Insights
Expert perspectives, analysis and deep dives on the interface between European benefit assessment and Germany's AMNOG procedure.
How manufacturer discounts, price-volume arrangements and rebate contracts affect AMNOG, market access, net revenue and dossier strategy.
A practical introduction to how EU HTA, Joint Clinical Assessments and Germany's AMNOG procedure interact — and why national decision-making remains decisive.
Why Germany will need more than references from the JCA dossier — and where PICO, comparator choice, endpoints, evidence updates and timing become critical.
The first German benefit assessment after a JCA reveals key differences for tovorafenib in PICO, MAIC, endpoints, data cuts and timing. What this means for the delta dossier.
What the first JCA report shows about PICO, comparator data, endpoints, uncertainty and national translation for the Delta-Dossier.
How the first JCAs are changing European evidence assessment and what that means for manufacturers, comparator strategy and the Delta Dossier.
Why the first discontinued JCAs show that dossier completeness, PICO coverage, methodological transparency and AMNOG readiness need to be prepared early and together.
For complex PICO and comparator questions in JCA scoping.
A peer-reviewed publication mapping methodological similarities and misalignments between EU JCA guidance and selected national HTA requirements.
A peer-reviewed publication on how real-world evidence can support JSC, JCA and national HTA submissions, including Delta-Dossiers.
The critical questions do not start with the national dossier submission. PICO, comparator choice, endpoints, evidence synthesis and timing need to be assessed early for their national usability.
