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:
evidence of the superiority of KEYTRUDA (pembrolizumab) in combination with enfortumab vedotin compared to platinum-containing chemotherapy (gemcitabine + cisplatin or carboplatin), in a randomised, open-label phase 3 study in terms of overall survival, with an absolute difference of +15.4 months (HR = 0.468; CI95%[0.376; 0.582]), and in progression-free survival of +6.2 months (HR = 0.450; CI95%[0.3777; 0.538]);
and despite:
the absence of improvement in terms of time to pain progression;
a toxicity profile marked by the frequent occurrence of skin disorders, peripheral sensory neuropathy, and treatment discontinuations due to adverse events (39.8% versus 21.5%);
the lack of evidence of an improvement in quality of life (exploratory endpoint);
the Committee deems that KEYTRUDA (pembrolizumab) 25 mg/mL concentrate for solution for infusion provides a moderate clinical added value (CAV III) compared to platinum containing chemotherapy.
In the other situations of the MA: Not applicable.
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