Sodium Zirconium Cyclosilicate
Treatment of chronic hyperkalaemia in patients with chronic kidney disease Stage 3-4 who are receiving or indicated for renin angiotensin aldosterone system inhibitor (RAASi) medicines.
Decisions on record
- Meeting Mar 2026 Noted Hyperkalaemia in patients with chronic kidney disease no PSD
- Meeting Mar 2024 Recommended Chronic hyperkalaemia in patients with chronic kidney disease (CKD) Stage 3-4
Access path
- Mar 2024Recommended · restricted
vs patiromer sorbitex calcium
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended the listing of sodium zirconium cyclosilicate (SZC) on the basis that it is available as a General Schedule Authority Required (telephone/online) for the treatment of chronic hyperkalaemia in patients with chronic kidney disease 24PSD · Mar 2024
7.2 The PBAC acknowledged the consumer comments relating to SZC which described the benefits of treatment and the need for alternate therapies in this setting.PSD · Mar 2024
6.45 The submission presented a cost-minimisation of SZC versus patiromer for the treatment of chronic hyperkalaemia in patients with chronic kidney disease Stage 3-4.PSD · Mar 2024
6.46 Table 7 summarises the key components of the cost- minimisation approach. 17PSD · Mar 2024
6.40 The submission described SZC as equivalent in terms of effectiveness compared with patiromer and similar in terms of safety compared to patiromer, in the treatment of chronic hyperkalaemia.PSD · Mar 2024
6.41 The ESC considered that SZC was non-inferior to patiromer in terms of lowering serum potassium levels to within normal limits. The ESC considered that SZC was likely to be non-inferior in terms of enabling patients to remain on RAASi therapy, if achieving maintaining normokalaemia were accepted as appropriate surrogate outcomes for the maintenance of RAASi treatment. The ESC noted the following limitations with the clinical evidence:PSD · Mar 2024
6.2 The PBAC noted and welcomed the input from an individual, health care professionals (2), a medical organisation and a consumer group via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with SZC, including allowing individuals to (i) continue beneficial therapies such as RAASis (which slow the progression of CKD and heart failure), (ii) maintain a healthy diet while undergoing treatment, and …PSD · Mar 2024
6.3 Kidney Health Australia noted that CKD is most prevalent in the most disadvantaged Australians, and that individualised dietary intervention via a specialised renal dietitian is not available/possible for many individuals. As such, they note that SZC provides an additional treatment option that is readily accessible to all patients.PSD · Mar 2024
Cost-effectiveness
Cost-minimisation analysis used; no ICER calculated by design.
The submission presented a cost-minimisation of SZC versus patiromer for the treatment of chronic hyperkalaemia in patients with chronic kidney disease Stage 3-4. PSD · 2024
Decision context
PopulationAdults with CKD stage 3-4 with chronic hyperkalaemia (≥2 episodes of serum potassium ≥6.0 mmol/L in the previous 12 months), receiving ≥1 RAASi medicine or indicated for RAASi but unable to tolerate due to prior hyperkalaemia, with disease inadequately controlled by low potassium diet.
Risk sharingSpecial pricing arrangements apply, consistent with patiromer listing.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended · restricted | patiromer sorbitex calcium | — | RCT · Serum potassium lowering / maintenance |
Consumer voice
Consumer input described multiple benefits of sodium zirconium cyclosilicate (SZC) treatment, including enabling continuation of beneficial therapies, maintaining healthy diet, and delaying dialysis initiation. Kidney Health Australia emphasized SZC as an accessible treatment option for disadvantaged populations, while the nephrology society confirmed its clinical utility and monitoring requiremen
SZC provides an additional treatment option that is readily accessible to all patients. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to chronic hyperkalaemia in CKD stage 3-4 patients on/indicated for RAASi; TGA label covers all adult hyperkalaemia.