Xarelto with Heart valve

[Marvelous]

My wife has been on Xarelto for 17 months and she has a St Jude aortic cow valve. She started on Xarelto to prevent stroke and Afib. Now the insuirance (Medicare) says that she is not eligible for coverage because Xarelto is not FDA approved for a heart valve. Is there any others that have this problem?

 

[Superman]

My wife has been on Xarelto for 17 months and she has a St Jude aortic cow valve. She started on Xarelto to prevent stroke and Afib. Now the insuirance (Medicare) says that she is not eligible for coverage because Xarelto is not FDA approved for a heart valve. Is there any others that have this problem?

True for mechanical heart valves. Only warfarin is approved. I do not know about tissue valves. Sometimes it's intent vs. implementation. If the language just says that it's not approved for heart valve patients and doesn't specify "mechanical", then it's probably best to switch to warfarin (which is approved to prevent stroke and afib) vs. staying on Xarelto. If the coverage language specifies "mechanical" I would contact your insurance and let them know that she has a tissue valve, not a mechanical and see if that changes anything.

 

[W. Carter]

My wife has been on Xarelto for 17 months and she has a St Jude aortic cow valve. She started on Xarelto to prevent stroke and Afib. Now the insuirance (Medicare) says that she is not eligible for coverage because Xarelto is not FDA approved for a heart valve. Is there any others that have this problem?

I agree with Superman, although Xarelto is probably safe with a tissue valve there is probably no differential between valves with the insurance companies. Their (Xarelto) commercials just say it is not recommended for "heart valves". She should talk to her doctor about getting switched to Warfarin. The difference is with Warfarin she will have INR blood checks every 2-4 weeks, with Xarelto there is no periodical blood checks needed.

 

[RobThatsMe]

Here is some information from the Xarelto Web site.

https://www.xareltohcp.com/about-xarelto/faq.html

Just a side note: As their site indicates, it is not easy to reverse the anticoagulation effects of this drug in the event of an emergency.
That being said, although warfarin requires monitoring, the anticoagulation effects can be quickly reversed should you require emergency medical care in a hospital.

 

[Marvelous]

Thanks for the information which we had already obtained. Our doctor has appealed the decision. It does not seem to matter as to the type of valve since studies have not been conducted. One study with mechanical valves may finish in 2017.

 

[W. Carter]

Thanks for the information which we had already obtained. Our doctor has appealed the decision. It does not seem to matter as to the type of valve since studies have not been conducted. One study with mechanical valves may finish in 2017.

They have already conducted the RE-ALIGN trial in 2011 with xa inhibitor Pradaxa. It was halted early due to a high mortality rate compared to Warfarin with mechanical heart valves. Xarelto is also in the xa inhibitor drug class like Pradaxa.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4104382/

 

[Marvelous]

The current study notes the differences between Pradaxa and Xarelto. see https://clinicaltrials.gov/ct2/show/record/NCT02128841 . The basis for the current study is also explained.

 

[Protimenow]

I don't get it. Probably the biggest issue with Warfarin is that you have to watch diet and other things that may impact your INR, and you need to get your INR tested to confirm that your INR is in range. As others have noted, it's easy to reverse the anticoagulant effects of Warfarin. FWIW, warfarin costs just pennies a day. Testing, if you do it at home, weekly, is about $5 for the strips, if you already own your monitor.

Until there's an alternative that can be easily reversed and that is proven to work effectively with mechanical valves (and not cost a knee and an elbow), personally, I'll stick with Warfarin. At least I know how it works and my insurance can afford it.

I would not take Xarelto off label, even if a doctor thinks (yes THINKS) that something else may work - the risks would be too high, and the doctor wouldn't look all that good if his advice caused injury to the patient. .