Avoiding Another EPO: Amgen's Nplate Has FDA Restrictions, But May Escape Medicare Controls
This article was originally published in RPM Report
Executive Summary
The Centers for Medicare & Medicaid Services is considering national coverage restrictions for Amgen's newly approved Nplate (romiplostim). CMS is ostensibly concerned about a lack of long-term data. Based on Medicare's experience with previous Amgen products, CMS may also be worried about long-term costs. But Amgen says CMS there is no need for Amgen to get involved: FDA has the situation well in-hand with a REMS risk management program.