EU HTA Regulation Enters Transitional Phase Ahead of 2025 Implementation

The European Union’s Health Technology Assessment Regulation (EU 2021/2282) has officially entered its transitional phase, marking a pivotal moment in the evolution of HTA processes across Europe. The Regulation, which will become fully operational in January 2025, aims to harmonize clinical assessment procedures across EU Member States and reduce duplication for health technology manufacturers.

As part of the phased rollout, the first health technologies to undergo Joint Clinical Assessment (JCA) will be oncology medicines and advanced therapy medicinal products (ATMPs). These categories were selected due to their rapidly evolving evidence landscape, high clinical complexity, and substantial budget impact on national healthcare systems.

What the transitional phase means for stakeholders

During 2024–2025, Member States, HTA bodies, and manufacturers are engaged in establishing the practical frameworks needed for operational JCAs. This transitional period includes:

• defining submission templates and evidence requirements,
• finalizing procedural timelines,
• preparing JCA coordination groups,
• and running preparatory exercises and voluntary pilots.

Several national HTA agencies—including AIFA (Italy), HAS (France), and G-BA (Germany)—have already begun aligning parts of their national processes with the Regulation. This alignment does not replace national decision-making but ensures that the clinical evidence evaluation used by countries originates from a common EU-level assessment.

Key challenges for manufacturers

Health technology developers are expected to face several new challenges as the Regulation becomes operational:

1. Earlier evidence consolidation

Manufacturers must prepare high-quality clinical evidence packages much earlier than before, as JCA submissions will run parallel to EMA regulatory assessments. This requires:

• early identification of comparators relevant to multiple countries,
• transparent systematic literature reviews,
• consistent endpoint selection aligned with HTA requirements, not just regulatory ones.

2. Increased scrutiny on methodological transparency

EUnetHTA 21 guidance documents have placed strong emphasis on:

• transparent search strategies,
• clear reporting of risk of bias,
• reproducible synthesis methods,
• endpoint justification and hierarchy.

These expectations will likely become baseline requirements for JCA submissions starting in 2025.

3. Harmonization vs. national variability

While JCAs will unify the clinical assessment component, each Member State will continue to conduct its own:

• economic evaluation,
• pricing and reimbursement assessment,
• contextual analysis.

Manufacturers must therefore strike a balance between preparing for a centralized EU-level procedure and maintaining country-specific market access strategies.

What to expect in early 2025

January 2025 marks the initiation of mandatory JCAs for:

• oncology drugs,
• ATMPs.

Medical devices and diagnostics will join the process later, based on a staggered implementation timeline extending to 2030. The European Commission and the HTA Coordination Group are expected to publish more operational details during the second half of 2024 and early 2025, including:

• finalized templates,
• submission portal specifications,
• interaction pathways for manufacturers,
• and quality requirements for evidence dossiers.

These documents will provide essential clarity for companies planning submissions under the new framework.

Why the Regulation matters

The new EU HTA Regulation is considered one of the most significant shifts in European market access policy in decades. Its goals include:

• reducing duplicative national clinical assessments,
• increasing consistency in evidence evaluation,
• strengthening collaboration among Member States,
• accelerating patient access to innovative therapies.

If implemented effectively, it could improve predictability for manufacturers and support more equitable access to promising treatments across Europe.

IS4Health’s perspective

As a consultancy specializing in HTA, HEOR, and evidence generation, IS4Health is closely monitoring all developments related to the Regulation. We are actively supporting clients in adapting to new requirements—particularly in areas such as:

• PRISMA-compliant systematic reviews,
• comparator justification,
• clinical effectiveness assessment,
• and cross-country evidence alignment.

We will continue providing updates as the transitional phase progresses and additional guidance becomes available.