[Ip-health] NICE loses appeal

[Michelle Childs]

http://news.bbc.co.uk/1/hi/health/7376993.stm
<snip>

In the Appeal Court ruling, Lord Justice Richards said withholding
information put drugs companies at "a significant disadvantage" if
they wanted to challenge a NICE ruling.

Eisai will now be able to assess NICE's cost-benefit analysis.

Its comments will have to be considered by the drugs body, which may
then have to review its decision.

Other drug appraisals are also likely to be affected.


Alzheimer's drugs appeal victory


The Appeal Court has ruled an NHS advisory body should have been more
transparent in the way it made decisions over Alzheimer's drugs.

Three judges said NICE should have released details of how it reached
its decision to limit drugs like Aricept to people with late stage
disease.

Its maker Eisai had challenged NICE's refusal to release the
information.

However access to the drugs will remain limited as the court did not
overturn NICE's ruling on their use.

The National Institute for Health and Clinical Excellence (NICE), has
concluded drugs are not cost-effective in early disease.

But Eisai claimed it should have been able to see the detail of how
that decision was reached, saying almost 100,000 patients a year with
early-stage disease were being denied access to the medication.

In the Appeal Court ruling, Lord Justice Richards said withholding
information put drugs companies at "a significant disadvantage" if
they wanted to challenge a NICE ruling.

Eisai will now be able to assess NICE's cost-benefit analysis.

Its comments will have to be considered by the drugs body, which may
then have to review its decision.

Other drug appraisals are also likely to be affected.

Access

Nick Burgin, managing director of Eisai, said: "We believe that this
decision represents a victory for common sense.

"We hope that this action will ultimately restore access to anti-
dementia medicines for those patients at the mild stages of
Alzheimer's disease."

The company brought its case with support from fellow drugs firms
Pfizer and Shire, which manufacture other drugs affected by the NHS
ruling, and the Alzheimer's Society.

John Young, Pfizer's managing director, said: "Contrary to NICE's
position that they follow a fully fair and transparent process, the
Court of Appeal found that this is not the case.

"The failure to disclose these fundamentally important calculations
has impaired the ability of stakeholders to engage fully in the
appraisal process."

The Association of the British Pharmaceutical Industry (ABPI) said the
Appeal Court's decision would allow greater scrutiny of how NICE worked.

'Longer appraisals'

Neil Hunt, chief executive of the Alzheimer's Society said the
decision was a damning indictment of the "fundamentally flawed
process" used by NICE.

He urged it to review its ruling on the drugs and make them more
widely available.

Andrew Dillon, chief executive of NICE, said: "We will be considering
very carefully the findings and the implications for the time it takes
us to provide advice to patients and the NHS on the use of new
treatments.

"The ruling will increase the complexity of our drug appraisals in
some cases and they may take longer as a result."

NICE guidance in 2001 recommended the drugs - which can make it easier
to carry out everyday tasks - should be used as standard.

But advice published in November 2006, stated that the drugs should
only be prescribed to people with moderate-stage disease.

NICE said the drugs, which cost about =A32.50 a day, did not make enough
of a difference to recommend them for all patients and were not good
value for money.

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Michelle Childs
Head of European Affairs
Knowledge Ecology International
michelle.childs@keionline.org

"The world we have made, as a result of the level of thinking we have
done thus far, creates problems we cannot solve at the same level of
thinking at which we created them=94  Albert Einstein