UK court rules against NICE over Alzheimer’s guidance

The Court of Appeal pointed that the National Institute for Health and Clinical Excellence’s (NICE’s) refusal to allow Pfizer and Eisai full access to a computer model used by the agency to assess the cost-effectiveness of Aricept has unfairly hampered their appeal. The Court asked NICE to provide Eisai with an executable version of the economic model used in the appraisal of the drug so that the firm can work on it and later make informed presentations to the NICE.

Based on the grounds of cost-effectiveness, NICE, in March 2005, has ruled that Pfizer’s Aricept (donepezil), plus Novartis’s Exelon (rivastigmine), Ortho McNeil’s Razadyne (galantamine) and Lundbeck’s Ebixa (memantine), should no longer be funded by the National Health Service. However, in January 2006, it revised its guidance to allow their use in patients with moderately severe disease but not those with milder symptoms. Eisai and Pfizer, plus other manufacturers appealed the decision but failed to get a favourable ruling in the UK’s High Court.

Nick Burgin, managing director of Eisai, said: “As soon as we have reviewed their cost-effectiveness calculations we will submit any new findings to NICE”. He also added that the firm hopes this action “will ultimately restore access to anti- dementia medicines for those patients at the mild stages of Alzheimer’s disease”.

However, Andrew Dillon, CEO of NICE, said the “ruling will increase the complexity of NICE’s drug appraisals in some cases and they may take longer as a result”. He also said that “it is important to recognize that we have not been asked to amend or withdraw our current guidance on the use of these drugs” and they continue to be recommended only for people with moderate Alzheimer’s disease.