NICE Alzheimer's Treatment Decision Subject to Judicial Review
High Court judgement clears the
way for landmark legal challenge
LONDON, March 27, 2007 - Eisai Limited, the
licence holder of Aricept® (donepezil hydrochloride), announced
today that the High Court has granted permission to proceed to a
Judicial Review challenging 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, with the full support and backing of Pfizer Limited, its co-promotion partner, applied for permission to proceed to Judicial Review on the following three grounds:
Mr John Young, Managing Director of Pfizer Limited, said: “We accept that NICE has an important role to play on behalf of the NHS and our issue is not what NICE do, but how it has reached this decision.”
Eisai, with the full support and backing of Pfizer Limited, its co-promotion partner, 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 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
- Human Rights/Discrimination: the use of MMSE (Mini Mental State Examination) scores as a rigid diagnostic tool discriminates against certain patient groups
Mr John Young, Managing Director of Pfizer Limited, said: “We accept that NICE has an important role to play on behalf of the NHS and our issue is not what NICE do, but how it has reached this decision.”
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. |
| 05 January 2007 | Eisai and Pfizer confirmed Eisai's application
for Judicial Review submission, fully supported by Pfizer. |
| 23 March 2007 | Following consideration of documents lodged, the
High Court grants permission to proceed to judicial review on all
grounds (procedural, irrationality and human
rights/discrimination.) |
Posted: March 2007
