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.