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