KEYTRUDA (pembrolizumab) - Urothelial carcinoma
Reason for request
Summary of opinion
Favourable opinion for reimbursement only in combination with enfortumab vedotin, in the first-line treatment of unresectable or metastatic urothelial carcinoma in adults eligible for platinum-containing chemotherapy.
Unfavourable opinion for reimbursement in the other situations covered by the MA indication.
Clinical Benefit
Substantial |
The Committee deems that the clinical benefit of KEYTRUDA (pembrolizumab) 25 mg/mL concentrate for solution for infusion is substantial only “in combination with enfortumab vedotin, in the first-line treatment of unresectable or metastatic urothelial carcinoma in adults eligible for platinum containing chemotherapy”.
|
Insufficient |
The Committee deems that the clinical benefit of KEYTRUDA (pembrolizumab) 25 mg/mL concentrate for solution for infusion is insufficient to justify public funding in the other MA situations. |
Clinical Added Value
moderate |
Considering:
and despite:
|
Not applicable |