[A20-118] Nivolumab (non-small cell lung cancer, combination with ipilimumab) - Benefit assessment according to §35a Social Code Book V

Last updated 04.06.2021

Project no.:
A20-118

Commission:
Commission awarded on 14.12.2020 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

Indication:

First-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumours have no sensitizing EGFR mutation or ALK translocation

Result of dossier assessment:

PD-L1 expression (TPS) of at least 50 percent: added benefit not proven.

PD-L1 expression (TPS) below 50 percent: non-squamous histology: indication of added benefit; extent “non-quantifiable". Squamous histology: added benefit not proven.

Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

Project no. Title Status
A19-11 Nivolumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A18-53 Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A18-40 Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Commission completed
A17-29 Nivolumab (urothelial carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A17-27 Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Commission completed
A17-24 Nivolumab (squamous cell carcinoma of the head and neck) - Benefit assessment according to §35a Social Code Book V Commission completed
A16-76 Nivolumab (Hodgkin lymphoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A16-35 Nivolumab (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V Commission completed
A16-25 Nivolumab (new therapeutic indication) – Benefit assessment according to §35a SGB V Commission completed
A16-24 Nivolumab (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V Commission completed
A15-32 Nivolumab (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment) Commission completed
A15-27 Nivolumab – Benefit assessment according to §35a Social Code Book V (dossier assessment) Commission completed
A21-57 Nivolumab (NSCLC) - Addendum to Commission A20-118 Commission completed
A21-146 Nivolumab (gastric adenocarcinoma, adenocarcinoma of the gastroesophageal junction or the oesophagus) - Benefit assessment according to §35a Social Code Book V Commission completed
A21-99 Nivolumab (colorectal cancer) - Benefit assessment according to §35a Social Code Book V Commission completed
A21-89 Nivolumab (malignant pleural mesothelioma) - Benefit assessment according to §35a Social Code Book V Commission completed
A21-108 Nivolumab (oesophageal or gastro-oesophageal junction cancer) - Benefit assessment according to §35a Social Code Book V Commission completed
A21-39 Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Commission completed
A21-59 Nivolumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed

Federal Joint Committee (G-BA)

2021.06.04 A G-BA decision was published.

G-BA documents on this decision

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