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 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 C.
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 patients.
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 fueled 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.
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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 afterwards.
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.
(Editing by Raissa Kasolowsky)
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