Presentation (CTI)

OBJECTIVES: All eyes are on the first assets undergoing Joint Clinical Assessment (JCA), as the new processes and methodologies introduced under the EU HTA Regulation are put to the test. Appropriate metrics to measure their effectiveness are a prominent subject of debate. However, reliability lies in numbers, and it may take several years until enough assets have completed JCA and launched across the EU to draw robust conclusions, which is why the JCA process will only be formally reviewed in 2028. The aim of this research is to explore which insights may be distilled from individual assets at this early stage, and how these can be used to inform stakeholder decision-making between now and 2028.
METHODS: Based on the JCA Implementing Act, MPG guidance and stakeholder publications, we mapped asset-specific performance metrics against the JCA process and assessed: • Feasibility of measuring these, considering data availability and accessibility; • Any conclusions to be drawn, and their relevance for different stakeholders. We considered the following stakeholder types: HTA Coordination Group (HTA CG), Health Technology Developers (HTDs) and national HTA bodies.
RESULTS: JCA performance metrics were defined in line with the objectives of the EU HTA Regulation: • Harmonizing methods: e.g., number of PICOs; overlap of PICOs requested at EU and Member State level; expert involvement; • Predictability: e.g., number of PICOs assessed; scope explanation; • Avoiding duplication: e.g., amount of additional data requested at Member State level; • Accelerating patient access: e.g., time to patient access; regulatory timings.
CONCLUSIONS: Our research shows that relevant metrics can be defined for the different stakeholders involved in JCA, which allow them to identify and plan for potential challenges early on, as they gain experience with the new processes - one asset at a time.