The UK Court of Appeal has released details of its May 1 ruling that the process by which the National Institute for Health and Clinical Excellence reached its decision that anti-dementia medicines should not be made available to newly-diagnosed patients with mild Alzheimer’s disease on the National Health Service in England and Wales was procedurally unfair.

The case was brought by Eisai, the license-holder of Aricept (donepezil), and its co-promotion partner Pfizer, which formally applied to the High Court in January 2007 for permission to request a judicial review of the process by which NICE reached its decision. This case marks the first time that NICE has been challenged in the Courts.

In making their ruling in the case - Regina (Eisai Ltd) vs NICE - Lords Justice Tuckey, Jacob and Richards concluded that: NICE must make available to all consultees, within 14 days of the end of the period for appealing to the House of Lords, a copy of the fully-executable version of the cost-effectiveness model used to produce guidance for the treatment of patients with Alzheimer's; Eisai and other consultees have 42 days from receipt of the FEV in which to review the model and make representations to NICE; NICE is to pay 60% of Eisai’s costs resulting from the original Judicial Review; and NICE is to pay the costs of Eisai’s appeal.

NICE has also been refused permission to appeal to the House of Lords.

While there have been exceptions to NICE’s policy of not releasing the FEV of economic models, no such exception was made on this occasion, said the judges. NICE’s position was that there had already been sufficient disclosure, and it was unable to go further because of confidentiality and the delay to the appraisal process that would be caused by releasing the FEV.

There was no express or implied duty of confidentiality restricting the use or disclosure of the model, said the Court, adding: “it would be very surprising if a model commissioned and paid for by the Secretary of State for Health for the purpose of NICE’s appraisal process were subject to obligations of confidentiality preventing disclosure…of the FEV…to those consulted.”

While the concern raised by NICE was serious and one to which weight should be given, the extra time that would be added to the appraisal process had to be viewed in the context of an already lengthy process, said the Court. “Neither the additional time nor the additional cost to NICE should weigh heavily in the balance in deciding whether fairness required release of the [FEV],” the judges commented, adding: “if fairness otherwise required it, the court should be very slow to allow administrative decisions of that kind to stand in the way of its release.”

Restored access to AD medicines
Eisai responded that the Court ruling “brings the prospect of restored access to anti-dementia medicines for those patients at the mild stages of Alzheimer’s disease one stage closer.” If the company should find that the calculations relied on by NICE to determine the cost-efficacy of anti-dementia medicines in mild Alzheimer’s contain errors or are unreliable, it will submit its findings to the NICE Appraisal Committee who will be required to review their recommendations in light of any such fresh evidence, the firm added.

Eisai also pointed out that NICE is on public record as stating that, “in the meantime, and in accordance with the judges’ ruling, we will provide Eisai with an executable version of the economic model used in our appraisal, so that they comment on it. We will then take those comments into account.” However, the Institute has not yet confirmed a date for when it plans to release the fully executable version of the model, said the firm.