The National Institute for Clinical Excellence (NICE) is to reconsider the evidence for using interferon beta in the treatment of multiple sclerosis. The move follows an appeal against the provisional opinion of the appraisal committee of NICE that the drug had a modest clinical benefit outweighed by a high cost.
After the appeal hearing, the Multiple Sclerosis Society and Biogen, one of two drug makers who lodged appeals, said they were concerned about the length of time the evaluation had taken and the effects on patients. In its verdict, the NICE appeal panel said that the appraisal committee had not explained the basis of its conclusion that interferon beta was not cost effective. The committee's reasoning for rejecting other data was misleading, and the panel said it questioned whether the issues relating to long term benefits of the treatment had been fully considered by the committee.
The original guidance was also said to have given insufficient weight to the importance of data from magnetic resonance imaging. The appraisal committee will now meet again in December to reconsider and to look at new data put forward by Biogen and Schering. "As the appeals panel upheld certain points from this appeal, the institute is following its usual process and has asked the appraisal committee to reconsider the original evidence," said the chief executive of NICE, Andrew Dillon. In a statement after the decision, Biogen said, "We are pleased that NICE's appraisal committee has been asked to revisit the evidence and reconsider its guidance. MS patients in England and Wales would have been denied access to the only treatment available that delays the progression of this debilitating disease if the guidance had been accepted."
It added, "While this announcement offers hope to the MS community, Biogen regrets that it has taken NICE over a year to come this far. Patients are still subject to uncertainty and anxiety as to whether beta interferon treatment will be available." Peter Cardy, chairman of the Multiple Sclerosis Society, said, "NICE tells us its decision has been referred back to a meeting next month, more than 10 months since our original submission was made. The upshot is that many more people who could already be receiving these proven and licensed drugs may now fail to meet the clinical criteria for them because their MS has progressed too far,"
The original NICE appraisal was meant to be confidential, but in response to a leak of information last June, the institute's chairman, Michael Rawlins, said: "In order to avoid any further uncertainty in the minds of patients and those who care for them, I have no option other than to confirm that the provisional opinion of the institute's appraisal committee is that, other than for those patients who are already receiving these medicines, they should not be made available in the NHS at the present time. This is because, on the basis of a very careful consideration of the evidence, their modest clinical benefit appears to be outweighed by their very high cost."
Further details of the decision of the appeal panel are available on http://www.nice.org.ukwww.nice.org.uk