[Ip-health] UK: BBC: NICE first Court challenge to cost benefit analysis for Alzheimer's drugs

[Michelle Childs]

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[ Picked text/plain from multipart/alternative ]
http://news.bbc.co.uk/1/hi/health/6230530.stm
Alzheimer's drugs court challenge

The drugs cost about =A32.50 a day

A decision by the government's health watchdog to deny Alzheimer's
drugs to patients with mild-stage disease is being challenged at the
High Court.

The National Institute for Health and Clinical Excellence (NICE)
ruled the medicines - donepezil, rivastigmine and galantamine - were
not cost effective.

But critics argue the decision process was flawed and did not take
into account the benefits to carers.

It is the first time a judicial review has been sought on a NICE
decision.

Drugs company Eisai has brought the case to the High Court with
support from fellow drugs firm Pfizer and the Alzheimer's Society.

Test 'flawed'

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

But guidance published in November 2006, after months of appeals,
stated that the drugs should only be prescribed to people with
moderate-stage disease.


NICE's analysis of the evidence showed 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.

Campaigners are angry that people suffering from Alzheimer's have to
get worse before they are eligible for treatment.

They will tell the court that NICE did not properly evaluate the
impact of the drugs on the quality of life of carers and that the
figures on the cost of long-term care used in their analysis were too
low.

In addition, the test used to determine the severity of a patient's
Alzheimer's discriminates against people who do not speak English as
their first language or those with learning difficulties, they argue.


About 700,000 people in the UK have a form of dementia and more than
half of those have Alzheimer's disease.

The outcome of the four-day hearing will have an impact on the whole
of the UK as regulators in Scotland and Northern Ireland are waiting
for the result before making a decision.

Consultation 'fair'

Neil Hunt, chief executive of the Alzheimer's Society, said: "People
with Alzheimer's disease and their carers have fought long and hard
for their day in court.

"These treatments have benefited so many families already - where is
the justice in NICE's decision to snatch them away?

"We have to fight NICE's fatally flawed process, which has failed to
recognise the benefits these treatments have for carers."

A spokesperson for Pfizer said: "We believe the process was flawed.

"They are asking clinicians to say to their patients 'you have to get
worse and then we can treat you'."

Andrew Dillon, chief executive of NICE, said: "Our consultation,
decision-making and appeals processes are transparent and fair.

"The recommendations on the use of drugs for treating Alzheimer's
disease were developed over a three-year period in which careful
analysis and detailed discussions with patient groups, doctors and
the drug manufacturers demonstrated our commitment to involving those
whom our decisions affect.

"The reality is that, for Alzheimer's disease, drugs are only part of
the care that needs to be offered.

"Non-drug interventions have an important part to play and the
evidence indicates that drugs are simply not effective for some
patients."


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