Unlock the complex EU HTA Regulation and drive Market Access and P&R success
As of January 2025, the EU HTA Regulation transforms how new medicines are evaluated across Europe. Centrally authorized medicines, starting with oncology and ATMPs, expanding to orphan drugs (2028), and all others (2030), now undergo a single Joint Clinical Assessment (JCA). The result: one evidence base on clinical relative effectiveness that all Member States must consider.
A unified assessment does not mean a unified outcome. Added benefit and pricing decisions remain at national level. This means the evidence strategy must satisfy both EU-level standards and national appraisal criteria. Joint Scientific Consultations (JSCs) offer a critical early touchpoint to engage HTA bodies alongside EMA advice to shape pivotal trials from the start and build a dossier that holds up across European markets.
We support pharmaceutical and biotech companies with End2End EU HTA and national HTA strategies across the full product lifecycle: aligning clinical development, evidence generation, and access planning to secure optimized pricing outcomes across Europe.
Key challenges for developers
- Parallel EMA and EU HTA proccesses introduces uncertainties
- Early PICO definition shapes development strategy
- Policy-driven JCA scope may not match trial endpoints / comparator
- ~100 days to finalize JCA dossier based on policy-driven PICO scope
- HTA requirements and frameworks across the EU are heterogeneous
How to prepare 1 year pre-EMA Submission
- Seek early JSC HTA advice to shape pivotal trial design
- Align subgroups, endpoints, and comparators with HTA expectations
- Identify JCA and key national evidence requirements early
- Anticipate EU and national methodological expectations
- Plan timelines and budgets for JCA and national HTA submissions
Our EU HTA Services
Strategy & Scoping
Phase 2 to Phase 3
- JSC Request & Briefing
- European-PICO Prediction
- Treatment & Pricing Landscape
- Gap Analysis & Mitigation
Evidence Synthesis
Phase 3 to JCA Submission
- Systematic Literature Review
- Confounder & Statistical Analysis
- ITCs & Network Meta-Analysis
- Real-World Data Analysis
European Market Access
EU JCA to National HTA & Pricing
- JCA Dossier Development
- JCA Integration in HTA Strategy
- Stakeholder Engagement
- National HTA + P&R Support
What our clients say
News & Events
Sonrotoclax JCA Update
9 Feb 2026
Sonrotoclax has entered the EU Joint Clinical Assessment process for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. The EMA marketing authorisation evaluation began on 22 January 2026, with Belgium (NIHDI) and Sweden (TLV) acting as assessor and co-assessor.
Sonrotoclax is a BCL-2 inhibitor designed to induce apoptosis in malignant B-cells. The product has received regulatory designations in the United States, including Breakthrough Therapy, Fast Track and Orphan Drug status, and has obtained first approval in China.
The initiation of this JCA reflects the continued operationalisation of the EU HTA framework in oncology. Early alignment between regulatory strategy and EU HTA evidence requirements remains critical for successful market access across Member States.
HTACG Annual Report
17 Feb 2026
The first Annual Report 2025 of the HTA Coordination Group outlines the initial implementation phase of the EU HTA Regulation. Governance remains led by the European Commission’s HTA Unit, with Member States continuing joint cooperation for the next three years. The Stakeholder Network has expanded to 71 organisations, and preparations for the 2026 evaluation of the Regulation are underway.
In 2025, 13 Joint Clinical Assessments were initiated, primarily in oncology and advanced therapies. By year-end, no JCA had reached endorsement, with the first reports expected in mid-2026. Two Joint Scientific Consultation request cycles resulted in seven selected procedures, reflecting continued capacity limitations despite strong demand. Stakeholder involvement was systematically integrated across both JCAs and JSCs.
Overall, 2025 represents a structural build-up phase. The true impact of EU HTA will become clearer once endorsed JCA reports are integrated into national decision-making processes.
Upcoming Webinar
07 Apr 2026
Real-world evidence (RWE) is playing an increasingly important role in shaping HTA decisions across Europe. However, understanding when and how to use RWE, identifying suitable data sources, and navigating emerging infrastructures such as the German Health Data Lab (FDZ) remain key practical challenges.
Our upcoming webinar, “RWE in HTA: Use Cases and the German Health Data Lab (FDZ)” – part of the Mastering EU HTA series – provides a focused overview of how RWE can be effectively integrated into HTA strategies. The session will explore real-world use cases, outline the FDZ process and timelines, and share early lessons learned from first applications as an early adopter.
Designed for professionals in HEOR, Market Access, Regulatory Affairs, Strategy, and Clinical teams involved in EU or national HTA submissions.
April 28, 2026 | 4:00–5:00 PM CEST
Strengthen your RWE strategy and prepare for the evolving EU HTA landscape.
Apply to participate >>
Connect with our EU HTA experts
Start Preparations early
- Schedule an EU market access strategy call
- Request an EU HTA training for your team
- Apply to participate in upcoming expert webinars
