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Landmark ruling on dementia drugs


Three judges have found that the process by which the National Institute for Health and Clinical Excellence (NICE) restricts medicines for Alzheimer’s sufferers is procedurally unfair.

In a landmark ruling by the Court of Appeal, judges found that the procedure NICE employs to hold back drugs from from newly diagnosed patients with mild Alzheimer’s should be reviewed.

The judges ruled that procedural fairness demanded that NICE should provide full details of the cost-effectiveness model it used to produce guidance for the form of treatment.

Eisai Ltd, licence holder of Aricept, wanted the full model statistics so they could make representations to NICE.

Nick Burgin, managing director of Eisai, 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.”

Judges also agreed that if findings go against the drug company, Eisai has the right to take the matter to the Appeal Panel.

John Young, managing director of Pfizer who challenged the NICE decision, said: “The failure of NICE to disclose these fundamentally important calculations has impaired the ability of stakeholders to engage fully in the appraisal process.”

Copyright © PA Business 2008

National Institute for Health and Clinical Excellence

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