Biotech company Amgen said last week it would pay refunds for 340B overcharges occurring in the third and fourth quarters of 2019.
The posting on the U.S. Health Resources and Services Administration website marks Amgen’s second 340B refund notice so far this year. The first was in May. Products include Amgen’s blockbuster rheumatoid arthritis therapy Enbrel ($4.4 billion in U.S. sales in 2021), neutropenia drug Neulasta ($1.5 billion), cholesterol treatment Repatha ($557 million), anemia drug Epogen ($521 million), cancer drug Kyprolis ($736 million) and anemia therapy Aranesp ($537 million).
The drug maker, based in Thousand Oaks, Calif., is among the 18 that have imposed limits on 340B pricing when covered entities contract with outside pharmacies to dispense 340B-purchased drugs.
HRSA posted Amgen’s notice about the refunds Oct. 4, with a total of 43 NDCs affected. Nearly three-quarters of the overcharges occurred in the third quarter of 2019, with the rest occurring in the fourth quarter.
Amgen said it was issuing the refunds after recalculating lower 340B ceiling prices for the NDCs listed for Q3 and Q4 2019 and that 340B covered entities that purchased the impacted products during this timeframe would get a credit through a third-party vendor.
Specifically, the company said it would issue refunds directly to 340B covered entities that it determines are owed a cumulative refund amount equal to or in excess of $25 in aggregate for all applicable NDCs for the time periods listed.
Covered entities that may be owed less than $25 can request a refund, Amgen said. It said entities that purchased one or more of the listed NDCs in the applicable time period and do not receive an automatic refund by Nov. 30, 2022, should contact the company “if it wishes to request a refund or has any questions.” The notice includes an email address.
“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). Upon validation that a requested refund less than $25 is owed, Amgen will approve the refund request,” the notice said.