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Limited access to Alzheimer's drugs leaves patients groups dissatisfied

Published on 25/01/06 at 11:58am

Patient groups have expressed disappointment at NICE plans to allow only some patients with Alzheimer's disease to have drug treatment, with those suffering either early stages of the disease or the advanced condition denied the medicines.

The new ruling partially reverses a decision made in March 2005 to bar any use of the cholinesterase inhibitor drugs (such as Eisai/Pfizer's Aricept) on the NHS, but patient groups, doctors and pharma companies remain critical of NICE's decision-making.

NICE has ruled that evidence now suggests that the cholinesterase inhibitors are only cost-effective in treating patients with the moderate form (the middle stage) of the degenerative disease.

Dr Paul Hooper, managing director of Eisai said: "Naturally we welcome the decision by NICE to allow patients with moderate Alzheimer's disease to receive treatment. But it is worrying that patients in the early stages of the illness are to be excluded.

"In every other branch of medicine, the emphasis is on finding and treating early before the illness progresses, he added. "Yet NICE proposes a different medical approach with dementia. It makes no clinical sense."

The Action on Alzheimer's Drugs alliance represents over thirty charitable and professional organisations and was formed in protest at NICE's original decision.  

Dr David Wilkinson, a leading old age psychiatrist, and member of the alliance said the new guidance still had 'serious flaws'.

"If approved, professionals will be in the impossible situation of withholding beneficial treatments from people with dementia because they are not ill enough. Drug treatments that work must be available to those who need them, and clinicians should be able to use their professional judgment to decide when to prescribe them," he said.

He added that experts in the field have spent many years promoting the importance of early diagnosis of the disease, but said this draft decision would have a detrimental impact on diagnosis and care if it remained unchanged.

Campaigners now hope that enough can be done in the three week consultation period to persuade NICE to change its mind on providing treatment in the early stages of the disease.

Ebixa and treating severe Alzheimer's disease

Meanwhile, NICE is recommending no use of Lundbeck's Ebixa (memantine) on the NHS, the only treatment currently licensed to treat patients with severe Alzheimer's.

NICE ruled nearly a year ago that the drug should not be used at all on the NHS, citing a lack of clinical or cost effectiveness data, and has left this decision unchanged.

Patient group The Alzheimer's Society said combined with the ruling not to treat mild Alzheimer's, the decisions were a 'double blow' for patients and carers.

Ebixa is a moderate affinity NMDA (N-methyl-D-aspartate) receptor antagonist and works differently to the other available treatments.

The drug works by modulating the effect of abnormal levels of a chemical messenger called glutamate seen in Alzheimer's patients.

James Cooper, Lundbeck's Head of Neurodegenerative Disease Clinical Research in the UK said the company would use the consultation period to show NICE the significance of the data presented to them.

"We think there is a lack of clarity for NICE about the drug's mode of action. What we aim to do is to underline the data in front of them and to its clinical relevance."

He said because the drug was different to the cholinesterase inhibitor class, its data had different scales and parameters, which Lundbeck needed to make meaningful to NICE.

Morten Kold Mikkelsen, managing director, Lundbeck UK said: "NICE is proposing to leave advanced Alzheimer's disease patients and their carers without any treatment options at all, at the critical point where the patient is losing autonomy and the burden on the carer is increasing. In Alzheimer's disease, the significant benefits of Ebixa to the patient, and in particular to patients with behavioural disturbances, result in an average of one week's respite per month for carers."

He indicated that the decision was inequitable and against the prevailing principle of choice in the NHS.

"At a time when patients are offered choice in all areas of healthcare, it is inconsistent that one drug class may be provided free by the NHS where the other effective class will only be available to patients who pay for it."

NICE said Ebixa should only be given to patients in a clinical trial setting. Lundbeck is currently running a clinical study in UK (and France, Germany, Switzerland) looking at patient response to treatment over one year.

The NICE decision comes just weeks after Ebixa was granted an EU-wide licence to extend its use into patients with moderate Alzheimer's disease.

Lundbeck says the time scope of the NICE appraisal meant it was unable to submit this new data for the cost and clinical effectiveness review, with no further data available to support its case.

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