BMPs Used Off-Label in 85% of Cases
BY LAUREN UZDIENSKI, SEPTEMBER 8, 2010
A new study in Spine documents the rise of BMPs and the prevalence of off-label use, demonstrating that between 2003 and 2007, the annual number of procedures utilizing BMPs increased 4.3-fold from 23,900 to 103,194. Of those, 85% were identified as off-label uses of the material. The data came from the Nationwide Inpatient Sample, which the paper touts as the "single largest all-payer inpatient care database in the United States."
There are two BMPs currently on the market: BMP-7, formulated as Stryker's OP-1, which has been available since 2001 under an HDE for long bone non-union and certain revision posterolateral fusions. The HDE allows a device to be used in up to 4,000 patients annually, and the company has failed to secure broader indications for the OP-1. Medtronic's InFuse (BMP-2) has been commercially available since 2002 for certain anterior fusions, as well as open tibial shaft fractures and certain OMF indications. The article notes that 93% of cases where BMP was used were spinal fusions, and off-label uses included posterolateral spine fusion, PLIF, TLIF, anterior cervical fusion and posterior cervical fusion.
While the 85% figure is high, that number may not represent current levels of off-label use. The cases surveyed were performed between 2002 and 2007, before concerns about off-label use began to gain attention from regulatory bodies, physicians and the media. In 2008, the FDA issued an alert warning surgeons about off-label use of BMPs in cervical cases, and sales for InFuse have since decelerated, with Medtronic's biologics sales in FY 2010 flat over FY 2009. Stryker faces ongoing legal issues over alleged off-label marketing of OP-1, with the company facing a federal inquiry and recently settling similar allegations in Massachusetts.
