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Finding legitimacy for the role of budget impact in drug reimbursement decisions

Published online by Cambridge University Press:  06 January 2009

Maartje G. H. Niezen
Affiliation:
Erasmus MC
Antoinette de Bont
Affiliation:
Erasmus MC
Jan J. V. Busschbach
Affiliation:
Erasmus MC and De Viersprong
Joshua P. Cohen
Affiliation:
Tufts University
Elly A. Stolk
Affiliation:
Erasmus MC

Abstract

Objectives: Research has shown that effectiveness, cost-effectiveness, and severity of illness each play a role in drug reimbursement decisions. However, the role of budget impact in such decisions is less obvious. Policy makers almost always demand a budget impact estimate yet seem reluctant to formally include budget impact as a rationing criterion. Health economists even reject budget impact as a legitimate criterion. For these reasons, it is important to examine its use in rationing decisions, and rationales underlying its use.

Methods: We trace several rationales supporting the use of budget impact through a literature review, supplemented by semistructured interviews with eleven key stakeholders involved in drug reimbursement decisions in the Netherlands.

Results: Budget impact arguments are used in certain instances, although policy makers appear uncomfortable with its use because well described rationales still are lacking. In addition, we identify the following rationales to support budget impact as a rationing criterion: opportunity costs, loss aversion, uncertainty and equal opportunity.

Conclusions: Budget impact plays a role in drug reimbursement decisions and has rationales to support its use. However, policy makers do not easily admit that they consider budget impact and are even reluctant to explicitly use budget impact as a formal criterion. A debate would strengthen the theoretical foundation of budget impact as a legitimate criterion in the context of drug reimbursement decisions. Such discussion of budget impact's role will also enhance policy-makers' accountability.

Type
General Essays
Copyright
Copyright © Cambridge University Press 2009

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References

REFERENCES

1. Al, MJ, Feenstra, TL, Hout, BA. Optimal allocation of resources over health care programmes: Dealing with decreasing marginal utility and uncertainty. Health Econ. 2005;14:655667.CrossRefGoogle ScholarPubMed
2. Amerongen, L. Crisis on clopidogrel. [in Dutch: Crisis over clopidogrel] Med Contact (Bussum). 2003:58.Google Scholar
3. Anand, P. QALYs and the integration of claims in health-care rationing. Health Care Anal. 1999;7:239253.CrossRefGoogle ScholarPubMed
4. Bal, R, Van de Lindeloof, A. Public participation in benefit package decisions. Learning from experiences abroad. [in Dutch: Publieksparticipatie bij pakketbeslissingen. Leren van buitenlandse ervaringen]. Rotterdam: Instituut Beleid en Management Gezondheidszorg; 2005.Google Scholar
5. Berg, M, Van Der Grinten, T, Klazinga, N. Technology assessment, priority setting and appropriate care in Dutch health care. Int J Technol Assess Health Care. 2004;20:3543.CrossRefGoogle ScholarPubMed
6. Birch, S, Gafni, A. Information created to evade reality (ICER): Things we should not look to for answers. Pharmacoeconomics. 2006;24:11211131.CrossRefGoogle Scholar
7. Borstkankervereniging Nederland. Report undertreatment of breast cancer patients with metastatic HER2-positive tumours [in Dutch: Rapport onderbehandeling van borstkankerpatienten met uitgezaaide HER2-positieve tumoren]. Utrecht: Borstkankervereniging Nederland; 2005.Google Scholar
8. Braat, D, Van Rijen, O, Ottes, L. Sensible and durable care. [in Dutch: Zinnige en duurzame zorg]. Nieuwsbrief Ned Vereniging Bio-ethiek. 2007:14;35.Google Scholar
9. Briggs, A, Gray, A. Using cost-effectiveness information. BMJ. 2000;320:246.CrossRefGoogle ScholarPubMed
10. Cohen, J, Stolk, EA, Niezen, MGH. The increasingly complex fourth hurdle for pharmaceuticals. Pharmacoeconomics. 2007;25:727734.CrossRefGoogle ScholarPubMed
11. Cohen, JP, Stolk, EA, Niezen, MGH. Role of budget impact in drug reimbursement decisions. J Health Polit Policy Law. 2008;33:225247.CrossRefGoogle ScholarPubMed
12. Dakin, HA, Devlin, NJ, Odeyemi, IA. “Yes”, “No” or “Yes, but”? Multinomial modelling of NICE decision-making. Health Policy. 2006;77:352367.CrossRefGoogle Scholar
13. Drummond, M, Jonsson, B, Rutten, F. The role of economic evaluation in the pricing and reimbursement of medicines. Health Policy. 1997;40:199215.CrossRefGoogle ScholarPubMed
14. Dupont, D, Lee, SL. The endowment effect, status quo bias and loss aversion: Rational alternative explanation. J Risk Uncertain. 2002;25:87101.CrossRefGoogle Scholar
15. Eijgelshoven, M, Wieringa, N, Van Der Vaart, R, et al. Clopidogel: Evaluation of its use and the additional conditions. [in Dutch: Clopidogrel: Evaluatie van de inzet en de nadere voorwaarden]. Amstelveen: College voor Zorgverzekeringen; 2003.Google Scholar
16. Fox, DM, Oxman, AD, eds. Informing judgment: Case studies of health policy and research in six countries. New York: Milbank Memorial Fund; 2001.Google Scholar
17. Gafni, A, Birch, S. Incremental cost-effectiveness ratios (ICERs): The silence of the lambda. Soc Sci Med. 2006;62:20912100.CrossRefGoogle ScholarPubMed
18. Gafni, A. Walter, SD, Birch, S, et al. An opportunity cost approach to sample size calculation in cost-effectiveness analysis. Health Econ. 2008;17:99107.CrossRefGoogle ScholarPubMed
19. Green, J, Thorogood, N. Qualitative methods for health research. London: SAGE; 2004.Google Scholar
20. Ham, C, Coulter, A. Explicit and implicit rationing: Taking responsibility and avoiding blame for health care choices. J Health Serv Res Policy. 2001;6:163169.CrossRefGoogle ScholarPubMed
21. Harris, A, Buxton, M, O'Brien, B, et al. Using economic evidence in reimbursement decisions for health technologies. Expert Rev Pharmacoeconomics Outcomes Res. 2001;1:712.CrossRefGoogle ScholarPubMed
22. Harris, J. Cost-effectiveness and resource allocation. Reply to Dr. Cohen. JAMA. 2007;295:27232724.CrossRefGoogle Scholar
23. Hoedemaekers, R, Oortwijn, W. Problematic notions in Dutch Health Care package decisions. Health Care Anal. 2003;11:287–94.CrossRefGoogle ScholarPubMed
24. Kahneman, D, Tversky, A. Prospect theory: An analysis of decision under risk. Econometrica. 1979;47:263291.CrossRefGoogle Scholar
25. Mauskopf, J. Budget impact analysis: Review of the state of the art. Expert Rev Pharmacoeconomics Outcomes Res. 2005;5:6579.CrossRefGoogle ScholarPubMed
26. Mauskopf, J, Sullivan, SD, Annemans, L, et al. Principles of good practice for budget impact analysis: Report of the ISPOR Task Force on good research practices—budget impact analysis. Value Health. 2007;10:336347.CrossRefGoogle ScholarPubMed
27. Mauskopf, J. Prevalence-based economic evaluation. Value Health. 1998;1:251259.CrossRefGoogle ScholarPubMed
28. McCabe, C, Claxton, K, Tsuchiya, A. Orphan drugs and the NHS: Should we value rarity? BMJ. 2005;331;1016–9.CrossRefGoogle ScholarPubMed
29. Ministerie van Volksgezondheid, Welzijn en.Sport. IVF back in the benefit package. [in Dutch: IVF komt weer in basispakket.] Nieuwsbericht Den Haag; 2006.Google Scholar
30. Neumann, PJ. Commentary on the ISPOR Task Force Report on budget impact analyses. Boston: Center for the Evaluation of Value and Risk in Health; 2007.Google Scholar
31. Niezen, MGH, De Bont, A, Stolk, EA, et al. Conditional reimbursement within the Dutch drug policy. Health Policy. 2007;84:3950.CrossRefGoogle ScholarPubMed
32. Niezen-van der Zwet, MGH, Stolk, EA, Eijck, A, et al. Evaluation of Schedule 2 as a policy instrument. [in Dutch: Evaluatie van Bijlage 2 als beleidsinstrument]. Rotterdam: Instituut Beleid en Management Gezondheidszorg / Erasmus MC; 2004.Google Scholar
33. Niezen, MGH, Stolk, EA, Uyl-de Groot, CA, et al. Inequalities in oncology care: Economic consequences of high cost drugs. Eur J Cancer. 2007;42:28872892.CrossRefGoogle Scholar
34. Orlewska, E, Mierzejewski, P. Proposal of Polish guidelines for conducting financial analysis and their comparison to existing guidance on budget impact in other countries. Value Health. 2004;7:110.CrossRefGoogle ScholarPubMed
35. Sendi, P, Gafni, A, Birch, S. Ethical economics and cost-effectiveness analysis: Is it ethical to ignore opportunity costs? Expert Rev Pharmacoeconomics Outcomes Res. 2005;5:661665.CrossRefGoogle ScholarPubMed
36. Sendi, P, Gafni, A, Birch, S. Opportunity costs and uncertainty in the economic evaluation of health care interventions. Health Econ. 2002;11:2331.CrossRefGoogle ScholarPubMed
37. Sendi, P, Al, MJ, Rutten, FF. Portfolio theory and cost-effectiveness analysis: A further discussion. Value Health. 2004;7:595601.CrossRefGoogle ScholarPubMed
38. Sendi, PP, Briggs, AH. Affordability and cost-effectiveness: Decision-making on the cost-effectiveness plane. Health Econ. 2001;10:675680.CrossRefGoogle ScholarPubMed
39. Stolk, EA, Brouwer, WB, Busschbach, JJ. Rationalising rationing: Economic and other considerations in the debate about funding of Viagra. Health Policy. 2002;59:5363.CrossRefGoogle ScholarPubMed
40. Trueman, P, Drummond, M, Hutton, J. Developing guidance for budget impact analysis. Pharmacoeconomics. 2001;19:609621.CrossRefGoogle ScholarPubMed
41. Ubel, PA, DeKay, ML, Baron, J, et al. Cost-effectiveness analysis in a setting of budget constraints-is it equitable? N Engl J Med. 1996;334:11741177.CrossRefGoogle Scholar
42. Van Luijn, JCF. CFH-rapport 99/05 Clopidogrel (Plavix) Ferrioxidesaccharaat (Venofer) Lactulose Granulaat (Legendal). Amstelveen; CVZ: 1999.Google Scholar
43. Van Oostenbruggen, MF, Jansen, RB, Mur, K, et al. Penny and pound wise: Pharmacoeconomics from a governmental perspective. Pharmacoeconomics. 2005;23:219226.CrossRefGoogle ScholarPubMed