Oncologists who split their purchases of erythropoiesis-stimulating agents evenly between Amgen's Aranesp and Johnson & Johnson's Procrit will still be eligible for the "best" Aranesp discount under a new contracting policy, Amgen said.

The company will restructure its oncology clinic contract, previously known as the Amgen portfolio contract, effective Oct. 1.

Previously, the company linked rebates for its white blood cell growth factors Neulasta (pegfilgrastim) and Neupogen (filgrastim) to purchases of Aranesp (darbepoetin alpha). J&J's Ortho Biotech unit claimed this product bundling unfairly pushed physicians to favor Aranesp over Procrit and sued for an injunction against the practice; the firms settled for $200 million in July (¹ Also see "Amgen Pays $200M To Settle Antitrust Claim" - Pink Sheet, 11 July, 2008.).

Now, Amgen "is unbundling its multi-product oncology clinic contract and is offering oncology clinics separate contracts" for Aranesp, Neulasta and Neupogen, an Amgen spokesperson explained in an e-mail. Amgen said the settlement with Ortho Biotech "is not connected to these contract changes."

Under the new policy, "Aranesp discounts will be given at the time of purchase as off-invoice discounts based on the share of ESAs purchased," Amgen said. "Clinics who purchase Aranesp at least half of the time they purchase an ESA are eligible for our best discounts. This is irrespective of how much or how little ESAs they purchase. For example, if they purchase two ESAs, and at least one of them is Aranesp, they can get the discount."

Discounts for Neulasta and Neupogen will be based on the volume purchased.

The criticism Amgen received for its bundling policy and the impact it could have on patient safety played a role in the decision to do away with it. One example is a March letter from House Energy and Commerce Committee Chairman John Dingell, D-Mich., that expressed concern the bundling practice "helped fuel excessive and dangerous off-label uses of Aranesp." The company made a change early in 2008 to placate those concerns by switching the basis for rebates from sales volume to sales share (² Also see "Amgen’s Bundling Of ESAs With Neulasta and Neupogen Draws House Scrutiny" - Pink Sheet, 7 April, 2008., p. 13).

Amgen cited "stakeholder feedback" as one consideration that went into the latest restructuring and went on to note that the move will "help to clear up those possible misperceptions" that bundling created incentives for physicians to prescribe more ESAs.

Amgen also cited "changing marketplace conditions" as a reason for the change and referred to the recent addition of warnings to ESA labeling for cancer patients (³ Also see "FDA Flexes New FDAAA Muscle With ESA Safety Labeling - And May Help Tone Up Amgen’s Franchise" - Pink Sheet, 30 July, 2008.).

- Scott Steinke (s.steinke@elsevier.com)

Aranesp Contracts Revised: 50% Share Of ESA Purchases Qualifies Clinics For Best Discount

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