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NICE backs use of Amgen's Parsabiv to treat secondary hyperparathyroidism.

M2 EQUITYBITES-March 7, 2017-NICE backs use of Amgen's Parsabiv to treat secondary hyperparathyroidism

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In an appraisal consultation document, the National Institute for Health and Care Excellence (NICE) has recommended Amgen's (NASDAQ: AMGN) Parsabiv (etelcalcetide) to treat secondary hyperparathyroidism (sHPT), if treatment with a calcimimetic is indicated but cinacalcet is not suitable, and as long as the company provides the drug with the discount agreed in the patient access scheme, Pharma Times reported on Tuesday.

sHPT is a common, serious and often progressive condition that occurs in patients with chronic kidney disease (CKD). It 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, this excess production is not enough to maintain normal levels, resulting in abnormal amounts of PTH, calcium and phosphorus.

Parsabiv is a novel calcimimetic agent that binds to and activates the calcium-sensing receptor on the parathyroid gland, suppressing the secretion of PTH. It is the first calcimimetic agent that can be administered intravenously three times per week at the end of each dialysis session.

The drug received European approval in November last year, following data from three Phase III clinical studies, one of which revealed that 74% of patients given Parsabiv experienced a greater than 30% reduction from baseline in PTH compared with 8.3% in the placebo group.

The most believable incremental cost effectiveness ratio for the comparison of etelcalcetide and cinacalcet was found to be between GBP14,778 to GBP26,647 per QALY gained, however, the committee considered that differences in the price of the vial sizes could further increase this uncertainty.

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Date:Mar 7, 2017
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