Bristol-Myers Squibb was dealt a bitter blow last week after The High Court turned down its application for a judicial review of a decision by the National Institute for Health and Clinical Excellence that rejected Orencia for rheumatoid arthritis on the National Health Service.

The cost watchdog ruled back in April last year that Orencia (abatacept) was simply too expensive for use on the NHS to treat patients with moderate-severe forms of the disease, despite appeals from the company, the British Society for Rheumatology, the Royal College of Physicians, the National Rheumatoid Arthritis Society and the Royal College of Nursing.

At the time, the Institute argued that it had already given the OK to Abbott Laboratories’ Humira (adalimumab), Wyeth’s Enbrel (etanercept) and Schering-Plough’s Remicade (infliximab) for the treatment of RA, as well as Roche’s MabThera/Rituxan (rituximab) as an option for severe forms of the condition for some people, and that Orencia was no more effective than these drugs but came with a higher price tag and thus was not a cost-effective use of NHS resources.

However, Ailsa Bosworth, Chief Executive of NRAS, called the decision “perverse and short sighted” claiming that it would condemn patients with severe RA who have failed to respond to other therapies to “a lifetime of misery” as “for many patients Orencia provides their last chance of controlling the disease”.

B-MS subsequently filed an application to challenge NICE’s decision in court on the basis that the consultation process during the appraisal was unfair and the criteria used in the decision making process breached the EU transparency directive, but while agreeing with the company on a number of points the High Court ruled that these were not sufficient to warrant a judicial review.

Professor Peter Littlejohns, NICE Clinical and Public Health Director, has applauded the decision, which, he says, is “a welcome endorsement of the rigorous methods we use to produce our guidance”, and he stressed 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”.

Furthermore, he pointed out that the legal challenge was not against the recommendations or the Institute itself, but was directed specific parts of the process that NICE followed, and said it was “disappointing that BMS has forced NICE to divert resources to defending this legal claim”.

However, Richard Marsh, Director of External Affairs and Market Access at Bristol-Myers Squibb UK, told PharmaTimes UK News that the company’s objectives were to secure a review of guidance “that we believe is wrong” as well as raise points of principle over how the review was conducted.

Points of principle
For example, the Institute reached its decision on Orencia using a revised model prepared by an Expert Review Group but failed to disclose this to the company because this was held by the ERG and not the appraisals committee, an argument rejected by the judge.

In addition, the cost watchdog also refused to release certain information on the basis that it would then have to reveal this information – which it considered commercially sensitive - to all consultees. However, the judge agreed that the manufacturer is in a different position to other consultees involved in the appraisals process, siding with B-MS on this point.

But perhaps the most astonishing aspect of the hearing was NICE’s apparent attempt to argue that it does not have a duty to act fairly, going against B-MS’ point that the Institute’s decision making is subject to the general principles of procedural fairness. As Marsh told PharmaTimes UK News: “BMS found it extraordinary that NICE should even try to argue this - as I am sure will any other party that has dealings with NICE when this fact becomes more broadly known”.

However the cost watchdog was shot down on this point, as the judge stressed: “Fairness is now a requirement in every area of public law functioning where serious consequences result to individuals irrespective of how those serious consequences can be categorised”.