Medicare Seeks Limits on Anemia Drugs for Cancer Patients
CMS on Monday announced a proposal to limit Medicare reimbursements for the treatment of cancer patients with anemia medications manufactured by Amgen and Johnson & Johnson, the Wall Street Journal reports.
The proposal states that anemia medications -- synthetic forms of the protein erythropoietin -- will not be covered if used as treatment to prevent anemia or if after four weeks there is evidence of "poor drug response." In addition, the maximum length of time that Medicare will reimburse for EPO drugs is 12 weeks per year. Patients must have hemoglobin levels below nine grams per deciliter of blood in order to receive Medicare coverage for EPO drug treatment (Corbett Dooren/Chase, Wall Street Journal, 5/15).
CMS' proposal states that treatment with anemia drugs is "not reasonable and necessary" for 13 conditions (Reichard, CQ HealthBeat, 5/14). These conditions include anemia of cancers caused by iron or B-12 deficiency, myelodysplasia or myeloid cancers, treatment-associated anemia of myeloid or erythroid cancers, anemia associated with radiotherapy and treatment to prevent chemotherapy-induced anemia.
Under the proposal, CMS also would not pay for EPO drugs in patients being treated with certain cancer drugs including Genentech's Avastin (Wall Street Journal, 5/15).
The proposal lists 18 types of cancer for which use of anemia drugs would be reasonable if scientific literature has shown that EPO receptors are present on either normal or malignant cell lines or tissues. CMS said the list of 18 is not exhaustive.
Health care consultant Alec Vachon said the timing of the proposal comes as a "surprise" because CMS previously had said that the proposed coverage decision would not be issued until September (CQ HealthBeat, 5/14).
An FDA advisory committee on Thursday recommended that FDA place new restrictions on anemia medications because of safety concerns for cancer patients undergoing chemotherapy (Costello, Los Angeles Times, 5/15). The panel recommended labeling changes to establish a baseline hemoglobin limit but did not assign a number.
"CMS beat everybody to the punch" by proposing a level of nine grams per deciliter of blood to qualify for treatment, according to Gene Mack, a biotechnology analyst with HSBC Securities (Wall Street Journal, 5/15).
FDA in March issued a black box warning for the medications to advise physicians that they should use only the lowest dose necessary to avoid the need for blood transfusions in anemia patients. FDA recommended that physicians use EPO medications to target hemoglobin levels at no higher than 12 grams per deciliter of blood.
According to FDA, recent studies have found EPO medications prescribed to cancer patients in some cases can increase risk for death, cardiovascular disease and tumor growth (American Health Line, 3/12).
Medicare spends more on EPO drugs, which are taken by more than one million people annually, than on any other drugs. According to the Los Angeles Times, if the proposal is finalized, sales of anemia drugs "would most certainly suffer."
CMS Acting Administrator Leslie Norwalk estimated that Medicare reimbursement rates for anemia drugs could fall by as much as 10%. Norwalk said, "The safety of our Medicare beneficiaries is paramount. We are ensuring that members only get medications and dosages that are necessary and beneficial" (Los Angeles Times, 5/15).
The proposal is open for a 30-day public comment period ending on June 13. The government has 60 days to finalize the decision and then issue a memo by Sept. 14.
According to the Journal, final proposal decisions "typically reflect much of what's outlined in proposed coverage decisions" (Wall Street Journal, 5/15).