NICE update doubles eligible patients for AZ's Lokelma

AstraZeneca's Lokelma therapy for high potassium levels in the blood (hyperkalaemia) should see much wider usage by the NHS after becoming one of the first medicines to be assessed under NICE's raised cost-effectiveness threshold.

After a review of real-world evidence for Lokelma (sodium zirconium cyclosilicate), the reimbursement authority has published new draft guidance that more than doubles the number of patients in England and Wales who can access treatment with the drug, used to treat adults with persistent hyperkalaemia caused by chronic kidney disease or heart failure.

The drug can now be used in patients with a confirmed serum potassium of at least 5.5 mmol/L, down from an earlier level of 6.0mmol/L or more, and the new guidance also removes a restriction that meant treatment with Lokelma could only be initiated by a specialist.

Hyperkalaemia is generally associated with the use of renin-angiotensin-aldosterone system (RAAS) inhibitor therapies that are used to treat CKD and heart failure, and raises the risk of serious complications, including hospitalisation, major cardiovascular events, and death.

"Because hyperkalaemia at a level of 6.0 mmol/L represents such an immediate health concern for so many healthcare practitioners and prescribers, it is highly likely that patients will have had their foundation treatments for heart failure and kidney disease stopped or reduced in dose before reaching that point," commented Prof Jim Burton, a consultant nephrologist for University Hospitals of Leicester.

"Reducing the potassium threshold to 5.5 mmol/L enables us to proactively manage hyperkalaemia at an earlier stage, thereby keeping patients on the most effective, guideline-recommended treatments to protect their heart and kidneys."

At the start of this month, NICE's earlier cost-effectiveness threshold of £20,000 to £30,000 per quality adjusted life year (QALY) was raised to £25,000 to £35,000, a move that has been welcomed by industry as recognising that the decades-old level had become misaligned with the value of modern medicines.

Lokelma is a fast-growing mid-tier product for AZ, with sales rising 28% to $698 million last year, a pace that outstripped its main rival, CSL's Veltassa (patiromer sorbitex calcium). The company has predicted that Lokelma could eventually cross the $1 billion blockbuster threshold.

Tom Keith-Roach, president of AstraZeneca UK, said the RWE data shows a clear relationship between potassium levels and clinical outcomes and demonstrates lower rates of reducing or discontinuing RAAS inhibitors in patients treated with Lokelma.

He added that the new guidance will help "ensure effective, evidence-based medicines reach more people who need them."