Since January 2025 new cancer drugs and advanced therapies get an EU-level clinical assessment. Germany still runs AMNOG, still sets the price and still wants its own dossier. Here is how the two fit — and where the timing can bite.
The EU HTA Regulation (2021/2282) adds a Joint Clinical Assessment (JCA) of relative clinical effectiveness — no value judgement, no price. It covers new oncology medicines and ATMPs since 12 January 2025, orphan medicines from 2028 and all new centrally authorised medicines from 2030, plus selected high-risk devices. In Germany AMNOG continues: a national dossier is still due at launch, the G-BA still judges added benefit against its own comparator, and the price is still negotiated from month 7. The JCA report is taken into account only if it is published in time — for the first case, tovorafenib, it was not.
The JCA answers one question for the whole EU: how does a new medicine compare clinically with the alternatives that matter in each Member State?
It assesses relative effectiveness and safety for the populations, comparators and outcomes Member States ask for (PICOs). It does not rate the size of the added benefit, judge value or say anything about price or reimbursement. Member States must give the report “due consideration” and annex it to their national assessments — but pricing and reimbursement stay national. For how the German side works, start with AMNOG explained.
A dossier that does not meet the requirements can lead to the JCA being discontinued — one was, in September 2026.
AMNOG continues, normally starting after the EU procedure. The G-BA supplies Germany’s PICO input, and the rules were updated in 2025 (AM-NutzenV in March, G-BA procedures and IQWiG commission in July).
The German dossier is due at launch; the JCA report can arrive up to roughly 40 days after marketing authorisation. Launch early in Germany and the report may not count. That is exactly what happened with tovorafenib: the German procedure started on 15 May 2026, the JCA report was published on 9 June 2026, so the G-BA did not consider it as a dossier basis. And if a JCA is discontinued for a non-compliant dossier, no EU references are allowed in the German dossier at all.
One evidence package, two filters — and the German one still decides the price.
An EU-level assessment of a new medicine’s relative clinical effectiveness under Regulation (EU) 2021/2282, run in parallel with the EMA procedure. It makes no value judgement and has no bearing on price; Member States must give it due consideration.
No. In Germany a national AMNOG dossier is still required at launch, the G-BA still assesses added benefit against its own comparator, and the price is still negotiated nationally. The JCA can be referenced and taken into account.
New oncology active substances and ATMPs since 12 January 2025, orphan medicines from 13 January 2028 and all new centrally authorised medicines from 13 January 2030. Selected high-risk devices are also assessed.
If the report is published before the German dossier deadline, it is part of the assessment basis. If it comes later but before the G-BA assessment is published, it enters the hearing. Reports published after that may not count.
Tovorafenib (Ojemda), a paediatric cancer medicine, published on 9 June 2026. Its German AMNOG procedure started earlier, on 15 May 2026, so the report was not part of the German dossier basis.
We plan PICO and comparator strategy, launch timing against the JCA report, and a German dossier that references the EU evidence without losing the national arguments.