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New Data Highlighting Possible Impact of ESA Reimbursement Policies on Patient Care, Nation's Blood Supply, to be Presented at American Society of Clinical Oncology (ASCO) Annual Meeting

BRIDGEWATER, N.J., May 16 /PRNewswire/ -- 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 <10 g/dL vs. 10-11 g/dL. Hospital- and community-based outpatient practices were included in the analysis.

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


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.


-- 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 greater than or equal to 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


-- 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.


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:

- 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.

- 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 greater than or equal to 20% and

ferritin should be greater than or equal to 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 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

Note: Data in this release correspond to ASCO abstracts 6637 and 6548 and publication number 20637

SOURCE Ortho Biotech Products, L.P.
Copyright©2008 PR Newswire.
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