Abstract
Objective
Medical devices can offer important therapeutic advances but, as for any medical interventions, there are questions about their costs and benefits. We examined health benefits and costs for pre-market approved (PMA) devices approved by the US Food and Drug Administration (FDA) (1999–2015), grouping them by generic category (e.g., drug-eluting stents) and indication.
Methods
We searched PubMed for incremental health gain estimates [measured in quality-adjusted life-years (QALYs)] and incremental costs for each device category compared to previously available treatments. We calculated incremental cost-effectiveness ratios by dividing the average incremental costs by the average incremental QALY gains. In sensitivity analysis, we repeated the analysis when excluding industry-funded studies.
Results
We identified at least one relevant cost-utility or comparative-effectiveness study for 88 devices (15.9% of non-cosmetic devices approved from 1999 to 2015), and at least one device across 53 (26.2%) generic categories. The median (mean) incremental cost across generic device categories was $1701 ($13,320). The median (mean) incremental health gain across generic device categories was 0.13 (0.46) QALYs. We found that cost-effectiveness ratios for 36 of 53 (68%) and 43 of 53 (81%) device categories fell below (were more favorable than) $50,000 and $150,000 per QALY, respectively. Results were roughly similar when we excluded industry-funded studies.
Conclusions
We found that roughly one-quarter of the major PMA medical device categories have published cost-effectiveness evidence accessible through a large, publicly available database. Available evidence suggests that devices generally offer good value, as judged relative to established cost-effectiveness benchmarks.
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References
Healthy Savings: Medical Technology and the Economic Burden of Disease. Milken Institute. 2014. https://www.advamed.org/sites/default/files/resource/714_healthysavingsfinal_0.pdf.). Accessed 4 Oct 2019.
Eastman RC, Leptien AD, Chase HP. Cost-effectiveness of use of the GlucoWatch Biographer in children and adolescents with type 1 diabetes: a preliminary analysis based on a randomized controlled trial. Pediatr Diabetes. 2003;4:82–6.
Ekman M, Sjogren I, James S. Cost-effectiveness of the Taxus paclitaxel-eluting stent in the Swedish healthcare system. Scand Cardiovasc J. 2006;40:17–24.
Moreno SG, Novielli N, Cooper NJ. Cost-effectiveness of the implantable HeartMate II left ventricular assist device for patients awaiting heart transplantation. J Heart Lung Transplant. 2012;31:450–8.
Premarket Approval (PMA) U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm. Accessed 22 Jul 2019.
Neumann P, Ganiats T, Russel L, Sanders G, Siegel J. Cost-effectiveness in health and medicine. Oxford: Oxford University Press; 2016.
Grosse SD. Assessing cost-effectiveness in healthcare: history of the $50,000 per QALY threshold. Expert Rev Pharmacoecon Outcomes Res. 2008;8:165–78.
PubMed. National Center for Biotechnology Information. 2019. https://www.ncbi.nlm.nih.gov/pubmed. Accessed 4 Oct 2019.
Reddy VY, Akehurst RL, Amorosi SL, Gavaghan MB, Hertz DS, Holmes DR Jr. Cost-effectiveness of left atrial appendage closure with the WATCHMAN device compared with warfarin or non-vitamin K antagonist oral anticoagulants for secondary prevention in nonvalvular atrial fibrillation. Stroke. 2018;49:1464–70.
Boston Scientific Receives FDA Approval for WATCHMAN™ Left Atrial Appendage Closure Device. 2015. https://news.bostonscientific.com/2015-03-13-Boston-Scientific-Receives-FDA-Approval-for-WATCHMAN-Left-Atrial-Appendage-Closure-Device. Accessed 4 Oct 2019.
Doble B, Blackhouse G, Goeree R, Xie F. Cost-effectiveness of the Edwards SAPIEN transcatheter heart valve compared with standard management and surgical aortic valve replacement in patients with severe symptomatic aortic stenosis: a Canadian perspective. J Thorac Cardiovasc Surg. 2013;146:52-60 e3.
Consumer Price Index [Internet]. Washington (DC): Department of Labor. http://www.bls.gov/cpi/. Accessed 22 Jul 2019.
Foreign exchange rates—H.10 [Internet]. Board of Governors of the Federal Reserve System. http://www.federalreserve.gov/releases/H10/Hist/default.htm. Accessed 18 July 2021.
Pulikottil-Jacob R, Suri G, Connock M, et al. Comparative cost-effectiveness of the HeartWare versus HeartMate II left ventricular assist devices used in the United Kingdom National Health Service bridge-to-transplant program for patients with heart failure. J Heart Lung Transplant. 2014;33:350–8.
Final Value Assessment Framework: Updates for 2017–2019. Institute for Clinical and Economic Review. 2017. https://icer-review.org/wp-content/uploads/2017/06/ICER-value-assessment-framework-Updated-050818.pdf. Accessed 26 Sep 2019.
Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness—the curious resilience of the $50,000-per-QALY threshold. N Engl J Med. 2014;371:796–7.
Bell CM, Urbach DR, Ray JG, et al. Bias in published cost effectiveness studies: systematic review. BMJ. 2006;332:699–703.
Eisenstein EL, Leon MB, Kandzari DE, et al. Long-term clinical and economic analysis of the Endeavor zotarolimus-eluting stent versus the cypher sirolimus-eluting stent: 3-year results from the ENDEAVOR III trial (Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2009;2:1199–207.
Kim DD, Wilkinson CL, Pope EF, Chambers JD, Cohen JT, Neumann PJ. The influence of time horizon on results of cost-effectiveness analyses. Expert Rev Pharmacoecon Outcomes Res. 2017;17:615–23.
Chambers JD, Silver MC, Berklein FC, Cohen JT, Neumann PJ. Orphan drugs offer larger health gains but less favorable cost-effectiveness than non-orphan drugs. J Gen Intern Med. 2020;35:2629–36.
Onwudiwe NC, Baker AM, Belinson S, Gingles B. Assessing the value of medical devices—choosing the best path forward: where do we go from here? Value Outcomes Spotlight. 2017;4:15–7.
Tarricone R, Torbica A, Drummond M. Challenges in the assessment of medical devices: the MedtecHTA project. Health Econ. 2017;26(Suppl 1):5–12.
Sanders GD, Neumann PJ, Basu A, et al. Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: second panel on cost-effectiveness in health and medicine. JAMA. 2016;316:1093–103.
Basu A, Maciejewski ML. Choosing a time horizon in cost and cost-effectiveness analyses. JAMA. 2019;321:1096–7.
Husereau D, Drummond M, Petrou S, et al. Consolidated health economic evaluation reporting standards (CHEERS) statement. Int J Technol Assess Health Care. 2013;29:117–22.
Taylor RS, Iglesias CP. Assessing the clinical and cost-effectiveness of medical devices and drugs: are they that different? Value Health. 2009;12:404–6.
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This study was funded by AdvaMed.
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All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by James D. Chambers, Madison C. Silver, and Flora C. Berklein. The first draft of the manuscript was written by James D. Chambers and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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Chambers, J.D., Silver, M.C., Berklein, F.C. et al. Are Medical Devices Cost-Effective?. Appl Health Econ Health Policy 20, 235–241 (2022). https://doi.org/10.1007/s40258-021-00698-6
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DOI: https://doi.org/10.1007/s40258-021-00698-6