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Eisai Announce Application to Appeal NICE Judicial Review Verdict
London (ots/PRNewswire) - Eisai Limited, the licence holder of Aricept(R) (donepezil hydrochloride) and Pfizer Limited, its co-promotion partner, announced today that Eisai has applied to the Court of Appeal for permission to appeal the recent High Court ruling on 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.
Eisai has lodged an application to appeal on the point of procedural fairness based on NICE's repeated refusal to disclose a working version of the cost effectiveness model they used to determine the value of treatment in patients with mild Alzheimer's disease.
Dr Paul Hooper, Managing Director of Eisai Limited said: "We are sad that we are having to take this further action. We maintain our belief that NICE should be required to be fully transparent in the way in which they reach their decisions surrounding the cost effectiveness of medicines."
Notes to Editors
Earlier this year the High Court granted permission to proceed to a Judicial Review on three grounds:
- Procedural: since NICE had 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 Final Appraisal Determination (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
- Discrimination: the use of MMSE (Mini Mental State Examination) scores as a rigid diagnostic tool discriminates against certain patient groups
January 2001 NICE approved the use of these medicines by
the NHS (donepezil, rivastigmine and
galantamine) for the treatment of mild and
moderate Alzheimer's disease.
March 2005 NICE first proposed banning NHS prescription
of the medicines to newly diagnosed
July 2005 NICE postponed ratifying the ban but instead
asked the manufacturers to supply extra data
showing which patients responded best to the
December 2005 NICE considered the data supplied by the
23 January 2006 NICE proposed that moderate AD be treated on
the NHS, but not mild. Moderate was defined
as starting at 20 on the MMSE scale. A
consultation period followed this
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
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:
- withdraw the current FAD and postpone
issuing the new guidance
- disclose a fully transparent working
version of the calculations used in the
cost-effectiveness model for independent
evaluation and comment
- develop a new FAD using both a more
accurate cost-effectiveness model and data.
22 November 2006 NICE issued new Guidance banning the use of
medicines for NHS patients with newly
diagnosed mild Alzheimer's disease.
05 January 2007 Eisai and Pfizer confirmed Eisai's
application for Judicial Review submission.
23 March 2007 Following consideration of documents lodged,
the High Court grants permission to proceed
to judicial review on all grounds (procedural
fairness, irrationality and discrimination).
25 June 2007 Judicial Review hearing commences at High
10 August 2007 High Court upholds claim of discrimination.
28 September 2007 Eisai and Pfizer announce Eisai's application
to the Court of Appeal on the ground of
ots Originaltext: Eisai Europe Limited
Im Internet recherchierbar: http://www.presseportal.ch
For further information contact: Andrew Day, Eisai Europe Corporate
Affairs Department, +44-(0)208-600-1400, Andrew_Day@Eisai.net