Sodium Zirconium Cyclosilicate (Lokelma®). HTA ID: 24039

Assessment Status NCPE Assessment Process Complete
HTA ID 24039
Drug Sodium Zirconium Cyclosilicate
Brand Lokelma®
Indication Sodium Zirconium Cyclosilicate is indicated for the treatment of hyperkalaemia in adult patients.
Assessment Process
Rapid review commissioned 01/10/2024
Rapid review completed 06/11/2024
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost-effectiveness of SZC for this indication compared with the current standard of care.
Full HTA commissioned by the HSE 27/11/2024
Pre-submission consultation with Applicant 05/03/2025
Full submission received from Applicant 04/09/2025
Preliminary review sent to Applicant 10/03/2026
NCPE assessment re-commenced 15/04/2026
Follow-up to preliminary review sent to Applicant 27/04/2026
NCPE assessment re-commenced 13/05/2026
Factual accuracy sent to Applicant 23/06/2026
NCPE assessment re-commenced 01/07/2026
NCPE assessment completed 21/07/2026
NCPE assessment outcome The NCPE recommends that SZC, for treatment of HK in patients with S-K levels ≥ 5.5 mmol/L who have advanced CKD (stage 3 to 5) and/or HF and are being treated with RAASi, not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments.* The full licensed population is broader than the subpopulation used to inform the cost-effectiveness analysis.

Summary

Plain English Summary

 

*Next steps: 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.