The UK’s National Institute for Clinical Excellence – the country’s cost-effectiveness body – has delivered a blow to the manufacturers of Alzheimer’s disease drugs in challenging them to identify sub-groups of patients likely to benefit from treatment.

The appraisal committee has requested clinical evidence from Eisai/Pfizer, Novartis, Shire and Lundbeck before publishing its final review, demonstrating whether or not the drugs may be particularly effective for certain groups of people. Andrew Dillon, NICE chief executive, commented: “We think there is more data which could affect our decision and we are asking the drug companies for access to it.”

The news follows a preliminary ruling early this year that the drugs are not cost-effective and therefore should not be prescribed for use on the UK’s National Health Service [[02/03/05e]] – despite an average cost of just £2.50 per patient per day. An original decision in 2001 deemed that the drugs should be obtainable for patients [[22/01/01b]].

However, until the final decision is put in force in October, the drugs in question – Eisai/Pfizer’s Aricept (donepezil), Novartis’ Exelon (rivastigmine), Shire’s Reminyl (galantamine), and Lundbeck’s Exiba (memantine) – will continue to be made available for prescription. But it’s a ticking time bomb as far as the manufacturers and patient groups are concerned.

Professor Nick Bosanquet, professor of healthcare policy at Imperial College London, said he was astounded that the NICE appraisal committee “has not re-evaluated its initial position and persists with unacceptable and inappropriate methods of evaluation.” He added that neither the carer burden nor the potential cost savings in delaying a patient’s entry into nursing care are addressed within the appraisal, which “unfairly tips the balance against these treatments and incorrectly lead to calculations that they are not cost effective.”

And Shire’s John Freeman, chief executive, fears the move could deny thousands of patients’ treatment.