UK court puts NICE AD drug limits on trial

A groundbreaking court case in the UK is placing on trial the economic modeling utilized by the National Institute of Health and Clinical Excellence (NICE), the UK advisory body which recommends medical treatments, including drugs, in England and Wales under the National Health Service. Following a number of complaints about the NICE's secrecy and inconsistent rulings compared with its counterpart for Scotland, the Scottish Medicines Consortium (Marketletters passim), a decision on Alzheimer's disease drugs last year provoked a legal challenge.

Japan's Eisei and global behemoth Pfizer united with the UK's Alzheimer's Society to seek a a judicial review of the NICE's decision on Aricept (donepezil), which is co-marketed by the two drugmakers. Other products affected by last year's NICE ruling are Switzerland-based Novartis' Excelon (rivastigmine) and Reminyl (galantamine), co-marketed by USA-based Johnson & Johnson and the UK's Shire.

The grounds put forward and accepted by the High Court as the basis for the review are procedural fairness, as the NICE refused to disclose its cost effectiveness model; the irrationality of certain assumptions and conclusions; and the discrimination in the use of the Mini Mental State Examination with certain patients.