Very interesting. Seems they are seeking approval to have S&O no longer be "off-label."

This is rather odd and somewhat redundant as both drugs are already approved so if it's just for SOC status well I have wondered about that too.
There can be more than one SOC for any ailment, cancer, RA, etc. It's up to the Dr.s to concoct the best cocktail of drugs that is suitable to the patient's clinical presentation.
Again I'm not sure what the purpose is?

You pioneer you! Now, let's see if the cost comes down. Yeah, right. lol

Kramer. each drug is FDA approved but the combination of the two is not. It's a not a question of SOC, it's just a question of "off-label' use vs approved combination use, I THINK. I don't know if Canada has the equivalent of off-label use or not...

Price will still be an issue, but doctors are more likely to prescribe the combo and work harder for ins approval, I THINK, if it is an approved combo as opposed to an off-label combo.

Yes we use the term off label up here too but I still don't see the point of having them approved together. What will it change? I'm thinking of HIV cocktails where combinations of different drugs are used tailor made for each patient. There is no "on label" for each combination..
Standard of care: 1. A diagnostic and treatment process that a clinician should follow for a certain type of patient, illness, or clinical circumstance. Adjuvant chemotherapy for lung cancer is "a new standard of care, but not necessarily the only standard of care." (New England Journal of Medicine, 2004) "
Sorry I don't mean to belabor the subject. I just don't see how FDA approval will change much. Dr.s have access to this combo already. Even if it receives some sort of new status, insurance companies may still balk at the price and choose to cover the less expensive "SOC" treatments available.
Even the press release does not say what the hopes of FDA approval are. Maybe it will become more clear to me in time.

My doctor's group will not allow him to prescribe off label so this would help me.

Thanks Tulsa. Maybe it will assure more Dr.s to think outside the Interferon box! Maybe it has to do with those Dr.s not wanting to leave themselves open to controversy or liability.

My dr won't order off label, either. Perhaps a combination of concerns - law suits, their insurance provider, and the reason its still off label is all the data is not in yet and some care providers do try to consider whats best & safest for the patient in my ideal world.

I believe the comments about this combo not being off-label after this FDA approval are spot on. The "off-label" issue for sure causes some docs to not want to prescribe it and some insurance companies to resist paying for it. Having Sova/Oly being an FDA approved tx will/should ease the burden of trying to get it approved. It's a good thing and a major step in the right direction. Many of us are proving that this combo WORKS very very well for Geno 1's. The price, though, well, that probably will remain constant for a while - at $150K total for both drugs for 12 weeks of tx. Insurance companies will still balk, but having that "off-label" stigma taken away will mean the docs can much more easily defend prescribing it.

Many docs.will only prescribe approved txs and many ins companies only pay for approved txs. It took a lot of time and. Couargeous docs to come up with decent cocktails to tx hiv that worked. We in the forefront of hcv know off label works but we neef access and approval of tbis combo will help encourage that.

that's the ticket! that's what i was trying to say!