Challenges in the German AMNOG Procedure: The Need for National PICO Transparency and Optimized Consultation Windows in the Context of EU-HTA
Author(s)
Hanna Bayer, PhD, Beate Berning, PhD, Angela Missbach, PhD, Sarah Schmidt, MSc.
Roche Pharma AG, Grenzach-Wyhlen, Germany.
Roche Pharma AG, Grenzach-Wyhlen, Germany.
OBJECTIVES: The German AMNOG procedure offers health technology developers (HTDs) the opportunity for consultation to clarify the PICO (Population, Intervention, Comparator, Outcome) and optimally prepare their dossiers for benefit assessment. However, the advice is not binding and details might change over time. Therefore, with publication of the European PICO a mismatch between the advised national PICO and the European PICO might become obvious and thereby sets a timely submission of an appropriate national dossier and launch of the product at risk. This poster aims to highlight a key challenge: the lack of transparency of the final national PICO for the HTD and its implication for national dossier preparation.
METHODS: Based on an analysis of current processes within the EU-HTA and national AMNOG procedures, timelines from the publication of European PICO to the mandatory submission of the national dossier were compared. Special consideration was given to the timing of a G-BA advice. The feasibility of conducting further advice was assessed based on the identified timelines.
RESULTS: The final national PICO, despite being transmitted to European HTA authorities, is not transparently communicated to the HTD. Our analysis indicates that, if national PICO changed, the time between the publication of PICO requirements and the required submission of the national dossier is extremely limited and further advice within this critical window is not practicable. This leads to suboptimal preparation of national dossiers and carries the risk of double work.
CONCLUSIONS: The lack of national PICO transparency for HTDs in the context of EU-HTA implementation represents a significant hurdle for efficient national dossier preparation in Germany. To best facilitate the preparation of national dossiers and enhance process quality, it is essential that national PICOs are transparently communicated to the HTD in parallel with the scoping process. That would significantly improve the German early benefit assessment.
METHODS: Based on an analysis of current processes within the EU-HTA and national AMNOG procedures, timelines from the publication of European PICO to the mandatory submission of the national dossier were compared. Special consideration was given to the timing of a G-BA advice. The feasibility of conducting further advice was assessed based on the identified timelines.
RESULTS: The final national PICO, despite being transmitted to European HTA authorities, is not transparently communicated to the HTD. Our analysis indicates that, if national PICO changed, the time between the publication of PICO requirements and the required submission of the national dossier is extremely limited and further advice within this critical window is not practicable. This leads to suboptimal preparation of national dossiers and carries the risk of double work.
CONCLUSIONS: The lack of national PICO transparency for HTDs in the context of EU-HTA implementation represents a significant hurdle for efficient national dossier preparation in Germany. To best facilitate the preparation of national dossiers and enhance process quality, it is essential that national PICOs are transparently communicated to the HTD in parallel with the scoping process. That would significantly improve the German early benefit assessment.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA73
Topic
Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas