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1 Recommendations

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1 Recommendations

1.1

Sodium zirconium cyclosilicate should not be used to treat hyperkalaemia in adults when:

  • it is persistent and

  • serum potassium levels are between 5.5 mmol/litre and 5.9 mmol/litre.

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 healthcare professional consider it appropriate to stop.

What this means in practice

Sodium zirconium cyclosilicate is not required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because there is not enough evidence to determine whether sodium zirconium cyclosilicate is value for money in this population.

Why the committee made these recommendations

For people with persistent hyperkalaemia and chronic kidney disease or heart failure, NICE technology appraisal guidance 599 recommends sodium zirconium cyclosilicate (a potassium binder), if they have a serum potassium level of at least 6.0 mmol/litre. This evaluation reviews the evidence for sodium zirconium cyclosilicate for persistent hyperkalaemia when serum potassium levels are between 5.5 mmol/litre and 5.9 mmol/litre. For this population, the company has provided new evidence since the last evaluation.

Standard care for persistent hyperkalaemia with a serum potassium level between 5.5 mmol/litre and 5.9 mmol/litre is:

  • dietary changes to maintain normal potassium levels and

  • changes to current medicines such as renin–angiotensin–aldosterone system (RAAS) inhibitors, which are commonly used to treat chronic kidney disease and heart failure.

Evidence suggests that people who have sodium zirconium cyclosilicate are less likely to have to reduce their RAAS inhibitor dosage than people on standard care. But it is unclear whether this is because sodium zirconium cyclosilicate lowers potassium levels or whether it has an additional impact independent of this.

There are uncertainties in the economic model. This is because of some of the assumptions it uses, including how:

  • sodium zirconium cyclosilicate affects RAAS inhibitor treatment

  • serum potassium levels are linked to adverse outcomes.

Because of the uncertainties in the clinical evidence and economic modelling, it is not possible to determine the most likely cost-effectiveness estimates for sodium zirconium cyclosilicate.

So, sodium zirconium cyclosilicate should not be used to treat persistent hyperkalaemia in adults with a potassium level between 5.5 mmol/litre and 5.9 mmol/litre.