Sacroiliac Joint Fusion Surgery Update

Important announcement for people with sacroiliac joint (SI joint) dysfunction.

The Blue Cross Blue Shield Association (BCBSA) elevated its quality evidence rating to “Moderate” for the triangular iFuse Implant System® implants for sacroiliac joint (SI joint) fusion. The BCBSA’s recommendation came after an extensive review of all existing peer-reviewed clinical safety and effectiveness data.1

iFuse Implant System, triangular implants in sacroiliac joint, sacrumMinimally invasive surgical treatment of sacroiliac joint dysfunction using the iFuse Implant System's triangular implants is depicted in this anatomical illustration. This image is copyrighted, and used courtesy of SI-BONE, Inc.

Why is this announcement important?
Evidence-based medical recommendations provided by impartial and reputable sources enable patients to make informed choices about their health care—and, in this particular case, minimally invasive surgical treatment of SI joint dysfunction.

BCBSA’s Evidence Street is the impartial organization that rigorously evaluated the data and literature and released its revised upward recommendation from “Uncertain” to “Moderate” regarding SI joint fusion with the iFuse Implant System® (SI-BONE, Inc.). Evidence Street provides impartial medical evidence reviews for devices, diagnostics and pharmaceuticals.2

What was involved in Evidence Street’s evaluation?
First, it should be explained that Evidence Street assigns a technology to one of four different grade levels: (1) Uncertain, (2), Low to None, (3) Moderate, (4) Substantial.

Evidence Street’s recent comprehensive evaluation considered the number and quality of published studies (eg, research, clinical) and the impact of the iFuse Implant on overall health outcomes.

  • Considering their earlier recommendation of the triangular iFuse Implant was “Uncertain," the upward jump to “Moderate” is certainly significant.

What’s important about the studies evaluated in evidence?
Clinical studies were well-designed to include clearly-defined populations, and conducted to exclude opportunity for bias.

  • The number participants in the studies were sufficient in size to test the researchers and clinical investigators’ hypotheses and assumptions.
  • Both the benefits and harmful effects on length of life, quality of life, and functional ability were carefully assessed.
  • Results from post-marketing observational studies were included. Post-marketing studies are those that monitor and track the safety and effectiveness of a treatment intervention after the FDA approves it for marketing and use outside a clinical trial’s controlled setting.

How did iFuse compare to another implantable device for SI joint fusion?
Evidence Street’s updated summary included cylindrical threaded implants for SI joint fusion. They indicated there is not sufficient evidence to determine the effects of cylindrical threaded implants for SI joint fusion on health outcomes and therefore, maintained an “Uncertain” rating.

Could the “Moderate” rating improve insurance coverage for the iFuse Implant System?
There are 36 independent, community-based and locally operated Blue Cross Blue Shield (BCBS) companies in the United States that rely on BCBSA’s Evidence Street evidence review to establish coverage policies. It is hoped the impact of this updated evidence influences all Blue Cross Blue Shield plans that currently do not cover iFuse for SI joint fusion to update their coverage policies to include iFuse.

Updated on: 02/05/19
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