Presentation (CTI)

OBJECTIVES: The Joint Clinical Assessment (JCA) dossier template defines requirements for evidence presentation, yet it reveals several areas of flexibility. These can accommodate content supporting the overall value narrative and downstream national Health Technology Assessment (HTA). This analysis explored where the template offers such flexibility and how it can be leveraged to maximize the value of the JCA output for national HTA decision-making.
METHODS: We examined the JCA dossier template, identifying optional and unspecified components, and synthesized observations from early population, intervention, comparator, and outcome (PICO) scoping outcomes and submissions to date, informed by our local HTA understanding and feedback received from JCA assessors.
RESULTS: Contextual and value supporting content can be added in several sections throughout the template. In the health outcomes section, the patient voice, responder threshold validations, and explanations of adverse events can be included. Real-world treatment patterns supporting PICO justification in the assessment scope section, and national HTA research outputs can also be shared in the section covering the EU Joint Scientific Consultation. Outcomes on disease symptoms are often requested without a specified instrument, permitting multiple analyses of a single endpoint and selection of instruments that generate quality-adjusted life-year weights. Subgroups are mostly loosely defined, allowing for flexible interpretations. Data useful locally, including further comparative estimates, utility data, and long-term effect assumptions, can be incorporated, and pre-prepared non-requested PICO analyses can serve as sensitivity analyses.
CONCLUSIONS: The flexibility in data presentation permitted in the JCA dossier template creates opportunities to align submissions with diverse Member State needs, including inputs relevant to cost-effectiveness modeling. The “guardrail” should be whether these data support interpretation in terms of added benefit and are usable for national HTAs; flexibility should serve that objective rather than exceed the intended scope.