12:00 AM
Aug 13, 2007
 |  BioCentury  |  Regulation

Totting up the arguments

Totting up the arguments

Plaintiff arguments NICE arguments Court discussion
Procedural Unfairness: While Eisai argued it had been unfairly denied materials, the court agreed with NICE that the company had been given all it was entitled to receive.
A party has a right to be told the basis of the "case against them." Fairness requires that the claimant see all thematerial that NICE sees. The NICE process is more than a simple consultation because it is a highly structured process that requires a high degree of fairness, transparency and involvement of parties in the decision-making process. Lack of access to NICE's fully executable model hampered Eisai in contesting the appropriateness of using a QALY-based model to assess cost-effectiveness and in challenging the model's assumptions, features and techniques The process is not judicial or quasi-judicial and thus it is inappropriate to speak of "the case against" Eisai. Eisai was not the subject of the NICE decision-making process but was one party among others with an interest in the outcome of the appraisal, which was carried out in the public interest. Because Eisai's interest was commercial and in the nature of a hope, not a right or expectation, it had no entitlement to all the material in front of the Appraisal Committee. Sufficient material was provided to enable Eisai to make an intelligent response. It is inappropriate for a body with a financial interest in the outcome to test the model

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