Alzheimer's judicial review
In November 2006 NICE published guidance on four drugs for Alzheimer's disease alongside a clinical guideline on dementia. NICE recommended that donepezil, galantamine and rivastigmine should only be considered as options in the treatment of people with moderate Alzheimer's disease. Memantine was only recommended as part of clinical studies for people with moderately-severe to severe Alzheimer's disease.
Following publication of this guidance Eisai Limited, supported by their co-promotion partner Pfizer Limited, applied for a judicial review of the NICE appraisal. The judicial review hearing took place on the 25 June 2007.
What were the specific grounds for this judicial review?
The grounds on which the Claimant sought to challenge the decision by NICE, to issue guidance in its present form, fall under three broad headings. First, it was said that the decision was irrational, on four different but very limited grounds. Secondly, it was said that the decision was procedurally unfair, in one specific respect - that NICE breached principles of procedural fairness by providing a ‘read only' version of the economic model used in the appraisal. Thirdly, it was said that the decision was indirectly discriminatory against certain groups.
What was the outcome of the judicial review?
On 10 August 2007 the judge ruled in favor of NICE on five out of the six grounds bought in court. The judge found that NICE:
- did appropriately take into account the benefits these drugs bring to carers
- appropriately reflected the costs of long term care in its calculations
- did not breach principles of procedural fairness by providing a ‘read only' version of the economic model
- was not irrational in concluding that there is no cumulative benefit to patients after 6 months' treatment with these drugs
- that NICE's assessment and consideration of the AD 2000 study was not irrational.
The judge ruled against NICE on one of the six grounds bought in court. She found that NICE did breach its duties under the Disability Discrimination Act and the Race Relations Act by not offering specific advice regarding people with learning disabilities and people for whom English is not their first language in its technology appraisal guidance.
What did this mean for the guidance?
The judge asked NICE to amend its guidance within 28 days. The amendment related to the use of the MMSE score for people with learning disabilities, linguistic difficulties and those whose first language is not English, so that due account can be taken by those with responsibility for the care of such people.
On 7 September 2007 NICE published an amended version of its technology appraisal to fully comply with the judge's ruling on the judicial review. The amended guidance has been published on the NICE website at http://www.nice.org.uk/guidance/TA111.
Did Eisai appeal against this ruling?
Yes, in September 2007 Eisai applied for leave to appeal against the judge's ruling on one point: that NICE did not breach principles of procedural fairness by providing a ‘read only' version of the economic model. An ‘executable' version is the same spreadsheet but with some additional functionality to enable different numbers to be put in and new calculations to be made.
What was the outcome of the appeal?
The Court of Appeal upheld Eisai's appeal and ruled that NICE release the economic model used in the technology appraisal of drugs for the treatment of Alzheimer's disease. In accordance with this ruling NICE released the fully executable version of the model to stakeholders for their comment in November 2008.
NICE considered the comments from consultees on the reliability of the model and instructed its Decision Support Unit (DSU) to review the responses received and to prepare a report for the independent Appraisal Committee. The DSU report was sent to consultees and commentators for consultation prior to consideration by the Appraisal Committee. Having fully reviewed all the resulting comments the Appraisal Committee concluded that, although a number of technical inaccuracies were highlighted and amendments were made to the economic model, these were not sufficient to change the original conclusion that these treatments are not cost effective in the mild stages of the disease.
What happens now?
NICE has issued a Final Appraisal Determination or FAD which includes the review of these comments and consultees now have a chance to appeal against this decision.
NICE guidance on the use of donepezil, galantamine and rivastigmine and memantine for the treatment of Alzheimer´s disease remains unchanged and the drugs continue to be recommended only for people with moderate Alzheimer's disease.
NICE was not asked by the Court of Appeal to carry out a new appraisal of these treatments, NICE has a process of regularly reviewing its guidance to take into account any new evidence. If no appeals are received, this review can start as soon as possible.
This page was last updated: 26 April 2010