Anemia drugs for cancer patients limited in CMS plan

The move comes amid Food and Drug Administration warnings about the medications, and criticisms that manufacturer rebates encourage doctors to prescribe them.

By David Glendinning, AMNews staff. June 11, 2007.

Washington -- A federal plan to impose limitations on when Medicare will pay for cancer patients' anemia drugs would put the medications off-limits to many beneficiaries, thus putting undue strain on the nation's blood supply and worsening patients' quality of life, physicians warned.

The Centers for Medicare & Medicaid Services on May 14 announced a proposed national coverage decision that would restrict coverage of erythropoiesis stimulating agents, known generically as epoetin and darbepoetin, for some cancer patients. Patients with certain types of cancer or undergoing certain cancer treatments would see coverage of the medications end altogether. For several other cancer types, patients would be able to obtain coverage only with strict limits on timing and dosage.

Preliminary study results suggesting that the drugs can cause strokes and heart attacks if used too readily in cancer patients -- as well as the possibility that the drugs in some cases can make tumors worse -- prompted the CMS decision.

"Although the data are less robust than we would like, particularly for geriatric patients, they are sufficient to identify patient characteristics and treatment practices that increase the likelihood of unfavorable clinical outcomes," stated Steve E. Phurrough, MD, writing the proposed coverage memo for the Coverage and Analysis Group he chairs at CMS.

Oncologists and hematologists acknowledged that some of the risks might be real. But they also said the agency has relied on incomplete studies and gone too far too quickly in shutting off an entire treatment avenue to whole categories of patients who need the drugs. Patients with myelodysplasia, for instance, have a disease that affects bone marrow and can lead to severe anemia, but these beneficiaries would fall in one of the groups unable to receive Medicare coverage for the drugs that could boost hematocrit levels to within normal limits.