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FDA and ESA Safety: A Conversation with Bob Temple and Ellis Unger

This article was originally published in RPM Report

Executive Summary

The cardiovascular risks associated with ESAs in the renal disease population are being reevaluated by FDA with the outcome of three clinical trials now in hand. The agency is considering a number of issues as it decides what to do with these therapies

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The ESA Disconnect Between FDA and CMS

Another major decision is looming at CMS on whether to open up a national coverage analysis for ESAs in the renal disease area-a MEDCAC meeting appears to be the first step. The Medicare agency previously jumped out in front of FDA on a coverage decision in the oncology setting. This time, it appears that CMS will wait to hear what FDA has to say. But FDA isn't paying much attention to CMS.

The ESA Disconnect Between FDA and CMS

Another major decision is looming at CMS on whether to open up a national coverage analysis for ESAs in the renal disease area-a MEDCAC meeting appears to be the first step. The Medicare agency previously jumped out in front of FDA on a coverage decision in the oncology setting. This time, it appears that CMS will wait to hear what FDA has to say. But FDA isn't paying much attention to CMS.

The Rebirth of A Niche Product: Three Silver Linings on the ESA REMS

The long-awaited Risk Evaluation & Mitigation Strategy for Aranesp and Procrit is here. For the oncology indication, it requires provider training program enrollment. It may not seem like the best outcome for Amgen and J&J, but there are some upsides.

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