NICE expands guidance for AstraZeneca’s hyperkalaemia drug

The National Institute for Health and Care Excellence (NICE) has updated Technology Appraisal Guidance (TAG) TA599 for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate [SZC]) in the treatment of adult patients with hyperkalaemia in England, Wales, and Northern Ireland.  

Context  

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 

The guidance 

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/litreand 
  • because of hyperkalaemia, are not taking an optimiseddosage of renin-angiotensin-aldosterone system inhibitor (RAASi), and 
  • are not on dialysis.1

Official comments 

Dr Andrew Frankel, Consultant Renal Nephrologist at Imperial College Healthcare NHS Trust, said: “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.” 

Professor Zaheer Yousef, Consultant Cardiologist at University hospital of Wales & Cardiff University, said: “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.” 

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”.   

Background 

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 

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 

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  

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