Ivosidenib (Tibsovo®) monotherapy HTA ID: 23016

Assessment Status NCPE assessment ongoing
HTA ID 23016
Drug Ivosidenib
Brand Tibsovo®
Indication For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R 132 mutation who were previously treated by at least one prior line of systemic therapy
Assessment Process
Rapid review commissioned 08/03/2023
Rapid review completed 17/04/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ivosidenib compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 28/06/2023
Pre-submission consultation with Applicant 05/09/2023
Full submission received from Applicant 16/02/2024
Preliminary review sent to Applicant 01/11/2024
NCPE assessment re-commenced 29/11/2024
Follow-up to preliminary review sent to Applicant 11/12/2024
NCPE assessment re-commenced 17/12/2024