The National Institute for Health and Care Excellence has recommended Vifor Pharma’s Veltassa®▼ for adults with hyperkalaemia in England.
The positive final appraisal determination (FAD) for Veltassa® (patiromer) recommends patients in England have access to a new treatment option for treating hyperkalaemia (raised serum potassium levels) in adults.
Hyperkalaemia is a potentially life-threatening condition, which can cause fatal cardiac arrest and muscle paralysis, due to elevated levels of potassium in the blood. It is often a consequence of the use of blood pressure treatments, known as RAAS inhibitors and has historically been managed by reducing the dosage or by discontinuing these medicines, despite evidence of improvement of cardiovascular deaths and worsening of renal function.
The announcement by NICE recognises the need for new options to treat patients with persistent hyperkalaemia as well as those in emergency care for acute life-threatening hyperkalaemia alongside standard care.
The NICE approval follows data from multiple phase II and III trials which have shown patiromer lowers serum potassium and that it may allow people to stay on RAAS inhibitors for longer or at a higher dose. NICE acknowledged the value of RAAS inhibitors in treating CKD and HF patients as they may extend life and improve quality of life.
NICE recommends patiromer as an option for treating hyperkalaemia in adults only if used:
- in emergency care for acute life-threatening hyperkalaemia alongside standard care or
- for people with persistent hyperkalaemia and stages 3b to 5 chronic kidney disease or heart failure, if they:
− have a confirmed serum potassium level of at least 6.0 mmol/litre and
− are not taking, or are taking a reduced dosage of, a renin-angiotensin-aldosterone system (RAAS) inhibitor because of hyperkalaemia and
− are not on dialysis.
The guidance from NICE does not affect treatment with patiromer that was started in the NHS before it was published. People having treatment outside of this recommendation may continue without change to the funding arrangements currently in place for them, until they and their NHS clinician consider it appropriate to stop. Further, primary care and patient access to patiromer should be facilitated through establishment of local shared care protocols. Patiromer should be started in hospital.
Professor Iain Squire, Professor of Cardiovascular Medicine, University Hospitals of Leicester NHS Trusts, said, “This is as great a result for us as clinicians as it is for our patients. For decades we have lacked effective drugs to treat hyperkalaemia, which has left us in a treatment paradox, confusing patients and leaving them in ‘limbo’. We have a robust array of life-preserving drugs for heart failure and chronic kidney disease, but the adverse effect on potassium levels of the use of some of these drugs in some patients has prevented us from using them to their full life-saving effect in many of the patients who need them the most.”