Presentation (CTI)

OBJECTIVES: The EU HTA Regulation (HTAR) is reshaping planning for evidence generation and market access in Europe through mandatory Joint Clinical Assessments (JCA). Joint Scientific Consultations (JSCs) allow manufacturers to obtain early advice on trial design and anticipated JCA expectations. Two JSC formats are available: HTA-only and parallel (pJSCs, involving both EMA and HTA bodies). This analysis examines strategic considerations guiding the choice between these pathways and evaluates alternative approaches when formal JSC participation is not feasible.
METHODS: A qualitative strategic assessment framework was developed based on early HTAR implementation experience, published procedural guidance, and cross-functional expert perspectives from regulatory, market access, and evidence generation functions. Scenarios in which HTA-only or pJSCs may provide greatest strategic value were assessed, considering development complexity, uncertainty around PICOs, divergence between regulatory and HTA expectations, resource constraints, and evidence generation timelines. Alternative approaches for evidence alignment and JCA preparedness were also evaluated.
RESULTS: pJSCs were identified as particularly valuable for products with complex development programs, uncertain comparator selection, novel endpoints, or high risk of divergent regulatory and HTA evidence expectations. Simultaneous engagement with EMA and HTA bodies may improve predictability and support integrated evidence planning ahead of JCA submission. Compared with sequential advice procedures, pJSCs may reduce duplication and facilitate earlier cross-functional alignment, although procedural complexity and limitations regarding the number and scope of questions may apply. HTA-only JSCs may provide a more targeted and efficient option where regulatory pathways are established but uncertainty remains regarding PICOs or HTA evidence expectations. Alternative approaches, including PICO analyses, evidence gap assessments, simulated consultation exercises and national HTA advice procedures may additionally support JCA preparedness
CONCLUSIONS: Selection between HTA-only and pJSCs should be guided by product-specific evidence risks, anticipated stakeholder divergence, and strategic development needs. Alternative evidence alignment approaches may provide support for JCA preparedness and broader European market access planning.