The UK’s National Institute for Health and Clinical Excellence – the country’s cost-effectiveness body - has released its revised proposal for treating Alzheimer’s disease under the National Health Service. The new guidelines, which lessen the restrictions imposed on the use of certain drugs, have received a tentative welcome by some pharma companies, but have sparked further outrage from charities and patient groups.

NICE’s initial proposal, unveiled in March last year, to reject the use of Pfizer and Eisai’s Aricept (donepezil), Novartis’ Exelon (rivastigmine), Shire’s Reminyl (galantamine) and Lundbeck’s Ebixa (memantine), on the basis that they would not be cost effective for use under the NHS, was slammed by all sides of the Industry. Psychiatrists recently issued a damning indictment of the proposal, with 96% of those surveyed not supporting the decision, and 87% believing that their dementia service would suffer as a result of the withdrawal of these treatments.

In response to this giant wave of protest, NICE reconvened late last year to evaluate the matter further, and has now decided that treatment with Aricept, Exelon and Reminyl be funded only when new patients have moderate-to-severe symptoms, and that Ebixa should not be used at all, as the agency feels there is not enough evidence to support its clinical benefit.

This means that the estimated 72,000 patients in the UK with mild forms of Alzheimer’s will be denied access to these medicines, marking a controversial decision which seems to go against the grain of all other treatment strategies that aim to treat a patient as early as possible. And many fear that the guidelines will induce a shift in the point at which the disease is diagnosed.

In a statement, UK charity The Alzheimer's Society said that the group “welcomes the fact that Nice has acknowledged the effectiveness of Alzheimer’s drug treatments and the vital role they have to play in dementia care. However, the new draft guidance still raises serious ethical and practical concerns about the availability of drug treatments for people with Alzheimer’s disease.”

Companies were also cautious in dishing out support for the new proposals. Shire welcomed the news, but John Freeman, managing director of the group’s UK operation, pointed out that, although obviously good news for those patients at the moderate stage of disease, “NICE also states that new patients diagnosed with mild AD will not be eligible for these drugs on the NHS until their condition deteriorates to moderate AD, which we do not agree with.”

Similarly, Eisai and Pfizer said that NICE’s revised proposals “better reflects the views of patients, clinicians and the body of evidence on these important medicines. But it has unfortunately missed the opportunity in these draft proposals to highlight the value of earlier usage in mild Alzheimer’s disease.”

A final decision will be made at a meeting in April, with the full guidance being published later in the year. Although any decision will be UK-centric, if the 'thumbs down' is issued the resulting shockwaves could be felt by other global health organisations, which may think twice before advocating the use of these 'costly' therapies.