OBJECTIVES Immunotherapy agents (atezolizumab and pembrolizumab) targeting programmed cell death protein-1 (PD-1) and programmed death ligand-1 (PD-L1) for the treatment of metastatic urothelial carcinomas (UC) was approved by the EC in 2018. Following platinum-based chemotherapy, atezolizumab and pembrolizumab have clinical efficacy in patients with metastatic UC with disease progression. These drugs are considered as second-line therapy over single-agent chemotherapy for patients who fail or progress after platinum-based treatment.

METHODS Atezolizumab and pembrolizumab for UC were subject to HTA evaluation, in several EU countries, Bulgaria, , France, Germany, Ireland , Scotland and UK, where clinical data, safety profile and reimbursement parameters were reviewed.

RESULTS In 4 (66%) countries, except Scotland, pembrolizumab has a positive HTA assessment. Scotland - SMC does not recommend it for reimbursement because no robust clinical data had been presented. The NCPE in Ireland recommends that pembrolizumab could be considered for UC reimbursement if cost-effectiveness is improved to existing treatments. Regarding atezolizumab, two countries (33%) Bulgaria and UK recommend it for reimbursement, respectively Positive Drug List and Cancer Drugs Fund. GBA in Germany required cost/benefit dossier for both UC products in January 2019 and obviously the process is still under evaluation. There is yet no HTA assessment published for UC indication of atezolizumab at HAS. Two countries (33%) (Ireland -NCPE and Scotland - SMC) have not considered atezolizumab for reimbursement.

CONCLUSIONS The results for atezolizumab with various HTA authorities in the surveyed EU countries differ due to absence of cost effectiveness or uncertainty in relative effectiveness. For pembrolizumab, HAC and NICE show clinical benefit and minor clinical added valuе, superiority over chemotherapy and overall survival of 2.9 months respectively.