SAN FRANCISCO, Dec. 6 /PRNewswire/ -- Researchers today report that after the implementation of Medicare coverage limitations for erythropoiesis-stimulating agents (ESAs), a significantly greater proportion of anemic cancer patients who were on chemotherapy and who received ESAs needed blood transfusions and utilized more units of blood per patient than those patients who received ESAs prior to implementation of coverage limitations. The findings from this observational study will be presented at the 50th Annual Meeting of the American Society of Hematology on Saturday, December 6th at 9:00 a.m. PST.

In July 2007, the Centers for Medicare and Medicaid Services (CMS) issued coverage limitations, in the form of a National Coverage Determination (NCD), for the use of ESAs in anemic cancer patients receiving chemotherapy. An ongoing, prospective, observational study [Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) registry] is evaluating ESA-treated anemic cancer patients receiving chemotherapy. The present analyses were conducted using data from this study, focused on patients covered by Medicare before and after implementation of the CMS NCD for ESAs.

"We wanted to examine the potential impacts on transfusion patterns and hematologic changes in anemic Medicare patients receiving chemotherapy treated with ESAs before and after implementation of the ESA coverage limitations," said study director Chris L. Pashos, PhD, Vice President, Abt Bio-Pharma Solutions, Inc. "Our analyses found increased transfusion rates and greater blood utilization in anemic Medicare patients receiving chemotherapy and treated with ESAs after implementation of the ESA NCD compared with before implementation of the ESA NCD."

Study Methods and Results

Data from 288 Medicare patients (pre-NCD: 230, post-NCD: 58) from 41 sites included in the DOSE registry were analyzed. Data were categorized into two timeframes based on date of initial ESA administration (pre-NCD: April 2006 through April 2007; post-NCD: October 2007 through May 2008). Baseline characteristics of pre-NCD and post-NCD patients were similar for age, gender, weight and tumor type.

Compared to the pre-NCD patient group, a significantly greater proportion of Medicare patients in the post-NCD group received blood transfusions (post-NCD 32.8 percent vs. pre-NCD 18.3 percent, p= 0.0157), with greater blood utilization per patient (mean units of blood/patient: post-NCD 1.1 vs. pre-NCD 0.5, p= 0.0089). Significantly lower mean Hb levels (g/dL) were reported in the post-NCD group at all time points [Hb level (g/dL): post-NCD vs. pre-NCD: 9.6 vs. 10.6, 9.9. vs. 11.1, 10.4 vs. 11.2, 9.8 vs. 11.1 and 9.7 vs. 11.0 at baseline, Week 4, Week 8, Week 12 and Week 16, respectively]. The post-NCD ESA dosing guideline that impacts ESA utilization for anemic cancer patients receiving chemotherapy is the requirement to discontinue ESA dosing for Hb levels exceeding 10 g/dL. Safety, including thrombovascular events, was not examined in this analysis. An increased relative risk of thrombovascular events has been observed in ESA-treated patients; physicians should use the lowest dose needed to avoid red blood cell transfusion.

About the DOSE Registry

The Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) Registry is an ongoing prospective, observational study that aims to characterize ESA dosing patterns, hematologic outcomes, costs and patient-reported outcomes of anemic cancer patients receiving chemotherapy treated in United States (U.S.) oncology clinics. Centocor Ortho Biotech Services, LLC, supported the DOSE registry and this study.

About PROCRIT (Epoetin alfa)

PROCRIT 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 Safety Information

WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, and increased risk of tumor progression OR recurrence

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 increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers (see WARNINGS: Table 1).
• To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
• Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
• ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
• Discontinue following the completion of a chemotherapy course.

Perisurgery: PROCRIT (Epoetin alfa) 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

• Patients with chronic renal failure experienced greater risks for death and serious cardiovascular events (including myocardial infarction, stroke, congestive heart failure, and hemodialysis vascular access thrombosis) when administered ESAs to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies; these risks also increased in controlled clinical trials of patients with cancer. A rate of hemoglobin rise of 1 g/dL over 2 weeks may contribute to these risks.
• Dose of PROCRIT
  • Chronic renal failure patients: The dose of PROCRIT should be titrated for each patient to achieve and maintain 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 patients: PROCRIT therapy should not be initiated at hemoglobin levels greater than or equal to 10 g/dL. The dose of PROCRIT should be titrated for each patient to achieve and maintain the lowest hemoglobin level sufficient to avoid the need for blood transfusion. Discontinue if after 8 weeks of therapy there is no response as measured by hemoglobin levels or if transfusions are still required (see recommended Dose Modification section in DOSAGE and ADMINISTRATION of the PROCRIT Prescribing Information).
  • HIV patients: The dose of PROCRIT should be titrated for each patient to achieve and maintain the lowest hemoglobin level sufficient to avoid transfusion and not to exceed the upper safety limit of 12 g/dL.
• Monitor hemoglobin regularly during therapy, weekly 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 treated with PROCRIT; predominantly 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.
• Treatment of patients with grossly elevated serum erythropoietin levels (e.g., >200 mUnits/mL) is not recommended.
• 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 www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS, and for the Medication Guide and Patient Instructions for Use.

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.

Note: Data in this release correspond to ASH abstract 1301

SOURCE Ortho Biotech Products, L.P.