Alzheimer's patients betrayed by NICE
22 November 2006
The new recommendations on the management of dementia issued by the National Institute for Health and Clinical Excellence (NICE) and the Social Care Institute for Excellence (SCIE) today (22 November) mark a shamefully wasted opportunity to provide best care for people with mild Alzheimer's disease and their families, say Eisai Limited, the licence holder of Aricept (donepezil hydrochloride) and Pfizer Limited, its co-promotion partner.
NICE has ignored calls to postpone issuing its health technology appraisal, and has disregarded the concerns of patient groups, carers and independent medical experts who have openly criticised NICE's views on the cost-effectiveness of the treatments for mild Alzheimer's disease.
Eisai and Pfizer announced last week that Eisai has informed NICE of its intention to apply for a judicial review of the process by which NICE reached its decision.
Should such a review proceed and be upheld, NICE would be required to give further consideration to the use of treatments for Alzheimer's disease, using a fair procedure.
Dr Paul Hooper, Managing Director of Eisai Ltd said: "Whilst we note that the clinical guideline now makes some concessions for a minority of mild patients, this is inconsistent with the inflexible wording of the health technology appraisal and remains a fundamentally flawed decision.
"We believe that NICE's ruling on the cost-effectiveness of the treatments for mild Alzheimer's disease in its health technology appraisal has fatally undermined the work and recommendations of the Dementia Guidelines Group - with very distressing implications for patients.
"By proceeding with the publication of its health technology appraisal, NICE has very publicly turned its back on the medical professionals, patients and carers with actual experience of Alzheimer's disease," Dr Hooper concluded.
Dr Olivier Brandicourt, Managing Director of Pfizer Limited, said: "It is illogical to draw up wide-ranging guidelines on the care and treatment of people with dementia and then say patients with mild Alzheimer's disease have to become seriously ill before they can receive medication."
NICE has until 28 November to formally respond to Eisai's letter informing them of its intention to apply for a judicial review of the process by which NICE reached its decision proposing to ban medicines for NHS patients with newly diagnosed mild Alzheimer's disease. After this time Eisai may apply immediately to the High Court for permission to proceed to judicial review.
Notes to Editors:
NICE's own Guidelines Development Group have previously written to NICE asking them to re-consider their proposed recommendations. See links at
http://www.nice.org.uk/page.aspx?o=288559http://www.nice.org.uk/page.aspx?o=324234The National Clinical Practice Guideline on Dementia published today mirrors the decision by NICE to ban treatment for the majority of NHS patients with newly diagnosed mild Alzheimer's disease, as confirmed in the NICE Health Technology Appraisal, also published today.
The clinical guidance allows doctors to prescribe cholinesterase inhibitors for people with mild Alzheimer's only if they show signs of behavioural disturbance (aggression or violence).
The UK licence for Aricept is for mild to moderately-severe Alzheimer's disease, which has been granted by the regulatory agency based on the body of evidence provided to them.
NICE first proposed banning NHS prescription of the medicines to newly diagnosed Alzheimer's patients in March 2005. This was a reversal of existing policy as NICE had approved the drugs for use by the NHS in January 2001.
NICE postponed ratifying the ban in July last year but instead asked the manufacturers to supply extra data showing which patients responded best to the medication. The data were supplied, and considered by NICE on 20 December 2005.
NICE defines the severity of Alzheimer's disease according the scores of the Mini Mental State Exam (MMSE) which runs from 30 to zero. From 30 to 27 is normal. Mild Alzheimer's disease is defined as 26 to 21 points. Moderate is 20 to 10, and severe is under 10.
On 23 January 2006 NICE proposed that moderate AD be treated on the NHS, but not mild. Moderate is being defined as starting at 20 on the MMSE scale. A consultation period followed this announcement.
On 26 June NICE announced that despite the views of patients and doctors, it planned to stick to its ban on using the treatments for mild AD.
Eisai and Pfizer appealed this decision, along with other manufacturers, the Alzheimer's Society and the Royal College of Psychiatrists. The appeal was heard on 13 and 14 July.
On 11 October NICE announced that all grounds of appeal from all parties had been dismissed.
On 14 November, Eisai and Pfizer called on NICE to
· withdraw the current FAD and postpone issuing the new guidance
· disclose a fully transparent working version of the calculations used in the cost-effectiveness model for independent evaluation and comment
· develop a new FAD using both a more accurate cost-effectiveness model and data