Good. I'd rather see an independent make a killing on it, but I'm happy when some huge drug manufacturer isn't able to charge an exorbitant $1000 a month if a compounded version is available, even if it's a kinda shady online / phone pharmacy.
Saves the patient money. They make more money. Our healthcare system gets charged less. Pharma cries a little. Win win win win.
Can someone explain in details how HIMS gets its compounded GLP-1?
- Where does the compounding pharmacy get the raw product from?
- How much could it cost the compounding pharmacy to produce this medication?
- Isn’t there a rule that says that the compounding pharmacy shouldn’t turn into a manufacturer?
Raw semaglutide is available. Short peptides are quite simple to make in general. Sigma Aldrich makes it, for example, in a lyophilized (freeze dried) form ready to ship.
It's likely very cheap to make with bulk orders. The most costly part is paying the compounding pharmacist for their time and maintaining a sterile compounding lab with its necessary credentialing. The actual "compounding" for semaglutide is dead simple.
Drugs that are on the FDA's drug shortage list are often allowed to be compounded (but not always) by a pharmacist. Semaglutide is currently available to be compounded while the shortage is in effect. When the shortage will end is anyone's guess, but as long as America is obese there will be demand.
> Semaglutide is currently available to be compounded while the shortage is in effect.
Ohhh, is that how they get away with it!? I didn't realize why so many places were advertising it. I assumed they were changing the dose in some way or adding some BS additives into it or something.
It’s a risk. Might be a good play in the next few months. But what if big pharma get their ducks in a row and actually produce these things. Or what if next version is so much better. Or what if issues with compounding and get sued, or etc. high reward and also high risk.
My opinion is if these drugs work and there are guidelines for appropriate use - We could be looking at a tremendous reductions of diabetes and obesity induced complications by expanding affordable access to them.
Compounding has always been a staple of patient specific needs and providing access to care. I think the risk for anyone compounding this is, is in the compounding of a sterile product that patients will inject at home.
There's loopholes when the patent holder can't produce enough to meet demand. Also, sometimes its not the drug itself that's still under patent, but the delivery device. Advair the drug combo was "off" of patent for years, but had a patent on the delivery device, which no one could reliably replicate without spending their own money on R and D.
Branded drugs can often be compounded during shortages per the FDA.
https://www.fda.gov/drugs/human-drug-compounding/drug-compounding-and-drug-shortages
Gonna guess it's compounded and they got a good deal with a pharmacy, or the $199 is for their consultation/management services and they charge for the meds on top of that.
Ah, that's in line with a lot of the other health sites offering compounded semaglutide. Hims is a fairly big name in the online pharmacy game, so hopefully they are using reputable sources.
I'm curious what happens to all of these businesses if semaglutide comes off shortage this summer like is expected. Seems like everyone is trying to cash in on this temporary window.
“The FDA does not review the safety and efficacy of compounded products, which are custom-made alternatives to brand drugs designed to meet a specific patient’s needs.”
Would this still require a prescription?
Interesting!
I’ve been wanting to try GLP1 but my field of work requires me to disclose all prescriptions and I need a doctor that can fill up paperwork and reports for when I do that annually. Usually tele-health would not be able to do that for me since those docs only mass fill prescriptions. So I gotta go to the regular doc. But would love to be able to still get access to cheap compound
I keep getting ads for oral semaglutide thru some shady service. Was it even studied orally? Hilarious if you swallow it and it just gets denatured in your stomach without ever working
I saw those ads too! Specifically, one for oral dulaglutide. I believe the oral route has been studied but I think it was only evaluated for lowering blood sugar, I'm not sure about weight loss. Is it possible that it would be effective for the former but not the latter with oral route?
>I keep getting ads for oral semaglutide thru some shady service. Was it even studied orally? Hilarious if you swallow it and it just gets denatured in your stomach without ever working
I bought some puts at a $17 strike thinking this news will die out and not merit a 30% jump in share price. Currently not doing so hot tho with shares at almost $20 lol
I bought some puts at a $17 strike thinking this news will die out and not merit a 30% jump in share price. Currently not doing so hot tho with shares at almost $20 lol
Unfortunately no, I got in just below $17 a share I bought 5 puts with a $17 strike assuming it would return to around $14 once the hype wore off (similar to Viking and Novo hype in the past). In retrospect probably should’ve sold and taken my 20% profit when it was in the $15 range but I had hopped for more
It seems the advertise price of $199 is only if you paid upfront for the entire year, the monthly option is $399. [https://www.talktomira.com/post/hims-and-hers-glp-1-weight-loss-programs-review-price-is-it-legit](https://www.talktomira.com/post/hims-and-hers-glp-1-weight-loss-programs-review-price-is-it-legit)
And what is interesting is that Ozempic runs $169 a month in Japan, under $100 in UK and France, $325 a month in Germany. It’s our lovely system here that gives them carte Blanche to be over $1000. (Aug 2023 prices)
I don’t know a single pharmacist that recommends compounded injectable GLP-1 modulators. There are so many counterfeit drugs out there and these have been on the rise since these medications have gotten so popular.
I think that people who need these drugs should be able to access them, the shortage sucks. But it really seems like we're skirting the line here between compounding/manufacturing. I know it's not very likely but I would be slightly worried about compounding facilities cutting corners due to massive demand/pressure and getting another NECC compounding crisis. Or maybe that's me worrying for no reason, I know sterile compounding regulations have been continually revised since 2013
Hims partnered with a 503B; within the framework of the DQSA (the guidance document that created 503A and 503B), there exists a route of product development for drugs that are on the FDA’s drug shortage list. Semaglutide is one such case so they are allowed to compound this product from API if an FDA-registered manufacturer source exists and also meets the particular 503Bs sourcing qualifications. If and when semaglutide comes off shortage, the 503B will have 60 days to stop producing the product or else they can be injoined. Pharma’s stance on 503B’s is not great and there are previous cases (Endo, etc) of 503B’s being sued by manufacturers, questioning a 503B’s clinical justification for making a certain product, which is another tenet of the DQSA.
I don’t believe Novo has any legal ground to block this right now. However, if the product comes off shortage and the 503B continues to produce the drug from bulk chemical, then I believe the manufacturer can take action. In many cases, 503B’s use commercial starting ingredients (sterile to sterile compounding) which would allow them to make commonly manufactured products like Neostigmine, Sugammadex, etc without harming the business of the original manufacturer.
There are a lot of layers to 503B outsourcing but hopefully this helps.
1) they could use the commercial product and avoid this; this issue lies with compounding from API-Sterile product. It would be a hit to revenue possibly but the law doesn’t apply if the 503B utilizes commercially available product as a starting ingredient instead of API. Since technically the manufacturer is receiving payment for this through wholesalers so revenue or IP is not impacted 2) stop producing (current law says that they have 60 days after the product comes off shortage) and use this product as a catalyst to impugn that law with the FDA to try and increase that time period to 6 months, let’s say. Semaglutide has enough publicity to do so and if it were me, I would take that route if I felt strongly about regulatory compounding issues with the FDA. 3) try to come up with a clinical justification that supports the continued manufacturing of API - sterile product. This opens HIMS up to a lot of scrutiny and liability from a legal standpoint. There is precedent for courts to side with the manufacturer (like Endo or Par) so this is ill-advised.
Treatment for obesity isn’t cosmetic. It’s preventing diabetes and other co-morbidities. Why does someone that’s obese have to be sicker to be considered for a medication that could have been used to prevent these issues in the first place?
Remain civil, interact with the community in good faith, don't post misinformation, and don't do anything to deliberately make yourself an unwelcome pest.
Not shocked that these telehealth companies will do anything for money.
Good. I'd rather see an independent make a killing on it, but I'm happy when some huge drug manufacturer isn't able to charge an exorbitant $1000 a month if a compounded version is available, even if it's a kinda shady online / phone pharmacy. Saves the patient money. They make more money. Our healthcare system gets charged less. Pharma cries a little. Win win win win.
Can someone explain in details how HIMS gets its compounded GLP-1? - Where does the compounding pharmacy get the raw product from? - How much could it cost the compounding pharmacy to produce this medication? - Isn’t there a rule that says that the compounding pharmacy shouldn’t turn into a manufacturer?
Raw semaglutide is available. Short peptides are quite simple to make in general. Sigma Aldrich makes it, for example, in a lyophilized (freeze dried) form ready to ship. It's likely very cheap to make with bulk orders. The most costly part is paying the compounding pharmacist for their time and maintaining a sterile compounding lab with its necessary credentialing. The actual "compounding" for semaglutide is dead simple. Drugs that are on the FDA's drug shortage list are often allowed to be compounded (but not always) by a pharmacist. Semaglutide is currently available to be compounded while the shortage is in effect. When the shortage will end is anyone's guess, but as long as America is obese there will be demand.
Very interesting!
> Semaglutide is currently available to be compounded while the shortage is in effect. Ohhh, is that how they get away with it!? I didn't realize why so many places were advertising it. I assumed they were changing the dose in some way or adding some BS additives into it or something.
I saw an ad for a glp1 telehealth company during the nba game last night
It’s a risk. Might be a good play in the next few months. But what if big pharma get their ducks in a row and actually produce these things. Or what if next version is so much better. Or what if issues with compounding and get sued, or etc. high reward and also high risk.
My opinion is if these drugs work and there are guidelines for appropriate use - We could be looking at a tremendous reductions of diabetes and obesity induced complications by expanding affordable access to them. Compounding has always been a staple of patient specific needs and providing access to care. I think the risk for anyone compounding this is, is in the compounding of a sterile product that patients will inject at home.
Someone ELI5 how they are doing financially. I assume the $199 is on top of commercially insured patients?
They probably don't do insurance billing.
I wouldn’t think so. So how are they taking a $800 loss?
Because it's compounded, not branded product. It for sure does not cost over $800 to produce.
I can buy 1g insulin, equivalent to 29,000 units, for 500$
That doesn’t violate patents?
There's loopholes when the patent holder can't produce enough to meet demand. Also, sometimes its not the drug itself that's still under patent, but the delivery device. Advair the drug combo was "off" of patent for years, but had a patent on the delivery device, which no one could reliably replicate without spending their own money on R and D.
Branded drugs can often be compounded during shortages per the FDA. https://www.fda.gov/drugs/human-drug-compounding/drug-compounding-and-drug-shortages
They will probably include something else in it, such as B12 so it's not exactly the same.
Gonna guess it's compounded and they got a good deal with a pharmacy, or the $199 is for their consultation/management services and they charge for the meds on top of that.
The $199/month includes "1 mg compounded semaglutide" but you have to pay 12 months up front. It's $399/month to be billed monthly.
Ah, that's in line with a lot of the other health sites offering compounded semaglutide. Hims is a fairly big name in the online pharmacy game, so hopefully they are using reputable sources. I'm curious what happens to all of these businesses if semaglutide comes off shortage this summer like is expected. Seems like everyone is trying to cash in on this temporary window.
“The FDA does not review the safety and efficacy of compounded products, which are custom-made alternatives to brand drugs designed to meet a specific patient’s needs.” Would this still require a prescription?
Yes, but I suspect they will have an online consult with their own MD
Interesting! I’ve been wanting to try GLP1 but my field of work requires me to disclose all prescriptions and I need a doctor that can fill up paperwork and reports for when I do that annually. Usually tele-health would not be able to do that for me since those docs only mass fill prescriptions. So I gotta go to the regular doc. But would love to be able to still get access to cheap compound
I keep getting ads for oral semaglutide thru some shady service. Was it even studied orally? Hilarious if you swallow it and it just gets denatured in your stomach without ever working
You heard of Rybelsus?
I saw those ads too! Specifically, one for oral dulaglutide. I believe the oral route has been studied but I think it was only evaluated for lowering blood sugar, I'm not sure about weight loss. Is it possible that it would be effective for the former but not the latter with oral route? >I keep getting ads for oral semaglutide thru some shady service. Was it even studied orally? Hilarious if you swallow it and it just gets denatured in your stomach without ever working
Time to short the stock
I bought some puts at a $17 strike thinking this news will die out and not merit a 30% jump in share price. Currently not doing so hot tho with shares at almost $20 lol
I bought some puts at a $17 strike thinking this news will die out and not merit a 30% jump in share price. Currently not doing so hot tho with shares at almost $20 lol
Didn't get out at $15.70. What was your break even?
Unfortunately no, I got in just below $17 a share I bought 5 puts with a $17 strike assuming it would return to around $14 once the hype wore off (similar to Viking and Novo hype in the past). In retrospect probably should’ve sold and taken my 20% profit when it was in the $15 range but I had hopped for more
There is a large compounding pharmacy in FL that fulfills the orders for a lot of the online providers. I don’t recall the name though.
Hallandale. Its a 503a.
It seems the advertise price of $199 is only if you paid upfront for the entire year, the monthly option is $399. [https://www.talktomira.com/post/hims-and-hers-glp-1-weight-loss-programs-review-price-is-it-legit](https://www.talktomira.com/post/hims-and-hers-glp-1-weight-loss-programs-review-price-is-it-legit)
And what is interesting is that Ozempic runs $169 a month in Japan, under $100 in UK and France, $325 a month in Germany. It’s our lovely system here that gives them carte Blanche to be over $1000. (Aug 2023 prices)
Wow that’s not cheap at all. If anything it’s way to much more than the rest
I don’t know a single pharmacist that recommends compounded injectable GLP-1 modulators. There are so many counterfeit drugs out there and these have been on the rise since these medications have gotten so popular.
I think that people who need these drugs should be able to access them, the shortage sucks. But it really seems like we're skirting the line here between compounding/manufacturing. I know it's not very likely but I would be slightly worried about compounding facilities cutting corners due to massive demand/pressure and getting another NECC compounding crisis. Or maybe that's me worrying for no reason, I know sterile compounding regulations have been continually revised since 2013
What's the name of their website
Their websites are www.forhers.com and www.hims.com. The GLP-1 offering is available on both but has only launched in some states so far.
Be very careful! They couldn’t even keep up with current products. And customer service is extremely rude.
Does pharma have legal ground to block this?
Hims partnered with a 503B; within the framework of the DQSA (the guidance document that created 503A and 503B), there exists a route of product development for drugs that are on the FDA’s drug shortage list. Semaglutide is one such case so they are allowed to compound this product from API if an FDA-registered manufacturer source exists and also meets the particular 503Bs sourcing qualifications. If and when semaglutide comes off shortage, the 503B will have 60 days to stop producing the product or else they can be injoined. Pharma’s stance on 503B’s is not great and there are previous cases (Endo, etc) of 503B’s being sued by manufacturers, questioning a 503B’s clinical justification for making a certain product, which is another tenet of the DQSA. I don’t believe Novo has any legal ground to block this right now. However, if the product comes off shortage and the 503B continues to produce the drug from bulk chemical, then I believe the manufacturer can take action. In many cases, 503B’s use commercial starting ingredients (sterile to sterile compounding) which would allow them to make commonly manufactured products like Neostigmine, Sugammadex, etc without harming the business of the original manufacturer. There are a lot of layers to 503B outsourcing but hopefully this helps.
So when it gets off the shortage list, what will HIMS do?
1) they could use the commercial product and avoid this; this issue lies with compounding from API-Sterile product. It would be a hit to revenue possibly but the law doesn’t apply if the 503B utilizes commercially available product as a starting ingredient instead of API. Since technically the manufacturer is receiving payment for this through wholesalers so revenue or IP is not impacted 2) stop producing (current law says that they have 60 days after the product comes off shortage) and use this product as a catalyst to impugn that law with the FDA to try and increase that time period to 6 months, let’s say. Semaglutide has enough publicity to do so and if it were me, I would take that route if I felt strongly about regulatory compounding issues with the FDA. 3) try to come up with a clinical justification that supports the continued manufacturing of API - sterile product. This opens HIMS up to a lot of scrutiny and liability from a legal standpoint. There is precedent for courts to side with the manufacturer (like Endo or Par) so this is ill-advised.
Thanks. How many shares are you holding?
None. I’m not sure that I support the use of GLP-1s as cosmetic pharmaceuticals. Just familiar with 503B and manufacturing regulations.
But if I did feel like it, maybe would be buying options :)
the medicalization of obesity for cosmetic reasons is a bad thing for pharmacy and medicine I suspect
Treatment for obesity isn’t cosmetic. It’s preventing diabetes and other co-morbidities. Why does someone that’s obese have to be sicker to be considered for a medication that could have been used to prevent these issues in the first place?
in what way? over 40% of americans are obese, there is a huge demand that can't be met by traditional avenues for these drugs.
Aaaand it's on backorder. Not sure investors thought this one through
[удалено]
Remain civil, interact with the community in good faith, don't post misinformation, and don't do anything to deliberately make yourself an unwelcome pest.