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NICE calls for more Alzheimer's evidence to head off row

Published on 20/07/05 at 07:34pm

Manufacturers of three Alzheimer's treatments have been asked to supply more information to NICE to help decide whether or not the drugs should be available on the NHS.

In March this year, NICE shocked patient groups and the companies when it said the three treatments - Aricept, Exelon and Reminyl - were not cost-effective treatments and should no longer be prescribed to NHS patients.

The news caused uproar, with many experts condemning the cost-effectiveness modelling used to reach the decision. The then health secretary John Reid also expressed his concern at the decision, but was careful not to threaten to overrule its final decision.

The Institute, which is used to being at the centre of controversy, has now called for further clinical evidence from the companies involved - Eisai/Pfizer, Novartis and Shire.

"We are acutely aware of our responsibility to people with Alzheimer's disease, their families and carers, to ensure that every effort is made to obtain all the available evidence on these drugs," said NICE's chief executive Andrew Dillon.

"We need to make the right decision, based on all the relevant evidence. We think there is more data which could affect our decision and we are asking the drug companies for access to it."

Dillon has disclosed that the request follows the appraisal committee voting against the drugs for a second time in recent days, by a vote of 12 votes to eight. Dillon is then understood to have intervened to seek out a compromise.

NICE has written to the companies requesting the additional data, with the aim of identifying subsets of patients who respond well to the treatments, and subsets which don't, to help bolster the cost-effectiveness argument.

John Freeman, managing director of Shire Pharmaceuticals in the UK said his company and its competitors have already submitted substantial data proving the value of the drugs.

"We are alarmed that NICE is attempting to exclude subsets of patients with Alzheimer's disease from receiving these drugs on the NHS," he added.

"Thousands of patients could be denied this treatment which has been found to be clinically effective in trials involving over 10,000 patients with mild to moderately severe Alzheimer's disease."

Once the data has been collected from the companies, NICE's appraisal committee must make public its decision in light of the evidence, and allow stakeholders to comment on this.

The committee will then meet in October to arrive at its final decision.

Patient group the Alzheimer's Society said it is not confident NICE will arrive at a positive decision, despite what it said is 'overwhelming' evidence that the drugs work and are good value for money.

Clive Ballard, the Society's director of research commented on the call for new evidence: "It's a complete cop out. There is no evidence that this delaying tactic will have more positive results.

"NICE is clearly trying to defer its decision and reduce interest until it becomes a non-issue, but this is a very, very big issue. It just shows the arrogance NICE has in ignoring messages from stakeholders."

Dr Roger Bullock, consultant old age psychiatrist at Victoria Hospital, Swindon and an opinion leader for Shire said patients are already reviewed every six months for their response to the drugs, in line with the original 2001 NICE guidance which recommended them.

"Taking this practice into account demonstrates that these drugs are not only clinically effective, but also cost-effective. All patients should be given the opportunity to benefit from them," said Dr Bullock.

NICE may be seeking a similar compromise to the one arrived at for multiple sclerosis drugs. After its appraisal committee rejected the drugs on two separate occasions, a 'risk sharing' deal was agreed, which linked payment for the drugs only in those who responded to treatment.

Related articles:

NICE U-turn will 'set Alzheimer's treatment back 10 years' 

Wednesday, March 02, 2005




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