EU HTA is now live: what do we do now?
Please note, in this article we won’t cover the core processes of the JCA and JSC, as a lot of information is now available from the European Commission (see sources below).
Key opportunities: accelerate access and reduce duplicative effort
The new JCA framework creates real opportunities to make administrative savings and accelerate drugs to market:
- Reduce Duplication: A single JCA dossier minimises redundant national submissions, saving time and resources
- Streamline Evidence Requirements: Greater alignment between decision making bodies could lead to more consistent evidence demands
- Reduce times for market access: With the clinical HTA undertaken parallel to marketing authorisation, time should be reduced for pricing and reimbursement
In the midst of fulfilling the JCA requirements, it can be easy to forget that this represents a major opportunity for the HTD. Therefore, biopharma companies should ensure that these benefits are realised through process improvement projects and monitoring.
Key challenges: limited HTD engagement, scope complexity and national divergence
The new processes contain several key challenges and risks that companies should be preparing for well in advance of the assessment:
- Complex Scoping Phase: It is likely that in the scoping exercise numerous PICOs (Population, Intervention, Comparator, Outcome) will be agreed, thereby increasing the complexity of the evidence gathering and assessment. This will require the HTD to identify ahead of submission all possible PICOs and perform the associated comparison analyses. All relevant data on the PICOs must be included in the dossier
- Member State Adoption: There’s a risk that national authorities may not fully leverage JCAs in their HTA or pricing and reimbursement decisions, undermining the harmonisation effort
- Limited Engagement Opportunities: The JCA subgroup’s interaction with HTDs—especially during scoping—remains restricted, limiting opportunities to shape assessments proactively
- Resource Pressure: Adapting to JCA timelines while meeting national HTA demands could strain internal teams
Plan, Monitor and Engage!
In order to be ready for the new assessment processes, HTDs should:
- Plan Early at Both National and EU Levels: Align submission timelines and prepare comprehensive evidence packages tailored to both JCA and national HTA needs. Ensure close alignment with regulatory affairs throughout
- Monitor JSCs and JCAs in Progress: Stay informed about ongoing consultations and assessments to understand actual outcomes, pitfalls and learnings
- Engage with EU Stakeholders Prior to JCA: Build relationships with relevant professional associations, key opinion leaders and advocacy groups to ensure their needs are reflected in your planning, strategy and submission
