Data from three studies evaluating associations between lower mean baseline hemoglobin (Hb) levels and the rate of blood transfusions, as well as the possible effect of restrictions on reimbursement for erythropoiesis-stimulating agents (ESAs) in Medicare patients on the nation’s blood supply, will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting later this month. The meeting will take place in Chicago from May 30 to June 3, 2008.
Data from the following studies will be presented:
Transfusion Outcomes in Erythropoiesis-Stimulating Agent (ESA)-Treated Cancer Chemotherapy Patients Based on Achieved Hemoglobin (Hb) Levels
Kay Larholt, Sc.D., Abt Associates, Lexington, MA
Presentation: Health Svcs Research, Sunday, June 1, 2008; 8:00am – 12:00pm CST, S Hall A1 Abstract Number: 6637 Last year, the Centers for Medicare and Medicaid Services (CMS) implemented a National Coverage Determination (NCD) largely eliminating coverage for non-renal ESA administration when patients have hemoglobin concentrations above 10 grams per deciliter of blood (g/dL). This study assessed the potential clinical implications of these policy changes by evaluating data from an ongoing prospective registry of ESA-treated patients in 55 U.S. oncology clinics between December 2003 and November 2007. Data were analyzed from 330 adult chemotherapy-treated oncology patients who had hemoglobin concentrations less than 10 g/dL prior to ESA administration and received two or more ESA doses. Transfusion-related outcomes were categorized based on mean Hb values achieved during ESA treatment into three cohorts: mean achieved Hb between 9.1 g/dL and 10 g/dL, between 10.1 g/dL and
11 g/dL, or between 11.1 g/dL and 12 g/dL.
Hematologic and Transfusion Outcomes Following Implementation of the Erythropoiesis-Stimulating Agent (ESA) National Coverage Determination (NCD) in Medicare Cancer Patients Receiving Chemotherapy
James Gilmore, PharmD, Georgia Cancer Associates, Atlanta, GA
Presentation: Health Svcs Research, Sunday, June 1, 2008, 8:00am – 12:00pm CST, S Hall A1 Abstract Number: 6548 The purpose of this study was to describe the association between the CMS NCD and clinical outcomes for patients with chemotherapy-induced anemia requiring ESA therapy, as determined by the treating physician. A total of 285 Medicare patients receiving two or more ESA doses with concurrent chemotherapy and a cancer diagnosis were included in this retrospective observational study of an electronic medical record database.
Transfusion Outcomes Among Oncology Patients Initiated with Erythropoiesis-Stimulating Agents (ESAs) at Baseline (BL) Hemoglobin (Hb) of < 10 v. 10-11g/dL: Observational Data from the Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) Registry
Tanya Burton, Ph.D., Abt Associates, Lexington, MA Publication Number: 20637 Limited real-world data exist on transfusion patterns in patients initiated with ESAs at different baseline Hb levels. Observational data from an ongoing, prospective registry of 1,059 ESA-treated patients in 59 U.S. oncology clinics from December 2003 to November 2007 were analyzed to investigate transfusion outcomes in chemotherapy-treated oncology patients initiated on ESAs at baseline Hb of
About PROCRIT (Epoetin alfa)
PROCRIT(r) (Epoetin alfa) is an ESA 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.
Cancer:
* ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ≥ 12 g/dL.
* The risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL. * To minimize these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusions. * Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy. * Discontinue following the completion of a chemotherapy course. Perisurgery: PROCRIT(r) 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. Additional Important Safety Information * The dose of PROCRIT should be titrated for each patient to achieve and maintain the following hemoglobin levels: o Chronic renal failure patients – hemoglobin levels between 10 to 12 g/dL. If a patient does not attain hemoglobin levels of 10 to 12 g/dL despite 12 weeks of appropriate PROCRIT therapy, see DOSAGE and ADMINISTRATION in the PROCRIT Prescribing Information. o Cancer or HIV patients – the lowest hemoglobin level sufficient to avoid transfusion and not to exceed 12 g/dL. * Monitor hemoglobin regularly during therapy, more frequently following a dosage adjustment or until hemoglobin becomes stable. * Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients with chronic renal failure receiving PROCRIT by subcutaneous administration. If any patient develops a sudden loss of response to PROCRIT, accompanied by severe anemia and low reticulocyte count, and anti-erythropoietin antibody-associated anemia is suspected, withhold PROCRIT and other erythropoietic proteins. Contact ORTHO BIOTECH (1-888-2ASKOBI or 1-888-227-5624) to perform assays for binding and neutralizing antibodies. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT should be permanently discontinued and patients should not be switched to other erythropoietic proteins. * The safety and efficacy of PROCRIT therapy have not been established in patients with a known history of a seizure disorder or underlying hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes or hypercoagulable disorders). * In some female patients, menses have resumed following PROCRIT therapy; the possibility of pregnancy should be discussed and the need for contraception evaluated. * Prior to and regularly during PROCRIT therapy monitor iron status; transferrin saturation should be P 20% and ferritin should be 100 ng/mL. During therapy absolute or functional iron deficiency may develop and all patients will eventually require supplemental iron to adequately support erythropoiesis stimulated by PROCRIT. * During PROCRIT therapy, blood pressure should be monitored carefully and aggressively managed, particularly in patients with an underlying history of hypertension or cardiovascular disease. * In studies, the most common side effects included fever (pyrexia), diarrhea, nausea, vomiting, swelling of hands or feet (edema), lack or loss of strength or weakness (asthenia, fatigue), shortness of breath, high blood pressure, headache, joint pain (arthralgias), abnormal skin sensations (as tingling or tickling or itching or burning; paresthesia), rash, constipation and upper respiratory infection. Please visit procrit 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. Ortho Biotech Products