September 9, 2013—Biopharmaceutical manufacturer Onyx, which is being purchased by biotech giant Amgen for $10.4 billion, has announced that 340B covered entities that bought its injectable oncology medication Kyprolis during the first quarter of 2013 might be eligible for refunds for overcharges.[ms-protect-content id=”2799″]
The Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) posted a notice from Onyx about the potential refunds on its home page today. The California-based company markets just two drugs in the United States: Kyprolis, which is for the treatment of multiple myeloma, and Nexavar, an oral medication for liver and kidney cancer.
According to the notice on the OPA website, Onyx launched Kyprolis during the third quarter of 2012. The company said that, consistent with HRSA regulations for the setting of 340B ceiling prices on new covered outpatient drugs, it estimated the drug’s 340B price for the initial quarters after launch. Later, also pursuant to HRSA regulations, it said, it reconciled its estimated price with the actual average manufacturer price and unit rebate amount “and determined that the estimated ceiling price for Kyprolis in Q1 2013 exceeded the reconciled ceiling price by $12.94 per vial.”
Onyx said that under HRSA regulations for refunds when a new product’s estimated ceiling price exceeds its reconciled price, “the manufacturer bears the burden of identifying the lower reconciled ceiling price and covered entities bear the burden of requesting refunds for the price differential.”
The notice directs covered entities that believe they are owed a refund to contact Onyx at 340B-Refund@onyx.com by no later than Dec. 31, 2013 and to provide the number of vials purchased, distributor invoice dates, and a contact name and email address.
In late August, the biopharmaceutical manufacturer Genentech announced that it will be providing refunds to 340B covered entities on 19 of its products sold from the third quarter of 2008 through the second quarter of 2011 due to a recalculation of its Medicaid average manufacturer prices and best prices.
Like Onyx, Genentech is not providing its refunds to covered entities automatically, but instead is requiring them to contact the manufacturer if they believe they were overcharged.
Unlike Onyx, however, Genentech has not disclosed the amounts that covered entities are owed for overcharges.[/ms-protect-content]