NICE EXPANDS GUIDANCE FOR LOKELMA®▼(sodium zirconium cyclosilicate) IN ADULT PATIENTS WITH PERSISTENT HYPERKALAEMIA

NICE EXPANDS GUIDANCE FOR LOKELMA^®▼(sodium zirconium cyclosilicate) IN ADULT PATIENTS WITH PERSISTENT HYPERKALAEMIA

• People living with persistent hyperkalaemia in England, Wales and Northern Ireland will now be able to access repeat prescriptions of sodium zirconium cyclosilicate (SZC) in the community.[1]
• This guidance update will enable continuity of care outside of hospital, ensuring they can continue to receive crucial treatments and reducing unnecessary hospital visits.¹

Luton, UK, Monday 24 January 2022 – AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) have updated Technology Appraisal Guidance (TAG) TA599 for Lokelma (sodium zirconium cyclosilicate [SZC]) in the treatment of adult patients with hyperkalaemia in England, Wales, and Northern Ireland. This guidance update follows the removal of the previous commercial arrangement, meaning that access to SZC for the treatment of persistent hyperkalaemia is no longer restricted to hospital use only, allowing continuity of care for patients through management in a primary care setting.¹

Within the guidance, NICE recommend SZC as an option for treating hyperkalaemia in adults if used: 

• for people with persistent hyperkalaemia and chronic kidney disease (CKD) stage 3b to 5 or heart failure (HF), if they:
• have a confirmed serum potassium level of at least 6.0 mmol/litre and
• because of hyperkalaemia, are not taking an optimised dosage of renin-angiotensin-aldosterone system inhibitor (RAASi), and
• are not on dialysis.¹

Dr Andrew Frankel, Consultant Renal Nephrologist, Imperial College Healthcare NHS Trust: “This update will help healthcare professionals be able to adapt and match the 21st century way patients are managed across the care pathway. Many patients are managed in primary care, with secondary care giving advice and, in some cases, not seeing them for long periods of time. This change will allow people who are living with heart failure and chronic kidney disease, to more readily access treatments that can help manage persistent hyperkalaemia."

Patients have previously only been able to access SZC through prescription by a specialist in secondary care, despite an ongoing need for management after leaving hospital due to the presence of associated comorbidities.[2] This NICE guidance update represents an important change in the treatment journey for people living with persistent hyperkalaemia, allowing them to access repeat prescriptions from their primary care professional following specialist initiation.¹ Crucially, this will also help reduce the need for repeat hospital visits and alleviate the secondary care service burden at a time when it is needed most. COVID-19 has demonstrated a need for the effective management of patients outside of the hospital setting where possible and continuing to expand the role of primary care will be vital in reducing unnecessary pressure on the health service in the wake of the pandemic.[3]

Professor Zaheer Yousef, Consultant Cardiologist, University hospital of Wales & Cardiff University: “Hyperkalaemia can develop not only from living with heart failure and chronic kidney disease, but from the medicines that help treat those conditions. For a long time, HCPs have been in the difficult position of having to choose between managing potassium levels and optimising key therapies that can improve outcomes for these patients. This guidance update is therefore welcome news and will hugely benefit people who have hyperkalaemia, as it will reduce the need for them to come into hospital for repeat prescriptions and gives clinicians the facility to further optimise their care. This change will also allow us to develop more robust pathways between secondary and primary care, ensuring continuity of care outside of hospital, particularly at a time when reducing health service burden has never been more critical.”

Hyperkalaemia is a medical condition of elevated potassium levels in the blood. In severe cases, it may lead to cardiac arrest and death.[4] There is an increased risk of developing hyperkalaemia in people with CKD and HF and in those who take life-saving cardio-renal medications, such as RAASi therapy (e.g. angiotensin-converting-enzyme inhibitors [ACEi] and angiotensin receptor blockers [ARBs]), compared to the general population.[5] The presence of persistent hyperkalaemia in the community is often regarded as chronic, usually in the context of drugs that exacerbate the condition and is associated with long-term health service burden given frequent hospitalisation due to recurrent episodes.⁴

Tom Keith-Roach, President, AstraZeneca UK: “This guidance update is an important step-change in the treatment journey for people with persistent hyperkalaemia. This opens up care in the community and essential medicines can now be optimised to improve patient outcomes in heart failure and chronic kidney disease for the long term. This is a great example of how we are committed to work with NICE and the NHS to deliver scalable solutions that can make a difference for patients and our health system at the population level”. 

SZC is indicated for the treatment of hyperkalaemia in adult patients.[6] In September 2019, NICE gave a positive recommendation for the use of SZC in England, Wales and Northern Ireland: SZC was recommended as an option for treating hyperkalaemia in adults only if used:

• in emergency care for acute life-threatening hyperkalaemia alongside standard of care or
• in outpatient care for people with persistent hyperkalaemia and chronic kidney disease (CKD) stage 3b to 5 or heart failure (HF), if they:
• have a confirmed serum potassium level of at least 6.0 mmol/litre and
• because of hyperkalaemia, are not taking an optimised dosage of renin-angiotensin-aldosterone system inhibitor (RAASi), and
• are not on dialysis.[7]

Following this most recent guidance update, use of SZC for acute life-threatening hyperkalaemia should continue to be managed in the emergency setting.¹

The most commonly reported adverse reactions associated with SZC were hypokalaemia (4.1%) and oedema related events (5.7%).⁶ The full summary of product characteristics for SZC can be accessed at: https://www.medicines.org.uk/emc/product/10059/smpc. For Northern Ireland please visit: https://www.emcmedicines.com/en-gb/northernireland/medicine?id=6bb4b84e-d5d3-4fd8-847c-fedb290bf1cf&type=smpc.  

– ENDS –

CONTACTS

UK Media Enquiries

Tatiana Allan, AstraZeneca: 07385 037254/ tatiana.allan@astrazeneca.com

Alex Larkinson, Edelman: 07980 687255 / alex.larkinson@edelman.com

NOTES TO EDITORS

About Lokelma (sodium zirconium cyclosilicate [SZC])
SZC is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, that acts as a highly selective potassium-removing agent.[8] It is administered orally, is odourless, tasteless, and stable at room temperature.

SZC was specifically designed to preferentially capture potassium ions throughout the entire gastrointestinal (GI) tract, reducing the concentration of free potassium in the GI lumen, thereby lowering serum potassium levels, and increasing faecal potassium excretion to resolve hyperkalaemia.⁶

The summary of product characteristics for SZC 5g is available here: https://www.medicines.org.uk/emc/product/10059/smpc. 

About Hyperkalaemia

Hyperkalaemia is a serious condition characterised by elevated potassium levels in the blood, associated with cardiovascular, renal and metabolic diseases.⁴ The risk of hyperkalaemia increases significantly for people living with chronic kidney disease (CKD) and heart failure (HF), especially advanced disease or when people are prescribed life-saving cardiorenal medications to treat CKD or HF that can interfere with renal potassium excretion. The prevalence of hyperkalaemia is considerably higher in patients with CKD than in the general population. Those living with advanced CKD and diabetes or taking renin-angiotensin-aldosterone system inhibitor (RAASi) are amongst the highest at risk.⁴ Persistent hyperkalaemia caused by RAASi therapies can therefore prevent the optimal use of these standard therapies for the treatment of CKD or HF.¹

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

AstraZeneca is based in five different locations across the UK, with its global headquarters in Cambridge. In the UK, around 8,300 employees work in research and development, manufacturing, supply, sales and marketing. We supply 40 different medicines to the NHS.

For more information, please visit www.astrazeneca.co.uk and follow us on Twitter @AstraZenecaUK.

References

[1] National Institute for Health and Care Excellence [NICE] Guidance [2022] Sodium zirconium cyclosilicate for treating hyperkalaemia. Technology Appraisal Guidance [TA599] Available from: https://www.nice.org.uk/guidance/ta599. Last accessed Jan 2022.

[2] Sidhu K, et al. Hyperkalemia in heart failure. Current Opinion in Cardiology. 2020;35:150-5.

[3] OECD Policy Responses to Coronavirus (COVID-19). Strengthening the frontline: How primary health care helps health systems adapt during the COVID 19 pandemic. Available at: https://read.oecd-ilibrary.org/view/?ref=1060_1060243-snyxeld1ii&title=Strengthening-the-frontline-How-primary-health-care-helps-health-systems-adapt-during-the-COVID-19-pandemic Last accessed January 2022.

[4] National Kidney Foundation. Clinical update on hyperkalemia. 2014. Available at: https://www.kidney.org/sites/default/files/02-10-6785_HBE_Hyperkalemia_Bulletin.pdf Last accessed January 2022.

[5] Kovesdy CP. Management of hyperkalaemia: an update for the internist. Am J Med. 2015;128:1281-87.

[6] Lokelma 5g powder for oral suspension Summary of Product Characteristics. Updated 28 April 2021. Available at https://www.medicines.org.uk/emc/product/10059/smpc Last accessed January 2022.

[7] National Institute for Health and Care Excellence. NICE Guidance [2019] Sodium zirconium cyclosilicate for treating hyperkalaemia. Technology Appraisal Guidance [TA599]

[8] Ash SR, Singh B, Lavin PT, Stavros F, Rasmussen HS. A phase 2 study on the treatment of hyperkalemia in patients with chronic kidney disease suggests that the selective potassium trap, ZS-9, is safe and efficient. Kidney Int. 2015;88:404-11.