Evidence-based healthcare and the need of conditional decision

Silvia Park; Sang Moo Lee

doi:10.5124/jkma.2011.54.12.1319

J Korean Med Assoc > Volume 54(12); 2011 > Article

Park and Lee: Evidence-based healthcare and the need of conditional decision

Healthcare Policy

Journal of the Korean Medical Association

Journal of the Korean Medical Association 2011; 54(12): 1319-1329.

Published online: December 13, 2011

DOI: http://dx.doi.org/10.5124/jkma.2011.54.12.1319

Evidence-based healthcare and the need of conditional decision

Silvia Park, PhD¹, Sang Moo Lee, MD²

¹Korea Institute for Health and Social Affairs, Seoul, Korea.

²National Evidence-based Healthcare Collaborating Agency, Seoul, Korea.

Corresponding author: Sang Moo Lee, lsm@neca.re.kr

Received November 16, 2011 Accepted November 25, 2011

This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

The decision making for reimbursement has become more difficult than before because of the high cost innovative new technologies and limitation of healthcare resources. Evidence-based healthcare system has been introduced in Korea since 2007. Not infrequently, however, decision makers have been confronted with uncertainties caused by lack of information related to comparative effectiveness, real world outcomes, off-label drug use, combination therapy and cost-effectiveness. Under these circumstances, the decision making of whether or not to reimburse is inadequate because undesirable results may be induced. Managed entry agreement has been introduced globally. This kind of decision is conditional and linked with monitoring and following the results and adjusting the policy according to the results. Especially access with evidence development is a form of prospective data correction with conditional coverage in the case of existing uncertainties of effectiveness and safety. In Korea, there have been several examples including off-label drug use in oncologic drugs, new healthcare intervention and re-evaluation of existing drugs. Even though there has been some conflict and confusion because of inadequate systematization, it is strongly recommended to establish the conditional decision making system in Korea since this is a unique answer to manage the uncertainty in maintaining development of health science, keeping patients' right and using healthcare resources rationally.

Evidence-based medicine; Decision making; Conditional decision

References

1. Park SH, Lee SM. Evidence-based decision-making and health technology assessment in South Korea. Value Health 2008;11:Suppl 1. S163-S164.

2. Lee SM. Evidence-based healthcare: seeking for the broken virtuous circle. J Korean Med Assoc 2009;52:532-535.

3. Stafinski T, McCabe CJ, Menon D. Funding the unfundable: mechanisms for managing uncertainty in decisions on the introduction of new and innovative technologies into healthcare systems. Pharmacoeconomics 2010;28:113-142.

4. Klemp M, Fronsdal KB, Facey K. HTAi Policy Forum. What principles should govern the use of managed entry agreements? Int J Technol Assess Health Care 2011;27:77-83.

5. Eden J, Wheatley B, McNeil B, Sox H. Knowing what works in health care: a roadmap for the nation 2008;Washington, DC: The National Academies Press. 280.

6. Park S. Risk-sharing agreement on the pricing and reimbursement of new drugs. Korean J Health Econ Policy 2010;16:125-153.

7. Organisation for Economic Co-operation and Development (OECD). Pharmaceutical pricing policies in a global market 2008;Paris: OECD. 215.

8. Park S, Park EJ, Ko SJ. Policy measures to enhance access to drugs for rare diseases 2010;Seoul: Korea Institute for Health and Social Affairs.

9. Olsen LA, Aisner D, McGinnis JM. The learning healthcare system: workshop summary 2007;Washington, DC: National Academies Press. 374.

10. Singh AK, Szczech L, Tang KL, Barnhart H, Sapp S, Wolfson M, Reddan D. CHOIR Investigators. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 2006;355:2085-2098.

11. Rubin RJ, Mendelson DN. Translating guidelines into policy. Clin J Am Soc Nephrol 2007;2:209-210.

12. Green Park Collaborative (GPC) [Internet]. Center for Medical Technology Policy c2008;cited 2011 Oct 20. Baltimore, MD: Center for Medical Technology Policy. Available from: http://www.cmtpnet.org/gpc

13. Carino T, Williams RD 2nd, Colbert AM, Bridger P. Medicare's coverage of colorectal cancer drugs: a case study in evidence development and policy. Health Aff (Millwood) 2006;25:1231-1239.

14. Chalkidou K, Hoy A, Littlejohns P. Making a decision to wait for more evidence: when the National Institute for Health and Clinical Excellence recommends a technology only in the context of research. J R Soc Med 2007;100:453-460.

15. Beta interferon and glatiramer acetate for the treatment of multiple sclerosis [Internet]. National Institute for Clinical Excellence 2002;cited 2011 Oct 20. London: National Institute for Clinical Excellence. Available from: http://www.nice.org.uk/nicemedia/live/11441/32290/32290.pdf

16. Lexchin J. Coverage with evidence development for pharmaceuticals: a policy in evolution? Int J Health Serv 2011;41:337-354.

17. McCabe CJ, Stafinski T, Edlin R, Menon D. Banff AED Summit. Access with evidence development schemes: a framework for description and evaluation. Pharmacoeconomics 2010;28:143-152.

18. Boggild M, Palace J, Barton P, Ben-Shlomo Y, Bregenzer T, Dobson C, Gray R. Multiple sclerosis risk sharing scheme: two year results of clinical cohort study with historical comparator. BMJ 2009;339:b4677.

19. Raftery J. Multiple sclerosis risk sharing scheme: a costly failure. BMJ 2010;340:c1672.

20. Wlodarczyk JH, Cleland LG, Keogh AM, McNeil KD, Perl K, Weintraub RG, Williams TJ. Public funding of bosentan for the treatment of pulmonary artery hypertension in Australia: cost effectiveness and risk sharing. Pharmacoeconomics 2006;24:903-915.

21. Trueman P, Grainger DL, Downs KE. Coverage with Evidence Development: applications and issues. Int J Technol Assess Health Care 2010;26:79-85.

22. Persson U, Willis M, Odegaard K. A case study of ex ante, value-based price and reimbursement decision-making: TLV and rimonabant in Sweden. Eur J Health Econ 2010;11:195-203.

23. Fishman A, Martinez F, Naunheim K, Piantadosi S, Wise R, Ries A, Weinmann G, Wood DE. National Emphysema Treatment Trial Research Group. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med 2003;348:2059-2073.

24. Mohr PE, Tunis SR. Access with evidence development: the US experience. Pharmacoeconomics 2010;28:153-162.

25. Tu JV, Bowen J, Chiu M, Ko DT, Austin PC, He Y, Hopkins R, Tarride JE, Blackhouse G, Lazzam C, Cohen EA, Goeree R. Effectiveness and safety of drug-eluting stents in Ontario. N Engl J Med 2007;357:1393-1402.

26. Park BJ, Heo DS, Ahn HS, Lee SM, Lee YH, Kim SY, Kim SS, Han SG, Bae EY, Park DA. Evidence-based healthcare 2009;Seoul: Korean Medical Book Publisher. 364.

Figure 1

Pipeline from evidence generation to practice and dealing with uncertainties.

Figure 2

Stage of regulation and decision process for adoption of new health technology and need for conditional decision with evidence generation. KFDA, Korean Food and Drug Administration; CnHTA, Committee for New Health Technology Assessment; HIRA, Health Insurance Review and Assessment Service; MoHW, Ministry of Health and Welfare, Korea.

Table 1

Concerning points for performing access with evidence development