THE legality of how the Government’s medicines watchdog rations drugs is going to be challenged in court for the first time.

Two drug companies announced yesterday that they were seeking a judicial review of guidance issued by the National Institute for Health and Clinical Excellence (NICE) over drugs to treat Alzheimer’s disease. If the challenge is successful, the entire legal basis of NICE recommendations will be undermined, with significant implications for the NHS.

Esai and Pfizer, which comarket the drug Aricept, want to challenge the process by which NICE rejected it.

At issue is NICE’s refusal to reveal exactly how it measures cost-effectiveness. The computer model used in such assessments has never been made public, so it is impossible for outsiders to be sure that the process is fair.

Esai and Pfizer also claim that many of the conclusions reached by NICE “cannot be supported legally or are irrational”.

NICE’s rejection of three Alzheimer’s drugs — donepezil (Aricept), galantamine (Reminyl) and rivastigmine (Excelon) — provoked widespread anger among patients, carers, doctors and charities.

The Royal College of Psychiatrists urged NICE to change its mind and joined the drug companies and the Alzheimer’s Society in an appeal. That was rejected by NICE on October 11. Esai has told NICE that it would be applying to the High Court to seek leave for a judicial review. NICE now has 14 days to respond.

Paul Hooper, the managing director of Esai, said: “We are deeply concerned about the way that NICE’s decision on treatment recommendations for early Alzheimer’s disease was reached.

“These flawed conclusions will have a devastating impact on the lives of thousands of people affected by this terrible disease.”

Olivier Brandicourt, the managing director of Pfizer UK, said: “NICE has failed to listen to the voices of patients, carers and numerous medical experts.”

Richard Barker, the director-general of the Association of the British Pharmaceutical Industry, said: “NICE has an essential, if unenviable, role to play in defining priorities and setting standards of care which makes it vital that it stands for clinical excellence and that the thinking behind its decision-making is clear to all.”

Neil Hunt, the chief executive of the Alzheimer’s Society, said: “This has been a flawed process from start to finish.”

Andrew Dillon, the chief executive of NICE, said: “We will respond to Esai’s letter and act appropriately in any court proceedings which may follow.

“In the meantime, we will publish our recommendations, both on the best ways of caring for people with all forms of dementia and on the use of drugs for treating Alzheimer’s disease, on November 22.”

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