A detailed comparison of dutch and swedish drug reimbursement decisions: What evidence is available, which criteria are used, and is the decision-making process transparent?

OBJECTIVES: To compare Dutch and Swedish drug reimbursement decisions and to investigate the available evidence, used criteria, outcomes and transparency of the decision-making process. METHODS:Weinvestigated Dutch and Swedish publicly available drug reimbursement dossiers from 2005 until July 2011. Applications and outcomes were compared and classified into different categories. For dossiers that included a full pharmacoeconomic evaluation (i.e. cost-effectiveness and/ or cost-utility analysis) in both countries, we compared in detail how the available evidence was assessed to appraise societal value. RESULTS: Pharmacoeconomic evaluations were more often available in Swedish dossiers due to many exemptions in The Netherlands (mainly orphan and HIV drugs). Reimbursement dossiers only provided a full economic evaluation in both countries for eleven drugs. The reimbursement decision differed for four drugs, in which relatively more restrictions were observed. Although Dutch dossiers provided more details, all dossiers included information of underlying clinical and economic studies. Comparators were always reported. Using a similar comparator (8x) resulted in a similar (5x) and a different (3x) therapeutic value judgement, while a different comparator (3x) resulted twice in a similar judgement. Swedish 'yes' decisions (10x) were judged cost-effective; 'no' decisions (two for one drug) were judged cost-ineffective. Dutch 'yes' decisions (9x, including two second decisions) were evaluated sufficiently (3x), reasonably (1x), moderately (2x), and insufficiently (3x) founded pharmacoeconomic evidence; all 'no' decisions (4x) were insufficiently founded. Appraisal elements were descriptively reported. The (high) severity of the disease was explicitly mentioned in three overlapping cases. However, the actual influence of disease severity on the final 'yes' decision remained unclear. CONCLUSIONS: Both countries make their reimbursement reports publicly available. Although the assessment is reasonable transparent, both countries could improve transparency of the appraisal process by more explicitly showing the actual role of each different (societal) criterion in drug reimbursement decision making.