Pembrolizumab (Keytruda®) for Urothelial Carcinoma 2L

Assessment Status Assessment process complete
Drug Pembrolizumab
Brand Keytruda®
Indication As monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.
Assessment Process
Rapid review commissioned 06/12/2017
Rapid review completed 21/12/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 04/02/2018
Pre-submission consultation with Applicant 12/02/2018
Full submission received from Applicant 03/10/2018
Preliminary review sent to Applicant 05/12/2018
NCPE assessment re-commenced 18/01/2019
Factual accuracy sent to Applicant 06/03/2019
NCPE assessment re-commenced 20/03/2019
NCPE assessment completed 25/03/2019
NCPE assessment outcome The NCPE recommends that pembrolizumab (Keytruda®) be considered for reimbursement for this indication if cost-effectiveness can be improved relative to existing treatments*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations – February 2021.