| Assessment Status | 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.
