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British cost agency to take broader view of drug value

Thu, 27th Mar 2014 00:01

* 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 (Reuters) - British healthcare cost agencyNICE is to take a broader view of the value offered by newmedicines under proposals that may make it more likely that itwill say "yes" to novel drugs in future.

Chief Executive Andrew Dillon told Reuters that wider uptakewould only occur, however, if pharmaceutical manufacturers kepta tight rein on prices.

The National Institute for Health and Clinical Excellence(NICE), which determines the use of treatments on the state-runhealth service, will in future look at the "wider societalimpact" of therapies, as well as their cost-effectiveness onmore limited clinical grounds.

This could, for example, take into account the fact that adrug enables a patient to return to work, resulting in him orher paying more taxes to the wider benefit of society.

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.

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.

"It has the potential for increasing the number of positiveappraisals that NICE produces, but that is only going to happenif companies offer the very best price to the NHS (NationalHealth Service)," said Dillon.

"Companies need to recognise that the NHS is under hugepressure."

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 could fuel fears ofdiscrimination against older patients, since they may be seen ascontributing less. But Dillon said NICE's appraisal committeeswould not use the age of people with particular conditions tomake the difference between a new drug being recommended or not.

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.

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.

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 Tom Heneghan)

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