The EU has officially entered a new phase in health technology assessment (HTA). The first two Marketing Authorisation Applications (MAAs) have now been submitted in parallel with Joint Clinical Assessments (JCAs) under the EU HTA Regulation (EU) 2021/2282, marking a crucial step toward a more harmonized approach to clinical value assessment across Member States.
These two initial JCAs cover:
- A paediatric oncology treatment
- An advanced therapy medicinal product (ATMP) for skin cancer
Both are being assessed concurrently with EMA’s regulatory review, representing a new level of integration between the regulatory and HTA landscapes in Europe.
What is the EU HTA Regulation?
Adopted in December 2021 and applicable from January 2025, the HTA Regulation aims to provide joint clinical assessments at the EU level for selected health technologies. Moreover, it eliminates duplication of clinical assessments across EU countries, accelerates patient access to innovative therapies and supports evidence-based pricing and reimbursement decisions.
The Regulation starts with a focus on:
– All new oncology medicines
– All new ATMPs (e.g., gene, cell, tissue therapies)
It will gradually expand to include additional therapeutic classes from 2028 onward.
Why This Matters for Regulatory Professionals
The Regulation introduces both opportunities and challenges for regulatory and market access teams. Submissions will need to align more closely with EMA timelines and HTA requirements, prompting:
- Earlier integration of regulatory and HTA strategy
- Stronger cross-functional coordination across clinical, access, and regulatory functions
- Proactive management of evidence generation plans to meet both regulatory and HTA needs
While Member States will continue to make national decisions on pricing and reimbursement, the clinical evaluation component will be centralized which reflects a major shift in how value is demonstrated and communicated in the EU.
We are entering an era where regulatory approval alone is not enough. Joint clinical value demonstration is becoming just as critical.
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