Intravenous Form of Sensipar® Has Been Approved by the FDA

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Parsabiv™ (etelcalcetide), an IV formulation similar to the oral calcimimetic Sensipar® (cinicalset), was recently approved by the U.S. Food and Drug Administration to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. This is the first medication that has been approved to treat secondary hyperparathyroidism in 12 years.

Calcimimetic drugs like Sensipar® and Parsabiv™ work to lower the parathyroid hormone (PTH) level, which controls calcium, phosphorus, and vitamin D in the blood. This in turn helps regulate bone growth. High PTH is common in patients with chronic kidney disease, and many of the patients on dialysis who use FreseniusRx are treated with Sensipar®.

Pharmacists are a critical component of the integrated care teamSensipar® is moving to the Medicare bundle

Since its approval, both Parsabiv™ and Sensipar® will move from a Medicare Part D benefit to a Medicare Part B as early as July 2017.

The Centers for Medicare & Medicaid Services (CMS) bundles together payments for renal dialysis services such as drugs, labs, supplies, and other costs related to treatment provided to Medicare recipients. When an IV and oral version of a medication become available, both of the medications move to the CMS bundle.

Why does the shift to the Medicare bundle matter?

CMS introduced the ESRD bundled payment model in 2011 to reduce healthcare costs, improve outcomes, and better manage patient care. Fresenius Medical Care North America (FMCNA) is committed shifting away from traditional fee-for-service models toward value-based care because we know that integrated care improves outcomes, and we are committed to helping our patients.

FreseniusRx knows that pharmacists are a critical component of the integrated care team. In fact, FreseniusRx pharmacists specialize in renal medications. This shift to the CMS bundle provides additional opportunities to further integrate pharmacists into the care of our patients.

Dr. Jeffrey HymesJeffrey L. Hymes, M.D., is Chief Medical Officer and Senior Vice President of Fresenius Kidney Care. Dr. Hymes was a fellow in the Clinical Nephrology department at the Boston University Medical Center and subsequently became a Clinical Instructor at the Boston University Medical Center, practicing nephrology in the Boston area. He has developed a large and extensive nephrology practice in the Nashville area, serving as President of Nephrology Associates in Nashville. Dr. Hymes is a graduate of Yale University and the Albert Einstein College of Medicine.

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