SMC EXPANDS GUIDANCE FOR LOKELMA® (sodium zirconium cyclosilicate) TO THE EMERGENCY CARE SETTING FOR ADULT PATIENTS WITH HYPERKALAEMIA IN SCOTLAND

• People admitted to an emergency care setting in Scotland with acute, life-threatening hyperkalaemia will now be able to access sodium zirconium cyclosilicate (SZC) as a treatment option to be used alongside standard care¹
• SZC becomes first and only pharmacological therapy recommended by the Scottish Medicines Consortium (SMC) in this setting for adults with acute, life-threatening hyperkalaemia, or in outpatient settings when treating patients with heart failure (HF) or chronic kidney disease (CKD) with serum potassium >6.0mmol/L. ¹
• Approximately 2,060 people in Scotland would be eligible for treatment under this updated advice from the SMC.²

London, UK, Monday 7 November 2022 – AstraZeneca UK today announced that the Scottish Medicines Consortium (SMC) has updated its advice for Lokelma (sodium zirconium cyclosilicate [SZC]) for adult patients with hyperkalaemia in Scotland. The advice to the SMC now means patients can access SZC in the emergency care setting for the treatment of acute, life-threatening hyperkalaemia alongside standard of care.¹

SZC is accepted for restricted use within NHS Scotland in:

• Outpatient care for people with hyperkalaemia in adult patients (defined as a serum potassium of >6.0mmol/L) with chronic kidney disease (CKD) stage 3b to 5 and/or heart failure, who would otherwise need to down-titrate or discontinue their renin-angiotensin-aldosterone system inhibitor (RAASi) therapy to maintain a clinically acceptable serum potassium level (normokalaemia) and
• The emergency care setting for the treatment of acute, life-threatening hyperkalaemia alongside standard care.¹

Dr Iain Macintyre, Consultant Nephrologist and Clinical Pharmacologist New Royal Infirmary of Edinburgh NHS Lothian, said: “For adult patients in Scotland who develop high potassium levels, today’s announcement will be an extremely welcome milestone. Risk of developing hyperkalaemia is increased for patients taking life-saving cardio-renal medications and the decision today from the Scottish Medicines Consortium means that patients with this condition will now have access to an important treatment option in the emergency care setting when the condition is potentially life-threatening.”

Hyperkalaemia is a medical condition of elevated potassium levels in the blood. In severe cases, it may lead to cardiac arrest and death.^3,4 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]).^4,5

This updated SMC advice addresses an acute need in the emergency care setting in Scotland for access to a potassium-binding treatment such as SZC, that removes potassium from the blood.^1,6 In July 2019, the National Institute for Health and Care Excellence (NICE) for England, Wales, and Northern Ireland issued a positive recommendation for SZC in the emergency care setting and therefore, this updated SMC advice also addresses any potential equality of care issues in enabling access for Scottish patients as well.⁷

Tom Keith-Roach, President, AstraZeneca UK, said: “We are delighted by this important decision for adult patients living with hyperkalaemia in Scotland which marks a step-change

in the treatment journey. Hyperkalaemia in emergency care is an area of acute need in Scotland, and it is great news that patients can now access SZC, a treatment option to correct potentially life-threatening high potassium in the blood. Hyperkalaemia is a serious condition, which in severe cases can lead to cardiac arrest and death. We remain dedicated to continuing our collaboration with the NHS to deliver innovative and accessible treatment options for patients.”

In clinical trials, SZC reduced serum potassium and maintained normal serum potassium levels regardless of the underlying cause of hyperkalaemia, age, sex, race, comorbid disease or concomitant use of RAASi therapy. No dietary restrictions were imposed; patients were instructed to continue their usual diet without any specified alterations.²

The most commonly reported adverse reactions associated with SZC were hypokalaemia (4.1%) and oedema related events (5.7%).²

For complete information on SZC, the summary of product characteristics, including a full list of side effects and adverse reactions is available here: https://www.medicines.org.uk/emc/product/10074/smpc; for Northern Ireland please visit: https://www.emcmedicines.com/en-gb/northernireland/medicine?id=20479e64-b5ef-4c5e- 9c90-5a007491cf28&type=smpc.