The U.S. Senate unanimously passed a resolution on September 4 asking the federal Centers for Medicare and Medicaid Services (CMS) to reconsider its July decision not to pay for anemia drugs.
According to CMS, multiple studies show erythropoiesis stimulating agents (ESAs) could increase tumor progression and decrease survival rates among cancer patients.
The U.S. Oncology Physician Network (USOPN) is one of several groups joining the Senate in asking the agency to reassess its decision. CMS says it will not do so unless USOPN provides new evidence or shows how CMS has misinterpreted earlier findings.
Physician Freedom
Much of the controversy hinges on whether doctors should be compensated for treating their patients as they see fit, said Trish Hawkins, spokesperson for the pharmaceutical company Amgen, which manufactures Aranesp, an ESA.
“We believe physicians should be free to make the decisions about how to care for their patients,” Hawkins said. “This policy really undermines their clinical judgment.”
Treatment Decisions
A flurry of political action has accompanied the CMS decision.
At press time, Sen. Max Baucus (D-MT) was planning to introduce a resolution about ESA reimbursements by the end of October, said a source in his office who asked to remain anonymous.
“It’s important that Medicare beneficiaries get the care they need according to their physician’s best judgment,” the source said. “You say it sounds like a simple question, but it’s actually the most important question.”
In September, the Senate unanimously approved Resolution 305, calling for CMS to immediately reconsider its National Coverage Determination, consult members of the clinical oncology community to determine appropriate revisions, brief Congress, and then implement the changes as soon as possible.
CMS officials declined to comment for this story.
Questionable Studies
In March the Food and Drug Administration gave the anemia drugs a black box warning–the most serious possible for prescription medications–saying they increase the likelihood of tumor progression and decrease survival in cancer patients.
In a July 30 memo, CMS noted, “FDA also warned that ESAs are not indicated for anemic cancer patients undergoing treatment, and that the mortality is increased when ESAs are used by this population.”
But USOPN says six of the studies CMS used are irrelevant because they focus on hemoglobin levels oncologists don’t use when treating cancer patients, said Dan Cohen, USOPN’s senior vice president of government relations and public policy.
One study CMS cited was conducted by Dr. Michael Henke of Germany. In its memo, CMS quoted Henke saying, “I am convinced that ESA treatment negatively affects disease control and survival of head and neck cancer patients.”
The problem, Cohen said, is that Henke’s trial sample was too small–only 350 patients–and studied patients receiving high doses of ESAs outside the clinical range oncologists use. Cohen said the tumor progression Henke found can be attributed to other factors.
Hurting Blood Supply
Oncologists say the policy has serious ramifications for cancer patients and the national blood supply. Some in the medical community also worry the decision inhibits doctors’ ability to treat their patients the way they deem best and causes more cancer patients to need blood transfusions, compromising the national blood bank.
“I think we would definitely [consider] this is a step backward in cancer care,” Hawkins said.
Chemotherapy reduces a cancer patient’s hemoglobin level; ESAs help the body retain enough hemoglobin so patients can remain comfortable during chemotherapy and maintain their normal lives instead of being hospitalized, said Dan Cohen, USOPN’s senior vice president of government relations and public policy.
Cohen said because Medicare patients cannot pay for ESAs but must somehow increase their hemoglobin levels, they would need blood transfusions to manage their anemia–which could affect the nation’s blood supply.
CMS said the adequacy of the nation’s blood supply “is not a relevant factor for consideration in this national coverage decision.” According to the memo, “Our focus is whether the use of ESA is reasonable and necessary to treat a particular illness.”
But Cohen said although the blood supply is generally safe, people who get repeated transfusions are at a higher risk of contamination or iron toxicity. He also noted using repeated blood transfusions to keep the red blood count at a certain level without ESAs is a procedure that has never been tested clinically.
The transfusions may interfere with the doctors’ ability to attack patients’ cancer as aggressively as possible, Cohen said, because transfusions are less effective than drugs at maintaining a steady hemoglobin level that can endure strong chemotherapy.
Expensive Drugs
The “unspoken 800-pound gorilla in the room,” as Cohen called it, is the financial aspect of CMS’s decision.
In an interview for this story, Medicare spokesperson Donald McLeod said Medicare spends almost $5.4 billion annually on ESAs, about 30 percent of which treats cancer patients.
In its July memo, CMS said it doesn’t “consider financial implications for these issues.” But Cohen noted ESAs are some of the most expensive drugs on the market.
Jillian Melchior ([email protected]) writes from Michigan.
For more information …
CMS Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for non-renal disease indications: http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=203
Senate Resolution: http://www.npaf.org/images/pdf/news/sr305.pdf
