* NICE to look at "wider societal impact" of new drugs
* Move may mean more positive recommendations in future
* But NICE CEO says firms must offer "very best price"
By Ben Hirschler
LONDON, March 27 British healthcare cost agency
NICE is to take a broader view of the value offered by new
medicines under proposals that may make it more likely that it
will say "yes" to novel drugs in future.
Chief Executive Andrew Dillon told Reuters that wider uptake
would only occur, however, if pharmaceutical manufacturers kept
a tight rein on prices.
The National Institute for Health and Clinical Excellence
(NICE), which determines the use of treatments on the state-run
health service, will in future look at the "wider societal
impact" of therapies, as well as their cost-effectiveness on
more limited clinical grounds.
This could, for example, take into account the fact that a
drug enables a patient to return to work, resulting in him or
her paying more taxes to the wider benefit of society.
Manufacturers have long complained that NICE unfairly
restricts access to new drugs by taking too narrow a view of
their benefits, resulting in a much lower uptake of new products
in Britain than in the rest of Europe or the United States.
Under the latest plan set out in a consultation document on
Thursday and designed to be implemented in the autumn, NICE
experts would have greater leeway to give a green light to
"It has the potential for increasing the number of positive
appraisals that NICE produces, but that is only going to happen
if companies offer the very best price to the NHS (National
Health Service)," said Dillon.
"Companies need to recognise that the NHS is under huge
The agency's evaluation system is based on the additional
quality adjusted life years, or QALYs, offered by new drugs,
with one QALY equal to one year of perfect health or two years
of 50 percent-reduced health.
The current cut-off for NICE to approve a treatment varies
between 20,000 and 30,000 pounds ($33,000-$50,000) per QALY,
with the exception of some end-of-life products - mainly cancer
drugs - where it may be as high as 50,000.
Under the new so-called "value-based assessment" scheme, the
band will be more flexible, with a ceiling ranging from 20,000
up to 50,000 pounds, with the higher limit no longer confined to
drugs for patients who are close to death.
The focus on societal impact could fuel fears of
discrimination against older patients, since they may be seen as
contributing less. But Dillon said NICE's appraisal committees
would not use the age of people with particular conditions to
make the difference between a new drug being recommended or not.
NICE was been operating for 15 years and has pioneered the
concept of systematically evaluating the cost-effectiveness of
new drugs. It has spawned the creation of a number of other
similar agencies in Europe and other parts of the world and its
deliberations are followed widely internationally.
The Association of the British Pharmaceutical Industry,
which represents British drug firms like GlaxoSmithKline
and AstraZeneca as well as multinationals operating in
the country, reacted cautiously to the new proposals.
Paul Catchpole, director of value and access at the lobby
group, said there was still "a huge amount of work to be done"
to ensure the new system actually improved drug availability.
He also expressed concern that the changes might lead to
fewer drugs for patients at the end of their lives.
Moving towards a more value-based system of drug appraisals
has been a tortuous process in Britain, with earlier plans under
the previous health minister, which had been due to take effect
at the start of 2014, undergoing major revisions.
In the meantime, the pharmaceuticals industry agreed a
separate deal with government last November to cap NHS spending
on branded drugs for two years, in the hope of winning improved
access for innovative drugs in the healthcare system.
($1 = 0.6037 British Pounds)
(Editing by Tom Heneghan)