Eisai and partner Pfizer were yesterday effectively given a green light to continue their fight to overturn the National Institute for Health and Clinical Excellence’s decision to bar patients with newly-diagnosed, mild Alzheimer’s disease access to anti-dementia drugs on the National Health Service.

Specifically, the UK arm of the Japanese drugmaker – licence holder for Aricept (donezepil), which is co-promoted with Pfizer - has been given permission to appeal the recent High Court ruling on the process by which NICE reached its guidance.

The appeal focuses on the point of procedural fairness, based on NICE’s refusal to disclose a working version of the cost-effectiveness model it used to calculate the value of treatment in patients with mild forms of the disease.

“We are delighted that the court has granted us permission to appeal the decision of the High Court which supported NICE’s lack of transparency over the way that cost effectiveness has been calculated,” commented Paul Hooper, Executive Vice President of Eisai Europe Ltd. “It is disgraceful that NICE can restrict medicines used to treat a most vulnerable group of patients based upon secret calculations,” he added.

The story so far
NICE first ruled against the use of the acetyl cholinesterase inhibitors Aricept, Novartis’ Exelon (rivastigmine) and Shire’s Reminyl (galantamine) in March 2005, on grounds that they were not a cost effective use of NHS resources.

Widespread outcry, however, resulted in a partial overturn of the decision in November 2006, with NICE allowing patients with moderate-severe disease access to the drugs. A subsequent appeal to extend this to patients with mild disease was unsuccessful, spurring the first ever judicial review of NICE guidance with Eisai/Pfizer as the lead claimant.

During the four-day, landmark hearing in June, it was argued that NICE had “drastically underestimated costs of care” and had “overlooked carer benefits” when drawing up its cost-effectiveness decision for Aricept, Exelon and Reminyl. But, in August, the court sided with the Institute in five out of the six grounds listed in the case, leaving Eisai the only option of applying for permission to appeal.

In-house analysis
If the company is ultimately successful in its appeal in that NICE is ordered to provide a working version of its model, the group’s own health economists will then be able to analyse the assumptions made in the model.

“If, as many people believe, we find the working model is flawed and the cost per QALY [quality adjusted life year] calculated is inaccurate, we can go back to NICE” and point out the mistakes. One would then presume that [the Institute] would reconsider its guidance,” an Eisai spokesperson told PharmaTimes UK news back in September.