| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22032 |
| Drug | Selumetinib |
| Brand | Koselugo® |
| Indication | For the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and above. |
| Assessment Process | |
| Rapid review commissioned | 10/05/2022 |
| Rapid review completed | 25/05/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of selumetinib (Koselugo®) compared with the current standard-of-care. |
| Full HTA commissioned by the HSE | 01/07/2022 |
| Pre-submission consultation with Applicant | 20/09/2022 |
| Full submission received from Applicant | 29/01/2024 |
*A full HTA submission was received on 09/01/2023 and withdrawn by the company on 23/06/2023.
Resubmission of HTA
| Assessment Process | NCPE Assessment Process Complete |
| Full submission received from Applicant | 29/01/2024 |
| Preliminary review sent to Applicant | 15/08/2024 |
| NCPE assessment re-commenced | 17/10/2024 |
| Factual accuracy sent to Applicant | 06/11/2024 |
| NCPE assessment re-commenced | 14/11/2024 |
| NCPE assessment completed | 13/12/2024 |
| NCPE assessment outcome | The NCPE recommends that selumetinib (Koselugo®) 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.
The HSE has approved reimbursement following confidential price negotiations; June 2026