Setting the Bar Higher For Off-Label Use of Biologics: Off-label use of biologics is common as physicians strive for optimal treatment. Patients want whatever works. Drug makers want expanded labeling, but payers chafe at the lack of efficacy data. Is there an answer to this conundrum?

Abstract

Off-label use of biologics is common as physicians strive to treat patients as best they can. But payers and purchasers want evidence of value before they pay for off-label use, and the FDA has moved to mitigate off-label prescribing. With patient activism increasing, how should off-label use be handled? And where do the drug makers fit in?