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12:00 AM
 | 
Jul 17, 2006
 |  BioCentury  |  Regulation

Opaque transparency

Officials at the National Institute for Health and Clinical Excellence, the guardians of government healthcare cost effectiveness in England and Wales, have found themselves under increasing pressure from stakeholder groups beyond the pharmaceutical industry. Hardly a month seems to go by without the British media focusing on the victims of a decision by NICE to restrict National Health Service coverage as it seeks to determine the wisest use of limited NHS resources.

Last week, three companies and coalitions of healthcare professionals and patient/care giver advocacy groups gave evidence at a hearing called to consider appeals against draft recommendations that would restrict the use of registered Alzheimer's disease drugs. While the various stakeholders had a number of grievances, it was clear that a lack of transparency was at the heart of key issues.

Not surprisingly, industry appellants were Eisai Co. Ltd. (Tokyo:4523; Osaka:4523, Tokyo, Japan), the manufacturer of Aricept donepezil; H. Lundbeck A/S (CSE:LUN; Copenhagen, Denmark), the developer of Ebixa memantine; and Shire Pharmaceuticals Group plc (LSE:SHP; SHPGY, Basingstoke, U.K.), the manufacturer of Razadyne galantamine, formerly known as Reminyl.

Also against the draft recommendations were joint appeals from the Royal College of Physicians (RCP) and the British Geriatrics Society (BGS), and from the Alzheimer's Society, Age Concern, Counsel and Care, the Dementia Care Trust, and the Royal College of Nursing.

Current NICE guidance on the use of three acetylcholinesterase inhibitors - donepezil, galantamine and rivastigmine - issued in January 2001, recommended they should be available in the NHS to essentially all sufferers with mild and moderate AD, with treatment stopping as soon as the drugs no longer have an effect.

The 2001 guidance promised that NICE would review its decision in December 2003 based on new evidence. That review also included a new appraisal of the clinical and cost effectiveness of Ebixa, a voltage-dependent NMDA receptor antagonist, to treat patients with moderate to severe AD.

Each subsequent review has further restricted use of AD treatments.

An earlier draft of the 2003 review, circulated in 2005, revealed that while NICE acknowledged that the drugs were clinically effective, it concluded that they were not cost effective and so should not be available through the NHS.

After a public outcry, the appraisal committee called for more data from the manufacturers and revisited its calculations.

In the latest draft guidance, issued in May, NICE recommends that the three acetylcholinesterase inhibitors should be available on the NHS only to AD patients with moderate severity - those with a Mini Mental State Examination score of 10-20 points - and only under certain circumstances.

NICE recommended against the use of memantine except as part of clinical studies.

In reviewing the clinical effectiveness of the acetylcholinesterase inhibitors, NICE concluded the quality of the reporting and methods of...

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