| 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. |
*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.
