2007-07-30
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:
- The hemoglobin level immediately prior
to initiation or maintenance of ESA treatment is <10 g/dL (or the
hematocrit is <30 percent).
- 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.
- 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).
- 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.
- 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.
- 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.
back to top
