EU HTAR and the Draft JCA Implementing Act: What is it and what are the implications for the industry?

What is EU HTAR? 

Part of the revision of the pharmaceutical legislation in Europe, the European Health Technology Assessment Regulation (HTAR) provides a permanent framework for horizon scanning and joint clinical assessment (JCA) in the European Union (EU) and is aimed at:  

• Reducing the burden of submitting and performing Health Technology Assessments (HTAs) for the industry and EU Member States and; 
• Increasing the quality of HTA and evidence-based decision-making. 

According to the regulation, JCA will provide a comprehensive assessment of the evidence required within the predefined Population, Intervention, Comparator, and Outcome (PICO) scope, but Member States’ HTA bodies may still request complementary analyses following the joint work.  

JCA must be inclusive, meaning that all Member States’ needs will be taken into account via a survey, but those needs will be converted into as few PICOs as possible. The implementing act on JCA of medicinal products provides some details on how the PICO assessment scoping will take place. However, it is still unclear how optimization of PICOs will take place to ensure the most meaningful impact across the EU while capturing all individual stakeholders' and Member States’ requirements. 

JCA Implementing Act – Joint Clinical Assessments of Medicinal Products 

The eagerly anticipated draft of the inaugural implementing act for the EU joint HTA has been officially released, a commendable 10 months ahead of when the regulation is set to go into effect. While largely aligned with expectations, the document harbors a few unexpected elements. As expected, timelines are extremely tight. On top of the challenging timelines, a few other elements of the implementing act are worth further consideration.

Scoping phase (PICOs)

What influence does the implementing act have on the PICOs scoping phase?
The JCA Subgroup is directed to strive for the minimal number of PICO elements. The assessment scope phase is planned to be intensive both in terms of timeline (~140 days) and extent of involvement of stakeholders (national and EU stakeholders). Consultation with national authorities and stakeholders is imperative to ensure that the scope of assessment aligns with Member States’ needs.

Company Involvement 

To what extent can the Health Technology Developer (HTD) influence the scoping process?
HTDs wield limited influence during the assessment scoping process, yet the JCA Subgroup may, if deemed necessary and via the HTA secretariat only, invite the HTD to provide additional information. This can be done either in a meeting or in writing. Furthermore, an invitation may be extended for an assessment scope explanation meeting within 30 days of finalizing the assessment scope.

Stakeholder Engagement

Who are the key stakeholders in the JCA process, and how can they be involved?
Patients, clinical experts, and other relevant stakeholders are encouraged to contribute their insights during the assessment scope consolidation meeting. In the selection of experts for the JCA, priority is given to individuals with expertise spanning multiple Member States within the relevant therapeutic area.

Data Requirements

 How have data requirements changed based on the current version of the implementing act (draft 02 March)? The template for the JCA dossier comprises an extensive list of data requirements, including

• The degree of certainty regarding relative effectiveness and safety pertaining to the specified PICOs (specifying any PICO[s] for which results were not submitted and explain the reasons for their omission).
• Epidemiological data for relevant European Economic Area (EEA) states, highlighting any significant differences.
• For medical conditions necessitating disability or family caregiver support, and treatments leading to substantial changes in healthcare systems, detailed information on the organizational and societal impact.
• Insights into substantial variations in clinical pathways among EEA states, incorporating European clinical guidelines.
• Details of early access, compassionate use programs and already existing HTA reports from EEA states, Australia, Canada, the UK, and the US.

This comprehensive framework aims to establish a robust and collaborative approach to HTA within the EU, fostering transparency, stakeholder engagement, and data-driven decision-making. The challenges ahead are many, from the difficulties in reducing heterogeneity in PICOs to time and resource constraints. Each stakeholder has a lot to do in terms of preparing internally to address those challenges. Nonetheless, in our opinion, key areas for a successful implementation include: Addressing uncertainties and expectations, Incorporating national stakeholder perspectives, and Streamlining stakeholder engagement (primarily patients and clinicians).

Download the PDF below to find out more about the implications for the industry and the 5 key areas for successful implementation. 

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