chair of the President’s Advisory Council on HIV/AIDS. “It will free up the federal government from having to spend potentially billions of dollars over the next 11 years for the purchase of PrEP for the uninsured.”
Leading activists, though, expressed frustration.
“We know Truvada costs $4 a bottle to make, so this donation costs them only $9.6 million a year. But no lowered price, so they keep selling $3 billion of Truvada a year,” Peter Staley, a former ACT UP activist who is a member of the PrEP4All Collaboration, wrote on his Facebook page. “Why didn’t they do this seven years ago? How many infections would have been prevented for just $10 million a year?”
“Don’t get me wrong, this is exactly the kind of public health program PrEP4All has been calling for. We are thrilled at this expanded access to those who need it most. But generic PrEP might reach three to four times as many people.”
Similarly, James Krellenstein of PrEP4All, told us “This is seven years too late. For years, Gilead has been claiming there is no access problem, which is an abject lie, and now they’re getting credit? And now we’re getting an assistance program? It’s 240,000 inflections later. It’s completely unacceptable. The company expects to be patted on the back for a problem they caused by their price gouging.”
He also noted that Gilead may benefit from any tax breaks associated with the donation.
Their remarks reflect ongoing cynicism toward the company. Activists have tried to convince the Trump administration to either sidestep a Truvada patent, which is held by the Centers for Disease Control and Prevention, or negotiate a royalty from Gilead and use the funds to fight the virus.
Adding to their frustration, the CDC collects royalties from Mylan, which sells a generic version of Truvada in several European countries and Australia as the result of patent litigation in Europe. The Department of Justice is investigating the issue, although it is not clear if the donation is part of any arrangement with the company. Gilead has denied the patent is valid in the U.S.
At the same time, activists note that Gilead is hoping to transition HIV patients to its newer Descovy treatment as generic competition to Truvada nears. Descovy is currently approved for treating HIV, but not yet for prevention, although the company released data several weeks ago demonstrating the pill can prevent the virus.
“Let’s call a spade a spade. The real cost of Truvada is about $60 a year. If you really wanted to cover everybody, you’d cut the price to everyone,” Dr. Rochelle Walensky, who led a team at Massachusetts General Hospital who analyzed the Obama administration AIDS plan, told The New York Times. “If I put on my cynical hat, I think this is the way they make sure they grow the market for Descovy.”
A recent survey of 40 physicians by SVB Leerink analyst Geoffrey Porges found that they expect to be treating nearly double the number of PrEP patients from 2018 to 2020, and 63% were familiar with the recent Descovy Phase 3 trial data. Already, some are using the newer drug for prevention and over half expected using Descovy for prevention to increase their overall prevention treatment by 17%.
Moreover, the physicians expected to quickly migrate 60% of their PrEP treatments to Descovy through next year. “More importantly, the physicians expected generic Truvada to only cannibalize branded Truvada volume, and actually expected to increase the proportional use of Descovy over time after the launch of generic Truvada,” Porges wrote in a note to investors.
Pharmalot Columnist, Senior Writer
Ed covers the pharmaceutical industry.