Methods for Socio-Economic Evaluation of Marketed MedicinesⅢ: Factors Affecting Methodological Quality and Transferability_Chinese Journal of Evidence-Based Medicine

Authors：

SUN Xin ¹ , LI Youping ¹ , Thomas Alured Faunce ² , CHENG Gang ³

1. Evidence-Based Medicine Center and Clinical Epidemiology Center, West China Hospital, Sichuan University, Chengdu 610041, China2. Medical School and College of Law, Australian National University, Australia3. Center for Drug Evaluation, State Food and Drug Administration, Beijing, 10061, China;

Corresponding author：

Keywords：

Socio-economic evaluation; Cost-effectiveness evaluation; Value for marketed medicines; Methodological quality; Transferability

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Methodological quality and transferability will be important issues for the credibility and usefulness of both published studies and administrative methods for evaluating the socio-economic value of marketed medicines in China. This paper critically examines factors commonly contributing to, or inhibiting, the quality and transferability of socio-economic evidence of the value of medicines, with specific reference to the Chinese community. It discusses appropriate approaches to design, performance, and reporting of published economic evaluation studies, as well as guides on assessment of quality of economic evaluations and recommends two internationally established methods that may be suitable for training in this setting.

Citation： SUN Xin,LI Youping,Thomas Alured Faunce,CHENG Gang. Methods for Socio-Economic Evaluation of Marketed MedicinesⅢ: Factors Affecting Methodological Quality and Transferability. Chinese Journal of Evidence-Based Medicine, 2006, 06(4): 282-291. doi: Copy

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2.	Hailey D. Australian economic evaluation and government decisions on pharmaceuticals, compared to assessment of other health technologies. Soc. Sci. Med,1997;45(4):563-581.
3.	Garceau L, Henderson J, Davis LJ, et al. Davidson LL. Economic implications of assisted reproductive techniques: a systematic review. Human reproduction, 2002;17(12):3090-3109.
4.	Moayyedi P, Soo S, Deeks J, et al. Systematic review and economic evaluation of Helicobacter pylori eradication treatment for non-ulcer dyspepsia. BMJ, 2000;321;659-664.
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8.	Drummond MF, Jefferson TO. On behalf of the BMJ Economic Evaluation Working Party. Guidelines for authors and peer reviewers of economic submissions to the BMJ. BMJ, 1996;313:275-283.
9.	Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.5 [updated May 2005]. In: The Cochrane Library, Issue 3, 2005. Chichester, UK: John Wiley & Sons, Ltd.
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11.	Green C, Brazier J, Deverill M. Valuing Health-Related Quality of Life. A Review of Health State Valuation Techniques. Pharmacoeconomics, 2000; 17 (2): 151-165.
12.	Oostenbrink JB, Koopmanschap MA, Rutten FFH. Standardisation of Costs: The Dutch Manual for Costing in Economic Evaluations. Pharmacoeconomics, 2002; 20 (7): 443-454.
13.	Buxton MJ, Drummond MF, van Hout BA, et al. Modelling in economic evaluation: an unavoidable fact of life. Health Economics, 1997; 6: 217–227.
14.	Birkett DJ, Mitchell AS, McManus P. A Cost-Effectiveness Approach to Drug Subsidy and Pricing in Australia. Health Affairs, 2001; 20(3): 104-114.
15.	Adams ME, McCall NT, Gray DT, et al. Economic analysis in randomized control trials. Med Care, 1992;30:231–238.
16.	Drummond MF, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. BMJ Economic Evaluation Working Party. BMJ, 1996;313:275–283.
17.	Gold MR, Siegel JE, Russell LB, et al. Cost-effectiveness in health. 1996. Oxford, Oxford University Press.
18.	Nixon J, Pang F. Economic evaluations in Japan: a review of published studies, methodological issues and practice. In: Kondo S, Furuta K (eds) 2000 PSAM 5 – probabilistic safety assessment and management, vol 3. Universal Academy: Tokyo, pp 2077–2084.
19.	Evers S, Goossens M, de Vet H, et al. Criteria list for assessment of methodological quality of economic evaluations: Consensus on Health Economic Criteria. International Journal of Technology Assessment in Health Care, 2005;21(2):240–245.
20.	Shannon S. Critical appraisal of economic analysis studies. Can Assoc Rodiol J, 2002;53(5):251-4.
21.	Drummond MF, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press, 1987.
22.	Chiou CF, Hay JW, Wallace JF, et al. Development and Validation of a Grading System for the Quality of Cost-Effectiveness Studies. Medical Care, 2003;41(1):32-44.
23.	Gonzalez-Perez JG. Developing a scoring system to quality assess economic evaluations. Eur J Health Econom, 2002;3:131–136.
24.	Crowley S, Tognarini D, Desmond P, et al. Introduction of lamivudine for the treatment of chronic hepatitis B: Expected clinical and economic outcomes based on 4-year clinical trial data. Journal of Gastroenterology and Hepatology, 2002; 17:153–164.

1. Salkeld F, Davey P, Arnolda G. A critical review of health-related economic evaluation in Australia: implications for health policy. Health Policy, 1995;31:111-125.
2. Hailey D. Australian economic evaluation and government decisions on pharmaceuticals, compared to assessment of other health technologies. Soc. Sci. Med,1997;45(4):563-581.
3. Garceau L, Henderson J, Davis LJ, et al. Davidson LL. Economic implications of assisted reproductive techniques: a systematic review. Human reproduction, 2002;17(12):3090-3109.
4. Moayyedi P, Soo S, Deeks J, et al. Systematic review and economic evaluation of Helicobacter pylori eradication treatment for non-ulcer dyspepsia. BMJ, 2000;321;659-664.
5. Jefferson T, Demicheli V, Vale L. Quality of systematic reviews of economic evaluations in health care. JAMA, 2002;287:2809-2812.
6. Sulpher MJ, Pang FS, Manca A, et al. Generalisability in economic evaluation studies in healthcare: a review and case studies. Health Technol Assess, 2004;8(49).
7. Boulenger S, Nixon J, Drummond M, et al. Can economic evaluations be made more trans fer able? Eur J Health Econom, 2005, 6:334–346.
8. Drummond MF, Jefferson TO. On behalf of the BMJ Economic Evaluation Working Party. Guidelines for authors and peer reviewers of economic submissions to the BMJ. BMJ, 1996;313:275-283.
9. Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.5 [updated May 2005]. In: The Cochrane Library, Issue 3, 2005. Chichester, UK: John Wiley & Sons, Ltd.
10. National Health and Medical Research Council. How to use the evidence: assessment and application of scientific evidence Handbook series on preparing clinical practice Guidelines. Commonwealth of Australia, 2000.
11. Green C, Brazier J, Deverill M. Valuing Health-Related Quality of Life. A Review of Health State Valuation Techniques. Pharmacoeconomics, 2000; 17 (2): 151-165.
12. Oostenbrink JB, Koopmanschap MA, Rutten FFH. Standardisation of Costs: The Dutch Manual for Costing in Economic Evaluations. Pharmacoeconomics, 2002; 20 (7): 443-454.
13. Buxton MJ, Drummond MF, van Hout BA, et al. Modelling in economic evaluation: an unavoidable fact of life. Health Economics, 1997; 6: 217–227.
14. Birkett DJ, Mitchell AS, McManus P. A Cost-Effectiveness Approach to Drug Subsidy and Pricing in Australia. Health Affairs, 2001; 20(3): 104-114.
15. Adams ME, McCall NT, Gray DT, et al. Economic analysis in randomized control trials. Med Care, 1992;30:231–238.
16. Drummond MF, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. BMJ Economic Evaluation Working Party. BMJ, 1996;313:275–283.
17. Gold MR, Siegel JE, Russell LB, et al. Cost-effectiveness in health. 1996. Oxford, Oxford University Press.
18. Nixon J, Pang F. Economic evaluations in Japan: a review of published studies, methodological issues and practice. In: Kondo S, Furuta K (eds) 2000 PSAM 5 – probabilistic safety assessment and management, vol 3. Universal Academy: Tokyo, pp 2077–2084.
19. Evers S, Goossens M, de Vet H, et al. Criteria list for assessment of methodological quality of economic evaluations: Consensus on Health Economic Criteria. International Journal of Technology Assessment in Health Care, 2005;21(2):240–245.
20. Shannon S. Critical appraisal of economic analysis studies. Can Assoc Rodiol J, 2002;53(5):251-4.
21. Drummond MF, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press, 1987.
22. Chiou CF, Hay JW, Wallace JF, et al. Development and Validation of a Grading System for the Quality of Cost-Effectiveness Studies. Medical Care, 2003;41(1):32-44.
23. Gonzalez-Perez JG. Developing a scoring system to quality assess economic evaluations. Eur J Health Econom, 2002;3:131–136.
24. Crowley S, Tognarini D, Desmond P, et al. Introduction of lamivudine for the treatment of chronic hepatitis B: Expected clinical and economic outcomes based on 4-year clinical trial data. Journal of Gastroenterology and Hepatology, 2002; 17:153–164.

Chinese Journal of Evidence-Based Medicine

Methods for Socio-Economic Evaluation of Marketed MedicinesⅢ: Factors Affecting Methodological Quality and Transferability

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