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CMS Coverage Proposal for Erythropoiesis-Stimulating Agents (ESAs) Jeopardizes Cancer Clinical Practice and Patient Access

Posted on: Wednesday, 13 June 2007, 18:02 CDT

BRIDGEWATER, N.J., June 13 /PRNewswire/ -- In comments submitted today, Ortho Biotech echoes the concerns of medical associations, health care professionals, patient advocates and individual patients who have voiced opinion that the Centers for Medicare and Medicaid Services (CMS) proposed National Coverage Determination (NCD) for erythropoiesis-stimulating agents (ESAs) may lead to unintended consequences for public health and adversely impact appropriate patient access to an approved treatment. The company, which markets PROCRIT(R) (Epoetin alfa), has made its comments available at http://www.orthobiotech.com/.

"We believe that if the proposed NCD were implemented, it would significantly restrict the ability of doctors to exercise good clinical decision-making in treating their individual patients, and could deny cancer patients undergoing chemotherapy access to an important medication that has long been the standard of care," said Craig Tendler, M.D., Vice President of Oncology Clinical Affairs, Ortho Biotech. "We recommend that CMS cover those uses of prescription drugs, including PROCRIT and other ESAs, that the U.S. Food and Drug Administration (FDA) has approved in product labeling. FDA approves prescription drug labels only after careful consideration of all available data and a thoughtful determination that the approved uses are safe and effective as supported by substantial evidence."

Medicare has provided coverage for Epoetin alfa since 1989. However, in its proposed NCD, CMS has broadly applied results of investigational studies researching uses of ESAs outside of labeled indications, and highly theoretical models, to propose non-coverage for a wide range of clinical conditions where the use of ESAs may be appropriate. In fact, recent discussions regarding ESA safety do not stem from approved uses for these drugs, but primarily from several studies conducted to test the hypothesis that investigational uses of ESAs beyond the correction of anemia might improve survival.

Ortho Biotech has provided detailed recommendations to CMS regarding several important areas, including supporting the agency's proposed coverage determination on a number of conditions that are proposed to be not reasonable and necessary. In its comments, the company disagrees with CMS' proposal to limit coverage in important conditions such as myelodysplasia or myelodysplastic syndrome (MDS), and disagrees with the agency's proposals regarding treatment initiation, duration of treatment and maximal dose based on substantial clinical evidence. PROCRIT is not FDA-approved for the treatment of patients with MDS.

Ortho Biotech believes that PROCRIT is safe and effective and has an acceptable benefit/risk profile for the treatment of anemia in patients with most types of cancer receiving concurrent chemotherapy when used according to its FDA-approved prescribing information. Epoetin alfa has been studied for more than 20 years and used in four million patients worldwide for approved indications.

About PROCRIT (Epoetin alfa)

PROCRIT can be 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.

U.S. FDA-Approved Oncology Usage for PROCRIT -- PROCRIT is indicated for the treatment of anemia in patients with nonmyeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. PROCRIT is indicated to decrease the need for transfusions in patients who will be receiving concomitant chemotherapy for a minimum of 2 months. -- PROCRIT is not indicated in patients with active malignant disease not receiving chemotherapy. PROCRIT is also not indicated for the treatment of anemia due to other factors such as iron or folate deficiencies, hemolysis or gastrointestinal bleeding, which should be managed appropriately. Important U.S. Safety Information for PROCRIT From the Boxed Warnings -- Use the lowest dose of PROCRIT that will gradually increase the hemoglobin (Hb) concentration to the lowest level sufficient to avoid the need for red blood cell (RBC) transfusion. -- PROCRIT and other erythropoiesis-stimulating agents (ESAs) increased the risk for death and for serious cardiovascular events (including serious arterial and venous thromboembolic events, myocardial infarction, stroke, congestive heart failure) when administered to target a Hb of greater than 12 g/dL. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may also contribute to these risks. -- Cancer patients: Use of ESAs: -- Shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a Hb of greater than 12 g/dL. -- Shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a Hb of greater than 12 g/dL. -- Increased the risk of death when administered to target a Hb of 12 g/dL in patients with active malignant disease receiving neither chemotherapy nor radiation therapy. ESAs are not indicated for this population. -- Patients receiving PROCRIT pre-operatively for reduction of allogeneic RBC transfusions: A higher incidence of deep venous thrombosis was documented in patients receiving PROCRIT who were not receiving prophylactic anticoagulation. Antithrombotic prophylaxis should be strongly considered when PROCRIT is used to reduce allogeneic RBC transfusions. 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 rate of Hb increase should not exceed 1 g/dL in any two-week period and the Hb concentration should not exceed 12 g/dL. -- If the Hb approaches 12 g/dL or increases by more than 1 g/dL in a 2- week period, the dose should be reduced by 25%. Withhold the dose of PROCRIT if the Hb exceeds 12 g/dL until the Hb falls below 11g/dL; restart dose at 25% below the previous dose. -- Monitor Hb regularly during therapy, weekly until Hb 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. -- 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. -- Seizures in PROCRIT-treated patients have been reported in the context of a significant increase in hemoglobin from baseline; increases in blood pressure were not always observed; and patients may have had other underlying central nervous system pathology. -- The most commonly reported side effects (>10%) for PROCRIT in clinical trials were pyrexia, diarrhea, nausea, vomiting, edema, asthenia, fatigue, shortness of breath, paresthesia, and upper respiratory infection.

Please visit http://www.procrit.com/ for the full Prescribing Information, including the Boxed Warning.

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 http://www.orthobiotech.com/.

Ortho Biotech Products, L.P.

CONTACT: Media, Kassy McGourty, +1-908-541-4090 office, +1-908-377-5873cell, kmcgourt@obius.jnj.com; or Investors, Louise Mehrotra, +1-732-524-6491,Stan Panasewicz, +1-732-524-2524, Lesley Fishman, +1-732-524-9322, all forOrtho Biotech Products, L.P.

Web site: http://www.orthobiotech.com/http://www.procrit.com/

Source: PRNewswire

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