23 Payers Now Cover SI-BONE’s iFuse, Exclusively

SI-BONE, Inc., based in Santa Clara, California, announced that ”…23 commercial health plans have published exclusive positive coverage policies for the triangular iFuse Implant System.” This means that minimally invasive SI joint (sacroiliac joint) fusion using this system is now accessible to over 35 million health plan members in the following plans:

“Payers continually tell us that long-term outcomes data from well-designed, well-executed randomized controlled trials [RCT] are critically important when determining coverage for new procedures or technologies,” said Jeffrey Dunn, president, CEO and chairman of SI-BONE. “The threshold for positive coverage includes a reliable diagnostic algorithm combined with a broadly adoptable treatment that is safe and clinically effective with a low revision rate and is cost-effective.”

Asked what about the RCTs they are particularly proud of, Dunn told OTW, “We are proud of the fact that seven years ago, we decided to invest substantially in high quality clinical research and sponsor two RCTs, one in the U.S. and one in Europe. Both RCTs used almost identical algorithms and patient selection criteria and both showed almost identical positive results.”

“Furthermore, the positive results from both RCTs were nearly identical to the positive results from a large multicenter prospective single-arm trial done in the U.S. Results from these studies show that patients diagnosed with certain types of chronic SI joint dysfunction, using the same diagnostic algorithm, who fail to respond to non-surgical care, obtain clinically significant early and sustained relief of pain, improvement in function and quality of life, when treated with the triangular iFuse Implant (available since 2009).”

“We believe that the positive consistent results from these studies have established the standard of care for the surgical treatment of SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.”

As for details about the algorithm, Dunn commented to OTW, “The diagnostic algorithm used to identify surgical candidates in each study was the same simple, straightforward protocol consisting of a thorough patient history, including a positive Fortin finger test (i.e., patient points to posterior superior iliac spine as the location of their most severe pain), simple physical examination tests that stress the SI joint, and confirmatory diagnostic SI joint injections.”

“The physical exam included a thorough exam of the lumbar spine-SI joint-hip complex, palpation of the PSIS and 5 provocative maneuvers that stress the SI joint. If 3 of the 5 provocative tests were positive, a confirmatory SI joint block, resulting in at least 50% reduction in pain, was then performed to confirm the diagnosis. The tests for low back pain due to the SI joint are highly predictive of a positive SI joint block, as shown by a recent comprehensive systematic review and the consistent positive results from the iFuse studies provide further validation of the diagnostic algorithm.”

“SI joint dysfunction can be a debilitating condition that many healthcare practitioners often overlook, potentially resulting in misdiagnosis and misdirected treatments, including inappropriate surgery. A clinically proven surgical intervention is now available, and has been since 2009, for patients with SI joint dysfunction that can provide marked relief of pain, improved patient function and improved quality of life.”