CMS Unveils Plan to Limit Coverage of Anemia Drugs in Cancer Patients

BALTIMORE, May 15 -- Medicare has reacted to an FDA black box on erythropiesis stimulating agents (ESA) by drawing a red line on the coverage of treatment for cancer patients.

The proposed national coverage decision issued by the Centers for Medicare and Medicaid Services would put limits on dose and duration of therapy.

It also would set a baseline hemoglobin level of less than 9 g/dl/27% in patients without known cardiovascular disease and less than 10 g/dl/30% in patients with documented symptomatic ischemic disease that cannot be treated with blood transfusion.

The CMS announcement said the agency was responding to an FDA decision to add black box warnings to labels of all ESAs.

"We have carefully examined the evidence surrounding these labeling changes and have issued this proposed decision to protect our beneficiaries," said Leslie V. Norwalk, the acting administrator of CMS.

The agency said that because the "preponderance of emerging data for ESA use in the oncology setting," it limited the focus of the national coverage analysis to cancer and related neoplastic conditions. But kidney diseases were not forgotten.

"Medicare beneficiaries with cancer and renal disease are among our most vulnerable patients, and we are dedicated to ensuring that they are receiving appropriate care," said Barry M. Straube, M.D., CMS' chief medical officer.

The proposed ESA oncology limitations are:

• The hemoglobin/hematocrit levels immediately prior to initiation of dosing for the month should be less than 9 g/dl/27% in patients without known cardiovascular disease and less than 10 g/dl/30% in patients with documented symptomatic ischemic disease that cannot be treated with blood transfusion. The latter patients should be alerted to the increased potential for thrombosis and sequelae.
• The maximum covered treatment duration is 12 weeks per year.
• The maximum covered four-week treatment dose is 126,000 units for erythropoietin and 630 ?g for darbepoietin.
• Continued use of the drug is not reasonable and necessary if there is evidence of poor drug response (hemoglobin/hematocrit rise of less than 1 g/dl/< 3%) after four weeks of treatment.
• Continued administration of the drug is not reasonable and necessary if there is an increase in fluid retention or weight (5 kg) after two weeks of treatment.
• Continued administration of the drug is not reasonable and necessary if there is a rapid rise in hemoglobin/hematocrit of more than 1 g/dl/>3% after two weeks of treatment.

CMS proposed to allow payment to a list of cancers for which it said evidence supports a conclusion that ESA treatment is both reasonable and necessary.

Those cancers include -- but are not limited to -- bone (sarcoma), brain (neurologic), breast, cervical, colorectal, gastric, head-and-neck (squamous cell), hepatic, lung, melanoma, multiple myeloma, muscle (including cardiac), ovarian, pancreatic (exocrine), prostate, retinal, and uterine.

However, CMS proposed to no longer cover ESA treatment for these 13 conditions:

• Any anemia in cancer or cancer treatment patients due to folate deficiency, B-12 deficiency, iron deficiency, hemolysis, bleeding, or bone marrow fibrosis.
• The anemia of myelodysplasia.
• The anemia of myeloid cancers.
• The anemia associated with the treatment of myeloid cancers or erythroid cancers.
• The anemia of cancer not related to cancer treatment.
• Any anemia associated with radiotherapy.
• Prophylactic use to prevent chemotherapy-induced anemia.
• Prophylactic use to reduce tumor hypoxia.
• Patients with erythropoietin-type resistance due to neutralizing antibodies.
• Patients with treatment regimens including anti-angiogenic drugs such as bevacizumab (Avastin).
• Patients with treatment regimens including monoclonal/polyclonal antibodies directed against the epidermal growth factor receptor (EGFR).
• Anemia due to cancer treatment if patients have uncontrolled hypertension.
• Patients with thrombotic episodes related to malignancy.

The public comments period on the proposed national coverage decision continues through June 13.