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 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).