The National Institute for Health and Clinical Excellence issued a final appraisal determination Thursday which upheld an earlier decision by the agency to limit access to Pfizer’s and Eisai’s Aricept (donepezil), Novartis’ Exelon (rivastigmine) and Shire’s Reminyl (galantamine) on the NHS to patients with moderate forms of Alzheimer’s disease.

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NICE Chief Executive Andrew Dillon said that the decision was made after releasing for consultation “the executable version of the economic model used in this appraisal” and after the consideration of comments made by consultees. He explained that “although these comments resulted in minor changes to the model, our independent advisory committee concluded that these were not enough to make these treatments a cost-effective use of NHS resources in the mild stages of the disease.” A legal challenge by Pfizer and Eisai had resulted in a UK Court of Appeal ruling last year that NICE’s guidance process for the Alzheimer’s drugs was “procedurally unfair,” and the court suggested that the agency release details of its cost-effectiveness model.

The final appraisal also provides guidance for Lundbeck’s Ebixa (memantine), which NICE noted “is not recommended as a treatment option for patients with moderately severe to severe Alzheimer’s disease except as part of well-designed clinical studies.” The companies have until July 1 to appeal the appraisal.

Source: FirstWord

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