A comparative analysis of coverage decisions for outpatient pharmaceuticals: evidence from Denmark, Norway and Sweden.

This study analyses the reasons for differences and similarities in coverage recommendations for outpatient pharmaceuticals in Denmark, Norway and Sweden, following HTA appraisals. A comparative analysis of all outpatient drug appraisals carried out between January 2009 and December 2012, including an analysis of divergent coverage recommendations made by all three countries was performed. Agreement levels between HTA agencies were measured using kappa scores. Consultations with stakeholders in the three countries were carried out to complement the discussion on HTA processes and reimbursement outcomes. Nineteen outpatient drug-indication pairs appraised in each of the three countries were identified, of which 6 pairs (32%) had divergent coverage recommendations. An uneven distribution of coverage recommendations was observed, with the highest overlap in appraisals between Norway and Sweden (free-marginal kappa 0.89). Similarities were found in priority setting principles, mode of appraisal and reasoning for coverage recommendations. The study shows that health economic evaluation is less prominent or explicit in outpatient drug appraisals in Denmark than in Norway and Sweden, that all three countries could benefit from improved communication between appraisers and manufacturers, and that final coverage recommendations rely on factors other than safety, comparative efficacy or cost-effectiveness.