NICE cover their tracks as people with dementia miss out

People with dementia were let down today (Wedneday 11 October) as an internal NICE appeal panel supported an appraisal process rejected by both experts and patients.

The Alzheimer’s Society today reacted angrily to NICE appeal panel which:

  - Removed references from the final appraisal decision (FAD) rather than address concerns from experts

- Papered over major flaws in the FAD by saying it’s only guidance

- Continued to discriminate against people from different cultural and educational backgrounds

- Ignored the way the drugs can save money in other areas because it's outside NICE’s remit

- Defended their appraisal process which is not suited to evaluating mental health conditions

- Left dangerous sedatives that increase your risk of heart disease, stroke and falls as the remaining option for peple with Alzheimer's disease

  The decision will impact upon  those in early stages of dementia who will be forced to wait until their condition deteriorates before receiving drugs that work and give them the chance for  improved quality of life. In addition people in the later stages will also be denied access to the only licensed drugs proven to alleviate the distressing symptoms of late Alzheimer's such as aggression and agitation.

  Clive Ballard, leading old aged psychiatrist and director of research at the Alzheimer’s Society says,

  ‘NICE have admitted that they have made fundamental errors and that their guidance is discriminatory, yet unbelievably they are still not prepared to change their guidance.  It is disgusting that they are prepared to put preserving their own reputations ahead of doing their

job and making effective treatments available to people with Alzheimer's disease. It's now time for the Department of Health to take leadership over this farcical process and ensure appropriate and effective treatment's are available  for people with Alzheimer's disease.'

The decision has been rejected by the Action on Alzheimer’s Drugs Alliance an alliance of over 30 professional and patient organisations who have condemned the decision.

The NICE report:-

NICE announces Alzheimer’s disease drug appeal outcome and NHS guideline to support patients and carers

NICE has today (Wednesday 11 October) announced that the appeals lodged by stakeholders against draft guidance on the use of drugs to treat Alzheimer’s Disease have not been upheld.  NICE will recommend to the NHS in November that donepezil, galantamine and rivastigmine should only be considered as options in the treatment of people with moderate Alzheimer’s disease.  Memantine is only recommended as part of clinical studies for people with moderately-severe to severe Alzheimer’s disease.

Andrew Dillon , NICE Chief Executive, said: “Alzheimer’s is a cruel and devastating illness and we realise that today’s announcement will be disappointing to people with Alzheimer’s and those who treat and care for them.  But we have to be honest and say that based on all the evidence, including data presented by the drug companies themselves, our experts have concluded that these drugs do not make enough of a difference for us to recommend their use for treating all stages of Alzheimer’s disease.  We have recommended the use of these drugs where they have the potential to make a real difference, which is at the moderate stage of the illness.”

Under normal circumstances, guidance to the NHS would be published at the same time as the decision of the Appeal Panel.  However NICE is also developing a clinical guideline on the management of all types of dementia, including Alzheimer’s disease, jointly with the Social Care Institute for Excellence.  It is in the interests of patients and those who care for them that both pieces of advice are published at the same time.  The publication date for the appraisal and the dementia guideline will be 22 November 2006 .

Andrew Dillon continued: “Next month NICE will also publish, jointly with the Social Care Institute for Excellence, a clinical guideline on the treatment and care of people with dementia.  It will complement the guidance on drugs by making it clear what care and support should be provided to people in all stages of Alzheimer’s disease.”   

About this appraisal

3.       Background information:

·         The original and current NICE guidance on the use of donepezil, galantamine and rivastigmine for Alzheimer’s disease issued in 2001 recommends the use of these drugs for all patients, with treatment stopping as soon as they no longer had an effect.

·         NICE’s review of this guidance initially concluded that there was not enough evidence to support the use of these drugs for all patients as recommended in the original guidance. However, responses received from stakeholders during consultation on this first draft suggested that the drugs may be more effective for certain groups of people. NICE therefore asked the pharmaceutical companies involved in the appraisal to look for evidence to support this in data from their clinical trials.

·         The Appraisal Committee met on the 20 December 2005 to review this additional data. This new evidence, taken with data already seen by the Committee enabled the Committee to reach the conclusion that donepezil, galantamine and rivastigmine are both clinically and cost effective in patients with moderate Alzheimer’s disease (approximately 40% of all patients).

·         The appraisal committee met again on 27 April 2006 to consider comments on the draft document.  The Final Appraisal Determination can be found on the website at: http://www.nice.org.uk/page.aspx?o=appraisals.inprogress.alzheimersdisease#keydocs.

·         Consultees with a right to appeal could appeal against the Final Appraisal Determination.  The Institute received five appeals from Alzheimer's Society, Age Concern, Counsel and Care, Dementia Care Trust and Royal College of Nursing (joint appeal), Eisai Ltd, Lundbeck Ltd, Royal College of Psychiatrists and British Geriatrics Society (joint appeal) and Shire Pharmaceuticals Ltd. An appeal hearing was held on 13-14 July 2006.

 (11/10/06)