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A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Early Cost-effective Assessment from the Total Posterior Spine System (TOPS™) IDE Study

Background: Given the increased attention to functional improvement in spine surgery as it relates to motion preservation, activities of daily living, and cost, it is critical to fully understand the healthcare economic impact of new devices being tested in large FDA randomized controlled trials (RC...

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Autores principales: Ament, Jared D., Vokshoor, Amir, Badr, Yaser, Lanman, Todd, Kim, Kee D., Johnson, J. Patrick
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Columbia Data Analytics, LLC 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9132256/
https://www.ncbi.nlm.nih.gov/pubmed/35620455
http://dx.doi.org/10.36469/001c.33035
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author Ament, Jared D.
Vokshoor, Amir
Badr, Yaser
Lanman, Todd
Kim, Kee D.
Johnson, J. Patrick
author_facet Ament, Jared D.
Vokshoor, Amir
Badr, Yaser
Lanman, Todd
Kim, Kee D.
Johnson, J. Patrick
author_sort Ament, Jared D.
collection PubMed
description Background: Given the increased attention to functional improvement in spine surgery as it relates to motion preservation, activities of daily living, and cost, it is critical to fully understand the healthcare economic impact of new devices being tested in large FDA randomized controlled trials (RCT). The purpose of this analysis was to comprehensively evaluate the cost-effectiveness of the novel Total Posterior Spine (TOPS™) System investigational device compared with the trial control group, standard transforaminal lumbar interbody fusion (TLIF). Objective: To evaluate the cost-effectiveness of TOPS™ compared with TLIF. Methods: The study patient population was extracted from a multicenter RCT with current enrollment at n=121 with complete 1-year follow-up. The primary outcome was cost-effectiveness, expressed as the incremental cost-effectiveness ratio. Secondary outcomes were health-related utility, presented as quality-adjusted life-years (QALYs), and cost, calculated in US dollars. Analysis was conducted following Second Panel on Cost-Effectiveness Health and Medicine recommendations. The base case analysis utilized SF-36 survey data from the RCT. Both cost and QALY outcomes were discounted at a yearly rate of 3% to reflect their present value. A cohort Markov model was constructed to analyze perioperative and postoperative costs and QALYs for both TOPS™ and control groups. Scenario, probabilistic, and threshold sensitivity analyses were conducted to determine model discrimination and calibration. Results: The primary time horizon used to estimate cost and health utility was 2 years after index surgery. From a health system perspective, assuming a 50/50 split between Medicare and private payers, the TOPS™ cohort is cost-effective 2 years postoperatively ($6158/QALY) compared with control. At 6 years and beyond, TOPS™ becomes dominant, irrespective of payer mix and surgical setting. At willingness-to-pay thresholds of $100 000/QALY, 63% of all 5000 input parameter simulations favor TOPS, even with a $4000 upcharge vs TLIF. Discussion: The novel TOPS™ device is cost-effective compared with TLIF and becomes the dominant economic strategy over time. Conclusions: In the emerging, rapidly expanding field of value-based medicine, there will be an increased demand for these analyses, ensuring surgeons are empowered to make the best, most sustainable solutions for their patients and society.
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spelling pubmed-91322562022-05-25 A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Early Cost-effective Assessment from the Total Posterior Spine System (TOPS™) IDE Study Ament, Jared D. Vokshoor, Amir Badr, Yaser Lanman, Todd Kim, Kee D. Johnson, J. Patrick J Health Econ Outcomes Res Other Conditions Background: Given the increased attention to functional improvement in spine surgery as it relates to motion preservation, activities of daily living, and cost, it is critical to fully understand the healthcare economic impact of new devices being tested in large FDA randomized controlled trials (RCT). The purpose of this analysis was to comprehensively evaluate the cost-effectiveness of the novel Total Posterior Spine (TOPS™) System investigational device compared with the trial control group, standard transforaminal lumbar interbody fusion (TLIF). Objective: To evaluate the cost-effectiveness of TOPS™ compared with TLIF. Methods: The study patient population was extracted from a multicenter RCT with current enrollment at n=121 with complete 1-year follow-up. The primary outcome was cost-effectiveness, expressed as the incremental cost-effectiveness ratio. Secondary outcomes were health-related utility, presented as quality-adjusted life-years (QALYs), and cost, calculated in US dollars. Analysis was conducted following Second Panel on Cost-Effectiveness Health and Medicine recommendations. The base case analysis utilized SF-36 survey data from the RCT. Both cost and QALY outcomes were discounted at a yearly rate of 3% to reflect their present value. A cohort Markov model was constructed to analyze perioperative and postoperative costs and QALYs for both TOPS™ and control groups. Scenario, probabilistic, and threshold sensitivity analyses were conducted to determine model discrimination and calibration. Results: The primary time horizon used to estimate cost and health utility was 2 years after index surgery. From a health system perspective, assuming a 50/50 split between Medicare and private payers, the TOPS™ cohort is cost-effective 2 years postoperatively ($6158/QALY) compared with control. At 6 years and beyond, TOPS™ becomes dominant, irrespective of payer mix and surgical setting. At willingness-to-pay thresholds of $100 000/QALY, 63% of all 5000 input parameter simulations favor TOPS, even with a $4000 upcharge vs TLIF. Discussion: The novel TOPS™ device is cost-effective compared with TLIF and becomes the dominant economic strategy over time. Conclusions: In the emerging, rapidly expanding field of value-based medicine, there will be an increased demand for these analyses, ensuring surgeons are empowered to make the best, most sustainable solutions for their patients and society. Columbia Data Analytics, LLC 2022-03-25 /pmc/articles/PMC9132256/ /pubmed/35620455 http://dx.doi.org/10.36469/001c.33035 Text en https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (4.0) (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Other Conditions
Ament, Jared D.
Vokshoor, Amir
Badr, Yaser
Lanman, Todd
Kim, Kee D.
Johnson, J. Patrick
A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Early Cost-effective Assessment from the Total Posterior Spine System (TOPS™) IDE Study
title A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Early Cost-effective Assessment from the Total Posterior Spine System (TOPS™) IDE Study
title_full A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Early Cost-effective Assessment from the Total Posterior Spine System (TOPS™) IDE Study
title_fullStr A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Early Cost-effective Assessment from the Total Posterior Spine System (TOPS™) IDE Study
title_full_unstemmed A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Early Cost-effective Assessment from the Total Posterior Spine System (TOPS™) IDE Study
title_short A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Early Cost-effective Assessment from the Total Posterior Spine System (TOPS™) IDE Study
title_sort prospective study of lumbar facet arthroplasty in the treatment of degenerative spondylolisthesis and stenosis: early cost-effective assessment from the total posterior spine system (tops™) ide study
topic Other Conditions
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9132256/
https://www.ncbi.nlm.nih.gov/pubmed/35620455
http://dx.doi.org/10.36469/001c.33035
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