The clinical trial was conducted by investigators affiliated with the US Department of Veterans Affairs and reported in The New England Journal of Medicine this summer (NEJM 369, 307–318, 2013). The study enrolled 363 people, 90% of whom were white, who had active disease despite treatment with methotrexate, a common situation for this indication. Participants received a cocktail of three anti-rheumatic drugs—methotrexate combined with sulfasalazine and hydrochloroquine—or methotrexate with Enbrel. “The evidence here is not so strong,” says Richard Gliklich of Quintiles Outcome, a research firm in Cambridge, Massachusetts, owing to the small study size and corresponding inability to look at subgroups that may perform better or worse than the average and the lack of patient heterogeneity. However, other studies of Enbrel “have moved in a similar direction even though their designs were different,” he says. Eventually, that sum of information will make its way through professional society reviews, and perhaps also be picked up by internal technology assessment and review programs at payers. “If that happens, we'll see big changes,” he says. “There is a risk here. I think this is a brush fire and you pay attention to brush fires because they might become a bigger fire.”
As such, Amgen should be thinking about developing its own comparative effectiveness data, he says. “Others will do more studies because the differential in cost is so great and you don't want to be caught flat footed,” Gliklich adds. Depending on additional data, payers may consider not allowing Enbrel until after the triple therapy tested in the NEJM study has been prescribed, for instance. “The onus will be on the manufacturers to demonstrate more and more effectiveness against other therapies,” he says.
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