| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22021 |
| Drug | Ciltacabtagene autoleucel |
| Brand | Carvykti® |
| Indication | For the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. |
| Assessment Process | |
| Rapid review commissioned | 11/04/2022 |
| Rapid review completed | 12/05/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of cilta-cel (ciltacabtagene autoleucel) compared with the current standard-of-care. |
| Full HTA commissioned by the HSE | 27/05/2022 |
| Pre-submission consultation with Applicant | 12/07/2022 |
| Full submission received from Applicant | 30/11/2022 |
| Preliminary review sent to Applicant | 30/05/2023 |
| NCPE assessment re-commenced | 27/06/2023 |
| Factual accuracy sent to Applicant | 04/09/2023 |
| NCPE assessment re-commenced | 12/09/2023 |
| NCPE assessment completed | 27/09/2023 |
| NCPE assessment outcome | The NCPE recommends that cilta-cel 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.
The HSE has approved reimbursement following confidential price negotiations. October 2025