The Centers for Medicare & Medicaid Services (CMS) has told a physician group that more evidence is needed before the agency could reconsider its July decision that limits payments for drugs used to treat anemia in cancer patients.
Oncologists and hematologists have complained that CMS's rule to restrict payments for erythropoiesis-stimulating agents (ESAs) in patients with cancer interferes with a clinician's ability to provide the best possible treatment.
CMS's new policy, issued on July 30, limits payments for ESA use in cancer patients to those whose hemoglobin levels decrease to less than 10 g/dL. Medicare will cover the drugs to treat anemia caused by chemotherapy but not anemia caused by the cancer itself.
Medicare's new payment rule does not affect use of ESAs in noncancer conditions, such as chronic renal disease.
Amgen Inc., which markets darbepoetin alfa as Aranesp and epoetin alfa as Epogen, has said that CMS's coverage restrictions have "no scientific basis and are incompatible with good clinical practice."
The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH), two groups that have issued clinical guidelines for ESA use in cancer patients, asked CMS in August to reconsider its rule.
Earlier this month, the Senate passed a nonbinding resolution calling for CMS to reexamine its payment policy for ESAs. The House is reportedly considering its own resolution.
The agency opened a review of its payment policy on the use of ESAs in cancer and related neoplastic conditions last spring in response to new safety concerns about the products.
Results of two randomized, controlled clinical trials showed increased cardiovascular risks for patients randomized to hemoglobin targets exceeding 13 g/dL compared with patients at lower targets.
Results of a Danish clinical trial showed an increased risk of rapid tumor growth in patients with head and neck cancer who received ESAs in higher-than-recommended dosages. Those study results prompted the FDA in March to call for a black-box warning on ESA labeling alerting that the products increased the risk of serious cardiovascular events and death when targeting a hemoglobin of greater than 12 g/dL.
The boxed warning advises prescribers to use the lowest dosage of the products that gradually will increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red-blood-cell transfusion.
In a letter this week to ASCO, CMS said its final National Coverage Decision (NCD) for ESAs in cancer patients was based an "exhaustive review of more than 800 individual publications and approximately 2,600 comment letters received during the two public comment periods."
The agency said it reconsiders an NCD only when new evidence or arguments are presented that the agency materially misinterpreted existing evidence.
Despite ASCO's detailed, eight-page request for reconsideration of the rule, along with other requests filed by various stakeholders, CMS said that "no new evidence" had been presented.
In its request for reconsideration, ASCO accused CMS of misapplying clinical evidence or failing to apply relevant, currently available scientific information when restricting coverage of ESA use in patients with hemoglobin levels above 10 g/dL.
CMS's final coverage decision, the group asserted, "ignores established studies, the FDA label and clinical guidelines by restricting the allowable dose increase and the timing of dose escalation."
ASCO contended that restrictions of ESAs above a hemoglobin of 10 g/dL may result in more patients needing blood transfusions. Implementation of many of the NCD's restrictions, ASCO argued, are "confusing and inconsistent," particularly for how the decision should be applied to payments for ESA use in cancer patients with comorbidities.
But CMS responded that it needed evidence beyond ASCO's request to support a different conclusion than that reached by the agency in July.
CMS asked ASCO to answer six questions and to specifically provide evidence that cancer patients undergoing chemotherapy require hemoglobin levels above 10 g/dL and proof that those patients have better outcomes from ESA therapy vs. transfusions. The agency gave ASCO and other groups 30 days to respond.
Deborah Kamin, senior director of cancer policy and clinical affairs for ASCO, said her organization was "disappointed" that CMS failed to "acknowledge any of the points that we raised in our formal request for reconsideration of the policy."
"We believe that CMS has enough information to warrant reopening the policy," she told BioWorld Today.
Over the next few weeks, Kamin said, ASCO will be consulting with an expert panel - the same group of experts that recently updated ASCO's clinical guidelines for ESA use - for help in responding to CMS's questions.
"We will continue to pursue this so that cancer patients can get what they need," she declared.
In a statement this week, Amgen charged that CMS has "already received answers to a number of the questions" posed in the agency's Sept. 24 letter.
The Thousand Oaks, Calif.-based company said it "remains very concerned" that the current NCD is "resulting in Medicare beneficiaries receiving a different standard of care than privately covered patients, who are being appropriately treated according to current clinical guidelines from the leading medical societies."
Physicians must be free to make decisions about when and how to manage anemia with ESAs to prevent blood transfusions and provide patients with the care they need, Amgen stated. "This government policy undermines clinical judgment, effectively removes physicians' ability to make decisions, and is unreasonable and impractical," the firm asserted.