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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, amednews staff. June 11, 2007.

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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.

"This proposed national coverage decision is fairly draconian," said J. Leonard Lichtenfeld, MD, an oncologist and deputy chief medical officer for the American Cancer Society. "Everybody gets very upset when you have trials that say that these drugs may be harmful, and sometimes the pendulum swings too far in the wrong direction."

If CMS were to impose the restrictions, the need for blood transfusions among cancer patients would explode, physicians predicted. Patient quality of life would suffer from the inconvenient, inaccessible and anxiety-laden transfusion process, and patient safety could be at risk, they said.

"We are at a very critical level for the number of blood products in this country," said Samuel M. Silver, MD, PhD, a hematologist/oncologist at the University of Michigan and member of the American Society of Hematology Executive Committee. "This may be enough to pressure and break the system."

The quest for evidence

The CMS proposal came within days of a Food & Drug Administration advisory committee recommendation that the agency call for more clinical trials of epoetin and darbepoetin in cancer patients.

The FDA also could further restrict the drugs' labeling. Earlier this year, it started heading down that path by issuing a "black box" warning on epoetin agents. It instructs physicians to use the lowest dose necessary to avoid blood transfusions in cancer and dialysis patients.

In May, the advisory committee kept the ball rolling by agreeing that the drugs should not be used in patients with certain cancers until more risk-benefit analyses can be completed on those populations. The FDA will decide whether to take this advice and make the labeling changes later this year.

Physicians and drugmakers are upset that Medicare officials are not waiting for the drug agency to make these determinations before rolling out coverage restrictions that have little or no basis in medical literature.

"CMS seems to be preempting the scientific deliberation of the agency that's tasked with determining safety and efficacy," said Deborah Kamin, senior director of cancer policy and clinical affairs for the American Society of Clinical Oncology. ASCO and the hematology society plan to challenge CMS during the comment process on several major elements of the proposed determination, including the coverage prohibition on anemia drug use in patients with myelodysplasia and the termination of coverage after 12 weeks in patients whose cancer cells contain epoetin receptors that could be stimulated by the drug.

Roy Baynes, MD, PhD, Amgen's vice president of oncology and supportive care, and Craig Tendler, MD, vice president of Ortho Biotech Clinical Affairs for Johnson & Johnson, said CMS simply did not have the requisite scientific evidence to back up its move to restrict coverage in these areas. Amgen manufactures the drug under the brand name Aranesp for cancer patients and Epogen for dialysis patients. Johnson & Johnson produces Procrit for cancer patients.

Incentives for more use

Underlying the debate over epoetin use is a controversy about whether physicians are responding to financial incentives toward more widespread use of the anemia drugs. The drugmakers offer rebates to physicians who buy the medications in bulk to administer to their patients. This comes on top of what Medicare or private insurers reimburse.

Drs. Baynes and Tendler said they are confident that physicians are prescribing their firms' drugs based on patients' clinical needs, not monetary considerations. Spokeswomen for the companies declined to detail the rebate system or the size of the discounts, saying only that they are a completely legal response to stiff market competition for the medications.

Some physicians think the companies' rebates and the impact of direct-to-consumer advertisements have played significant roles in determining how often doctors have prescribed the medications. The incentives sometimes tipped the balance toward more utilization at a time when the benefits of the drugs were obvious but before any serious patient safety concerns about them had emerged, they said.

"Human nature is human nature, and doctors are people," said Peter D. Eisenberg, MD, an oncologist in Greenbrae, Calif. "We know that people are susceptible to incentives, good ones and bad ones."

Dr. Eisenberg's practice decided to discontinue the use of Aranesp with its patients because Amgen offered significant rebates to doctors if they bought the anemia drugs in a bundle with white-blood-cell growth factors. This was the right move from the ethical standpoint, he said, even though it would hurt the practice's income.

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