Preliminary guidelines released by the National Institute for Health and Care Excellence do not recommend NHS funding for hyperkalaemia treatments Lokelma and Veltassa.
Hyperkalaemia is characterised by elevated potassium levels in the blood. Risk of developing the condition increases significantly for patients with chronic kidney disease and for those who take life-saving medications for heart failure, such as renin-angiotensin-aldosterone system (RAAS) inhibitors, which can increase potassium in the blood.
There is a need for new treatment approaches for hyperkalaemia, as currently RAASi therapy is either reduced or discontinued in patients with high levels of potassium, but effective management of elevated levels could allow patients with CKD and heart failure to carry on taking RAASi therapy.
Both AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) and Vifor Pharma’s Veltassa (patiromer) were turned down on grounds that clinical evidence showing their ability to lower serum potassium is “not considered relevant” to clinical practice, “because it comes mostly from people with a level of serum potassium that would not be treated in the NHS”.
Also, there was no evidence to show that either drug extends life or improves quality of life compared with standard care in people who would have treatment for hyperkalaemia in the NHS, NICE noted.
“Because of the lack of relevant clinical evidence the drugs could not be recommended as a cost-effective use of NHS resources,” it concluded.
AstraZeneca said it is now “preparing a robust response to this draft decision”, that will address the questions raised by NICE’s committee, to ensure that adults in England with hyperkalaemia can access its drug.