(Adds Gilead data from Japanese study)
LONDON, June 16 Britain's healthcare
cost-effectiveness watchdog said on Monday it needed more
information about Gilead Sciences' pricey new hepatitis
C drug Sovaldi before deciding if it should be used on the state
The National Institute for Health and Care Excellence (NICE)
said it was "minded not to recommend" the drug, which is also
known as sofosbuvir. The decision poses a hurdle to its
widespread adoption in Britain.
"The available evidence shows that sofosbuvir is an
effective treatment for chronic hepatitis C in certain
patients," said Carole Longson, director of the NICE Centre for
Health Technology Evaluation.
"However, evidence is lacking for some subgroups of patients
with chronic hepatitis C, and there are also substantial
uncertainties in the evidence base presented by the
Meanwhile, Gilead released more data on Sovaldi in
combination with its second hepatitis C drug ledipasvir that
should make it more difficult for NICE to reject.
In a Japanese study of patients with the most common and
often difficult to treat Genotype 1 form of the virus, the
Sovaldi/ledipasvir combination demonstrated a 100 percent cure
rate - 83 of 83 previously untreated patients and all 88 of
those who had not been helped by prior treatment - with 12 weeks
Once ledipasvir gains approval, the combination with Sovaldi
is expected to become a one pill, once a day treatment regimen
sold by Gilead.
Sovaldi is far more effective and better-tolerated than
older treatments, but its high cost has provoked criticism from
healthcare campaigners and insurers.
The U.S. price for a 12-week course of treatment with
Sovaldi is $84,000, or $1,000 for each once-daily pill. The
price in Britain has been set lower at around 35,000 pounds
Gilead and the pharmaceutical industry trade group has
argued that the 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 hospitalizations for liver
failure and the need for transplants as the disease progresses.
($1 = 0.5956 British Pounds)
(Reporting by Ben Hirschler, additional reporting by Bill
Berkrot in New York; Editing by Louise Heavens and Grant McCool)