NICE result for Eisai

The Court of Appeal has overturned in part some guidance of the National Institute for Clinical Excellence (NICE) on the grounds of procedural unfairness. In doing so, it rejected NICE's argument that the executable version of a computer program used by NICE in its consultation process could not be released to consultees because it was confidential.

Background

NICE reviews the clinical benefits and cost-effectiveness of medicines referred to it by the Secretary of State. It then makes recommendations as to whether or not such medicines should be used in the National Health Service (NHS).

In 2006, NICE issued new guidelines that certain medicines (AChEIs) for the treatment of Alzheimer's disease (AD) were not recommended for mild AD although they would continue to be recommended for moderately severe AD. Eisai, the claimant in the proceedings, is the owner of the marketing authorisation for an AChEI sold as Aricept.

NICE's guidance that ACEIs are not cost-effective for mild AD was based mainly on an economic model in the form of an Excel spreadsheet. The spreadsheet was created by Southampton University for the purposes of the NICE consultation under an agreement with the Secretary of State. During the course of the NICE consultation process, NICE provided a read-only version of the spreadsheet to Eisai but not a fully executable version i.e., one where changes can be made to inputs and assumptions.

Eisai's complaint was that it was not able to test the reliability of the model and therefore NICE's procedure was unfair.

In response, NICE argued that:

1. it was prevented from disclosing the executable version to Eisai because of an obligation of confidence owed to Southampton University;
2. Eisai had access to enough information in the read-only version to make representations on the assumptions behind it; and
3. disclosure of the executable version was not proportionate as it would lead to an increased workload for NICE and a delay of two to three months in the consultation process.

Outcome

The Court of Appeal held that the reliability of the model was important. Although the read-only model did give Eisai access to certain information underlying the model, it could not check the model's reliability. The principle of procedural fairness means that Eisai should have the opportunity to check the reliability of the model and make informed representations on it.

The Court of Appeal dismissed NICE's confidentiality arguments. The Agreement provided that the model could and should be published and the only obligation of confidence on the Secretary of State was in respect of Southampton University's business and affairs. There was no express obligation in respect of the model and the Court would not imply one. Indeed, the court commented that it would be surprising if a model that was paid for by the Secretary of State and supplied for the purposes of a NICE consultation could not be provided in executable form to consultees. In addition, NICE had previously supplied other executable models to consultees ( under obligations of confidence that Eisai would have agreed to) and NICE's claim that Eisai had all the relevant information in the read-only version led to the conclusion that there could not be a valid objection on the basis of confidentiality to the provision of the executable version.

As to any delay caused by providing the executable version, the evidence was conflicting and in any event two to three months in the context of a consultation that had taken two and a half years was proportionate.

Eisai's claim to be provided with a copy of the executable version of the model was therefore granted. Eisai did not seek for the existing guidance to be quashed but just that it could make representations on the basis of the executable version which NICE would take into account and it could appeal again if NICE made a finding that was adverse to Eisai.

Comment

The need for pharmaceutical companies to demonstrate economic value in respect of their medicines (termed the "Fourth Hurdle"; quality, safety and efficacy being the other three) is increasing. The fact that this judicial review of NICE has gone to the Court of Appeal shows the importance (both in terms of access to treatment for patients and sales of medicines) that is placed on the guidance that it issues.

As to the confidentiality arguments, this is yet another example that if you are on the receiving end of a claim that certain information is confidential, it is always worth fully testing the legal basis for such a claim and, if indeed there is a legal basis, whether the particular information in question is caught.