Indications for ESA Treatment for Patients with Myelodysplastic Syndromes (MDS)

(The following coverage criteria apply to both EPO and DPA)

Anemia is observed in 90 percent of individuals with MDS. Those MDS patients with an endogenous EPO level of less than 500 mU/mL are more likely to respond to erythropoiesis-stimulating agent ESA therapy. ESA therapy is indicated for patients with a confirmed diagnosis of MDS, when the anemia is symptomatic, there is a reasonable expectancy of longer survival and therapy is provided in order to end or reduce the need for transfusions.

Medicare will cover either EPO or DPA for the treatment of anemia in MDS when the following criteria are met:

• Patient with anemia associated with MDS with bone marrow blast count of less than 10 percent blasts (238.72, 238.73, 238.74, and 238.75)
• Patient's anemia is symptomatic
• Pretreatment Hgb level of <10 g/dL or Hct of <30 percent obtained within one week of the initial injection.

Dosing Management:

• Dose, dosage frequency, and increases:
• If no increase in Hgb of 1 g/dL or greater in first month, increase dose to 60,000 units of EPO or proportionate increase in DPA dosage to 300 micrograms.
• If no increase in Hgb of 1 g/dL or greater in second month, increase dose to 80,000 units or a proportionate increase in DPA dosage to 400 micrograms.
• If no increase in Hgb of 1 g/dL or greater in third month, discontinue therapy.
• Dosage should be titrated so that the Hgb is within a range of 10 - 12 g/dL or Hct of 30 - 36 percent.
• Once the patient's Hgb is >10 g/dL or Hct >30 percent, decrease the current dose by 10 - 25 percent to maintain the target range of 10-12 g/dL or 30-36 percent.
• After 12 weeks of EPO/DPA therapy with the appropriate dose titrations, Hgb must increase by at least 1 g/dL or transfusion requirement must decrease by 50 percent resulting in a rate of two units per month or less for treatment to continue.

ESA therapy would not be covered if Hgb/Hct levels are above 12 g/dL/36 percent.