Court Of Appeal Makes Decision Following Ruling That Nice Process On Anti-Dementia Medicines Unfair, UK

Main Category: Alzheimer's / Dementia
Article Date: 09 May 2008 - 10:00 PDT

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Eisai Limited, the licence holder of Aricept® (donepezil hydrochloride) and Pfizer Limited, its co-promotion partner, announced today that the Court of Appeal has released its decision on the consequential issues arising from Court of Appeal's recent ruling that the process by which the National Institute for Health and Clinical Excellence (NICE) decided to restrict anti-dementia medicines for newly diagnosed patients with mild Alzheimer's disease was procedurally unfair. The decision today will now be reflected in a Court order.

The Court has decided 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 (FEV) of the cost-effectiveness model used to produce guidance for the treatment of patients with Alzheimer's

-- Eisai and other consultees have a period of 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

-- NICE is to pay the costs of Eisai's appeal

-- NICE has been refused permission to appeal to the House of Lords

We believe this now brings the prospect of restored access to anti-dementia medicines for those patients at the mild stages of Alzheimer's disease one stage closer.

Should Eisai find that the calculations relied on by NICE to determine the cost-efficacy of anti-dementia medicines in mild Alzheimer's to contain errors or to be unreliable, they will submit their findings to the NICE Appraisal Committee who will be required to review their recommendations in light of any such fresh evidence.

Eisai and Pfizer remain fully committed to working with NICE to ensure that all patients in the UK with mild to moderate Alzheimer's disease will have access to these medicines.

Notes

-- As with all cases heard by the Court of Appeal, the Courts decision can be challenged by further appeal to the House of Lords. The House of Lords will only usually allow appeal on points of law

-- In this case, the Court of Appeal went as far as stating in its judgment that "…this case depends not on the resolution of any real dispute about the legal principles, but on the application of well established principles to the particular context and particular circumstances of NICE's appraisal process"

-- In its decision announced today, the Court of Appeal has refused NICE permission to appeal to the House of Lords, although NICE may apply directly to the House of Lords should they wish

-- NICE is on public record as stating "…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"

-- NICE have not yet confirmed a date for when they plan to release the fully executable version of the model

-- Eisai has now won two out of the three points of its original appeal; discrimination and procedural fairness

http://www.eisai.co.uk
http://www.pfizer.co.uk