Released 12 November 2009

NICE backed by High Court over arthritis drug guidance

Criticisms of the consultation process carried out by the National Institute for Clinical Excellence (NICE) prior to the publication of its final guidance for a new treatment of rheumatoid arthritis have been dismissed by the High Court.

NICE's failure to recommend the use of abatacept (brand name Orencia) as a treatment option for people with rheumatoid arthritis had been challenged by the drug's manufacturer.

Bristol Myers Squibb (BMS) was not contesting the decision to exclude the drug from NICE's guidance.

Indeed, the company has subsequently admitted that while abatacept is no more effective than comparable drugs, it is nevertheless more expensive.

Rather, BMS sought to force a judicial review to investigate whether the consultation process carried out by NICE during its appraisal was fair and if the decision-making process complied with the European Union's transparency directive.

However, the judge dismissed the application in what Professor Peter Littlejohns, NICE clinical and public health director, saw as a vindication of the independent organisation's processes.

He went on to criticise the decision of BMS to pursue legal action, pointing out it acted as an unnecessary drain on NICE resources.

"We are pleased to have won this case - the judgment is a welcome endorsement of the rigorous methods we use to produce our guidance," Professor Littlejohns commented.

"We have argued that our decision-making processes are open, transparent and fair and that the diversion of NHS resources into funding treatments that are not cost-effective would be likely to cause real injustice to people suffering from other serious conditions."

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