* NICE to look at "wider societal impact" of new drugs
* Move may mean more positive recommendations in future
* NICE CEO says firms must offer NHS "very best price"
* Cancer campaigners fear less money for end-of-life care
(Adds further reaction from cancer charity)
By Ben Hirschler
LONDON, March 27 Britain's healthcare agency
NICE, which determines the use of treatments in the state-run
health service, may be more likely to say 'yes' to new drugs
under proposals that enable it to take a broader view of the
value they offer.
The National Institute for Health and Clinical Excellence
(NICE), will in future look at the "wider societal impact" of
therapies - whether they enable a patient to go back to work
faster, for example, for the wider benefit of society - as well
as their cost-effectiveness on more limited clinical grounds.
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.
But campaigners said the new proposals risked jeopardising
access to some expensive cancer drugs and could discriminate
against old people who contributed less to society, and against
people nearing death, since it would do away with current
special provisions for end-of-life care.
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
Chief Executive Andrew Dillon told Reuters that wider
overall uptake of new drugs would depend on pharmaceutical
manufacturers keeping a tight rein on prices.
"Companies need to recognise that the NHS is under huge
pressure," he said, adding that the new framework "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)."
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 fueled 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.
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 - a worry
echoed by Paul Workman, deputy chief executive of the Institute
of Cancer Research.
"The suggestion from NICE that it could remove its end of
life criteria is extremely worrying and could deny thousands of
patients with diseases such as cancer access to life-extending
drugs," Workman said.
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.
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 Sophie Walker)