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Coverage Updated for ESA Treatment

January 22, 2008:
The Centers for Medicare and Medicaid Services (CMS) has updated its national coverage determination (NCD) for erythropoiesis stimulating agents (ESAs) treatment, saying that it is reasonable and necessary for treating anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma and lymphocytic leukemia under specified conditions.

The agency has also determined that ESA treatment is not reasonable and necessary for certain clinical conditions, either because of adverse effects on the underlying disease or because the underlying disease increases the risk of adverse effects related to ESA use.

The ESA treatment for anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia is only reasonable and necessary under the following specified conditions:
  • The hemoglobin level immediately prior to initiation or maintenance of ESA treatment is <10 g/dL (or the hematocrit is <30%).
  • The starting dose for ESA treatment is the recommended Food and Drug Administration label starting dose, no more than 150 U/kg/3 times weekly for epoetin and 2.25 mcg/kg/1 time weekly for darbepoetin alpha. Equivalent doses may be given over other approved time periods.
  • Maintenance of ESA therapy is the starting dose if the hemoglobin level remains below 10 g/dL (or hematocrit is <30%) 4 weeks after initiation of therapy and the rise in hemoglobin is >1g/dL (hematocrit >3%).
  • For patients whose hemoglobin rises <1 g/dl (hematocrit rise <3%) compared with pretreatment baseline over 4 weeks of treatment and whose hemoglobin level remains <10 g/dL after the 4 weeks of treatment (or the hematocrit is <30%), the recommended FDA label starting dose may be increased once by 25%. Continued use of the drug is not reasonable and necessary if the hemoglobin rises <1 g/dl (hematocrit rise <3 %) compared with pretreatment baseline by 8 weeks of treatment.
  • Continued administration of the drug is not reasonable and necessary if there is a rapid rise in hemoglobin >1 g/dl (hematocrit >3%) over 2 weeks of treatment unless the hemoglobin remains below or subsequently falls to <10 g/dL (or the hematocrit is <30%). Continuation and reinstitution of ESA therapy must include a dose reduction of 25% from the previously administered dose.
  • ESA treatment duration for each course of chemotherapy includes the 8 weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regimen.
Below are those clinical conditions for with ESA is not reasonable and necessary and therefore not covered:
  • 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 (CML, AML), or erythroid cancers
  • The anemia of cancer not related to cancer treatment
  • 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
  • Anemia due to cancer treatment if patients have uncontrolled hypertension

Deborah C. Hall
Clinical/Technical Editor


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