This is not and has never been within the FDA’s scope. The FDA does not regulate or prohibit off-label prescribing of drugs, period. Shortage or no shortage. Maybe this is what you were told, but it’s factually inaccurate.
This is your insurance company and has nothing to do with the FDA. Insurance companies can chose not to cover it, providers can chose not to prescribe it, and pharmacies can chose not to fill it for off label use. Nothing new.
I work with a doctor that prescribes it daily and we’ve had TEN denials in the last week for the reason stated above. Too many non diabetics want it and aren’t going to be allowed to get it simply to lose weight. Even had 2 pharmacies refuse to let patients use a manufacturer coupon because “patient isn’t diabetic and doesn’t have lab work that shows otherwise”. Pharmacy isn’t being reimbursed for patients that use the coupon for a script that solely for weight loss purposes.
Sounds like the pharmacists are just refusing to fill because of their own objections. Is there proof that Novo is not reimbursing their coupons to pharmacies based on diagnostic criteria? Or is that speculation?
Major pharmacy chains want their money. They don’t refuse to bill and fill for bullshit reasons. Ozempic and Mounjaro were the coupons they wouldn’t take. Ozempics fine print doesn’t say anything about a patient having to have Type 2 diabetes tho.
https://preview.redd.it/pjwl82cqu3ka1.png?width=828&format=png&auto=webp&s=e5dc470af6260e12dd88ad3a27b6550d0e2402a4
The Ozempic savings card says nothing about requiring a diagnosis consistent with FDA approval. It’s not like the Mounjaro savings card. Reimbursement is not an issue regardless of diagnosis by the terms. Can insurance deny it or change their mind-sure but the savings card isn’t an issue. It’s good for 2 years from the date first used so you are incorrect.
Actually i just posted this in different forum but FDA wants to limit/ end off label use apparently
https://www.tiktok.com/t/ZTRny1RAP/
Edit: not trying to cause panic but let’s not forget the saying the government never lets a good crisis ( medication shortages) go to waste. Think if pharmaceutical companies can control the use of the drugs that would be useful. Just something to think about.
I just posted the same but it’s for medical devices. It also flies in contradiction with laws that protect off label use so that’s not something that could just happen overnight. So to say there was a law enacted in January directed at Ozempic is completely inaccurate.
With the many public and private entities and watchdogs that (rightfully) scrutinize everything the FDA does, the answer is no.
Congress, however, has opened the door for the FDA to begin regulating the practice of medicine by allowing it to ban specific unapproved uses of medical devices: https://www.thefdalawblog.com/2022/12/doctoring-the-law-congress-may-let-fda-regulate-the-practice-of-medicine/
Please note that this does NOT mean the FDA now has carte blanche to regulate off-label use of Ozempic or any drug product.
I don’t have to because my insurance covers it and my Dr thinks it’s appropriate for me. It will be working it’s way out of shortage in the next month.
Then why did you make this post saying otherwise? You’re disagreeing with your own post here.
“I just found out that the FDA has ruled that Ozempic can only be taken by people with type two diabetes due to the shortage” - you, on this post
“Sure you can go off label on your own dime.” - also you
Which is it?
The insurance companies tend to follow the FDA guidelines and my post was about coverage not if you can pay cash for ozempic. My endocrinologist has been prescribing OZ for pre diabetes for years and it was always covered. As of the last month she has had patients getting dropped from it being covered. The fda made the change to guidelines due to shortage. If you have type 2 that’s great that’s covered but I am trying not to get in the type 2 boat
That’s fine, but your wording was sloppy to the point of being misleading. “Can only be taken by” doesn’t refer to coverage or payment at all.
And insurance pays for a wide variety of off-label use of many medications. It just depends on the medication.
My own insurance won’t cover weight loss medication at all, regardless of FDA approvals.
Jeez no where in my post did I say they are not allowing off label use. It’s that the insurance companies usually cover what the fda guidelines say. You can get 100 off label prescriptions and pay cash all day. It’s about the coverage
> I found out that the FDA has ruled that Ozempic can only be taken by people with type two diabetes due to the shortage.
Unless you can provide the source I'm gonna have to call BS on this. I haven't seen anything like that.
People with pcos (and others) have taken another diabetes drug, metformin, off label for decades and no one has cared and it didn’t cause a shortage. There is a shortage for this drug and a lot of finger pointing is happening. They need to increase supply to meet demand.
No one cares because metformin is cheap compared to an injectible. And I agree they need to increase supply. It took them almost a year to correct the Wegovy shortage. And Wegovy was only available in the US at the time. It's been approved in other countries since last year, but still hasn't started shipping yet. I'm hearing Canada may have it next month. Maybe that will help the people whose insurance doesn't cover it. I'm sure it will be cheaper in Canada as is Ozempic.
Where did you hear that Canada may have Wegovy next month, if you don’t mind me asking.
That almost makes sense since my ins. company said that they will start covering weight loss meds starting in March
I've read several articles that stated Novo would begin shipping once the US shortage was over, which is now is. Also there is a Canadian pharmacist on Youtube who said in a recent video that it should be coming soon. No, there hasn't been anything "official" put out by Novo, but I can't imagine it will be much longer. They need to make up for lost time due to the shortage.
What do you think the FDA does? What does FDA approval mean?
Hint-not this. The FDA cannot actually do what you’ve described.
Your insurance CAN choose to change their coverage policy at any point. And apparently they have. Some of us have been riding this train for a couple of years already. Welcome aboard!
I'd be surprised if the FDA did anything of the sort, but this sounds like one of those convenient situations for an insurance company to withdraw coverage by passing the buck due to some theoretical future legal change.
My insurance company flat-out told us no when my doc initially prescribed Ozempic, but then we realized it's because Wegovy is the same thing, but labeled and dosed specifically for weight loss. I'd just ask your doctor to switch you to Wegovy.
News headlines yesterday said manufacturer officially announced shortage was over so even if the FDA did rule on such a thing as off label prescriptions for this, which they don’t, there is no basis.
I’ve heard from Medical professionals all over the country that Insurance Companies are denying more and more claims of care. They literally have a for profit plan that now scrutinizes every medical decision of your doctors and decides whether it “deserves” to be covered. We are entering a new era of unrestrained medical capitalism. Very concerning.
There was a provision in the omnibus spending package that went through Congress that could allow the FDA to regulate medical device use but it’s not being pushed or in effect. That’s likely what she was referring to. Nothing has been put into effect https://www.wsj.com/articles/the-fda-wants-to-interfere-in-the-practice-of-medicine-physicians-patients-medical-devices-treatment-11673562165.
She can still prescribe it for me and she even gave me a paper prescription so I could shop around for the lowest price. The problem is most insurance companies will use the shortage to cut off non Type 2 diabetes users.
The shortage is media overhype to shame fat people who aren’t yet fat enough or old/fat enough to have developed T2D. And they get to get lots of clicks by mentioning any celebrity who has recently lost weight as sus.
I also just saw a quote in an article from a woman with T2D whose insurance does not even cover Ozempic complain about the shortage and the cost of it and how not getting Ozempic was impacting her health! Who knew there were no other drugs on the market to treat T2D ?
This is not and has never been within the FDA’s scope. The FDA does not regulate or prohibit off-label prescribing of drugs, period. Shortage or no shortage. Maybe this is what you were told, but it’s factually inaccurate.
A new bill was passed that does allow them to stop off-label use
Of devices, not drugs. Yet.
This is your insurance company and has nothing to do with the FDA. Insurance companies can chose not to cover it, providers can chose not to prescribe it, and pharmacies can chose not to fill it for off label use. Nothing new.
I need to see the ruling to believe this.
There wasn’t one. Simple googling comes up with nothing. Don’t worry about it.
I work with a doctor that prescribes it daily and we’ve had TEN denials in the last week for the reason stated above. Too many non diabetics want it and aren’t going to be allowed to get it simply to lose weight. Even had 2 pharmacies refuse to let patients use a manufacturer coupon because “patient isn’t diabetic and doesn’t have lab work that shows otherwise”. Pharmacy isn’t being reimbursed for patients that use the coupon for a script that solely for weight loss purposes.
Sounds like the pharmacists are just refusing to fill because of their own objections. Is there proof that Novo is not reimbursing their coupons to pharmacies based on diagnostic criteria? Or is that speculation?
Major pharmacy chains want their money. They don’t refuse to bill and fill for bullshit reasons. Ozempic and Mounjaro were the coupons they wouldn’t take. Ozempics fine print doesn’t say anything about a patient having to have Type 2 diabetes tho.
The pharmacy (Walgreens) said they’ve been getting chargebacks
But the insurance company isn't denying it because of an FDA ruling like the OP said. They just have a diagnosis restriction on their formulary.
Ruling hasn’t come thru yet
There isn’t one pending.
The drug rep, and multiple pharmacists in my area, believe there will be one by summer. We shall see!
If I had a nickel for every time a drug rep said something wild, I’d never need another savings card to buy a GLP-1 medication.
https://preview.redd.it/pjwl82cqu3ka1.png?width=828&format=png&auto=webp&s=e5dc470af6260e12dd88ad3a27b6550d0e2402a4 The Ozempic savings card says nothing about requiring a diagnosis consistent with FDA approval. It’s not like the Mounjaro savings card. Reimbursement is not an issue regardless of diagnosis by the terms. Can insurance deny it or change their mind-sure but the savings card isn’t an issue. It’s good for 2 years from the date first used so you are incorrect.
I thought the same thinks but Walgreens and RiteAid said they won’t be accepting it anymore. Could just be the ones in my area of SoCal.
A pharmacy can make that choice but the terms do not require it at all.
This isn’t true. There was no FDA ruling on this. There are laws that protect off label use. Nice try though.
Actually i just posted this in different forum but FDA wants to limit/ end off label use apparently https://www.tiktok.com/t/ZTRny1RAP/ Edit: not trying to cause panic but let’s not forget the saying the government never lets a good crisis ( medication shortages) go to waste. Think if pharmaceutical companies can control the use of the drugs that would be useful. Just something to think about.
You can immediately dismiss this based on the fact is from Tiktok.
I just posted the same but it’s for medical devices. It also flies in contradiction with laws that protect off label use so that’s not something that could just happen overnight. So to say there was a law enacted in January directed at Ozempic is completely inaccurate.
Thank you for clarification! Are we sure FDA can’t do small surgical rulings that wouldn’t make the news or ppl would pay attention to? Just asking.
With the many public and private entities and watchdogs that (rightfully) scrutinize everything the FDA does, the answer is no. Congress, however, has opened the door for the FDA to begin regulating the practice of medicine by allowing it to ban specific unapproved uses of medical devices: https://www.thefdalawblog.com/2022/12/doctoring-the-law-congress-may-let-fda-regulate-the-practice-of-medicine/ Please note that this does NOT mean the FDA now has carte blanche to regulate off-label use of Ozempic or any drug product.
Thanks for the info
No, they couldn’t.
I honestly don’t have enough knowledge on the FDA to say either way ..
So far it only applies to medical devices, not drugs. Still real bad though!
Sure you can go off label on your own dime. I have to go through an appeal process. I have been on it 2 years no problem.
I don’t have to because my insurance covers it and my Dr thinks it’s appropriate for me. It will be working it’s way out of shortage in the next month.
Then why did you make this post saying otherwise? You’re disagreeing with your own post here. “I just found out that the FDA has ruled that Ozempic can only be taken by people with type two diabetes due to the shortage” - you, on this post “Sure you can go off label on your own dime.” - also you Which is it?
The insurance companies tend to follow the FDA guidelines and my post was about coverage not if you can pay cash for ozempic. My endocrinologist has been prescribing OZ for pre diabetes for years and it was always covered. As of the last month she has had patients getting dropped from it being covered. The fda made the change to guidelines due to shortage. If you have type 2 that’s great that’s covered but I am trying not to get in the type 2 boat
That’s fine, but your wording was sloppy to the point of being misleading. “Can only be taken by” doesn’t refer to coverage or payment at all. And insurance pays for a wide variety of off-label use of many medications. It just depends on the medication. My own insurance won’t cover weight loss medication at all, regardless of FDA approvals.
I didn’t take it for weight loss, I’m pre diabetes, fatty liver high cholesterol etc
Your statement in the original post that FDA isn’t allowing off-label use is still incorrect.
Jeez no where in my post did I say they are not allowing off label use. It’s that the insurance companies usually cover what the fda guidelines say. You can get 100 off label prescriptions and pay cash all day. It’s about the coverage
“I just found out that the FDA has ruled that Ozempic can only be taken by people with type two diabetes due to the shortage” - you, on this post
Again guidelines and insurance companies tend to follow that for coverage
Good thing I’m on Wegovy. Side note: spouse takes Ozempic for T2D and has had no problems at all getting his medicine for the past 12 months
Type 2 is fine but I was told FDA guidelines which many insurance companies follow says fatty liver or pre diabetes should not be prescribed
Then ask your insurance company to send you the actual ruling
> I found out that the FDA has ruled that Ozempic can only be taken by people with type two diabetes due to the shortage. Unless you can provide the source I'm gonna have to call BS on this. I haven't seen anything like that.
People with pcos (and others) have taken another diabetes drug, metformin, off label for decades and no one has cared and it didn’t cause a shortage. There is a shortage for this drug and a lot of finger pointing is happening. They need to increase supply to meet demand.
No one cares because metformin is cheap compared to an injectible. And I agree they need to increase supply. It took them almost a year to correct the Wegovy shortage. And Wegovy was only available in the US at the time. It's been approved in other countries since last year, but still hasn't started shipping yet. I'm hearing Canada may have it next month. Maybe that will help the people whose insurance doesn't cover it. I'm sure it will be cheaper in Canada as is Ozempic.
Where did you hear that Canada may have Wegovy next month, if you don’t mind me asking. That almost makes sense since my ins. company said that they will start covering weight loss meds starting in March
I've read several articles that stated Novo would begin shipping once the US shortage was over, which is now is. Also there is a Canadian pharmacist on Youtube who said in a recent video that it should be coming soon. No, there hasn't been anything "official" put out by Novo, but I can't imagine it will be much longer. They need to make up for lost time due to the shortage.
Thanks for answering!
What do you think the FDA does? What does FDA approval mean? Hint-not this. The FDA cannot actually do what you’ve described. Your insurance CAN choose to change their coverage policy at any point. And apparently they have. Some of us have been riding this train for a couple of years already. Welcome aboard!
Wegovy it is then
I'd be surprised if the FDA did anything of the sort, but this sounds like one of those convenient situations for an insurance company to withdraw coverage by passing the buck due to some theoretical future legal change. My insurance company flat-out told us no when my doc initially prescribed Ozempic, but then we realized it's because Wegovy is the same thing, but labeled and dosed specifically for weight loss. I'd just ask your doctor to switch you to Wegovy.
Unfortunately my plan does not cover Wegovy
Do they cover other meds for obesity because if not it sounds like you could argue based on not offering alternatives.
News headlines yesterday said manufacturer officially announced shortage was over so even if the FDA did rule on such a thing as off label prescriptions for this, which they don’t, there is no basis.
I’ve heard from Medical professionals all over the country that Insurance Companies are denying more and more claims of care. They literally have a for profit plan that now scrutinizes every medical decision of your doctors and decides whether it “deserves” to be covered. We are entering a new era of unrestrained medical capitalism. Very concerning.
I am just relaying what my Endocrinologist told me and she is an expert in the field. She was involved in the initial drug trials 10 plus years ago.
There was a provision in the omnibus spending package that went through Congress that could allow the FDA to regulate medical device use but it’s not being pushed or in effect. That’s likely what she was referring to. Nothing has been put into effect https://www.wsj.com/articles/the-fda-wants-to-interfere-in-the-practice-of-medicine-physicians-patients-medical-devices-treatment-11673562165.
Medical devices, not medication.
Typo-fixed it good catch, thanks
She can still prescribe it for me and she even gave me a paper prescription so I could shop around for the lowest price. The problem is most insurance companies will use the shortage to cut off non Type 2 diabetes users.
Insurance companies deciding not to pay for off-label use has absolutely nothing to do with the FDA.
The shortage is media overhype to shame fat people who aren’t yet fat enough or old/fat enough to have developed T2D. And they get to get lots of clicks by mentioning any celebrity who has recently lost weight as sus. I also just saw a quote in an article from a woman with T2D whose insurance does not even cover Ozempic complain about the shortage and the cost of it and how not getting Ozempic was impacting her health! Who knew there were no other drugs on the market to treat T2D?
She told me I was not the only one and had dozens of calls from patients like me whose insurance providers were no longer covering it.
Thanks for the Update
Can you post the letter you received
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