| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22027 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | Is indicated in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. |
| Assessment Process | |
| Rapid review commissioned | 27/04/2022 |
| Rapid review completed | 26/05/2022 |
| 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 | 01/07/2022 |
| Pre-submission consultation with Applicant | 30/08/2022 |
| Full submission received from Applicant | 16/03/2023 |
| Preliminary review sent to Applicant | 11/09/2023 |
| NCPE assessment re-commenced | 09/10/2023 |
| Factual accuracy sent to Applicant | 27/11/2023 |
| NCPE assessment re-commenced | 04/12/2023 |
| NCPE assessment completed | 18/12/2023 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab (Keytruda®) plus chemotherapy, followed by pembrolizumab monotherapy, be considered for reimbursement if 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 2024
