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Alzheimer's drugs appeal victory Alzheimer's drugs appeal victory
(10 minutes later)
The Appeal Court has ruled an NHS advisory body should have been more transparent in the way it made decisions over Alzheimer's drug. 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.
Thhree 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.
Today's decision is a damning indictment of the fundamentally flawed process used by NICE Neil Hunt, Alzheimer's Society
NHS advisers, the National Institute for Health and Clinical Excellence (NICE), had said the drugs are not cost effective in early disease.NHS advisers, the National Institute for Health and Clinical Excellence (NICE), had said the drugs are not cost effective in early disease.
That decision was upheld by the High Court earlier last year.That decision was upheld by the High Court earlier last year.
But Eisai said nearly 100,000 patients a year with early-stage disease would be refused the medication if the restrictions remained.But Eisai said nearly 100,000 patients a year with early-stage disease would be refused the medication if the restrictions remained.
The company brought the case to the High Court with support from fellow drugs firms Pfizer and Shire, which manufactures other drugs affected by the NHS ruling, and the Alzheimer's Society.The company brought the case to the High Court with support from fellow drugs firms Pfizer and Shire, which manufactures other drugs affected by the NHS ruling, and the Alzheimer's Society.
EvidenceEvidence
The legal debate is about whether NICE followed a fair and transparent process in reaching its decision. Neil Hunt, chief executive of the Alzheimer's Society welcomed the ruling.
David Pannick QC, representing pharmaceutical company Eisai, told a panel of three appeal judge during the hearing that the latest guidance ruling by NICE will have "a very substantial effect upon the availability and the potential duration of treatment" with the drugs. He said: "Today's decision is a damning indictment of the fundamentally flawed process used by NICE to deny people with Alzheimer's disease access to drug treatments."
He said: "The evidence suggest that, when the guidance takes full effect annually 96,600 patients with mild Alzheimer's disease will be refused treatment." He urged NICE to review its ruling on the drugs to make them more widely available.
"Time and quality of life has been snatched away from thousands of vulnerable people who learned they have this devastating disease this year."
The legal debate centred on whether NICE followed a fair and transparent process in reaching its decision.
After the ruling, 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."
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.