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Alzheimer's drugs appeal victory | Alzheimer's drugs appeal victory |
(about 3 hours later) | |
The Appeal Court has ruled an NHS advisory body should have been more transparent in the way it made decisions over Alzheimer's drugs. | The Appeal Court has ruled an NHS advisory body should have been more transparent in the way it made decisions over Alzheimer's drugs. |
Eisai, which makes Aricept, had challenged the process by which it and similar medicines were restricted to people with late stage disease. | Eisai, which makes Aricept, had challenged the process by which it and similar medicines were restricted to people with late stage disease. |
Three judges said the advisory body should have released details of how it reached its decision. | Three judges said the advisory body should have released details of how it reached its decision. |
However, the ruling does not mean the drugs will be more widely available. | However, the ruling does not mean the drugs will be more widely available. |
We hope that this action will ultimately restore access to anti-dementia medicines for those patients at the mild stages of Alzheimer's disease Nick Burgin, Eisai | |
The National Institute for Health and Clinical Excellence (NICE), had ruled the drugs were not cost-effective in early disease. | |
But Eisai claimed it should have been able to see the detail of how that decision was reached, saying almost 100,000 patients a year with early-stage disease were being denied access to the medication. | |
In the Appeal Court ruling, Lord Justice Richards said withholding information put drugs companies at "a significant disadvantage" if they wanted to challenge a NICE ruling. | |
Eisai will now be able to assess NICE's cost-benefit analysis. | |
Its comments will have to be considered by the drugs body, which may then have to review its decision. | |
Other drug appraisals are also likely to be affected. | |
Access | |
Nick Burgin, managing director of Eisai, said: "We believe that this decision represents a victory for common sense. | |
"We hope that this action will ultimately restore access to anti-dementia medicines for those patients at the mild stages of Alzheimer's disease." | |
The ruling will increase the complexity of our drug appraisals in some cases Andrew Dillon, NICE | |
The company brought its case with support from fellow drugs firms Pfizer and Shire, which manufacture other drugs affected by the NHS ruling, and the Alzheimer's Society. | |
John Young, Pfizer's managing director, said: "Contrary to NICE's position that they follow a fully fair and transparent process, the Court of Appeal found that this is not the case. | |
"The failure to disclose these fundamentally important calculations has impaired the ability of stakeholders to engage fully in the appraisal process." | |
The Association of the British Pharmaceutical Industry (ABPI) said the Appeal Court's decision would allow greater scrutiny of how NICE worked. | |
'Longer appraisals' | |
Neil Hunt, chief executive of the Alzheimer's Society said the decision was a damning indictment of the "fundamentally flawed process" used by NICE. | |
He urged it to review its ruling on the drugs and make them more widely available. | |
Andrew Dillon, chief executive of NICE, said: "We will be considering very carefully the findings and the implications for the time it takes us to provide advice to patients and the NHS on the use of new treatments. | |
"The ruling will increase the complexity of our drug appraisals in some cases and they may take longer as a result." | "The ruling will increase the complexity of our drug appraisals in some cases and they may take longer as a result." |
NICE guidance in 2001 recommended the drugs - which can make it easier to carry out everyday tasks - should be used as standard. | NICE guidance in 2001 recommended the drugs - which can make it easier to carry out everyday tasks - should be used as standard. |
But advice published in November 2006, stated that the drugs should only be prescribed to people with moderate-stage disease. | But advice published in November 2006, stated that the drugs should only be prescribed to people with moderate-stage disease. |
NICE said the drugs, which cost about £2.50 a day, did not make enough of a difference to recommend them for all patients and were not good value for money. | NICE said the drugs, which cost about £2.50 a day, did not make enough of a difference to recommend them for all patients and were not good value for money. |