Abstract
Objective
The Swedish Dental and Pharmaceutical Benefits Agency (TLV) is the government body responsible for deciding whether outpatient drugs are to be included in the pharmaceutical benefits scheme. This paper analyzes the impact of cost effectiveness and severity of disease on reimbursement decisions for new pharmaceuticals.
Methods
Data has been extracted from all decisions made by the TLV between 2005 and 2011. Cost effectiveness is measured as the cost per quality-adjusted life-year (QALY) gained, whereas disease severity is a binary variable (severe–not severe). In total, the dataset consists of 102 decisions, with 86 approved and 16 declined reimbursements.
Results
The lowest cost per QALY of declined reimbursements is Swedish kronor (SEK) 700,000 (€79,100), while the highest cost per QALY of approved reimbursements is SEK1,220,000 (€135,600). At a cost per QALY of SEK702,000 Swedish kronor (non-severe diseases) and SEK988,000 (severe diseases), the likelihood of approval is estimated to be 50/50 (€79,400 and €111,700).
Conclusions
The TLV places substantial weight on both the cost effectiveness and the severity of disease in reimbursement decisions, and the implied willingness to pay for a QALY is higher than the often cited ‘rule of thumb’ in Swedish policy debates.
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Acknowledgments
The authors are grateful for suggestions and comments from two anonymous reviewers. MS, FN and KA planned the study. FN and KA extracted the data. MS analysed and interpreted the data and wrote most components of the manuscript. FN and KA provided feedback and contributed to various parts of the manuscript. All authors read and approved the final manuscript. MS is the overall guarantor of this work.
Compliance with ethical standards
The preparation of this manuscript was partly funded by the Swedish Research Council for Health, Working Life and Welfare (for the corresponding author). Mikael Svensson, Fredrik Nilsson and Karl Arnberg all declare that they have no conflicts of interest.
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Svensson, M., Nilsson, F.O.L. & Arnberg, K. Reimbursement Decisions for Pharmaceuticals in Sweden: The Impact of Disease Severity and Cost Effectiveness. PharmacoEconomics 33, 1229–1236 (2015). https://doi.org/10.1007/s40273-015-0307-6
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DOI: https://doi.org/10.1007/s40273-015-0307-6