ATLANTA, Dec. 10 /PRNewswire/ -- A new analysis presented today at the American Society of Hematology (ASH) 49th Annual Meeting and Exposition predicts that limiting the use of erythropoiesis-stimulating agents (ESAs) for chemotherapy-induced anemia (CIA) would place considerable pressure on the available marginal U.S. blood supply. Using a modeling simulation technique that allowed for varying the magnitude of reduction in ESA use, findings suggested that even at the lowest reduction evaluated, 25 percent, there was a substantial impact on the available marginal blood supply.
“The nation’s blood supply is a limited resource and this analysis underscores the vulnerability of the situation,” said Francis Vekeman, M.A., Economist, Groupe d’analyse, Ltee, and lead author of the new analysis. “Given the small margin between usable blood and transfusion demand, understanding the impact of limiting ESA use in cancer chemotherapy patients is essential. Over the last 18 years, a large body of scientific data has demonstrated the ability of ESAs to help patients avoid blood transfusions.”
Background
Between 1987 and 1997, the demand for allogeneic blood [whole blood and packed red blood count (RBC)] in the U.S. decreased due to safety concerns. In the same period, the blood supply also decreased, resulting in a 48 percent reduction in the margin between available supply and demand. Despite increases in both supply and demand by 2004, the last year data was available, the margin further declined to only 6.1 percent (allogeneic blood collection of 14.8 million units and transfusion at 13.9 million units). After screening, 240,000 units were rejected leaving a margin of only 648,000 units available, or 4.5 percent of the supply.
Study Methodology
The primary purpose of the study was to estimate the impact of limiting the use of ESAs for CIA patients on the U.S. blood supply.
A modeling simulation was used to compare the number of RBC units transfused in ESA-treated patients to the number of RBC units that would be transfused if ESAs were discontinued or limited in the same population. The excess number of RBC units required if limiting ESA treatment in CIA patients was then contrasted with the available marginal blood supply from 2004.
Inputs to the model included: incident cases of CIA patients treated with an ESA; transfusion rates from clinical trials; and volume of RBC units required for ESA-treated and untreated patients. Estimates were developed for multiple scenarios highlighting various levels of ESA reduction, and sensitivity analyses were conducted using a range of +/- 10 percent for each input parameter.
Study Results
Under the base case scenario, it was estimated that 492,002 CIA patients received a total of 372,809 RBC units despite ESA treatment. Additional estimates are as follows:
The added pressure on the blood supply does not consider additional exacerbations due to regional and seasonal variation in the number of available units, as well as donation frequency variations.
About PROCRIT (Epoetin alfa)
PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.
Important U.S. Safety Information for PROCRIT
Boxed WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION
Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
Perisurgery: PROCRIT increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
Contraindications
PROCRIT is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.
Please visit www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.
About Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients’ health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit www.orthobiotech.com.
CONTACT: Media, Stephanie Fagan, +1-908-541-4029, or cell,
+1-201-572-9581, sfagan@obius.jnj.com, for Ortho Biotech Products, L.P.
Web site: http://www.orthobiotech.com/
http://www.procrit.com/