Health Technology Assessment Regulation (HTA)

Support for EU HTA compliance and successful market access through Asphalion’s expert services

Health Technology Assessment Regulation (HTA)

Navigating the EU HTA Regulation

Asphalion helps you successfully prepare for the European Union Health Technology Assessment Regulation (HTAR), which enters into application on January 12, 2025. This regulation introduces mandatory Joint Clinical Assessments (JCA) for oncology products and advanced therapy medicinal products (ATMPs), with phased implementation for orphan drugs and high-risk medical devices by 2030.

A new regulatory framework for coordinated clinical assessments

This regulation aims to:

Harmonize clinical evaluation methodologies across EU member states.
Reduce duplication through centralized evidence submissions.
Facilitate faster patient access to innovative medicines and medical devices.
Streamline reimbursement processes across diverse markets.

Implementation roadmap of the EU HTA Regulation (Regulation 2021/228), detailing the timeline for Joint Clinical Assessments (JCA) of oncology products, ATMPs, orphan medicines, and high-risk medical devices.

End-to-end support across the HTA lifecycle

From early development to post-authorisation, Asphalion provides strategic and technical support across every stage of the HTA and regulatory process, including scientific advice, JCA dossier preparation and local adaptation.

Health Technology Assessment Regulation (HTA) Solutions

At Asphalion, we provide comprehensive support to help you navigate the complexities of the new EU HTA regulation and ensure successful market access across Europe:

Early HTA Strategy Development

We work closely with clients from early development phases to design robust, HTA-compliant strategies:

Identification of relevant comparators, endpoints, and data gaps.
Alignment of clinical trial design with HTA requirements.
Evidence gap analysis for JCA readiness.

EU JCA Dossier Preparation

Our team ensures efficient and compliant JCA dossier development:

Coordination and writing of all JCA dossier modules.
Adaptation of regulatory documents (EPAR, SmPC) for HTA use.
Alignment of PICO elements with EU HTA expectations.
Integration of clinical, regulatory, and market access insights.

Parallel EMA-HTA Scientific Advice

We help clients optimise their strategy by leveraging parallel EMA-HTA advice:

Strategic planning for parallel consultations.
Preparation of briefing packages tailored to HTA needs.
Facilitating stakeholder engagement for early alignment.

HTA Training and Internal Readiness

We equip your teams with practical knowledge to operate under HTAR:

In-house training on EU HTA processes.
Strategic workshops on cross-functional HTA readiness.
Clear definition of roles, responsibilities, and timelines.

National HTA Support

Beyond the JCA, we support adaptation to national contexts:

Customisation of dossiers for country-specific HTA submissions.
Price and reimbursement strategy support.
Development of local evidence generation plans, including RWE.

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Discuss your case with our experts and receive a valuable feedback

Why Asphalion?

With over 25 years of experience in regulatory science, Asphalion combines scientific expertise and strategic insight to help you succeed under the new EU HTA framework:

Integrated Expertise: Cross-functional team covering regulatory affairs, clinical development, health economics, and market access.
Proven Track Record: 5,000+ successful projects for more than 1,000 clients worldwide.
Tailored Solutions: Custom strategies that align with both EU-level and national requirements.
End-to-End Support: From early development to national post-JCA adaptation.
Innovative Methods: Use of NMA and ML-NMR for advanced evidence synthesis.

Main benefits

Whether you are preparing your first JCA submission or scaling market access across the EU, our team helps you do it faster, safer, and with full regulatory confidence.

The EU HTA regulation is transforming how clinical evidence is assessed in Europe. At Asphalion, we help you anticipate change, build compliant strategies, and reach your markets faster.

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