By Donato Paolo Mancini
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.
By rolling out the treatment under the banner of a clinical
trial, the NHS can use a low-cost generic version of the drug
without infringing patents because drugs used in clinical trials
are exempt from patent litigation under English law.
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.
Under the trial, the NHS will make a generic form of the drug,
made by rival firm Mylan NV, available for at least 10,000 people.
The generic isn't otherwise directly available in the U.K. The move
could also 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 use of a trial in this manner is very rare in the U.K., but
the unconventional move stands to deliver the drug at a significant
discount.
Truvada costs patients about GBP355.73 ($461.69) a month when
bought privately via the NHS, according to the most recent British
National Formulary figures, while generics bought online usually
cost a fraction of that.
The NHS declined to comment on commercial terms of the
arrangement, citing confidentiality. Mylan said it has worked with
Gilead to expand access to Truvada and its generic version around
the world, and it is pleased to support the NHS for the clinical
trial on PrEP. It didn't comment on how much the agreement was
worth. Gilead Sciences declined to comment.
However, while the use of a clinical trial to circumvent patents
and use generics could set a precedent for this is particular drug,
it is unlikely to be used more widely because generics aren't
typically available for new, high-price drugs. The reason generic
drugs are widely available for HIV is because drug companies have
allowed their development for use in low-income countries.
The Wall Street Journal first 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.
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 because of its
high cost, with a lengthy legal battle over who should pay for the
drug in England lasting years.
In December the NHS announced it would put out a tender for the
trial and would review proposals from a number of manufacturers,
including those of generic versions of the drug.
"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.
Activists have cautiously welcomed the NHS's decision to launch
a trial using a generic.
"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. The NHS also said
the trial would address the issue of drug penetration among
demographics other than men who have sex with men.
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.
--Denise Roland contributed to this article
(END) Dow Jones Newswires
August 11, 2017 18:12 ET (22:12 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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