Enbrel etanercept regulatory update

The U.K.'s NICE issued a preliminary appraisal for five drugs to treat rheumatoid arthritis after treatment with a TNF inhibitor has failed. NICE reiterated recommendations in favor of using MabThera rituximab, a mAb against CD20 from Roche; and against use of Orencia abatacept, a CTLA-4-Ig fusion protein from Bristol-Myers. The committee also recommended against TNF inhibitors Humira adalimumab, Enbrel etanercept and Remicade infliximab to treat RA after the failure of a previous anti-TNF drug. That recommendation reiterates a July 2008 final appraisal determination (FAD) that was invalidated by a November 2008 appeal panel while making one change: The three drugs are now recommended only in the context of research. NICE called for a new appraisal of the TNF inhibitors following the appeal panel's decision (see BioCentury, Dec. 8, 2008).

The committee said the limited evidence for a second TNF inhibitor did not suggest they would be more cost-effective than MabThera. NICE also said Orencia appeared to be no better than MabThera despite being more expensive than the Roche drug. MabThera is specifically recommended in combination with methotrexate in patients that have responded inadequately to other DMARDs, including at least one TNF inhibitor, or who are intolerant to other DMARDs. Comments on the appraisal are due March 24. ...