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Pin to quick picksGlaxosmithkline Share News (GSK)

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SW UPDATE 1-UK healthcare agency to take broader view of new drugs

Thu, 27th Mar 2014 17:48

* 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 (Reuters) - Britain's healthcare agencyNICE, which determines the use of treatments in the state-runhealth service, may be more likely to say 'yes' to new drugsunder proposals that enable it to take a broader view of thevalue they offer.

The National Institute for Health and Clinical Excellence(NICE), will in future look at the "wider societal impact" oftherapies - whether they enable a patient to go back to workfaster, for example, for the wider benefit of society - as wellas their cost-effectiveness on more limited clinical grounds.

Manufacturers have long complained that NICE unfairlyrestricts access to new drugs by taking too narrow a view oftheir benefits, resulting in a much lower uptake of new productsin Britain than in the rest of Europe or the United States.

But campaigners said the new proposals risked jeopardisingaccess to some expensive cancer drugs and could discriminateagainst old people who contributed less to society, and againstpeople nearing death, since it would do away with currentspecial provisions for end-of-life care.

Under the latest plan set out in a consultation document onThursday and designed to be implemented in the autumn, NICE experts would have greater leeway to give a green light topromising treatments.

Chief Executive Andrew Dillon told Reuters that wideroverall uptake of new drugs would depend on pharmaceuticalmanufacturers keeping a tight rein on prices.

"Companies need to recognise that the NHS is under hugepressure," he said, adding that the new framework "has thepotential for increasing the number of positive appraisals thatNICE produces, but that is only going to happen if companiesoffer the very best price to the NHS (National Health Service)."

The agency's evaluation system is based on the additionalquality adjusted life years, or QALYs, offered by new drugs,with one QALY equal to one year of perfect health or two yearsof 50 percent-reduced health.

The current cut-off for NICE to approve a treatment variesbetween 20,000 and 30,000 pounds ($33,000-$50,000) per QALY,with the exception of some end-of-life products - mainly cancerdrugs - where it may be as high as 50,000.

Under the new so-called "value-based assessment" scheme, theband will be more flexible, with a ceiling ranging from 20,000up to 50,000 pounds, with the higher limit no longer confined todrugs for patients who are close to death.

INDUSTRY CAUTIOUS

The focus on societal impact fueled fears of discriminationagainst older patients, since they may be seen as contributingless. But Dillon said NICE's appraisal committees would not usethe age of people with particular conditions to make thedifference 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 inthe country, reacted cautiously to the new proposals.

Paul Catchpole, director of value and access at the lobbygroup, 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 tofewer drugs for patients at the end of their lives - a worryechoed by Paul Workman, deputy chief executive of the Instituteof Cancer Research.

"The suggestion from NICE that it could remove its end oflife criteria is extremely worrying and could deny thousands ofpatients with diseases such as cancer access to life-extendingdrugs," Workman said.

NICE was been operating for 15 years and has pioneered theconcept of systematically evaluating the cost-effectiveness ofnew drugs. It has spawned the creation of a number of othersimilar agencies in Europe and other parts of the world and itsdeliberations are followed widely internationally.

Moving towards a more value-based system of drug appraisalshas been a tortuous process in Britain, with earlier plans underthe previous health minister, which had been due to take effectat the start of 2014, undergoing major revisions.

In the meantime, the pharmaceuticals industry agreed aseparate deal with government last November to cap NHS spendingon branded drugs for two years, in the hope of winning improvedaccess for innovative drugs in the healthcare system.

($1 = 0.6037 British Pounds) (Editing by Sophie Walker)

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