How nice is NICE?28th January 2007
1 How nice is NICE?
Last week Radio 4 broadcast ‘How nice is NICE’. The programme reviewed whether the National Institute of Health and Clinical Excellence (NICE) is necessary, how its topics for investigation are chosen and the long term effects for the NHS.
The independent organisation was set up 1999 and is responsible for providing national guidance on the promotion of good health and the prevention / treatment of ill health. Its’ guidance covers 3 areas - public health, health technologies and clinical practice.
The programme concluded that:
• A body, such as NICE, is essential to ensure the quality and equity of provision and treatment across the NHS.
• Their decisions about which drugs should be available to patients must, in part, be based on cost-benefit analysis.
• There is broad support for the organisation from patient groups and the pharmaceutical industry. Although many are critical of:
o Current working arrangements.
o The lack of transparency and clinical input to decision making.
o The difficulty of influencing NICE’s workplan and ensuring that timely decisions are made.
• PCTs have the difficult job of funding the consequences of NICE’s decisions. This needs good forward planning as existing services may need to be de-commissioned.
• Very often the opportunity costs associated with funding new treatments are not fully appreciated, and ‘soft’ services such as palliative care do not receive required investment.
• In time, a pan-European body, such as NICE, may be required to provide similar guidance across the EU.
2 NICE and the judicial review
NICE is no stranger to controversy and its decisions about clinical practice and whether new drugs should be prescribed by the NHS keeps the organisation in the headlines. Recent debates have raged on a number of topics, including the use of Herceptin and the treatment of obesity in children and adults.
Now for the first time, NICE’s guidelines will be subject to a judicial review - over the decision not to recommend drugs for patients with early Alzheimer’s.
What is the fuss about?
In 2005 NICE reviewed its original guidance on the drug treatments for patients with early Alzheimer’s disease, and stated that:
• Patients in the early stages of the disease should no longer be given donepezil (Aricept), galantamine (Reminyl) and rivastigmine (Exelon).
• Patients in the late stages of dementia should only be given memantine (Ebixa) as part of clinical trials.
These decisions were taken because ‘based on all the evidence, including data presented by the drug companies themselves, our experts have concluded that the drugs do not make enough of a difference for us to recommend their use for treating all stages of Alzheimer’s disease.’ (Andrew Dillon, Chief Executive NICE).
In October 2006 NICE announced that 5 separate appeals which had been lodged against the draft guidance had been rejected.
How many people are affected?
According to Help the Aged, 1 in 5 people over 80 are affected by dementia and the number of people living with the disease is set to double over the next 10 years. In the UK, approximately 750,000 people suffer from Alzheimer’s disease and c. 78,000 take donepezil, galantamine and rivastigmine.
How much do the drugs cost?
Campaigners argue that the drugs cost roughly £2.50 a day.
Who is requesting the judicial review?
The application for judicial review has been made by Eisai Ltd and its co-promotion partner Pfizer Ltd. Both companies produce donepezil which is prescribed to around two thirds of the 78,000 patients receiving the banned drugs.
3 NICE rejects other appeals
Although this is the first time NICE has been involved in a judicial review, the organisation has rejected other drugs at appeal. In January 2007 it rejected 2 appeals from Bowel Cancer UK, Cancerbackup, and Merck Pharmaceuticals over the use of Erbitux (cetuximab) for advanced bowel cancer.
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