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Costs and frequency of “off-label” use of INFUSE for spinal fusions at one institution in 2010

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...

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Autores principales: Epstein, Nancy E., Schwall, Garry S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications Pvt Ltd 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3162796/
https://www.ncbi.nlm.nih.gov/pubmed/21886888
http://dx.doi.org/10.4103/2152-7806.83929
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author Epstein, Nancy E.
Schwall, Garry S
author_facet Epstein, Nancy E.
Schwall, Garry S
author_sort Epstein, Nancy E.
collection PubMed
description 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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spelling pubmed-31627962011-08-31 Costs and frequency of “off-label” use of INFUSE for spinal fusions at one institution in 2010 Epstein, Nancy E. Schwall, Garry S Surg Neurol Int Original Article 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). Medknow Publications Pvt Ltd 2011-08-17 /pmc/articles/PMC3162796/ /pubmed/21886888 http://dx.doi.org/10.4103/2152-7806.83929 Text en Copyright: © 2011 Epstein NE. http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Original Article
Epstein, Nancy E.
Schwall, Garry S
Costs and frequency of “off-label” use of INFUSE for spinal fusions at one institution in 2010
title Costs and frequency of “off-label” use of INFUSE for spinal fusions at one institution in 2010
title_full Costs and frequency of “off-label” use of INFUSE for spinal fusions at one institution in 2010
title_fullStr Costs and frequency of “off-label” use of INFUSE for spinal fusions at one institution in 2010
title_full_unstemmed Costs and frequency of “off-label” use of INFUSE for spinal fusions at one institution in 2010
title_short Costs and frequency of “off-label” use of INFUSE for spinal fusions at one institution in 2010
title_sort costs and frequency of “off-label” use of infuse for spinal fusions at one institution in 2010
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3162796/
https://www.ncbi.nlm.nih.gov/pubmed/21886888
http://dx.doi.org/10.4103/2152-7806.83929
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