SAN JOSE, Calif., Nov. 25, 2013 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), a medical device company that pioneered the use of the iFuse Implant System®, a minimally invasive surgical (MIS) device used to fuse the sacroiliac (SI) joint, announced today the publication of an economic analysis entitled "Comparison of the Costs of Nonoperative Care to Minimally Invasive Surgery for Sacroiliac Joint Disruption and Degenerative Sacroiliitis in a United States Medicare Population: Potential Economic Implications of a New Minimally-Invasive Technology." The study, which included development of an economic model and a review of approximately 300,000 Medicare health insurance claims, concluded that lifetime costs of treating appropriately selected Medicare patients with MIS SI joint fusion could result in savings from $660 million to as much as $4 billion when compared to the lifetime costs of non-operative care.1
The authors developed an economic model to simulate the lifetime costs of treating Medicare patients with minimally invasive SI joint fusion in the hospital inpatient setting and compared it to the costs of treating similar patients with nonoperative care as determined by a retrospective claims data analysis using the Medicare 5% Standard Analytic File for years 2005 through 2010. The analysis, which showed a potential savings of $660 million, included patients with a limited number of diagnosis codes in order to conservatively estimate the total population of patients with SI joint disorders. Based on this analysis, 196,452 Medicare beneficiaries had an SI joint diagnosis resulting in an estimated lifetime cost for nonoperative care of $51,543 per patient compared to an estimated lifetime cost of $48,185 per patient for MIS SI joint fusion.
The authors performed sensitivity analyses on a number of input variables to assess the robustness of the model. One of those variables was the addition of a more general diagnosis code for low back disorders that ensured inclusion of additional patients with SI joint pain. However, that diagnosis code also includes patients with other back disorders. When this code was included in the analysis, the number of Medicare beneficiaries with possible SI joint pain increased to 478,764 patients, with a per patient lifetime cost savings of $8,692 according to the model. This resulted in a potential cost savings to Medicare of $4.16 billion if MIS SI joint fusion is performed instead of non-operative care in all these patients.
Dr. William Mangold, MD, JD**, former Contractor Medical Director at Noridian Administrative Services said: "SI-BONE is acutely aware, as are all Medicare Medical Directors, that cost, even significant cost savings, cannot control any Medicare coverage determination. However, when viewed along with the positive clinical results demonstrated in numerous publications,2,3,4 as well as data confirming the widespread usage of MIS SI joint fusion throughout the U.S.5, it seems clear that Medicare should consider the procedure to have met the Medicare criteria for "medically reasonable and necessary," and should thereby be granted coverage by Medicare Contractors."
Dr. David Polly, a coauthor of this study commented: "My belief is that SI joint disorders represent a significant physical and financial burden to the U.S. population. This paper is a rigorous investigation that, if the parameter estimates are correct, shows minimally invasive SI joint fusion is cost saving. Several of my colleagues and I are working on a burden of disease analysis that will show SI joint- related disability in the U.S. to be similar to that of knee and hip osteoarthritis."
Michael Mydra, Vice President of Health Outcomes & Reimbursement at SI-BONE stated: "Based on the published data, the iFuse Implant System is a safe, effective and cost saving treatment option for patients suffering from low back pain (LBP) due to sacroiliac joint disruption or degenerative sacroiliitis. Given the significant economic burden associated with the treatment of LBP in the U.S., the iFuse procedure offers the potential to lower healthcare costs and save the Medicare program millions of dollars over the coming years."
SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System for fracture fixation of long bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and an additional clearance in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The CE mark for European commercialization was obtained in November 2010.
The iFuse Implant System is a commercially available device in the U.S. and Europe. The procedure requires a small incision for delivery and placement of triangular shaped titanium implants. The implants are coated with a porous, titanium plasma spray that creates an interference surface designed to help decrease implant motion, allow immediate fixation and provide for biological fixation to support long-term fusion. These implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional screws used to surgically fix bony structures. Clinical publications regarding the safety and effectiveness of the iFuse system can be found at www.si-bone.com/health_care_professionals/ifuse_implant_system/clinical_publications/. The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant. The product labeling provides additional details in this regard.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back pain related to SI joint disorders. The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of certain SI joint pathology. SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2013 SI-BONE, Inc. All Rights Reserved. 8566.112113
1Ackerman SJ, Polly DW Jr, Knight T, Schneider K, Holt T, Cummings J. Comparison of Cost of Non-Operative Care to Minimally Invasive Surgery for Sacroiliac Joint Disruption and Degenerative Sacroiliitis in a United States Medicare Population: Potential Economic Implications of a New Minimally Invasive-Technology. ClinicoEconomics Outcomes and Research. 2013;5:575-87.
2Rudolf L. Sacroiliac Joint Arthrodesis – MIS Technique with Titanium Implants: Report of the First 50 Patients and Outcomes. The Open Orthopaedics Journal. 2012;6:495-502.
3Sachs D, Capobianco R. Minimally Invasive Sacroiliac Joint Fusion: One-Year Outcomes in 40 patients. Advances in Orthopedics. 2013;2013:536128.
4Cummings J Jr, Capobianco RA. Minimally invasive sacroiliac joint fusion: one-year outcomes in 18 patients. Annals of Surgical Innovation and Research. 2013;7:12.
5Statement on Coding Changes for Minimally Invasive SI Joint Fusion. International Society for the Advancement of Spine Surgery (ISASS). July 2013. http://www.isass.org/public_policy/2013-08-07-isass-statement-minimally-invasive-si-joint-fusion-coding-changes.html
SJA, TK, and KS are consultants to SI-BONE through their employment at Covance.
TH and JC are paid teaching and clinical research consultants for SI-BONE.
DWP has not received any financial support from SI-BONE. DWP receives research support from the Department of Defense, Orthopaedic Research and Education Foundation, Minnesota Medical Foundation, and Chest Wall and Spine Deformity Foundation.
LR is a paid teaching and clinical research consultant for, and an investor in, SI-BONE.
DS and JC are paid teaching and clinical research consultants for SI-BONE.
RC is an SI-BONE employee.
SOURCE SI-BONE, Inc.