Innovative technologies for reverse total shoulder arthroplasty in Australia: Market access challenges and implications for patients, decision-makers, and manufacturers

References

• Ponce BA, Oladeji LO, Rogers ME, et al. Comparative analysis of anatomic and reverse total shoulder arthroplasty: in-hospital outcomes and costs. J Shoulder Elbow Surg. 2015;24(3):460–10.
   PubMed Web of Science ®Google Scholar
• Australian Orthopaedic Association National Joint Replacement Registry, Hip, knee & shoulder arthroplasty: 2021 annual report. Adelaide: Australian Orthopaedic Association, Adelaide; 2021. https://aoanjrr.sahmri.com/annual-reports-2021:1–432.
   Google Scholar
• Malchau H, Garellick G, Berry D, et al. Arthroplasty implant registries over the past five decades: development, current, and future impact. J Orthop Res. 2018;36(9):2319–2330.
   PubMed Web of Science ®Google Scholar
• National Joint Registry for England, Wales, Northern Ireland and Isle of Man. 17th annual report. 2020. https://reports.njrcentre.org.uk/portals/0/pdfdownloads/njr%2017th%20annual%20report%202020.pdf, National Joint Registry: Hertfordshire, UK. p. 1–312.
   Google Scholar
• Neer CS 2nd, Kirby RM. Revision of humeral head and total shoulder arthroplasties. Clin Orthop Relat Res. 1982;1982(170):189–195.
   Google Scholar
• Sheridan BD, Ahearn N, Tasker A, et al. Shoulder arthroplasty. Part 2: normal and abnormal radiographic findings. Clin Radiol. 2012;67(7):716–721.
   PubMed Web of Science ®Google Scholar
• Department of Health and Aged Care. Why is health technology assessment (HTA) important? 2020. Accessed 22 03 2022. Available from: https://www1.health.gov.au/internet/hta/publishing.nsf/Content/hta-1.
   Google Scholar
• Department of Health and Aged Care, . . Guidelines for preparing assessments for the medical services advisory committee , Editor. : ; 2021 Accessed 28 03 2022 http://www.msac.gov.au/internet/msac/publishing.nsf/Content/E0D4E4EDDE91EAC8CA2586E0007AFC75/$File/MSAC%20Guidelines-complete-16-FINAL(18May21).pdf.
   Google Scholar
• Department of Health and Aged Care. The Prostheses List. 2021. Accessed 22 03 2022. Available from: https://www.health.gov.au/health-topics/private-health-insurance/the-prostheses-list?utm_source=health.gov.au&utm_medium=callout-auto-custom&utm_campaign=digital_transformation.
   Google Scholar
• Department of Health and Aged Care. Prostheses List. Guide to listing and setting benefits for prostheses., Editor. 2020 Accessed 23 03 2022. https://www.health.gov.au/resources/publications/prostheses-list-guide.
   Google Scholar
• Reckers-Droog V, Federici C, Brouwer W, et al. Challenges with coverage with evidence development schemes for medical devices: a systematic review. Health Policy Technol. 2020;9(2):146–156.
   Web of Science ®Google Scholar
• Harreld K, Clark R, Downes K, et al. Correlation of subjective and objective measures before and after shoulder arthroplasty. Orthopedics. 2013;36(6):808–814.
   PubMed Web of Science ®Google Scholar
• Rees JL, Dawson J, Hand GCR, et al. The use of patient-reported outcome measures and patient satisfaction ratings to assess outcome in hemiarthroplasty of the shoulder. J Bone Joint Surg Br. 2010;92-B(8):1107–1111.
   Google Scholar
• Zywiel MG, Mahomed A, Gandhi R, et al. Measuring expectations in orthopaedic surgery: a systematic review. Clin Orthop Relat Res. 2013;471(11):3446–3456.
   PubMed Web of Science ®Google Scholar
• Meislin RJ, Sperling JW, Stitik TP. Persistent shoulder pain: epidemiology, pathophysiology, and diagnosis. Am J Orthop. 2005;34(12 Suppl):5–9.
   PubMedGoogle Scholar
• Nicholson JA, Jones R, MacDonald DJ, et al. Cost-effectiveness of the reverse total shoulder arthroplasty. Does indication affect outcome? Shoulder Elbow. 2021;13(1):90–97.
   PubMedGoogle Scholar
• Martin RC 2nd, Brennan MF, Jaques DP. Quality of complication reporting in the surgical literature. Ann Surg. 2002;235(6):803–813.
   PubMed Web of Science ®Google Scholar
• Sims MT, Detweiler BN, Scott JT, et al. Inconsistent selection of outcomes and measurement devices found in shoulder arthroplasty research: an analysis of studies on ClinicalTrials.gov. PLOS ONE. 2017;12(11):e0187865.
   PubMed Web of Science ®Google Scholar
• McCormick KL, Tedesco LJ, Swindell HW, et al. Statistical fragility of randomized clinical trials in shoulder arthroplasty. J Shoulder Elbow Surg. 2021;30(8):1787–1793.
   PubMed Web of Science ®Google Scholar
• Clarke M, Williamson P. Core outcome sets and trial registries. Trials. 2015;16(1):1–3.
   PubMedGoogle Scholar
• Horner NS, de Sa D, Heaven S, et al. Indications and outcomes of shoulder arthroscopy after shoulder arthroplasty. J Shoulder Elbow Surg. 2016;25(3):510–518.
   PubMed Web of Science ®Google Scholar
• Rongen JJ, Hannink G. Comparison of registered and published primary outcomes in randomized controlled trials of orthopaedic surgical interventions. J Bone Joint Surg Am. 2016;98(5):403–409.
   PubMed Web of Science ®Google Scholar
• Gorst SL, Gargon, E, Clarke, M et al, . Choosing important health outcomes for comparative effectiveness research: an updated review and user survey. PLoS One. 2016;11(1):e0146444.
   PubMed Web of Science ®Google Scholar
• Gagnier JJ, Page MJ, Huang H, et al. Creation of a core outcome set for clinical trials of people with shoulder pain: a study protocol. Trials. 2017;18(1):336.
   PubMedGoogle Scholar
• National Guideline Centre (UK).Evidence review for shoulder replacement – intact rotator cuff: joint replacement (primary): hip, knee and shoulder: evidence review. London: National Institute for Health and Care Excellence (NICE); 2020. https://www.ncbi.nlm.nih.gov/books/NBK561417/
   Google Scholar
• Niederländer CS, Kriza C, Kolominsky-Rabas P. Quality criteria for medical device registries: best practice approaches for improving patient safety – a systematic review of international experiences. Expert Rev Med Devices. 2017;14(1):49–64.
   PubMed Web of Science ®Google Scholar
• Kendrick B, Palmer A, Taylor A. How best to regulate new implants in the market—is radiostereometric analysis enough? Ann Joint. 2019;4:45.
   Web of Science ®Google Scholar
• Kriechling P, Waltenspül M, Bouaicha S, et al. Establishing an institutional reverse total shoulder arthroplasty registry. Obere Extremität. 2021;16(4):265–271.
   Google Scholar
• Brown JS, Gordon, RJ, Peng, Y et al, . Lower operating volume in shoulder arthroplasty is associated with increased revision rates in the early postoperative period: long-term analysis from the Australian Orthopaedic Association National Joint Replacement Registry. J Shoulder Elbow Surg. 2020;29(6):1104–1114.
   PubMed Web of Science ®Google Scholar
• Karelse A, Van Tongel A, Gosens T, et al. Limited value of current shoulder arthroplasty registries in evidence-based shoulder surgery: a review of 7 national registries. Expert Rev Med Devices. 2021;18(12):1189–1201.
   PubMed Web of Science ®Google Scholar
• Al Sayah F, Lahtinen, M, Bonsel, G.J. et al, . A multi-level approach for the use of routinely collected patient-reported outcome measures (PROMs) data in healthcare systems. J Patient Rep Outcomes. 2021;5(Suppl 2):98.
   PubMedGoogle Scholar
• Wilson I, Bohm, E, Lübbeke, A et al, . Orthopaedic registries with patient-reported outcome measures. EFORT Open Rev. 2019;4(6):357–367.
   PubMed Web of Science ®Google Scholar
• Rolfson O, Bohm E, Franklin P, et al.; Recommendations for selection, administration, and analysisReport of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries Part II. Recommendations for selection, administration, and analysis. Acta Orthop. 2016;87(Suppl 1):9–23.
   PubMed Web of Science ®Google Scholar
• Dawson J, Fitzpatrick R, Carr A. Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br. 1996;78(4):593–600.
   PubMedGoogle Scholar
• Lo IK, Griffin S, Kirkley A. The development of a disease-specific quality of life measurement tool for osteoarthritis of the shoulder: the Western Ontario Osteoarthritis of the Shoulder (WOOS) index. Osteoarthritis Cartilage. 2001;9(8):771–778.
   PubMed Web of Science ®Google Scholar
• McCormack P, Cowling PD. Determining the outcomes after shoulder surgery. Orthop Trauma. 2022;36(3):185–189.
   Google Scholar
• Rasmussen JV, Brorson, S, Hallan, G et al, . Is it feasible to merge data from national shoulder registries? A new collaboration within the Nordic Arthroplasty Register Association. J Shoulder Elbow Surg. 2016;25(12):e369–e377.
   PubMed Web of Science ®Google Scholar
• Lübbeke A, Rees JL, Barea C, et al. International variation in shoulder arthroplasty. Acta Orthop. 2017;88(6):592–599.
   PubMed Web of Science ®Google Scholar
• Aveledo R, Holland P, Thomas M, et al. A comparison of the minimum data sets for primary shoulder arthroplasty between national shoulder arthroplasty registries. Is international harmonization feasible? Shoulder Elbow. 2019;11(2 Suppl):48–55.
   PubMedGoogle Scholar
• Page RS, Navarro RA, Salomonsson B. Establishing an international shoulder arthroplasty consortium. J Shoulder Elbow Surg. 2014;23(8):1081–1082.
   PubMed Web of Science ®Google Scholar
• Australian Orthopaedic Association National Joint Replacement Registry, AOA PROMs pilot project final report. . 2020. https://aoanjrr.sahmri.com/documents/10180/681914/AOANJRR+PROMs+Pilot+Final+Report, Australian Orthopaedic Association National: Adelaide.
   Google Scholar
• Harris IA, Peng Y, Cashman K, et al. Association between patient factors and hospital completeness of a patient-reported outcome measures program in joint arthroplasty, a cohort study. J Patient Rep Outcomes. 2022;6(1):32.
   PubMedGoogle Scholar
• Sayers A, Crowther MJ, Judge A, et al. Determining the sample size required to establish whether a medical device is non-inferior to an external benchmark. BMJ Open. 2017;7(8):e015397.
   PubMed Web of Science ®Google Scholar
• Deere KC, Whitehouse MR, Porter M, et al. Assessing the non-inferiority of prosthesis constructs used in total and unicondylar knee replacements using data from the national joint registry of England, Wales, Northern Ireland and the Isle of Man: a benchmarking study. BMJ Open. 2019;9(4):e026736.
   PubMed Web of Science ®Google Scholar
• Department of Health and Aged Care. Prostheses list—Guide to listing and setting benefits for prostheses, 2017, Editor 2017. Accessed 28 03 2022. https://www.health.gov.au/sites/default/files/documents/2020/06/prostheses-list-guide.pdf
   Google Scholar
• National Joint Registry (UK). Archive 11th Edition. Highlights: orthopedic Data Evaluation Panel (ODEP). 2013. Accessed 24 03 2022. Available from: https://reports.njrcentre.org.uk/2013/Orthopedic-Data-Evaluation-Panel
   Google Scholar
• Poolman RW, Verhaar, JA, Schreurs, BW et al, . Finding the right Hip implant for patient and surgeon: the Dutch strategy–empowering patients. Hip Int. 2015;25(2):131–137.
   PubMed Web of Science ®Google Scholar
• International Prosthesis Benchmarking Working Group, . Guidance Document Hip and Knee Arthroplasty Devices. 2018 Accessed 31 03 2022 https://www.isarhome.org/publications.
   Google Scholar
• Australian Orthopaedic Association. National Joint Replacement Registry, Australian orthopaedic association national joint replacement registry annual report: 2016 annual report. 2016 https://aoanjrr.sahmri.com/annual-reports-2016: Adelaide: Australian Orthopaedic Association.
   Google Scholar
• Farmer KW, Hammond JW, Queale WS et al . Shoulder Arthroplasty versus Hip and Knee Arthroplasties: A Comparison of Outcomes. Clinical Orthopaedics and Related Research. Vol. 455, 183–189; 2007. doi:10.1097/01.blo.0000238839.26423.8d.
   PubMedGoogle Scholar
• Chubb HA, Cornish ER, Hallstrom BR, et al. Early benchmarking total hip arthroplasty implants using data from the michigan arthroplasty registry collaborative quality initiative (MARCQI). Orthop Res Rev. 2021;13:215–228.
   PubMed Web of Science ®Google Scholar
• Ritter MA, Albohm MJ, Keating EM, et al. Comparative outcomes of total joint arthroplasty. J Arthroplasty. 1995;10(6):737–741.
   PubMed Web of Science ®Google Scholar
• Mahendraraj KA, Carducci MP, Galvin JW, et al. Reassessing the minimum two-year follow-up standard after total shoulder arthroplasty-Is one year sufficient? Shoulder Elbow. 2021;13(5):527–533.
   PubMedGoogle Scholar
• Shervin N, Rubash HE, Katz JN. Orthopaedic procedure volume and patient outcomes: a systematic literature review. Clin Orthop Relat Res. 2007;457:35–41.
   PubMed Web of Science ®Google Scholar
• Campbell B, Wilkinson J, Marlow M, et al. Generating evidence for new high-risk medical devices. BMJ Surg Interv Health Technol. 2019;1(1):e000022.
   PubMedGoogle Scholar
• Federici C, Reckers-Droog V, Ciani O, et al. Coverage with evidence development schemes for medical devices in Europe: characteristics and challenges. Eur J Health Econ. 2021;22(8):1253–1273.
   PubMed Web of Science ®Google Scholar
• Drummond M, Federici, C, Reckers-Droog, V et al, . Coverage with evidence development for medical devices in Europe: can practice meet theory?. Health Econ; 2022. Sep;31, Suppl 1(Suppl 1):179–194. doi:10.1002/hec.4478 .
   Google Scholar
• Garrison LP Jr., Towse A, Briggs A, et al. Performance-based risk-sharing arrangements-good practices for design, implementation, and evaluation: report of the ISPOR good practices for performance-based risk-sharing arrangements task force. Value Health. 2013;16(5):703–719.
   PubMed Web of Science ®Google Scholar
• Trueman P, Grainger DL, Downs KE. Coverage with Evidence Development: applications and issues. Int J Technol Assess Health Care. 2010;26(1):79–85.
   PubMed Web of Science ®Google Scholar
• Brügger U. A review of Coverage with Evidence Development (CED) in different countries: what works and what doesn’t. Manchester: NICE; 2014.
   Google Scholar
• Myung J-E, Tanaka Y, Choi H, et al. Coverage with evidence development programs for medical technologies in Asia-Pacific regions: a case study of Japan and South Korea. JMA J. 2021;4(4):311–320.
   PubMedGoogle Scholar
• Facey KM, Rappagliosi WT, A TRS, et al., Adaptive HTA for innovative implantable medical devices? Report of HTAi 2019 sponsored symposium. 2019, Health Technology Assessment International: Canada.
   Google Scholar
• Kovacevic D. Editorial commentary: delivering the PROMIS for patients with shoulder disorders—fool’s gold, a mirage, or an oasis. arthroscopy. J Arthroscop Relat Surg. 2021;37(4):1310–1313.
   PubMed Web of Science ®Google Scholar
• Black N. Patient reported outcome measures could help transform healthcare. BMJ. Vol. 346; 2013. p. f167. doi:10.1136/bmj.f167.
   PubMed Web of Science ®Google Scholar
• Williams K, Morris SJ, D GP, et al., Patient-reported outcome measures: literature review. 2016, ACSQHC: Sydney.
   Google Scholar
• Damman OC. The use of PROMs and shared decision-making in medical encounters with patients: an opportunity to deliver value-based health care to patients. J Eval Clin Pract. 2020;26(2):524–540.
   PubMed Web of Science ®Google Scholar
• Scott AM, Wale JL. Patient advocate perspectives on involvement in HTA: an international snapshot. Res Involv Engagem. 2017;3(1):2.
   PubMedGoogle Scholar
• Porter ME. What is value in health care? N Engl J Med. 2010;363(26):2477–2481.
   PubMed Web of Science ®Google Scholar
• Department of Health and Aged Care . The Prostheses List Reforms. 2022. Accessed 21 11 2022. https://www.health.gov.au/topics/private-health-insurance/the-prostheses-list/the-prostheses-list-reforms?language=und
   Google Scholar
• Favre P, Maquer G, Henderson A, et al. In silico clinical trials in the orthopedic device industry: from fantasy to reality? Ann Biomed Eng. 2021;49(12):3213–3226.
   PubMed Web of Science ®Google Scholar