NICE expands funding for AstraZeneca's high potassium drug

NICE has recommended extended funding on the NHS for AstraZeneca’s high potassium drug Lokelma in final draft guidance.

In a decision applying to England and Wales the cost-effectiveness body said that the drug could also be funded in outpatient care.

A previous draft published in April had only recommended funding in emergency care settings.

Lokelma (sodium zirconium cyclosilicate) is used to treat hyperkalaemia in patients with chronic kidney disease or heart failure.

In this final guidance NICE recommended funding in emergency care for acute life-threatening hyperkalaemia alongside standard care.

It also recommended funding in outpatient care for people with persistent hyperkalaemia and chronic disease stage 3b to 5, and heart failure.

To receive Lokelma patients must have confirmed high potassium levels, must not be taking an optimised dosage of renin-angiotensin-aldosterone system (RAAS) inhibitor because of hyperkalaemia, and must not be on dialysis.

NICE also recommended to stop Lokelma in outpatient care if RAAS inhibitors are no longer suitable.

Hyperkalaemia is the medical condition of elevated potassium levels in the blood. In severe cases, it may lead to cardiac arrest and death.

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.

These medications include RAAS inhibitors, angiotension-converting enzyme inhibitors and angiotensin receptor blockers.

As a result there is a need for new treatment strategies for hyperkalaemia – at the moment doctors often reduce the dose or stop RAAS therapy to manage it, even if this means removing drugs with proven cardiovascular mortality benefits.

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.

It is administered orally, is odourless, tasteless and stable at room temperature and is designed to capture potassium throughout the gastrointestinal tract.

This results in the body drawing potassium from the blood into the GI tract, and increasing the amount of potassium excreted in the faeces.

AZ added Lokelma to its pipeline after buying ZS Pharma, the US company that developed it, for $2.7 billion in 2016.

It was approved by the FDA in 2018 after being rejected twice because of manufacturing issues, but is predicted to become a blockbuster.