Presentation (CTI)

OBJECTIVES: Joint Clinical Assessments (JCA) are mandatory evaluations to harmonise assessment of the clinical effectiveness of new health technologies across EU member states. The UK does not participate in JCA; therefore, this project sought to evaluate potential implications of the JCA for the UK affiliate of a global pharmaceutical company and identify strategies to maximise opportunities and mitigate any JCA-related risks.
METHODS: Information was gathered regarding the internal and external JCA process and timeline. Potential UK implications were distilled, and tactics were identified and prioritised to support UK market access.
RESULTS: Four key areas of potential JCA impact for the UK were identified: evidence requirements, timelines and access routes, resourcing and support, and early scientific advice. Additionally, maintaining the UK’s internal influence and supporting NICE’s international leadership remain important. With the introduction of the JCA, early alignment on UK-specific needs within global clinical development, evidence generation plans, and economic modelling take on increased strategic importance. Ensuring UK priorities are embedded from the outset supports timely and equitable access to treatments for UK patients.
CONCLUSIONS: The introduction of the JCA may place additional demands on internal pharmaceutical company teams to deliver data analyses for simultaneous regulatory submissions, JCA assessments, and other submissions to HTA bodies. Maintaining the UK’s position as a strategically important global launch market requires a continued commitment to ensuring timely and equitable patient access in the UK, through early alignment of evidence generation and access planning with global development timelines.