| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 25046 |
| Drug | Durvalumab |
| Brand | Imfinzi® |
| Indication | Durvalumab is indicated in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by durvalumab as monotherapy adjuvant treatment after radical cystectomy, for the treatment of adults with resectable muscle invasive bladder cancer. |
| Assessment Process | |
| Rapid review commissioned | 25/07/2025 |
| Rapid review completed | 11/08/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of durvalumab in combination with gemcitabine and cisplatin compared with the current standard of care. |
| Full HTA commissioned by the HSE | 27/08/2025 |
| Pre-submission consultation with Applicant | 01/10/2025 |
| Full submission received from Applicant | 10/03/2026 |
| Preliminary review sent to Applicant | 12/06/2026 |
| NCPE assessment re-commenced | 10/07/2026 |
| Factual accuracy sent to Applicant | 26/08/2026 |
| NCPE assessment re-commenced | 02/09/2026 |
| NCPE assessment completed | 28/09/2026 |
| NCPE assessment outcome | The NCPE recommends that durvalumab for this bladder cancer indication (in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by durvalumab as adjuvant monotherapy treatment after radical cystectomy, for the treatment of adults with resectable muscle invasive bladder cancer) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*. |
*Next steps: The NCPE Assessment Report and recommendation and Patient Organisation submission, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health Pricing and Supply of Medical Goods Act 2013.
Further information on this process may be found here.
Please see the HSE Pricing and Reimbursement Tracker for any updates on the reimbursement status of this drug.
HSE Pricing and Reimbursement Tracker