Hostname: page-component-cd9895bd7-mkpzs Total loading time: 0 Render date: 2024-12-27T07:21:46.627Z Has data issue: false hasContentIssue false

Implementing accountability for reasonableness – the case of pharmaceutical reimbursement in Sweden

Published online by Cambridge University Press:  01 April 2007

SANDRA JANSSON*
Affiliation:
The Swedish Institute for Health Economics
*
*Correspondence to: IHE, The Swedish Institute for Health Economics, Box 2127, SE-220 02 Lund, Sweden. Tel: +46 46 329100; Email: [email protected]

Abstract

This paper aims to describe the priority-setting procedure for new original pharmaceuticals practiced by the Swedish Pharmaceutical Benefits Board (LFN), to analyse the outcome of the procedure in terms of decisions and the relative importance of ethical principles, and to examine the reactions of stakeholders. All the ‘principally important’ decisions made by the LFN during its first 33 months of operation were analysed. The study is theoretically anchored in the theory of fair and legitimate priority-setting procedures by Daniels and Sabin, and is based on public documents, media articles, and semi-structured interviews. Only nine cases resulted in a rejection of a subsidy by the LFN and 15 in a limited or conditional subsidy. Total rejections rather than limitations gave rise to actions by stakeholders. Primarily, the principle of cost-effectiveness was used when limiting/conditioning or totally rejecting a subsidy. This study suggests that implementing a priority-setting process that fulfils the conditions of accountability for reasonableness can result in a priority-setting process which is generally perceived as fair and legitimate by the major stakeholders and may increase social learning in terms of accepting the necessity of priority setting in health care. The principle of cost-effectiveness increased in importance when the demand for openness and transparency increased.

Type
Articles
Copyright
Copyright © Cambridge University Press 2007

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Anell, A. (2004), Priority setting for pharmaceuticals: the use of health economic evidence by reimbursement and clinical guidance committees, The European Journal of Health Economics, 5: 2835.Google Scholar
Anell, A. and Persson, U. (2005), Reimbursement and clinical guidance for pharmaceuticals in Sweden: do health-economic evaluations support decision making?, The European Journal of Health Economics, 50: 274279.CrossRefGoogle Scholar
Bell, J.A.Hyland, S.DePellegrin, T.Upshur, R.E.Bernstein, M., and Martin, D.K. (2004), SARS and hospital priority setting: a qualitative case study and evaluation, BMC Health Services Research, 4(1): 36.CrossRefGoogle ScholarPubMed
Daniels, N. and Sabin, J.E. (1997), Limits to health care: fair procedures, democratic deliberation, and the legitimacy problem for insurers, Philosophy and Public Affairs, 26(4): 302350.CrossRefGoogle ScholarPubMed
Daniels, N. and Sabin, J.E. (1998), The ethics of accountability in managed care reform, Health Affairs, 17(5): 5064.CrossRefGoogle ScholarPubMed
Daniels, N. and Sabin, J.E. (2002), Setting Limits Fairly: Can We Learn to Share Medical Resources? New York: Oxford University Press.Google Scholar
Daniels, N.Teagarden, J.R., and Sabin, J.E. (2003), An ethical template for pharmacy benefits: a way to encourage broader public learning and debate about setting limits fairly, Health Affairs, 22(1): 125137.Google Scholar
Gibson, J.L.Martin, D.K., and Singer, P.A. (2002), ‘Priority setting for new technologies in medicine: a transdisciplinary study’, www.biomecentral.com/1472–6963/2/14.CrossRefGoogle Scholar
Gibson, J.L.Martin, D.K., and Singer, P.A. (2005), Priority setting in hospitals: fairness, inclusiveness, and the problem of institutional power differences, Social Science of Medicine, 61(11): 23552362.CrossRefGoogle ScholarPubMed
Ham, C.Robert, G.Martin, D.K., and Singer, P.A. (2003), Reasonable Rationing: International Experience of Priority Setting in Health Care, Philadelphia: Open University Press.Google Scholar
Henry, D. (1992), Economic analysis as an aid to sudsidisation decisions: the development of Australian guidelines for pharmaceuticals, PharmacoEconomics, 1(1): 5467.CrossRefGoogle ScholarPubMed
Hill, S.Garattini, S.van Loenhout, J.O’Brien, B., and de Joncheere, K. (2003), ‘Technology Appraisal Programme of the National Institute for Clinical Excellence: a review by WHO.Google Scholar
Holm, S. (1998), Goodbye to the simple solutions: the second phase of priority setting in health care, British Medical Journal, 317: 10001007.Google Scholar
Jansson, S. and Anell, A. (2005), ‘Subventionering av läkemedel – förutsättningar för öppna och legitima beslutsprocesser i Läkemedelsförmånsnämnden’ (Reimbursement of pharmaceuticals – conditions of explicit and legitimate decision making processes at the Pharmaceutical Benefits Board), Report 2005:1, The National Centre for Priority Setting in Health Care, http://e.lio.se/prioriteringscentrum, 2005-02-13.Google Scholar
Jansson, S. and Anell, A. (2006), The impact of decentralised drug-budgets in Sweden – a survey of physicians’ attitudes towards cost and cost-effectiveness, Health Policy, 76: 299311.CrossRefGoogle ScholarPubMed
Kapiriri, L.O.F.Norheim, Norheim,, and D.K.Martin, Martin, (2006), Priority setting at the micro-, meso- and macro-levels in Canada, Norway and Uganda, Health Policy (E-pub in head of publication).Google Scholar
Laupacis, A. (2006), Economic evaluations in the Canadian Common Drug Review, Pharmacoeconomics, 24(11): 11571162.Google Scholar
Liss, P.-E. (2004), ‘The usefulness of the need-principle in setting of priorities’, Paper presented at the 5th International Conference on Priorities in Health Care, 3–5 November, Wellington, New Zealand.Google Scholar
Madden, S.Martin, D.K.Downey, S., and Singer, P.A. (2005), Hospital priority setting with an appeals process: a qualitative case study and evaluation, Health Policy, 73(1): 1020.Google Scholar
Martin, D.K.Pater,, J.L. and Singer, P.A. (2001), Priority setting decisions for new cancer drugs: what rationales are used?, Lancet, 358: 16761681.CrossRefGoogle Scholar
Martin, D.K.Shulman, K.Santiago-Sorrell, P., and Singer, P. (2003a), Priority setting and hospital strategic planning: a qualitative case study, Journal of Health Services and Research Policy, 8(4): 197201.Google Scholar
Martin, D.K.Walton, N., and Singer, P. (2003b), Priority setting in surgery: improve the process and share the learning, World Journal of Surgery, 27(8): 962966.Google Scholar
McMahon, M.Morgan, S., and Mitton, C. (2006), The common drug review: a NICE start for Canada?, Health Policy, 77: 339351.CrossRefGoogle ScholarPubMed
Ministry of Health and Social Affairs (2000), Den nyaläkemedelsförmånen, Betänkande av utredningen om läkemedelsförmånen. (The new pharmaceutical benefit system), SOU: 86.Google Scholar
Mitton, C.R.McMahon, M.Morgan, S., and Gibson, J. (2006), Centralized drug review processes: are they fair?, Social Science and Medicine, 63: 200211.Google Scholar
Morgan, S.G.McMahon, M.Mitton, C.Roughead, E.Kirk, R.Kanavos, P., and Menon, D. (2006a), Centralized drug review processes in Australia, Canada, New Zealand, and the United Kingdom: Well-designed processes can help policymakers make tough, evidence based decisions, Health Affairs, 25(2): 337347.Google Scholar
Morgan, S.McMahon, M., and Mitton, C. (2006b), Centralising drug review to improve coverage decisions: economic lessons from (and for) Canada, Applied Health Economics and Health Policy, 5(2): 6773.Google Scholar
Persson, U. and Hjelmgren, J. (2003), Hälso- och sjukvården behöver kunskap om hur befolkningen värderar hälsa’ (Information of the public assessment of the value of health is needed in health care), Läkartidningen, 43(100): 34363437.Google Scholar
Pope, C.Ziebland, S., and Mays, N. (2000), Qualitative research in health care: analysing qualitative data, British Medical Journal, 320: 114116.Google Scholar
Ramsberg, J.Lundin, D.Engström, A., and Jacob, J. (2004), ‘How drugs for rare diseases are and should be treated in pricing and reimbursement’, Paper presented at the 5th International Conference on Priorities in Health Care, 3–5 November, Wellington, New Zealand.Google Scholar
Singer, P.A.Martin, D.K.Giacomini, M., and Purdy, L. (2000), Priority setting for new technologies in medicine: qualitative case study, British Medial Journal, 321: 13161318.Google Scholar
Towse, A. and Pritchard, C. (2002), National Institute for clinical Excellence (NICE): is economic appraisal working?, Pharmacoeconomics, 20(Suppl. 3): 95105.CrossRefGoogle ScholarPubMed
Yin, R. K. (2003), Case study research: Design and Methods, third edition, Applied Social Research Methods Series, vol. 5, London: Sage Publications.Google Scholar