- A decrease in the proportion of patients receiving chemotherapy using ESAs;
- An increase in the proportion of patients receiving chemotherapy who initiate ESAs at a hemoglobin level < 10 g/dL; and
- An increase in the proportion of patients who initiate ESAs at a dosage consistent with product prescribing information.
Full implementation of the ESA REMS in 2011 had minimal impact on trends in these 3 ESA utilization metrics beyond the changes observed after the CMS coverage determination and multiple other FDA regulatory actions.
This information led the FDA to conclude that it was no longer necessary to require the certification of prescribers and hospitals that prescribe and/or dispense ESAs to patients with cancer in order to ensure that the benefits outweigh the risks.
The FDA has released the REMS requirements for the epoetin alfa and darbopoetin alfa ESA products, and the risks can be communicated by the current product prescribing information. The appropriate use of ESAs is supported by the CMS NCD, the American Society of Clinical Oncology, and American Society of Hematology clinical guidelines, which are evidence-based guidelines intended to provide a basis for the standard of care in clinical oncology.
Education
While the REMS is no longer necessary to ensure the benefits outweigh the risks, the serious risks of shortened OS and/or increased risk of tumor progression or recurrence associated with these drugs remain. The boxed warning language remains as follows: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. Health care providers are encouraged to discuss the risks and benefits of using ESAs with each patient before initiating use.
