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Avatar universal

Off-Lable ??

Can someone tell me what Off-Lable means. I sometimes see it used in a sentence like this. "COSMOS (sofosbuvir and simeprevir )  study may influence clinicians’ decisions to prescribe them together off-label, in particular for patients with more urgent needs for treatment."

Do you think insurance would cover this kind of scenario?
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Avatar universal
I thought it was something like that, but seems like Doctors would be going out on a limb, but it's great that they do that. Thanks!!
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Avatar universal
48weeks - good handle. :)

One thing you may wonder, at least I did, was whether it's okay for a doctor to prescribe "off label."  It is, there's nothing wrong with it.  Interferon is not even approved for HCV for Liver transplant patients yet, but is prescribed all the time.  Insurance always covers it  Incivek same thing.  Ribavirin same as well.

That's one of the issues I see with the ACA.  If the government says it's not going to pay for it, then you're just out of luck, while if a doctor under private healthcare does it, you have a chance, if turned down.  You can get your doctor to make the case to the insurance company and your insurance reseller or the company you work for to be your advocate.  
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148588 tn?1465778809
I think it varies a lot by what insurance you have. You will probably have to get your doctor to prescribe and then see if they decide to cover. I take a fancy Rx B vitamin off-label and Texas BCBS covers it aprox. 70%.
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Avatar universal
You might want to ask the member here that goes by Bali05 to answer your question about insurance as his doctor went off-label and treated him with Alinia (Nitozoxanide when he treated...
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1815939 tn?1377991799
Off-Label definition:

"Definitions

“Off-label” use for prescription drugs, biologics, and approved medical devices means any use that is not specified in the labeling approved by the U.S. Food and Drug Administration (FDA). "

http://www.aaos.org/about/papers/position/1177.asp


The FDA has not yet approved the use of Sofosbuvir and Simeprevir in combination for the treatment of HCV. So if a physician prescribes them together, they would be Off-label.

If there are studies indicating the medication/medications works/work for a specific purpose, even though the FDA has not yet approved it, the health insurance companies may approve it. Your doctor may have to send a specific request for approval to the insurance company and document the reasons why using an off-label combination would be necessary.  
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