Taking on CMS
This article was originally published in RPM Report
Amgen and J&J have billions of dollars at stake in the battle to convince CMS to change its coverage proposal for EPO in cancer patients. Win or lose, their efforts will be a valuable case study for any other manufacturer that fi nds itself facing an adverse reimbursement policy.
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Avoiding Another EPO: Amgen's Nplate Has FDA Restrictions, But May Escape Medicare Controls
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.
Leads & Contacts
Members of FDA Risk Communications Advisory Committee. Wyeth R&D senior execs meet with FDA drug review managers in September 2007. Oncologists, an ex-Congresswoman, and a former Bush Administration health policy advisor met with FDA senior managers (including Commissioner von Eschenbach) in October before FDA decidied to support the Centers for Medicare and Medicaid Services in its effort to restrict use of EPO for chemotherapy patients.
What's the Difference? Sepracor's Xopenex Hit Hard by Coverage Cut
Xopenex reimbursement is being slashed by Medicare. The message: CMS wants proof of differentiation before it will pay more for line extensions and new formulations. That means trouble ahead for a lot of other products.