Everyone is waiting to see what CMS decides to do. Recently in the UK in London there are plans to open clinics just for this purpose and after the initial clinic more are to follow, so how we handle it in the US, everyone is waiting to see. BD
September 9, 2008 | Payers, physicians, and the pharmaceutical industry are closely watching CMS
deliberations over whether or not to pay for a genetic-based test that provides guidance on Warfarin dosing. The FDA, which approved the test, says its an important tool, but the CMS isn't so sure and opened a National Coverage Analysis (NCA) on the subject in August.
This is an important first test for personalized medicine (PM). Achieving the right dosing for the anticoagulant Warfarin is notoriously tricky. Something like half a million patients begin taking Warfarin each year and adverse affects (bleeding) are not uncommon. The test in question determines a patients haplotype for CYP2C, a key protein in Warfarin metabolism.
Hi Barbara,
ReplyDeleteMore important than the decision itself (which may be wrong or right) is the scientific basis for it. Do we have evidence that pharmacogenetic information in warfarin dosing is cost effective?
There is a scientific paper on this very issue (Eckman MH et al. "Cost-effectiveness of using pharmacogenetic information in warfarin dosing for patients with nonvalvular atrial fibrillation" in the January Issue of Ann Inern Med), concluding: "Warfarin-related genotyping is unlikely to be cost-effective for typical patients with nonvalvular atrial fibrillation, but may be cost-effective in patients at high risk for hemorrhage who are starting warfarin therapy."
It is one of the papers referred to in the editorial on personalized genetics in this Ann Intern Med issue, with the clear message that personalized genetics hasn't fulfilled its promises yet. I've summarized these articles in the post Personalized-genetics too soon too little (2009/02/09).
Jacqueline ("Laikas on Twitter")