Presentation (CTI)

OBJECTIVES: The introduction of Joint Clinical Assessment (JCA) in Europe has raised concerns among pharmaceutical manufacturers about the potential for an increased bureaucratic burden and costs. This study compared the methodologies and scopes of the Institute for Clinical and Economic Review (ICER) in the United States (US) and JCA to highlight potential effects of diverse health technology assessment (HTA) submission requirements on global market access strategies.
METHODS: A structured examination of ICER and JCA approaches to HTA was conducted, including evidence requirements, review timelines, stakeholder engagement and assessment scope. Sources included publicly available guidelines and expert commentary.
RESULTS: While both ICER and JCA synthesize clinical evidence through comprehensive reviews of available data, other methodologies notably differ. ICER emphasizes value-based pricing and affordability, while JCA aims to standardize the clinical assessment process to inform regional decision making, leaving economic value to European Union member states. These differing priorities are reflected in their timelines: ICER reviews medicines nearing regulatory approval when US payers must make pricing and coverage decisions, while JCA is conducted alongside the European Medicines Agency’s marketing authorization process. Additionally, included throughout ICER’s review process are formal public comment periods, when input from patient groups, clinicians, manufacturers and payers is collected. Conversely, the JCA process limits stakeholder engagement primarily to the scoping period, when expert input is solicited by the HTA Secretariat. Finally, while JCA will prioritize oncology drugs in 2025, ICER only completed two oncology reviews since April 2021, reflecting a potential shift away from value-based management of oncology treatments in the US.
CONCLUSIONS: The differing timelines and focus of the ICER and JCA frameworks may present evidence generation and value story challenges for manufacturers entering US and European markets. Therefore, it is vital for manufacturers to proactively adapt access plans to meet global HTA requirements.