Evaluating novel antimicrobials within EU joint clinical assessments 

Antimicrobial resistance (AMR) is a growing global health and economic threat. It is responsible for an additional 9.5 million hospital days and costs across the European Union (EU) and European Economic Area (EEA) economies €11.7 billion annually. Globally, in 2021, an estimated 5.8 million deaths related to bacterial AMR occurred. This burden is expected to increase, with projections of up to 10 million deaths per year by 2050. 

The pipeline for new antimicrobials to combat AMR remains insufficient, for several reasons which have been already documented extensively, underscoring the need for renewed incentives to stimulate research and development (R&D). As part of this, it is critical that population-level health benefits generated by new antimicrobials, such as reducing transmission, enabling medical procedures, and providing insurance against resistant outbreaks, are recognised and valued. The STEDI framework (spectrum, transmission, enablement, diversity, and insurance) provides a structured approach for this. 

Yet current health technology assessment (HTA) approaches rarely capture these broader benefits. The EU’s Joint Clinical Assessment (JCA), operational since 2025, offers a harmonised evaluation of clinical effectiveness and safety at the European level, creating an opportunity to facilitate recognition of these wider health benefits in subsequent national HTA processes for antimicrobials. 

This study explores how the JCA could be adapted to incorporate wider population-level health benefits like STEDI by leveraging a three-part framework of change focused on willingness, capability, and feasibility. We analysed the literature and convened an expert panel to discuss the current state of play, barriers, and recommendations for adapting JCA for antimicrobials.

Willingness: EU policy documents and some national pilots show high-level recognition of AMR and interest in new incentives, but the HTA regulation and current JCA practice lack an explicit AMR focus. Stakeholders view practical adaptation as unlikely without a stronger European Commission mandate.

Capability: Robust methods to quantify the wider health benefits of antimicrobials (dynamic transmission and risk models; The National Institute for Health and Care Excellence (NICE) and National Health Service (NHS) England pilots) exist but these are not standardised or accepted by decision makers. Data gaps also persist for reliably quantifying these wider health benefits. As a result, further research is required to solidify the selection of outcomes that could usefully be captured within JCA.

Feasibility: The JCA’s PICO (Population, Intervention, Comparator, Outcomes) based assessment framework and patient-centred relative-effect mandate limits inclusion of population-level health outcomes. Practical adaptations are possible (e.g. via a structured evidence repository, broader evidence acceptance, and standardised modelling) but would require procedural change and capacity building.

In conclusion, we found that the current approach to JCA is not fit-for-purpose for antimicrobials and risks undermining other European efforts to combat AMR. There is an urgent need to adapt JCA for antimicrobials, but there are significant barriers in willingness to adapting JCA processes, capability barriers in measuring and evidencing wider population-level health benefits of antimicrobials, and feasibility barriers due to JCA’s current focus on direct patient-level outcomes within a PICO-based relative effectiveness framework. It is critical that these barriers and challenges are addressed before 2030, when antimicrobials will become part of EU.

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Recommendations 

Willingness:

• Use the flexibility stated in Recital 24 of the EU HTA Regulation to develop technology-specific guidance for antimicrobials.
• In future HTA revisions, ensure AMR and antimicrobial assessments receive special consideration in line with wider AMR policy.

Capability:  

• Broaden JCA’s evidentiary scope and agree on a core set of outcome measures capturing population-level health benefits for JCA integration, which can subsequently inform (national) HTA decision making.
• Advance methodological development of the STEDI framework for JCA and HTA.

Feasibility:  

• Develop a roadmap for gradual JCA adaptation for antimicrobials under Recital 24. 
• Short term: Use JCAs as structured evidence repositories for comprehensive data.
• Medium term: Expand evidentiary scope to include broader outcome measures and surrogate indicators.
• Long term: Build modelling capacity to support population-level health assessments.