| 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 pharmacoeconomic assessment commissioned by 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*A full HTA submission was received on 09/01/2023 and withdrawn by the company on 23/06/2023.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.