1 Recommendations

1.1

Sodium zirconium cyclosilicate can be used as an option for treating hyperkalaemia in adults only if used:

in emergency care for acute life-threatening hyperkalaemia alongside standard care or
for persistent hyperkalaemia in people with chronic kidney disease stage 3b to 5 or heart failure, if they:
- have confirmed serum potassium level of at least 5.5 mmol per litre and
- because of hyperkalaemia, are not taking an optimised dosage of renin-angiotensin aldosterone system (RAAS) inhibitor and
- are not on dialysis.

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 must be funded in the NHS in England for the condition and the population in the recommendations, if it is considered the most suitable treatment option. Sodium zirconium cyclosilicate must be funded in England within 90 days of final publication of this guidance.

There is enough evidence to show that sodium zirconium cyclosilicate provides benefits and value for money, so it can be used routinely across the NHS in this population.

Why the committee made these recommendations

This evaluation is a partial review of NICE technology appraisal guidance on sodium zirconium cyclosilicate for treating hyperkalaemia (TA599). This partial review assesses evidence on sodium zirconium cyclosilicate for persistent hyperkalaemia with serum potassium levels of 5.5 mmol per litre to 6.0 mmol per litre. The committee papers and committee discussion for TA599 have full details of the evidence for serum potassium levels of 6.0 mmol per litre and over.

Usual treatment for persistent hyperkalaemia with a serum potassium level between 5.5 mmol per litre and up to 6.0 mmol per litre is:

dietary changes to maintain normal potassium levels, and
reducing the dosage of medicines being taken for chronic kidney disease or heart failure, such as RAAS inhibitors.

Clinical trial evidence suggests that people having sodium zirconium cyclosilicate are less likely to have to reduce their RAAS inhibitor dosage than people making dietary changes alone. The evidence also suggests that sodium zirconium cyclosilicate may lower the chance of adverse outcomes such as hospitalisation, major adverse cardiac events and death.

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

sodium zirconium cyclosilicate affects RAAS inhibitor dosage beyond its effect on lowering sodium levels
serum potassium levels are linked to adverse outcomes directly and indirectly, because of the likelihood that RAAS inhibitor dose will be reduced when serum potassium levels are high.

But the most likely cost-effectiveness estimate is within the range that NICE considers an acceptable use of NHS resources. So, sodium zirconium cyclosilicate can be used.