BALTIMORE -- Medicare has reacted to an FDA black box on erythropiesis stimulating agents by drawing a red line on the coverage of treatment for 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:
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:
The public comments period on the proposed national coverage decision continues through June 13.