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New HTA Decisions in England
November 2019
Drug name
LOKELMA® (sodium zirconium cyclosilicate)
Company
AstraZeneca
Decision date
26/07/2019
Therapeutic area
Blood and immune system conditions
Therapeutic sub area
Blood conditions
Decision
Recommended with restrictions
Indication
Sodium zirconium cyclosilicate is recommended as an option for treating hyperkalaemia in adults
Decision Detail
Only to be used in emergency care for acute life-threatening hyperkalaemia alongside standard care or in outpatient care for people with persistent hyperkalaemia and chronic kidney disease stage 3b to 5 or heart failure, if they: ● have a confirmed serum potassium level of at least 6.0 mmol/litre ● are not taking an optimised dosage of renin-angiotensin-aldosterone system (RAAS) inhibitor because of hyperkalaemia and ● are not on dialysis. Sodium zirconium cyclosilicate is recommended only if the company provides it according to the commercial arrangement. In outpatient care, stop sodium zirconium cyclosilicate if RAAS inhibitors are no longer suitable.
Summary
The clinical effectiveness evidence for sodium zirconium cyclosilicate came from the ZS004 and ZS005 trials, performed in outpatient care. They included people who had lower serum potassium levels than would be treated in the NHS. Clinical trials show that sodium zirconium cyclosilicate lowers serum potassium when used in outpatient care. But there is no clinical evidence that it extends life or improves quality of life. Sodium zirconium cyclosilicate may allow people to stay on RAAS inhibitors (drugs used to treat heart failure and kidney disease) for longer. Staying on these drugs may extend life and improve quality of life. The committee agreed that people with life-threatening hyperkalaemia would value the option of another treatment to lower serum potassium levels that was better tolerated than calcium resonium. It therefore concluded that it could recommend sodium zirconium cyclosilicate alongside standard care as an option for people needing treatment for acute hyperkalaemia in emergency care. The committee then considered the cost-effectiveness results in outpatient care. The committee noted that the company's base case included an association between serum potassium levels and mortality, which the committee did not accept. However, in the scenario removing this association, the ICERs were also below £20,000 per QALY gained. Therefore, the committee concluded that sodium zirconium cyclosilicate was a cost-effective use of NHS resources for treating chronic hyperkalaemia in outpatient care. The committee noted that, in this scenario, most of the benefits arise because more people are able to have RAAS inhibitors with sodium zirconium cyclosilicate. However, it recalled that some people do not benefit from RAAS inhibitors, and so concluded that it would not be appropriate for these people to start sodium zirconium cyclosilicate. It further concluded that some people may have to stop RAAS inhibitors for reasons other than hyperkalaemia. The committee concluded that, in these situations, people should also stop having sodium zirconium cyclosilicate. It emphasised that uncertainties remained around the clinical benefit of sodium zirconium cyclosilicate and that these could be addressed by clinical trials.