Pharma Industry News
Eisai Confirms Application for Judicial Review of NICE
January 6, 2007
Eisai's European subsidiary Eisai Limited formally applied to the High Court for permission to request a Judicial Review of the process by which the National Institute for Health and Clinical Excellence (NICE) reached its decision to ban anti-dementia medicines for NHS patients with newly diagnosed mild Alzheimer's disease. The following press release was distributed in the United Kingdom by Eisai Limited and Pfizer Limited, its co-promotion partner, on January 5, 2007 (the local time in U.K.).
NICE subject to potential Judicial Review following unfair and irrational decision on treatments for Alzheimer's
LONDON, Jan. 5, 2007-Eisai Limited, the licence
holder of Aricept®(donepezil hydrochloride) and Pfizer Limited,
its co-promotion partner, confirmed today that Eisai has formally
applied to the High Court for permission to request a Judicial
Review of the process by which the National Institute for Health
and Clinical Excellence (NICE) reached its decision to ban anti
dementia medicines for NHS patients with newly diagnosed mild
Alzheimer's disease.
Before making its application for Judicial Review, Eisai wrote to NICE on 14 November 2006, calling on NICE to withdraw its Final Appraisal Document (FAD) and postpone issuing new guidance on 22 November, to disclose a fully transparent working version of the model used in the calculation of cost effectiveness and develop a new FAD using rational clinical assumptions and also to prevent discrimination against certain vulnerable groups of patients.
NICE responded to this letter, refusing to make any changes to the FAD or to disclose the requested model, and published its guidance on 22 November. As a result Eisai, fully supported by Pfizer, has now formally applied for permission to proceed to Judicial Review on the following three grounds:
Before making its application for Judicial Review, Eisai wrote to NICE on 14 November 2006, calling on NICE to withdraw its Final Appraisal Document (FAD) and postpone issuing new guidance on 22 November, to disclose a fully transparent working version of the model used in the calculation of cost effectiveness and develop a new FAD using rational clinical assumptions and also to prevent discrimination against certain vulnerable groups of patients.
NICE responded to this letter, refusing to make any changes to the FAD or to disclose the requested model, and published its guidance on 22 November. As a result Eisai, fully supported by Pfizer, has now formally applied for permission to proceed to Judicial Review on the following three grounds:
- Procedural: since NICE has repeatedly refused to
disclose a fully working version of the cost effectiveness model
used to determine the value of treatment in patients with mild
Alzheimer's disease, the process leading to the FAD and the new
treatment guidance breached the principles of procedural
fairness
- Irrationality: some of the assumptions made or
conclusions drawn in the FAD are irrational or cannot be
supported
- Human Rights/Discrimination: the use of MMSE (mini mental state examination) scores as a rigid diagnostic tool discriminates against certain patient groups
Background
| January 2001 | NICE approved the use of these medicines
(donepezil, rivastigmine and galantamine) for treatment of mild
Alzheimer's disease for use by the NHS. |
| March 2005 | NICE first proposed banning NHS prescription of
the medicines to newly diagnosed Alzheimer's patients. |
| July 2005 | NICE postponed ratifying the ban but instead
asked the manufacturers to supply extra data showing which patients
responded best to the medication. |
| December 2005 | NICE considered the data supplied by the
manufacturers. |
| 23 January 2006 | NICE proposed that moderate AD be treated on the
NHS, but not mild. Moderate is being defined as starting at 20 on
the MMSE scale. A consultation period followed this
announcement. |
| 26 June 2006 | NICE announced that despite the views of patients
and doctors, it planned to stick to its ban on using the treatments
for mild AD. |
| 13/14 July 2006 | Eisai and Pfizer appealed this decision, along
with other manufacturers and organisations including the
Alzheimer's Society and the Royal College of Psychiatrists. |
| 11 October 2006 | NICE announced that all grounds of appeal from
all parties had been dismissed. |
| 14 November 2006 | Eisai and Pfizer called on NICE to:
|
| 22 November 2006 | NICE issued new Guidance banning the use of
medicines for NHS patients with newly diagnosed mild Alzheimer's
disease. |
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