GSK GlaxoSmithKline logo on office building
GlaxoSmithKline said last week it would pay refunds for 340B overcharges occurring in Q1 2021.

GSK Announces Refunds for 340B Overcharges on Respiratory Drugs

Pharmaceutical manufacturer GlaxoSmithKline said last week it would pay refunds for 340B overcharges occurring in the first quarter of 2021, including overcharges for blockbuster respiratory drugs Trelegy and Nucala.

The refund notice posted Feb. 2 on the U.S. Health Resources and Services Administration’s (HRSA) Office of Pharmacy Affairs website covers mainly GSK powder formulated inhaled drugs. The list includes Trelegy Ellipta, Anoro Ellipta, Breo Ellipta, and Incruise Ellipta, all inhalers indicated to treat chronic obstructive pulmonary disease; Arnuity Ellipta, an asthma treatment; and Ventolin, indicated for bronchospasm. The refund notice also includes GSK’s injectable drug Nucala for treatment of severe asthma.

GSK’s refund notice covers 18 NDCs and lists all of the overcharges as occurring during Q1 2021.

GSK said the recalculated ceiling prices resulted from revised pricing data that were submitted to the Centers for Medicare & Medicaid Services (CMS).

The company said it would refund directly to the 340B covered entity of record any amount equal to or in excess of $100 (aggregate for all applicable NDCs) for the time period listed in the notice. It said it would send separate correspondence, including a check and details of the payment, directly to the covered entity.

GSK’s notice includes contact information for 340B covered entities that may be owed less than $100 in aggregate or that have questions regarding the price recalculations or want additional information.

GSK sent out four refund notices for drug overcharges last year, also on inhaled medicines.

Trelegy and Nucala exceeded one billion British pounds in sales in 2021 for the first time, GSK’s full-year earnings results showed, with sales totaling 1.22 pounds ($1.47 billion) and 1.14 pounds ($1.37 billion), respectively.  The U.K.-based company is one of 21 drug manufacturers that have imposed limits on 340B pricing when covered entities contract with outside pharmacies to dispense 340B-purchased drugs. It announced its policy in February 2022. Drug makers EMD Serono and Bayer followed suit last week.