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Statement from Akebia Therapeutics Regarding Litigation Against Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services
CAMBRIDGE, Mass., Oct. 25, 2021 /PRNewswire/ -- At Akebia Therapeutics, we are driven by a collective purpose to better the lives of people impacted by kidney
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., Oct. 25, 2021 /PRNewswire/ -- At Akebia Therapeutics, we are driven by a collective purpose to better the lives of people impacted by kidney disease. As part of our charge to support kidney disease patients, we work to develop and market innovative therapies and ensure that all patients, especially patients disproportionately impacted by chronic kidney disease (CKD), have access to and are reimbursed for these critical therapies. \n\n \n \n \n \n \n \n\n \nAkebia has one marketed product, Auryxia® (ferric citrate), which was approved by the FDA for the control of serum phosphorus levels in adult patients with CKD on dialysis, and for the treatment of iron deficiency anemia (IDA) in adult patients with CKD not on dialysis.\nIn 2018, the Centers for Medicare & Medicaid Services (CMS) made the decision to deny coverage for Auryxia for one of those indications, the treatment of iron deficiency anemia (IDA), under Medicare's outpatient prescription drug program (Medicare Part D). We filed a lawsuit in October 2019 against CMS and the U.S. Department of Health and Human Services (HHS) challenging their decision, hoping to restore coverage for those patients. We also asked the federal district court to issue an injunction to immediately restore coverage for Auryxia when used for IDA while the lawsuit was pending. We filed the lawsuit and the preliminary injunction as we believed that people living with CKD were being deprived of an FDA-approved drug, in an approved indication, because of CMS's withdrawal of full Medicare coverage for the treatment of IDA with Auryxia. \nUnfortunately, the federal district court denied our motion for a preliminary injunction and the U.S. Court of Appeals for the First Circuit affirmed the district court's decision. However, the district court recently rejected a motion by CMS to dismiss our lawsuit, concluding that a drug manufacturer such as Akebia has standing and satisfies other jurisdictional requirements necessary to bring a court action directly challenging a CMS coverage decision. This is important as it opens the door for other biopharmaceutical companies to challenge unlawful CMS coverage decisions in the future, rather than requiring patients to do so through a resource-intensive and convoluted appeals process. \nGiven the importance of reestablishing CMS coverage for Auryxia...