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When is an FDA-Approved Drug Not a Drug?

Posted on March 14, 2022March 21, 2022 by Devon Herrick

Auryxia is a phosphorus binding drug to treat renal anemia. It contains iron and is used to both lower phosphate levels and for iron deficiency in chronic kidney disease (CKD) patients. It was approved by the U.S. Food and Drug Administration (FDA) in 2014 to control serum phosphorus levels in patients on dialysis with CKD.

In 2018 the Centers for Medicare and Medicaid Services (CMS) suddenly removed Auryxia (ferric citrate) from the Medicare Part D drug formulary and began to require prior authorization for the few indications it would reimburse. CMS gave little information about the reversal but apparently made the decision because it views ferric citrate at a mineral product, like dietary supplements such as Vitamin C. Dietary supplements are not covered by Medicare except in a few cases.

The list price is about $8 per pill. Some patients take 1 a day, some take 3 a day with meals, while the highest dose is 12 a day. The decision remove access to Auryxia for all but a few Medicare patients would seem odd from a cost-benefi standpoint. End Stage Renal Disease is the only condition that is specifically covered by Medicare regardless of age. The alternative for those with chronic kidney disease are injections of erythropoiesis-stimulating agents (ESA). For example, Procrit is an ESA. Its price ranges from $70 per vial of 1ml of 2,000/ml to $1,100 for 1ml of 20,000/ml.  ESAs require a trip to the doctor or an infusion center, further adding to their cost. Procrit can be administered once a week, three times a week or every day. It’s easy to see that injections would almost always exceed the cost of an $8 tablet.

Read more here: Medicare coverage should empower kidney patients to choose home-based health options | TheHill

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For many years, our health care blog was the only free enterprise health policy blog on the internet. Then, when the NCPA closed its doors, the health blog stopped as well.

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John C. Goodman,

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