| Assessment Status | Assessment process complete |
| HTA ID | - |
| 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.
The HSE has approved reimbursement following confidential price negotiations – February 2021.
