Mylan to pay US government $465m over EpiPen

Mylan has agreed to pay the US Department of Justice and other government agencies $465 million to settle questions about the classification of EpiPen Auto-Injector (epinephrine) under the Medicaid Drug Rebate Program.

The focus of the case was whether EpiPen Auto-Injector was properly classified with the Centers for Medicare & Medicaid Services (CMS) as a non-innovator drug rather than a brand product.

Generic products incur a smaller rebate than brand drugs.

The programme, which includes CMS, state Medicaid agencies, and participating drug manufacturers, helps to offset the Federal and state costs of most outpatient prescription drugs dispensed to Medicaid patients.

It requires a drug manufacturer to have a national rebate agreement with the government in exchan ge for state Medicaid coverage of most of the manufacturer’s drugs.

According to Mylan, the settlement resolves all potential rebate liability claims by the Federal and state governments surrounding whether the product should have been classified as an innovator drug and subject to a higher rebate.

CMS had classified EpiPen Auto-Injector as a non-innovator drug since before Mylan acquired the product in 2007.

In the case, centring on the emergency treatment for allergy (also known as anaphylaxis), the settlement does not provide for any finding of wrongdoing by Mylan.

Heather Bresch, CEO of Mylan, said in a statement: “This agreement is another important step in Mylan’s efforts to move forward and bring resolution to all EpiPen Auto-Injector related matters.”

She added: “The agreement is in addition to the significant steps Mylan has taken in relation to EpiPen Auto-Injector over the past several weeks, including the unprecedented, pending launch of a generic version of EpiPen Auto-Injector and expansion of our patient access programmes for this product.”