ASH-ASCO 2007 Clinical Practice Guideline Update on the Use of Epoetin and Darbepoetin Released

October 22, 2007 – The American Society of Hematology has pre-published the "ASH-ASCO 2007 Clinical Practice Guideline Update on the Use of Epoetin and Darbepoetin" in its scientific journal, Blood.

This just-released guideline is an update of the "2002 ASH-ASCO Clinical Practice Guideline on the Use of Epoetin." To provide an evidence-based update, the expert panel members reviewed and analyzed all relevant data published since 2002 and up to July of 2007 as well as unpublished data presented at the May Food and Drug Administration Oncologic Drugs Advisory Committee briefing. To assure a thorough review of the literature, searches of Medline and the Cochrane Collaboration Library databases were performed. The update process began when the drug darbepoetin was made available. The update also expands the original guideline to address thromboembolic risk with erythropoiesis-stimulating agents (ESAs). The update was peer reviewed by both organizations and underwent further peer review by ASH’s scientific journal Blood.

In contrast to Medicare’s National Coverage Decision (NCD) on the use of ESAs, based on an extensive review of the available evidence, the update recommends the continued use of ESA therapy on a maintenance basis in situations where the patient is brought to a hemoglobin level between 10 and 12g/dL from <10 g/dL in order to appropriately manage care. The guideline further recommends dose reductions when the hemoglobin exceeds 11 g/dL.

ASH believes the Medicare NCD reflects a misinterpretation of the evidence. ASH has sent the updated guidelines to the Centers for Medicare and Medicaid Services (CMS) and hopes this will result in CMS reopening the coverage policy and revising the provision concerning maintenance of therapy.

"ASH-ASCO 2007 Clinical Practice Guideline Update on the Use of Epoetin and Darbepoetin"
ASH’s letter to CMS requesting a reopening of the NCD
ASH-ASCO press release