Venofer at home on Nxstage

Hi,
Would like to hear from anyone administering Venofer on NextStage at home…
How they administer, what dose, how often…techniques and payment arrangements…

Thanks,
A Traveler

It is my understanding that is not an option. In order for Medicare to pay, they require it be administered in clinic. I am sure there are other reasons as well.

I take Venofer at home with NxStage and it is covered under Medicare. I have done it this way since I came home with the cycler. I take 100 mg per week except right now it is on hold. It is given through the filter.

That is interesting. I need to follow up on that. I was given bad info.

Thanks.

Section 30.4.2.1 of the Medicare Benefit Policy Manual (http://www.cms.hhs.gov/manuals/Downloads/bp102c11.pdf) says that certain drugs, including IV iron, are separately billable (to Medicare) “if they are actually provided in the dialysis clinic by the facility staff.” If your clijnic is being paid for the drug, it must be billing IV iron “as if” it is administering it to you at the clinic vs. you self-administering.

The FDA has approved IV iron when administered by medical professionals (in the hospital, doctor’s office, or clinic). Although most people on IV iron have no problem with it, some people have had allergic reactions to IV iron, including stopping breathing. That is why clinics are supposed to be giving the drug at the facility. Your clinic must have chosen to accept the very low risk of liability if you were to have a reaction to it to increase the convenience for you. Anyone who takes IV iron at home should know what to do if he/she has an allergic reaction to it.

Hi’ PMB
So you’re doing a ‘push’ through the venous port of the Dialyzer?
Do you mix with Saline…do you push over time? if so how much time…
Did someone prescribe a technique?
Do you know the medicare claim code?
I can cover it through a secondary insurance but it would be good to have the medicare coding to start the process.

Thanks,
A Traveler

Hi Beth,
Venofer has no history, apparently, of negative reactions other than sometimes nausea.

Have you heard otherwise?

A Traveler

I give Ralph Venefer through the top of the dialyiser slowly.
We order it through his drug plan and we pay $50 for 6 bottles. Using 2 per month.
Works great.
Pat

[QUOTE=A Traveler;13076]Hi Beth,
Venofer has no history, apparently, of negative reactions other than sometimes nausea.

Have you heard otherwise?[/QUOTE]
Thje package insert for Venofer says:
A total of 104 anaphylactoid reactions including serious or life-threatening reactions have been reported in post-marketing spontaneous reports worldwide between 1992 and February 2005 based on estimated use in more than 3.8 million patients.

It goes on to report that 78.8% of patients on HD taking Venofer have reported some kind of adverse event with 3.5% of them reporting shortness of breath, 39.4% reporting hypotentsion, 29.4% reporting muscle cramps, 14.7% reporting nausea, 12.6% reporting headache, and 9.5% reporting graft complications. Smaller percentages of patients reported other adverse events.

I talked with folks from America Regent, the company that distribures Venofer a while back. Probably on lawyers’ advice, I was told that the company could not recommend that someone self-administer Venofer. I don’t see a prohibition against self-administration in the package insert but maybe I missed it.

Beth, Any chance you can come up with the insert for EPO and post it. I am curious as to what that reads for side affects.

Marty

Sorry about that. I thought that the link in the email I posted last night would take you to the package insert, but apparently it doesn’t. I tried to post the link again but the message board shortens it so it doesn’t work. Therefore, start at the Venofer website (http://www.venofer.com) and scroll down the page to the “full prescribing information” link.

Ooops. Marty, I misread your posting. You asked for the EPO insert.

If you’re asking about Epogen:
http://www.epogen.com/professional/resources/prescribing_information/pi.jsp

If you’re asking about Aranesp:
http://www.aranesp.com/professional/prescribing_information.jsp

Procrit has prescribing information on its website, including prominently placed information about the new boxed warning:
http://www.procrit.com

Typically to view the package insert information for any drug, you need to look at information for professionals.

What is the reason some home programs allow their patients to self -administer IV iron and others do not? I see where Medicare says it is to be given in-center if they are to cover the cost, but what if the patient pays for it? Read where Pat is getting it at a reasonable cost via her drug plan. Would it be much more expensive if one did not have a drug plan? Is this a unit liability issue, profit issue or is there true concern for patient safety?

Jane,

Iron is VERY expensive if you don’t have a drug plan that covers it.

Marty