Janssen Biotech is paying refunds for overcharges on certain 340B drugs purchased in the third quarter of 2020.

Janssen to Pay Refunds for 340B Overcharges in Q2 2020

Drug manufacturer Janssen Pharmaceuticals said last week it would pay refunds for overcharges on 340B drugs purchased in the second quarter of 2020, including top-selling psoriasis drug Stelara.

Janssen, part of Johnson & Johnson, said it owes or may owe refunds for charges above 340B ceiling prices on seven NDCs for drugs purchased between April 1 and June 30, 2020, according to a May 4 notice posted on the U.S. Health Resources and Services Administration website.

The Belgian company said the refunds are due to “standard restatements of Medicaid pricing data” made to the U.S. Centers for Medicaid & Medicare Services. The covered products include Stelara, which generated $9.72 billion in 2022 sales and reportedly accounted for about 10% of J&J’s total revenues last year. The other affected products are Procrit, indicated for anemia due to chronic kidney disease; Tracleer, used to treat pulmonary arterial hypertension; and schizophrenia drug Paliperidone.

Janssen said it would communicate with and issue refunds through the wholesalers that submitted the original sale on behalf of the 340B covered entities. The notice includes an email address for refund inquiries.

The notice is Janssen’s second so far this year, with the company in January announcing refunds on 14 NDCs for overcharges during Q1 2020.  Janssen previously announced 340B overcharge refunds in March 2022 for 14 NDCs and in September 2021, also covering 14 NDCs.