12:00 AM
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Dec 22, 2008
 |  BioCentury  |  Regulation

Sequential sequel

For the first time since the National Institute of Health and Clinical Excellence was founded in 1999, an appeal panel has invalidated a final appraisal determination. The Department of Health now must decide whether to restart the appraisal of the sequential use of TNF alpha inhibitors for rheumatoid arthritis. At least one patient group says it will step up pressure on the government in January if it doesn't see progress toward a new review.

In October 2007, NICE published a final appraisal determination (FAD) on multiple technology appraisal (MTA) 130 recommending use of the TNF alpha inhibitors Humira adalimumab, Enbrel etanercept and Remicade infliximab to treat RA patients who had either failed two DMARDs including methotrexate (MTX), or were intolerant to MTX.

Enbrel is marketed by Wyeth and Amgen Inc., while Humira is marketed by Abbott Laboratories. Remicade is marketed by Johnson & Johnson and Schering-Plough Corp.

Last month, the appeal panel invalidated a subsequent FAD, issued in July, in which the appraisal committee recommended against the use of Humira, Enbrel and Remicade...

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