| Assessment Status | Rapid Review Complete |
| HTA ID | 25028 |
| Drug | Melphalan flufenamide |
| Brand | Pepaxti® |
| Indication | Melphalan flufenamide in combination with dexamethasone, is indicated for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least three years from transplantation. |
| Assessment Process | |
| Rapid review commissioned | 01/04/2025 |
| Rapid review completed | 09/05/2025 |
| Rapid review outcome | A full HTA is not recommended until additional efficacy and/or safety data is submitted. On the basis of current evidence, the NCPE recommends that melflufen+dex not be considered for reimbursement*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Further information on this process may be found here.
Further information on the status of this decision may be found here
