Criteria for Drug Reimbursement Decision-Making: An Emerging Public Health Challenge in Bulgaria

Year 2016, Volume: 33 Issue: 1, 27 - 35, 01.01.2016

Georgi Iskrov Rumen Stefanov

Abstract

Background: During times of fiscal austerity, means of reimbursement decision-making are of particular interest for public health theory and practice. Introduction of advanced health technologies, growing health expenditures and increased public scrutiny over drug reimbursement decisions have pushed governments to consider mechanisms that promote the use of effective health technologies, while constraining costs. Aims: The study’s aim was to explore the current rationale of the drug reimbursement decision-making framework in Bulgaria. Our pilot research focused on one particular component of this process – the criteria used – because of the critical role that criteria are known to have in setting budgets and priorities in the field of public health. The analysis pursued two objectives: to identify important criteria relevant to drug reimbursement decision-making and to unveil relationships between theory and practice. Study Design: Cross-sectional study. Methods: The study was realized through a closed-ended survey on reimbursement criteria among four major public health stakeholders – medical professionals, patients, health authorities, and industry. Empirical outcomes were then cross-compared with the theoretical framework, as defined by current Bulgarian public health legislation. Analysis outlined what is done and what needs to be done in the field of public health reimbursement decision-making. Results: Bulgarian public health stakeholders agreed on 15 criteria to form a tentative optimal framework for drug reimbursement decision-making. The most apparent gap between the empirically found preferences and the official legislation is the lack of consideration for the strength of evidence in reimbursement decisions. Conclusion: Bulgarian policy makers need to address specific gaps, such as formal consideration for strength of evidence, explicit role of efficiency criteria, and means to effectively empower patient and citizen involvement in public health decision-making. Drug reimbursement criteria have to be integrated into legitimate public health decision support tools that ensure the achievement of national public health objectives. These recommendations could be expanded to all Eastern European countries who share common public health problems.

Keywords

Bulgaria, decision-making, decision support models, health technology assessment, reimbursement, reimbursement criteria

References

• 1. Leider JP, Resnick B, Kass N, Sellers K, Young J, Bernet P, et al. Budget- and priority-setting criteria at state health agencies in times of austerity: a mixed-methods study. Am J Public Health 2014;104:1092-9. [CrossRef]
• 2. Sibbald SL, Gibson JL, Singer PA, Upshur R, Martin DK. Evaluating priority setting success in healthcare: a pilot study. BMC Health Serv Res 2010;10:131. [CrossRef]
• 3. Simoens S. Health economic assessment: a methodological primer. Int J Environ Res Public Health 2009;6:2950-66. [CrossRef]
• 4. Stoykova M, Mussurlieva N. Some problems of prevention and promotion of dental health in Bulgaria. Dentalna Medicina 2011;93:178-82.
• 5. Chabot I, Rocchi A. Oncology drug health technology assessment recommendations: Canadian versus UK experiences. Clinicoecon Outcomes Res 2014;6:357-67. [CrossRef]
• 6. Eichler HG, Kong SX, Gerth WC, Mavros P, Jönsson B. Use of cost-effectiveness analysis in health-care resource allocation decision-making: how are cost-effectiveness thresholds expected to emerge? Value Health 2004;7:518-28. [CrossRef]
• 7. Kolasa K, Kalo Z, Zah V, Dolezal T. Role of health technology assessment in the process of implementation of the EU Transparency Directive: relevant experience from Central Eastern European countries. Expert Rev Pharmacoecon Outcomes Res 2012;12:283-7. [CrossRef]
• 8. Kolasa K, Schubert S, Manca A, Hermanowski T. A review of Health Technology Assessment (HTA) recommendations for drug therapies issued between 2007 and 2009 and their impact on policymaking processes in Poland. Health Policy 2011;102:145-51. [CrossRef]
• 9. Iskrov GG, Raycheva RD, Stefanov RS. Insight into reimbursement decision-making criteria in Bulgaria: implications for orphan drugs. Folia Med (Plovdiv) 2013;55:80-6. [CrossRef]
• 10. Lopert R, Ruiz F, Chalkidou K. Applying rapid ‘de-facto’ HTA in resource-limited settings: experience from Romania. Health Policy 2013;112:202-8. [CrossRef]
• 11. Gulácsi L, Rotar AM, Niewada M, Löblová O, Rencz F, Petrova G, et al. Health technology assessment in Poland, the Czech Republic, Hungary, Romania and Bulgaria. Eur J Health Econ 2014;15(Suppl 1):S13-25. [CrossRef]
• 12. Ordinance on the terms, rules and procedure for regulation and registration of prices for medicinal products. Adopted by Council of Ministers Decree No. 97 of 19 April 2013. Promulgated in the State Gazette No. 40 of 30 April 2013.
• 13. Guindo LA, Wagner M, Baltussen R, Rindress D, van Til J, Kind P, et al. From efficacy to equity: Literature review of decision criteria for resource allocation and healthcare decisionmaking. Cost Eff Resour Alloc 2012;10:9. [CrossRef]
• 14. Rosenberg-Yunger ZR, Daar AS, Thorsteinsdóttir H, Martin DK. Priority setting for orphan drugs: an international comparison. Health Policy 2011;100:25-34. [CrossRef
• 15. Sussex J, Rollet P, Garau M, Schmitt C, Kent A, Hutchings A. A pilot study of multicriteria decision analysis for valuing orphan medicines. Value Health 2013;16:1163-9. [CrossRef]
• 16. Baltussen R, Niessen L. Priority setting of health interventions: the need for multi-criteria decision analysis. Cost Eff Resour Alloc 2006;4:14. [CrossRef]
• 17. Stolk EA, Poley MJ. Criteria for determining a basic health services package. Recent developments in The Netherlands. Eur J Health Econ 2005;6:2-7. [CrossRef]
• 18. Dupont AG, Van Wilder PB. Access to orphan drugs despite poor quality of clinical evidence. Br J Clin Pharmacol 2011;71:488- 96. [CrossRef]
• 19. Lorenc T, Tyner EF, Petticrew M, Duffy S, Martineau FP, Phillips G, et al. Cultures of evidence across policy sectors: systematic review of qualitative evidence. Eur J Public Health 2014;24:1041-7. [CrossRef]
• 20. Defechereux T, Paolucci F, Mirelman A, Youngkong S, Botten G, Hagen TP, et al. Health care priority setting in Norway a multicriteria decision analysis. BMC Health Serv Res 2012;12:39. [CrossRef]
• 21. Tony M, Wagner M, Khoury H, Rindress D, Papastavros T, Oh P, et al. Bridging health technology assessment (HTA) with multicriteria decision analyses (MCDA): field testing of the EVIDEM framework for coverage decisions by a public payer in Canada. BMC Health Serv Res 2011;11:329. [CrossRef]
• 22. Iskrov G, Stefanov R. Post-marketing access to orphan drugs: a critical analysis of health technology assessment and reimbursement decision-making considerations. Orphan Drugs: Research and Reviews 2014;4:1-9. [CrossRef]
• 23. Niezen MG, de Bont A, Busschbach JJ, Cohen JP, Stolk EA. Finding legitimacy for the role of budget impact in drug reimbursement decisions. Int J Technol Assess Health Care 2009;25:49-55.
• 24. Rocchi A, Menon D, Verma S, Miller E. The role of economic evidence in Canadian oncology reimbursement decisionmaking: to lambda and beyond. Value Health 2008;11:771-83. [CrossRef]
• 25. Cho E, Park EC, Kang MS. Pitfalls in reimbursement decisions for oncology drugs in South Korea: need for addressing the ethical dimensions in technology assessment. Asian Pac J Cancer Prev 2013;14:3785-92. [CrossRef]
• 26. Stolk EA, van Donselaar G, Brouwer WB, Busschbach JJ. Reconciliation of economic concerns and health policy: illustration of an equity adjustment procedure using proportional shortfall. Pharmacoeconomics 2004;22:1097-107. [CrossRef]
• 27. Green CJ, Maclure M, Fortin PM, Ramsay CR, Aaserud M, Bardal S. Pharmaceutical policies: effects of restrictions on reimbursement. Cochrane Database Syst Rev 2010:CD008654. [CrossRef] 28. Sax P, Shmueli A. Impact of pharmaceutical regulation and policies on health system performance goals in Israel. Adv Health Econ Health Serv Res 2010;22:77-101. [CrossRef]
• 29. Pizzo E, Doyle C, Matthews R, Barlow J. Patient and public involvement: how much do we spend and what are the benefits? Health Expect 2014.
• 30. Rosenberg-Yunger ZR, Thorsteinsdóttir H, Daar AS, Martin DK. Stakeholder involvement in expensive drug recommendation decisions: an international perspective. Health Policy 2012;105:226-35. [CrossRef]