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Industry 'alarmed' by Alzheimer's proposals

Pharma companies and charities speak out over controversial plans by NICE to withdraw Alzheimer's drugs from the NHS

Pharmaceutical companies and the Association of the British Pharmaceutical Industry (ABPI) have voiced concerns about requests from the National Institute for Health and Clinical Excellence (NICE) to identify subgroups of patients who may get real benefit from Alzheimer's treatment.

The request to Eisai, Novartis, Shire and Lundbeck follows a preliminary NICE judgement earlier this year that, according to the latest evidence, Alzheimer's drugs are not cost effective for treating mild-to-moderate forms of dementia in the condition.

ìWe are alarmed that NICE is attempting to exclude subsets of patients with Alzheimer's disease from receiving these drugs on the NHS,î said John Freeman, managing director of Shire Pharmaceuticals in the UK. ìThousands of patients could be denied this treatment which has been found to be clinically effective in trials involving over 10,000 patients with mild-to-moderately severe Alzheimer's disease.î

If the companies do not identify the subgroups as requested, in October NICE will go ahead with its controversial proposal to ban the use of Alzheimer's medicines in the NHS. This would represent a U-turn on a decision made in 2001 that the NHS should pay for drugs, which cost around £1,000-a-year and include Aricept (Eisai) and Reminyl (Shire).

Dr Paul Hooper, managing director of Eisai UK believes that ìit would be fundamentally wrong and not in the interests of the patients and carers to withhold these valuable treatmentsî when no alternative drugs are available.

ìI am astounded that the NICE appraisal committee has not re-evaluated its initial position and persists with unacceptable and inappropriate methods of evaluation,î said Professor of healthcare policy at Imperial College London, Nick Bosanquet. ìFor example, the evaluation does not address the carer burden or potential gain to carers when Alzheimer's patients receive treatment, nor does it account for the potential cost savings made in delaying the need for nursing home placement or additional nursing care when patients are taking these medicines.î

Following the decision of its Guidance Executive not to approve the committee's final appraisal, which suggested that the NHS should not support acetylcholinesterase inhibitors licensed for Alzheimer's, NICE wrote to the four pharma companies asking them to submit more detailed data from pivotal trials.

NICE has reportedly received 4,000 individual objections in response to its proposals from professional and patient organisations, the Department of Health, Members of Parliament and patients.

The ABPI believes that there is still time to ìcorrect the decision being madeî.

ìThe door remains open for further discussions and it is vital that it is not slammed in the faces of people with Alzheimer's and those working with them to alleviate this distressing condition,î said Dr Richard Barker, director-general of the ABPI.

Charities have also criticised NICE proposals and accused the government watchdog of once again putting cost before patient care. The move by NICE has led to the establishment of a new alliance, Action on Alzheimer's.

30th September 2008

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