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Date for NICE court showdown announced

Published on 14/05/07 at 11:10am

NICE's decision to block access to Alzheimer's drugs will be put under legal scrutiny on 25 June when a much anticipated judicial review begins.

The court date will be the first time a NICE decision has been legally challenged, and could not only force a re-think on Alzheimer's drugs (such as Eisai/Pfizer's Aricept) but also compel NICE to open up its decision-making process to greater scrutiny.

The High Court judge cannot, however, directly overturn NICE's ruling, and there may be no clear cut victory either for NICE or for Pfizer and Eisai, the pharma companies who have mounted the legal challenge.

Campaigners hope the court's ruling will be sufficiently critical to force NICE to review once again their decision on Alzheimer's drugs, which was finalised in October last year after 18 months of dispute and deliberation.

The review is expected to last up to four days and has been given the earliest possible court date, which the companies have welcomed.

"It is vital to have the Judicial Review heard as soon as possible, and we are delighted to now be one step closer to concluding this process," said Dr Paul Hooper, managing director of Eisai.

"We believe that patients suffering from mild stages of Alzheimer's should be treated as soon as possible rather than having to wait until they have deteriorated further. Time lost before commencing treatment can never be regained."

Shire, which markets rival treatment Reminyl and patient organisation the Alzheimer's Society will also be allowed to give evidence in court.

John Freeman, managing director of Shire's UK commercial operation, said: "Shire is pleased that, by arranging the hearing for the first possible date, James Goudie QC has acknowledged the importance and urgency of this matter to the general public and to the many thousands who will be diagnosed with Alzheimer's disease of mild severity this year.

"Shire agrees completely with the grounds for the Judicial Review and will be supporting all stakeholders by participating in the High Court action as an interested party."

Commenting on the effect of NICE guidance on his newly-diagnosed patients, Professor Stephen Curran, Old Age Psychiatrist and Lead Clinician at Wakefield Memory Service said it had caused significant distress and concern to those in the early stages of the disease.

"Adherence to the NICE Guidance has meant I am unable to offer them the drug treatment. It is good news that the court has expedited the hearing of this Judicial Review," he added.

Eisai and Pfizer first announced their plans to legally challenge NICE in November last year, but had to wait until March before the case was accepted for review.

NICE must now file its evidence by 1 June, with all interested parties filing their responses within ten days in preparation for the start date of 25 June.

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