NICE Expands NHS Funding for AstraZeneca's Lokelma to Include Outpatient Care
核心洞察
NICE has recommended extended NHS funding for AstraZeneca's Lokelma (sodium zirconium cyclosilicate) to include outpatient care for patients with persistent hyperkalaemia (搜索) and chronic kidney disease (搜索) or heart failure (搜索).
The expanded guidance allows adults with persistently high potassium levels to receive repeat prescriptions in the community, removing the previous restriction to hospital settings.
Lokelma is indicated for non-dialysed patients with chronic kidney disease (搜索) stage 3b-5 or heart failure (搜索) who have persistent hyperkalaemia (搜索) preventing optimal RAAS (搜索) inhibitor therapy.
The UK's National Institute for Health and Care Excellence (NICE) has expanded NHS funding recommendations for AstraZeneca's hyperkalaemia (搜索) treatment Lokelma (sodium zirconium cyclosilicate), extending coverage from emergency care settings to include outpatient care for patients with persistent high potassium levels.
The final draft guidance, applying to England, Wales, and Northern Ireland, represents a significant expansion from NICE's previous April recommendation that limited funding to emergency care settings only. The updated guidance now allows adults with persistently elevated potassium levels in the blood to receive repeat prescriptions for Lokelma in community settings, eliminating the previous restriction to hospital visits.
Treatment Criteria and Patient Population
Under the new guidance, NICE recommends funding Lokelma in emergency care for acute life-threatening hyperkalaemia (搜索) alongside standard care. For outpatient care, the drug is recommended for people with persistent hyperkalaemia and chronic kidney disease (搜索) stage 3b to 5, as well as heart failure (搜索) patients.
To qualify for Lokelma treatment, patients must have confirmed high potassium levels and must not be taking an optimized dosage of renin-angiotensin-aldosterone system (搜索) (RAAS (搜索)) inhibitor because of hyperkalaemia (搜索). Additionally, patients must not be on dialysis. NICE specifically recommends the drug for non-dialysed patients with chronic kidney disease (搜索) or heart failure (搜索) who have persistent hyperkalaemia with a potassium level of 6.0 mmol/litre or more that prevents them from receiving recommended RAAS drug treatment.
Clinical Significance and Unmet Need
Hyperkalaemia (搜索), the medical condition of elevated potassium levels in the blood, poses significant risks to patients, potentially leading to cardiac arrest and death in severe cases. Patients with chronic kidney disease (搜索) and heart failure (搜索) face an increased risk of developing hyperkalaemia compared to the general population, particularly those taking cardio-renal medications including RAAS (搜索) inhibitors, angiotensin-converting enzyme inhibitors, and angiotensin receptor blockers.
Dr. Andrew Frankel, consultant nephrologist at Imperial College Healthcare NHS Trust, emphasized the importance of the update, stating it will allow doctors to "adapt and match the 21st century way patients are managed across the care pathway." He noted that many patients are currently managed in primary care, with secondary care providing advice and sometimes not seeing patients for extended periods.
"This change will allow people who are living with heart failure (搜索) and chronic kidney disease (搜索) to more readily access treatments that can help manage persistent hyperkalaemia (搜索)," according to Frankel.
Drug Mechanism and Administration
Lokelma is an insoluble, non-absorbed sodium zirconium silicate formulated as a powder for oral suspension that acts as a highly-selective potassium-removing agent. The drug is administered orally, is odourless, tasteless, and stable at room temperature. It is designed to capture potassium throughout the gastrointestinal tract, resulting in the body drawing potassium from the blood into the GI tract and increasing the amount of potassium excreted in the faeces.
Market Position and Commercial Performance
AstraZeneca acquired Lokelma through its $2.7 billion acquisition of US company ZS Pharma (搜索) in 2016. The drug received FDA approval in 2018 after being rejected twice due to manufacturing issues and was approved in Europe the same year. While AstraZeneca has predicted blockbuster sales potential, Lokelma has proven to be a relatively slow grower, with sales of $122 million in the third quarter of 2021, though this represented an increase of more than 150% over the same period in 2020.
The drug competes in the market with Vifor (搜索)'s Veltassa (patiromer), which received NICE clearance for NHS use in hospital settings in 2019. Both Veltassa and Lokelma work by binding phosphate in the gut and preventing its absorption.
AstraZeneca anticipates potential sales growth for Lokelma if it receives approval in new indications, such as reducing serious adverse cardiovascular events in dialysis patients with recurrent hyperkalaemia (搜索). The FDA recently granted fast-track status to Lokelma for this indication.