GlaxoSmithKline is one of three drug manufacturers that recently announced refunds for 340B overcharges.

GlaxoSmithKline, Exelan, and BioMarin Issue 340B Refunds

Three drug manufacturers recently announced they are refunding 340B overpayments to covered entities, part of a growing number of companies that have disclosed they miscalculated the pricing of their products.

The U.S. Health Resources and Services Administration posted GlaxoSmithKline, Exelan, and BioMarin’s refund notices on its website late last week.

Exelan, which is part of the Indian pharmaceutical giant Cipla, Ltd., had the largest list of drugs for which it was providing refunds: 19 in all. They include the anti-depressant Setraline; cholesterol drug Pravastatin; and blood thinner Warfarin, among others. Altogether, it was offering refunds on 69 NDCs altogether. The refunds are connected to drugs sold between April 1 and Aug. 11, 2021.

BioMarin is offering refunds on one drug, Naglazyme, which is used in enzyme replacement therapy. For the time period Q4 2020 through Q1 2021. Earlier this year, it announced refunds for overcharges on five of its six approved medicines, including Naglazyme, from Q1 2019 through Q4 2020.

GSK is offering refunds on four drugs used to treat chronic obstructive pulmonary disease: Anoro, Breo Incruse and Trelegy; Arnuity, a nasal spray that treats rhinitis; Dovato, an anti-retroviral used to treat HIV; and diabetes drug Tanzeum. The refunds are connected to 340B sales that occurred between October and December 2019.

GSK said it is paying refunds directly to any covered entity owed $100 or more. For refunds of less than $100, it has asked covered entities to contact the company directly. Exelan said it is issuing direct refunds totaling $10 or more.

The three companies either declined comment or did not respond to a query seeking comment.

Altogether, 16 340B refund notices have been released by manufacturers in 2021, versus 15 in 2020, seven in 2019 and five in 2018.

Barbara Straub Williams, a principal with the Washington, D.C., law firm of Powers Pyles Sutter & Verville, observed that HRSA began publicly issuing its audits of manufacturers in 2018.

“The audit findings may have spurred manufacturers to review their pricing practices,” Williams said.

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