OBJECTIVES: We identified a number of challenges that EUnetHTA21 will face in developing Joint Clinical Assessments (JCAs) and wanted to assess whether differences between the approaches of HTA bodies would challenge the development of JCAs.

METHODS: We reviewed the Council of Europe draft Regulation on health technology assessment to identify the drivers and constraints that have been imposed on JCAs. We then identified HTA decisions where the decisions diverged due to different interpretations or acceptance of evidence including patient sub-groups, different comparators, different acceptance of outcome measures, patient reported outcomes, etc. The assessment of the divergence of decisions was limited to the four clinical domains of assessment referred to in the Council of Europe draft regulations.

RESULTS: A number of areas were identified that will need resolving as part of the JAC process – choice of comparator, non-acceptance of certain outcome measures, the prominence of quality of life data and patient reported outcomes, the acceptability of indirect treatment comparisons, etc. We identified HTA reports where decisions by HTA bodies diverged related to these areas to see if the divergence was related to the four clinical domains. Our findings were that the evidence assessment and the criteria used to drive these assessments were the key reasons behind the divergence.

CONCLUSIONS: JCAs are meant to reduce the need for multiple evidence submissions to HTA bodies. However, Member States can still ask for additional analyses or evidence relating to patient groups, comparators or outcomes or even using a different methodology than the JCA. EUnetHTA21 will have a difficult time developing JCAs that will satisfy everyone and there is a risk that companies will still have to submit analyses, data and evidence to multiple HTA bodies.