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Study Shows Transfusions Increase After CMS Rule(BioWorld Today Via Acquire Media NewsEdge) Blood transfusions doubled for patients with chemotherapy-induced anemia at one Georgia clinic after the government issued a policy that markedly restricted payments for anemia drugs used in cancer patients, researchers reported Sunday. That policy, issued July 2007 by the Centers for Medicare & Medicaid Services (CMS), largely eliminated coverage for erythropoiesis-stimulating agents (ESAs) when patients with chemotherapy-induced anemia have hemoglobin concentrations above 10 g/dL. ESAs historically have been the largest prescription drug cost for Medicare under its Part B program. CMS's payment rule, known as the National Coverage Decision (NCD), does not affect use of ESAs in noncancer conditions, such as chronic renal disease. While Medicare covers the drugs to treat anemia caused by chemotherapy, it does not cover ESAs used to treat anemia caused by the cancer itself. CMS opened a review of its payment policy on the use of ESAs in cancer and related neoplastic conditions in response to the FDA's March 2007 call for a black-box warning on the drugs. The black box has been expanded twice since with stronger warnings. (See BioWorld Today, March 12, 2007, Nov. 9, 2007, and March 11, 2008.) The American Society of Clinical Oncology (ASCO) and the American Society of Hematology, which maintain joint clinical guidelines for ESA use in cancer patients, asked CMS to reconsider its rule, arguing that the policy interferes with a clinician's ability to provide the best possible treatment and could lead to an increase in red-blood-cell transfusions. Thousand Oaks, Calif.-based Amgen Inc. and Bridgewater, N.J.-based Ortho Biotech Products LP, which market ESAs, also have asked the agency to amend its policy. The firms have contended that the restrictive payment policy is a one-size-fits-all approach that could result in negative outcomes for patients. But so far, CMS has stood by its controversial NCD policy. However, the agency said it would consider any new evidence that showed the policy was having a negative effect on patient care. (See BioWorld Today, Sept. 26, 2007.) A retrospective observational study of electronic medical records of 285 patients at the Georgia Cancer Associates, a community-based oncology practice in Atlanta, found that blood transfusions for cancer patients with chemotherapy-induced anemia receiving ESAs in the second half of 2007 were double the rate of those in the first half of the year before the NCD policy was implemented, said Craig Tendler, vice president of medical affairs for Ortho Biotech. Results of that study were presented in a poster presentation Sunday in Chicago at ASCO's annual meeting. Tendler noted that the patients in the study, sponsored by Ortho Biotech, had received two or more dosages of ESAs with concurrent chemotherapy. Researchers did not collect data about any adverse events associated with the transfusions for the single-center study, Tendler told BioWorld Today. However, he added, the firm currently is conducting a larger study involving about 27 community-based oncology practices across the U.S. examining the broader impact of the NCD policy on patient care. "As we look at the initial study, it's a hypothesis-generating study that suggests that there is an increase in transfusion rates with the NCD policy," Tendler said. "Now we're trying to get more granular with that and really see what the impact is of more transfusions in a patient population that is anemic from chemotherapy." The larger study, he said, will investigate not only whether there has been an increase of blood transfusions, but also whether the transfusions have created more problems for patients with comorbid conditions or have interfered with patients receiving their chemotherapy treatments on time. "It's not that all transfusions are bad," Tendler said. "Sometimes the transfusion may be a good option, especially if the patient already is symptomatic and needs relief from symptoms of anemia. But the real issue that we are trying to get at with the larger study is, what are the downstream effects in terms of all patients getting a transfusion?" For instance, he said, a blood transfusion in a patient with congestive heart failure could exacerbate the condition. He noted that the larger study is examining a mix of large and small practices with electronic and paper medical records. Ortho Biotech hopes to have data from the larger study by the third quarter, which the firm will share with CMS, Tendler said, noting that the agency has "expressed an interest in seeing what the outcome is from a patient perspective with this policy." n ? ? Copyright ? 2008 Thomson BioWorld, All Rights Reserved. |