July 31, 2014—In response to the Health Resources and Services Administration’s new 340B orphan drug exclusion interpretive rule, the biopharmaceutical manufacturer Amgen has decided to continue providing 340B pricing on its orphan-designated products to critical access hospitals, sole community hospitals, rural referral centers, and free-standing cancer hospitals.[ms-protect-content id=”2799″]
Amgen had informed distributors in late June that, effective July 1, it would cease offering 340B pricing to rural and free-standing cancer hospitals on Sensipar, Nplate, Epogen, Enbrel, and Neulasta. But soon after the interpretative rule’s July 21 release, Amgen restored the hospitals’ access to 340B discounts on these products, with a July 1 effective date. Amgen has informed distributors that it will reprocess any affected transactions and provide credits.
On June 5, Apexus, the 340B Prime Vendor, said on its website that Genentech had notified it that “they have stopped providing 340B discounts on orphan drugs effective today” for rural and free-standing cancer hospitals.
Pharmaceutical Research and Manufacturers of America persuaded a federal district court in May to vacate HRSA’s original substantive 340B orphan drug regulation. It has asked the court to vacate the new interpretive rule, arguing that it is the old rule in disguise.[/ms-protect-content]