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PharmacoEconomics

, Volume 31, Issue 4, pp 257–267 | Cite as

Korean Guidelines for Pharmacoeconomic Evaluation (Second and Updated Version)

Consensus and Compromise
  • SeungJin Bae
  • SooOk Lee
  • Eun Young Bae
  • Sunmee Jang
Practical Application

Abstract

The first version of the Korean guidelines for pharmacoeconomic evaluation was published by Health Insurance Review and Assessment Service (HIRA) in 2006. Since the introduction of the first version, domestic experience with the application of the recommendations has accumulated, and methodologies in certain areas have progressed considerably. Based on these experiences, HIRA initiated a guidelines revision project to address the need for revisions. The purpose of this study is to share the process used to complete these guideline revisions and to provide the contents of the revised guidelines. In developing the current revision, meetings with the advisory committee and working-level meetings with pharmaceutical companies were held several times to reach as much of a consensus as possible, and the results of a survey of pharmaceutical companies and decision makers regarding the existing guidelines were considered. The second version of the guidelines clarified the level of data requirement (‘must’, ‘recommended’, ‘preferred’) based on the data availability, the information needs of the decision makers and the strength of the evidence. The recommended perspective economic studies should take has been modified and additional guidance has been provided on QALY measurement. Manuals for systematic reviews and indirect comparisons have been published, and a standardized reporting format for expert opinions has been added. Sections on preferred methods for evaluations, sensitivity analysis, modelling and time horizon have been elucidated. The revised guidelines clarify the expression of the recommendations, making them more user-friendly, and provide more specific guidance to improve the quality and comparability across submissions.

Keywords

Decision Maker Advisory Committee Societal Perspective Indirect Comparison Surrogate Outcome 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

This study has been financially supported by HIRA in Seoul, The Republic of Korea. SeungJin Bae led the Guideline Development Team at HIRA. SooOk Lee and Sunmee Jang were members of the team, both of whom were employed by HIRA. Eun Young Bae has served as a member of the DREC since 2011 and the economic subcommittee of the DREC since 2009, and was the principal investigator of the first version of the Korean guidelines for pharmacoeconomic evaluation.

Conflicts of interest

No author has conflicts of interest or financial arrangements that could have potentially influenced the described research.

Author contributions

All authors participated in the design of the study. SeungJin Bae and SooOk Lee reviewed the submitted dossiers, conducted the survey and did the literature review. SeungJin Bae and Eun Young Bae drafted the manuscript. Sunmee Jang critically edited and commented on the manuscript. All authors read and approved the final manuscript. SeungJin Bae is the guarantor for the overall content of this article.

References

  1. 1.
    Bae EY, Lee EK. Pharmacoeconomic guidelines and their implementation in the Positive List System in South Korea. Value Health. 2009;12:S36–41.PubMedCrossRefGoogle Scholar
  2. 2.
    Yang BM, Bae EY, Kim JH. Economic evaluation and pharmaceutical reimbursement reform in South Korea’s National Health Insurance. Health Affairs. 2008;27(1):179–87.Google Scholar
  3. 3.
    Garrison LP, Mansley EC, Abbott TA, et al. Good research practices for measuring drug costs in cost-effectiveness analyses: a societal perspective. The ISPOR Drug Cost Task Force report: part II. Value Health. 2010;13(1):8–13.PubMedCrossRefGoogle Scholar
  4. 4.
    Hay JW, Smeeding J, Carroll NV, et al. Good research practices for measuring drug costs in cost effectiveness analyses: issues and recommendations. The ISPOR Drug Cost Task Force report: part I. Value Health. 2010;13(1):3–7.PubMedCrossRefGoogle Scholar
  5. 5.
    Canadian Agency for Drugs and Technologies in Health. Guidelines for the economic evaluation of health technologies: Canada. 3rd ed. Ottawa: CADTH; 2006. http://www.cadth.ca/media/pdf/186_EconomicGuidelines_e.pdf. Accessed 21 Mar 2011.
  6. 6.
    National Institute for Health and Clinical Excellence. Guide to the methods of technology appraisal. London: NICE; 2008. http://www.nice.org.uk/aboutnice/howwework/devnicetech/technologyappraisalprocessguides/?domedia=1&mid=B52851A3-19B9-E0B5-D48284D172BD8459. Accessed 21 Mar 2011.
  7. 7.
    Pharmaceutical Benefits Advisory Committee. Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (version 4.3). Canberra: Department of Health and Ageing, Australian Government; 2008. http://www.health.gov.au/internet/main/publishing.nsf/content/AECB791C29482920CA25724400188EDB/$File/PBAC4.3.2.pdf. Accessed 21 Mar 2011.
  8. 8.
    Guidelines for economic evaluation for pharmaceuticals: second version. Seoul: Health Insurance Review and Assessment Service; 2011.Google Scholar
  9. 9.
    International Society for Pharmacoeconomics and Outcomes Research. Country-specific pharmacoeconomic guidelines. http://www.ispor.org/PEguidelines/COUNTRYSPECIFIC.asp. Accessed 21 Mar 2011.
  10. 10.
    Guidelines for economic evaluation for pharmaceuticals: first version. Seoul: Health Insurance Review and Assessment Service; 2006.Google Scholar
  11. 11.
    Meltzer D, Johannesson M. Inconsistencies in the “societal perspective” on costs of the Panel on Cost-Effectiveness in Health and Medicine. Medical Decision Making. 1999;19(4):371–7.Google Scholar
  12. 12.
    Rappange DR, van Baal PHM, van Exel NJA, et al. Unrelated medical costs in life-years gained: should they be included in economic evaluations of healthcare interventions? Pharmacoeconomics. 2008;26(10):815–30.PubMedCrossRefGoogle Scholar
  13. 13.
    Garber AM, Phelps CE. Future costs and the future of cost-effectiveness analysis. J Health Econ. 2008;27(4):819–21.PubMedCrossRefGoogle Scholar
  14. 14.
    Weinstein MC, Siegel JE, Gold MR, et al. Recommendations of the panel on cost-effectiveness in health and medicine. JAMA J Am Med Assoc. 1996;276(15):1253–8.CrossRefGoogle Scholar
  15. 15.
    Bae SJ, Lee SO, Choi SE, et al. Development of 2nd version of Korean pharmacoeconomic guideline [report; in Korean]. Seoul: Health Insurance Review and Assessment Service; 2011.Google Scholar
  16. 16.
    Neumann PJ. Costing and perspective in published cost-effectiveness analysis. Med Care. 2009;47(7 Suppl. 1):S28–32.Google Scholar
  17. 17.
    Institute for Quality and Efficiency in Health Care. Methods for health economic evaluation. Cologne: IQWiG; 2009. http://www.iqwig.de/index.736.en.html. Accessed 24 Mar 2011.
  18. 18.
    Mitchell AS, Viney R. Meeting the information needs of a national drug payer: aspirations of the guidelines from Australia. Drug Dev Res. 2010;71(8):463–9.CrossRefGoogle Scholar
  19. 19.
    Brouwer WB, Van Exel NJ, Baltussen RM, et al. A dollar is a dollar is a dollar—or is it? Value Health. 2006;9(5):341–7.PubMedCrossRefGoogle Scholar
  20. 20.
    Collège des Économistes de la Santé. French guidelines for the economic evaluation of health care technologies. Paris: CES; 2004. http://www.ispor.org/PEguidelines/source/France_Guidelines_HE_Evaluation.pdf. Accessed 24 Mar 2011.
  21. 21.
    Dutch Health Care Insurance Board. Guidelines for pharmacoeconomic research, updated version. Diemen: CVZ; 2006. http://www.ispor.org/PEguidelines/source/HTAGuidelinesNLupdated2006.pdf. Accessed 25 Mar 2011.
  22. 22.
    Ministry of Social Affairs and Health, Finland. Decree of the Ministry of Social Affairs and Health on applications and price notifications made to the Pharmaceutical Pricing Board: guidelines for preparing a health economic evaluation [Appendix]. Helsinki: Ministry of Social Affairs and Health, Finland; 2009. http://www.ispor.org/PEguidelines/source/GuidelinesinFinland_EnglishVersion.pdf. Accessed 25 Mar 2011.
  23. 23.
    López-Bastida J, Oliva J, AntoAanzas F, et al. Spanish recommendations on economic evaluation of health technologies. Eur J Health Econ. 2010;11(5):513–20.PubMedCrossRefGoogle Scholar
  24. 24.
    Scuffham PA, Whitty JA, Mitchell A, et al. The use of QALY weights for QALY calculations: a review of industry submissions requesting listing on the Australian Pharmaceutical Benefits Scheme 2002–4. PharmacoEconomics. 2008;26(4):297–310.PubMedCrossRefGoogle Scholar
  25. 25.
    Brazier J, Tsuchiya A. Preference-based condition-specific measures of health: what happens to cross programme comparability? Health Econ. 2010;19(2):125–9.PubMedCrossRefGoogle Scholar
  26. 26.
    King JT, Styn MA, Tsevat J, et al. “Perfect health” versus “disease free”: the impact of anchor point choice on the measurement of preferences and the calculation of disease-specific disutilities. Med Decis Mak. 2003;23(3):212–25.CrossRefGoogle Scholar
  27. 27.
    Chancellor J, Coyle D, Drummond MF. Constructing health state preference values from descriptive quality of life outcomes: mission impossible? Qual Life Res. 1997;6(2):159–68.Google Scholar
  28. 28.
    Fryback DG, Dunham NC, Palta M, et al. US norms for six generic health-related quality-of-life indexes from the National Health Measurement Study. Med Care. 2007;45(12):1162–70.PubMedCrossRefGoogle Scholar
  29. 29.
    Nord E, Daniels N, Kamlet M. QALYs: some challenges. Value Health. 2009;12:S10–5.PubMedCrossRefGoogle Scholar
  30. 30.
    Drummond M, Brixner D, Gold M, et al. Toward a consensus on the QALY. Value Health. 2009;12(Suppl. 1):S31–5.PubMedCrossRefGoogle Scholar
  31. 31.
    Coons SJ, Rao S, Keininger DL, et al. A comparative review of generic quality-of-life instruments. Pharmacoeconomics. 2000;17(1):13–35.PubMedCrossRefGoogle Scholar
  32. 32.
    Green C, Brazier J, Deverill M. Valuing health-related quality of life: a review of health state valuation techniques. Pharmacoeconomics. 2000;17(2):151–65.PubMedCrossRefGoogle Scholar
  33. 33.
    Brazier J, Deverill M. A checklist for judging preference-based measures of health related quality of life: learning from psychometrics. Health Economics. 1999;8(1):41–51.PubMedCrossRefGoogle Scholar
  34. 34.
    Weinstein MC, Torrance G, McGuire A. QALYs: the basics. Value Health. 2009;12(Suppl. 1):S5–9.PubMedCrossRefGoogle Scholar
  35. 35.
    Kang EJ, Shin HS, Park HJ, et al. Valuing health states of the Korean EQ-5D using time trade-off [in Korean]. Kor J Health Econ Policy. 2006;12(2):19–43.Google Scholar
  36. 36.
    Jo MW, Yun SC, Lee SI. Estimating quality weights for EQ-5D health states with the time trade-off method in South Korea. Value Health. 2008;11(7):1186–9.PubMedCrossRefGoogle Scholar
  37. 37.
    Lee Y-K, Nam H-S, Chuang L-H, et al. South Korean time trade-off values for EQ-5D health states: modeling with observed values for 101 health states. Value Health. 2009;12(8):1187–93.PubMedCrossRefGoogle Scholar
  38. 38.
    Norman R, Cronin P, Viney R, et al. International comparisons in valuing EQ-5D health states: a review and analysis. Value Health. 2009;12(8):1194–200.PubMedCrossRefGoogle Scholar
  39. 39.
    Brazier J, Roberts J, Tsuchiya A, et al. A comparison of the EQ-5D and SF-6D across seven patient groups. Health Econ. 2004;13(9):873–84.PubMedCrossRefGoogle Scholar
  40. 40.
    Garau M, Shah KK, Mason AR, et al. Using QALYs in cancer: a review of the methodological limitations. Pharmacoeconomics. 2011;29(8):673–85.PubMedCrossRefGoogle Scholar
  41. 41.
    Economics Sub-Committee, Pharmaceutical Benefit Advisory Committee. Report of the Indirect Comparisons Working Group to the Pharmaceutical Benefits Advisory Committee: assessing indirect comparisons. Canberra: Department of Health and Ageing, Australian Government; 2010. http://www.health.gov.au/internet/main/publishing.nsf/Content/B11E8EF19B358E39CA25754B000A9C07/$File/ICWG%20Report%20FINAL2.pdf. Accessed 25 Mar 2011.
  42. 42.
    Canadian Agency for Drugs and Technologies in Health. Indirect evidence: indirect treatment comparisons in meta-analysis. Ottawa: CADTH; 2009. http://www.cadth.ca/media/pdf/H0462_itc_tr_e.pdf. Accessed 21 Mar 2011.
  43. 43.
    Manual for systematic reviews. Seoul: Health Insurance Review and Assessment Service; 2011.Google Scholar
  44. 44.
    Manual for indirect comparison. Seoul: Health Insurance Review and Assessment Service; 2011.Google Scholar
  45. 45.
    Weinstein MC, O’Brien B, Hornberger J, et al. Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices—Modeling Studies. Value Health. 2003;6(1):9–17.PubMedCrossRefGoogle Scholar
  46. 46.
    Pickard AS, Wilke CT, Lin HW, et al. Health utilities using the EQ-5D in studies of cancer. PharmacoEconomics. 2007;25(5):365–84.PubMedCrossRefGoogle Scholar
  47. 47.
    Pliskin JS, Shepard DS, Weinstein MC. Utility functions for life years and health status. Oper Res. 1980;28(1):206–24.CrossRefGoogle Scholar
  48. 48.
    Miyamoto JM, Eraker SA. A multiplicative model of the utility of survival duration and health quality. J Exp Psychol Gen. 1988;117(1):3–20.PubMedCrossRefGoogle Scholar
  49. 49.
    Laupacis A. Economic evaluations in the Canadian Common Drug Review. PharmacoEconomics. 2006;24(11):1157–62.PubMedCrossRefGoogle Scholar
  50. 50.
    Philips Z, Bojke L, Sculpher M, et al. Good practice guidelines for decision-analytic modelling in health technology assessment: a review and consolidation of quality assessment. PharmacoEconomics. 2006;24(4):355–71.PubMedCrossRefGoogle Scholar
  51. 51.
    Yim EY, Lim SH, Oh MJ, et al. Assessment of pharmacoeconomic evaluations submitted for reimbursement in Korea. Value Health. 2012;15(1 Suppl.):S104–10.PubMedCrossRefGoogle Scholar
  52. 52.
    Mitka M. Amid lingering questions, FDA reprieves LDL cholesterol-lowering medication. JAMA. 2009;301(8):813–5.PubMedCrossRefGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2013

Authors and Affiliations

  • SeungJin Bae
    • 1
  • SooOk Lee
    • 1
  • Eun Young Bae
    • 2
  • Sunmee Jang
    • 3
  1. 1.Health Insurance Review and Assessment Service, Research and Development CenterSeoulThe Republic of Korea
  2. 2.Department of Health Policy and ManagementSangji UniversityWonjuThe Republic of Korea
  3. 3.College of PharmacyInje UniversityGimhaeThe Republic of Korea

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