* Sovaldi recommended after U.S. firm provides more data
* Gilead says decision potentially covers most patients
* Hepatitis C drug 30 percent cheaper in UK than in U.S.
* J&J cancer drug Zytiga rejected for use pre-chemotherapy
By Ben Hirschler
LONDON, Aug 15 Gilead Sciences'
expensive new hepatitis C pill has been endorsed for use in
certain patients by Britain's healthcare cost-effectiveness
watchdog, after the U.S. firm provided more information.
The National Institute for Health and Care Excellence (NICE)
had told Gilead in June to come back with more data to support
the use of Sovaldi, a drug whose sky-high U.S. price of $1,000
per pill has sparked fierce debate over costly modern medicines.
Carole Longson, director of the NICE Centre for Health
Technology Evaluation, said on Friday it was now provisionally
recommending Sovaldi, also known as sofosbuvir, as a
cost-effective treatment for some people with chronic hepatitis
Gilead welcomed the decision to endorse Sovaldi as part of a
combination treatment regimen, which it said would potentially
make the drug available for the majority of hepatitis C
The new drug is recommended for people chronically infected
with certain strains, or genotypes, of the disease, which can
cause liver cirrhosis and, in a small percentage of people,
liver cancer. The conditions attached to its use vary according
to a patient's disease state and any past treatments.
Gilead argues its drug's high price is justified by the near
guarantee of a cure, far fewer side effects and the treatment's
ability to help patients avoid far more expensive hospital
treatment, including potential liver transplants.
But the sheer cost of the drug - which has already sold $5.8
billion in its first six months, making it the most successful
new drug launch ever - has fuelled controversy. Two members of
the U.S. Senate Finance Committee wrote to Gilead last month
asking the company to justify the price.
In Britain, where NICE's control over which drugs are used
on the state health service exerts downward pressure on prices,
Sovaldi is priced at 35,000 pounds ($58,400) for a 12-week
course of treatment - 30 percent less than in the United States.
NICE was set up by the government in 1999 to decide in a
rational way which drugs and treatments should be available on
the National Health Service in England and Wales, making it an
early pioneer of so-called healthcare technology assessment.
Since then it has had numerous run-ins with the
pharmaceuticals industry, especially over cancer drugs.
The latest cancer drug row involves a decision, also
announced on Friday, not to recommend the use of Johnson &
Johnson's prostate cancer medicine Zytiga before
chemotherapy, even though it is already recommended for use
J&J said it was very disappointed by the ruling, which comes
hard on the heels of a rebuff for Roche's new breast
cancer drug Kadcyla last week.
($1 = 0.5992 British Pounds)
(Editing by Raissa Kasolowsky)