Selumetinib (Koselugo®). HTA ID: 22032

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*A full HTA submission was received on 09/01/2023 and withdrawn by the company on 23/06/2023.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