OBJECTIVES: Health Technology Assessment (HTA) agencies across Europe can take different reimbursement decisions for the same drug, despite using the same clinical trial evidence and a similar assessment methodology. This study applied a mixed method framework, developed by Nicod and Kanavos (2015), and examined ophthalmology technology appraisals across four European countries to systematically investigate the factors driving HTA reimbursement decisions and to identify cross-country differences.

METHODS: After purposefully sampling the ophthalmic technology appraisals published between January 2006 and June 2017, the HTA decision process of each agency (England NICE, Scotland SMC, France HAS, Sweden TLV) was broken down into three stages. The first stage compared the clinical and cost-effectiveness evidence reviewed by each agency for the same drug. In the second stage, thematic analysis was used to examine how the evidence was interpreted by each agency, and the influence of the interpretation on the decision. The third stage provided statistical measures of agreement (kappa coefficient) and correspondence analysis, based on the findings of the previous stages.

RESULTS: The study included five ophthalmic drug-indication pairs across four European HTA agencies. The overall agreement was less than what is expected by chance, with Fleiss’ Kappa averaging -0.17. Correspondence analysis uncovered weakly significant yet meaningful associations (p=0.09 for “Uncertainties”, p=0.028 for “Other Considerations”) between the agencies and their interpretation of the evidence. Each agency had unique characteristics and value preferences that influenced the final recommendation, which partially explains the divergence in the reimbursement decisions.

CONCLUSIONS: While the generalizability of the results is limited by the small sample, this study successfully tested the flexibility of the method developed by Nicod and Kanavos (2015) on a different class of drugs; the results provide useful insights into the process of ophthalmology technology appraisals.