i-FACTOR peptide enhanced bone graft is cost-effective compared to local autograft in ACDF surgery

Cerapedics’ i-FACTOR peptide enhanced bone graft

Cerapedics has announced the publication of the results of a study to evaluate the cost-effectiveness of i-FACTOR peptide enhanced bone graft compared to autograft for patients undergoing anterior cervical discectomy and fusion (ACDF) surgery in ClinicoEconomics and Outcomes Research. Study data demonstrate that i-FACTOR was cost-effective compared to local autograft in ACDF surgery.

Jared Ament, director of outcomes research and co-director of Spine Neurosurgery at the Neurosurgery & Spine Group and president and founder of Neuronomics, a professional corporation specialising in cost-effective analyses in the neurosciences, led this study.

The patient cohort was extracted from a prospective, multicentre randomised control trial from 22 North American centres. The study analysed various real-world scenarios, including inpatient and outpatient surgical settings and 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.

“In a robust cost-utility analysis, i-FACTOR reduced costs within the first year compared to the control group (autograft) in the ACDF IDE trial population. The incremental cost-effectiveness ratio proved highly cost-effective even at 90 days (US$13,333 per QALY). At one 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 Ament.

i-FACTOR has already demonstrated safety and improved outcomes compared to local autograft based on one- and two-year published data in Spine & Neurosurgery journals. This cost-effectiveness analysis was the next step to provide support for an alternative to autograft.

“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, these data puts us in a unique position relative to our competition. The technologies we displace with i-FACTOR do not have cost-effectiveness data, and most have no meaningful clinical data as well,” said Jeffrey G Marx, president, and chief operating officer, Cerapedics.

i-FACTOR bone graft has over 10 years of clinical success in Europe and was approved in the USA for use in ACDF procedures in 2015. The drug-device combination product is based on small peptide (P-15) technology that accelerates new bone formation in patients with degenerative disc disease. It is in a new category of bone graft technology and is one of only two drug-device combination products approved by the US Food & Drug Administration (FDA). In 2018, the company enrolled the first patients in an IDE clinical trial evaluating the safety and efficacy of its next-generation product, P-15L Peptide Enhanced Bone Graft, for use in patients undergoing Transforaminal lumbar interbody fusion (TLIF) surgery.


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