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Prescribers ready to defy NICE in Alzheimer's drug row

Published on 18/01/06 at 12:01pm

Patient groups and manufacturers are hoping NICE will reverse its decision to deny access to Alzheimer's drugs on the NHS, with an announcement due in the next few days.

NICE is expected to announce its decision on Monday after ten months of controversy, but a new survey has also revealed that most psychiatrists are prepared to keep prescribing the medicines, regardless of NICE's decision.

NICE stunned stakeholders in March 2005 with its conclusion that existing Alzheimer's treatments were not cost-effective and should not be prescribed on the NHS in England and Wales.

The decision met with huge protest, with patient organisation the Alzheimer's Society co-ordinating a large-scale campaign to have the ruling reversed.

The charity has brought together dozens of stakeholder groups in the Action on Alzheimer's Drugs alliance to fight the ruling, with supporters urged to write to their MP under the campaign slogan Hands Off Dementia Drugs.

Seeking a way out of the impasse, NICE has suggested that supplying the drugs to only those patients who will benefit most will improve the cost-effectiveness of the drugs, which include Eisai/Pfizer's Aricept, Novartis' Exelon and Shire's Reminyl.

NICE asked manufacturers to re-analyse their data to see if these patients could be identified in the early stages of treatment.

Manufacturers submitted newly analysed data in December which they say demonstrates the drugs are more cost-effective than previously thought.

Eisai managing director Dr Paul Hooper said: "NICE had been looking for evidence that these medicines work better in certain groups of patients. The evidence presented shows they can help a broad range of patients and their cost-effectiveness may have been underestimated.

"Since it isnt 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."

The analysis submitted by Eisai and Pfizer for donepezil re-examined six trials (randomised, double-blind, placebo trials) involving a total of 2,400 patients.

The companies said between 30% and 68% of patients were deemed 'responders', depending which trial was looked at. The definition of a 'responder' was laid down by NICE in their existing guidance.

As Alzheimer's is a progressive disease, a responder is defined as a patient who showed improvement or no deterioration and evidence of global improvement either on the basis of function or behaviour after six months of therapy.

The companies said the analysis found even 'non-responders' did somewhat better than was previously understood. Donepezil-treated patients classified as non-responders maintained their cognition levels above baseline after six months of therapy; in contrast, placebo-treated patients declined.

The companies said Alzheimer's disease patients responded to therapy in different ways at different times, and that clinicians use a number of different approaches to assess whether a patient is benefiting in the first few months of treatment.

The analysis concludes: "The results suggest that the benefits on donepezil therapy may have been underestimated to date, as the subgroup of responders derive more than average benefit from treatment. We believe that the information uncovered by these new analyses will have a positive affect on the cost-effectiveness estimates of donepezil in Alzheimer's disease."

The Alzheimer's Society said NICE's original assessment was flawed in a number of respects, including the cost to carers of looking after patients (355) which the charity called a serious underestimate.

Meanwhile, a survey of psychiatrists shows an overwhelming majority are in favour of using the drugs - with two out of three claiming they will continue prescribing them even if NICE does not change its mind.

Survey results

The Faculty of Old Age Psychiatry at the Royal College of Psychiatrists questioned 134 of its members and found 96% believed cholinesterase inhibitors should be available on the NHS, while the same number opposed NICE's proposal to withdraw them. It also found:

  • 87% of psychiatrists polled believed that, in general, patients with Alzheimer's benefited from the drugs.
  • More than two out of three (67%) said they would carry on prescribing them anyway, while 21% were undecided.
  • Of those who said they would continue to prescribe the drugs, 37% said they would do it on the NHS only, 14% would prescribe privately and 23% would prescribe both on the NHS and privately.
  • Three-quarters (74%) predicted pressure from NHS trusts and PCTs not to prescribe the drugs.
  • The majority (87%) also said they believed that their dementia service would experience a negative impact as a result of withdrawing approval.
  • Some psychiatrists polled also suggested there was an element of ageism on the part of the NHS.
  • They also said that although the response to the drugs could be modest, there were real benefits to patients and carers.
  • A small minority of those questioned supported the withdrawal of approval for the drugs, saying that funding them removed resources from other forms of dementia care.

Professor Clive Ballard, director of research at the Alzheimer's Society and a member of the Action on Alzheimer's Drugs Alliance, supported the findings of the survey. "This survey demonstrates the strength of feeling among professionals that NICE has got it wrong," he said.

"These are the only drug treatments for people with dementia, and psychiatrists see their benefits in their daily practice."

He said it would be untenable for doctors not to be able to offer the drugs which he said cost just 2.50 a day per patient.

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