The model accounted for health state, direct medical costs and indirect costs, such as work productivity, and assumed a cost of $750 for i-FACTOR over (free) autograft. The research team used the IDE study patient outcome data to generate a Markov model with nodes representing transitions between health states and associated costs and utility scores. Again, overall success remained statistically superior in the i-FACTOR cohort.ĥ,000 Iterations Modeling / 52 Input Parameters These patients were also included in a 24-month follow-up study published in 2018 which found that more patients had fused in the following year, reaching a rate of 97.3% (versus 94.4% for autograft). More importantly, i-FACTOR demonstrated a statistically higher rate of overall clinical success than the autograft control at 12 months.
The study randomly assigned patients to receive autograft (n=154) or i-FACTOR (n=165) and showed that i-FACTOR was significantly non-inferior to autograft in terms of fusion rate, significant improvements in neck disability index (NDI), high neurological success rate, or rate of adverse events individually. The model used data from the 319-patient FDA approved investigational device exemption (IDE) study published in 2016. How, in a practical way, can this be translated into a clear, unambiguous cost effectiveness measure? For the i-FACTOR economic study, the research team used, in part, the well-studied and validated 36-item short-form survey (SF-36) and then transformed it into a weighted utility to calculate a quality-of-life measure for patients.Īccording to senior author Jared Ament, M.D., the goal of the economic study was to compare Cerapedics’ i-FACTOR cost-benefit to local autograft in patients undergoing anterior cervical discectomy and fusion (ACDF) surgery. One QALY equates to one year of perfect health or two or more years of less than perfect health. Insurers require unambiguous data that a treatment or solution provides enough benefit to justify its cost.Īn insurer’s willingness-to-pay (WTP) is based on factors such treatment cost, the quality-adjusted life years (QALYs) provided by the treatment, and the value assigned to each QALY.Ī typical value assigned to a QALY is $100,000. The cost of a device or treatment often has an outsized weighting when it comes to coverage decisions.
Significant Cost Benefit Differential for i-FACTOR It took Cerapedics almost 15 years to achieve the rare (only two ever granted by the FDA) premarket approval for i-FACTOR in spinal fusion.Ĭerapedics describes i-FACTOR as a peptide enhanced bone graft that will “Attract, Attach, and Activate” osteogenic cells to build bone where placed and nowhere else. Later it was reformulated as i-FACTOR Bone Graft Putty and began the arduous PMA (premarket approval) regulatory and clinical study process for use as a spine fusion biologic in single-level ACDF. The first bone graft with the P-15 peptide was originally formulated and commercialized in 1999 for dental applications by Ceramed, the predecessor company to Cerapedics. Food and Drug Administration (FDA) has approved two spine fusion biologic products via the rigorous Pre-Market Approval process-one is a recombinant BMP-2 bone graft and the other is a peptide-based bone graft manufactured by Westminster, Colorado-based Cerapedics, Inc.
Only Two FDA Approved Spine Fusion Biologics in the United States. The economic analysis is titled: “ Cost-Effectiveness of Peptide Enhanced Bone Graft i-Factor versus Use of Local Autologous Bone in Anterior Cervical Discectomy and Fusion Surgery.” A robust, cost-utility analysis of bone graft, which was recently published in ClinicoEconomics and Outcomes Research, found that one particular spine fusion biologic, when put up against the cost of (free) local autograft in cervical fusion procedures (considered the gold standard) would be justified even if the price was increased 70 times.
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