Epogen, Aranesp, and Procrit:
The Centers for Medicare and Medicaid Services (CMS) has released new rules regarding coverage of anemia drugs such as Epogen, Aranesp and Procrit. These drugs treat anemia caused by chemotherapy for cancer diagnoses or myelodysplasia, a bone marrow disorder. (They are also used to treat anemia in end-stage and chronic renal disease and those requiring kidney dialysis as well, but this is covered by another set of rules.)
Amgen Inc. manufactures the erythropoiesis-stimulating agents Epogen and Aranesp. Procrit is manufactured by Ortho Biotech, a division of Johnson & Johnson. These two drug manufacturers led the complaint process when CMS proposed dramatic decreases in coverage of these drugs. More than 2600 public comments were sent to CMS as well.
Stricter Guidelines Relaxed
CMS wanted stricter guidelines for the use of the erythropoiesis-stimulating drugs due to possible side effects of increased risk of cardiovascular problems such as hypertension, stroke, and heart attacks. Studies had shown these increased risks as well as others such as stimulating the growth of the cancerous tumors being treated by the chemotherapy which causes the anemia.
The new guidelines specify that a chemotherapy patient must have a hemoglobin level that is less than 10 grams per deciliter of blood. Originally, CMS had proposed the level had to be less than 9. Normal hemoglobin levels are 14 to 18 for men; 12 to 15 for women. (The levels for children are slighty less and based on age.) Physicians argued that 9 was too low and placed patients in significant danger.
Patients with the bone-marrow disorder, myelodysplasia are no longer eliminated from coverage, but it will be up to their local contractors (intermediaries) providing Medicare coverage as to whether or not to pay for the drug.
What is Hemoglobin?
Hemoglobin is an iron-containing pigment of the blood. (Heme is an iron containing pigment and globin is a simple protein.) The hemoglobin carries oxygenated blood from the lungs to the tissues of the body. (There are hundreds of types of hemoglobin in the body; each with more specific functions involved with oxygenation of tissue.)
Lack of hemoglobin is characterized by crushing fatigue, cardiac arrhythmias, and shortness of breath. Without the use of these drugs, patients on chemotherapy and those with myelodysplasia have to resort to blood transfusions to increase the hemoglobin levels. When the hemoglobin drops below 10, it is more difficult to raise the hemoglobin again with these drugs alone; often a blood transfusion is also necessary.
With certain tumors, and for those at increased risk for cardiovascular problems, these anti-anemia drugs may not be the best choice. However, the use of these drugs can sometimes outweigh the risks associated with blood transfusions.
Summary of New Rules:
- Treatment is limited to those on chemo with a hemoglobin of 10 or less
- Duration of the treatment is maximum of eight weeks after chemo session ends
- For MDS patients, no federal restrictions apply. Local Medicare contractors can decide about coverage (contact your intermediary for information)
Source: The Wall Street Journal Online; July 31, 2007; Page D1
