JCA and AMNOG: The EU Assessment Does Not Replace the German One

"The JCA will make the German benefit assessment go away." That expectation has followed the EU HTA Regulation for years, and it is wrong. Regulation (EU) 2021/2282 pools the clinical assessment, not the assessment decision. Since 12 January 2025, new oncology medicines and ATMPs go through a joint clinical assessment (JCA); from 13 January 2028 orphan medicines follow, and from 13 January 2030 all remaining medicinal products with new active ingredients. For high-risk medical devices and class D IVDs, the first joint assessments start in small numbers from 2026.

What changes is not the number of procedures. It is the point in time by which the evidence package has to be complete.

What the JCA delivers, and what it explicitly does not

The JCA report describes the relative clinical effects of a technology against comparators. It contains no health-economic assessment, no cost-effectiveness conclusion and no statement on price. Member states must give the report due regard, but they continue to draw their own conclusion on the value of a technology and decide on pricing and reimbursement themselves.

For Germany this means: the Federal Joint Committee (G-BA) still assesses added benefit under Section 35a SGB V, determines the appropriate comparator therapy and decides on the extent of added benefit. The reimbursement amount is negotiated separately under Section 130b SGB V. The JCA supplies material for that procedure; it does not substitute for it.

There is, however, genuine relief in Article 13(2) of the Regulation: whatever a developer has submitted at Union level may not be requested again at national level for the national assessment. Germany implemented that mechanism in 2025. The first regulation amending the AM-NutzenV governs how the content of the EU dossier enters the national procedure, and on 17 July 2025 the G-BA amended Chapter 5 of its Code of Procedure accordingly: companies can reference the data submitted at EU level and the JCA report in their national dossier.

The timetable is the actual news

Implementing Regulation (EU) 2024/1381 sets the deadlines. In the order in which they hit a company:

• Member states submit their PICO questions (population, intervention, comparator, outcomes). The subgroup consolidates them into one assessment scope, finalised no later than 75 days after the EMA validates the marketing authorisation application.
• The JCA dossier is due 100 days after receipt of the assessment scope, and at the latest 45 days before the CHMP opinion.
• The JCA report is published after the authorisation decision; the Regulation provides a 30-day window for that.

Read the second bullet again. The complete evidence package falls due before authorisation is granted, and against comparators that were only finalised a few weeks earlier. The national dossier under Section 35a SGB V follows at the point of market launch.

One scope, many comparators

The consolidated assessment scope contains the PICO questions of all participating member states. Because standards of care diverge across Europe, comparators add up. Simulations and the first procedures point to magnitudes of 10 to 30 PICOs per assessment, with dossiers growing to several thousand and, in individual cases, around 30,000 pages. Each PICO question has to be answered with evidence of its own.

This is where the break hurts in practice. A comparator that was never studied cannot be produced retrospectively. For oncology products, increasingly authorised on the basis of single-arm trials, the problem sharpens: the relative effect against a national standard then has to be derived through indirect comparisons, and the EU methodological guidelines explicitly consider single-arm or non-randomised evidence as potentially insufficient for estimating relative effectiveness.

Two procedures, one evidence package

In practice this reorders the work rather than adding to it in the same place:

• Establish comparators early. Which appropriate comparator therapy Germany is likely to apply, and which comparators other member states are likely to submit, belongs in the planning of the pivotal studies, not in the dossier phase. Early scientific advice with the G-BA and a joint scientific consultation at EU level are the instruments provided for that.
• Check endpoints twice. Patient-relevant endpoints in the G-BA sense and the outcomes of the submitted PICO questions are not automatically the same. Serve only one side and you have a gap in the other procedure.
• One core dossier, derived versions. The EU dossier and the national dossiers should come from one source. Separately maintained documents drift apart, and the divergence is noticed during assessment.
• Hold subgroups ready. A PICO population is often narrower than the authorised label. Analyses requested only after database lock are expensive or impossible.

What to do now

For products intended to reach the European market in 2027 or later, the moment for evidence planning is now. A workable starting point is a JCA readiness read: planned authorisation route, likely scope, available comparator evidence and the gaps in between, assessed against the deadlines of the Implementing Regulation.

Entourage supports pharma, biotech, MedTech and IVD companies with exactly this interlocking: deriving the likely assessment scope, reconciling it with the study program, building a core dossier from which both the JCA dossier and the Section 35a SGB V dossier can be derived, and preparing scientific advice at national and European level. The starting point is usually the uncomfortable question of which comparator your studies already produce data against, and which they do not.