(UPDATED September 3, 2013 with comment from Genentech)
August 29, 2013—The biopharmaceutical giant Genentech 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, according to a notice by the company posted on the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) home page.[ms-protect-content id=”2799″]
The products cover 10 specific medications, including four of the top 30 in terms of overall U.S. sales—Rituxan, Avastin, Herceptin, and Lucentis. A HRSA spokesperson said the agency lacks the information to be able to answer what the range of potential refunds might be and referred such questions to Genentech. “The process of refunds is an issue to be handled between covered entities and manufacturers,” HRSA said. “HRSA is only posting the information to ensure entities that may be affected have the opportunity to receive a refund.” A Genentech spokesperson said: “As part of routine 340B program integrity efforts, Genentech is restating 340B drug prices for the products listed in the OPA notice. We are not disclosing specific refund amounts, but will discuss details with individual 340B covered entities who contact us if they feel they may be eligible for a refund.”
Genentech’s announcement comes at a time of intense scrutiny of 340B covered entities and allegations of widespread program abuse that providers strongly contest. Hospital groups are displeased that while HRSA has audited more than 100 hospitals and health centers for program compliance, it has not audited a drug manufacturer. Hospitals also note that HRSA still has not implemented a 2010 law requiring it to begin verifying the accuracy of 340B ceiling prices; to perform spot checks of 340B sales; to establish procedures for providing 340B refunds; to make 340B ceiling prices accessible to providers via a secure website; and to impose civil monetary penalties on manufacturers for knowing and intentional overcharges.
In its announcement on the OPA home page, Genentech said it “will issue refunds to 340B covered entities where our data indicates a difference between the original and recalculated 340B ceiling price for direct and indirect purchases” of the 19 affected products.
Genentech is giving covered entities until Dec. 31, 2013 to contact the company if they believe they are eligible for a refund. Entities should contact Marinell Javier at (650) 467-3370 or javier.marinell@gene.com.
In addition to Rituxan, Avastin, Herceptin, and Lucentis, the other Genentech drugs subject to refunds are:
- Activase
- Boniva
- Nutropin
- Pegasys
- TNKase
- Xolair
Covered entities should refer to Genentech’s notice for the affected products’ NDC numbers and descriptions.[/ms-protect-content]