Getting insurance to pay for IV infusion

[AndreaK]

Hello, I've gotten my doctor to agree to order an iv iron infusion but she has told me that my insurance may not pay for it as I am not anemic.

I have not contacted the insurance company yet because I wanted to see if there were any tips on this board as to how to phrase my request to the insurance company so they do approve it.

Does anyone have any suggestions? Should this be something my doctor has to "code" appropriately when submitting the order, for it to be approved by insurance?

Thanks for any advice.

[stjohnh]

Unfortunately, this is a common and Big problem, as the recommended IV iron, Injectafer, is quite expensive in the USA. Also, many insurance companies will routinely deny coverage for using a drug for a purpose not approved by the FDA, AND the FDA has not approved any iron product for RLS.
In other words, unless you are very lucky, you may have to pay out of pocket. I have had insurance pay for mine, but am unsure why they are covering it. Perhaps the doc or nurse mistakenly put iron deficiency anemia on the drug request form. Don't know, but I'm not going to rock the boat by asking too many questions.

[ViewsAskew]

Mine did put iron deficiency anemia on it...and this latest time the insurance company denied it because they said the test results do not show deficiency!

[nrpardee]

Unfortunately, this is a common and Big problem, as the recommended IV iron, Injectafer, is quite expensive in the USA. Also, many insurance companies will routinely deny coverage for using a drug for a purpose not approved by the FDA, AND the FDA has not approved any iron product for RLS.
In other words, unless you are very lucky, you may have to pay out of pocket. I have had insurance pay for mine, but am unsure why they are covering it. Perhaps the doc or nurse mistakenly put iron deficiency anemia on the drug request form. Don't know, but I'm not going to rock the boat by asking too many questions.

Recommended where (just asking)? I've been watching a bunch of the RLS webinars and reading articles, and all of them say that while most (all?) of the trials were with injectafer, but iron dextran and others have been used, and that any of the iron injections should work. Here's one source https://www.rls.org/file/general-free-p ... edings.pdf . So if they won't pay for injectafer, they might pay for one of the others (if there's no reason not to use it).

As a side note, you can find articles talking about how expensive injectables have taken over the market, often at the expense of self injectables and even oral meds because they are much more profitable for doctors (I'm NOT saying that about RLS research, just about injectable iron in general. ). You might look here https://www.npr.org/sections/health-sho ... r-scrutiny where at the end the doctor is quoted as saying all of them work the same.
Aside: As someone on Horizant, the actual cost might well exceed Injectafer! (My Horizant without insurance is ~$700 per month).
I'm getting too deep into the weeds here, but I encourage you to read the articles and watch the webinars on rls.org and what they say about which injectables.

[stjohnh]

Recommended where (just asking)? I've been watching a bunch of the RLS webinars and reading articles, and all of them say that while most (all?) of the trials were with injectafer, but iron dextran and others have been used, and that any of the iron injections should work.

Here is a link to the official consensus guidelines of the International Restless Legs Syndrome Guidelines task force:

https://www.sciencedirect.com/science/a ... via%3Dihub

The only IV iron prep that has Level A evidence is FCM (ferric carboxymaltose=Injectafer). Section 5.3.1 page 33.

The only "inexpensive" IV iron that has considerable evidence for benefit in RLS (but not randomized, placebo controlled double blind studies) is low molecular weight dextran. While the guidelines list this as a possible alternative, they also note (section 5.5.1, page 35): "There is inadequate evidence to make any conclusions on the efficacy or safety of low molecular weight (LMW) iron dextran for the treatment of RLS (Level U).

The only other treatment algorithm that I know of has been recently published is the one in the Mayo Clinic Proceedings. They note (last paragraph, page 1924) that while any IV iron "may" be used, "The majority of the class I clinical trials for intravenous iron therapy in RLS used, however, ferric carboxymaltose," which is Injectafer. Remember that overall, only about 1/2 of RLS patients respond to IV iron. The reason is unknown. Certainly using the preparation with the best evidence is prudent. If you get treated with LMW iron dextran, and don't get better, how would you know if you didn't get better because you used an inferior iron product? The only way to know (currently) if you are a responder is to use the med with the best evidence of efficacy.

The general thinking of why there is a difference in the effectiveness of different forms of IV iron in RLS is that different formulations release their iron into the blood brain barrier with different kinetics, even though the total amount of molecular iron delivered to the blood stream is about the same, and all work equally well for the treatment of iron deficiency anemia.

Insurance companies don't like paying for expensive medications, and all or nearly all, in their contracts won't cover an expensive med unless it has FDA authorization for the disease to be treated. NO IV iron formulation has received such FDA authorization for treatment of RLS.

[nrpardee]

Thanks for your long and thoughtful reply. I just think there are other factors to consider that make Iron Dextran a viable option- YMMV.

Reading further in the science direct article https://www.sciencedirect.com/science/a ... ia%3Dihub "Evidence-based and consensus clinical practice guidelines for the iron treatment of restless legs syndrome/Willis-Ekbom disease in adults and children: an IRLSSG task force report" you quote:

"5.5.4. Expert-consensus clinical recommendations
There is a lack of data on LMW iron dextran for the treatment of RLS, but there is substantial clinical experience that shows it to be clinically effective in both anemic and non-anemic RLS patients. "

People have different criteria for deciding which treatments they will take and under what conditions. One reasonable criteria is the one you give, which is requiring Level A evidence. I love clinical trials and objective evidence (just ask the people around me), and I prefer to have Level A evidence. It drives me nuts when treatments go against objective evidence, e.g., take a treatment when there's evidence it doesn't work. But I'm willing to take other evidence if it meets my personal test of objectivity. We need to remember that 40-60% of the drugs prescribed are for off-label purposes, i.e., there's never been FDA approval. Doctors don't just do this willy-nilly- they have evidence convincing them to do it.

For me, the following meets that test: if you watch the rls.org webinar on Iron and RLS, Christopher Earley, no mean expert:-) says at approximately 43:45 that he uses iron Dextran. Now prior to this point, all of the numbers he uses in explaining iron injections are from the Injectafer studies- these studies are the gold standard . So those are the numbers he uses in his presentation. And then he adds this one sentence statement immediately, saying what he does- give iron dextran. This clinical practice is obviously the sort of thing that precipitated 5.5.4 above. In short, he prescribes it and it works. BTW, he is one of the authors of two of the level A studies, so he knows Injectafer and dextran both really well. One can speculate as to why one vs the other, but an obvious candidate is cost. I google dextran and got $300-600 a treatment. For Injectafer, at drugs.com it appears to be about $1700 for 1000 ml JUST for the drug; costs at other places may vary, and the description is typically "expensive."

Sidebar: One conclusion that can't be made from the above article is that Injectafer is better than dextran. That's not what the article says. The studies on dextran don't miss out on level A evidence because of lower efficacy. The problem is that the data from the dextran studies isn't good enough, i.e., the studies weren't well enough done. So I wholly agree with the statement that Injectafer has "the best evidence of efficacy" due to the fact that they have high quality studies that prove efficacy. Dextran does not. But it has not been proved that Injectafer is a better formulation than dextran for rls. THis is a subtle point, but an important one. Someday, hopefully soon, someone will do some high enough quality studies on dextran so we'll know if there's a difference in efficacy.

Going back to Dr. Earley- if he thought there was significant issues with efficacy, he wouldn't be prescribing dextran. And if the authors of the above article thought there was a problem with people prescribing dextran, 5.5.4 wouldn't be there.

This is more than an academic question for me, as I'm hoping to be able to get an iron injection. I'm not sure that I fit the guidelines as I've been in treatment for some time, but I'm still not symptom free and dealing with side effects of medications.
So if I can get physician approval, my preference is Injectafer. But if I can't get injectafer due to cost and insurance not paying it- I'm comfortable with the evidence for iron dextran. It's still not cheap- but one of my meds, Horizant, is running from $45-$200/month after insurance already. If the iron works, it could actually save me money. No guarantees. But it looks like a reasonable "risk".

Back to the original question in the thread: if you can't get an insurance company to pay for Injectafer, and you really want iron, especially if you're hurting, one option might be to pursue the Dextran route.

As always, there are differing opinions.

[stjohnh]

Thanks for your long and thoughtful reply. I just think there are other factors to consider that make Iron Dextran a viable option- YMMV.

...
For me, the following meets that test: if you watch the rls.org webinar on Iron and RLS, Christopher Earley, no mean expert:-) says at approximately 43:45 that he uses iron Dextran. ...
Sidebar: One conclusion that can't be made from the above article is that Injectafer is better than dextran. That's not what the article says. The studies on dextran don't miss out on level A evidence because of lower efficacy. The problem is that the data from the dextran studies isn't good enough,
...

So if I can get physician approval, my preference is Injectafer. But if I can't get injectafer due to cost and insurance not paying it- I'm comfortable with the evidence for iron dextran.
...
Back to the original question in the thread: if you can't get an insurance company to pay for Injectafer, and you really want iron, especially if you're hurting, one option might be to pursue the Dextran route.

As always, there are differing opinions.

Thanks for your response. That is the most carefully reasoned reply I've seen on using LMD instead of Injectafer, and I agree with all the points you make. While Level A evidence is preferable to me, I'm not a "Level A or I won't use it snob." I use kratom and THC nearly every day, and there is little if any Level A evidence for those. I recently restarted dipyridamole, and while there is accumulating evidence for efficacy, it certainly isn't Level A.

One other point, however: For docs that are not experts in RLS treatment, iron for RLS is entirely new for them. Persuading a doc without experience in using IV Iron, I believe it may be easier to persuade one of those to let you try IV Iron if it has Level A evidence. So it may be that getting a doc to agree to Injectafer may be easier than LMWD.