Largest Medicare Part D Provider Now Covers Auryxia for CKD Patients on Dialysis

Largest Medicare Part D Provider Now Covers Auryxia for CKD Patients on Dialysis

Keryx Biopharmaceuticals announced that its phosphate binder Auryxia (ferric citrate) has been immediately added to the formularies for the country’s largest Medicare Part D plan provider. This will allow more unrestricted access to the drug for chronic kidney disease (CKD) patients on dialysis and their caregivers.

Increased levels of phosphates are commonly detected in CKD patients with severe kidney impairment. Because of this, most of these patients require chronic treatment with phosphate-binding drugs to control phosphorus levels in their blood. Also, many patients on dialysis suffer from low levels of iron as a secondary effect of the treatment, and need to receive intravenous iron.

Previous clinical studies have shown that Keryx’s lead product Auryxia could reduce the levels of phosphorus compounds to guideline levels and increase the levels of iron in the blood of patients with end-stage renal disease (ESRD) who require dialysis treatment.

Based on these results, in 2014 the U.S. Food and Drug Administration (FDA) approved Auryxia for CKD patients who are dependent on dialysis.

In the United States, the majority of the treatment-related costs for people with ESRD, including phosphate binder prescriptions, are covered by Medicare Part D and commercial insurance companies.

Auryxia is now included in the Medicare Part D plan coverage, which will expand access to this drug to about 85 percent of patients who require phosphate binder therapy.

“We are pleased that another large insurance provider has recognized the value that Auryxia can bring to patients,” said Greg Madison, president and CEO of Keryx Biopharmaceuticals, in a company press release.

“The addition to these formularies, which covers both the remainder of 2017 and the full year 2018, will support continuing growth of Auryxia in dialysis as well as ensuring that we can provide broad access to Auryxia for people with iron deficiency anemia (IDA) and non-dialysis dependent (NDD) CKD, pending approval of this indication later this year,” Madison said.

Based in Boston, Massachusetts, Keryx Biopharmaceuticals expects to extend the use of Auryxia to patients with non-dialysis-dependent CKD (NDD-CKD). First results from Phase 3 clinical trial (NCT02268994) in NDD-CKD patients on Auryxia treatment showed promising results. However, research is still ongoing regarding safety and effectiveness.

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