CMS Finalizes Coverage Policy for ESAs; Changes Reflect ASH Recommendations

July 30, 2007 –The Centers for Medicare and Medicaid Services (CMS) posted a national coverage determination (NCD) for coverage of erythropoiesis-stimulating agents for non-renal uses.

The new policy does not include myelodysplasia (MDS), which means that ESA treatment for Medicare beneficiaries with MDS is covered without any conditions or limitations. Local Medicare carriers may continue to make local coverage decisions that are not included in this NCD.

The NCD includes several limitations for patients undergoing ESA treatment for the anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia:

1. The hemoglobin level immediately prior to initiation or maintenance of ESA treatment is <10 g/dL (or the hematocrit is <30 percent).
   
   
2. The starting dose for ESA treatment is the recommended FDA label starting dose, no more than 150 U/kg/three times weekly for epoetin and 2.25 mcg/kg/weekly for darbepoetin alpha. Equivalent doses may be given over other approved time periods.
   
   
3. Maintenance of ESA therapy is the starting dose if the hemoglobin level remains below 10 g/dL (or hematocrit is <30 percent) four weeks after initiation of therapy and the rise in hemoglobin is >1g/dL (hematocrit >3 percent).
   
   
4. For patients whose hemoglobin rises <1 g/dl (hematocrit rise <3 percent) compared to pretreatment baseline over four weeks of treatment and whose hemoglobin level remains <10 g/dL after the four weeks of treatment (or the hematocrit is <30 percent), the recommended FDA label starting dose may be increased once by 25 percent. Continued use of the drug is not reasonable and necessary if the hemoglobin rises <1 g/dl (hematocrit rise <3 percent) compared to pretreatment baseline by eight weeks of treatment.
   
   
5. Continued administration of the drug is not reasonable and necessary if there is a rapid rise in hemoglobin >1 g/dl (hematocrit >3 percent) over two weeks of treatment unless the hemoglobin remains below or subsequently falls to <10 g/dL (or the hematocrit is <30 percent). Continuation and reinstitution of ESA therapy must include a dose reduction of 25 percent from the previously administered dose.
   
   
6. ESA treatment duration for each course of chemotherapy includes the eight weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regimen.

ASH was deeply concerned with CMS’s proposed coverage decision that was released in May because the proposal was not supported by scientific data and was in conflict with expert analysis. ASH submitted comments and met with CMS officials as well as testified before FDA’s Oncology Drug Advisory Committee and met with FDA officials to discuss concerns and recommendations. ASH and The American Society of Clinical Oncology (ASCO) are scheduled to jointly publish an update of our guidelines on the appropriate use of EPO in September.

During the ASH annual meeting in December, the Practice Forum will address this issue. The Practice Forum, “Evidence, Safety, and Clinical Decision Making: The Case of ESAs” is scheduled for Saturday, December 8 at 6:00 p.m.

ASH will also provide additional information about the NCD and Medicare Carrier responses shortly.

If you have any questions, please contact the ASH Policy and Practice Department at 202-776-0544.