Alzheimer’s sufferers wait for judgment as NICE put in dock
pharmafile | June 28, 2007 | News story | Sales and Marketing |Â Â Â
Alzheimer's sufferers are just weeks away from finding out if the judicial review of NICE's decision-making will be successful.
The High Court has heard representations from drug companies, patient groups, dementia experts and NICE executives over four days, with the hearings finishing today.
The judge, Mrs Justice Dobbs, is expected to announce her decision within the next few weeks – what campaigners hope will be an end to the bitter two-year battle over access to drugs for patients with early and late-stage Alzheimer's.
The case hinges on whether or not NICE's decision-making was flawed and if the judge finds it was, NICE may be forced to review the Alzheimer's drugs once again.
The legal challenge to NICE, the UK's clinical and cost-effectiveness body, was mounted by Pfizer and Eisai, the two pharma companies which market the leading Alzheimer's drug Aricept.
David Pannick QC for Eisai said: "We are asking the court to conclude that NICE and its appeal panel failed properly to assess the issues and so the matter must go back for consideration."
Opening the case, Mr Pannick said there were an estimated 96,000 people in Britain with the mild form of Alzheimer's disease.
Eisai and Pfizer have the support of the Alzheimer's Society, which strongly believes NICE's decision-making process was fundamentally flawed when it found the drugs weren't cost-effective at £2.50 per person, per day.
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?
"Another 100,000 people will develop dementia this year alone and the result of this case will affect not only them but their families, too. We have to fight NICE's fatally flawed process, which has failed to recognise the benefits these treatments have for carers."
Andrew Dillon, NICE's chief executive has always maintained that the decision to restrict access to the drug was sound and based on clinical evidence. In November, he said: "We have to be honest and say the evidence [suggests] these drugs do not make enough of a difference for us to recommend their use for treating all stages of the disease."
NICE's guidance said only patients with moderate Alzheimer's disease, the middle stage of the progressive disease should receive the drugs on the NHS.
The judicial review comes after two years of legal challenges, including five failed appeals to NICE, and a final decision is now expected to be made within the next few weeks.
