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The company will provide new scientific evidence and highlight specificareas in which it believes that CMS materially misinterpreted existing data inreaching its current NCD. These two conditions are specified by CMS asnecessary for reconsideration of an NCD.
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"The goal of our reconsideration request is to re-open an evidence-baseddialogue with CMS to ensure that Medicare reimbursement for ESAs supports safeand effective treatment of anemia for patients receiving chemotherapy," saidCraig Tendler, M.D., Vice President, Medical Affairs, Oncology/Nephrology,Ortho Biotech Products L.P. "The policy of most concern is the imposition ofa coverage limit on ESA treatment once hemoglobin levels reach 10 grams perdeciliter of blood (g/dL). We will present CMS with additional scientificdata demonstrating the importance of individualizing ESA therapy --particularly when to initiate and stop therapy -- based on the medical needsof Medicare patients."
Ortho Biotech believes that PROCRIT is safe and effective for thetreatment of anemia in patients with most types of cancer receiving concurrentchemotherapy when used according to its FDA-approved prescribing information.Epoetin alfa has been studied for more than 20 years and used in four millionpatients worldwide for approved indications.
About PROCRIT (Epoetin alfa)
PROCRIT is used for the treatment of anemia in patients with most types ofcancer receiving chemotherapy, with chronic renal failure who are on dialysisand those who are not on dialysis, who are being treated with zidovudine forHIV infection, and to reduce the need for transfusion in anemic patients whoare scheduled for elective noncardiac, nonvascular surgery. Depending on thecountry in which Epoetin alfa is marketed, these indications may differ.
Important U.S. Safety Information for PROCRIT
Boxed WARNINGS: Increased Mortality, Serious Cardiovascular andThromboembolic Events, and Tumor Progression
Renal failure: Patients experienced greater risks for death and seriouscardiovascular 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 andmaintain hemoglobin levels within the range of 10 to 12 g/dL.
Perisurgery: PROCRIT increased the rate of deep venous thromboses inpatients not receiving prophylactic anticoagulation. Consider deep venousthrombosis prophylaxis.
Contraindications
PROCRIT is contraindicated in patients with uncontrolled hypertension orwith known hypersensitivity to albumin (human) or mammalian cell-derivedproducts.
Please visit www.procrit.com for the full Prescribing Information,including the Boxed WARNINGS.In its request, Ortho Biotech will present new evidence, including: -- Data addressing the hemoglobin concentrations at which Medicare patients receive transfusions; -- Data addressing transfusion risks associated with various hemoglobin concentrations at which ESA therapy is initiated; -- Data correlating maximum hemoglobin limits to achieved hemoglobin levels; -- Recent product labeling reviews in the EMEA and in the United States; -- New national practice guidelines; -- Further information concerning ESA U.S. registration trials; and -- Interim safety results of a large, randomized, placebo-controlled trial in patients with advanced Hodgkin's disease
