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| ORIGINAL ARTICLE |
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| Year : 2011 | Volume
: 2
| Issue : 1 | Page : 115 |
Costs and frequency of "off-label" use of INFUSE for spinal fusions at one institution in 2010
Nancy E Epstein1, Garry S Schwall2
1 Clinical Professor of Neurological Surgery, Department of Neurological Surgery, The Albert Einstein College of Medicine, Bronx, NY, 10461, USA 2 Chief of Neurosurgical Spine and Education, Chief Operating Officer, Winthrop University Hospital, Mineola, N.Y 11501, USA
Correspondence Address:
Nancy E Epstein Clinical Professor of Neurological Surgery, Department of Neurological Surgery, The Albert Einstein College of Medicine, Bronx, NY, 10461 USA

© 2011 Epstein et al; This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
DOI: 10.4103/2152-7806.83929 PMID: 21886888
Background : INFUSE, bone morphogenetic protein-2 combined with bovine Type I collagen in the lumbar tapered fusion device (LT Cage), is used to promote anterior lumbar interbody fusion (ALIF). In spinal surgery, INFUSE is only Federal Drug Administration (FDA) approved for this "on-label" use. While the efficacy and possible complications due to INFUSE have been debated, we know less about the costs and frequency of "on-label" versus "off-label" use of INFUSE to perform spinal fusions.
Methods : At one institution, we determined the costs (with overhead) and frequency of utilizing INFUSE "on-label" and "off-label" in performing spinal fusions during 2010.
Results : During 2010, 177 spinal fusions utilized INFUSE. Ninety-six percent, or 170 of 177 spinal fusions, utilized INFUSE in an "off-label" capacity at a cost of $4,547,822. Only 4%, or seven of 177 cases, utilized INFUSE in an "on-label" capacity (ALIF); the total cost was $296,419.
Conclusions : In 2010, at one institution, 96% of the spinal fusions utilized INFUSE in an "off-label" capacity (cost $4,547,822), while only 4% were performed "on-label" (cost $296,4194).
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