Development of an Official Guideline for the Economic Evaluation of Drugs/Medical Devices in Japan

Value in Health

Volumn 20, Issue 3, 2017, Pages 372-378

  Shiroiwa, Takeru ^a   Fukuda, Takashi ^a   Ikeda, Shunya ^b   Takura, Tomoyuki ^c   Moriwaki, Kensuke ^d  

^a NATIONAL INSTITUTE OF PUBLIC HEALTH   (Japan)

^b INTERNATIONAL UNIVERSITY OF HEALTH AND WELFARE   (Japan)

^c OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^d KOBE PHARMACEUTICAL UNIVERSITY   (Japan)

Author keywords

cost effectiveness analysis; discount; guideline; productivity loss; QALY

Indexed keywords

DRUG; PRESCRIPTION DRUG;

ARTICLE; CONSENSUS DEVELOPMENT; COST EFFECTIVENESS ANALYSIS; HEALTH CARE COST; HUMAN; JAPAN; LONG TERM CARE; MEDICAL DEVICE; OUTCOME ASSESSMENT; PHARMACOECONOMICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLIC HEALTH SERVICE; QUALITY ADJUSTED LIFE YEAR; ADVISORY COMMITTEE; COST BENEFIT ANALYSIS; DEVICES; ECONOMICS; HEALTH CARE DELIVERY; MEDICAL LEAVE; PROCEDURES;

ADVISORY COMMITTEES; COST-BENEFIT ANALYSIS; DELIVERY OF HEALTH CARE; EQUIPMENT AND SUPPLIES; GUIDELINES AS TOPIC; HUMANS; JAPAN; PRESCRIPTION DRUGS; QUALITY-ADJUSTED LIFE YEARS; SICK LEAVE;

EID: 85005931307     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1016/j.jval.2016.08.726     Document Type: Article

References (53)

1. [1] Ministry of Health, Labor and Welfare. On submitted economic data of healthcare technologies (third meeting of cost-effectiveness sub-committee) [in Japanese]. 2012. Available from: http://www.mhlw.go.jp/stf/shingi/2r9852000002f163-att/2r9852000002fev7.pdf. [Accessed September 17, 2016].
2. [2] Cabinet office. Basic Policy on Economic and Fiscal Management and Reform 2015. 2015.
3. [3] Fukuda, T., Shiroiwa, T., Ikeda, S., et al. Guideline for economic evaluation of healthcare technologies in Japan [in Japanese]. J Natl Inst Public Health 62 (2013), 625–640.
4. [4] Bae, E.Y., Lee, E.K., Pharmacoeconomic guidelines and their implementation in the positive list system in South Korea. Value Health 12:Suppl. 3 (2009), S36–S41.
5. [5] Bae, S., Lee, S., Bae, E.Y., et al. Korean guidelines for pharmacoeconomic evaluation (second and updated version): consensus and compromise. Pharmacoeconomics 31 (2013), 257–267.
6. [6] Taiwan Society for Pharmacoeconomics and Outcomes Research. Guidelines of Methodological Standards for Pharmacoeconomic Evaluations in Taiwan. 2006, Taiwan Society for Pharmacoeconomics and Outcomes Research, Taiwan.
7. [7] Teerawattananon, Y., Chaikledkaew, U., Thai health technology assessment guideline development. J Med Assoc Thai 91:Suppl. 2 (2008), S11–S15.
8. [8] National Authority of Medicines and Health Products (INFARMED). Gudelines for Economic Drug Evaluation Studies. 1998, National Authority of Medicines and Health Products, Lisboa, Portugal.
9. [9] Dental and Pharmaceutical Benefits Board (TLV). General Guidelines for Economic Evaluations from the Pharmaceutical Benefits Board. 2003, Dental and Pharmaceutical Benefits Board, Stockholm, Sweden.
10. [10] Canadian Agency for Drugs and Technologies in Health. Guidelines for the Economic Evaluation of Health Technologies. 3rd ed., 2006, Canadian Agency for Drugs and Technologies in Health, Ottawa, ON.
11. [11] Scottish Medicines Consortium. Guidance to Manufacturers for Completion of New Product Assessment Form (Version 2.1). 2007, Scottish Medicines Consortium, Glasgow, Scotland.
12. [12] Pharmaceutical Benefits Advisory Committee. Guidelines for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (Version 4.3). 2008, Pharmaceutical Benefits Advisory Committee, Canberra, Australia.
13. [13] Agency for Health Technology Assessment. Guidelines for Conducting Health Technology Assessment (Version 2.1). 2009, Agency for Health Technology Assessment, Warsaw, Poland.
14. [14] Health Information and Quality Authority. Guidelines for the Economic Evaluation of Health Technologies in Ireland (Version 2.1). 2010, Health Information and Quality Authority, Dublin, Ireland.
15. [15] The China Society for Pharmacoeconomics and Outcomes Research (Chinese Pharmaceutical Association Pharmacoeconomic Committee). China Guidelines for Pharmacoeconomic Evaluations. Beijing, China Pharmacoeconomics Guidelines Taskforce, 2011.
16. [16] Haute Autorité, de Santé, Choices in Methods for Economic Evaluation. 2012, Haute Autorité de Santé, Paris, France.
17. [17] Belgian Health Care Knowledge Centre. Belgian Guidelines for Economic Evaluations and Budget Impact Analysis. 2nd ed., 2012, Belgian Health Care Knowledge Centre, Brussels, Belgium.
18. [18] Norwegian Medicines Agency. Guidelines on How to Conduct Pharmacoeconomic Analyses. 2012, Norwegian Medicines Agency, Oslo, Norway.
19. [19] Pharmaceutical Management Agency. Prescription for Pharmacoeconomic Analysis. Methods for Cost-Utility Analysis (Version 2.1). 2012, Pharmaceutical Management Agency, Wellington, New Zealand.
20. [20] National Institute for Health and Care Excellence. Guide to the Methods of Technology Appraisal. 2013, National Institute for Health and Care Excellence, London.
21. [21] Pharmaceuticals Pricing Board. Preparing a Health Economic Evaluation to Be Attached to the Application for Reimbursement Status and Wholesale Price for a Medicinal Product. 2013, Pharmaceuticals Pricing Board, Helsinki, Finland.
22. [22] National Health Care Institute. Guideline for Economic Evaluations in Healthcare. 2016, National Health Care Institute, Diemen, The Netherlands.
23. [23] Kamae, I., Ikeda, S., A draft of socio-economic evaluation guideline for pharmaceuticals and medical devices based on Japanese experts consensus: potentials and issues [in Japanese]. Jpn J Pharmacoepidemiol 1 (2011), 21–26.
24. [24] Hay, J.W., Smeeding, J., Carroll, N.V., 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 13 (2010), 3–7.
25. [25] Garrison, L.P. Jr, Mansley, E.C., Abbott, T.A. 3rd, 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 13 (2010), 8–13.
26. [26] International Society for Pharmacoeonomics and Outcomes Research. Health Care Cost, Quality, and Outcomes. 2003, International Society for Pharmacoeonomics and Outcomes Research, Lawrenceville, NJ.
27. [27] Drummond, M.F., Sculpher, M.J., Claxton, K., et al. Methods for the Economic. Evaluation of Health Care Programmes, 4th ed., 2015, Oxford University Press, Oxford, UK.
28. [28] EuroQol, Group, EuroQol—a new facility for the measurement of health-related quality of life. Health Policy 16 (1990), 199–208.
29. [29] Tsuchiya, A., Ikeda, S., Ikegami, N., et al. Estimating an EQ-5D population value set: the case of Japan. Health Econ 11 (2002), 341–353.
30. [30] Shiroiwa, T., Ikeda, S., Noto, S., et al. Comparison of value set based on DCE and/or TTO data: scoring for EQ-5D-5L health states in Japan. Value Health 19 (2016), 648–654.
31. [31] Garber, A.M., Phelps, C.E., Economic foundations of cost-effectiveness analysis. J Health Econ 16 (1997), 1–31.
32. [32] Meltzer, D., Accounting for future costs in medical cost-effectiveness analysis. J Health Econ 16 (1997), 33–64.
33. [33] Weinstein, M.C., Manning, W.G. Jr, Theoretical issues in cost-effectiveness analysis. J Health Econ 16 (1997), 121–128.
34. [34] Lee, R.H., Future costs in cost effectiveness analysis. J Health Econ 27 (2008), 809–818.
35. [35] Garber, A.M., Phelps, C.E., Future costs and the future of cost-effectiveness analysis. J Health Econ 27 (2008), 819–821.
36. [36] Meltzer, D., Response to “Future costs and the future of cost-effectiveness analysis.”. J Health Econ 27 (2008), 822–825.
37. [37] Feenstra, T.L., van Baal, P.H., Gandjour, A., et al. Future costs in economic evaluation. A comment on Lee. J Health Econ 27 (2008), 1645–1649.
38. [38] Koopmanschap, M.A., Rutten, F.F., van Ineveld, B.M., et al. The friction cost method for measuring indirect costs of disease. J Health Econ 14 (1995), 171–189.
39. [39] Brouwer, W.B., Koopmanschap, M.A., Rutten, F.F., Productivity costs measurement through quality of life? A response to the recommendation of the Washington Panel. Health Econ 6 (1997), 253–259.
40. [40] Knies, S., Severens, J.L., Ament, A.J., et al. The transferability of valuing lost productivity across jurisdictions. Differences between national pharmacoeconomic guidelines. Value Health 13 (2010), 519–527.
41. [41] Gold, M.R., Siegel, J.E., Russell, L.B., et al. Cost-Effectiveness in Health and Medicine, 1996, Oxford University Press, New York, NY.
42. [42] Gravelle, H., Smith, D., Discounting for health effects in cost-benefit and cost-effectiveness analysis. Health Econ 10 (2001), 587–599.
43. [43] Brouwer, W.B., Niessen, L.W., Postma, M.J., et al. Need for differential discounting of costs and health effects in cost effectiveness analyses. BMJ 331 (2005), 446–448.
44. [44] Claxton, K., Sculpher, M., Culyer, A., et al. Discounting and cost-effectiveness in NICE—stepping back to sort out a confusion. Health Econ 15 (2006), 1–4.
45. [45] Gravelle, H., Brouwer, W., Niessen, L., et al. Discounting in economic evaluations: stepping forward towards optimal decision rules. Health Econ 16 (2007), 307–317.
46. [46] Claxton, K., Paulden, M., Gravelle, H., et al. Discounting and decision making in the economic evaluation of health-care technologies. Health Econ 20 (2011), 2–15.
47. [47] Paulden, M., Claxton, K., Budget allocation and the revealed social rate of time preference for health. Health Econ 21 (2012), 612–618.
48. [48] Doubilet, P., Begg, C.B., Weinstein, M.C., et al. Probabilistic sensitivity analysis using Monte Carlo simulation. A practical approach. Med Decis Making 5 (1985), 157–177.
49. [49] Briggs, A., Fenn, P., Confidence intervals or surfaces? Uncertainty on the cost-effectiveness plane. Health Econ 7 (1998), 723–740.
50. [50] Husereau, D., Drummond, M., Petrou, S., et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS)—explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Value Health 16 (2013), 231–250.
51. [51] Williams, A., Intergenerational equity: an exploration of the “fair innings” argument. Health Econ 6 (1997), 117–132.
52. [52] Nord, E., Pinto, J.L., Richardson, J., et al. Incorporating societal concerns for fairness in numerical valuations of health programmes. Health Econ 8 (1999), 25–39.
53. [53] Stolk, E.A., van Donselaar, G., Brouwer, W.B., et al. Reconciliation of economic concerns and health policy: illustration of an equity adjustment procedure using proportional shortfall. Pharmacoeconomics 22 (2004), 1097–1107.