UK Government response to NICE consultation on Alzheimer's drugs

Main Category: Alzheimer's / Dementia
Article Date: 24 Mar 2005 - 11:00 PDT


Health Secretary John Reid has today met with the Alzheimer's Society and discussed the Government's response to the NICE consultation on its draft appraisal of drugs for Alzheimer's Disease.

On 1 March NICE published for consultation draft guidance recommending that donepezil, rivastigmine, galantamine and memantine should not be routinely used in the NHS.

John Reid said:

"We recognise the particular challenge that NICE has faced with this review and acknowledge the considerable efforts that have gone into it. Many individuals and organisations have expressed their concern about the proposed withdrawal of these drugs used for the treatment of Alzheimer's Disease.

"NICE is an independent and well respected organisation with an important role in giving advice to clinicians on a range of technologies and treatments. We fully support and value its advice and guidance.

"As a stakeholder, invited to comment, I have brought to NICE's attention a number of questions which this proposed guidance raises. In particular, whether NICE has carried out a cost effectiveness analysis of this medication compared to non-drug interventions for cognition, behaviour, activity of daily living and carer burden. I have also asked if NICE would consider reassessing cost effectiveness including a factor of carer time in the outcome. NICE is currently working on guidance on dementia care and we will discuss with NICE how both of these two pieces of guidance could be best managed, so that patients, carers and clinicians have access to a single suite of advice that covers the management of this condition."

Notes to editor

The full text of the Department of Health submission to NICE is below. It will also be available on the Department of Health website at: www.dh.gov.uk

SPECIFIC COMMENTS ON THE APPRAISAL CONSULTATION DOCUMENT
DONEPEZIL, RIVASTIGMINE, GALANTAMINE AND MEMANTINE FOR THE TREATMENT OF ALZHEIMER'S DISEASE
GENERAL

We note that the Appraisal Committee took evidence from patient, carer and professional organisations. Has appropriate weight been given to the views of these groups on both the direct benefits of the medications and the broader benefits to dementia care? For example, what weighting has been given to the views of clinicians working in memory clinics who may have experience of these treatments? It would be helpful if NICE could demonstrate more clearly the method used to weigh-up and balance the different sources of evidence. Other NICE assessments (e.g. on riluzone for motor neurone disease) have attached particular importance to the values placed by patients on specific benefits of treatment. Has the same weighting been attached to patient views in the current appraisal?

SECTION 4

Given the complexities of Alzheimer's disease and the care and support for those who have it, and the difficulty of constructing a robust economic model, is NICE satisfied that sufficiently clear conclusions can be drawn from the methodologies used to support convincingly the recommendations made on the availability of the drugs?

In the 2001 guidance on donepezil, rivastigmine and galantamine, NICE advised that these drugs should be made available to people with mild to moderate Alzheimer's disease, under strict prescribing rules. At that time, the technology appraisal did not include a health economic analysis using a cost per QALY methodology because of methodological weaknesses in this approach. The current appraisal also makes frequent reference to methodological weaknesses:

· in estimating quality of life

· modelling disease progression

· obtaining good quality information on the costs for AD patients treated in the community

· the sensitivity of cost per QALY estimates to relatively small changes to the estimated incremental costs

Could NICE give further thought to elaborating the factors that have changed its view on the methodological weaknesses in the cost per QALY approach?

Our understanding is that current prescribing practice for these drugs generally complies with existing NICE guidance - i.e. that prescribing is generally only continued where it is considered that the patient has been judged to benefit. Is NICE satisfied that the appraisal takes proper account of this practice in assessing drug and monitoring costs?

If NICE does consider that the cost-effectiveness methodology is robust enough to justify its conclusion, would you consider re-analysing the cost-effectiveness data using costs according to its 2001 technology appraisal guidance, where only people who were shown to benefit from medication continue to accrue drug and monitoring visit costs beyond a 3-4 month therapeutic trial?

To what extent has NICE looked at both the short-term and longer-term or continuing benefits of the drugs in question; how many people fit into each category and whether a more sensitive analysis might be possible?

In most existing NICE guidance on medication use, new treatments are compared to existing treatments. In this case, there are no other licensed pharmacological treatments than the four NICE is suggesting should be withdrawn from NHS use. Has NICE carried out any cost-effectiveness analyses to consider how the cost per QALY of these medications compares to other non-drug interventions for cognition, behaviour, activities of daily living and carer burden?

You will be aware of the CSM guidance on the risks of stroke with atypical antipsychotics, and more recent evidence suggesting that the typical antipsychotics and other sedative medications are likely to be as risky in the management of behavioural and psychiatric symptoms in dementia. Consensus guidance issued by professional and carer groups (RCPsych, BGS, RCN and AS) recommended that cholinesterase inhibitors should be used ahead of atypical antipsychotics in the treatment of behavioural and psychiatric symptoms in dementia. If these medications are withdrawn then there may be an increase in the prescribing of more harmful medications. Has NICE included an assessment of the potential risks and costs in its deliberations on this appraisal?

Has NICE considered whether there would be a different answer if the costs of carers as opposed to the benefits were included? Would this make a difference? It is our understanding that NICE generally only considers NHS costs. Is it satisfied that is sufficiently wide-ranging to cover adequately all the potential benefits of the drugs involved?

The care of people with dementia relies heavily on family caregivers. As there is data from RCTs on reduction in caregiver time as a benefit from these medications, would NICE consider re-assessing cost-effectiveness including a factor for carer time in the outcome?

SECTION 6

The Appraisal Consultation Document suggests that memory clinics are of benefit. As far as we are aware, that comment is not supported by any assessment of the clinical and cost-effectiveness of such clinics. Could you clarify this issue please in the final report?

For further information please contact Brenda Irons-Roberts, Department of Health media centre on the number provided:

Dept of Health, UK.

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