Cost-Utility Analysis of rhBMP-2 Use in Adult Spinal Deformity Surgery.
Adult
Bone Morphogenetic Protein 2
/ economics
Cost-Benefit Analysis
Humans
Postoperative Complications
/ economics
Prospective Studies
Pseudarthrosis
/ economics
Quality-Adjusted Life Years
Recombinant Proteins
/ economics
Reoperation
/ economics
Spinal Curvatures
/ economics
Spinal Fusion
/ adverse effects
Spine
Transforming Growth Factor beta
/ economics
Journal
Spine
ISSN: 1528-1159
Titre abrégé: Spine (Phila Pa 1976)
Pays: United States
ID NLM: 7610646
Informations de publication
Date de publication:
15 Jul 2020
15 Jul 2020
Historique:
pubmed:
26
2
2020
medline:
5
9
2020
entrez:
26
2
2020
Statut:
ppublish
Résumé
Economic modeling of data from a multicenter, prospective registry. The aim of this study was to analyze the cost utility of recombinant human bone morphogenetic protein-2 (BMP) in adult spinal deformity (ASD) surgery. ASD surgery is expensive and presents risk of major complications. BMP is frequently used off-label to reduce the risk of pseudarthrosis. Of 522 ASD patients with fusion of five or more spinal levels, 367 (70%) had at least 2-year follow-up. Total direct cost was calculated by adding direct costs of the index surgery and any subsequent reoperations or readmissions. Cumulative quality-adjusted life years (QALYs) gained were calculated from the change in preoperative to final follow-up SF-6D health utility score. A decision-analysis model comparing BMP versus no-BMP was developed with pseudarthrosis as the primary outcome. Costs and benefits were discounted at 3%. Probabilistic sensitivity analysis was performed using mixed first-order and second-order Monte Carlo simulations. One-way sensitivity analyses were performed by varying cost, probability, and QALY estimates (Alpha = 0.05). BMP was used in the index surgery for 267 patients (73%). The mean (±standard deviation) direct cost of BMP for the index surgery was $14,000 ± $6400. Forty patients (11%) underwent revision surgery for symptomatic pseudarthrosis (BMP group, 8.6%; no-BMP group, 17%; P = 0.022). The mean 2-year direct cost was significantly higher for patients with pseudarthrosis ($138,000 ± $17,000) than for patients without pseudarthrosis ($61,000 ± $25,000) (P < 0.001). Simulation analysis revealed that BMP was associated with positive incremental utility in 67% of patients and considered favorable at a willingness-to-pay threshold of $150,000/QALY in >52% of patients. BMP use was associated with reduction in revisions for symptomatic pseudarthrosis in ASD surgery. Cost-utility analysis suggests that BMP use may be favored in ASD surgery; however, this determination requires further research. 2.
Sections du résumé
STUDY DESIGN
METHODS
Economic modeling of data from a multicenter, prospective registry.
OBJECTIVE
OBJECTIVE
The aim of this study was to analyze the cost utility of recombinant human bone morphogenetic protein-2 (BMP) in adult spinal deformity (ASD) surgery.
SUMMARY OF BACKGROUND DATA
BACKGROUND
ASD surgery is expensive and presents risk of major complications. BMP is frequently used off-label to reduce the risk of pseudarthrosis.
METHODS
METHODS
Of 522 ASD patients with fusion of five or more spinal levels, 367 (70%) had at least 2-year follow-up. Total direct cost was calculated by adding direct costs of the index surgery and any subsequent reoperations or readmissions. Cumulative quality-adjusted life years (QALYs) gained were calculated from the change in preoperative to final follow-up SF-6D health utility score. A decision-analysis model comparing BMP versus no-BMP was developed with pseudarthrosis as the primary outcome. Costs and benefits were discounted at 3%. Probabilistic sensitivity analysis was performed using mixed first-order and second-order Monte Carlo simulations. One-way sensitivity analyses were performed by varying cost, probability, and QALY estimates (Alpha = 0.05).
RESULTS
RESULTS
BMP was used in the index surgery for 267 patients (73%). The mean (±standard deviation) direct cost of BMP for the index surgery was $14,000 ± $6400. Forty patients (11%) underwent revision surgery for symptomatic pseudarthrosis (BMP group, 8.6%; no-BMP group, 17%; P = 0.022). The mean 2-year direct cost was significantly higher for patients with pseudarthrosis ($138,000 ± $17,000) than for patients without pseudarthrosis ($61,000 ± $25,000) (P < 0.001). Simulation analysis revealed that BMP was associated with positive incremental utility in 67% of patients and considered favorable at a willingness-to-pay threshold of $150,000/QALY in >52% of patients.
CONCLUSION
CONCLUSIONS
BMP use was associated with reduction in revisions for symptomatic pseudarthrosis in ASD surgery. Cost-utility analysis suggests that BMP use may be favored in ASD surgery; however, this determination requires further research.
LEVEL OF EVIDENCE
METHODS
2.
Identifiants
pubmed: 32097274
doi: 10.1097/BRS.0000000000003442
pii: 00007632-202007150-00018
doi:
Substances chimiques
Bone Morphogenetic Protein 2
0
Recombinant Proteins
0
Transforming Growth Factor beta
0
recombinant human bone morphogenetic protein-2
0
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1009-1015Références
Hassanzadeh H, Jain A, El Dafrawy MH, et al. Clinical results and functional outcomes of primary and revision spinal deformity surgery in adults. J Bone Joint Surg Am 2013; 95:1413–1419.
Jain A, Hassanzadeh H, Puvanesarajah V, et al. Incidence of perioperative medical complications and mortality among elderly patients undergoing surgery for spinal deformity: analysis of 3519 patients. J Neurosurg Spine 2017; 27:534–539.
Sciubba DM, Yurter A, Smith JS, et al. A comprehensive review of complication rates after surgery for adult deformity: a reference for informed consent. Spine Deform 2015; 3:575–594.
Kim YJ, Bridwell KH, Lenke LG, et al. Pseudarthrosis in adult spinal deformity following multisegmental instrumentation and arthrodesis. J Bone Joint Surg Am 2006; 88:721–728.
Kim YJ, Bridwell KH, Lenke LG, et al. Pseudarthrosis in long adult spinal deformity instrumentation and fusion to the sacrum: prevalence and risk factor analysis of 144 cases. Spine (Phila Pa 1976) 2006; 31:2329–2336.
Pichelmann MA, Lenke LG, Bridwell KH, et al. Revision rates following primary adult spinal deformity surgery: six hundred forty-three consecutive patients followed-up to twenty-two years postoperative. Spine (Phila Pa 1976) 2010; 35:219–226.
Hamilton DK, Buza JA III, Passias P, et al. The fate of patients with adult spinal deformity incurring rod fracture after thoracolumbar fusion. World Neurosurg 2017; 106:905–911.
Burkus JK, Transfeldt EE, Kitchel SH, et al. Clinical and radiographic outcomes of anterior lumbar interbody fusion using recombinant human bone morphogenetic protein-2. Spine (Phila Pa 1976) 2002; 27:2396–2408.
Dimar JR, Glassman SD, Burkus KJ, et al. Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/compression resistant matrix versus iliac crest bone graft. Spine (Phila Pa 1976) 2006; 31:2534–2539.
Dawson E, Bae HW, Burkus JK, et al. Recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge with an osteoconductive bulking agent in posterolateral arthrodesis with instrumentation. A prospective randomized trial. J Bone Joint Surg Am 2009; 91:1604–1613.
Jain A, Kebaish KM, Sponseller PD. Factors associated with use of bone morphogenetic protein during pediatric spinal fusion surgery: an analysis of 4817 patients. J Bone Joint Surg Am 2013; 95:1265–1270.
Jain A, Hassanzadeh H, Strike SA, et al. rhBMP use in cervical spine surgery: associated factors and in-hospital complications. J Bone Joint Surg Am 2014; 96:617–623.
Passias PG, Soroceanu A, Yang S, et al. Predictors of revision surgical procedure excluding wound complications in adult spinal deformity and impact on patient-reported outcomes and satisfaction: a two-year follow-up. J Bone Joint Surg Am 2016; 98:536–543.
Puvanesarajah V, Jain A, Cancienne JM, et al. BMP use and the risk of revision surgery after long posterolateral fusions in the elderly. Clin Spine Surg 2017; 30:E931–E937.
Maeda T, Buchowski JM, Kim YJ, et al. Long adult spinal deformity fusion to the sacrum using rhBMP-2 versus autogenous iliac crest bone graft. Spine (Phila Pa 1976) 2009; 34:2205–2212.
Kim HJ, Buchowski JM, Zebala LP, et al. RhBMP-2 is superior to iliac crest bone graft for long fusions to the sacrum in adult spinal deformity: 4- to 14-year follow-up. Spine (Phila Pa 1976) 2013; 38:1209–1215.
Poorman GW, Jalai CM, Boniello A, et al. Bone morphogenetic protein in adult spinal deformity surgery: a meta-analysis. Eur Spine J 2017; 26:2094–2102.
Cahill KS, Chi JH, Day A, et al. Prevalence, complications, and hospital charges associated with use of bone-morphogenetic proteins in spinal fusion procedures. JAMA 2009; 302:58–66.
Deyo RA, Ching A, Matsen L, et al. Use of bone morphogenetic proteins in spinal fusion surgery for older adults with lumbar stenosis: trends, complications, repeat surgery, and charges. Spine (Phila Pa 1976) 2012; 37:222–230.
Singh K, Ahmadinia K, Park DK, et al. Complications of spinal fusion with utilization of bone morphogenetic protein: a systematic review of the literature. Spine (Phila Pa 1976) 2014; 39:91–101.
Glassman SD, Carreon LY, Campbell MJ, et al. The perioperative cost of Infuse bone graft in posterolateral lumbar spine fusion. Spine J 2008; 8:443–448.
Louie PK, Hassanzadeh H, Singh K. Epidemiologic trends in the utilization, demographics, and cost of bone morphogenetic protein in spinal fusions. Curr Rev Musculoskelet Med 2014; 7:177–181.
Miller EK, Neuman BJ, Jain A, et al. An assessment of frailty as a tool for risk stratification in adult spinal deformity surgery. Neurosurg Focus 2017; 43:E3.
Neuman BJ, Ailon T, Scheer JK, et al. Development and validation of a novel adult spinal deformity surgical invasiveness score: analysis of 464 patients. Neurosurgery 2018; 82:647–853.
Yeramaneni S, Gum JL, Carreon LY, et al. Impact of readmissions in episodic care of adult spinal deformity: event-based cost analysis of 695 consecutive cases. J Bone Joint Surg Am 2018; 100:487–495.
Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ 2002; 21:271–292.
Glassman SD, Dimar JR III, Burkus K, et al. The efficacy of rhBMP-2 for posterolateral lumbar fusion in smokers. Spine (Phila Pa 1976) 2007; 32:1693–1698.
Glassman SD, Dimar JR, Carreon LY, et al. Initial fusion rates with recombinant human bone morphogenetic protein-2/compression resistant matrix and a hydroxyapatite and tricalcium phosphate/collagen carrier in posterolateral spinal fusion. Spine (Phila Pa 1976) 2005; 30:1694–1698.
Crawford CH III, Carreon LY, McGinnis MD, et al. Perioperative complications of recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge versus iliac crest bone graft for posterior cervical arthrodesis. Spine (Phila Pa 1976) 2009; 34:1390–1394.
Pateder DB, Park YS, Kebaish KM, et al. Spinal fusion after revision surgery for pseudarthrosis in adult scoliosis. Spine (Phila Pa 1976) 2006; 31:E314–E319.
Luhmann SJ, Bridwell KH, Cheng I, et al. Use of bone morphogenetic protein-2 for adult spinal deformity. Spine (Phila Pa 1976) 2005; 30:S110–S117.
Mulconrey DS, Bridwell KH, Flynn J, et al. Bone morphogenetic protein (RhBMP-2) as a substitute for iliac crest bone graft in multilevel adult spinal deformity surgery: minimum two-year evaluation of fusion. Spine (Phila Pa 1976) 2008; 33:2153–2159.
Smucker JD, Rhee JM, Singh K, et al. Increased swelling complications associated with off-label usage of rhBMP-2 in the anterior cervical spine. Spine (Phila Pa 1976) 2006; 31:2813–2819.
Tannoury CA, An HS. Complications with the use of bone morphogenetic protein 2 (BMP-2) in spine surgery. Spine J 2014; 14:552–559.
Glassman SD, Carreon LY, Djurasovic M, et al. RhBMP-2 versus iliac crest bone graft for lumbar spine fusion: a randomized, controlled trial in patients over sixty years of age. Spine (Phila Pa 1976) 2008; 33:2843–2849.
Carreon LY, Glassman SD, Djurasovic M, et al. RhBMP-2 versus iliac crest bone graft for lumbar spine fusion in patients over 60 years of age: a cost-utility study. Spine (Phila Pa 1976) 2009; 34:238–243.
Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness--the curious resilience of the $50,000-per-QALY threshold. N Engl J Med 2014; 371:796–797.
McCarthy I, O’Brien M, Ames C, et al. Incremental cost-effectiveness of adult spinal deformity surgery: observed quality-adjusted life years with surgery compared with predicted quality-adjusted life years without surgery. Neurosurg Focus 2014; 36:E3.
Raman T, Nayar SK, Liu S, et al. Cost-effectiveness of primary and revision surgery for adult spinal deformity. Spine (Phila Pa 1976) 2018; 43:791–797.