BAVENCIO (avelumab), anti-PDL1 antibody
Reason for request
High clinical benefit as monotherapy, in adults previously treated with chemotherapy, for the treatment of metastatic Merkel cell carcinoma and minor clinical added value for management.
Insufficient clinical benefit to justify reimbursement in chemotherapy-naive adults
BAVENCIO has been granted a conditional marketing authorisation as monotherapy for the treatment of patients with metastatic Merkel cell carcinoma (MCC).
Following chemotherapy failure, due to comorbidities and contraindications to non-first-line chemotherapies, there is no medicinal alternative to BAVENCIO, except for supportive care.
In the absence of comparative studies versus first-line metastatic chemotherapy and/or, at least, versus supportive care in patients previously treated by chemotherapy, the level of evidence of the results, observed in a single phase II non-comparative study, is insufficient to demonstrate that BAVENCIO has an impact on mortality of quality of life.
Clinical Added Value