NICE extends recommendation for Lokelma ▼ in Hyperkalaemia

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AstraZeneca has announced that the National Institute for Health and Care Excellence (NICE) has extended its recommendation for Lokelma ▼ in Hyperkalaemia in its positive Final Appraisal Document (FAD).

The NICE recommendation for Lokelma (sodium zirconium cyclosilicate [SZC]) is as an option for treating hyperkalaemia in adults only if 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.

The NICE recommended to stop SZC in outpatient care if RAAS inhibitors are no longer suitable.

SZC is indicated for the treatment of hyperkalaemia in adult patients. The FAD is for a broader patient population than that initially proposed by NICE within the Appraisal Consultation Document 2 issued in April 2019, extending the availability of SZC to include patients in an outpatient setting as well as patients in an emergency care setting.

Hyperkalaemia is the medical condition of elevated potassium levels in the blood. In severe cases, it may lead to cardiac arrest and death. There is an increased risk of developing hyperkalaemia in patients with chronic kidney disease and heart failure compared to the general population and in particular some patients who take cardio-renal medications, such as renin-angiotensin-aldosterone system inhibitors (RAASi) therapy (e.g. angiotensin-converting-enzyme inhibitors [ACEi] and angiotensin receptor blockers [ARBs]).

Professor David Wheeler, Honorary Consultant Nephrologist and Professor of Kidney Medicine at the Royal Free London NHS Foundation Trust, said: “SZC provides a new treatment option for patients who develop high potassium levels. It may allow long-term treatment for patients who develop recurrent high potassium levels, such as those with chronic kidney disease.”

Lokelma▼ was licensed in the EU for adults with hyperkalaemia in March 2018.