Bulevirtide (Hepcludex®). HTA ID: 22067

Assessment Status NCPE Assessment Process Complete
HTA ID 22067
Drug Bulevirtide
Brand Hepcludex®
Indication Chronic hepatitis delta (CHD) infection in plasma (or serum) HDV RNA-positive adult patients with compensated liver disease.
Assessment Process
Rapid review commissioned 06/10/2022
Rapid review completed 10/11/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of bulevirtide compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 30/11/2022
Pre-submission consultation with Applicant 10/01/2023
Full submission received from Applicant 06/09/2023
Preliminary review sent to Applicant 06/10/2023
NCPE assessment re-commenced 09/11/2023
Factual accuracy sent to Applicant 19/01/2024
NCPE assessment re-commenced 26/01/2024
NCPE assessment completed 22/02/2024
NCPE assessment outcome The NCPE recommends that bulevirtide not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

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

The HSE has approved reimbursement following confidential price negotiations. May 2025