| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 24021 |
| Drug | Ciltacabtagene autoleucel |
| Brand | Carvykti® |
| Indication | For the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. |
| Assessment Process | |
| Rapid review commissioned | 04/06/2024 |
| Rapid review completed | 08/07/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ciltacabtagene autoleucel for this indication compared with the current standard of care. |
| Full HTA commissioned by the HSE | 31/07/2024 |
| Pre-submission consultation with Applicant | 04/09/2024 |
| Full submission received from Applicant | 05/02/2025 |
| Preliminary review sent to Applicant | 05/08/2025 |
| NCPE assessment re-commenced | 03/09/2025 |
| Factual accuracy sent to Applicant | 24/11/2025 |
| NCPE assessment re-commenced | 01/12/2025 |
| NCPE assessment completed | 16/12/2025 |
| NCPE assessment outcome | The NCPE recommends that ciltacabtagene autoleucel (Carvykti®) 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.