Studies Show SI-BONE’s iFuse Implant System Saves Time, Money

SI-BONE Inc. has announced the publication of two economic studies showing the cost benefits of MIS SI joint fusion for patients suffering from chronic SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.

In the first article, titled, “Cost Effectiveness of Minimally Invasive Sacroiliac Joint Fusion,” researchers combined data collected from INSITE, a prospective randomized controlled trial, and SIFI, a prospective single-arm trial, with 2015 Medicare national average reimbursement allowable data to calculate incremental costs and health benefits of SIJ fusion vs. non-surgical management (NSM) in patients with chronic SIJ dysfunction. The purpose of the study was to calculate an incremental cost effectiveness ratio (ICER), which measures the relative cost of gains in quality of life associated with SIJ fusion. Using a Markov model that describes health states of patients with SIJ dysfunction who undergo either surgical or non-surgical treatment, the study showed a five-year gain in quality of life of 0.74 quality-adjusted life years (QALYs) at an incremental cost of $9,833, which corresponds to an ICER of $13,313 per QALY gained.¹ This ICER, when compared with the $50,000 and $100,000 per QALY benchmarks commonly cited to assess treatment cost-effectiveness, was highly favorable. The article also compares the ICER of SIJ fusion to other interventions commonly performed by spine and orthopedic surgeons and studied in large multicenter trials like INSITE. The ICER of SIJ fusion was lower (meaning more favorable) than that of lumbar fusion for degenerative spondylolisthesis and was closer in range to technologies considered highly cost effective, such as knee and hip arthroplasty.

“Embedding the collection of healthcare resource utilization from INSITE’s subjects allowed us to perform this complex but informative analysis,” said Daniel Cher, M.D., head of clinical affairs at SI-BONE. “The result shows a relatively low ICER for MIS SI joint fusion and indicates a very attractive “buck for the bang” for the iFuse procedure for appropriately diagnosed patients with SI joint disruption or degenerative sacroiliitis.”

In the second article, titled, “Ignoring the Sacroiliac Joint in Chronic Low Back Pain is Costly,” David Polly, M.D., and Cher analyzed a cost model describing care for patients with severe chronic low back pain who are preoperative candidates for lumbar fusion. This analysis was done to address the direct cost implications of not considering the SI joint in the workup of chronic low back pain. Performing lumbar fusion for patients with undiagnosed SIJ pain rather than lumbar spine problems may result in a lack of postoperative improvement in pain (since the wrong condition was treated), worsened back pain as a result of a surgical mishap, potentially leading to failed back surgery syndrome, a disorder documented to be very costly to treat. In contrast, identifying and treating SI joint pain through a combination of history, physical examination and confirmatory diagnostic SI joint block, allows patients diagnosed with SI joint disruption or degenerative sacroiliitis to undergo SI joint fusion, which has high response rates as shown in numerous prospective and retrospective studies. Taking into account the additional costs of SIJ diagnosis and treatment, the cost model predicted a $3,100 expected two-year direct healthcare cost savings when considering the SI joint compared to not considering the SI joint.² Of note, this is a cost savings per patient evaluated.

“Shooting at the wrong target, i.e., performing surgery on the wrong body part, is clearly not in the patient’s best interest,” said Polly. “We were interested in understanding the financial impact of failing to consider the SI joint as a potential pain generator in patients with chronic lower back pain who are seeking surgical treatments. The results are edifying in terms of the amount of money, but perhaps not surprising given the high intensity and cost of surgical interventions.”

San Jose, Calif.-based SI-BONE develops tools and products for patients with low back issues related to certain SI joint disorders. The company develops, manufactures and markets minimally invasive products for patients with these disorders. SI-BONE, Inc. received original 510(k) clearance in November 2008 from the U.S. Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System is a minimally invasive surgical option that uses titanium implants coated with a porous, titanium plasma spray (TPS) that acts as an interference surface, designed to help decrease implant motion, provide immediate fixation and allow for biological fixation to support long term fusion. The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation.

References:

1. Cost-effectiveness of minimally invasive sacroiliac joint fusion. Cher DJ, Frasco MA, Arnold RJG, Polly DW a. Clinicoecon Outcomes Res. 2016;8:1-14.

2. Ignoring the sacroiliac joint in chronic low back pain is costly. Polly DW, Cher DJ. Clinicoecon Outcomes Res. 2016;8:23-31. Published online 2016 Jan 21.