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
AI in JCA: 3 Principles
Artificial intelligence can accelerate evidence generation for Joint Clinical Assessments (JCAs), but its use must meet clear regulatory expectations. In its General Principles on the Use of Artificial Intelligence, adopted on 15 July 2026, the HTA Coordination Group (HTACG) defines three key principles:
Accountability – Health Technology Developers remain fully responsible for all AI-assisted outputs. Human review and validation are mandatory.
Transparency – AI use throughout dossier preparation must be clearly disclosed.
Reporting – AI tools, versions, intended purpose, and prompts should be recorded to ensure a transparent audit trail and support regulatory review.
The message is clear: AI can support the JCA process, but regulatory integrity depends on accountability, transparency, and reporting.
Further reading: Read the full General Principles on the Use of Artificial Intelligence in the Preparation of the JCA Dossier on the European Commission website.
Upcoming Webinar
The next webinar in our Mastering EU HTA series:
“First JCA in National HTA Process – Tovorafenib in AMNOG (Germany)”
This session will explore how the Joint Clinical Assessment (JCA) for Tovorafenib was considered within the German AMNOG procedure and discuss key learnings from this first real-world case.
The webinar will cover:
- How JCA conclusions were reflected in the German AMNOG assessment
- Where European and national HTA approaches align and differ
- What manufacturers can learn for upcoming EU HTA submissions
Featuring expert insights from:
- Dr. Susanne Schneller, Senior Consultant, SmartStep Consulting
- Dr. Timm Volmer, MPH, CEO & Managing Partner, SmartStep Consulting
- Prof. Finn B. Kristensen, Former EUnetHTA Lead Person; Independent Consultant, Science & Policy
Designed for professionals in HEOR, Market Access, Regulatory/Strategy, Clinical teams, and teams involved in EU and national HTA submissions.
August 27, 2026 | 03:00 – 04:00 PM CEST
EU HTA Advanced Academy
Taking place just before ISPOR Europe 2026 in Vienna, the EU HTA Advanced Academy offers the opportunity to deepen your understanding of the evolving EU HTA landscape and enter the conference well prepared for the discussions ahead.
Designed for professionals in Market Access, HEOR, Regulatory Affairs and Evidence Generation, the Academy combines expert-led sessions, interactive workshops and real-world case discussions to translate EU HTA requirements into practical strategies.
Key topics include:
- JSC: process, strategy and practical case scenarios
- PICO scoping: interactive simulations and practical exercises
- Evidence requirements: ITCs and statistical expectations for JCA submissions
- From EMA to EU JCA to national HTA: strategic planning in practice
- Real-world case discussions, expert insights and peer exchange
Join us in Vienna, Austria, for an interactive two-day Academy focused on practical learning, knowledge exchange and navigating the future of EU HTA.
Virtual Kick-off: 29 October 2026
In-person Academy: 5–6 November 2026
The full programme and speaker line-up will be announced soon.
Interested in joining? Submit your details via this form to receive updates, further information and access the exclusive early-bird offer.
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
