JCA-to-AMNOG Gap Assessment and Delta Dossier Strategy
The JCA-to-AMNOG gap assessment determines how well the European evidence package addresses the requirements of the German benefit assessment. co.value assesses populations, the German appropriate comparator therapy, endpoints, available analyses and data cuts to determine which JCA elements can be reused and where German interpretation, adaptation or additional evidence is required.
Development of the German AMNOG Delta Dossier
co.value develops Delta Dossiers for submission within the German AMNOG process. We maximise the appropriate reuse of JCA content and analyses while adding the national content required for Germany. Depending on the evidence package, our support can include dossier development, AMNOG-specific statistical analyses, additional data cuts, quality assurance and preparation for G-BA submission.
This approach reflects our current delivery model, which combines structured JCA-to-AMNOG mapping with Germany-specific additions, cross-module consistency checks, quality control and finalisation of the submission package.
Combining JCA Expertise with German AMNOG Expertise
co.value and Cytel combine European JCA expertise with local expertise in the German AMNOG process. Cytel contributes international HTA, evidence synthesis and analytics capabilities, while co.value translates the evidence into the requirements of the German benefit assessment and coordinates development of the Delta Dossier.
Cytel's experience includes several EU JCA PICO simulations, JCA readiness trainings, completed first-wave and in development EU JCA Dossiers..
Delta Dossier Consulting Services
- JCA-to-AMNOG gap assessment and strategy
- Assessment and reuse of relevant JCA evidence
- Development and completion of the German Delta Dossier
- AMNOG-specific statistical analyses and evidence preparation
- Quality assurance and preparation for G-BA submission
- Support with the written statement and oral hearing
Frequently Asked Questions About Delta Dossier Consulting
Does co.value develop complete Delta Dossiers for Germany?
Yes. co.value develops Delta Dossiers for submission within the German AMNOG process. Support can include JCA-to-AMNOG strategy, dossier development, Germany-specific content, additional analyses and preparation for G-BA submission.
Can JCA evidence be reused for the German Delta Dossier?
Yes, where the JCA evidence is suitable for the German benefit assessment. co.value assesses which European evidence can be leveraged and identifies where German-specific interpretation, additional content or further analyses are required.
Does a JCA eliminate the need for German AMNOG work?
No. A JCA provides a European clinical evidence basis, but German requirements still need to be addressed for the AMNOG process. co.value assesses the JCA evidence against the German decision context and identifies the national content and analyses required for the Delta Dossier.
Does co.value provide support after Delta Dossier submission?
Yes. co.value can continue to support the German AMNOG process after dossier submission. This includes analysis of the benefit assessment, preparation of the written statement and preparation for the G-BA oral hearing.
Where can I find guidance on JCA, AMNOG and the Delta Dossier?
Delta-Dossier.de provides guidance and analysis on the interface between EU JCA and the German AMNOG process. co.value focuses on consulting and operational delivery for companies preparing a German Delta Dossier.