Akebia Therapeutics, a small Cambridge, Mass.-based drugmaker, has filed a lawsuit against CMS, claiming Medicare's denial to cover its anemia drug violates the law, according to STAT.
Akebia's only drug on the market is Auryxia, an anemia treatment for some kidney disease patients. It was approved by the FDA in November 2017. In September 2018, CMS sent emails to private Medicare plans notifying them that the agency wouldn't pay for Auryxia.
Medicare is legally required to cover any FDA-approved drug unless it fits into an exclusion. CMS' email did not give the details of why coverage of Auryxia was denied, just saying the denial was "consistent with other iron products."
Akebia believes its drug was denied coverage because CMS officials consider it a mineral, which Medicare typically doesn't cover. Akebia says its treatment is a "synthetic, highly processed compound with a unique structure and novel pharmacologic properties," so it should not be denied, according to STAT.
At the time of CMS' decision, Auryxia was already covered by other government programs like the Veterans Health Administration and virtually every private health insurance plan.
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