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Akebia Files Lawsuit Against CMS for 2018 Action Rescinding Medicare Part D Coverage of FDA-Approved Auryxia® for its Iron Deficiency Anemia Indication and Imposing a Prior Authorization Requirement for its Hyperphosphatemia Indication
CMS continues to deny Medicare beneficiaries with chronic kidney disease full access to this innovative therapy CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Akebia
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"\nCMS continues to deny Medicare beneficiaries with chronic kidney disease full access to this innovative therapy\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAkebia Therapeutics, Inc. (Nasdaq: AKBA), a fully integrated biopharmaceutical company focused on bettering the lives of people impacted by kidney disease, today filed a complaint in federal district court against the Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS). The lawsuit challenges a September 2018 decision by CMS that rescinded Medicare Part D coverage of Auryxia® (ferric citrate), Akebia’s FDA-approved drug, when used for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) not on dialysis (the IDA Indication). The legal action also seeks to reverse a related decision by CMS that imposed a prior authorization requirement for Auryxia when used for the control of serum phosphorus levels in adult patients with CKD on dialysis (the Hyperphosphatemia Indication).\n\n\nIn the complaint, Akebia asks the court to restore coverage of Auryxia for the IDA Indication and to remove the prior authorization requirement for the Hyperphosphatemia Indication.\n\n\nAuryxia was approved by the U.S. Food and Drug Administration (FDA) on September 5, 2014 for the Hyperphosphatemia Indication and approved by the FDA on November 6, 2017 for the IDA Indication. Auryxia is the only oral product approved in the U.S. to treat both adult patients with CKD not on dialysis for IDA and adult patients with CKD on dialysis for hyperphosphatemia.\n\n\n“Together with medical experts and numerous patient advocacy groups, we’ve been working tirelessly over the past year to urge CMS to restore coverage for Auryxia’s IDA indication and remove the prior authorization requirement for the hyperphosphatemia indication. We believe CMS has a legal obligation to restore coverage. Because CMS has failed to act, we find ourselves with no other choice than to pursue litigation seeking to restore access for Medicare patients to this innovative, clinically effective treatment,” said John P. Butler, President and Chief Executive Officer of Akebia.\n\n\nFor additional information, a copy of the complaint can be found by visiting HERE.\n\n\nAbout Akebia Therapeutics\n\n\nAkebia Therapeutics, Inc. is a fully integrated bi...