C64Malignant neoplasm of kidney, except renal pelvis
Alpha-ID codes (AIS)
I19876Renal cell carcinoma
DDD
17
mg
P
Therapeutic area
Oncological diseases
Renal cell carcinoma (RCC)
Reason for procedure
New therapeutic indication
Specialty
Bundling
Therapeutic indication of the resolution
OPDIVO as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.
Subpopulation
Indication
Comparator
D1)
Adult patients with advanced renal cell carcinoma after anti-angiogenic pre-therapy
Everolimus
D2)
Adult patients with advanced renal cell carcinoma after previous therapy with temsirolimus
Sunitinib
Studies and Results
No. of studies
(best subpopulation)
1
(CA 209-025)
Study design
(best subpopulation)
H2H vs. ACT
Meta analysis
(best subpopulation)
no
Reason for dividing into subpopulations (G-BA)
Previous treatment
1) Patients who have previously received anti-angiogenic therapy
The G-BA has reached its decision on whether an additional benefit of nivolumab can be established compared with the appropriate comparator therapy, on the basis of the dossier submitted by the pharmaceutical manufacturer, the dossier assessment prepared by the IQWiG, the statements presented during the written and oral consultation procedures, and the addendum to the benefit assessment prepared by the IQWiG.
In order to determine the extent of the additional benefit, the G-BA assessed the data justifying the identification of an additional benefit in terms of their therapeutic relevance (qualitatively), in accordance with the criteria set out in Chapter 5, Section 5(7) of the VerfO.
2) Patients following prior treatment with temsirolimus
The G-BA based its decision on whether an additional benefit of nivolumab over the appropriate comparator therapy could be established on the basis of the dossier submitted by the pharmaceutical manufacturer, the dossier assessment prepared by the IQWiG, the statements presented during the written and oral consultation procedures, and the addendum to the benefit assessment prepared by the IQWiG.
In order to determine the extent of the additional benefit, the G-BA assessed the data justifying the identification of an additional benefit in terms of their therapeutic relevance (qualitatively), in accordance with the criteria set out in Chapter 5, Section 5(7) of the VerfO.
Courtesy translation only, please refer to the German original.
