NICE Judicial review begins

The UK High Court has begun a judicial review this week into the National Institute for Health and Clinical Excellence's (NICE's) decision to restrict access on the NHS to Alzheimer's disease drugs.

Pfizer and Eisai, the manufactuer and licence-holder of Aricept (donepezil), with the support of the UK Alzheimer's Society, won the right to challenge NICE's ruling in March; the hearing began on Monday and is expected to last four days.

This is the first ever judicial review of the UK's cost effectiveness body and follows its decision to deny patients with the early stages of Alzheimer's to acetyl cholinesterase inhibitors Aricept, Novartis' Exelon (rivastigmine) and Shire's Reminyl (galantamine), which cost GBP2.50 (EUR3.71/USD4.99) per day.

In March 2005, NICE ruled that all drug treatments for Alzheimer's disease should not be prescribed on the NHS because of cost. Following overwhelming condemnation from the public, professionals and campaigns NICE changed its position to allow limited access to the treatments.

"Our overall goal is to make sure all patients with mild dementia are not denied access [to anti-dementia medicines]. The experts are quite capable of managing patients' [medication] - they are specialists and don't need the help of NICE," said Dr Paul Hooper, Managing Director of Eisai Limited.

"It is inevitable I suppose that other companies will ask for a Judicial Review but it depends on the merits of individual assessment. I have had one assessment where I couldn't fault NICE and it made sense, and I have had one that didn't make sense," continued Hooper.

NICE has defended its processes. Andrew Dillon, CEO of NICE said: "Our consultation, decision-making and appeals processes are transparent and fair. We share our methodology and enable our stakeholders to see the basis on which our experts arrive at their decisions. We invite patients, medical professionals and anyone who has an interest to express their views and comment on our proposals."