OBJECTIVES: The European Joint Clinical Assessment (JCA), a centralized framework to aid HTAs across European countries, will be introduced in January 2025. Oncology and advanced therapy products will be the first to be evaluated through the JCA, which will expand to cover all medicinal products by 2030. The introduction of the JCA poses significant uncertainty, making it crucial for Pharmaceutical and MedTech companies to prepare for potential impacts on their manufacturing planning from an evidence-generation and value-demonstration perspective.

This study aims to provide insight into how industry experts are preparing for JCA, the impact it has had, and the impact it will have on their planning ahead of launch.

METHODS: This study utilized secondary research to understand how Pharmaceutical and MedTech companies prepare for the JCA rollout. It investigated these topics through a quantitative survey of industry experts across HEOR, access, and commercial functions.

RESULTS: Based on an interim analysis of secondary research, it is expected that upon initial adoption, JCA will lead to duplication of value communication materials, evidence generation, and extension of evaluation timelines, delaying the time required to give access to potentially lifesaving medications. Additionally, there are uncertainties around how national, regional, and local HTA authorities will adopt and rely on the outcomes from the JCA.

Misalignments in the importance of the different elements of the population, intervention, comparison, and outcomes (PICO) framework across markets were also identified as a barrier to integrating the JCA outcomes with country-level decision-making.

CONCLUSIONS: Increased internal cross-functional collaboration will ensure the evidence generated meets JCA and national, regional, and local HTA requirements across Pharma and MedTech companies. Collaboration across the regional and local HEOR and market access teams will be critical to the success of launches and to ensuring familiarity across teams with processes and requirements across evaluation authorities.