Cost-Effectiveness of Peptide Enhanced Bone Graft i-Factor versus Use of Local Autologous Bone in Anterior Cervical Discectomy and Fusion Surgery

Abstract

We conducted decision analytical modeling using a Markov model to determine the ICER of i-factor compared to autograft in ACDF surgery. Objective: The efficacy and safety of traditional anterior cervical discectomy and fusion (ACDF) surgery has improved with the introduction of new implants and compounds. Costeffectiveness of these innovations remains an often-overlooked aspect of this effort. To evaluate the cost-effectiveness of i-FACTOR compared to autograft for patients undergoing ACDF surgery. Methods: The patient cohort was extracted from a prospective, multicenter randomized control trial (RCT) from twenty-two North American centers. Patients randomly received either autograft (N = 154) or i-Factor (N = 165). We analyzed various real-world scenarios, including inpatient and outpatient surgical settings as well as private versus public insurances. Two primary outcome measures were assessed: cost and utility. In the base-case analysis, both health and societal system costs were evaluated. Health-related utility outcome was expressed in quality-adjusted life years (QALYs). Cost-effectiveness was expressed as an incremental cost-effectiveness ratio (ICER). Results: In all scenarios, i-FACTOR reduced costs within the first year by 1.4% to 2.1%. The savings proved to be incremental over time, increasing to 3.7% over an extrapolated 10 years. The ICER at 90 days was $13,333 per QALY and became negative ("dominated") relative to the control group within one year and onwards. In a threshold sensitivity analysis, the cost of i-FACTOR could theoretically be increased 70-fold and still remain cost-effective. Conclusion:The novel i-FACTOR is not only cost-effective compared to autograft in ACDF surgery but is the dominant economic strategy.

Biodegradable biomaterials in orthopedic surgery: A narrative review of the current evidence

“…43 None of the randomized clinical trials included in this review assessed the cost-effectiveness of biomaterials. However, Thaci et al 55 demonstrated that 15-aminoacid polypeptide bone substitute significantly reduced costs compared to autograft in cervical discectomy and fusion. Nevertheless, the evidence on the cost-effectiveness of biomaterials on orthopedic surgery is limited and warrants further studies.…”

A Systematic Review and Meta-Analysis of Silicon Nitride and Biomaterial Modulus as it Relates to Subsidence Risk in Spinal Fusion Surgery

“…Improved healing and adequate fusion are associated with improved quality of life, faster return to work, less pain, less opiate use, and fewer repeat surgeries. [1] This is in stark contrast properties of native bone. Similarly, radiolucent biomaterials were preferred so that future radiographic interpretation was not hindered.…”

“…Improved healing and adequate fusion are associated with improved quality of life, faster return to work, less pain, less opiate use, and fewer repeat surgeries. [1] This is in stark contrast to failed fusions, often due to pseudoarthrosis or subsidence. Failures are associated with costly and often more complicated revisions as well as serious downstream consequences for patients.…”

Controversies in Spine Surgery

“…The unit cost of i-Factor ranges from $757 to $2090, depending on the size ordered. Thaci et al 12 determined the incremental cost-effectiveness ratio of i-Factor use in ACDFs was $13,333 per quality-adjusted life year at 90 days and demonstrated a greater benefit and a lower cost at 1 year compared with the bone autograft cohort. An analysis comparing the total direct medical costs of BMP found that from a payer perspective, the cost of the utilization of BMP is offset by the reduction of medical resources associated with costs associated with fusion failures and the adverse events associated with ICBG harvest 13 .…”