| Assessment Status | NCPE Assessment Process complete |
| HTA ID | 23009 |
| Drug | Durvalumab |
| Brand | Imfinzi® |
| Indication | Durvalumab in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with unresectable or metastatic biliary tract cancer. |
| Assessment Process | |
| Rapid review commissioned | 20/02/2023 |
| Rapid review completed | 16/03/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of durvalumab used in combination with gemcitabine and cisplatin compared with the current SOC (gemcitabine and cisplatin). |
| Full pharmacoeconomic assessment commissioned by HSE | 29/03/2023 |
| Pre-submission consultation with Applicant | 06/06/2023 |
| Full submission received from Applicant | 04/10/2023 |
| Preliminary review sent to Applicant | 12/08/2024 |
| NCPE assessment re-commenced | 10/09/2024 |
| Factual accuracy sent to Applicant | 26/11/2024 |
| NCPE assessment re-commenced | 29/11/2024 |
| NCPE assessment completed | 19/12/2024 |
| NCPE assessment outcome | The NCPE recommends that durvalumab (Imfinzi®) 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.