Enbrel autoinjector product tubes
Amgen is providing refunds for 340B overcharges for four NDCs of its top-selling drug Enbrel during 2016 and 2017.

Amgen and GSK Announce Refunds for 340B Overcharges

Drug manufacturer Amgen is providing refunds for overcharges during varying periods over three years on some of its top selling drugs including Enbrel ($4.8 billion in U.S. sales in 2020), Neulasta ($2 billion), Kyprolis ($710 million), Aranesp ($629 million), Epogen ($598 million), Repatha ($459 million), and Blincyto ($231 million).

GlaxoSmithKline has similarly announced it is providing refunds for 340B overcharges during Q2 2020 on six drugs (a total of 16 NDCs)—the inhaled drugs Anoro Ellipta, Arnuity Ellipta, Breo Ellipta, Incruse Ellipta, and Trelegy Ellipta and the injectable diabetes type 2 medicine Tanzeum.

Both drug companies are among the 16 that have imposed limits on 340B pricing when covered entities contract with outside pharmacies to dispense 340B-purchased drugs.

Amgen’s Overcharges

The U.S. Health Resources and Services Administration (HRSA) posted Amgen’s notice about the refunds late last week. Fifty NDCs are affected. The overcharges took place between Q2 2016 and Q2 2019. Amgen said the reason for the refunds is that it “has recalculated lower 340B ceiling prices for the NDCs.”

Amgen said if it determines that it owes covered entities $25 or more cumulatively for all applicable NDCs it will work with a third-party vendor to issue refunds directly to covered entities. It is unclear what third party vendor Amgen is referring to.

The notice says if an entity bought any of the listed products during the specified quarters and does not receive an automatic refund by Jun 27, 2022, it should contact Amgen “if it wishes to request a refund or has any questions.”

“The covered entity may be asked to provide additional information for verification purposes, such as the applicable NDC(s), purchase volume(s) and time period(s),” the notice said. “Upon validation that a requested refund less than $25 is owed, Amgen will approve the refund request.”

GSK’s Overcharges

HRSA posted GSK’s notice about refunds for overcharges yesterday. The company said it lowered its 340B ceiling prices “the result of revised pricing data that were submitted to the Centers for Medicare & Medicaid Services.”

Similarly to Amgen, GSK is providing refunds automatically if it determines an entity is owed $100 or more collectively for all the NDCs involved. “For 340B Covered Entities who may be owed less than $100 in aggregate or who have questions about the above-referenced recalculation for this period, GSK invites interested parties to contact it via email at GSK.340BRefunds@gsk.com, with a reference to the NDC and time period,” GSK’s notice said.

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