The UK Court of Appeal in London has begun hearing the appeal brought by drugmaker Eisai against a ruling in 2007’s High Court judicial review of the process by which the National Institute for Health and Clinical Excellence (NICE) reached its decision that anti-dementia medicines should not be prescribed for National Health Service (NHS) patients with newly-diagnosed mild Alzheimer’s disease (AD).

Mrs Justice Dobbs conducted the judicial review last June, following a request lodged by Eisai, manufacturer of the Alzheimer’s disease drug Aricept (donepezil) and its co-promotion partner Pfizer. In her decision, she found against NICE in just one of the six grounds for complaint brought by the plaintiffs, agreeing that the Institute had breached its duties under the Disability Discrimination Act and the Race Relations Act by not offering, in its technology appraisal guidance, specific advice regarding people with learning disabilities and people for whom English is not their first language.

However, finding in favour of NICE on the other five grounds of the challenge, the judge ruled that the Institute:
- appropriately took into account the benefits which the AD drug treatments bring to carers;
- appropriately reflected the costs of long-term care in its calculations;
- was not irrational in concluding that there is no cumulative benefit to patients after six months treatment with these drugs;
- was not irrational in its assessment and consideration of the AD 2000 study; and
- did not breach principles of procedural fairness by providing a “read only” version of the economic model. This last point is the issue on which Eisai is bringing its new appeal.

Shortly before the two-day appeal hearing began yesterday (April 14), NICE’s chief executive, Andrew Dillon, said the Institute was disappointed that the firm wished to challenge Mrs Justice Dobbs’ ruling, particularly as she had not given it leave to appeal against her decision.

NICE considers the company’s claim to be “without foundation, and going back to court will require us to divert energy and taxpayer’s money from the work we do to support patients and health professionals and get the most out of the resources available to the NHS,” he said.

“Health service funding is limited, and it is our job to assess the clinical and cost-effectiveness of both drug and non-drug interventions to ensure the money spent by the NHS is well-spent. 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,” Mr Dillon added.

- In March 2005, NICE ruled that four drug treatments licensed for AD - Aricept, Novartis’ Exelon (rivastigmine), Ortho McNeil’s Reminyl, now Razadyne (galantamine) and Lundbeck’s Ebixa (memantine) - should no longer be funded by the NHS on the grounds of cost-effectiveness. Then in January 2006, it revised its guidance to allow their use 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 the decision not to include patients with mild disease, but this was rejected, and in November that year Eisai and Pfizer announced their intention of challenging the decision in the High Court.