Akebia Therapeutics Inc. (NASDAQ: AKBA) focuses on bettering the lives of people affected with kidney disease. The company develops and markets various innovative therapies ensuring patients, especially those disproportionately affected by CKD, can access and are reimbursed for the vital therapies.
Akebia challenging decision to deny Auryxia coverage for IDA
One of the company’s marketed therapy is Auryxia which the FDA has approved for serum phosphorous levels control in adults with CKD ion dialysis. Auryxia is also used for iron deficiency anemia (IDA) treatment in CKD patients on dialysis.
Unfortunately, then Centres for Medicare and Medicaid Services decided to deny Auryxia coverage for iron deficiency anemia treatment in 2018 under Medicare Part D. As a result, the company filed a suit in October 2019 challenging CMS and the Department of Health and Human Services’ decision seeking to restore coverage for this indication. Akebia also requested the federal district court to issue an injunction for immediate restoration of coverage for IDA treatment pending the case’s conclusion.
However, the district court rejected the company’s motion for a preliminary injunction, and when the company tried to seek the same at a higher court, the US Court of Appeal for the First Circuit, the district court’s decision was affirmed.
District court rejects CMS’s motion to dismiss Akebia’s lawsuit.
Recently, the district court rejected CMS’s motion to dismiss the laws suit stating that Akebia has standing and meets jurisdictional conditions necessary to seek the court action to challenge CMS’s coverage decision. The decision is critical since it opens the door for other drugmakers to challenge unlawful coverage decisions instead of patients doing it through a convoluted and resource-intensive appeal process.
Considering the significance of re-establishing CMS coverage for Auryxia for IDA treatment, Akebia has received support for its efforts over the last two years. Several organizations have joined the cases as amicus, with the district court backing up the company’s decision.