NICE Review

In November 2009, the High Court in R (On the application of Bristol-Myers Squibb Pharmaceuticals Ltd) v National Institute for Health & Clinical Excellence, rejected the application of Bristol Myers Squibb (BMS), for judicial review of NICE's refusal in April 2008 to recommend abatacept as a treatment option for patients suffering from rheumatoid arthritis.

Article 6 of Council Directive 89/105/EEC ("Transparency Directive") requires Member States to disclose and to the Commission and apply its criteria used to decide whether to include or exclude products from national health insurance systems.

In its submission to NICE, BMS provided a on the cost effectiveness model on the treatment but this model was amended by NICE which ultimately decided following appraisal that it would not be cost-effective BMS applied to have the decision judicially reviewed. In addition to alleging that NICE had breached the requirements of the Transparency Directive, BMS argued that it should have had the opportunity to make representations on the amended model. NICE argued were it to have to disclose the model to BMS, it have meant disclosing competitors' commercially-sensitive information.

The High Court decided that NICE had fulfilled the requirements of the Transparency Directive in relation to the prior disclosure inclusion/exclusion criteria had been met by NICE. NICE's duty to act fairly did not necessarily require disclosure of the model used.

Comment - NICE's guidance has been challenged before the courts on a number of occasions recently but this case serves to reiterate the difficulties in doing so. Whilst on some occasions there has been criticism as to whether the procedures and the weight given to evidence within the appraisal process had been done in an irrational or unfair manner the courts have not ordered NICE to reconsider its substantive decision or guidance basic underlying guidance on whether or not a particular drug should be made available on the NHS.