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.
By Cathy Kelly
Amgen learned the hard way what happens when the Centers for Medicare & Medicaid Services gets involved in a drug safety issue.
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