June 12, 2013—The Health Resources and Services Administration (HRSA) says Amgen’s decision to sell its biologic drug Neulasta at 340B pricing exclusively through specialty distributors “will not violate the 340B statute,” the agency has told both the association representing 340B hospitals and the 340B prime vendor.
Neulasta is an expensive, man-made human protein used to reduce the risk of infection in patients undergoing chemotherapy.[ms-protect-content id=”2799″] Amgen has said that it complies with all 340B program requirements and that it made the change to track and audit 340B sales more efficiently and accurately.
In a June 10 letter to Safety Net Hospitals for Pharmaceutical Access (SNHPA), HRSA Office of Pharmacy Affairs (OPA) Dir. Cmdr. Krista Pedley said Amgen’s policy is permissible because it “is providing the 340B ceiling price [on Neulasta] to covered entities and this distribution plan is in place for both 340B and other non-340B customers.” Apexus 340B Prime Vendor Program has said that HRSA told it the same in a separate communication.
While HRSA said that Amgen’s policy applies to “other” non-340B customers, it did not specify whether the policy applies to all non-340B customers. This leaves open the possibility than an undetermined number of Amgen’s customers will continue to be able to buy Neulasta outside of 340B through normal wholesale channels.
HRSA guidelines forbid drug manufacturers from singling out 340B customers for restrictive conditions or limitations on transactions that undermine the 340B program’s purpose or discourage participation.
SNHPA argues that forcing Neulasta sales through specialty distributors when they are made through 340B accounts places “significant administrative and financial challenges” on 340B covered entities.
According to the group, purchases through specialty distributors are normally more expensive than through normal wholesalers and deliveries often take longer. Such delays, it says, can erode savings achieved on high-cost drugs through “just-in-time” delivery. SNHPA also says hospitals will be exposed to higher costs and greater risk of program noncompliance because they will have to enter purchases from specialty distributors into their inventory management systems manually. Hospitals’ split-billing software programs, which hospitals rely on for 340B compliance purposes, automatically load purchases made from wholesalers into their virtual inventory systems.
HRSA told both SNHPA and Apexus that it “will continue to monitor Amgen to ensure 340B covered entities have access to Neulasta at 340B discounted pricing.”[/ms-protect-content]