OBJECTIVES: European health technology assessment (HTA) bodies vary with regards to methodology, willingness to accept uncertainty, and preferences for different types of evidence. Previous studies have revealed substantial differences in the focus of European HTA processes and final decisions on recommendation. We therefore set out to explore how exactly the variation in decision drivers results in discrepancies in recommendations between the payer archetypes.

METHODS: A critical review of HTA reports from NICE (England), HAS (France), and IQWiG (Germany) was conducted. These agencies were selected because they are representative of different payer archetypes, have large associated markets, and are relatively transparent in reporting. Qualitative semi-structured interviews provided added context. Cabazitaxel and pixantrone were selected as case studies due to the mixture of recommendations and rejections received for these products in the target countries. The review investigated the key evidence considered and the agencies’ responses to the evidence, particularly with regards to accounting for uncertainty.

RESULTS: Cabazitaxel was approved for prostatic neoplasms by HAS and IQWiG, yet rejected by NICE on the grounds of a high ICER (~£90,000/QALY). On the other hand, pixantrone received restricted approval for non-Hodgkin’s lymphoma by NICE and HAS, despite uncertainties created by a small trial population and post hoc sub-group analyses, while IQWiG found no added benefit. The inconsistency in decision-making in European HTA processes is therefore likely to relate, in part, to the relative emphasis placed on different aspects of the clinical and economic evidence, and the willingness of agencies to accept associated uncertainty.

CONCLUSIONS: While understanding the international HTA processes is important, establishing the key drivers for previous decisions across agencies could be an efficient way to achieve approval and access. This is best achieved through a combination of expert elicitation and a critical review of previous HTA decisions.