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Manufacturers’ perceptions of the decision-making process for new drug reimbursement in South Korea

Published online by Cambridge University Press:  17 September 2021

Kyung-Bok Son
Affiliation:
School of Pharmacy, Sungkyunkwan University, Gyeonggi-do, South Korea College of Pharmacy, Ewha Womans University, Seoul, South Korea
Sylvia Park
Affiliation:
Korea Institute for Health and Social Affairs, Sejong City, South Korea
Myoungsoon You*
Affiliation:
Department of Public Health Science, Graduate School of Public Health, Seoul National University, Seoul, South Korea Institute of Health and Environment, Seoul National University, Seoul, South Korea
*
Author for correspondence: Myoungsoon You, E-mail: msyou@snu.ac.kr

Abstract

This study aimed to evaluate manufacturers’ perceptions of the decision-making process for new drug reimbursement and to formulate implications in operating a health technology assessment system. In 2019, we conducted a questionnaire survey and a semistructured group interview for domestic (n = 6) and foreign manufacturers (n = 9) who had vast experience in introducing new medicines into the market through a health technology assessment. Representatives of manufacturers indicated that disease severity, budget impact, existence of alternative treatment, and health-related quality of life were relevant criteria when assessing reimbursement decisions. Compared with domestic manufacturers, foreign manufacturers were risk takers when making reimbursement decisions in terms of adopting a new drug and managing pharmaceutical expenditure. However, foreign manufacturers were risk-averse when evaluating new drugs with uncertainties based on real-world data such as clinical effectiveness. Based on manufacturers’ perceptions of the decision-making process for new drug reimbursement, there is room for improvement in health technology assessment systems. Explaining the underlying reasons behind their decisions, unbiased participation by various stakeholders and their embedded roles in the decision-making process need to be emphasized. However, the measures suggested in this study should be introduced with cautions. The process of health technology assessment might be a target for those who undermine the system in pursuit of their private interests.

Type
Policy
Copyright
Copyright © The Author(s), 2021. Published by Cambridge University Press

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References

Belloni, A, Morgan, D, Paris, V. Pharmaceutical expenditure and policies; 2016Google Scholar
Figueras, J, McKee, M, Cain, J, Lessof, S, World Health Organization. Health systems in transition: Learning from experience. Copenhagen: WHO Regional Office for Europe; 2004.Google Scholar
Ferrario, A, Kanavos, P. Dealing with uncertainty and high prices of new medicines: A comparative analysis of the use of managed entry agreements in Belgium, England, the Netherlands and Sweden. Soc Sci Med. 2015;124:3947.CrossRefGoogle ScholarPubMed
Leopold, C, Morgan, SG, Wagner, AK. A rapidly changing global medicines environment: How adaptable are funding decision-making systems? Health Policy. 2017;121:637–43.CrossRefGoogle ScholarPubMed
Lorenzoni, L, Belloni, A, Sassi, F. Health-care expenditure and health policy in the USA versus other high-spending OECD countries. Lancet. 2014;384:8392.CrossRefGoogle ScholarPubMed
Mossialos, E, Le Grand, J. Health care and cost containment in the European Union. New York: Routledge; 2019.CrossRefGoogle Scholar
Mills, M, Kanavos, P. Do pharmaceutical budgets deliver financial sustainability in healthcare? Evidence from Europe. Health Policy. 2020;124:239–51.CrossRefGoogle ScholarPubMed
Granlund, D, Rudholm, N, Wikström, M. Fixed budgets as a cost containment measure for pharmaceuticals. Eur J Health Econ. 2006;7:3745.CrossRefGoogle ScholarPubMed
Fleming, TR. Surrogate endpoints and FDA's accelerated approval process. Health Aff. 2005;24:6778.CrossRefGoogle ScholarPubMed
Johnson, JR, Ning, Y-M, Farrell, A, Justice, R, Keegan, P, Pazdur, R. Accelerated approval of oncology products: The food and drug administration experience. J Natl Cancer Inst. 2011;103:636–44.CrossRefGoogle ScholarPubMed
Chuk, MK, Chang, JT, Theoret, MR, Sampene, EHe, K, Weis, S, et al. FDA approval summary: Accelerated approval of pembrolizumab for second-line treatment of metastatic melanoma. Clin Cancer Res. 2017;23:5666–70.CrossRefGoogle ScholarPubMed
Sherman, RE, Anderson, SA, Dal Pan, GJGray, GWGross, T, Hunter, NL, et al. Real-world evidence – what is it and what can it tell us. N Engl J Med. 2016;375:2293–7.CrossRefGoogle ScholarPubMed
Demets, DL. Methods for combining randomized clinical trials: Strengths and limitations. Stat Med. 1987;6:341–8.CrossRefGoogle ScholarPubMed
Auraaen, A, Fujisawa, R, De Lagasnerie, G, Paris, V. How OECD health systems define the range of good and services to be financed collectively; 2016Google Scholar
Svensson, M, Nilsson, FO, Arnberg, K. Reimbursement decisions for pharmaceuticals in Sweden: The impact of disease severity and cost effectiveness. Pharmacoeconomics. 2015;33:1229–36.CrossRefGoogle ScholarPubMed
Kim, C-y. Health technology assessment in South Korea. Int J Technol Assess Health Care. 2009;25:219–23.CrossRefGoogle ScholarPubMed
Bae, EY, Lee, EK. Pharmacoeconomic guidelines and their implementation in the positive list system in South Korea. Value Health. 2009;12:S36S41.CrossRefGoogle ScholarPubMed
Bae, E-Y, Hong, J-M, Kwon, H-Y, Jang, SLee, H-J, Bae, S, et al. Eight-year experience of using HTA in drug reimbursement: South Korea. Health Policy. 2016;120:612–20.CrossRefGoogle ScholarPubMed
WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies. PPRI Pharma Profile South Korea. Vienna: WHO Collaborating Centre; 2018.Google Scholar
Park, SE, Lim, SH, Choi, HW, Lee, SM, Kim, DW, Yim, EY, et al. Evaluation on the first 2 years of the positive list system in South Korea. Health Policy. 2012;104:32–9.CrossRefGoogle ScholarPubMed
Yang, B-m, Bae, E-y, Kim, J. Economic evaluation and pharmaceutical reimbursement reform in South Korea's national health insurance. Health Aff. 2008;27:179–87.CrossRefGoogle ScholarPubMed
Health Insurance Review and Assessment Service. Regulation for evaluation criteria and procedures, etc. for reimbursement eligibility, etc. of drugs. Sect. 4. 2021.Google Scholar
Son, K-B, Lee, T-J. Review of pharmaceutical economic evaluation studies in Korea. J Health Tech Assess. 2014;2:8392.Google Scholar
Son, K-B. Understanding the adoption of new drugs decided by several stakeholders in the South Korean market: A nonparametric event history analysis. Health Econ Rev. 2018;8:31.CrossRefGoogle ScholarPubMed
Health Insurance Review and Assessment Service. The list of the Pharmaceutical Benefits Committee. Published 2020 [accessed 2020 Aug 20]. Available from: http://www.hira.or.kr/dummy.do?pgmid=HIRAA030051000006.Google Scholar
Health Insurance Review and Assessment Service. The appraisal summary. Published 2020 [accessed 2020 Aug 20]. Available from: http://www.hira.or.kr/bbsDummy.do?pgmid=HIRAA030014040000.Google Scholar
Oortwijn, W, Determann, D, Schiffers, K, Tan, SS, van der Tuin, J. Towards integrated health technology assessment for improving decision making in selected countries. Value Health. 2017;20:1121–30.CrossRefGoogle ScholarPubMed
Yoo, S-L, Kim, D-J, Lee, S-M, Kang, WG, Kim, SY, Lee, JH, et al. Improving patient access to new drugs in South Korea: Evaluation of the national drug formulary system. Int J Environ Res Public Health. 2019;16:288.CrossRefGoogle ScholarPubMed
Siddiqi, S, Masud, TI, Nishtar, S, Peters, DH, Sabri, BBile, KM, et al. Framework for assessing governance of the health system in developing countries: Gateway to good governance. Health Policy. 2009;90:1325.CrossRefGoogle ScholarPubMed
Tanios, N, Wagner, M, Tony, M, Baltussen, R, van Till, JRindress, D, et al. International task force on decision criteria. Which criteria are considered in healthcare decisions? Insights from an international survey of policy and clinical decision makers. Int J Technol Assess Health Care. 2013;29:456–65.CrossRefGoogle ScholarPubMed
Baltussen, R, Jansen, MP, Mikkelsen, ETromp, NHontelez, JBijlmakers, L, et al. Priority setting for universal health coverage: We need evidence-informed deliberative processes, not just more evidence on cost-effectiveness. Int J Health Policy Manage. 2016;5:615.CrossRefGoogle Scholar
Goetghebeur, MM, Wagner, M, Samaha, D, O'Neil, WBadgley, D, Castro-Jaramillo, H, et al. Exploring values of health technology assessment agencies using reflective multicriteria and rare disease case. Int J Technol Assess Health Care. 2017;33:504.CrossRefGoogle ScholarPubMed
Oortwijn, W, Sampietro-Colom, L, Trowman, R. How to deal with the inevitable: Generating real-world data and using real-world evidence for HTA purposes – from theory to action. Int J Technol Assess Health Care. 2019;35:346–50.CrossRefGoogle Scholar
Lou, J, Sarin, K, Toh, KYDabak, S, Adler, AAhn, J, et al. Real-world data for health technology assessment for reimbursement decisions in Asia: Current landscape and a way forward. Int J Technol Assess Health Care. 2020;36:474–80.CrossRefGoogle Scholar
Byun, J. Utilizing real word data in health technology assessment. Wonju: Health Insurance Review and Assessment Service; 2018.Google Scholar
Brinkerhoff, DW. Accountability and health systems: Toward conceptual clarity and policy relevance. Health Policy Plann. 2004;19:371–9.CrossRefGoogle ScholarPubMed
Mulgan, R. ‘Accountability’: An ever-expanding concept? Public Adm. 2000;78:555–73.CrossRefGoogle Scholar
Thurston, WE, MacKean, G, Vollman, A, Casebeer, AWeber, M, Maloff, B, et al. Public participation in regional health policy: A theoretical framework. Health Policy. 2005;73:237–52.CrossRefGoogle ScholarPubMed
Mitton, C, Smith, N, Peacock, S, Evoy, B, Abelson, J. Public participation in health care priority setting: A scoping review. Health Policy. 2009;91:219–28.CrossRefGoogle ScholarPubMed
Keeney, RL, Von Winterfeldt, D, Eppel, T. Eliciting public values for complex policy decisions. Manag Sci. 1990;36:1011–30.CrossRefGoogle Scholar
Abelson, J, Bombard, Y, Gauvin, F-P, Simeonov, D, Boesveld, S. Assessing the impacts of citizen deliberations on the health technology process. Int J Technol Assess Health Care. 2013;29:282.CrossRefGoogle ScholarPubMed
Oortwijn, W, Klein, P. Addressing health system values in health technology assessment: The use of evidence-informed deliberative processes. Int J Technol Assess Health Care. 2019;35:82–4.CrossRefGoogle Scholar
Oh, J, Ko, Y, Baer Alley, A, Kwon, S. Participation of the lay public in decision-making for benefit coverage of national health insurance in South Korea. Health Syst Reform. 2015;1:6271.CrossRefGoogle ScholarPubMed
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