Course 01
Real-world evidence for health technology assessment
The course for market access, HEOR and medical teams who keep being told to "add some real-world evidence" and need to know what would actually count.
We work through how assessment bodies read an RWE package: where real-world data is accepted without argument, where it is treated as supportive only, and where it is rejected outright — and why those lines sit where they do. Participants then plan an evidence package for a case of their own, and defend it to the room.
Covered
- What RWE is used for in HTA: burden of disease, comparative effectiveness, external controls, managed entry
- The EU HTA Regulation and the Joint Clinical Assessment — what changed, and what it means for evidence planning
- Nordic and national assessment practice, and how much it still varies
- Data sources: registries, EHR, claims, cohorts — strengths and known traps of each
- Why RWE submissions fail: unclear estimand, unfixable confounding, undocumented decisions
- Building an evidence generation plan that survives contact with a reviewer