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New HTA Decisions in England
February 2020
Drug name
VELTASSA® (patiromer)
Company
Vifor Pharma
Decision date
16/12/2019
Therapeutic area
Kidney conditions
Therapeutic sub area
Chronic kidney disease
Therapeutic area 2
Cardiovascular conditions
Therapeutic sub area 2
Heart failure
Decision
Recommended with restrictions
Indication
Patiromer is recommended as an option for treating hyperkalaemia in adults.
Decision Detail
Patiromer is recommended 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.
Summary
The clinical evidence for patiromer was presented via OPAL-HK, a phase 3, 12‑week, single-blind study that included people with stages 3 and 4 chronic kidney disease, with or without heart failure, who were having a RAAS inhibitor, with serum potassium between 5.1 mmol/litre and 6.5 mmol/litre. The committee concluded that the trials show that patiromer lowers serum potassium, but there is no clinical evidence that it increases length or quality of life for people having treatment for chronic hyperkalaemia. Considering the benefit from more people being able to stay on RAAS inhibitors, the cost-effectiveness estimates for patiromer suggest that it is a reasonable use of NHS resources. Therefore, it is recommended for treating confirmed persistent hyperkalaemia when started in hospital and alongside standard care for treating acute life-threatening hyperkalaemia in emergency care.