Technology Assessment

Bone Morphogenetic Protein: The State of the Evidence of On-Label and Off-Label Use


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The Centers for Medicare and Medicaid Services (CMS) has called this meeting to consider the currently available evidence regarding the clinical benefits and harms of on-label and off -label use of BMPs. More than 20 BMPs have been identified, but only BMPs -2, -4, -6 and -7 have been shown to have significant osteogenic properties. The main physiologic role of BMP is to promote differentiation of mesenchymal cells into chrondrocytes and osteoblasts, to promote differentiation of osteoprogenitors into osteoblasts, and to influence skeletal pattern formation.

Human BMPs are now produced using recombinant DNA technology. Currently, two recombinant BMPs have some form of FDA approval and are commercially available in the United States: rhBMP-2 and rhBMP-7. The on-label and off -label use of BMPs has rapidly grown since becoming clinically available in 2001. There are reports stating that up to 85% of BMP use is for off-label indications, mostly in the spine. There have also been a number of reports of adverse events associated with the use of BMPs.

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