Etelcalcetide for treating secondary hyperparathyroidism

Description of the technology

Etelcalcetide (Parsabiv, Amgen) is a calcimimetic. It binds directly to the extracellular domain of the calcium-sensing receptor and activates it at a site distinct from the calcium-activating site. This suppresses secretion of parathyroid hormone because of an increased sensitivity of the receptor to calcium, and leads to a decrease in calcium levels. Etelcalcetide is given by intravenous injection.

Marketing authorisation

Etelcalcetide is indicated for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on haemodialysis.

Adverse reactions

Very common adverse reactions with etelcalcetide are decreased blood calcium, muscle spasms, diarrhoea, nausea and vomiting. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

The recommended initial dose of etelcalcetide is 5 mg administered by bolus injection 3 times per week. Corrected serum calcium should be at or above the lower limit of the normal range before administration of the first dose of etelcalcetide. Etelcalcetide should be titrated so that doses are individualised between 2.5 mg and 15 mg.

Price

NHS list prices:

£136.87 per pack of 6 vials of 2.5 mg in 0.5 ml solution (£9.12 per mg; excluding VAT).

£163.92 per pack of 6 vials of 5 mg in 1 ml solution (£5.46 per mg).

£327.84 per pack of 6 vials of 10 mg in 1 ml solution (£5.46 per mg).

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of etelcalcetide, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.