| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23056 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | Pembrolizumab (Keytruda®) In combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥1. |
| Assessment Process | |
| Rapid review commissioned | 07/09/2023 |
| Rapid review completed | 03/10/2023 |
| 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 | 01/11/2023 |
| Pre-submission consultation with Applicant | 05/12/2023 |
| Full submission received from Applicant | 02/05/2024 |
| Preliminary review sent to Applicant | 19/12/2024 |
| NCPE assessment re-commenced | 31/01/2025 |
| Factual accuracy sent to Applicant | 15/04/2025 |
| NCPE assessment re-commenced | 23/04/2025 |
| NCPE assessment completed | 12/05/2025 |
| NCPE assessment outcome | The NCPE recommends that Pembrolizumab (Keytruda®) not be considered for reimbursement, for this indication, 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