Etelcalcetide (trade name: Parsabiv) has been approved in Germany since November 2016 for the treatment of secondary hyperparathyroidism (overactive parathyroid gland) in adults. It is an option for people with chronic kidney disease who are on dialysis.
Hyperparathyroidism is a disorder of the parathyroid glands and can have a number of causes. Secondary hyperparathyroidism is usually caused by a chronic kidney disease. The parathyroid gland regulates the body's mineral metabolism through the parathyroid hormone. In kidney failure (renal insufficiency), the parathyroid gland reacts by greatly increasing the production of this hormone. The increased amount then often causes problems such as mineral metabolism disorders and bone loss. Bone pain and bone fractures may occur later on. The risk of cardiovascular disease can also increase.
Etelcalcetide inhibits the production of the parathyroid hormone in the parathyroid gland, and aims to prevent bone loss and other secondary diseases.
Etelcalcetide is available as a solution for injecting, in three doses: 2.5, 5, and 10 mg. It is given three times a week at the end of dialysis sessions, intravenously through the dialysis machine. The recommended initial dose is 5 mg per treatment.
Based on blood samples, the dose of the drug is adjusted individually and can be increased to up to 15 mg per injection.
For people with secondary hyperparathyroidism caused by a kidney disease that is being treated with dialysis, the standard treatment with the drug cinacalcet is an option.
In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether etelcalcetide has any advantages or disadvantages when compared with the standard treatments.
But the manufacturer didn't provide any suitable data with which to do the assessment.
This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of etelcalcetide (Parsabiv).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Etelcalcetide (secondary hyperparathyroidism) - Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A17-25. August 30, 2017. (IQWiG reports; Volume 535).
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