NICE defies pressure and keeps restrictions on Alzheimer’s
pharmafile | June 15, 2009 | News story | Research and Development | Alzheimer's, NICE
Patients with early stage Alzheimer's disease will still be denied access to drug treatment after NICE decided to retain its existing guidance.
NICE had been forced to review its guidance after pharmaceutical companies won a legal battle over its Alzheimer's guidance in May 2008.
Eisai and Pfizer, which market drug treatment Aricept won their case at the Appeal Court, forcing NICE to release a full version of its formerly confidential economic model, and allow stakeholders to make further submissions based on the new information.
But despite the calls for NICE to include other economic factors in its costing, the newly published and amended Final Appraisal Determination (FAD) remains unchanged.
Andrew Dillon, NICE chief executive said: "We have complied with the Court of Appeal's ruling to release the executable version of the economic model used in this appraisal for consultation and to consider the comments made by consultees. Although these comments resulted in minor changes to the model, our Independent Advisory Committee concluded that these were not enough to make these treatments a cost-effective use of NHS resources in the mild stages of the disease."
Neil Hunt, chief executive of the Alzheimer's Society, said: "Alzheimer's Society has long campaigned for the thousands of people in the early stages of dementia to be given access to the effective treatments that they are currently denied because of cost. It is completely unacceptable to deny people with dementia the only treatments that could improve quality of life for them and their carers.
"We are extremely disappointed to see that the NICE guidance is essentially unchanged, despite what we feel are fundamental flaws in the economic model they have used to inform their recommendations. The glimmer of hope is that NICE has finally committed to a full review to address these concerns, as soon as possible. This will be little consolation for the thousands of people who will develop Alzheimer's disease this year but provides hope for the future that this incomprehensible decision will be changed.
"We look forward to working with NICE to ensure the problems with the current economic model are overcome and people with dementia are given a fair deal."
In a press statement Eisai and Pfizer said they were 'frustrated' that patients with mild Alzheimer's would still not receive the drugs. The companies say the new model submitted to the Appraisal Committee incorporated the latest techniques for determining cost effectiveness in Alzheimer's disease and shows a cost saving to the NHS and society by treating mild Alzheimer's disease patients.
They say NICE acknowledged the model and its implications but chose not to incorporate them into its guidance.
The companies said: "Serious concerns remain about the quality of the economic models developed by NICE and their own quality assurance processes. That NICE sought to keep these calculations from independent scrutiny fails to serve well either themselves or the integrity of the decision-making process."
The companies and other stakeholders have the chance to work with NICE in the an entirely new review of the evidence which is expected to be launched in the near future. Eisai and Pfizer have called on NICE to start this process as a matter of urgency and conduct an expedited review.
As part of the review process, Eisai commissioned United BioSource Corporation (UBC) to conduct an independent assessment of the NICE model. The UBC team was lead by Professor Jamie Caro, who developed the original 'AHEAD' economic model, which was modified by NICE for use in this appraisal. The UBC team concluded that NICE had made a series of serious incorrect assumptions in their economic modelling.
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