Mylan said late Thursday that the settlement, announced Oct. 7, resolves claims over the classification of the EpiPen and EpiPen Jr epinephrine auto-injectors in the Medicaid Drug Rebate Program. Both products are used as emergency treatments for anaphylaxis, a potentially life-threatening allergic reaction.
At issue was whether the EpiPen products were properly classified with the Centers for Medicare & Medicaid Services (CMS) as a non-innovator drug under the applicable definition in the Medicaid Rebate statute and subject to the formula used to calculate rebates to Medicaid, according to Mylan.
The company noted that EpiPen has been classified with CMS as a non-innovator drug since before it acquired the product in 2007, based on longstanding written guidance from the federal government.
The settlement provides for resolution of all potential Medicaid rebate liability claims by the federal government, as well as potential claims by certain hospitals and other covered entities that participate in the 340B Drug Pricing Program, Mylan said. In addition, the settlement allocates money to the Medicaid programs of all 50 states and establishes a framework for resolving all potential state Medicaid rebate liability claims within 60 days.
Mylan said it will reclassify the EpiPen for the Medicaid Drug Rebate Program and pay the rebate applicable to innovator products effective as of April 1, 2017.
“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,” Mylan chief executive officer Heather Bresch said in a statement. “Over the course of the last year, we have taken significant steps to enhance access to epinephrine auto-injectors, including bringing a solution to the fast-changing health care landscape in the U.S. by launching an authorized generic version at less than half the wholesale acquisition cost of the brand and meaningfully expanding our patient access programs. Mylan has always been committed to providing patients in the U.S. and around the world with access to medicine, and we look forward to continuing to deliver on this mission.”
In connection with the settlement, Mylan also entered into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. The company said the settlement doesn’t include an admission or finding of wrongdoing.