| Assessment Status | 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.
