Off-label use of bone morphogenetic proteins in the United States using administrative data

Abstract

Study design: Epidemiological study using national administrative data.

Objective: To evaluate the temporal trends in on-label and off-label bone morphogenetic protein (BMP) usage in primary and revision spine fusion by spine region and surgical approach, and nonspine applications in the United States from 2002 to 2007.

Summary of background data: The prevalence of BMP usage for spine fusion has been on the rise, but its use has not been stratified by surgical approach, particularly for lumbar fusion where it has only been Food And Drug Administration-approved for anterior lumbar interbody fusion (ALIF).

Methods: The prevalence of BMP usage in the United States was evaluated using the Nationwide Inpatient Sample between October 1, 2002 and December 31, 2007. The Nationwide Inpatient Sample is the single largest all-payer inpatient care database in the United States. The principal procedure associated with BMP use was determined, and the prevalence of BMP use was calculated for various population subgroups.

Results: A total of 340,251 inpatient procedures with BMP usage were identified. Between 2003 and 2007, the annual number of procedures involving BMP increased by 4.3-fold from 23,900 to 103,194. Spine fusion accounted for the vast majority (92.8%) of principal procedures with BMP. The predominant use of BMP was in primary posterior lumbar interbody fusion or transforaminal lumbar interbody fusion (PLIF/TLIF) (30.0%), followed by primary posterolateral spine fusion (20.4%), primary ALIF (16.6%), primary cervical fusions (13.6%), and primary thoracolumbar fusions (3.9%). Of primary ALIF with BMP, 19.3% did not involve the implantation of an interbody device.

Conclusion: At least 85% of principal procedures using BMP were for off-label applications. With uncertainty regarding the risks of using BMP in certain off-label applications, further research will be needed to better define the appropriate indications. Our study also demonstrates that disparities in the differential rates of BMP use exist in the spine fusion population.