BCBS Rating Clears Way for SI-BONE’s iFuse Coverage

San Jose, California-based SI-BONE, Inc. has announced that Blue Cross Blue Shield Association (BCBSA) has assigned triangular implants for sacroiliac (SI) joint fusion a “Moderate” quality evidence recommendation.

According to SI-BONE, “The BCBSA rating system encompasses a four-level rating scale of Substantial, Moderate, Low to None and Uncertain. In order for a technology to receive a moderate or substantial rating, the clinical evidence must be sufficient to determine the effects of the technology on health outcomes with confidence.”

“The BCBSA updated technology assessment states that for individuals with common disorders affecting the sacroiliac joint who are treated with sacroiliac fusion/fixation with a triangular implant, the evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.”

“The evidence used to develop the upgraded assessment was developed exclusively using the patented triangular iFuse Implants, which have been commercially available since 2009. The updated assessment further states that for patients with SI joint pain, the evidence is insufficient for treatment with therapeutic corticosteroid injections, radiofrequency ablation or cylindrical threaded implants.”

Daniel Cher, M.D., Vice President of Clinical Affairs at SI-BONE commented, “There is abundant evidence showing that the sacroiliac joint is a significant contributor to lower back pain and that common types of SI joint dysfunction can be effectively treated with a minimally invasive surgical procedure using the triangular iFuse Implant, which we brought to market in 2009. That said, the SI joint has been under-diagnosed and under-treated for decades and our philosophy has been to take a high level scientific approach, including well-designed and well-executed clinical studies so that the data from these studies could stand on their own for educational, clinical and patient purposes.”

SI-BONE Vice President of Marketing Joe Powers told OTW, “The January 1 announcement by BCBSA represents a historic milestone and a significant shift in how healthcare insurance companies view clinical evidence for new technologies and products. The BCBSA decision signifies to companies that new products must have level 1 evidence to obtain coverage by payers. New technologies and products are now required to demonstrate long term safety and effectiveness, which they can best accomplish through randomized controlled clinical trial data.”

“Over the past six years, we have invested substantially in multiple clinical trials that demonstrate that our patented triangular iFuse Implant, which we launched commercially in 2009, provides long term pain relief and improvement in patient function and quality of life. Through our extensive efforts and investment in evidence, we have established that among SI joint products and therapies, only iFuse has sufficient evidence to obtain a positive evaluation by BCBSA.”

“This means long-term that thousands of BCBS patients throughout the U.S. who are suffering from the pain caused by common types of chronic SI joint dysfunction who are appropriately selected surgical candidates will have access to our clinically proven iFuse Implant. Ultimately, each payer will have to make their own decision, but the recommendation from the BCBSA is very positive.”