John P. Butler
Akebia Therapeutics has filed a lawsuit against CMS for rescinding Medicare Part D coverage of the company’s FDA-approved iron drug Auryxia and for the agency’s decision to impose a prior authorization requirement for use of the drug to treat hyperphosphatemia.
The suit, filed Oct. 15, challenges a September 2018 decision by CMS that rescinded Medicare Part D coverage of Auryxia (ferric citrate) when used for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease not on dialysis, the company said in a press release. 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.
In the complaint, filed in U.S. District Court in Massachusetts, the company said that CMS “abruptly reversed course” after previously providing coverage of Auryxia and revoked Part D coverage for the IDA indication for Auryxia and advised Part D plan sponsors to require patients to obtain prior authorization from the plan before Auryxia can be dispensed and reimbursed for the treatment of hyperphosphatemia. “In support of this unexpected reversal, CMS merely asserted in an email to the Part D plans that its new conclusion that Auryxia is not a covered Part D drug - despite its approval by FDA to treat disease - was ‘[c]onsistent with’ CMS’s treatment of ‘other iron products.’”
Akebia said in the complaint that the CMS decision violated Section 1860D-2(e) of the Social Security Act (“SSA”), 42 U.S.C. § 1395w-102(e), which specifies that FDA-approved drugs are covered Part D drugs unless they fall within certain statutory exclusions.
“Although CMS provided almost no explanation for its decision, CMS appears to have concluded that Auryxia falls within the exclusion for ‘mineral products,’” the complaint noted. “That conclusion is contrary to the plain meaning of the statute. Auryxia is a patented drug product consisting of a complex synthetic compound, not a naturally occurring mineral product,” the company said.
Auryxia is currently Akebia’s only commercially marketed product.
“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,” John P. Butler, president and CEO of Akebia, said in a press release. “We believe CMS has a legal obligation to restore coverage.”
The company said that 175 leading nephrologists and several patient organizations, including the American Kidney Fund, National Kidney Foundation and Dialysis Patient Citizens, have urged CMS to rescind the decision.
U.S. District Court of the State of Massachusetts, Case 1:19-cv-12132 Akebia Therapeutics v. Alex M. Azar II, Secretary of Health and Human Services, Seema Verma, Administrator of the CMS.