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.
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Harvey Katzen, MD, has a complaint. As a busy physician running a hematology and oncology practice in suburban Maryland, he's frustrated that two new drugs, both of which were recently approved to combat an unusual blood disorder called chronic ITP, require a lot of extra paperwork before a patient can begin treatment. Welcome to the new reality for pharmaceutical marketing. The paperwork for Amgen's Nplate and GlaxoSmithKline's Promacta is part of a formal Risk Evaluation and Mitigation Strategy, or REMS. The REMS system was created to give FDA greater authority to impose and enforce risk management plans, to address far-ranging concerns about drug safety and the FDA's credibility. Promacta and Nplate are among the first products approved under the new law--and hence provide an early opportunity to see how the new regulatory system plays out in the commercial marketplace.