Eisai Ltd is refusing to give up on its quest to overturn the National Institute for Health and Clinical Excellence’s ruling that only patients with moderate forms of Alzheimer’s disease get access to treatment on the National Health Service.

The UK arm of the Japanese drugmaker – which holds the licence to Aricept (donezepil), co-promoted with Pfizer - announced on Friday afternoon that it has applied for permission to appeal the recent High Court ruling on the process by which NICE reached its decision to ban anti-dementia medicines for NHS patients with newly diagnosed mild AD.

Eisai’s appeal focuses on the point of procedural fairness, based on NICE’s “repeated refusal to disclose a working version of the cost effectiveness model” used in calculating the value of treatment in patients with mild forms of the disease.

A spokesperson for Eisai told PharmaTimes that if the company is ultimately successful in its appeal, and NICE is ordered to provide a working version of its model, this will allow the group’s own health economists 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, the spokesperson explained, adding: “One would then presume that [the Institute] would reconsider its guidance.”

NICE rejection in 2005

NICE first ruled against the use of the acetyl cholinesterase inhibitors Aricept, Novartis’ Exelon (rivastigmine) and Shire’s Reminyl (galantamine) on the NHS in March 2005, acknowledging that they were clinically effective, but stating they could not be deemed cost effective.

Widespread public condemnation, however, lead to this decision being partly overturned in November 2006, allowing patients with moderate disease access to the drugs, but a subsequently unsuccessful appeal to extend this to patients with mild Alzheimer’s drove Eisai/Pfizer as the lead claimant to pursue the first-ever judicial review against a NICE decision, with support from the Alzheimer’s Society, which was acting as an interested party.

The four-day, landmark hearing in June marked the climax of an intense campaign involving around 11,000 objections, five appeals and nationwide protests against the decision, during which 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, although it found that NICE had breached its duties under the Disability Discrimination Act by not adequately clarifying its guidance for people with learning difficulties or language limitations.

“We are sad that we are having to take this further action,” commented Dr Paul Hooper, Managing Director of Eisai, adding: “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.”

Alzheimer’s Society bows out

Eisai’s appeal is being supported by Shire, which has confirmed that it will be acting as an interested party, but the Alzheimer’s Society has decided to bow out of the court battle. Its chief executive, Neil Hunt, explained: “We still believe that it makes no clinical, monetary or moral sense to deny people in the early stages of Alzheimer’s access to drugs but we do not plan to pursue our legal arguments further in the courts. Instead, we look to the government, in its review of NICE, to eradicate the glaring flaws in NICE’s process that have lead to this unacceptable position.”

“Caring for a person with dementia is an exhausting and difficult job, and unpaid carers save the UK £6 billion every year. It is only right that the impact treatment can have on a carer’s quality of life as well as that of the person with dementia is properly calculated,” he added.

Eisai hope to get a decision on its bit to appeal within the next couple of months, the spokesperson told PharmaTimes.