NICE Adds Arthritis Drugs To Fast Track Appraisal Pathway
This article was originally published in The Pink Sheet Daily
Executive Summary
Clinical and cost effectiveness of Rituxan, Orencia, Humira, and Arava to be evaluated under single technology appraisal process.
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Four arthritis treatments are among a new group of drugs to be appraised for clinical and cost effectiveness by the U.K.'s National Institute for Health & Clinical Excellence under a fast-track process, the institute announced Aug. 30. NICE will evaluate rituximab (Roche's MabThera ) and abatacept (Bristol-Myers Squibb's Orencia ) for treatment of refractory rheumatoid arthritis under a single technology appraisal. Rituximab is not yet licensed in the U.K. for RA, but received European Union approval as second-line treatment in combination with methotrexate for adults with inadequate response to one or more tumor necrosis factor inhibitors (1 (Also see "Roche’s Rituximab Gains Two New Indications In The EU" - Pink Sheet, 11 Jul, 2006.)). The drug is marketed in the U.S. by Biogen Idec/Genentech as Rituxan . Orencia, the first of a class of agents called selective T-cell co-stimulation modulators, is currently pending before the European Medicines Agency; Bristol submitted a marketing application for RA in January. The drug is approved in the U.S. for reducing the signs and symptoms in adults with inadequate response to TNF inhibitors. For psoriatic arthritis, NICE will evaluate adalimumab (Abbott's Humira ) and leflunomide (Sanofi-Aventis' Arava ). NICE also will examine idraparinux sodium (SanOrg-34006), an experimental treatment from Sanofi-Aventis, for the prevention of stroke in patients with atrial fibrillation as well as for prevention of recurrent venous thromboembolism. The therapy, a synthetic pentasaccharide, is in Phase III trials. Other drugs to be examined include intravenous alteplase (Boehringer Ingelheim's Actilyse ) for the treatment of acute ischemic stroke. Alteplase is marketed in the U.S. by Roche as Activase . A developmental drug from Eli Lilly for treatment of diabetic retinopathy, ruboxistaurin ( Arxxant ), also will receive NICE scrutiny. In August, Arxxant received an "approvable" letter from FDA (2 (Also see "Looking For More Data: Lilly’s Arxxant Gets “Approvable” Letter" - Pink Sheet, 18 Aug, 2006.)). The single technology appraisal process was instituted in November to help speed the availability of guidance to U.K. National Health Service authorities regarding single new drugs and drugs with new indications, NICE said. NICE also announced Aug. 30 that it had moved several drugs already under consideration for the longer MTA process to the STA path, including five oncologics (3 (Also see "Cancer Drugs Move To NICE's Fast-Track Appraisal Process" - Pink Sheet, 31 Aug, 2006.)). - Shirley Haley ([email protected]) |