NICE complies with judge's ruling on judicial review

The outcome of this judicial review was published on Friday 10 August. Donepezil, galantamine, rivastigmine continue to be recommended only for people with moderate Alzheimer’s disease.

The judge ruled in favour 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. It was always NICE’s intention that these groups should have equal access to these drugs in the moderate stage of the disease.

NICE has amended and reissued this guidance. The amended guidance clarifies the steps healthcare professionals should take when assessing whether Alzheimer’s disease is of moderate severity and highlights that clinicians should be mindful of the need to secure equality of access to treatment.

The amendments include new text that specifically addresses assessments, using the Mini Mental State Examination (MMSE) for patients:

• where the MMSE is not, or is not by itself, a clinically appropriate tool for assessing the severity of that patient’s dementia because of the patient's learning or other disabilities (for example, sensory impairments) or linguistic or other communication difficulties

or

• where it is not possible to apply the MMSE in a language in which the patient is sufficiently fluent for it to be an appropriate tool for assessing the severity of dementia, or there are similarly exceptional reasons why use of the MMSE, or use of the MMSE by itself, would be an inappropriate tool for assessing the severity of dementia in that individual patient’s case.

The amended guidance was 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. 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.

Following the outcome of a judicial review in August 2007, NICE has amended and reissued this guidance. The amended guidance clarifies the steps healthcare professionals should take when assessing whether Alzheimer’s disease is of moderate severity and highlights that clinicians should be mindful of the need to secure equality of access to treatment.

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.