Insurance and Off Label Drug Prescriptions

[y4m]

I have a chronic allergic rash that doesn't respond to traditional drugs (have had it for 3 years).  There's a promising clinical trial using an asthma drug, but for now it's considered an off label (non FDA approved) use.  The drug is approved though, just not for my condition.  I'm meeting with a specialist today and want to talk to her about the possibility of trying this drug, but want to understand the potential cost and my chances of getting insurance to cover it.    

Anyone had success getting their insurance company to cover a prescription for an off label use? I'd be interested in your tips or experience.

[Deleted]

Do you know what the drug is? What is the full cost? Is there a generic version of it?

[y4m]

It's Xolair - no generic, and I'm reading $800 or so per dose (I'd need one monthly). And it's injected at the Dr. office so it's also not coming up in my insurance drug database.

[Deleted]

You don't have Aetna, do you?

[y4m]

No--Blue Shield of CA.

But I think if I did have Aetna it would be covered, based on their policy stuff (http://www.aetna.com/cpb/medical/data/600_699/0670.html)

Can't find something similar for my insurer though.

[vtdiamond]

Could you participate in one of the Clinical Trials using it? I looked it up on clinicaltrials.gov and it looks like a few are still recruiting participants.

clinicaltrials.gov/ct2/results?term=Xolair+asthma&Search=Search

[y4m]

Sept 3, 2013 8:55:37 GMT -5 vtdiamond said:

Could you participate in one of the Clinical Trials using it? I looked it up on clinicaltrials.gov and it looks like a few are still recruiting participants.

clinicaltrials.gov/ct2/results?term=Xolair+asthma&Search=Search

I'll talk to her about that too.  How does it generally work?  Do you need to be physically near whoever is running the trial?

[Deleted]

I found the exact same info from Aetna, which is why I asked.

[Deleted]

clinicaltrials.gov/ct2/results?term=Xolair+urticaria&recr=&rslt=&type=&cond=&intr=&titles=&outc=&spons=&lead=&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&gndr=&rcv_s=&rcv_e=&lup_s=&lup_e=

[Deleted]

Also if you had UHC
www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Policies%20and%20Protocols/Medical%20Policies/Drug%20Policies/Xolair_policy.pdf

These aren't necessarily helpful now, but if you have access to coverage through UHC or Aetna, for instance, your H's employer it might be worth the switch even if the premiums are a higher cost.

[vtdiamond]

Sept 3, 2013 8:58:13 GMT -5 y4m said:

Sept 3, 2013 8:55:37 GMT -5 vtdiamond said:

Could you participate in one of the Clinical Trials using it? I looked it up on clinicaltrials.gov and it looks like a few are still recruiting participants.

clinicaltrials.gov/ct2/results?term=Xolair+asthma&Search=Search

I'll talk to her about that too.  How does it generally work?  Do you need to be physically near whoever is running the trial?

It depends on the study, but yes for study of a drug you would likely need to come in for physical visits to the doctors office to administer the drug and for blood work, etc to check on your safety.

[y4m]

Ooh DH has united I think.

[StJess80]

I'm not 100% certain this is the same, but for quite some time, I had to get a prior authorization form filled out once a year for my adderall script. It wasn't that I was necessarily using it off label, it's just that my insurance company would only cover it for those under 19. The form was just something that the insurance needed from my dr saying that yes, I do need it, and here's why. Like I said, not completely certain it's the same, but you might want to ask if that's what you need. If it is, it's fairly easy.

[chikastuff]

If it's an injectable then it might be considered a "specialty" drug, which would fall under a different class within your benefit design.

But first your MD should prescribe it and let the PBM reject it. Then try for a prior authorization.The doc will have to prove that you're profoundly affected by your condition and that you've tried X, Y, and Z. He might even have to provide lab results and such. But then you're at least in the system and there's a paper trail. Just keep escalating and appealing if your PBM rejects the request. At the same time, try and get into that trial.

[chikastuff]

Also, perhaps reaching out to the manufacturer is a good idea? They might have coupons/copay waivers that you can use.

[Deleted]

Usually you can't qualify for their copay card/assistance if you're using it for an off-label use, and oftentimes you can only qualify for the copay card if you have insurance coverage. Since it is likely that her insurance will not cover it with the off-label use that is the same, in their eyes, as no coverage.

[boiler717]

Have you tried singulair? It does wonders for my chronic urticaria and is generic and much cheaper than Xolair. I'm assuming you've tried it since you are going to that level though.

The best thing to do would be to appeal, appeal, appeal. Find out exactly what their Prior Authorization algorithm is and have your HCP write a letter.

[boiler717]

Here's info on the co-pay card program they have, it looks pretty good. It does block unapproved uses through. I wonder what their adjudication process is for that though.

www.xolairhcp.com/xolairhcp/co-pay-assistance-with-XOLAIR-debit-card-program.html

[pamela]

My estrogen pills right now are technically off-label and insurance covered it. And I know people take cytotec to soften the cervix for procedures or inductions which is off label and never heard of anyone rejected for that.