Eisai, NICE Claim Victory in Alzheimer’s Drug Legal Challenge

Both Eisai and the UK’s National Institute for Health and Clinical Excellence (NICE) are claiming a legal victory in a lawsuit challenging how the institute handled a cost-effectiveness determination for the company’s Alzheimer’s disease treatment Aricept.

“This is the first time that NICE has been challenged in the courts, and marks a major victory for the many critics of the process by which NICE reaches its often seemingly clinically perverse decisions,” Eisai and marketing partner Pfizer said.

Eisai brought the challenge after NICE issued guidance in November 2006 to the UK’s National Health Service that Aricept (donepezil HCl), Shire’s Reminyl XR (galantamine hydrobromide) and Novartis’ Exelon (rivastigmine tartrate) should be used to treat moderate Alzheimer’s disease only, and that administration of the products should be halted if a patient’s score on the Mini Mental State Examination (MMSE) falls below 10 points.

National Health Service guidance recommends that patients should score 12 points or more out of a maximum of 30 points to be considered for treatment with the drugs, according to the UK-based charity Alzheimer’s Society, also a party to the case.

Justice Linda Dobbs of the High Court of Justice of England and Wales ruled Aug. 8 that NICE’s recommendations that patients be assessed with the MMSE test violated the UK’s Disability Discrimination Act, because it does not take into account factors such as English language skills and learning disabilities, for example, Down’s syndrome, NICE said.

“Reliance on the MMSE test as a measure of [Alzheimer’s disease] severity is unreasonable, and that failure to make specific reference to, and exceptions for, atypical groups is discriminatory,” Dobbs said in the ruling.

However, during judicial proceedings Aug. 9, Dobbs ruled that the institute did not have to start the entire appraisal process over again. Adding a paragraph to the guidance document would suffice, she said. The institute has 28 days to comply, NICE said.

The issue revolving around MMSE tests was the only aspect of the case in which the judge ruled in favor of the companies, the institute said. “We were challenged on six grounds, and the court found in our favor on five of them. This ruling strengthens NICE by endorsing our approach to evaluating drugs.”

Those grounds include findings that NICE appropriately took into consideration the benefits of the drugs and appropriately reflected the costs of long-term care in its calculations, the institute said.

According to the institute, the judge also ruled that NICE was not irrational in concluding there is no cumulative benefit to patients after six months of treatment, or in its assessment and consideration of the specific study used in the analysis.

One aspect of the case involved Eisai’s claim that it should have been granted full and complete access to the cost-effectiveness model used by NICE. The institute only provided the company with a “read-only” version of the model. The judge, however, disagreed with Eisai.

While “highlighting its inability to run the model and thereby test its robustness and accuracy, Eisai was nevertheless still able to advise on the need to check the accuracy of figures and to run sensitivity analyses with the different assumptions,” Dobbs said. “What was not possible was to ‘run or play with the system’ to see how it would react to different data and assumptions.”

In response to that aspect of the ruling, Paul Hooper, managing director of Eisai, said, “We remain disappointed that NICE has not been required to reveal details of the calculations used to determine the value of treatment in patients with mild Alzheimer’s disease. We will continue to pursue access to these calculations through the courts and Information Commissioner’s Office.”

NICE said that the judge did not grant Eisai the right to appeal the court’s decision. — Christopher Hollis