UK NICE AD drug policy hearing set for June 25

UK-based drugmaker Shire has announced that its challenge of a decision by the National Institute of Health and Clinical Excellence (NICE) in the High Court for the refusal to approve a treatment in the NHS for mild-severity Alzheimer's disease (Marketletters passim) will be heard from June 25. The NICE is the UK government's advisory body for reviewing clinical practices and drug treatments for England and Wales. The hearing is expected to take four days.

Other drugmakers represented at the court hearing are global behemoth Pfizer and Japan-based Eisai, which co-market Aricept (donepezil). 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 alleged irrationality of certain assumptions and conclusions; and "discrimination" in the use of the Mini Mental State Examination with certain patients.

John Freeman, the managing director of Shire UK's commercial operations, said: "Shire is pleased that, by arranging the hearing for the first possible date, James Goudie QC has acknowledged the importance and urgency of this matter to the general public and to the many thousands who will be diagnosed with Alzheimer's disease of mild severity this year."