Hope For Mild Alzheimer's Patients As House Of Lords Refuses To Hear NICE's Appeal, UK

Main Category: Alzheimer's / Dementia
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 29 Oct 2008 - 4:00 PDT

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Eisai Limited, the licence holder of Aricept(R) (donepezil hydrochloride) and Pfizer Limited, its co-promotion partner, welcome the announcement by the House of Lords that they have refused the National Institute for Health and Clinical Excellence (NICE)'s application for leave to appeal against the Court of Appeal verdict handed down earlier this year.

In May this year the Court of Appeal found in favour of Eisai, and ruled that the process by which NICE decided to restrict anti-dementia medicines for newly diagnosed patients with mild Alzheimer's disease was procedurally unfair and that it put stakeholders at a significant disadvantage in their ability to engage fully with the process.

Nick Burgin, Managing Director of Eisai Ltd., said: "We are obviously pleased on behalf of patients by today's news. It finally brings to an end a long and arduous process and means that we now have an opportunity to review NICE's cost-effectiveness calculations. Most importantly, however, it means that the patients and carers affected by mild Alzheimer's disease are potentially one step nearer to receiving proven and effective treatments."

John Young, Managing Director of Pfizer Limited, said: "We are delighted that the highest court in the land has agreed that NICE did not follow a fully fair and transparent process. It is of the highest importance that stakeholders are able to engage fully in these crucially important processes if the highest quality decisions for patients are to be reached in confidence."

Eisai and Pfizer will make a further announcement once a rigorous review of the economic model has been completed.

The decision from the Appeal Committee of the House of Lords states:

"Permission is refused because the petition does not raise an arguable point of law of general public importance which ought to be considered by the House at this time, bearing in mind that the cause has already been the subject of judicial decision on appeal."

In addition to refusing the appeal, the House of Lords also upheld in full the Orders from the Court of Appeal that require NICE to:

- Disclose a fully executable version of the model to Eisai and Pfizer so that the robustness and reliability of the assumptions may be ascertained within 14 days

- Allow Eisai and any other consultee a period of 42 days within which to make representations following disclosure of the model

- Pay Eisai's costs of the Appeal as well as 60% of the costs of the original hearing

Eisai and Pfizer
www.pfizer.com
www.eisai.com