How cost effective is the PMA (premarket approval) approved bone growth peptide, i-FACTOR? Only two bone growth compounds have been PMA approved by the FDA, Medtronic’s Infuse and Cerapedics P-15 based bone graft, i-FACTOR.
New Cost Effectiveness Data for Bone Growth Peptide
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The new study (“Cost-Effectiveness of Peptide Enhanced Bone Graft i-Factor versus Use of Local Autologous Bone in Anterior Cervical Discectomy and Fusion Surgery”), which compares the cost effectiveness of i-FACTOR Peptide Enhanced Bone Graft to autograft in anterior cervical discectomy and fusion (ACDF) surgeries, was published in the July 2021 edition of ClinicoEconomics and Outcomes Research.
The study was a prospective, multicenter randomized control trial which was conducted at 22 North American centers. The study looked at real-world scenarios, including inpatient and outpatient surgical settings and private versus public insurances. The team collected data for two primary outcome measures: cost and utility.
Leading the study was Dr. Jared Ament, M.D., M.P.H., director of outcomes research and co-director of spine neurosurgery at the Neurosurgery & Spine Group and president and founder of Neuronomics, a company specializing in cost-effective analyses in the neurosciences.
“In a robust cost-utility analysis, i-FACTOR reduced costs within the first year compared to the control group (autograft) in the ACDF IDE. [investigational device exemption] trial population. The incremental cost-effectiveness ratio proved highly cost effective even at 90 days ($13,333 per QALY [quality-adjusted life-year]). At 1 year and beyond, these values became negative, suggesting a ‘dominant’ economic strategy. The results are felt to be conservative since, in a real-world setting, many surgeons are using other more costly grafts in addition to autograft,” commented Dr. Ament.
“We are grateful to Dr. Ament and his team for conducting this important and infrequently conducted analysis. As our healthcare system becomes ever more focused on value in addition to quality clinical outcomes, this data puts us in a unique position relative to our competition. The technologies we displace with i-FACTOR don’t have cost-effectiveness data, and most have no meaningful clinical data as well,” said Cerapedics President and COO Jeffrey G. Marx, Ph.D.
“In an environment of never-ending cost pressures,” stated Dr. Marx to OTW, “i-FACTOR is the only bone graft with demonstrated cost effectiveness. This study demonstrates that i-FACTOR saves payers money because of, and in addition to, the proven clinical effectiveness and safety.”
OTW asked Dr. Ament about the one-year outlook on i-Factor, Dr. Ament stated, “The rapid rate of clinical adoption of i-FACTOR in the last few years has been gratifying. As surgeons continue to see the results their patients are achieving with i-FACTOR, that momentum is accelerating. In the next 12 months we expect to see a huge number of patients, surgeons, hospitals, and insurers benefiting from the P-15 osteogenic cell binding peptide technology in i-FACTOR.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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