- For Print
- May 9, 2008
Eisai Limited (Headquarters: London, Managing Director: Nick Burgin), a UK subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) gained a positive ruling from the UK Court of Appeal, as reported on May 1, 2008 with our Press Release No. 08-26, in the appeal case against National Institute for Health and Clinical Excellence (NICE). The decision today will now be reflected in a Court order.
The Court has decided that
- NICE must make available to all consultees, within 14 days of the end of the period for appealing to the House of Lords, a copy of the fully executable version (FEV) of the cost-effectiveness model used to produce guidance for the treatment of patients with Alzheimer's
- Eisai and other consultees have a period of 42 days from receipt of the FEV in which to review the model and make representations to NICE
- NICE is to pay 60% of Eisai's costs resulting from the original Judicial Review
- NICE is to pay the costs of Eisai's appeal
- NICE has been refused permission to appeal to the House of Lords
We believe this now brings the prospect of restored access to anti-dementia medicines for those patients at the mild stages of Alzheimer's disease one stage closer.
Should Eisai find that the calculations relied on by NICE to determine the cost-efficacy of anti-dementia medicines in mild Alzheimer's to contain errors or to be unreliable, they will submit their findings to the NICE Appraisal Committee who will be required to review their recommendations in light of any such fresh evidence.
Eisai remains fully committed to working with NICE to ensure that all patients in the UK with mild to moderate Alzheimer's disease will have access to these medicines.
< Reference >
For your reference, our Press Release No.08-26 is enclosed.
No. 08-26
May 1, 2008
Eisai Co., Ltd.
Eisai Gained Favourable Ruling by Court of Appeal, as NICE Process for Developing Guidance on Anti-dementia Medicines Ruled Unfair
Eisai Limited (Headquarters: London, Managing Director: Nick Burgin), a UK subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) gained a positive ruling on May 1, 2008 (the UK time) from the UK Court of Appeal which found that the process by which the National Institute for Health and Clinical Excellence (NICE) made the current guidance which restrict anti-dementia medicines for newly diagnosed patients with mild Alzheimer's disease breached the principle of procedural fairness.
NICE's current guidance in effect bans the use of anti-dementia medicines for patients with mild Alzheimer's disease. The Court stated that procedural fairness required NICE to release a fully executable version of the cost effectiveness model it used to produce guidance for the treatment of patients with Alzheimer's. The Court also found that refusal by NICE to release the model put consultees at significant disadvantage in challenging its reliability.
When the model is released to Eisai it will be able to review NICE's cost effectiveness calculations and submit any new findings to NICE. Eisai is fully committed to working with NICE to ensure all patients in the UK with mild to moderate Alzheimer's disease will have access to these medicines.