BACKGROUND: To sustainably manage equitable access to effective drugs, many developed countries have established a national system to determine whether drugs should be reimbursed. OBJECTIVES: Our objectives were (i) to investigate the role of pharmacoeconomic evidence in Dutch and Swedish drug reimbursement decision making; and (ii) to determine the extent to which appraising the importance of full economic evaluations relative to other evidence is a transparent process. DATA SOURCES: Data sources included all Dutch and Swedish drug reimbursement information published in the period January 2005 to July 2011. METHODS: After categorising all the reimbursement applications and decisions in published data sources, we selected all dossiers-in both countries-that included a full economic evaluation (i.e. cost-effectiveness and/or cost-utility analysis) and then investigated how the evidence was appraised for its societal value. RESULTS: In The Netherlands, only 35 % of the 118 applications on List 1B (i.e. claiming added therapeutic value) were found to include pharmacoeconomic evidence. In all cases where drugs received a 'no' decision, combined with an evaluation that they were of similar (n = 7) or added (n = 5) therapeutic value, we found that the pharmacoeconomic evidence had been judged insufficiently robust. We also found that in 21 % of the 'yes' decisions, combined with an evaluation of similar (n = 2) or added (n = 2) therapeutic value, the pharmacoeconomic evidence had been judged insufficiently robust. In Sweden, we found that drugs that received a 'no' decision (n = 39) had been judged either not cost effective (74 %) or not supported by sufficiently credible data (26 %). Nearly all drugs that received a 'yes' decision (n = 252) had been judged cost effective (92 %). However, of all these judgements, 53 % were based on a price comparison and 10 % on a cost-minimisation analysis; only 33 % were based on a full economic evaluation. More economic evaluations were available in Sweden than in The Netherlands (97 vs. 31, respectively), mainly due to the numerous exemptions from pharmacoeconomic evidence in The Netherlands (65 %). Dossiers for only 11 drugs included a full economic evaluation in both countries; of these, the reimbursement decisions differed for four drugs. Appraisal elements were reported only descriptively; their actual influence on the final decision remained unclear. In four dossiers, the (high) severity of the treatable disease was explicitly mentioned in both countries; three of these were identical and related to indications in cancer. CONCLUSIONS: Both countries publish drug reimbursement information. Therapeutic value appears to be the most decisive criterion; the relative importance of full economic evaluations is more modest than would generally be expected, especially in The Netherlands. Although the assessment process is reasonably transparent, both countries could make the appraisal process more transparent by more explicitly showing the actual role of each different (societal) criterion in their decision making.
BACKGROUND: To sustainably manage equitable access to effective drugs, many developed countries have established a national system to determine whether drugs should be reimbursed. OBJECTIVES: Our objectives were (i) to investigate the role of pharmacoeconomic evidence in Dutch and Swedish drug reimbursement decision making; and (ii) to determine the extent to which appraising the importance of full economic evaluations relative to other evidence is a transparent process. DATA SOURCES: Data sources included all Dutch and Swedish drug reimbursement information published in the period January 2005 to July 2011. METHODS: After categorising all the reimbursement applications and decisions in published data sources, we selected all dossiers-in both countries-that included a full economic evaluation (i.e. cost-effectiveness and/or cost-utility analysis) and then investigated how the evidence was appraised for its societal value. RESULTS: In The Netherlands, only 35 % of the 118 applications on List 1B (i.e. claiming added therapeutic value) were found to include pharmacoeconomic evidence. In all cases where drugs received a 'no' decision, combined with an evaluation that they were of similar (n = 7) or added (n = 5) therapeutic value, we found that the pharmacoeconomic evidence had been judged insufficiently robust. We also found that in 21 % of the 'yes' decisions, combined with an evaluation of similar (n = 2) or added (n = 2) therapeutic value, the pharmacoeconomic evidence had been judged insufficiently robust. In Sweden, we found that drugs that received a 'no' decision (n = 39) had been judged either not cost effective (74 %) or not supported by sufficiently credible data (26 %). Nearly all drugs that received a 'yes' decision (n = 252) had been judged cost effective (92 %). However, of all these judgements, 53 % were based on a price comparison and 10 % on a cost-minimisation analysis; only 33 % were based on a full economic evaluation. More economic evaluations were available in Sweden than in The Netherlands (97 vs. 31, respectively), mainly due to the numerous exemptions from pharmacoeconomic evidence in The Netherlands (65 %). Dossiers for only 11 drugs included a full economic evaluation in both countries; of these, the reimbursement decisions differed for four drugs. Appraisal elements were reported only descriptively; their actual influence on the final decision remained unclear. In four dossiers, the (high) severity of the treatable disease was explicitly mentioned in both countries; three of these were identical and related to indications in cancer. CONCLUSIONS: Both countries publish drug reimbursement information. Therapeutic value appears to be the most decisive criterion; the relative importance of full economic evaluations is more modest than would generally be expected, especially in The Netherlands. Although the assessment process is reasonably transparent, both countries could make the appraisal process more transparent by more explicitly showing the actual role of each different (societal) criterion in their decision making.