UK curbs on Alzheimer drugs face legal challenge
Thu Nov 16, 2006 7:01 PM ET
By Ben Hirschler
LONDON, Nov 17 (Reuters) - A decision by Britain's cost-effectiveness watchdog to restrict access to Alzheimer's drugs on the state health service is to be challenged in court by makers of the biggest selling such product.
Eisai Co Ltd <4523.T> and Pfizer Inc. <PFE.N>, which jointly sell Aricept, said on Friday they would seek a judicial review by the High Court of the decision by the National Institute for Health and Clinical Excellence (NICE).
It would be the first time that the agency in charge of deciding which medicines are offered in the National Health Service in England and Wales faces such legal action.
Paul Hooper, managing director of Eisai in Britain, said his company had been left with no option, given what he described as the "unfair" and "flawed" actions of NICE.
NICE rejected a final appeal last month, arguing that all the evidence suggested drugs such as Aricept, Reminyl from Shire Plc <SHP.L> or Exelon from Novartis AG <NOVN.VX> did not make enough of a difference to be used at all stages of Alzheimer's disease.
In future, they will be prescribed only for a minority of patients with disease of moderate severity, thereby excluding the largest section of patients with early dementia.
A fourth drug, Ebixa, made by Lundbeck <LUN.CO>, was ruled unsuitable for use except in clinical trials.
Eisai and Pfizer said they had given notice to NICE of their intention to apply for a judicial review, because the agency had repeatedly refused to disclose a fully working version of its cost-effectiveness model.
In addition, many of its conclusions could not be supported legally or were irrational, the manufacturers said. They called on NICE to withdraw current guidance and postpone issuing it to the NHS on Nov. 22 as planned.
The legal move was welcomed by the Alzheimer's Society, representing patients and their carers, which said the NICE review had been flawed from start to finish.
The decision to bring in the lawyers will increase tensions between NICE and drugs industry, which has long criticised the organisation for blocking access to promising new medicines.
Richard Barker, director general of the Association of the British Pharmaceutical Industry, said there was widespread public dismay at recent NICE rulings that effectively denied patients access to therapies available elsewhere.
Anti-cholinesterase drugs such as Aricept can help but not cure some Alzheimer's patients. They are widely used in other countries, but NICE experts calculate that their cost -- around 1,000 pounds ($1,888) per patient a year -- means they are not cost-effective for most patients.