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Southampton Health Technology Assessments CentreNews

Etelcalcetide for treating secondary hyperparathyroidism is recommended by NICE

Published: 29 June 2017
Patient having dialysis
People with ckd experience a progressive worsening of their kidney function over time

The National Institute for Health and Care Excellence (NICE) has issued guidance to the national health service on the use of the drug etelcalcetide for treating secondary hyperparathyroidism in people with chronic kidney disease, informed by a report produced by SHTAC.

People with chronic kidney disease experience a progressive worsening of their kidney function over time and can develop complications such as secondary hyperparathyroidism.

Hyperparathyroidism is characterised by high levels of phosphate and low levels of calcium in the blood. Loss of kidney function causes secondary hyperparathyroidism by reducing how much phosphate is excreted from the body, which then results in the parathyroid gland producing more parathyroid hormone to stimulate the kidneys to excrete more phosphate. Eventually, the kidneys are unable to do this and phosphate levels build up. This process also results in the body having difficulty in converting vitamin D into calcium, resulting in low calcium levels, which further stimulates parathyroid gland to release parathyroid hormones. Eventually, the gland enlarges and over-produces the parathyroid hormone, resulting in secondary hyperparathyroidism. This can cause further problems such bone and cardiovascular diseases.

Treatment of secondary hyperparathyroidism include changes to patients’ diets, phosphate binders to control phosphate levels, vitamin D analogues, changes to dialysis treatment and sometimes removal of the parathyroid glands. The drug cinacalcet is used to treat secondary hyperparathyroidism that is resistant to these therapies.

Etelcalcetide (brand name: Parsabiv™, Amgen) is a new treatment for secondary hyperparathyroidism in chronic kidney disease, which is administered intravenously (through a vein) and which works by reducing the production and secretion of the parathyroid hormone.

NICE’s guidance recommends etelcalcetide as an option for treating secondary hyperparathyroidism in adults with chronic kidney disease on haemodialysis. However, it should only be given if patients are not able to take cinacalcet first. The company must provide etelcalcetide with the discount agreed in the patient access scheme.

NICE’s guidance is informed by an evidence review group report prepared by SHTAC, which critically appraised the drug company’s submission to NICE’s Single Technology Appraisal process.

For more information about SHTAC’s previous research into endocrine, nutritional and metabolic conditions please visit our Research page.

 

 

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