The Impact of the JCA on national HTA submissions

Abstract

This research project was carried out for Asc Academics, a Health Economics and Outcomes Research (HEOR) consultancy that supports pharmaceutical companies in preparing the evidence and documentation needed for HTA submissions. The aim was to explore how the introduction of the JCA will impact clinical evidence requirements and how Asc Academics can adapt its services to remain relevant and competitive in this changing environment.

The project used a mix of research methods, including reviewing JCA guidelines, consultation of recent webinars, creating a questionnaire for HTA authorities across the EU, and an expert interview with the Director of Market Access at Asc Academics. The research found that MS vary widely in their level of readiness for the JCA. Countries like Finland and the Czech Republic have made significant progress in preparing for the JCA, while others, including Estonia, Latvia, and Austria, are still in the early stages of adaptation. Some countries, like Sweden and France, are taking a “wait-and-see” approach, preferring to observe how the first JCA reports unfold before fully committing to procedural changes.

Across the board, HTA agencies expressed concerns about tight timelines, the challenge of aligning EU-level assessments with national priorities, the risk of adding rather than reducing workload, and the need for more clarity on how clinical experts, patients, and companies will be involved in the process. One of the most technically challenging parts of the JCA process is the PICO (Population, Intervention, Comparator, and Outcomes) scoping and consolidation. The PICO framework, is used to structure the clinical questions that the HTA report must address. Each MS receives a survey in which they submit their PICOs which may result in the identification of multiple PICOs for a single product, reflecting the clinical practice diversity across the EU, but also making it difficult to create a single PICO that satisfies everyone. HTDs need help understanding and predicting these expectations early in their product development. This is where consultancies like Asc Academics can play a vital role.