England's NHS Turns to Clinical Trial to Make Cheaper HIV Drug Available
August 11 2017 - 5:15AM
Dow Jones News
By Donato Paolo Mancini
LONDON--A branded HIV drug that is 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.
(END) Dow Jones Newswires
August 11, 2017 05:00 ET (09:00 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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