Assessment Status | Full HTA resubmission received 29/01/2024* |
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*A full HTA submission was received on 09/01/2023 and withdrawn by the company on 23/06/2023.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 ongoing |
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 |