Drugmakers and patient groups in the UK are celebrating after the country’s Court of Appeal ruled that the National Institute for Health and Clinical Excellence (NICE) has “breached the principle of procedural fairness” in making its current guidance which in effect bans the use of anti-dementia medicines for patients with mild Alzheimer's disease.

The ruling is the latest stage in the legal battle brought by Pfizer and Eisai who have been challenging NICE’s decision in March 2005 which stated that the firm’s Aricept (donepezil), plus Novartis’ Exelon (rivastigmine), Ortho McNeil’s Razadyne (galantamine) and Lundbeck’s Ebixa (memantine), should no longer be funded by the National Health Service on the grounds of cost-effectiveness. Then 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, the Alzheimer’s Society and the Royal College of Psychiatrists appealed that decision but the UK’s High Court backed NICE. However the firms continued their battle and yesterday’s ruling says that their appeal was unfairly hampered by 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.

The Court of Appeal said that “without the fully executable model, a consultee cannot check whether there are variables to which the model is particularly sensitive and make informed representations accordingly”. As a result, Eisai and Pfizer were left “making shots in the dark, in circumstances where the light could be so easily switched on”.

Welcoming the ruling, Nick Burgin, managing director of Eisai Ltd based in London, said that “as soon as we have reviewed their cost-effectiveness calculations we will submit any new findings to NICE”. He 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”.

Industry body the Association of the British Pharmaceutical Industry welcomed the Court of Appeal’s ruling, saying that it makes NICE’s “method of arriving at its recommendations on a medicine’s availability more open and subject to greater scrutiny”. ABPI director-general Richard Barker said it provides “further momentum behind the drive to make NICE processes more transparent” and “we look forward to working with NICE to make this greater transparency work for the benefit of patients.”

Fundamentally flawed process
A more forceful response came from Neil Hunt, chief executive of the UK’s Alzheimer's Society. He said that the decision is “a damming indictment of the fundamentally flawed process” used by NICE. He added that “time and quality of life has been snatched away from thousands of vulnerable people who learned they have this devastating disease this year”.

He went on to say that moves must be made to to ensure that everyone with Alzheimer's disease is given access to these drug treatments on the NHS, “which cost just £2.50 per person per day”. Mr Hunt concluded by saying that one in three people who live past the age of 65 will die with dementia but “for the price of a cup of coffee a day these treatments can improve their lives and the lives of their families”.

However NICE chief executive Andrew Dillon responded by saying that the ruling “will increase the complexity of our drug appraisals in some cases and they may take longer as a result”. In the meantime, and in accordance with the judges’ ruling, “we will provide Eisai with an executable version of the economic model used in our appraisal, so that they comment on it”.

He also noted that “it is important to recognise 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. Mr Dillon added that “the decisions NICE makes are amongst the most difficult in public life” and “we have worked very hard to ensure our decision-making process is as robust
and transparent as possible”.