Amgen Comment On New OPPS Rule
THOUSAND OAKS, Calif., - Amgen Inc, October 31, 2002 - (Nasdaq:AMGN). The Centers for Medicare & Medicaid Services (CMS) today announced changes to the hospital outpatient prospective payment system. This announcement includes a rule that sets a reimbursement rate for Aranesp® (darbepoetin alfa) for Medicare patients in the hospital outpatient setting that will be significantly reduced effective January 1, 2003. The hospital outpatient setting accounts for approximately 10% of the current revenues of Aranesp. Reimbursement in the physician's office remains unchanged and continues to be set at 95% AWP.
CMS is directing the National Cancer Institute to initiate a clinical study to evaluate the appropriate dose conversion ratio for the rule. The rule further states that "if (CMS) can estimate a more accurate conversion ratio based on this study or from our review of our own payment data, we will make a change to reflect this ratio as soon as practicable."
In the rule, Aranesp and Procrit® are inaccurately characterized as "functionally equivalent" products and Aranesp is not recognized as a new therapy. Amgen objects to this mischaracterization of Aranesp. Aranesp is a unique and innovative biologic with a three times longer half-life and is dosed less frequently than is Procrit. The unique character of Aranesp is widely accepted and has been recognized by the FDA. Further, the new reimbursement rate set by CMS for the hospital outpatient setting was based on an Aranesp dose that is inconsistent with actual clinical practice.
Amgen will work vigorously to correct the inaccuracies in the rule in all appropriate forums.
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent Form 10-Q. Amgen conducts research in the biotechnology/pharmaceutical field where movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product.
Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. In addition, sales of our products are affected by reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers. These government regulations and reimbursement policies may affect the development, usage and pricing of our products.
In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors.
Because forward-looking statements involve risks and uncertainties, actual results may differ materially from current results expected by Amgen. Amgen is providing this information as of October 31, 2002 and expressly disclaims any duty to update information contained in this press release.
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
||Amgen, Thousand Oaks
||Barbara Bronson Gray, 805/447-4949 (media)
||Cary Rosansky, 805/447-4634 (investors)
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