Cost regulators for treatments funded on the NHS in England and Wales are backing use of Amgen’s Parsabiv to treat secondary hyperparathyroidism (sHPT), which could give patients routine access to the first new option to treat the disease in more than a decade.
The National Institute for Health and Care Excellence has published an appraisal consultation document recommending the drug’s use, but only if treatment with a calcimimetic is indicated but cinacalcet is not suitable, and the company provides the drug with the discount agreed in the patient access scheme.
The most plausible incremental cost effectiveness ratio for the comparison of etelcalcetide and cinacalcet was between £14,778 to £26,647 per QALY gained, but the committee considered that differences in price of the vial sizes could increase this uncertainty further still.
sHPT is a common, serious and often progressive condition among patients with chronic kidney disease CKD, that develops in response to declining kidney function, when the parathyroid (PTH) glands increase the production of thyroid to maintain normal levels of calcium and phosphorus.
However, eventually this excess production is not enough to maintain normal levels, and at the point of CKD dialysis, this manifests as abnormal amounts of PTH, calcium and phosphorus that, in turn, can lead to significant clinical consequences, such as weakness and thinning of the bones.
Parsabiv (etelcalcetide) is a novel calcimimetic agent that suppresses the secretion of PTH by binding to and activating the calcium-sensing receptor on the parathyroid gland. The treatment is the first calcimimetic agent that can be given intravenously three times per week at the end of each dialysis session.
European approval was in November last year was based on data from three Phase III studies, one of which showed that 74 percent of patients given the drug experienced a greater than 30 percent reduction from baseline in PTH compared with 8.3 percent in the placebo arm.