DOI QR코드

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Pitfalls in Reimbursement Decisions for Oncology Drugs in South Korea: Need for Addressing the Ethical Dimensions in Technology Assessment

  • Cho, Eun (College of Pharmacy, Sookmyung Women's University) ;
  • Park, Eun-Cheol (Department of Preventive Medicine and Public Health, Yonsei University College of Medicine and Institute of Health Services Research, Yonsei University) ;
  • Kang, Myoung Sheen (Gangneung-Woniu National University, College of Dentistry)
  • 발행 : 2013.06.30

초록

This study aimed to discover to what extent ethical issues are considered in the reimbursement decision process based on health technology assessment (HTA) in Korea, especially for oncology medications. Public summary documents (PSDs) published by the Health Insurance Review and Assessment Service (HIRA) were analyzed for empirical and normative factors. For external comparison, PSDs presented by corresponding institutions of Australia and the United Kingdom were employed. Furthermore, the opinions of eight expert oncologists were obtained regarding the accountability of the evidence in PSDs. Among 7 oncology drugs, there were differences in the final decisions and empirical factors considered, such as selected comparators and interpretation of evidence between the PSDs from the three institutions. From an ethical viewpoint, the following matters were deficient in the HTA decision-making process for oncology drugs: clear and reasonable standards; identifying and evaluating ethical values; and public accountability for reasonableness about decisions and due process.

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참고문헌

  1. Abelson J, Giacomini M, Lehoux P, et al (2007). Bringing 'the public' into health technology assessment and coverage policy decisions: from principles to practice. Health Policy, 82, 37-50. https://doi.org/10.1016/j.healthpol.2006.07.009
  2. Burls A, Caron L, Cleret de Langavant G, et al (2011). Tackling ethical issues in health technology assessment: a proposed framework. Int J Technol Assess Health Care, 27, 230-7. https://doi.org/10.1017/S0266462311000250
  3. Chim L, Kelly PJ, Salkeld G, et al (2010). Are cancer drugs less likely to be recommended for listing by the pharmaceutical benefits advisory committee in Australia? Pharmacoeconomics, 28, 463-75. https://doi.org/10.2165/11533000-000000000-00000
  4. Daniels N, Sabin J (1997). Limits to health care: fair procedures, democratic deliberation, and the legitimacy problem for insurers. Philos Public Aff, 26, 303-50. https://doi.org/10.1111/j.1088-4963.1997.tb00082.x
  5. Daniels N, Teagarden JR, Sabin JE (2003). An ethical template for pharmacy benefits. Health Affairs, 22, 125-37. https://doi.org/10.1377/hlthaff.22.1.125
  6. DeJean D, Giacomini M, Schwartz L, et al (2009). Ethics in Canadian health technology assessment: a descriptive review. Int J Technol Assess Health Care, 25, 463-9. https://doi.org/10.1017/S0266462309990390
  7. Droste S, Dintsios CM, Gerber A (2010). Information on ethical issues in health technology assessment: how and where to find them. Int J Technol Assess Health Care, 26, 441-9. https://doi.org/10.1017/S0266462310000954
  8. Drummond M, Evans B, LeLorier J, et al (2009). Evidence and values: requirements for public reimbursement of drugs for rare diseases--a case study in oncology. Can J Clin Pharmacol, 16, 273-81.
  9. Drummond MF, Schwartz JS, Jonsson B, et al (2008). Key principles for the improved conduct of health technology assessments for resource allocation decisions. Int J Technol Assess Health Care, 24, 244-58.
  10. Hauck K, Tsuchiya A (2011). Health dynamics: implications for efficiency and equity in priority setting. Value Health, 14, 387-9. https://doi.org/10.1016/j.jval.2010.09.003
  11. Health Insurance Review and Assessment Service (HIRA) (2007). Guidelines and Scope for Economic Evaluation of Pharmaceuticals for Formulary Listing in Korea. Seoul.
  12. Hofmann BM (2008). Why ethics should be part of health technology assessment. Int J Technol Assess Health Care, 24, 423-9.
  13. Kamae I (2010). Value-based approaches to healthcare systems and pharmacoeconomics requirements in Asia: South Korea, Taiwan, Thailand and Japan. Pharmacoeconomics, 28, 831-8. https://doi.org/10.2165/11538360-000000000-00000
  14. Kwon S (2009). Pharmaceutical Policy in South Korea. In:Prescribing cultures and pharmaceutical policy in the Asia-Pacific. Eggleston K, ed. Stanford: The Walter H. Shorenstein Asia-Pacific Research Center, 444.
  15. Low E (2007). Many new cancer drugs in the United Kingdom are facing negative NICE rulings. J Clin Oncol, 25, 2635-6. https://doi.org/10.1200/JCO.2007.11.4272
  16. McKie J, Richardson J (2003). The rule of rescue. Soc Sci Med, 56, 2407-19. https://doi.org/10.1016/S0277-9536(02)00244-7
  17. Oortwijn W, Mathijssen J, Banta D (2010). The role of health technology assessment on pharmaceutical reimbursement in selected middle-income countries. Health Policy, 95, 174-84. https://doi.org/10.1016/j.healthpol.2009.12.008
  18. Pinkerton S (2002). Ethical issues in cost-effectiveness analysis. Evaluation and Program Planning, 25, 71-83. https://doi.org/10.1016/S0149-7189(01)00050-7
  19. Rawlins MD, Culyer AJ (2004). National Institute for Clinical Excellence and its value judgments. BMJ, 329, 224-7. https://doi.org/10.1136/bmj.329.7459.224
  20. Rocchi A, Menon D, Verma S, et al (2008). The role of economic evidence in Canadian oncology reimbursement decisionmaking: to lambda and beyond. Value Health, 11, 771-83. https://doi.org/10.1111/j.1524-4733.2007.00298.x
  21. Schlander M, Beck M (2009). Expensive drugs for rare disorders: to treat or not to treat? The case of enzyme replacement therapy for mucopolysaccharidosis VI. Curr Med Res Opin, 25, 1285-93. https://doi.org/10.1185/03007990902892633
  22. Schnipper LE, Meropol NJ, Brock DW (2010). Value and cancer care: toward an equitable future. Clin Cancer Res, 16, 6004-8. https://doi.org/10.1158/1078-0432.CCR-10-1643
  23. Weinstein MC (1988). A QALY is a QALY--or is it? J Health Econ, 7, 289-90. https://doi.org/10.1016/0167-6296(88)90030-6
  24. Yang BM (2009). The future of health technology assessment in healthcare decision making in Asia. Pharmacoeconomics, 27, 891-901. https://doi.org/10.2165/11310280-000000000-00000