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12:00 AM
 | 
Jul 02, 2007
 |  BioCentury  |  Politics, Policy & Law

NICE dragged to court

Having decided to restrict the availability of drugs once used to treat Alzheimer's patients in England and Wales, the National Institute for Health and Clinical Excellence found itself in the dock for the first time ever last week. But no matter how the court rules, any victory would likely be Pyrrhic, at least in the short term, given the budgetary constraints under which the National Health Service operates.

Eisai Co. Ltd., Shire plc and the Alzheimer's Society took their case to the High Court of England and Wales for a judicial review of NICE's decision to restrict access to Aricept donepezil from Eisai (Tokyo:4523; Osaka:4523, Tokyo, Japan), Razadyne galantamine (Reminyl) from Shire (LSE:SHP; SHPGY, Basingstoke, U.K.) and Exelon rivastigmine from Novartis AG (NVS; SWX:NOVN, Basel, Switzerland), to patients diagnosed with moderate Alzheimer's disease (see BioCentury, Dec. 4, 2006).

The three acetylcholinesterase inhibitors were first assessed for cost effectiveness by NICE in 2001 and at that time were recommended for use in AD. In 2004, the agency revisited its guidance and concluded the drugs were no longer cost effective and recommended they not be used. After appeals by a number of stakeholders, NICE modified its guidance to allow use of the drugs in a subset of patients said to benefit in a cost effective way.

In July 2006, NICE received five appeals. Eisai and SHP were joined by H. Lundbeck A/S (CSE:LUN, Copenhagen, Denmark), the developer of Ebixa memantine, which is not licensed for moderate AD in the U.K.

The patient groups appealing included the Alzheimer's Society, Age Concern, Counsel and Care, Dementia Care Trust and Royal College of Nursing. A fifth appeal was lodged jointly by the Royal College of Psychiatrists and the British Geriatrics Society(see BioCentury, July 17, 2006).

In November 2006, after turning down all five appeals, NICE issued guidance recommending that donepezil, galantamine and rivastigmine could be used in moderate AD - patients with a Mini Mental State Examination (MMSE) score of 10-20 - and then only under certain conditions (see BioCentury, Dec. 4, 2006).

Having exhausted the appeals process, the only option...

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