HORSHAM, Pa., May 13 /PRNewswire/ -- Data from a study of managed-care cancer patients receiving chemotherapy and newly treated with erythropoiesis-stimulating agents (ESAs) found that the cumulative ESA cost with Epoetin alfa (EPO) was 29 percent lower than treatment with darbepoetin alfa (DARB). The analysis, published in the Spring issue of the Journal of Medical Economics, was sponsored by Centocor Ortho Biotech Services, LLC.
The retrospective cohort study of 10,928 patients investigated the current real-world dosing patterns and associated ESA costs in an adult cancer chemotherapy population. The data showed that the cumulative ESA cost was $4,321 for patients receiving EPO vs. $6,089 for DARB patients (p<0.0001). The dose ratio was 255 units of EPO to 1 microgram (mcg) of DARB. The authors stated these findings are consistent with dose ratios from studies of randomized clinical trials and other observational studies.
The EPO:DARB dose ratio often is used to compare the relative utilization of EPO and DARB because EPO is measured in International Units and DARB is measured in micrograms. It is based on the agents' cumulative treatment doses and often is used for reimbursement purposes by payers.
"Information regarding the dose ratio between EPO and DARB in real-world settings is important to ensure healthcare resources are used efficiently," said Francis Vekeman, M.A., Senior Economist, Groupe d'analyse, Ltee, Montreal, Quebec, Canada. "Managed care organizations may find it informative that our retrospective analysis reported a dose ratio of EPO to DARB of 255:1, which was associated with lower ESA costs for patients receiving EPO in the managed care setting."
About the Study
Vekeman et al. conducted a retrospective cohort study of medical claims data from the PharMetrics Patient-Centric database of approximately 85 health plans from January 2006 to January 2008. Data were analyzed from 10,928 patients (4,111 EPO patients and 6,817 DARB patients) who had at least one cancer claim within 90 days prior to ESA treatment initiation, were newly initiated on EPO or DARB, received two or more EPO or DARB doses and were treated with concomitant chemotherapy during the treatment episode.
The average treatment duration was slightly longer in the EPO group (EPO: 58.4 days, DARB: 55.4 days, p=0.0019). During the course of the treatment period, patients in the EPO group received on average a total of 329,129 units while those in the DARB group received on average a total of 1,289 mcg, which resulted in a dose ratio of 255:1 (units EPO: mcg DARB). Based on April 2008 wholesale acquisition cost unit prices (EPO $13.13/1,000 units, DARB $4.722/mcg), the cumulative drug cost was 29 percent lower for EPO patients compared to those patients receiving DARB ($4,321 vs. $6,089, p<0.0001). Furthermore, EPO treatment was found to be 25 percent less expensive than DARB when physician visit costs were included ($4,868 vs. $6,459, p<0.0001).
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 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.
- 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.
- 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. PRCA has also been reported in patients receiving ESAs while undergoing treatment for Hepatitis C with interferon and ribavirin. 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 Centocor Ortho Biotech Products, L.P.
Centocor Ortho Biotech redefines the standard of care in immunology, nephrology, and oncology. The company was formed when Centocor, Inc. and Ortho Biotech Products, L.P. were consolidated in late 2008, and was renamed Centocor Ortho Biotech. Built upon a pioneering history, Centocor Ortho Biotech harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates, and healthcare professionals have access to the latest treatment information, support services, and quality care.
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