Group asks Amgen to withdraw 340B plan for Neulasta

A trade group representing nearly 1,000 hospitals that participate in Medicare's 340B discount program sent a Amgen Inc. (NASDAQ:AMGN) requesting the biotech withdraw a distribution plan that would require hospitals to purchase all 340B-priced Neulasta pegfilgrastim through the ASD healthcare specialty drug division of wholesaler Amerisource Bergen Corp. (NYSE:ABC). Safety Net Hospitals for Pharmaceutical Access (SNHPA), which said the requirement would apply to 340B purchases only, said Amgen's plan "violates federal policy prohibiting restrictions that create significant administrative and financial challenges for 340B providers" that do not apply to non-340B entities. The group claims wholesalers typically sell a drug at a lower price than specialty distributors, and that use of specialty distributors can require higher administrative costs to the hospital. The 340B program requires manufacturers to give deep discounts on outpatient drugs to hospitals and clinics that provide healthcare to low income and other special populations. SNHPA said it will ask HHS's Health Resources and Services Administration (HRSA) to investigate if Amgen does not withdraw its plan.

In a statement, Amgen said changing to a specialty distribution channel does not impact the wholesale acquisition price for Neulasta or the statutory discounts offered to 340B entities. The company, which noted that Neulasta has "predominantly been distributed through a specialty channel," also said the distribution plan will allow Amgen to "more efficiently and accurately track and audit sales to the 340B entity segment." ...