EU JCA: Two early takeaways for sponsors preparing for JCA from Swedish authorities (TLV and SBU)

A recent webinar hosted by the Swedish authorities, the Dental and Pharmaceutical Benefits Agency (TLV) and the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU), provided early insights into how national HTA bodies are operationalising the Joint Clinical Assessment (JCA).¹ Two themes are particularly relevant for sponsors: how national PICOs may evolve post-JCA, and how early visibility of member state PICOs can inform downstream strategy. 

1. Timing of local HTA submissions post JCA 

The TLV emphasised that the national PICO is not static. At the time of the national reimbursement assessment, the PICO may need to be reassessed and updated, especially if key changes (such as updates to clinical guidelines or shifts in treatment uptake) have occurred since the JCA report was finalised. This is particularly relevant given the typical 12 to 15-month delay (or longer, depending on clock-stops at day 120 and day 180 of the EMA review process) between PICO elicitation during EU HTA engagement and the availability of the final JCA report for national decision-making. In practice, this means that JCA compliance does not guarantee national relevance at the time of reimbursement. Critically, evidence aligned to the JCA PICO may not fully reflect the comparator landscape at the point of national decision-making. In other words, TLV will take due consideration of the JCA report, but if the context has evolved, they will adjust the PICO accordingly.  

Learnings for Health Technology Developers (HTDs): 

• For HTDs operating in disease areas with rapid innovation, multiple competitors, or recently approved comparators, the duration between the final JCA scope and the national reimbursement submission will be crucial. During that time, the standard of care may shift, meaning that a nationally relevant PICO at the time of reimbursement could differ from what was assessed as relevant in the JCA. 
• When undertaking PICO prediction, consider both the current landscape and anticipated changes to the Standard of Care (SoC) at the point of submission, including potential new entrants, evolving clinical guidelines, and shifts in treatment sequencing. 

2. HTDs can gain early insights from the Swedish PICO 

A key takeaway for HTDs is the opportunity to access the Swedish PICO from TLV after the JCA consolidation phase (the period in the JCA process when member states review and comment on the draft PICO proposal circulated by the assessor team before the scope is finalised). It should be noted that when the assessors provide the final scope to the HTD, the HTD will not have visibility on the list of PICOs requested by individual member states. 

Learnings for HTDs: 

• Access to the Swedish PICO may provide an early signal of national preferences and emerging areas of scrutiny. These insights would provide HTDs at the affiliate level with early guidance on optimal approaches to framing the downstream national submission. In the case of the Swedish PICO, it could also serve as a valuable proxy for understanding the needs of similarly structured markets, such as Finland and Norway. 
• Where feasible, sponsors should systematically compare predicted PICOs with those requested by the member states to identify early misalignment and optimise national HTA submissions. Particular attention should be given to instances where the predicted country-level PICO differs from the member state PICO, to either initiate early evidence-generation activities or prepare robust responses to expected objections.   
• HTDs should proactively engage with European HTA bodies, where opportunities exist, such as those in Sweden and Denmark, to gain clarity on the HTA scope in each market. Since national HTA agencies will consult clinicians during the JCA PICO scoping process, HTDs that cannot secure direct HTA engagement may instead benefit from early discussions with key clinical experts in these countries. This can help validate the intended PICOs before formal interactions with HTA bodies begin. 

Conclusion 

Taken together, these findings suggest that sponsors must navigate both uncertainty and opportunity within the JCA framework: national PICOs may diverge over time, but early signals from member states can be leveraged to validate and refine downstream HTA strategies. 

Parexel supports clients across the full JCA journey, from early evidence generation and PICO strategy to JCA dossier development, national HTA submissions, and post-assessment engagement. We welcome the opportunity to discuss how to optimise your JCA and national HTA planning. 

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References: 

1. Available in Swedish only: https://www.sbu.se/sv/nyheter/2026/tlv-och-sbu-haller-webbinarium-om-den-europeiska-hta-lagstiftningen/, Feb 20th, 2026 

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