Characterization of the Clinical Evidence Supporting Repository Corticotropin Injection for FDA-Approved Indications Scoping Review

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Repository corticotropin injection, also known as Acthar Gel, was approved for use by the US Food and Drug Administration (FDA) in 1952 for various inflammatory conditions. In 2001, Questcor Pharmaceuticals acquired the rights to this drug, and the price per vial was $36. Today, the price of a vial is close to $40,000. The list of indications for this drug also expanded after being acquired by Questcor Pharmaceuticals (purchased by Mallinckrodt Pharmaceuticals in 2014) including infantile spasms and multiple sclerosis. The increased cost of the drug has put extra attention on the published evidence that supports its efficacy and safety. On December 13, 2021, Dr. Kim Tran and her colleagues, including the Center’s co-research director, Dr. Curtis Harrod, published a scoping review in JAMA Internal Medicine that covers the published evidence of repository corticotropin injection for its FDA-approved indications. The authors found that 41 studies involving only 2,235 participants met inclusion criteria. Beyond the number of studies and people studied, the authors concluded “…few RCTs supported the clinical benefit of corticotropin for most FDA-approved indications. Most RCTs found that corticotropin was not superior to corticosteroids for treating relapses of MS or infantile spasms.” These findings are concerning for any drug, but particularly for one that is 1,000 times the price it was 20 years ago. To read more on this publication, click here.

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