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AMGEN EPO COST-BENEFIT STUDY HAS BEEN SUBMITTED TO HCFA AND FDA

Executive Summary

AMGEN EPO COST-BENEFIT STUDY HAS BEEN SUBMITTED TO HCFA AND FDA, according to the firm. The study was conducted by the Battelle Institute's Battelle Human Affairs Research Center in Seattle under the direction of Roger Evans. Following meetings between Amgen and HCFA that formally began in June 1988, the study was commissioned in an effort to ensure that a reimbursement policy is issued upon approval of Amgen's recombinant erythropoietin product, Epogen. The product's approval is expected at any time. Amgen filed its Product License Application at the end of 1987 for anemias in dialysis patients with end-stage renal disease. Medicare's End-Stage Renal Disease Program covers the cost of dialysis treatment for patients of all ages. As part of the analysis, Evans devised a questionnaire to collect data not gathered from the standard medical protocols for clinical trials. The questionnaire addressed such issues as patient activity levels and ability to return to work. For example, nurses treating patients in Epogen clinical trials were asked to estimate daily patient activity at home and the amount of strain on family members due to an inactive patient. Amgen's U.S. marketing partner, Johnson & Johnson, has estimated the cost of Epogen therapy at $ 4,000-$ 8,000 per patient per year. The Battelle study was aimed at demonstrating that Epogen's treatment benefits balanced its steep price tag. In touting the product's cost effectiveness, Amgen has cited the "virtual elimination" of blood transfusions for Epogen patients. At the time the study was begun, Amgen had predicted that cost benefits from Epogen would be most significant for patients in earlier stages of dialysis because they would not be weakened by chronic anemia and thus not require long-term therapy to reverse debilitation. The market for erythropoeitin is a potentially large one. Clinical Nephrology Professor Joseph Eschbach of the University of Washington has predicted that once approved, EPO would be used by two-thirds to three-fourths of the 75,000 U.S. dialysis patients.(ITEM 200)#050928M001J59307# #970804M001XFCWP5# (ITEM 201)(COPYRIGHT) 1989 F-D-C Reports, Inc., The Pink Sheet, February 20, 1989

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