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[A18-40] Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Last updated 17.09.2018

Project no.:
A18-40

Commission:
Commission awarded on 15.06.2018 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

Indication:

Treatment-naive adults with advanced (unresectable or metastatic) melanoma with BRAF V600 WT tumour

Result of dossier assessment:

Due to disadvantages in health-related quality of life and side effects, indication of lesser benefit in comparison with the appropriate comparator therapy (nivolomab alone)

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
A15-50 Nivolumab - Addendum to Commission A15-27 Commission completed
A16-76 Nivolumab (Hodgkin lymphoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A16-57 Nivolumab (NSCLC) - Addendum to Commission A16-25 Commission completed
A16-56 Nivolumab (renal cell carcinoma) - Addendum to Commission A16-24 Commission completed
A17-54 Nivolumab (squamous cell carcinoma of the head and neck) - Addendum to Commission A17-24 Commission completed
A18-53 Nivolumab (melanoma) - 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
G17-10 Nivolumab Squamous cell carcinoma of the head and neck - Addendum to A17-24 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
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
A16-35 Nivolumab (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V Commission completed
A17-29 Nivolumab (urothelial carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A16-68 Nivolumab (melanoma) - Addendum to Commission A16-35 Commission completed
A17-21 Nivolumab (classical Hodgkin lymphoma) - Addendum to Commission A16-76 Commission completed
A15-58 Nivolumab - Addendum to Commission A15-32 Commission completed
A23-59 Nivolumab (melanoma in adolescents, adjuvant) – Benefit assessment according to §35a Social Code Book V Commission completed
A24-70 Nivolumab (unresectable or metastatic urothelial carcinoma) – Benefit assessment according to §35a Social Code Book V Commission completed
A23-58 Nivolumab (melanoma) – Benefit assessment according to §35a Social Code Book V Commission completed
A20-121 Nivolumab (oesophageal cancer) - Benefit assessment according to §35a Social Code Book V Commission completed
A20-118 Nivolumab (non-small cell lung cancer, combination with ipilimumab) - Benefit assessment according to §35a Social Code Book V 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
A22-54 Nivolumab (oesophageal squamous cell carcinoma) - Benefit assessment according to §35a Social Code Book V Commission completed
A23-74 Nivolumab (NSCLC, combination with platinum-based chemotherapy, neoadjuvant) – 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
A22-55 Nivolumab (oesophageal cancer) - Benefit assessment according to §35a Social Code Book V Commission completed
A22-53 Nivolumab (urothelial carcinoma, adjuvant) - 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
A23-94 Nivolumab (melanoma, adjuvant, stage IIB or IIC) – Benefit assessment according to §35a Social Code Book V Commission completed

Federal Joint Committee (G-BA)

2018-12-20 A G-BA decision was published.

G-BA documents on this decision

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