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Second look at Alzheimer's drug costs

Pharma firms come out fighting as NICE mulls over possible ban on new use of Alzheimer's drugs within NHS

Pharma companies have reasserted their case to the National Institute for Health and Clinical Excellence (NICE) that all patients with Alzheimer's disease should be given access to the newest drug treatments.

The move comes as the organisation is reviewing new use of Alzheimer's drugs within the NHS today (Tuesday), having requested a broader analysis of data from companies making and selling the drugs.

NICE had planned to ban the supply of cholinesterase inhibitors to patients through the NHS on the basis that they are not sufficiently cost-effective as they do not always provide clear benefits to all patients.

A notable statement has been released from the marketing partners of number one Alzheimer's treatment Aricept, Pfizer and Eisai, which seeks to highlight what they claim is an earlier underestimation by NICE of the cost effectiveness of anti-dementia medicines.

Based on a re-examination of six randomised, double-blind, placebo-controlled trials involving 2,400 patients, the companies say that the potential benefits of donepezil (Aricept) extend not only to formerly defined 'responders', but to a number of so-called 'non-responders'.

The companies say it is currently unfeasible to distinguish between patients deemed potential 'responders' and those deemed 'non-responders'.

After six months of donepezil therapy, non-responders ìmaintained their cognition levels above baseline; in contrast, placebo-treated patients declinedî, a joint statement from the developers read.

ìSince it isn't possible to tell at the start of treatment which patients will do well and which patients will obtain less benefit, existing NICE guidance that all diagnosed patients be offered a chance of the medication in the first instance seems a sensible course of action,î said Paul Hooper, managing director of Eisai.

NICE has made clear that it may be possible that the NHS will be permitted to supply Alzheimer's drugs to treat certain sub-groups of receptive patients, even if the general ban on their use in all newly diagnosed patients goes ahead. Following the reappraisal underway today, NICE's final decision is expected to come in January next year.

Earlier in 2005, the Department of Health urged NICE to make its decision carefully. ìIn view of the public concern over the draft proposals, the government will want to ensure that all aspects have been fully considered,î it stated.

Former health minister, Stephen Ladyman, told the Observer: ìThey [NICE] have to look at the wider impact of this decision. It may well be that once they have looked at the extra evidence they will come to a different decision.î

The Alzheimer's Society (www.alzheimers.org.uk) has criticised the grounding for NICE's draft decision in March 2005 to remove cholinesterase inhibitors from the NHS drug list, citing ìserious flawsî in the economic model used. The Society claims that the estimated costs of full-time care for patients were inaccurate and that NICE's model did not adequately capture the change in quality of life imbued by drug treatments.

The market for Alzheimer's treatments, including the expensive cholinesterase inhibitors under extended NICE review, is anticipated to grow over the coming decades and could support more than 80 million sufferers by 2040.

30th September 2008

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