UK High Court rejects judicial review of NICE’s abatacept refusal

15 December 2009

Ewan Grist

In April 2008, NICE refused to recommend abatacept as a treatment option for patients suffering from rheumatoid arthritis. Bristol Myers Squibb (BMS), as manufacturer of abatacept, sought judicial review of this guidance but on 6 November 2009, the High Court rejected its application[1].

In its original submissions to NICE, BMS provided a model setting out a ratio figure based on the cost effectiveness of abatacept, which was then reviewed by an independent review group appointed by NICE under its appraisal process. BMS’ model was amended by the group to produce a higher ratio figure. After an appraisal committee produced a consultation document, NICE considered the differences between the models and concluded that the drug would not be cost-effective. Article 6 of Directive 89/105 requires Member States to communicate to the European Commission the criteria used to decide whether to include medical products on a list for use in their national health insurance systems or to exclude them from such systems. NICE complied with this obligation by notifying six criteria to the Commission. The fifth provided that a product could be excluded where its expected cost could not be justified.

Following NICE’s final recommendation that abatacept be excluded from approved NHS list, BMS applied to have the decision judicially reviewed. In addition to alleging that NICE had breached the requirements of the Directive, BMS argued in particular that it was unfair for NICE to make an appraisal of abatacept based upon the review group's amended model without first giving BMS the opportunity to make representations on those amendments. NICE argued that if it was required to disclose the model to BMS, it would also have to disclose it to BMS' competitors despite the fact it contained commercially-sensitive information.

The High Court (Blake J) considered that NICE's guidance on its appraisal processes was publicly available and well-known. It held that the requirements of the Directive to notify the Commission of the inclusion/exclusion criteria had been met by NICE. If, by applying a more detailed analysis of cost-effectiveness, NICE decided that abatacept was not cost-effective to justify its inclusion for being supplied on NHS prescription, then this was in compliance with the inclusion/exclusion criteria already notified to the Commission. NICE was under a duty to act fairly to BMS before issuing guidance about the cost-effectiveness of abatacept but fairness did not necessarily require disclosure of the model used. BMS had been able to make informed and effective representations without having access to the version of its model that the review group might have used.

This decision from the High Court again shows the difficulties that stakeholders face in attempting to have the final guidance of NICE overturned by recourse to judicial review proceedings. NICE’s guidance has been challenged before the courts on a number of occasions recently[2] but, to date, whilst criticising certain procedural aspects of NICE’s appraisal processes (in particular in relation to the degree of disclosure as to the economic models used), the Court has not ordered NICE to reconsider its basic underlying guidance on whether or not a particular drug should be made available on the NHS. It is not for the court to decide whether NICE had reached the correct decision but merely whether the procedures and evidential evaluation carried out during its appraisal process had been done in an irrational or unfair manner. As such, the threshold that must be met by applicants to achieve anything other than a pyrrhic victory against NICE’s decisions remains very high.

[1] R (On the application of Bristol-Myers Squibb Pharmaceuticals Ltd) v National Institute For Health & Clinical Excellence [2009] EWHC 2722 (Admin)

[2] Eisai v NICE [2008] EWCA Civ 438, Fraser & Short v NICE [2009] EWHC 452 and Servier v NICE [2009] EWHC 281