The National Institute for Health and Care Excellence (NICE) has issued draft final guidance recommending AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) for a broader group of patients with persistent hyperkalaemia, marking a significant expansion in treatment eligibility across England and Wales.

The recommendation lowers the serum potassium threshold for treatment to ≥5.5 mmol/L, compared with the previous ≥6.0 mmol/L limit set in NICE guidance from 2019. The change more than doubles the number of patients eligible for treatment and allows earlier intervention in chronic kidney disease (CKD) and heart failure populations.

Hyperkalaemia, defined as elevated potassium levels in the blood, is associated with increased risk of hospitalisation, cardiovascular events and mortality. Patients with CKD or heart failure are particularly vulnerable due to impaired kidney function and disease-related changes in potassium regulation.

A key clinical challenge in managing these patients is the use of renin-angiotensin-aldosterone system (RAAS) inhibitors, which provide important cardiorenal protective benefits but can also increase potassium levels. Elevated potassium can lead to dose reduction or discontinuation of these therapies, potentially worsening long-term outcomes.

Professor Jim Burton, professor of renal medicine and honorary consultant nephrologist at University Hospitals of Leicester, said the updated threshold supports earlier intervention in clinical practice.

“Reducing the potassium threshold to 5.5 mmol/L enables us to proactively manage hyperkalaemia at an earlier stage thereby keeping patients on the most effective, guideline-recommended treatments to protect their heart and kidneys,” Burton said.

He added that earlier management could help reduce cardiovascular risk and delay progression to dialysis in some patients.

The updated recommendation also increases flexibility in care delivery, allowing initiation of treatment outside specialist settings. NICE’s decision follows a reassessment of real-world evidence and cost-effectiveness data in patients with potassium levels between 5.5 and 6.0 mmol/L.

According to AstraZeneca, this evidence shows an association between earlier potassium control and improved ability to maintain RAAS inhibitor therapy, which is linked to better cardiorenal outcomes.

Tom Keith-Roach, president of AstraZeneca UK, said the decision represents an important step in widening patient access.

“This updated NICE guidance is an important step for patients with chronic kidney disease and heart failure who are at risk of hyperkalaemia, enabling earlier intervention in the community and in a broader population of patients,” Keith-Roach said.

He added that the decision reflects one of the first applications of NICE’s updated willingness-to-pay threshold and expands eligibility for Lokelma treatment in routine care.

If adopted in final guidance, the recommendation is expected to significantly increase uptake of Lokelma in primary and secondary care settings across the UK.