Gilead and the U.S. Department of Health and Human Services (HHS) are locked in a patent dispute over HIV prevention meds, but as the fight plays out, they’re also partners in a new program to provide the drugs for free to patients who need them.
The program, called Ready, Set, PrEP, debuted this week and will distribute Gilead’s PrEP meds to uninsured patients around the country. Gilead agreed to the donation back in May, starting with the older Truvada and transitioning to the newer Descovy following its recent FDA approval.
As part of the program, HHS is paying Gilead $200 per bottle of 30 pills until March 30 to cover distribution costs, the New York Times reports. That covers the amount Gilead pays to distributors to dispense the meds, according to the report, and HHS secretary Alex Azar said the agency hopes to lower its costs after March 30.
The program will distribute the meds to patients who have recently tested negative for HIV and who have a valid prescription for PrEP. It's also limited to those who don’t have insurance coverage. It’s part of a White House initiative to reduce new HIV infections by 75% over five years and 90% over 10 years.
But the effort has garnered criticism. Prep4All cofounder James Krellenstein told NYT the program doesn’t help people pay for testing or follow-up exams. If HHS didn’t pay for distribution costs, the agency would be able to pay for testing for about 6,000 people, he added.
The program's debut is the latest development in a busy year in PrEP for both Gilead and HHS. The parties are locked in a dispute over PrEP patents, and last month, HHS sued Gilead for patent infringement. HHS says it has tried to license its patent rights to Gilead, but that Gilead refused. A Gilead spokesman said the company “strongly” believes HHS patents are invalid and that it rejects "any notion of willful infringement."
Meanwhile, Gilead has inked a generics deal under which Truvada will lose exclusivity next year, so the company is working to switch patients over to its newer Descovy. In two months since Descovy scored FDA approval for HIV prevention, about 10% of Truvada patients have switched over, Jefferies analysts wrote in a recent note.