Hero visual for extracting evidence from the JCA into the Delta-Dossier

EU HTA / JCA / AMNOG

Delta-Dossier: Connecting JCA and AMNOG

Extracting evidence. Shaping access. The essential insights from the JCA - translated into a compelling Delta-Dossier.

co.value - A Cytel Brand brings European evidence and German benefit assessment together. Together with Cytel, co.value combines local AMNOG expertise with experience in PICO scoping, JCA dossiers and statistical evidence generation. This turns the essential evidence from the JCA into a robust foundation for a compelling Delta-Dossier - from evidence planning, comparator strategy and endpoints to alignment with the German assessment process.

Explore the Delta-Dossier Map Read the 5 theses

Explore our EU HTA, JCA and AMNOG insights.

Insights

Perspective for Germany

Five guiding theses for Germany

EU HTA does not replace Germany's national assessment

The JCA can inform national decision-making, but it does not replace Germany's early benefit assessment or the subsequent national price negotiation.

The Delta dossier is about translation, not cross-referencing

What matters is not simply referring to European content, but translating it into a nationally robust dossier for the German AMNOG process.

The real work starts long before the marketing authorization application

The critical strategic work begins earlier: with evidence planning, PICO scoping and preparation for the marketing authorization application.

The greatest risks lie in comparator therapy and endpoints

Whether European evidence can carry weight in Germany depends above all on PICOs, comparator therapy, endpoints and methodological alignment.

Publication timelines and evidence updates will become success factors

Additional data cuts, new studies and the timing of the JCA report can all shape the national evidence package and the German benefit assessment.

Article

The Delta-Dossier: Why Germany needs more than a reference-based approach

The full article explores the five theses in more depth and explains why the Delta-Dossier in Germany is more than a formal reference to the JCA dossier.

Read the 5 theses

Interactive visualization

What can be carried over from the JCA dossier - and where Germany requires additional work

The interactive map shows where JCA and AMNOG come together in the Delta-Dossier - from PICO scoping and appropriate comparator therapy to endpoints, evidence updates and timing.

JCA dossier

Delta dossier

Reference to the JCA dossier possible

Reference to the JCA dossier possible, but national adaptations may be required

No reference possible

Read the 5 theses

DELTA DOSSIER WATCH

The first Delta-Dossier is now taking shape.

With Tovorafenib/Ojemda, the first AMNOG procedure is underway in which the interface between the European JCA and Germany's national benefit assessment becomes practically relevant. The next public milestone is the publication of the benefit assessment on 17 August 2026.

Days until the benefit assessment

-- hours · -- minutes

Next public milestone

17 August 2026

Publication of the benefit assessment and start of the written statement procedure

15.05.2026
Procedure initiated
17.08.2026
Publication of the benefit assessment
07.09.2026
Deadline for written statement
Early November 2026
Final decision

Source: G-BA benefit assessment procedure for Tovorafenib

Services

Delta-Dossier support

We support companies at the critical points where European groundwork needs to become a nationally robust Delta-Dossier.

Understand EU HTA in Germany

PICO scoping and national alignment

We help align European assessment questions early so they robustly anticipate the assessment context of the German procedure.

Comparator therapy, endpoints and methodology

We identify where European evidence needs to be translated, supplemented or methodologically reinforced for Germany.

Evidence updates, timing and dossier strategy

We assess how additional data cuts, new studies and tight procedural timelines can reshape the national evidence package and dossier strategy.

Prepare strategically

Discuss the Delta-Dossier

Would you like to clarify early how a JCA dossier can be transferred into the German AMNOG process in a meaningful and efficient way? We would be happy to discuss where translation needs, evidence gaps and strategic risks may arise in your specific case.

co.value does not see the Delta-Dossier as a lean reference-based solution, but as a strategic translation between European benefit assessment and the German AMNOG process. From our perspective, the key question is not whether the JCA dossier can be referenced, but whether European evidence can carry weight in Germany - in relation to PICO scoping, comparator therapy, endpoints, evidence recency and tight procedural timelines.

Together with Cytel, we combine experience in JCA dossiers, PICO scoping and evidence generation with deep AMNOG expertise in the German market. This enables us to help companies align their European groundwork early, so that the resulting Delta-Dossier is not only formally connected to the JCA, but robust enough to support the national German assessment.