British court hears Alzheimer's drugs challenge

Drugmakers went to the London High Court on Monday to challenge a decision by the medicines cost-effectiveness watchdog NICE to restrict access to Alzheimer's drugs on the state National Health Service.

Manufacturers are contesting the way in which the National Institute for Health and Clinical Excellence reached its decision to deny drugs costing around $5 a day to NHS patients newly diagnosed with mild Alzheimer's disease.

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.

In May, the High Court granted a request to fast-track the judicial review at the request of Eisai Co. Ltd., which markets the top-selling Alzheimer's medicine Aricept with Pfizer Inc.

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

But Eisai's counsel David Pannick QC argued that decision was unlawful.

"The evidence shows there are about 96,000 people in this country with mild Alzheimer's disease," he said.

"The inevitable consequence of removing funding for those with mild Alzheimer's disease is that the opportunity is lost for delaying the onward march of this appalling disease and maintaining a relatively good way of life for patients as long as possible."

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) per patient a year -- means they are not cost-effective for most patients.

At issue, is the complex economic modeling used by NICE to reach its conclusions on cost-effectiveness.

The Alzheimer's Society, representing patients and their carers, has joined up with the drug industry in challenging the assessment, arguing the agency's analysis is flawed and unfair.

source : news.yahoo.com