Some JCA scoping questions cannot be reduced to a single comparator. The relevant decision context may be a bundle of patient-individual treatment options, while clinical trials cover only part of that bundle.
Key points
Some JCA scoping questions cannot be reduced to a single comparator. The relevant decision context may be a bundle of patient-individual treatment options, while clinical trials cover only part of that bundle.
Key points
- Not every PICO question can be reduced to a single comparator therapy.
- In some indications, the relevant comparator is a bundle of patient-individual treatment options.
- Clinical studies may cover only parts of this comparator bundle.
- The JCA can consider such evidence, while explicitly documenting its limitations.
- National HTA bodies decide whether the evidence is sufficient for local decision logic.
- For Germany, the AMNOG question remains tied to the appropriate comparator therapy, subgroups, patient-relevant endpoints and local robustness.
Relevance for the Delta-Dossier
Individualised comparators show why JCA does not replace AMNOG. European evidence can provide an important starting point, but it does not automatically answer the German added-benefit question. The Delta-Dossier is not an official regulatory term, but a working term used in the German market access context for the additional national content required between the JCA dossier and the AMNOG dossier. In comparator-bundle situations, that national content may include comparator justification, subgroup interpretation, sensitivity analyses or localized real-world evidence.