NICE says no to Alzheimer's appeal

The decision

From 22 November people in the early stages of Alzheimer's disease will be denied drugs that can stabilise their condition and give them a longer period of good quality life. At the same time those in the later stages of the disease will be denied access to drugs that can help; instead there is likely to be an increase in the inappropriate prescribing of powerful sedatives which we know cause harm and increase the risk of heart disease and stroke.

This is a bad decision for those who have Alzheimer's; those who will be diagnosed with the disease in the future; and for carers - who will bear much of the burden resulting from this decision.

Some of these drugs have been prescribed since 1997; they have been in frequent use since 2001. They are proven to work for a significant number of people and NICE agree with that. But they cost £2.50 a day per person. This decision looks like cost-cutting, which in the short term it might be, but the longer term consequence will be to increase the total cost of care.

Fortunately, those patients already being prescribed these drugs must continue to have them made available through the NHS.

The role NICE has played now comes to an end; they have provided their advice to the Department of Health. The Alzheimer's Society will be asking for some leadership from the Department so that this flawed advice does not damage the care and treatment of people with Alzheimer's disease.

What's wrong with the decision?

• Making people wait until their condition worsens before they can have access to effective drug treatment is cruel and unethical.
• Withdrawing access to anticholinesterase drug treatments in the mild stages of Alzheimer's disease is contrary to best practice in dementia care and to what people with dementia and their carers want.
• Withdrawing access to drugs in the mild stages discourages early diagnosis, which contradicts the recent positive work in this area (eg National service framework for older people, draft NICE clinical guideline)
• Ebixa can reduce behavioural symptoms such as aggression and agitation. This has not been given adequate weight in the NICE appraisal.
• The partial withdrawal of access to the four drug treatments for Alzheimer's contradicts the policy of the government to promote the independence and wellbeing of people in all stages of their lives.
• Relying on the MMSE test to decide who gets the drugs will discriminate against people based on their education and cultural background.

What is wrong with the appeal?

• We have no confidence in the appeal process. It is neither independent and appears to ignore sound evidence.
• The appeal panel has blatantly dismissed some key points. For example: we highlighted that the final appraisal decision (FAD) acknowledges the savings that the drugs make to carer's time. If carer time was costed at the minimum wage, an hour a day saved would represent twice the cost of the drugs. Rather than address this point they have simply removed the evidence from the FAD.
• The appeal panel have argued that this decision is only guidance and that clinicians have the right to continue prescribing using their clinical judgement. Given the huge pressure to reduce NHS spending, clinicians will not be given this freedom.
• NICE said that taking into account higher costs of full time care made no real difference - it actually improved cost effectiveness by around £10k, a significant saving.

What effects this will have?

• From the 22 November 2006 people in the early and late stages of Alzheimer's disease will be denied drugs that can stabilise their condition
• Carers will have to spend longer hours caring for people with dementia. This may lead to an increase in depression or physical problems for carers
• People in the late stages of Alzheimer's who have behavioural symptoms will be prescribed dangerous, unlicensed sedative drugs rather than Ebixa. Ebixa is more effective at reducing these symptoms and has none of the harmful side-effects.
• Early diagnosis may be discouraged. Memory Clinics will also be affected and people will find it harder to access a range of other support services for people with Alzheimer's disease.
• Psychiatrists will be put in the impossible position of having to tell patients that they have drugs that work but first they must get worse before they are able to receive them. This goes against best practice and a doctors duty to look to act in the best interests of his patient at all times.

Where do we go from here?

The Department of Health now have NICE's recommendation. But it is still only a recommendation. The Department of Health have the power to recommend that this guidance be noted but that clinicians should use their own judgement to prescribe dementia drugs on the NHS where they feel the patient will benefit.

After all, the NICE decision is one recommendation from a panel that contained no expert in dementia care. It contradicts the 8,000 responses from experts, professional bodies and patients that NICE received after it announced the decision to deny the drugs.

Would we consider a Judicial Review?

We hope not! Thousands of pounds of money and resources of experts all around the country have been wasted in the last 18 months as professionals all around the country have given evidence that shows this decision is the wrong one. We hope the Department of Health will step in to ensure that further resources aren't wasted on costly legal actions when funds could be being devoted to improving dementia care in the UK.

The option of pursuing a judicial review would only be considered as an absolute last resort.