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lüll Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy: Part 3, Imatinib for Chronic Myeloid Leukemia (CML)Abernethy AP; McCrory DCReport on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy: Part 3, Imatinib for Chronic Myeloid Leukemia (CML)-/-AHRQ Technology Assessments 2005[Nov]; ä (ä): äChronic myeloid leukemia (CML) is a malignant clonal disorder of blood cells resulting from the cancerous transformation of a very primitive hematopoietic stem cell. CML's hallmark is the chromosome 9;22 translocation that produces the BCR-ABL gene, which is present in more than 95 percent of all cases of CML. Imatinib (Gleevec(R)) is an orally administered drug that competitively inhibits the BCR-ABL tyrosine kinase, a cellular enzyme that is encoded in the BCR-ABL gene. Imatinib works by blocking, or turning off, the signal from the tyrosine kinase protein, so that cancerous cells stop growing. Imatinib is approved by the Food and Drug Administration (FDA) for patients in the first-line and relapsed settings of all phases of CML. There are three clinical phases of CML-chronic phase (CP), accelerated phase (AP), and blastic phase/blast crisis (BP)-distinguished by their prognoses and clinical presentation. Therapeutic options include imatinib, interferon-alpha with or without cytarabine, hydroxyurea, busulfan, other conventional chemotherapies, and stem cell transplantation (bone marrow transplantation, SCT). Allogeneic SCT is the only curative treatment for CML, however it is only available for 20-25 percent of patients predominantly due to lack of a suitable donor; 15-30 percent treatment-related mortality can be expected with SCT. This assessment of imatinib for treatment of CML was performed at the request of the Centers for Medicare and Medicaid Services (CMS) and is designed to inform the likely health outcomes associated with a current demonstration project which provides for payment for certain oral medications, including imatinib for CML, that are prescribed as replacements for other drugs currently covered under Medicare Part B.ä |