News
- EU HTA: Successfully navigating the methodological framework
New methodological guidance documents
- The Implementing Act on JCA is still pending – What to do next Monday?
SKCs Top 5 Essentials
- The "secret update"?
EUnetHTA Deliverable 4.2 on the PICO scoping process
- EU HTA authorities are still building the foundation for their work
Key takeaways from the last events of the coordination group and the German HTA institutions
- How to create a winning joint clinical assessment (JCA) dossier in 90 days?
Numerus and SKC launch joint solution JCA90
- EUnetHTA 21 PICO exercises provide further insights into JCA requirements
Concrete effort estimation for the JCA Submission Dossier is now possible
- European dossier in a German guise
The long awaited JCA dossier template is finally public
- EUnetHTA 21 service contract ends.
The countdown to 2025 is on.
- Announcement of the framework for European consultations on the JCA
The time to save a European consultation slot at G-BA is now!
- EU HTA benefit assessment: more tightly timed than suspected
Update on the Joint Clinical Assessment (JCA) timeframe
- July 2023 – JCAMD002 – Assessment Report
The second JCA assessment report is now available. This evaluates the relative clinical effectiveness and safety of the Evoke spinal cord stimulation (SCS) system medical device in the target patient population against relevant comparators.
- July 2023 – Parallel EMA/HTA body (HTAb) Scientific Advice during Interim Period post EUnetHTA 21
The Parallel EMA/EUnetHTA 21 Joint Scientific Consultations (JSCs) under the EUnetHTA 21 service contract will have to be completed by September 2023 and all available slots have already been allocated. To bridge the interim period between the closure of EUnetHTA 21 and the full application of the HTA Regulation in January 2025, EMA and national HTAb will offer Health technology developers (HTDs) the opportunity for parallel scientific advice.
- July 2023 – European consultations: G-BA acts as coordination contact for parallel consultations by EMA and HTA agencies in Europe in the interim period until the full implementation of the EU HTA Regulation
From September 2023, up to and including the end of 2024 (before the full application of the EU HTA Regulation), health technology developers can obtain scientific advice from the national HTA agencies and the EMA in a parallel procedure. The G-BA acts as the central HTA coordination contact: it coordinates all incoming requests for parallel scientific advice and facilitates the procedure with the national HTA agencies. This parallel scientific advice (so-called „Parallel EMA/HTA body (HTAb) Scientific Advice“) can be requested by the manufacturers via the G-BA as a transitional model until the application of the EU HTA Regulation.
- June 2023 – JCAMD001 – Assessment Report [updated on 16-06-2023]
The first JCA assessment report is now published assessing the relative clinical effectiveness and safety of the Optilume urethral drug-coated balloon (DCB) medical device in the target patient population against relevant comparators.
- June 2023 – The Future of HTA in Europe –The Joint Clinical Assessment (JCA)
Presentation delivered by Martin Scott, Numerus’s Scientific Director, at the 2023 PSI (Statisticians in the Pharmaceutical Industry) conference in London, UK.