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Sodium zirconium cyclosilicate for treating hyperkalaemia

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1 Recommendations

1.1 Sodium zirconium cyclosilicate is recommended as an option for treating hyperkalaemia in adults only if:

  • it needs treating in an emergency care setting

  • the drug is stopped after 28 days of maintenance treatment, or earlier if the hyperkalaemia resolves.

1.2 This recommendation is not intended to affect treatment with sodium zirconium cyclosilicate that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Sodium zirconium cyclosilicate is a treatment option for people with high blood serum potassium levels (hyperkalaemia). The company proposes that it would benefit people with heart failure or stages 3 to 5 chronic kidney disease who have high levels of serum potassium. The company also proposes that people may have treatment with sodium zirconium cyclosilicate either in an emergency care or outpatient setting.

There are clinical trials showing that sodium zirconium cyclosilicate is effective in lowering serum potassium levels and can resolve hyperkalaemia in the outpatient setting. However, the trials mostly include people with serum potassium levels that would not be treated in the NHS. There is no clinical evidence to show that sodium zirconium cyclosilicate extends life or improves quality of life compared with standard care in people having treatment in the NHS outpatient setting.

Because of the limitations in the clinical evidence, the cost-effectiveness estimates for sodium zirconium cyclosilicate in the outpatient setting are highly uncertain and likely to be above what NICE normally considers a cost-effective use of NHS resources. Therefore, sodium zirconium cyclosilicate is not recommended in the outpatient setting for people with hyperkalaemia.

Treating acute life-threatening hyperkalaemia in the emergency care setting is established clinical practice. The company has not presented clinical evidence for hyperkalaemia treated in the emergency care setting. However, evidence from people with high potassium levels having treatment in the outpatient setting is sufficient to show that sodium zirconium cyclosilicate could be a useful intervention in the emergency care setting. Other potassium-lowering treatments are rarely used in this setting because they are poorly tolerated.

The cost-effectiveness estimates for sodium zirconium cyclosilicate in the emergency care setting show that it is a good use of NHS resources. Therefore, sodium zirconium cyclosilicate is recommended as an option for people with hyperkalaemia that needs treating in the emergency care setting.