Renewed Hope For Mild Alzheimer's Patients As NICE Process On Anti-Dementia Medicines Ruled Unfair, UK

Main Category: Alzheimer's / Dementia
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 02 May 2008 - 2:00 PDT

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Eisai Limited, the licence holder of Aricept(R) (donepezil hydrochloride) and Pfizer Limited, its co-promotion partner, welcomed today's landmark ruling by the Court of Appeal. The Court found 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.

In its ruling, the Court of Appeal stated that procedural fairness required NICE to release a fully executable version of the cost-effectiveness model it used to produce guidance for the treatment of patients with Alzheimer's. The Court also found that refusal by NICE to release the model put consultees at significant disadvantage in challenging its reliability.

Commenting on today's positive ruling Nick Burgin, Managing Director of Eisai Ltd said: "We believe that this decision represents a victory for common sense. As soon as we have reviewed their cost-effectiveness calculations we will submit any new findings to NICE. We hope that this action will ultimately restore access to anti-dementia medicines for those patients at the mild stages of Alzheimer's disease," he concluded.

John Young, Managing Director of Pfizer Limited, said: "Contrary to NICE's position that they follow a fully fair and transparent process, the Court of Appeal found that this is not the case. The failure of NICE to disclose these fundamentally important calculations has impaired the ability of stakeholders to engage fully in the appraisal process in order to provide final guidance that truly helps budget holders and clinicians make the best quality decision possible for individual patients."

Eisai and Pfizer are 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.

http://www.eisai.co.uk