NICE Responds to Judicial Review Outcome

LONDON, Aug. 10, 2007-Commenting on today’s ruling, NICE Chief Executive, Andrew Dillon said: "The legal challenge to our recommendation that drugs for Alzheimer’s disease should only be prescribed to those in the moderate stage of the disease has failed. We were challenged on six grounds, and the court found in our favour on five of them. This ruling strengthens NICE by endorsing our approach to evaluating drugs.

"Our guidance stands and the drugs continue to be recommended only for people with moderate Alzheimer’s disease, but the court has asked us to clarify our guidance when it is used for certain groups. It was always our intention that people with learning disabilities or people whose first language is not English should have equal access to the drugs in the moderate stage of Alzheimer’s disease. We will reissue our guidance to the NHS to make this crystal clear.

"Alzheimer’s disease is a devastating illness, but the evidence indicates that these drugs are simply not effective for some patients. That is why we also issued advice last year on the broader support that should be provided for people with Alzheimer’s disease and those who care for them, creating core standards for the NHS and care homes that will make a real difference for patients and their families."

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.

NICE will be sending out an updated press release shortly with details of how the Institute will implement the court’s ruling.

Ends

Notes to Editors

About NICE

1. More information on the appraisal of drugs for Alzheimer’s disease can be found on the NICE website at http://guidance.nice.org.uk/TA111.

2. NICE did offer specific advice on prescribing drugs for Alzheimer’s disease for people with learning disabilities and people for whom English is not their first language in the clinical guideline on dementia that was jointly issued by NICE and the Social Care Institute for Excellence (SCIE) in November 2007. More information on the dementia guideline can be found on the NICE website at: http://guidance.nice.org.uk/cg42.

3. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

4. NICE produces guidance in three areas of health:

• public health – guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector

• health technologies – guidance on the use of new and existing medicines, treatments and procedures within the NHS

• clinical practice – guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

Tel: 020 7067 5900

www.nice.org.uk

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