THOUSAND OAKS, Calif.--(BUSINESS WIRE)--July 31, 2007--Amgen (NASDAQ:AMGN) today announced its response to the Centers for Medicare and Medicaid Services' (CMS) final National Coverage Determination (NCD) on the use of erythropoiesis-stimulating agents (ESAs) in cancer and related neoplastic conditions. Based on Amgen's preliminary review, it appears that CMS has adopted a policy that will limit the availability of these vital medicines to Medicare beneficiaries with cancer. While the decision makes several positive changes from the earlier proposed NCD, ESA treatment is not covered if the patient's hemoglobin (Hb) level is greater than 10 g/dL.
"The coverage restrictions placed on the FDA-approved indication have no scientific basis and are incompatible with good clinical practice," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Global Research and Development at Amgen. "We are concerned that inappropriately limiting coverage for ESAs at hemoglobin levels less than 10 g/dL will both increase blood transfusions and severely compromise the high quality of cancer care delivered by American physicians. In our view, restricting coverage in this way is unreasonable, impractical and unworkable. Moreover, through this coverage decision, the CMS has undermined the ability of physicians to decide how best to administer ESA therapy to their patients through carefully defined dosing guidance articulated by the FDA."
Limiting reimbursement to only patients who have a Hb level that is less than 10 g/dL is contrary to the U.S. Food and Drug Administration's (FDA) approved labeling for ESAs, the Oncologic Drugs Advisory Committee's (ODAC) recommendation against changing the upper hemoglobin limit of 12 g/dL in the current FDA label, and clinical practice guidelines from the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH). In addition, this criterion runs counter to the strongly held views of many patient groups, physicians, and other members of the oncology community who argued in response to the draft NCD for a coverage range up to 12 g/dL.
The decision makes several positive changes from the earlier proposed NCD, including:
-- ESA treatment for anemia due to chemotherapy is covered across
all tumor types, and will be covered for eight weeks following
the final dose of myelosuppressive chemotherapy.
-- Concomitant use with certain biologic therapies, such as Vectibix(TM) (panitumumab) and Avastin(R) (bevacizumab) was not excluded.
-- Coverage of ESAs for myelodysplastic syndromes (MDS) based on decisions by local carriers was retained.
-- The Hb level at which covered ESA therapy could be initiated was increased from 9 g/dL to 10 g/dL.
-- Coverage of ESAs was extended without requiring patients to enroll in clinical research programs or clinical trials, which CMS had raised as a possibility in its proposed NCD.
CMS also included some restrictions from the proposed NCD that many in the oncology community supported, including the following: any anemia in cancer or cancer treatment patients due to folate deficiency, B-12 deficiency, iron deficiency, hemolysis, bleeding, or bone marrow fibrosis; the anemia associated with the treatment of acute and chronic myelogenous leukemias (AML and CML), or erythroid cancers; any anemia associated only with radiotherapy; prophylactic use to prevent chemotherapy-induced anemia; prophylactic use to reduce tumor hypoxia; patients with erythropoietin-type resistance due to neutralizing antibodies; and anemia due to cancer treatment if patients have uncontrolled hypertension. In our communications with CMS, Amgen recommended that CMS finalize these restrictions. In the final NCD, CMS did so.
Details of the final NCD, which is effective as of July 30, 2007, are available at https://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=203.
CMS issued its proposed NCD on May 14, 2007 and accepted public comments on the proposal until June 13, 2007. On June 1, 2007, Amgen submitted a detailed response to the proposed NCD and offered specific scientific and clinical recommendations for the agency's consideration in preparing a finalized NCD on ESAs for non-renal indications. Amgen's full response is available at www.amgen.com.
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
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