| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23070 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | Pembrolizumab (Keytruda®) is indicated in combination with fluoropyrimidine and platinum-containing chemotherapy, for the first-line treatment of locally advanced, unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 |
| Assessment Process | |
| Rapid review commissioned | 21/11/2023 |
| Rapid review completed | 18/12/2023 |
| 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 | 09/01/2024 |
| Pre-submission consultation with Applicant | 30/01/2024 |
| Full submission received from Applicant | 01/08/2024 |
| Preliminary review sent to Applicant | 09/05/2025 |
| NCPE assessment re-commenced | 06/06/2025 |
| Follow-up to preliminary review sent to Applicant | 01/07/2025 |
| NCPE assessment re-commenced | 10/07/2025 |
| Additional follow-up to Preliminary Review sent to Applicant | 24/07/2025 |
| NCPE assessment re-commenced | 25/07/2025 |
| Factual accuracy sent to Applicant | 01/08/2025 |
| NCPE assessment re-commenced | 12/08/2025 |
| NCPE assessment completed | 25/08/2025 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab, in combination with fluoropyrimidine and platinum-containing chemotherapy, 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.