What Would Changes in Medicare Coverage of Anemia Drugs Mean for Cancer?

The Centers for Medicare & Medicaid Services (CMS) has provided coverage for epoetin alfa since 1989 and added reimbursement coverage guidelines for darbepoieten alfa approximately 10 years later. Development of these erythropoiesis-stimulating agents (ESAs) revolutionized the management of chemotherapy-induced anemia (CIA). For the past 15 years, the ESAs have been prescribed by physicians and advanced practice nurses to reduce the burden of red blood cell transfusions in patients receiving myelosuppressive chemotherapy and for patients with myelodysplastic syndrome (MDS). A number of published studies have confirmed the safety and efficacy of ESA use in MDS, providing information included in the compendium, and thus meeting the CMS requirement for positive coverage determination.

On May 14, 2007, CMS published a proposed coverage decision memorandum for the use of ESAs in cancer and related neoplastic conditions.1 The proposed changes in coverage would lead to multiple changes in ESA prescribing practices, with the potential to compromise quality of life for patients experiencing CIA. The proposed changes are the result of several reports of increased incidence of thrombosis, cardiovascular events, tumor progression, and reduced survival in patients receiving ESAs.

In response to these safety concerns, CMS concluded that “erythropoiesis stimulating agent (ESA) treatment is not reasonable and necessary for beneficiaries with certain clinical conditions, either because of a deleterious effect of the ESA on their underlying disease or because the underlying disease increases their risk of adverse effects related to ESA use.” Specific conditions for which ESA is considered inappropriate are listed in Table 1. In addition, CMS is considering restricted use of ESAs for patients undergoing treatment for cancers that exhibit erythropoietin receptors, as noted in Table 2. The proposed CMS limitations on prescribing ESAs for cancer patients undergoing treatment for these tumor types are summarized in Table 3.

A Nurse's Perspective on Proposed Changes

After reviewing the new black box warnings for epoetin alpha and darbepoetin alfa amended in March 2007, the studies that led to initiation of the black box warnings, and comments by The American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network, and the manufacturers of ESAs,2-6 I do not feel compelled to alter my current method of prescribing ESAs at this time. Both of these products have undergone rigorous safety and efficacy testing by the US Food and Drug Administration and, by current prescribing standards, have not demonstrated an increased threat to the safety of patients under my care over the past 15 years. My approach to prescribing starts with a thorough assessment of the patient's potential causes of anemia, including a review of iron, total iron-binding capacity, ferritin, B12, folate, and percent iron saturation laboratory values, as well as a review of transfusion patterns and of treatable factors contributing to fatigue. This assessment is initiated when the patient's hemoglobin is <11g/dL and is based on our institution's guidelines for the treatment of fatigue and anemia. Most of the physicians and advanced practice nurses at our cancer center initiate ESAs at the lowest starting dose when the hemoglobin is ≤10.5g/dL.

We then review hemoglobin levels weekly for trends and consider dose modification at 4- to 6-week intervals. The ESA dose is held if the hemoglobin is ≥12g/dL. I prescribe ESAs to patients enrolled in phase I clinical trials and thus I am intensely engaged in evaluating the relationships between side effects profiles and cancer treatment. Over the past 3 years while working with patients in phase I clinical trials including a vast array of targeted therapies, such as antiangiogensis and anti-EGFR antibodies, I have not seen any cause to suspect that ESAs prescribed according to FDA-approved guidelines cause increased risk to this patient population.

My colleagues and I have not identified any strong clinical evidence to warrant modifying our current method for prescribing and monitoring ESAs. As Georgia M. Decker, Oncology Nursing Society (ONS) president, and Paula Rieger ONS CEO, stated in their response to the CMS proposal, “ONS urges your agency to be deliberative in its review process and to take all the steps necessary to ensure that Medicare ESA coverage policy is evidence-based and aligned with expert opinion.”4

Clearly, oncology nurses in collaboration with medical oncologists will need to serve as cancer patient advocates in the challenge to preserve existing CMS coverage for ESAs. I encourage each of you to review the June 8, 2007, ASCO response to the CMS proposal as it addresses each point in detail.2 It is my hope that you will gain a greater appreciation of the concerns at hand that could affect the quality of life of our cancer patients undergoing chemotherapy.