Gilead Sciences : England's NHS Turns to Clinical Trial to Make Cheaper HIV Drug Available
By Donato Paolo Mancini
LONDON--A branded HIV drug that has been shown to reduce the risk of infection with the virus by 86% is proving too expensive for some at-risk European patients.
England's National Health Service thinks it has a solution.
The high price of Gilead Sciences Inc.'s HIV drug Truvada has deterred many countries from providing the pill as a preventive treatment for people at high risk of contracting the AIDS-causing virus, doctors, activists and patients say.
By rolling out the treatment under the banner of a clinical trial, the NHS can use a low-cost generic version of Truvada, made by rival firm Mylan N.V., without infringing Gilead's patent. It could pave the way for other European countries to follow suit.
"The unusual length, extent and nature of this 'implementation trial' may well set significant precedent for the unencumbered use of generics on the NHS," said Siva Thambisetty, an Associate Professor in Intellectual Property Law at the London School of Economics and Political Science.
The Wall Street Journal reported last week that the NHS would use the generic version of the drug for a large-scale clinical trial, with an allocated budget of GBP10 million ($12.98 million), providing the drug to at least 10,000 people. The NHS can strike the deal with Mylan without risking legal action from Gilead because drugs used in clinical trials are exempt from patent litigation under English law, it says.
The NHS declined to comment on how much the agreement was worth, citing confidential commercial terms. Mylan didn't respond to a request for comment. Gilead Sciences also didn't respond to requests for comment.
Truvada and its generic version are used in PrEP, or pre-exposure prophylaxis, a regimen that people at high risk of HIV can use to protect against acquiring the virus. Its use has been linked to a decrease in new HIV diagnoses in England recently, a first since numbers started being recorded.
Sheena McCormack, a professor of Clinical Epidemiology at University College London, said that increased testing and a rise in PrEP use played key roles in this decline.
In England, the potential benefits of PrEP are widely acknowledged. But the state-funded health system has been reluctant to make Truvada available for preventive purposes due to its high cost, with a lengthy legal battle over who should pay for the drug in England lasting years.
Currently, anyone who wants to use PrEP in England via the NHS would have to dip into their own pocket to buy the drug from Gilead at a price of GBP355.73 a month, according to the most recent British National Formulary figures.
"It was anticipated that a generic company would win, it's kind of what we've hoped", said Laura Waters, a doctor with the British HIV Association.
"By performing a trial and therefore opening up the drug access to generic companies it means it's cheaper."
Still, this solution, which will limit the provision of PrEP to those enrolled in the trial, falls short of a full rollout.
"This is a good step forward. We've been waiting for years for PrEP to become more widely available," said Will Nutland, an HIV activist and honorary lecturer at the London School of Hygiene and Tropical Medicine. But some caveats remain, he said: it is a trial, it isn't full access, and it is likely the 10,000 places on the trial will be filled quickly.
Mr. Nutland is among a handful of HIV activists who have been importing generic PrEP into the U.K. for personal use for several years in a bid to circumvent the high cost of the branded version of Truvada. He and others have also worked to make generic PrEP more widely available by having NHS HIV clinics test the purity of the drugs they import. But this depended heavily on how literate and wealthy PrEP users were, Mr. Nutland said.
PrEP is currently available in a number of European countries, including Belgium, France, and the Netherlands.
The move is likely to renew interest in generic PrEP elsewhere in Europe, activists and doctors say. In Ireland, where the import of generics is forbidden, shipments of generic drugs have been intercepted by customs.
"If the U.K. can do it, we can do it, too," said Julia Del Amo, a doctor and researcher at the Carlos III Institute of epidemiology in Madrid, Spain.