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Posts with tag Aranesp

Amgen challenges new Medicare policy for anemia drugs for cancer

Last Monday, the Centers for Medicare and Medicaid Services relaxed some of the limits that it had proposed in May for the use of anemia drugs in cancer patients, in the face of an outcry from cancer patients and their physicians.

However, CMS said it is still going to deny payment for drugs like Aranesp and Epogen from Amgen and Procrit from Johnson & Johnson if a patient's hemoglobin level is greater than 10 grams per deciliter. Physicians generally aim for a hemoglobin level of 10 to 12 g/deciliter in their cancer patients. Normal range is 12 to 18 g/deciliter.

Amgen is challenging this new limit, saying that such a limit will increase the need for blood transfusions. The company also noted such limits contradict the FDA's approved labeling for the drugs.

Debate over the use of anemia-fighting drugs

June's issue of Community Oncology explores the debate over the use of ESAs (erythropoiesis-stimulating agents).

ESAs are anemia drugs that increase the level of oxygen-carrying red blood cells and the protein hemoglobin. They are used by many cancer patients to fight fatigue and anemia, which occur either as a direct result of their disease or their treatments. The ESAs include EPO (epoetin alfa, or Procrit) and DARB (darbepoetin alfa, or Aranesp).

New data has come out on potentially dangerous side effects of these drugs including blood clots. These drugs are also very costly and some critics have accused oncologists of overprescribing them, swayed by rebates from pharmaceutical companies.

Medicare is currently reviewing their reimbursement policy for the use of these drugs to possibly limit coverage. According to David H. Henry, MD, FACP, and editor of Commmunity Oncology, if this new reimbursement policy is enacted, it would eliminate the use of almost 90% of ESAs in oncology.

FDA warns against common anemia drugs

Doctors prescribing anemia drugs for patients with kidney disease and cancer were urged by the Food and Drug Administration (FDA) on Friday to carefully dispense of these drugs due to an increased risk of death and other serious problems, such as blood clots, strokes, and heart attacks in patients with chronic kidney failure and rapid tumor growth in patients with head and neck cancer who receive doses higher than recommended.

The potentially harmful drugs, sold under than brand names Procrit, Epogen, and Aranesp, are genetically engineered versions of a natural protein -- called erythropoietin -- that increases the number of red blood cells. The drugs, with combined 2006 U.S. sales of $10 billion, are commonly used for patients with certain forms of kidney disease and for those receiving chemotherapy for cancer.

The FDA is adding warnings to the drugs' labels that will strongly instruct doctors to use the lowest possible dose needed to help patients avoid blood transfusions.

The FDA will also take a close look at how the drugs are marketed, including claims the drugs can improve the quality of life.

A meeting of FDA officials to further discuss this issue, believed to stem from drug overuse by dialysis centers and oncologists who make more money by using more of the drugs. is scheduled for May 10. Recommendations could lead to additional revisions of the drugs' labels.

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