| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23078 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | Pembrolizumab (Keytruda®) as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy*. |
| Assessment Process | |
| Rapid review commissioned | 20/12/2023 |
| Rapid review completed | 24/01/2024 |
| 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, on the basis of the proposed price relative to currently available therapies. |
| Full HTA commissioned by the HSE | 02/02/2024 |
| Pre-submission consultation with Applicant | 27/08/2024 |
| Full submission received from Applicant | 27/02/2025 |
| Preliminary review sent to Applicant | 09/10/2025 |
| NCPE assessment re-commenced | 07/11/2025 |
| Factual accuracy sent to Applicant | 28/01/2026 |
| NCPE assessment re-commenced | 06/02/2026 |
| NCPE assessment completed | 19/02/2026 |
| 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 treatment.* |
*The Applicant is seeking reimbursement in a subgroup of the eligible population whose tumours express PD-L1 <50%.
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.