Three drug manufacturers—including two that have imposed conditions on 340B contract pharmacy—posted public notices this week to 340B covered entities about refunds for charges above 340B ceiling prices.
Bristol Myers Squibb (BMS) and Novo Nordisk’s notices came to light yesterday and Ipsen’s on Wednesday. All appear on the U.S. Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) website.
BMS
BMS’s notice said it is providing refunds on five NDCs for 340B purchases from Q1 2019 through Q2 2020 due to Medicaid pricing data revisions. It said it is working with Apexus, the 340B prime vendor, to issue credits. The notice includes contact information for entities that think they are owed a refund but that have not heard from Apexus by Feb. 28.
Two of the NDCs are for the myeloma drug Thalomid. Many hospitals have been complaining for years about inability to buy Thalomid and the related BMS drugs Revlimid and Pomalyst at 340B price—the subject of a six-part 340B Report investigation last year. BMS was asked yesterday afternoon how many entities it expects to give 340B refunds to for overcharges on the drug. As of press time, we had not heard back.
Last week, BMS announced that starting March 1 it would let 340B hospital and grantee entities each pick one of the 23 specialty pharmacies in its closed network for Revlimid, Pomalyst, and Thalomid as their contract pharmacy for 340B purchases of those drugs. BMS simultaneously announced that, for all its other covered outpatient drugs, hospitals would have to make 340B purchases either through an owned and operated pharmacy if they have one or through just one contract pharmacy. It exempted grantee entities from this condition on 340B sales.
Novo Nordisk
Novo Nordisk announced it is providing refunds on two NDCs of its Tresiba long-acting insulin for purchases from Q1 2019 through Q2 2019 due to Medicaid pricing data revisions. It too is working with Apexus to issue refunds, and it included contact information for entities that think they are owed a refund but that have not heard from Apexus by Jan. 31.
Effective Jan. 1, 2021, Novo Nordisk began letting hospitals make 340B purchases of its drugs only through just one in-house pharmacy if they have one or through just one contract pharmacy. Grantee entities can keep using multiple contract pharmacies.
Ipsen
Ipsen Biopharmaceuticals notified covered entities that they might be eligible for partial refunds for 340B purchases of Somutuline Depot, a treatment for certain tumors in adults, from Q1 2015 through Q2 2015 due to an update to the product’s base date average manufacturer price.
Ipsen said it has provided refunds to more than 90% of eligible entities. The notice includes contact information for any entities that believe they are owed one. Claims must be received by July 1.
