| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 21041 |
| Drug | Daratumumab |
| Brand | Darzalex® in combination with cyclophosphamide, bortezomib and dexamethasone |
| Indication | For the treatment of adult patients with newly diagnosed systemic light chain amyloidosis. |
| Assessment Process | |
| Rapid review commissioned | 03/09/2021 |
| Rapid review completed | 13/10/2021 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of daratumumab compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 27/10/2021 |
| Pre-submission consultation with Applicant | 18/01/2022 |
| Full submission received from Applicant | 19/04/2022 |
| Preliminary review sent to Applicant | 26/09/2022 |
| NCPE assessment re-commenced | 24/10/2022 |
| Follow-up to preliminary review sent to Applicant | 03/11/2022 |
| NCPE assessment re-commenced | 09/11/2022 |
| Factual accuracy sent to Applicant | 02/12/2022 |
| NCPE assessment re-commenced | 09/12/2022 |
| NCPE assessment completed | 19/12/2022 |
| NCPE assessment outcome | The NCPE recommends that daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone 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. June 2024