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MEDICARE POSTS FINAL NATIONAL COVERAGE DETERMINATION FOR THE USE OF ERYTHROPOIESIS STIMULATING AGENTS

MEDICARE POSTS FINAL NATIONAL COVERAGE DETERMINATION FOR THE USE OF ERYTHROPOIESIS STIMULATING AGENTS
IN CANCER AND RELATED NEOPLASTIC CONDITIONS

For Immediate release July 30, 2007 5 MEDICARE POSTS FINAL NATIONAL COVERAGE DETERMINATION FOR THE USE OF ERYTHROPOIESIS STIMULATING AGENTS IN CANCER AND RELATED NEOPLASTIC CONDITIONS The Centers for Medicare & Medicaid Services (CMS) today announced its final national coverage determination (NCD) for the use of Erythropoiesis Stimulating Agents (ESA) in cancer and related neoplastic conditions. This NCD was opened in response to Food and Drug Administration�s (FDA) boxed warning regarding the use of ESAs. CMS published its proposed NCD on May 14, 2007, which opened a 30-day public comment period. The initial decision proposed that Medicare coverage of ESA treatment in beneficiaries with cancer should be limited to circumstances in which the treatment is not likely to worsen the cancer and in cases where the beneficiary�s anemia is responsive to the ESA. More than 2,600 public comments were received. After reviewing these public comments and additional evidence, CMS has modified the proposed coverage decision. The final NCD no longer distinguishes between those cancers that have erythropoietin receptors and cancers without such receptors. In addition, CMS has made no determination regarding ESA use for myelodysplastic syndrome (MDS). MDS is a premalignant syndrome that transforms into acute myeloid leukemia in many patients. In cases where no determination is made, Medicare local contractors have the discretion to make reasonable and necessary determinations regarding ESA use. The final NCD provides coverage with restrictions for the treatment of anemia secondary to myelosuppressive anticancer chemotherapy in certain cancer conditions, such as solid tumors, multiple myeloma, lymphoma and lymphocytic leukemia. The NCD details these restrictions, which include limiting initiation of ESA therapy to when the hemoglobin level is less than 10g/dL, limiting the ESA treatment duration to a maximum of 8 weeks after a chemotherapy session ends, limiting the starting dose to the FDA recommended starting dose, and limiting dose escalation levels. �Our goal was to maintain physician autonomy while ensuring the safety of our Medicare beneficiaries in light of the FDA boxed warnings,� CMS Acting Deputy Administrator Herb Kuhn said. �This final NCD is based on the best science to date and consistent with FDA labeling and warnings. We look forward to further reports from FDA and are prepared to make additional modifications to our policies to ensure that Medicare patients receive the best and most effective treatments.� CMS continues to be concerned with the safety signals highlighted by the FDA boxed warnings and encourages treating physicians to review the warnings and to take them into account when prescribing ESAs for their patients. ESAs are marketed in the US as Epogen, Aranesp and as Procrit. They are man-made versions of erythropoietin, a hormone that is produced in the kidney and stimulates the bone marrow to make more red blood cells. ESAs are FDA approved to reduce the need for blood transfusions in patients with end-stage renal disease, chronic kidney disease, patients with cancer on chemotherapy, patients scheduled for some major surgeries and patients with human immunodeficiency virus that are using Zidovudine (also known as AZT). Additional information from FDA can be found at: www.fda.gov/cder/drug/infopage/RHE/default.htm. The CMS decision will be effective on July 30, 2007. Details of the full coverage policy are available at the CMS coverage website at https://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=203.