18 August 2017Americas

Mylan finalises $465m settlement with US government

Mylan has finalised a $465 million payment to the US government to settle a lawsuit about the classification of EpiPen Auto-Injector (epinephrine) under the Medicaid Drug Rebate Program.

The US Department of Justice (DoJ) had alleged that the Epi-Pen was “knowingly misclassified” as a non-innovator drug rather than a branded product.

Generic products incur a smaller rebate than brand drugs.

Mylan said that the EpiPen had been classified with the Centers for Medicare and Medicaid Services (CMS) as a non-innovator drug since before Mylan acquired the product in 2007.

The Medicaid 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.

The settlement was announced in October last year, but was signed yesterday, August 17.

Mylan and its subsidiaries which were targeted (Mylan Inc and Mylan Specialty) haven’t admitted any wrongdoing.

All potential Medicaid rebate liability claims by the federal government, as well as potential claims by certain hospitals and other covered entities, are resolved under the settlement.

Mylan has entered into a corporate integrity agreement with the Department of Health and Human Services Office of Inspector General.

This requires an independent organisation to annually review multiple aspects of Mylan’s practices relating to the Medicaid programme, according to the DoJ in a statement made yesterday.

Mylan will also reclassify the EpiPen for the programme and pay the rebate applicable to innovator products effective as of April 1, 2017.

Heather Bresch, CEO of Mylan, said: “As we said when we announced the settlement last year, bringing closure to this matter is the right course of action for Mylan and our stakeholders to allow us to move forward.”

Over the past year, according to Bresch, Mylan has taken “significant steps” to enhance access to epinephrine auto-injectors.

This included the launch of an authorised generic version at less than half the wholesale acquisition cost of the brand and “meaningfully expanding” Mylan’s patient access programmes.

“Our five-year corporate integrity agreement requires intensive outside scrutiny to assess whether Mylan is complying with the rules of the Medicaid Drug Rebate Program,” said Gregory Demske, chief counsel to the inspector general for the US Department of Health and Human Services.

He added: “In addition, the CIA requires individual accountability by Mylan board members and executives.”

Sanofi had raised the matter with the US Attorney’s Office in 2014 and, in 2016, Sanofi filed a complaint against Mylan under provisions of the False Claims Act, which permit private parties to sue on behalf of the government and to receive a share of any recovery.

Sanofi will receive $38.7 million as its share of the federal recovery, plus a share of the recovery for the 50 US states.

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More on this story

Americas
11 October 2016   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 under the Medicaid Drug Rebate Program.
Americas
17 August 2018   The US Food and Drug Administration yesterday granted Teva approval for the first generic version of EpiPen, an autoinjector pen used for the emergency treatment of allergic reactions.

More on this story

Americas
11 October 2016   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 under the Medicaid Drug Rebate Program.
Americas
17 August 2018   The US Food and Drug Administration yesterday granted Teva approval for the first generic version of EpiPen, an autoinjector pen used for the emergency treatment of allergic reactions.