EU HTA ready for takeoff

Implementing Act on JCA officially adopted by European Commission

Thu, 2024 / 05 / 23
The JCA framework is now official: after the member states have given their input for a revised version of the draft Implementing Act (IA) on JCA in the comitology meeting on April 26th, the European Commission (EC) has adopted the updated Implementing Act today, on Thursday, May 23rd. As this is only considered a formal step, no further changes were introduced to the document. The changes to the original draft version of the act from March 5th can largely be viewed as concessions to the industry, which had voiced its concerns and demanded changes to the draft IA during the public consultation process. But the question remains: Have these adaptations truly alleviated the industry’s concerns in a meaningful way? Let’s delve deeper.

1. Health technology developers (HTD) now have an extended 100-day window to finalize the JCA dossier.

The timeline for the finalization of the dossier, from the communication of the final assessment scope to the dossier submission deadline, was increased from 90 to 100 days. While every day may prove to be crucial for the compilation of the dossier down the line, the key content of the dossier obviously still needs to be prepared before the 100 day countdown starts ticking – smart preparation prevents surprises and mitigates the risk. And even adapting the dossier contents in accordance with the final PICO scope in 100 days might be a significant challenge – easy-adaptable data orchestration, automated AI-supported table generation and interpretation as well as further tech-enabled delivery tools are key to getting things done in time.

2. HTDs may request a scope explanation meeting, taking place at latest 20 days from the time of finalization of the assessment scope.

It certainly is a positive development that now all HTDs are able to ask for a PICO scope explanation meeting, while before it was only to be held if the JCA subgroup considered it necessary. However, it is supposed to take place 20 days into the dossier finalization phase with only 80 days to complete the document, i.e., drawing the right strategic conclusion from the meeting and initiating effective action will be crucial to truly capitalizing on this opportunity.

3. HTDs will be able to appeal the refusal to redact information, after it has been marked as confidential in the factual accuracy check.

The fact that the HTD will retain control over the confidentiality of the data presented in the dossier is a significant relief for HTDs. Previously, the authorities had the final say on whether they considered information relevant for the public and therefore publishable. Still, close and transparent internal communication will be essential to identify and highlight potentially confidential information in the draft JCA report and to initiate the required actions if questioned.

Although the introduced changes can be considered positive from an industry perspective, almost all the existing challenges for companies going into their first JCA procedure remain. Internal workstreams and communication routines need to be synchronized across company’s functions. PICO scopes need to be anticipated, and strategic imperatives and actions for the relevant markets must be derived. Dossier strategy development, writing and statistical analyses have to be started before the JCA process even begins. And all relevant processes and tech-enabled delivery tools need to be in place to make the most of the 100 days for the JCA dossier finalization. However, you shall not forget the overall aim: JCA is not about pleasing the JCA subgroup by addressing all PICOs, it is about building the optimal basis for successful price negotiations to reach and help as many patients as possible.

As SKC we support our clients with all these challenges. In line with this, SKC has leveled up, too: We have developed a tech assisted EU HTA co-pilot that enables our clients and us to compile and finish the dossier in these 100 days. This innovation signifies not only our commitment to adapt and grow with the needs of the industry but represents our enhanced capabilities to guide our clients through this transformative journey.

If you are seeking support for your first JCA, whether it’s strategic, operational, or organizational, don’t hesitate to connect with us. We are the market access special forces mastering EU HTA.


About the author

Ihr Ansprechpartner  Sebastian  Vinzens
Sebastian Vinzens
M.Sc. Drug Research and Development
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18

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