The first new treatment in a decade for a common complication of chronic kidney disease has been given a green light by NICE, opening the door for its routine use in the NHS in England.
In draft guidance, the cost-effectiveness agency is backing use of Amgen’s Parsabiv (etelcalcetide) for secondary hyperparathyroidism caused by CKD in patients on haemodialysis, but only for patients who cannot be treated with Amgen’s older drug Sensipar/Mimpara (cinacalcet) – and provided Amgen supplies the drug at an agreed discount.
sHPT parathyroidism is a serious condition that affects a high proportion of CKD patients receiving dialysis. It involves excessive secretion of parathyroid hormone by the parathyroid glands in response to decreased kidney function, and causes bone pain, reduced mobility, stomach pain and depression.
NICE’s appraisal document says the Quality Adjusted Life Year (QALY) cost of the drug is likely to be around the £15,000-£27,000 range – within its usual threshold for cost-effectiveness – although it adds that differences in price of the vial sizes add a degree of uncertainty.
“Given that etelcalcetide has similar efficacy to cinacalcet but higher associated costs, the committee considered that it should be recommended as an option for people with secondary hyperparathyroidism whom a calcimimetic is indicated, only if cinacalcet is not considered suitable,” it notes.
Parsabiv was approved by the EMA last November and according to the company has advantages over its older drug. Specifically, it is administered three times a week as an infusion at the end of the dialysis process, while cinacalcet must be given orally every day.
It is estimated that only around 25% of eligible patients take cinacalcet, mainly because most people with sHPT have a substantial number of tablets to take, including phosphate binders that can be unpleasant because they are difficult to swallow and produce nausea.
Cinacalcet has been a big earner for Amgen for years, with sales of more than $1.6bn last year, holding up well even though it is starting to face generic competition in some markets and will lose US patent protection in 2018.
As there are around two million people worldwide who are on dialysis as a result of kidney failure, analysts have said Parsabiv has significant sales potential and could match or even exceed Sensipar’s sales at its peak, although rising levels of payer pushback in the US and elsewhere has led others to suggest a figure of $500m or so could be more likely.
NICE’s positive assessment is therefore a boost to Amgen’s ambitions for the new drug as it faces what could be a steep decline in cinacalcet sales over the next couple of years.