Background

Europe is striving towards greater cooperation in Health Technology Assessment (HTA). While there is increasing focus on the uptake of EUnetHTA joint clinical assessments (JCA), challenges need to be identified and addressed, before current efforts can translate into seamless and efficient HTA harmonization in Europe.

Objective: To evaluate the outcomes assessed and methods employed in the JCA (within the joint action 3 [JA3] framework) and the appraisals performed by the national HTA bodies (NICE, G-BA and HAS) in oncology.

Methods: We conducted a qualitative evaluation of the EUnetHTA JCA and national-level HTA appraisals from the HAS, G-BA/IQWIG and NICE. For reasons of consistency and to minimize variability, we chose the same three products and indications across all agencies – namely, alectinib in ALK+ advanced non-small cell lung cancer (NSCLC), midostaurin in acute myeloid leukemia (AML), and regorafenib in hepatocellular carcinoma (HCC).

Results: Across the three JCAs, there seems to be consistent focus on survival and health-related quality of life outcomes, and an increasing body of evidence has been included over time, to enable indirect treatment comparisons. JCAs have, at the very least, included comparators as deemed relevant by HAS, G-BA/IQWIG and NICE. There is heterogeneity in the use of safety endpoints as well as in the use of indirect treatment comparisons and patient engagement considered by the JCA and those used for decision-making by national HTAs.

Conclusion: The adoption of JCA, especially when operationalized through the European Commission (EC) regulation could potentially lead to a more agile system which can allow EU member states to re-allocate resources for HTA. This is however, dependent on the development of clear guidance on what constitutes appropriate quality of evidence and the creation of a framework outlining an optimal process that would deliver robust evidence while maximizing efficiency in HTA across the EU.