Maralixibat (Livmarli®). HTA ID: 25001

Assessment Status NCPE Assessment Process Complete
HTA ID 25001
Drug Maralixibat
Brand Livmarli®
Indication Maralixibat (Livmarli®) is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.
Assessment Process
Rapid review commissioned 06/01/2025
Rapid review completed 04/02/2025
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of maralixibat compared with the current standard of care.
Full HTA commissioned by the HSE 26/02/2025
Pre-submission consultation with Applicant 09/04/2025
Full submission received from Applicant 13/08/2025
Preliminary review sent to Applicant 11/12/2025
NCPE assessment re-commenced 19/01/2026
Factual accuracy sent to Applicant 20/02/2026
NCPE assessment re-commenced 27/02/2026
NCPE assessment completed 30/03/2026
NCPE assessment outcome The NCPE recommends that maralixibat (Livmarli®) not be considered for reimbursement, unless cost effectiveness can be improved relative to existing treatments.

Summary

Plain English Summary

 

The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

 

Further information on this process may be found here

 

Further information on the status of this decision may be found here