Akebia Therapeutics (NASDAQ:AKBA) has filed a complaint in
a district court against the U.S. Department of Medicare & Medicaid
Services (CMS) and the U.S. Department of Health and Human Services
(HHS) challenging CMS’s decision about a year ago to rescind Medicare
Part D coverage of Auryxia (ferric citrate) for the treatment of iron
deficiency anemia in adult patients with chronic kidney disease not on
dialysis.
The company also seeks a reversal of a related
decision by CMS requiring prior authorization for Auryxia when used to
control serum phosphorus levels in adult patients with CKD on dialysis.
The FDA first approved the product in September
2014 for the hyperphosphatemia indication followed by the IDA indication
in November 2017.
https://seekingalpha.com/news/3505969-akebia-sues-feds-dropped-auryxia-coverage
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