Has eBay stopped listing CoaguChek??

[Protimenow]

This would probably involve convincing the Food and Drug Administration (FDA) that their policy makes no sense. I'm not sure how this can be done.

I can ask my Senators and local Representatives if they can somehow intervene - or maybe see if a local news station can take up the cause, but I'm not so sure of any level of success.

Also - getting approval for a new medical device, like the XS, may not be as daunting as it would seem to manufacturers (who should already know this). IIRC, Coagusense got FDA approval by demonstrating that results were close enough to those of an already approved device (the XS) to get approval.

There are at least two other devices sold in other countries that can probably go through (and pass) this process. I suspect that having three or four competing devices (I don't think that Coag-Sense has made much of a penetration - and I don't know if they are selling anywhere else in the world) might help to reduce prices of meters and strips (or, in one case, something called a 'chip').

Having a choice of approved meters - a significant choice of meters that ARE in use globally - might help competition and give us some choices. They may eventually make a small chip into the Roche 'machine' (I'm not talking about the XS here).

Currently, I'm aware of two other devices (iLine Microsystems microINR and QLabs' Q3 meter) that might be good candidates for considering FDA approval.

 

[RAS]

FDA medical device classification is heavily dependent on risk/safety. Reclassifcation is possible. I think there is plenty of history of safe use by home testers but don't know how the case gets initiated with the FDA to reclassify a device for over the counter sale.

Not sure it can be done without some manufacturer initiating it. There would need to be an economic interest. We know it got done for glucose monitors.

Unfortunately INR devices are not a huge market. For example the market for glucose devices is in the $billions annually while INR device market is in the $millions annually. I don't know if that's enough to incent the current manufacturers to change what they are doing. Definitely need some innovation and competition in this market.

 

[Protimenow]

I was thinking about drafting something to the FDA director about this. Sure, there's not much money involved. There aren't a lot of self testers who get their testers and strips on eBay - but for some of them, the price for a new meter and strips from a medical supplier aren't trivial.

I see absolutely no incentive for Roche or Coagusense to ask for the change:

Why would they if they (especially Roche) have an almost complete stranglehold on the U.S. INR meter market? From Roche's perspective it would make no sense. Ditto for Coagusense.

The risk of self managers (and there probably aren't many of us) messing up their dosing is, I think, pretty low. Warfarin prescriptions have to come from doctors or physicians assistants, and I suspect that most self testers are reporting their INRs to clinics or doctors or organizations that 'specialize' in INR management, so the risk of management errors are low (although compliance is a whole other matter).

Yes, this may be too small an issue for the FDA to spend time on. And, yes, the small number of self testers who are priced out of the market by the prescription requirement also provides little incentive for the FDA to act, but it would sure be nice if they did.

 

[slipkid]

A very dumb question (from someone with strips expiring in about 6 months and no longer on a managed service) - is it possible for insurance to pay for strips/supplies or do they only do it via a managed service (I need to ask mine I guess), and another question, is a PRESCRIPTION needed to buy strips yourself direct from these vendors (since ebay is now out of the picture)???? THanks....

 

[Protimenow]

Not a dumb question at all.

I wish I had a good answer.

The services mentioned here by others will probably sell the strips without a prescription, but I have no idea if you can get an insurer to reimburse you for them.

I suggest that you call your carrier and see if they have an answer.

 

[slipkid]

Not a dumb question at all.

I wish I had a good answer.

The services mentioned here by others will probably sell the strips without a prescription, but I have no idea if you can get an insurer to reimburse you for them.

I suggest that you call your carrier and see if they have an answer.

Yeah, I will try doing that, but feel it will be a waste of time (will be given a wrong answer or them not even understanding at all). Heck, I recently had an MRI and I called them to ask in advance what my cost would be (long story). The $ amount answer they gave me for that straightforward question wasn't even right!!