May 31, 2013—The group that represents hospitals in the 340B drug discount program has asked the pharmaceutical manufacturer Amgen to withdraw its new requirement that all 340B purchases of the company’s drug Neulasta be made exclusively through specialty distribution channels.
In a May 30 statement, Safety Net Hospitals for Pharmaceutical Access (SNHPA) said the policy discriminates against 340B hospitals in violation of federal guidelines and will impose significant financial costs and administrative burdens upon them.[ms-protect-content id=”2799″] The group said one hospital told it that the change would cost it about $200,000 annually.
The purchasing restriction begins for some hospitals as soon as tomorrow, June 1. For others, it will take effect over the next two weeks, depending on which pharmaceutical wholesaler the hospital uses.
SNHPA said it will ask the Health Resources and Services Administration (HRSA) to investigate the matter if Amgen does not reverse course. The company could not be reached for comment. Amgen was quoted elsewhere as saying that it complies with all 340B program requirements and that it made the change to track and audit 340B sales more efficiently and accurately. It said Neulasta has predominantly been distributed through a specialty channel and that the change does not affect the drug’s wholesale acquisition price or the discounts offered to those in the 340B program.
Neulasta is an expensive, man-made human protein used to reduce the risk of infection in patients undergoing chemotherapy. SNHPA said a hospital informed it that it received a notice from its wholesaler that, beginning June 1, Amgen would require it to purchase all 340B-priced Neulasta through that wholesaler’s specialty drug division. The notice said that the new requirement does not apply to non-340B purchases of Neulasta. SNHPA said another hospital reported that it received a similar notice about 340B-purchased Neulasta from a different wholesaler stating that the new specialty distribution model would begin on June 6.
“We urge Amgen to withdraw this distribution plan for Neulasta,” SNHPA said in its May 29 letter to the company. “The plan violates federal policy prohibiting restrictions that create significant administrative and financial challenges for 340B providers. If Amgen moves forward with this plan, SNHPA will ask HRSA to look into the matter.”
The hospital group said Amgen’s new requirement will force 340B hospitals to pay more for Neulasta because wholesalers normally sell the drug at a lower price than specialty distributors. The policy will also cause shipments to take longer, increase staff costs, and raise the risk of program noncompliance due to the need to enter data manually that can no longer be handled by hospitals’ split-billing software programs, SNHPA added.[/ms-protect-content]