UK Alzheimer's drug case ends, judgement reserved

LONDON, June 30 (Reuters) A High Court case assessing a challenge to restrictions on Alzheimer's drugs in Britain ended with no immediate verdict.

After a week of legal argument, judge Linda Dobbs yesterday reserved judgment in the test case challenge and will give a decision in writing later. No date has yet been fixed for the judgment but legal experts said it was likely to be handed down before the end of next month when the current legal term ends.

The judge had been asked to quash the decision of the National Institute for Health and Clinical Excellence (NICE) to restrict access to Alzheimer's drugs on the state National Health Service.

Manufacturers argued that the way in which NICE reached its decision to deny drugs costing around 5 dollars a day to NHS patients newly diagnosed with mild Alzheimer's disease was flawed and unlawful.

It is the first time that the agency in charge of deciding which medicines are offered in the state health system in England and Wales has faced such legal action. If successful, it could trigger other challenges.

The case was brought by Japan's Eisai Co. Ltd., which markets top-selling Alzheimer's medicine Aricept with Pfizer Inc., and the Alzheimer's Society, representing patients and their carers.

NICE believes drugs such as Aricept do not make enough of a difference to be used at all stages of Alzheimer's disease and wants them to be prescribed only for a minority of patients with disease of moderate severity.

Anti-cholinesterase drugs such as Aricept can help but not cure some Alzheimer's patients. Other products affected by NICE's decision are Exelon from Novartis AG, Ebixa from Lundbeck A/S and Reminyl from Shire Plc, which is sold elsewhere by Johnson&Johnson as Razadyne.

Such drugs are widely used in other countries, but NICE experts calculate that their cost -- around 1,000 pounds (2,000 dollars) per patient a year -- means they are not cost-effective for most patients.

REUTERS SV BST0903