Navigating EU HTAR: Strategies for success in joint clinical assessment

By: Molebedi Segwagwe, George Agathangelou and Patrick Hopkinson

1. Where are we with joint clinical assessment?

The EU Health Technology Assessment Regulation (EU HTAR) came into effect on the 12th of January, 2025 and Joint Clinical Assessment (JCA) is now applicable for all cancer medicines and advanced therapy medicinal products (ATMPs) undergoing new European Medicines Agency (EMA) marketing authorization. Two JCAs have since been announced for an adult glioma medicinal product (MP) and for a pediatric melanoma ATMP.

JCA will also extend to all drugs, high-risk medical devices, in-vitro diagnostics and vaccines by January 2030. While its objective is to improve launch equity and accelerate patient access in Europe, EU HTAR will continue to create new procedural, resource and evidentiary hurdles for health technology developers (HTDs) to overcome, with further guidance updates and announcements expected until JCA is ‘business-as-usual.’

EU HTAR has also come into force at a time of accelerating economic headwinds, technological upheaval and fast-evolving global policy environments for industry, particularly considering recent announcements on pricing in the US. These dynamics might lead to some leaders thinking JCA preparations can be postponed while they address other competing priorities. This would be a strategic mistake.

Our JCA thought leadership series the page on this perspective, encouraging leaders to view the advent of JCA as a catalyst for accelerating the adoption of new technologies and cross-functional processes across industry that can strengthen competitive advantage in the face of a rapidly changing market. This first paper focuses on the solutions HTDs can apply to address the main challenges raised by JCA through transforming planning and processes.

2. What are the challenges?

A loss of control…

Prior to JCA, HTDs could plan evidence generation for European Member States sequentially based on their own decisions on launch sequencing. JCA loosens this control with evidence needs determined by a PICO survey going to all Member States (MS) at the point of EMA submission. HTDs that do not comprehensively respond to all requested PICOs during JCA may face resubmission or costly and duplicative data requests at local HTA submission, leading to delays in market access and reimbursement.

The high price of ‘getting it wrong’ necessitates comprehensive evidence planning in the product life cycle and stronger cross-functional collaboration by HTDs, as multiple capabilities are required for successful EMA and JCA submission. For example, significant biostatistics resources must be put in place well before ITC SAP development to engage HEOR and medical affairs and provide early insight on the volume of analyses needed for HTA and regulatory dossiers. Also, while JCA is led by global, affiliates must be closely engaged for PICO prediction and alignment between global JCA and all local HTA strategies.

3. Getting it right

Strategic planning for Joint Clinical Assessment dossier submission

A. Establish a cross-functional team

Globally led JCA program teams should be established as early as Phase 2 including HEOR, Biostatistics, Regulatory Affairs, medical affairs and Market Access.

Regular check-ins should be held with HTA leads in affiliates to ensure global and local HTA strategies and asset value messages remain aligned.

B. Hold EU HTA training sessions

Training should be held well before EMA submission to cover the material aspects of the JCA process and key updates, so teams are up to date with the latest guidance.

Global and local colleagues should be trained in how to perform PICO prediction exercises to increase the chances of identifying the same PICOs as JCA assessors.

C. Hold multiple PICO prediction exercises

Instead of a single-time event, we believe it is beneficial to hold increasingly in-depth PICO exercises throughout the development process to account for new information.

At minimum, this should be done at the start of Phase II to inform registrational study design, and then at the start Phase III to ensure the trial captures the data points.

D. Align evidence planning to PICOs

Evidence gap analyses should be performed post PICO prediction exercise completion, assessing the existing and planned evidence package to the anticipated JCA scope.

Integrated Evidence Strategic Plans (IESPs) should address the evidence gaps identified and be updated or revalidated each time PICO exercises are performed or reviewed.

E. Perform continuous KOL monitoring

Stakeholder mapping should be performed at multiple points in the JCA timeline to ensure up-to-date awareness of the important KOLs to engage with before submission.

KOLs engaged in paid work (e.g., Advisory Boards) should be mapped for a view of who is disqualified for participating in the JCA per the EU’s Conflict of Interest regulations.

4. How can ZS help?

Our next paper will focus on the areas where HTDs should embed technology to improve quality and generate efficiencies that help meet the challenges raised by EU HTAR.

To learn more about how these recommendations could be tailored to your company, reach out to us at: zs.com/contact-us

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This article reflects our personal views. They do not necessarily represent any official position of ZS.