Odevixibat (Bylvay®). HTA ID: 21058

Assessment Status NCPE Assessment Process Complete
HTA ID 21058
Drug Odevixibat
Brand Bylvay®
Indication For the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older.
Assessment Process
Rapid review commissioned 24/11/2021
Rapid review completed 22/12/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of odevixibat (Bylvay®) compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 31/01/2022
Pre-submission consultation with Applicant 07/03/2022
Full submission received from Applicant 16/08/2022
Preliminary review sent to Applicant 20/09/2022
NCPE assessment re-commenced 19/10/2022
Factual accuracy sent to Applicant 06/03/2023
NCPE assessment re-commenced 13/03/2023
NCPE assessment completed 14/03/2023
NCPE assessment outcome The NCPE recommends that odevixibat not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations. November 2024