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The Increasingly Complex Fourth Hurdle for Pharmaceuticals

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Abstract

There are three known criteria that underlie drug reimbursement decisions: therapeutic value, cost effectiveness and burden of disease. However, evidence from recent reimbursement decisions in several jurisdictions points to residual unexplained variables, one of which may be budget impact. An economic rationale for carrying out budget impact analyses is opportunity cost, measured by the economic benefits foregone by using resources in one way rather than another. Under certain assumptions, cost-effectiveness analysis accounts for opportunity cost while conveying to the decision maker the price of maximising health gains, subject to a budget constraint. However, the underlying assumptions are implausible, particularly in the context of pharmaceutical care.

Although drugs that are cost effective may lead to unambiguous health gains among patient groups for whom the drugs are indicated, the opportunity costs could conceivably lead to a reduction in aggregate health gains, or failure to meet different kinds of equity considerations. The pertinent policy question is where to find the resources to fund new innovations, such as cost-effective pharmaceuticals, or drugs targeting severe diseases. It may be a matter of redeployment of resources across healthcare sectors, cancelling the funding of (older) pharmaceuticals that are less cost effective, or delisting drugs that are cost effective but target less burdensome conditions.

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References

  1. OECD Health Data 2002. Paris: OECD Health Policy Unit, 2003 [online]. Available from URL: http://www.oecd.org [Accessed 2007 Feb 10]

  2. Smith C, Cowan C, Heftier S, et al. National health spending in 2004: recent slowdown led by prescription drug spending. Health Aff 2006; 25 (1): 186–196

    Article  Google Scholar 

  3. The Oxford Institute of Ageing. Ageing horizons: policies for ageing societies. Population ageing and health care expenditure [online]. Available from URL: http://www.ageing.ox.ac.uk/ageinghorizons [Accessed 2006 Feb 10]

  4. Baker L, Birnbaum H, Geppert J, et al. Relationship between technology availability and health care spending. Health Aff 2003 [online]. Available from URL: http://content.healthaffairs.org/cgi/reprint/hlthaff.w3.537vl [Accessed 2006 Feb 11]

    Google Scholar 

  5. Aaron H. Should public policy seek to control growth of health care spending? Health Aff 2003 [online]. Available from URL: http://content.healthaffairs.org/cgi/reprint/hlthaff.w328v1 [Accessed 2006 Feb 12]

    Google Scholar 

  6. Towse A. The efficient use of pharmaceuticals: does Europe have any lessons for a Medicare drug benefit? Health Aff 2003; 22 (3): 42–45

    Article  Google Scholar 

  7. Anell A. Priority setting for pharmaceuticals. Eur J Health Econ 2004; 5: 28–35

    Article  PubMed  Google Scholar 

  8. Neumann P, Sandberg E, Bell C, et al. Are pharmaceuticals cost-effective? A review of evidence. Health Aff 2000; 19 (2): 92–109

    Article  CAS  Google Scholar 

  9. George B, Harris A, Mitchell A. Cost-effectiveness analysis and the consistency of decision making: evidence from pharmaceutical reimbursement in Australia (1991 to 1996). Pharmacoeconomics 2001; 19 (11): 1103–1109

    Article  PubMed  CAS  Google Scholar 

  10. Taylor R, Drummond M, Salkfeld G, et al. Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdle. BMJ 2004; 329 (7472): 972–975

    Article  PubMed  CAS  Google Scholar 

  11. Stolk E Rutten F. The health basket in the Netherlands. Eur J Health Econ 2005; 6: 53–57

    Article  Google Scholar 

  12. Oostenbruggen MV, Jansen R, Mur K, et al. Penny and pound wise: pharmacoeconomics from a governmental perspective. Pharmacoeconomics 2005; 23 (3): 219–226

    Article  PubMed  Google Scholar 

  13. Devlin N, Parkin D. Does NICE have a cost-effectiveness threshold and what other factors influence its decisions? A binary choice analysis. Health Econ 2004; 13: 437–452

    Article  PubMed  Google Scholar 

  14. Cohen J, Cairns C, Paquette D, et al. Comparing patient access to pharmaceuticals in the UK and US. Appl Health Econ Health Policy 2006; 5 (3): 177–187

    Article  PubMed  Google Scholar 

  15. Spooner J, Gandhi P, Brown S, et al. AMCP format dossier requests: manufacturer response and formulary implications for one large health plan. J Managed Care Pharmacy 2007; 13 (1): 37–43

    Google Scholar 

  16. Neumann P. Evidence-based and value-based formulary guidelines. Health Aff 2004; 23 (1): 124–134

    Article  Google Scholar 

  17. Stolk E, Brouwer W, Busschbach J. Rationalizing rationing, economic and other considerations in the debate about funding of Viagra. Health Policy 2002; 59 (1): 53–63

    Article  PubMed  Google Scholar 

  18. NICE Citizens’ Council Report: rule of rescue, 2006 [online]. Available from URL: http://www.nice.org.uk/page.aspx?.o=343455 [Accessed 2007 May 4]

    Google Scholar 

  19. France’s Age nee National d’Accr’editation et d’Evaluation en Sant’e [online]. Available from URL: http://www.hassante.fr/protail/display.jsp?id=c_45261 [Accessed 2005 Nov 23]

  20. Le Pen C. The drug budget silo mentality: the French case. Value Health 2003; 6 (10): S10–S19

    Google Scholar 

  21. Koopmanschap M, Rutten F. Drug budget silo mentality: the Dutch case. Value Health 2003; 6: 46–51

    Article  Google Scholar 

  22. Cohen J, Faden L, Predaris S, et al. Patient access to pharmaceuticals: an international comparison. European J Health Econ. Epub 2007 Feb

    Google Scholar 

  23. Harris A, Buxton M, O’Brien B, et al. Using economic evidence in reimbursement decisions for health technologies: experience of 4 countries. Expert Rev Pharmacoeconomics Outcomes Research 2001; 1: 7–12 [online]. Available from URL: http://www.futuredmgs.eom/toc/erp/l/l [Accessed 2007 Jun 29]

    Article  CAS  Google Scholar 

  24. Rawlins M, Culyer A. National Institute for Clinical Excellence and its value judgments. BMJ 2004; 328: 224–227

    Article  Google Scholar 

  25. Brown L, Walker A, Waters AM, et al. Funding of high cost biotechnology and other innovative targeted therapies under the pharmaceutical benefits scheme [online]. Available from URL: http://www.natsem.canberra.edu.au/publications/papers/other pubs/pbs/pbs_and_highcostdrugs.pdf [Accessed 2006 Mar 6]

  26. Mauskopf J, Sullivan S, Annemans L, et al. Principles of good practice for budget impact analysis: report of the ISPOR task force on good research practices, 2005 [online]. Available from URL: http://www.ispor.org/workpaper/budget_imp act.asp [Accessed 2007 May 1]

    Google Scholar 

  27. Chang J, Sung J. Health plan budget impact analysis for pimecrolimus. J Managed Care Pharmacy 2005; 11 (1): 66–73

    Google Scholar 

  28. Fox P, Oxman A. Informing judgment: case studies from six countries [online]. Available from URL: http://www. milbank.org/200lcochrane/010903cochrane.html [Accessed 2006 February 14]

  29. Mossialos E, Mrazek M, Walley F, editors. Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality. London: Open University Press, 2004

    Google Scholar 

  30. Toenders W. CFH-Rapport vardenafil Bijlage FE rapport. Amstelveen: College voor Zorgverzekeringen, 2004 [online]. Available from URL: http://www.cvz.nl/resources/cfh0320%20verzamel%20rapport_tcm28-20310.pdf [Accessed 2007 February 21]

    Google Scholar 

  31. Kooijman H. Zorg Verzekerd: Internationaal vergelijkend onderzoek naar de samenstelling van het basispakket van de nationale ziektekostenverzekering. The Hague: PharMerit, 2003

    Google Scholar 

  32. Hughes D, Tunnage B, Yeo S. Drugs for exceptionally rare diseases: do they deserve special status for funding? Q J Med 2005; 98 (11): 829–836

    Article  CAS  Google Scholar 

  33. Gafni A, Birch S. Incremental cost-effectiveness ratios (ICERs): the silence of the lambda. See Sci Med 2006; 62: 2091–2100

    Article  Google Scholar 

  34. Zollner H, Stoddart G, Selby Smith C. Learning to live with health economics. Copenhagen: WHO, 2003 [online]. Available from URL: http://www.euro.who.int/document/ffa/hlth_econ_ch3.pdf [Accessed 2006 Dec 10]

    Google Scholar 

  35. Elbasha E, Messonnier M. Cost-effectiveness analysis and health care resource allocation: decision rules under variable returns to scale. Health Econ 2004; 13: 21–35

    Article  PubMed  Google Scholar 

  36. Maynard A, Bloor K, Freemantle N. Challenges for the National Institute for Clinical Excellence. BMJ 2004; 329: 227–229

    Article  PubMed  Google Scholar 

  37. Luijn JV. CFH-rapport 99/05 clopidogrel. Health Insurance Board [online]. Available from URL: http://www.cvz.nl [Accessed 2007 Jan 2]

  38. Niezen M, van der Zwet M. Evaluatie van Bijlage 2 als beleid-sinstrument. Rotterdam: Erasmus MC, Institute of Health Policy and Management, 2005

    Google Scholar 

  39. Cost-effective provision of disease modifying therapies for people with multiple sclerosis [online]. Available from URL: http://www.dh.gov.uk/assetRoot/04/01/22/14/04012214.pdf [Accessed 2006 Mar 6]

  40. Sculpher M, Claxton K. Establishing the cost-effectiveness of new pharmaceuticals under conditions of uncertainty: when is there sufficient evidence? Value Health 2005; 8 (4): 433–446

    Article  PubMed  Google Scholar 

  41. Coast J. Is economic evaluation in touch with society’s health values? BMJ 2004; 329: 1233–1236

    Article  PubMed  Google Scholar 

  42. Crowley J, Asher D, Elam L. Medicaid outpatient prescription drug benefits: findings from a national survey, 2003 [online]. Available from URL: http://www.kff.org/medicaid/upload/Medicaid-Outpatient-Prescription-Drag-Benefits-Findings-from-a-National-Survey-2003.pdf [Accessed 2007 Feb 21]

    Google Scholar 

  43. Eichler HG, Kong S, Gerth W, et al. Use of cost-effectiveness analysis in health-care resource allocation decision-making: how are cost-effectiveness thresholds expected to emerge? Value Health 2004; 7 (5): 518–528

    Article  PubMed  Google Scholar 

  44. Sendi P, Gafni A. The HAART side of resource allocation. Can Med Assoc J 2003; 169 (2): 120–121

    Google Scholar 

  45. Williams I, Bryan S, Mclver S. The use of economic evaluations in NHS decision-making: August 2006 [online]. Available from URL: http://www.pcpoh.bham.ac.uk/publichealth/nccrm/PDFs%20and%20documents/Publications/Williams_et_ al_Final_report.pdf [Accessed Feb 21]

    Google Scholar 

  46. Cutler D, McClellan M. Is technological change in medicine worth it? Health Aff 2001; 20 (3): 1–29

    Google Scholar 

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Acknowledgements

The authors acknowledge financial support from the Netherlands Organisation for Scientific Research (NWO) under project number 253-20-022 of the EOB (Section on Ethics and Policy) programme. The authors have no conflicts of interest to declare.

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Authors and Affiliations

  1. Tufts Center for the Study of Drug Development, 192 South Street, Suite 550, Boston, Massachusetts, 02111, USA

    Joshua Cohen

  2. Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands

    Joshua Cohen, Elly Stolk & Maartje Niezen

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Cohen, J., Stolk, E. & Niezen, M. The Increasingly Complex Fourth Hurdle for Pharmaceuticals. Pharmacoeconomics 25, 727–734 (2007). https://doi.org/10.2165/00019053-200725090-00002

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