| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 21032 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | In combination with platinum and fluoropyrimidine-based chemotherapy, for the first line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with CPS≥10. |
| Assessment Process | |
| Rapid review commissioned | 12/07/2021 |
| Rapid review completed | 05/08/2021 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 25/08/2021 |
| Pre-submission consultation with Applicant | 28/09/2021 |
| Full submission received from Applicant | 25/03/2022 |
| Preliminary review sent to Applicant | 23/09/2022 |
| NCPE assessment re-commenced | 24/10/2022 |
| Factual accuracy sent to Applicant | 08/12/2022 |
| NCPE assessment re-commenced | 15/12/2022 |
| NCPE assessment completed | 21/12/2022 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab not be considered for reimbursement unless 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; June 2023