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Outcome of judicial review for NICE guidance on drugs for Alzheimer's disease

The judicial review of our guidance on Alzheimer's disease ruled in favour of NICE on five out of the six grounds bought in court. As a result, Donepezil, galantamine, rivastigmine continue to be recommended only for people with moderate Alzheimer's disease.

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. It was always NICE's intention that these groups should have equal access to these drugs in the moderate stage of the disease. We will reissue our guidance to the NHS to make this clear.

The judge has asked NICE to amend its guidance within 28 days and to ensure that those affected by the guidance are aware of this order and of the amendment once it has been made. We will comply fully with the court's ruling.

The amendment will relate 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. In accordance with the ruling, we are consulting with the claimant in the judicial review, Eisai Limited, and the two interested parties, the Alzheimer's Society and Shire Pharmaceuticals Limited, on the detail of the amendment. No other parties are involved in this consultation.

The amended guidance will be published on our website on Friday 7 September and will have force from that date. It will be distributed to the NHS in paper form as part of our standard monthly mailing on Wednesday 26 September.

Below are some commonly asked questions and answers about judicial reviews and this case in particular.

Q. What is judicial review?

A. Judicial review is a High Court procedure for challenging administrative actions. Delegated legislation may also be challenged. It allows individuals, businesses or groups to challenge in court the lawfulness of decisions taken by Ministers, Government Departments and other public bodies. These bodies include local authorities, the immigration authorities, regulatory bodies and some tribunals.

Q. What were the specific grounds for this judicial review?

A. 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. Thirdly, it was said that the decision was indirectly discriminatory against certain groups.

Q. Who took NICE to Court?

A. A Japanese pharmaceutical company called Eisai, which is the licensed holder of one of the drugs NICE recommended for use in patients with moderate stage Alzheimer's. Their press releases state that they did so with the ‘full support' of Pfizer, the company which markets the drug.

Q. What was the role of the Alzheimer's Society in the case?

A. The Alzheimer's Society registered as an interested party and had the opportunity to contribute to the proceedings and submit evidence, however they will not be subject to any legal costs. The pharmaceutical company Shire Ltd also registered as an interested party in this case and also had the opportunity to contribute to the proceedings and submit evidence.

Q. What has the judge decided?

A. The judge ruled in favour of NICE on five out of the six grounds bought in court, including finding:

  • That NICE did appropriately take into account the benefits these drugs bring to carers.
  • That NICE appropriately reflected the costs of long term care in its calculations.
  • That NICE did not breach principles of procedural fairness by providing a ‘read only' version of the economic model.
  • That NICE was not irrational in concluding that there is no cumulative benefit to patients after six 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:

  • 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.

Q. What is your response to the judge's ruling?

A. We were challenged in court on six grounds, and the judge has rejected five of the six points made against us. It has always been our intention that people with learning disabilities or people whose first language is not English, should have equal access to these drugs in the moderate stage of Alzheimer's disease. We will reissue our guidance to the NHS to make this crystal clear.

The judge has asked NICE to amend its guidance within 28 days and to ensure that those affected by the guidance are aware of this order and of the amendment once it has been made. We will comply fully with the court's ruling.

We appreciate that Alzheimer's is a devastating illness for patients and their carers, and we hope that the advice we issued last year on the broader support that should be provided for people with Alzheimer´s disease and those who care for them will make a real difference for patients and their families.

This page was last updated: 24 June 2010

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Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.

Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.