Review on Recent New Technology Add-on Payment Decisions of Medical Devices by Center for Medicare and Medicaid Services and Its Implications
0
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Medical devices have different characteristics from pharmaceuticals including the limitations on evidence generation and it needs to be considered at the time of value assessment. This article provides an review on recent new technology add-on payment (NTAP) decisions in terms of evidence requirements for medical devices. We investigated recent NTAP cases for interventions, biologics, in vitro diagnosis, and artificial intelligence-based devices regarding substantial clinical improvement. Evidence from published or unpublished information sources such as clinical trials, peer reviewed journal articles, study results, meta-analyses, consensus statements and whitepapers may be sufficient to demonstrate substantial clinical improvement. Real world evidence are also used as the critical source even in the unpublished form. In addition, clinical improvement can be evaluated by reviewing the overall status of the existing treatment of the disease and analyzing the clinical impact for current and future healthcare environments. It is not limited to direct comparative clinical study results for substantial clinical improvement for NTAP decision. It also transparently discloses the details of review process and what evidences were discussed. It is expected that patient accessibility can be improved through revision of current technology evaluation system in evaluating breakthrough or improved medical devices based on the implications on the NTAP.
Abstract
Medical devices have different characteristics from pharmaceuticals including the limitations on evidence generation and it needs to be considered at the time of value assessment. This article provides an review on recent new technology add-on payment (NTAP) decisions in terms of evidence requirements for medical devices. We investigated recent NTAP cases for interventions, biologics, in vitro diagnosis, and artificial intelligence-based devices regarding substantial clinical improvement. Evidence from published or unpublished information sources such as clinical trials, peer reviewed journal articles, study results, meta-analyses, consensus statements and whitepapers may be sufficient to demonstrate substantial clinical improvement. Real world evidence are also used as the critical source even in the unpublished form. In addition, clinical improvement can be evaluated by reviewing the overall status of the existing treatment of the disease and analyzing the clinical impact for current and future healthcare environments. It is not limited to direct comparative clinical study results for substantial clinical improvement for NTAP decision. It also transparently discloses the details of review process and what evidences were discussed. It is expected that patient accessibility can be improved through revision of current technology evaluation system in evaluating breakthrough or improved medical devices based on the implications on the NTAP.
참고문헌 (40)
- Drummond M, "Economic evaluation for devices and drugs--same or different?", Value Health, 12, pp.402~404 (2009)
- Taylor RS, "Assessing the clinical and cost-effectiveness of medical devices and drugs: are they that different?", Value Health, 12, pp.404~406 (2009)
- Sorenson C, "Applying health economics for policy decision making: do devices differ from drugs?", Europace, 13(Suppl 2), pp.ii54~ii58 (2011)
- Drummond M, "Incentivizing research into the effectiveness of medical devices", Eur J Health Econ, 17, pp.1055~1058 (2016)
- Frieden TR, "Evidence for health decision making-beyond randomized, controlled trials", N Engl J Med, 377, pp.465~475 (2017)
- Kramer DB, "Practical improvements for medical device evaluation", JAMA, 318, pp.332~334 (2017)
- "A framework for regulatory use of real-world evidence" (2017)[URL]
- Carroll JD, "Transcatheter valve therapy registry is a model for medical device innovation and surveillance", Health Aff(Millwood), 34, pp.328~334 (2015)
- "Use of real-world evidence to support regulatory decisionmaking for medical devices; draft guidance for industry and Food and Drug Administration staff" (2016)[URL]
- Noriega D, "A prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures(SAKOS study)", Spine J, 19, pp.1782~1795 (2019)
- Noriega DC, "Long-term safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures : a pilot, monocentric, investigator-initiated study", Osteoporos Int, 30, pp.637~645 (2019)
- Arabmotlagh M, "Radiological evaluation of kyphoplasty with an intravertebral expander after osteoporotic vertebral fracture", J Orthop Res, 37, pp.457~465 (2018)
- Lin JH, "Better height restoration, greater kyphosis correction, and fewer refractures of cemented vertebrae by using an intravertebral reduction device : a 1-year follow-up study", World Neurosurg, 90, pp.391~396 (2016)
- Krüger A, "Height restoration and maintenance after treating unstable osteoporotic vertebral compression fractures by cement augmentation is dependent on the cement volume used", Clin Biomech(Bristol, Avon), 28, pp.725~730 (2013)
- Renaud C, "Treatment of vertebral compression fractures with the cranio-caudal expandable implant SpineJack® : technical note and outcomes in 77 consecutive patients", Orthop Traumatol Surg Res, 101, pp.857~859 (2015)
- Kapadia SR, "Protection against cerebral embolism during transcatheter aortic valve replacement", J Am Coll Cardiol, 69, pp.367~377 (2017)
- Haussig S, "Effect of a cerebral protection device on brain lesions following transcatheter aortic valve implantation in patients with severe aortic stenosis : the CLEAN-TAVI randomized clinical trial", JAMA, 316, pp.592~601 (2016)
- Seeger J, "Cerebral embolic protection during transcatheter aortic valve replacement significantly reduces death and stroke compared with unprotected procedures", JACC Cardiovasc Interv, 10, pp.2297~2303 (2017)
- Van Mieghem NM, "Filter-based cerebral embolic protection with transcatheter aortic valve implantation : the randomised MISTRAL-C trial", EuroIntervention, 12, pp.499~507 (2016)
- Haddara S, "A novel hemostatic powder for upper gastrointestinal bleeding : a multicenter study(the"GRAPHE"registry)", Endoscopy, 48, pp.1084~1095 (2016)
- Changela K, "Hemostatic powder spray : a new method for managing gastrointestinal bleeding", Therap Adv Gastroenterol, 8, pp.125~135 (2015)
- Moole V, "Sa1734 – Evaluating the Efficacy of Hemostatic Nanopowder (TC-325) When Used with Standard Therapy for Achieving Immediate Hemostasis in Patients with Nonvariceal Upper Gastrointestinal Bleeding. A Systematic Review and Meta-Analysis", Gastroenterology, 156, pp.S~381 (2017)
- Rodríguez de Santiago E, "Hemostatic spray powder TC-325 for GI bleeding in a nationwide study : survival and predictors of failure via competing risks analysis", Gastrointest Endosc, 90, pp.581~590.e6 (2019)
- Alzoubaidi D, "Outcomes from an international multicenter registry of patients with acute gastrointestinal bleeding undergoing endoscopic treatment with Hemospray", Dig Endosc, 32, pp.96~105 (2020)
- Chen YI, "Hemostatic powders in gastrointestinal bleeding : a systematic review", Gastrointest Endosc Clin N Am, 25, pp.535~552 (2015)
- Chen YI, "TC-325 hemostatic powder versus current standard of care in managing malignant GI bleeding : a pilot randomized clinical trial", Gastrointest Endosc, 91, pp.321~328.e1 (2020)
- Pittayanon R, "Prognostic factors affecting outcomes in patients with malignant GI bleeding treated with a novel endoscopically delivered hemostatic powder", Gastrointest Endosc, 87, pp.994~1002 (2018)
- Gray WA, "A polymer-coated, paclitaxel-eluting stent(Eluvia)versus a polymerfree, paclitaxel-coated stent(Zilver PTX)for endovascular femoropopliteal intervention(IMPERIAL) : a randomised, non-inferiority trial", Lancet, 392, pp.1541~1551 (2018)
- Müller-Hülsbeck S, "Long-term results from the MAJESTIC trial of the eluvia paclitaxeleluting stent for femoropopliteal treatment : 3-year follow-up", Cardiovasc Intervent Radiol, 40, pp.1832~1838 (2017)
- Girard D, "Biotechnological management of skin burn injuries : challenges and perspectives in wound healing and sensory recovery", Tissue Eng Part B Rev, 23, pp.59~82 (2017)
- Holmes JH, "T5preliminary analysis of a phase 3 open-label, controlled, randomized trial evaluating the efficacy and safety of a bioengineered regenerative skin construct in patients with deep partial-thickness thermal burns", J Burn Care Res, 41(Supplement_1), pp.S3~S4 (2020)
- Holmes JH 4th, "An open-label, prospective, randomized, controlled, multicenter, phase 1b study of StrataGraft skin tissue versus autografting in patients with deep partial-thickness thermal burns", Burns, 45, pp.1749~1758 (2019)
- Voigt C, "The T2Bacteria assay is a sensitive and rapid detector of bacteremia that can be initiated in the emergency department and has potential to favorably influence subsequent therapy", J Emerg Med, 58, pp.785~796 (2020)
- De Angelis G, "T2Bacteria magnetic resonance assay for the rapid detection of ESKAPEc pathogens directly in whole blood", J Antimicrob Chemother, 73(suppl_4), pp.iv20~iv26 (2018)
- Clancy CJ, "T2 magnetic resonance for the diagnosis of bloodstream infections : charting a path forward", J Antimicrob Chemother, 73(suppl_4), pp.iv2~iv5 (2018)
- Nguyen MH, "Performance of the T2Bacteria panel for diagnosing bloodstream infections : a diagnostic accuracy study", Ann Intern Med, 170, pp.845~852 (2019)
- "Evaluation of automatic class III designation for contact" (2018)[URL]
- Sun CH, ""Picture to puncture" : a novel time metric to enhance outcomes in patients transferred for endovascular reperfusion in acute ischemic stroke", Circulation, 127, pp.1139~1148 (2013)
- Barreira C, "E-108 Aladin study : automated large artery occlusion detection in stroke imaging study–a multicenter analysis", J Neurointerv Surg, 10, pp.A101~A102 (2018)
- Barreira CM, "Abstract WP61 : automated large artery occlusion detection in stroke imaging-ALADIN study", Stroke, 49(Suppl_1), pp.AWP61~ (2018)
