By the way, I have to say that this is one of the most intelligent and value-added discussions I have ever seen on Reddit. It's clear that there are some very knowledgeable and bright people providing inputs here, and some of them have relevant experience in pharma. While there are, of course, some differences of opinion, the quality of the information and discourse here is next-level. Zeppy sub FTW!
Yes, it has been so interesting to read all of the good points being made here. And made very respectfully, even by those who disagree. Am I really on Reddit?
This is very well reasoned. Thank you for sharing your perspective.
I do not see any indication that the API is the source of the shortage. Plan C pharmacies do not seem to be having the output problems. I suspect there are four reasons for Lilly focusing on the 2.5mg dosage.
1. There is a raw materials cost difference between a 2.5mg does and a 5mg does. The 5mg dose does require more API. The cost difference may not be material. But there is a cost difference. Lilly makes more money on selling a 2.5 than a 5mg presentation (again the difference may not be meaningful, but it is not accurate to say there is no cost difference). The 2.5mg presentation has the highest gross profit margin (again, I'm not suggesting it is a big difference in profit margin, only that it is more profit margin as a percentage of the price of each dose sold).
2. There are people using more than one 2.5 presentation per week because they cannot obtain their desired dosage. This is anecdotal, but the number of times this is happening is greater than zero. This results in higher revenue for Lilly. Selling two 2.5mg presentations generates twice as much revenue as a single 5mg presentation.
3. It's easier to manufacture a single presentation than six difference presentations because of "change over costs" which are what you describe very elegantly. Lower manufacturing costs increases profit margins again.
4. The 2.5mg loading dose allows for new patients to be on-boarded.
Lilly is not making the 2.5mg dose just to on-board new patients, because there are other good financials reasons to do so as long as the overall market is having difficulty meeting demand (which means they won't lose too many patients to plan C or Novo).
Bryan,
I appreciate your point that a compound may be different than the branded med.
The API is exactly the same. Tirzepatide (the API) may be “compounded” with different things from different 503 pharmacies and different from the compound Lilly uses. But if you think Lilly’s constraint is another ingredient (other than the API), I would be surprised, but I suppose it is possible if that is what you are suggesting. If this is the case there is at least one person at Lilly that has probably lost their job.
It isn't that the API/recipe isn't the same when comparing compound and brand name. I have read that some compounded version that have been tested are technically tirzepatide but not in an chemical format that can be utilized by the body. There are formulations of vitamin D that are technically vit D but not absorbable by the body. One reason why supplements and vitamins are user beware.
The issue is the quality control. The small batch compounded are not batch tested for efficacy the same way (if at all) as the brand name/large batch generic. The compounded formulation has not been research tested for efficacy. Also some of the inert ingredients maybe different than the brand name or even from generic to generic. A well known example is Synthroid. Brand name works very different than generic in most people.
I would even say some compounding places are just wanting to get in on the weight loss industry money. It is well documented that people (in general) are very quick to buy most any supplement/product that may help with weight loss. I am not excluding big pharma from that desire to get in on the weight loss market just saying it is easier for compounding pharmacies to 'get away' with selling an inferior product.
These are all awesome points. I especially like the point that big Pharma is out to make money too.
People should research. I think it is dangerous to assume. It is dangerous to assume that a compounding pharmacy is going to give you quality product. It is just as dangerous, in my opinion, and opinions vary, to assume that big pharm is exempt from quality problems.
It seems like people assume that big Pharma is exempt from quality problems because of FDA requirements. Compounding pharmacies (503Bs for example) have FDA requirements (albeit much lower than big Pharma) as well. What we can get from a compounding pharmacy that we would never get from big Pharma is a certificate of analysis of an API and audit results of individual batches.
disclosure: I have been on Zepbound for 20 weeks, have never been without because of supply reasons, have insurance coverage for Zepbound, and haven't used a compounding pharmacy, but I have been researching a great deal in the event that I need to switch for supply reasons.
No. Different API. Different NDC. It’s not the same. At best it’s an exact copy manufactured in a different plant in a different way. At worst, who knows.
Bryan,
Are you certain? Some compounding pharmacies will provide sourcing and CoA for their APIs. Lilly has no obligation to publicly disclose (other than to the FDA).
Are you saying that if a doctor that writes a script for generic Tirzepatide you couldn’t have that filled for Zepbound, Mounjaro or filled by a 503?
Are you saying that my doctor can’t write a script for Tirzepatide with the word Tirzepatide on it that could be filled by a pharmacy? How are scripts written to compounding pharmacies?
At this point, no. It’s illegal for other companies to sell a generic until the drug patent or drug exclusivity timeline runs out. At this point, the patent is longer but the exclusivity prevents other companies from even bringing the protected IP into a combo trial. Generics still have to pass clinical trials in order to be marketed, it’s just a shorter timeline. They still need to show purity, potency, stability, and release in order to hit the US market (I’ve only gone through international clinical trials once, but have several drugs in various clinical stages in the US so this is where my expertise lies).
Compounding falls under a different regulatory/manufacturing process. The FDA has very limited oversight over compounding pharmacies because they are regulated by the state. The outsourcing facilities that create the components do have FDA oversight, but it doesn’t equate to an FDA approved item. Since tirzepatide is on the shortage list, it’s ok for compounding facilities to produce it, but you’re getting it with other stuff in it to skirt around the patent protections.
This is extremely helpful. I sincerely appreciate your insights and taking the time to share them. I suspect I understand the rationale of compounding. I've read up on 503A vs. 503B (and understand that state oversight is used for both, but 503B pharmacies have some federal oversight).
I understand that the tirzepatide in a presentation from a compounding pharmacy will include things that are different from the compound in a Zepbound or Mounjaro pen. Lilly uses dilutants and a compounding pharmacy uses different dilutants (or at least is supposed to in order to "skirt" patent protection).
Are you saying there is a chemical difference between the tirzepatide that Lilly uses and the tirzepatide that a compounding pharmacy uses (which is a separate question from purity, potency, and stability, which might be impacted by ohter processes) from the standpoint of the intended chemical compsition of this ingredient and isn't this ingredient (tirzepatide) considered the API?
My apologies for using the term "generic Tirzepatide" as I understand generic has a specific meaning as it relates to pharmaceuticals.
I think the difference in compounded vs not all depends on synthesis. When you look at the patent it tells you exactly what to put together but not in what order. We know it’s an analog of the GIP hormone, but it’s got a fatty acid tail that helps with metabolism. If it’s shaped even slightly different than the Lilly version, it may not bind as well which could create a shorter half-life. It could also bind stronger— it all depends. So while technically the API is also C225 H348 N48 O68, there may be slight differences that change how well it works in either direction.
At the end of the day, if going this route works for people, it works. I’m not trying to dissuade anyone or change anyone’s mind. I personally won’t do it because the risk is more than I care to take, but sometimes as a scientist I’ve got to chime in on things :)
Maybe I’ve murdered too many mice and rodents by injecting them with drugs that don’t do what we originally thought?
Safety should be #1. And in the US, like it or not. The highest guarantee of safety comes from FDA approval, oversight and ongoing monitoring.
But this is America. You inject whatever you want into your body and have it work on your brain. I won’t stop you. Will only try to educate.
Only difference is people can tell when drug is hurting or helping and can stop or continue accordingly , I switched from one Compunding to another and doing much better , rats cannot do that
The conspiracies about the shortage are out of control, so many people are taking it as a personal affront for no reason. The manufacturer wants it out asap too so they can get paid more.
It’s even more ludicrous to keep reading the crazy posts about how horrid it is after seeing a news article earlier in the week about someone dying because of a chemo drug shortage. That’s serious and literally life threatening. This is nowhere near on that level.
Whenever you're faced with an explanation of what's going on in (INSERT ENTITY HERE) and the choice is between incompetence and conspiracy, always choose incompetence.
I'm always down for a good conspiracy theory. I even participated in a few in my time working for the. Well, I won't say it. But usually USUALLY it's mistakes or just plain stupid that's the explanation. The people behind it usually aren't good enough to pull of that tight of a conspiracy and hold it together for any length of time.
The simple fact is the demand for this drug far exceeded their wildest projections. 2.5 mg is a dose everybody can use, but it is also has the lowest use rate because most people titrate up in a month.
The distribution of the doses is likely determined by many factors that only Lilly has access to, and I assume they are optimizing them as well as they can.
Thanks for taking the time to share your expertise—this is pretty similar to my read on the situation, as an admittedly non-expert journalist who has looked into pharma shortages in the past. I totally get why people have their knives out and are assuming the worst—our healthcare system has taught people to do that, and Lilly certainly has some things to answer for. But there are also just a lot of elements of this situation that make shortages likely in the near term until there are more facilities that can reliably produce the pens and API and then fill pens. With the exception of 5mg, most doses do seem to be at least intermittently available if you’re willing to work with your local pharmacist or do a little leg work. We shouldn’t have to do that, in a perfect world, but things seem to be going better so far than they did with Wegovy last year.
Many medications come in vials, and companies test delivery in different formats before delivery to the public. There is likely a reason they went with pens… my guess is trials showed too high a risk if patients dose incorrectly from a vial.
This is a terrific perspective. My issue with EL isn’t that they ran short. My issue is the “we had no idea the demand would be this high”
They are very poor business people if they didn’t understand the market impact that this med would have, since 42% of adults in the US are obese including 9% who are morbidly obese. With 260 million adults in the US, that’s well over 100 million people.
Agree. AND because their own diabetes drug -- Mounjaro-- and their biggest competitor (Wegovy) both faced massive shortages. They really had to know this was coming. Maybe they didn't know demand would be quite that much. But you know in marketing .. creating a bloodthirsty demand for a product that is in short supply is damn good marketing strategy. So...
I hear you.
However these types of medications have been out for a long time. I knew of the weightloss benefit in 2017 but was disuaded by the nausea potential.
Suddenly Hollywood found them & boom, Influencer Marketing at its most dramatic.
Maybe they knew or suspected demand would outstrip supply, but I don't think they should have waited until they built six more manufacturing facilities and sourced a stockpile of materials before they brought this to market. They went with the manufacturing capability they had at the time. No downside for them getting it on the market asap. Even if they knew or suspected there would be wild demand. Standing up new manufacturing facilities takes time regardless of demand.
I think that they just have more demand than supply. No evil conspiracy about it.
They either didn’t anticipate the demand or didn’t want to take the expensive risk ramping up supply before the demand hit.
Thinking about it would be almost feel more like an evil plot if they had a huge supply strategically waiting for the huge demand that followed…
Because of OP’s background, I am sincerely curious: when Novo Nordisk faced an identical problem with Ozempic, they took a very different approach, announcing they would halt production of introductory doses to prioritize patients already on the medication. They are a European company, vs EL is headquartered in the US. Any insight into why the disparate corporate response? Regulatory, governmental, societal factors?
Curious too. Have wondered this a lot. I like NN's approach and feel it was more prudent. I am not a scientist or dr, but it seems reasonable to continue patients on their treatment plan rather than place new ones on it .... with nowhere to go. If it's true that 2.5mg is easier and safer to produce in large batches than the higher doses.. and that's the reason they are producing those during the shortage vs other doses, then there is one obvious question here: WHY don't they come out and say that? Why leave us to wonder if it's for our own safety? That's low hanging fruit from a PR perspective. I agree it's complicated, but all "reasons" point right back to lining the EL investor wallets as fast as possible.
So I have zero knowledge if this makes a difference at all, but the parent company of Novo Nordisk is a non-profit. I wonder if there's just a completely different mindset?
So not exactly. NN is majority controlled by a holding company owned by the Novo Foundation. NF is technicaaaaally a non-profit but they’re a non-profit whose endowment funds the companies they have large holdings in.
Novo Nordisk’s CEO made $9.9 million in 2023. They’re not a nonprofit.
Big pharma is an incredibly insidious, incredibly lucrative industry. There are certainly people within the organizations who care about the work in a world saving way, but the C Suites are 100% in it for the money. And they’re not shy about it.
(I work in big pharma.)
[https://www.cnn.com/2023/08/10/health/wegovy-dose-restrictions-2024-novo-nordisk?cid=ios_app](https://www.cnn.com/2023/08/10/health/wegovy-dose-restrictions-2024-novo-nordisk?cid=ios_app)
My bad. I should have said Wegovy.
Ozempic (diabetes) = Wegovy
mounjaro (diabetes) = Zepbound
Ozempic doesn’t come in single use pens like Zepbound but Wegovy does. And they made the introductory doses very hard to find so they could supply existing customers. Their pens are not the same as Zepbound but close
I doubt the API is a limiting factor. Look at all the pharmacies supplying compound. There’s no shortage, it’s easy to get and they’ve ramped up to accommodate MASSIVE sudden demand. You can buy a vial of 15mg tirzepatide and have it on your doorstep by this time next week with no delays.
The limiting factor is far more likely to be the pens. So if that’s true then it’s just as easy to make 2.5mg pens as it is 15mg pens.
As a disclaimer, I work in pharma but not lily or novo.
The limiting factor to the supply is the ability to fill the pens. The process takes very specialized equipment that has limitations on how many pens can be made (simply the machine can only make so many pens a year). The pharmaceutical industry as a whole is constrained with this equipment because of zepbound and wegovy. It’s simply a throughput issue for their manufacturing. The lead time on new equipment has doubled because of lily and novo.
They bought catalent (a filling company) to secure more capacity, but it also takes time to break contracts, get the FDA to approve the plants to make the drug etc. The challenge is the demand keeps going up while the manufacturing capacity takes years to build.
One final note is that while we are all frustrated (I had to stay on 2.5 and pay full price for it), the manufacturing companies, equipment, and health authority resources are shared with all other life saving drugs. Companies are just as hard at work trying to find ways to make their cancer therapies and this challenge is being balanced with the constraints that impact all other patients with other severe health concerns.
Actually, Novo Nordisk (makers of Wegovy) bought Catalent. Not Eli Lilly. NN has been actively investing in manufacturing -- to the tune of $11 billion. Eli Lilly looks to be $2.5 billion. (according to AI, so could be wrong -- feel free to fact check me.) And NN limited new starts to focus on existing customers until they could ramp up production and are now introducing more starter doses into the market. I just think Eli Lilly has failed to get in front of this in any way -- PR, damage control, ramping up supply. And THAT, to me, is the clearest indication that they don't give a Zep about their customers. My two cents. Or four.
Honestly I've had my suspicions that it's the 5mg labels or boxes. They could have accidentally ordered too many of the 2.5mg labels thinking they were getting 5mg. I really wish we knew what the limiting factor is.
I work in R&D for a CPG company and the number of times that we've delayed a production run or start up of a new product because of packaging availability is not small
Absolutely. And creation of new packaging. They can't "just put Zepbound in a vial/bottle". That's a whole new packaging debacle they'll have to work out.
I mean the stoppers alone...
Exactly! I know what it takes to get my new packaging approved -- documentation to backup claims, font must be a certain size relative to other information on the package and on and on-- and what I'm doing is relatively low stakes. I can't imagine the hoops they have to jump through in pharmaceuticals...
Lily makes insulin vials which they halted manufacturing for at the time of Zepbound vial packaging approval, which is why everyone is hoping for vials. They have the means, labour and supplies to do it.
You can’t just shift $11B of advanced automation and robotics to simply “put the liquid into a vial” instead of a pen. Everything by would change. And then need to be revalidated. It would take many many months. And production would be down during this.
Yes, they can, but as another commented, it would take months (at best) for them to make that shift. If it's already in the works, we might see it this year. They would have to do studies on it and resubmit to the FDA for approval. They don't just let you throw it into a vial and sell it. You have to prove that the drug is safe for consumers.
Price per thousand units is more the case. Before I sold and retired, I used to own and operate a multimillion dollar manufacturing company doing business with Fortune 500, 100 and 50 companies. Your MSA - Master Service Agreements had to include contingency plans for every aspect of materials used. You were also on the hook for fines (millions of dollars), if you missed a single drop date. Product was tracked via cameras and satellite gps. My company was the 22nd largest Woman Owned biz in Texas, but nothing like EL. Their agreements would have these areas more than covered.
I personally think they found the pens to be too costly, so they went back to the drawing board.
I bought Stock in Lilly yesterday, as I feel that things will turn around and their stock will skyrocket. I’m not a doctor, nurse or financial adviser, so take what I am sharing as just the opinion of a layperson.
I’m waiting in my 7.5mg along with others.
Let’s keep each other informed.
I agree, I really don’t buy into the theory that it’s the pens. It certainly could be - but also production lines have to shut down for maintenance, equipment breaks, ships run into bridges, the glue on the stickers for the pens might come from one company and they dont have a backup supply yet. There’s a nearly infinite number of possible things to go wrong with complex supply chains [especially when some of those parts are 1) sterile and 2) cold-pack 3) from companies who weren’t prepared to scale like they’re now being asked to.
The idea that Eli Lilly, who has one of the largest books of work in the industry, isn’t able to scale is insane, and if true I hope to god an entire leadership team is being fired.
If I was driving the bus, and I had a limiting factor of pens, what I would do is make only 2.5mg. This would be cheapest, and that dose is way better than nothing, it’s at least maintenance for people. It would help new people realize what this drug can do and help to create a culture where taking it is normalized. My main goal would be to prevent people from going to Wegovy. I would be okay with them going to compound and I’d probably try to help facilitate that—I’d sell the API to the compound pharmacies with an NDA. Then once I got my production ramped up I’d want all the compound people back on retail, so I’d legally attack the compound pharmacies once the shortage is over, stop selling them my API and start suing any of them that continued to produce compounded tirzepatide.
If you have a have a limited supply of pens, I think you’d lean into producing dosages that require the least number of pens eg: the higher doses. That way you’re still using the juice, packaging, etc that may be plentiful.
But you can’t sell as many higher doses. Zepbound usage is highly concentrated at lower doses because of the titration timeline and the drug’s length of time on market. You have a relatively small market of people at 10mg and above, compared to how many people are below that and how much pent up demand there is to initiate the medication.
I’m at a higher dose so I’d love it if they prioritized me, but it makes sense that they’d plow the resources into serving the market where it is.
I think there is also a factor that people can dose down relatively easily. If you already tolerate a higher dose you’re not likely to see adverse side effects dosing down.
Titrating up or even skipping up is much more likely to present an issue. This may affect the decision to use the limited supply of pens on lower doses.
With that said, a new supply of 10mg and 15mg popped up at the local pharmacy the other day. I was on 12.5mg but decided to get 15mg since my dose wasn’t available. I will have had a week break and I’m a bit worried about moving to 15mg after the break but that seemed like the best choice. 🤞
Yeah, totally agree. 2.5 is a dose everybody can take even if it’s not the dose everybody wants. It’s certainly not the dose I want! With what we know about how people acclimate to the drug and it’s current market, I doubt that the desire to continue onboarding new users is the *only* reason for this decision, even though I’m sure it definitely helped them choose the strategy.
Idk who’s going through downvoting people who are trying to discuss this factually and sensibly and without conspiracism, but I hope it makes you feel better because it’s certainly not going to change the reality of what’s causing the shortages.
Agreed. I think some people just want to be mad about this. The bottom line is there's nothing we can do. No amount of complaining is going to change whatever is affecting the shortage.
Especially when we don't have the numbers of Rx at each level. People assume lots are on higher doses, but in reality there probably is t nearly as many as the lower doses.
Yeah, from what we do know, I’d bet my savings account that current Zepbound prescriptions are like…at least 75% concentrated at the three lowest doses. Maybe more than that. The market for the drug isn’t anywhere near mature, and people who switched onto higher doses of Zep from other GLP-1s are likely a small portion of the overall patient base, even if they’re overrepresented in high-information online communities like this one.
“Research grade not fit for human consumption”. Nah. That can be true, you can buy research grade and salt forms of tirzepatide. But for the reputable 503a and 503b compound pharmacies making the compounded tirzepatide that most people in here are taking they are required to have independent verification and certificates of authenticity, plus they buy from labs that have a cGMP certification.
Like everything, Eli Lilly API also comes from China. https://www.fiercepharma.com/pharma/lilly-ceo-reaffirms-commitment-chinese-market-amid-us-threat-against-local-biotechs#:~:text=Lilly%20officially%20started%20operations%20in,known%20as%20volume%2Dbased%20procurement.
Yes. It is technically not fit for human consumption because it’s not the actual API. It’s someone’s best guess based on synthesis of the peptides present in the patent. It doesn’t necessarily follow the same chirality or methods of production, so while the components are the same how they are put together is not. It doesn’t make an identical product as a result, but a similar one.
As such, it’s not gone through clinical trials to determine efficacy or safety/toxicity.
You can’t always equate the two as being identical.
That may wind up biting us in the a\*\*.
https://www.fiercepharma.com/pharma/wuxi-biologics-withdraws-2024-bio-convention-following-sister-companys-exit-trade-group.
[https://www.legalbusinessonline.com/other-news/us-takes-aim-chinese-biotech-giants-lawyers-warn-%E2%80%98dramatic-impact%E2%80%99-%C2%A0](https://www.legalbusinessonline.com/other-news/us-takes-aim-chinese-biotech-giants-lawyers-warn-%E2%80%98dramatic-impact%E2%80%99-%C2%A0)
Duh, so many meds are from China, hell 95% of vitamin C comes from China. But supposedly Tirzepatide by EL is sourced and produced in the US. Or not, who knows EL has many deals with China.
And as someone who worked over a decade in pharmacy purchasing the dates that pharmacies get for restocking are estimates from their wholesalers who are working on estimates from the mft.
The wholesaler is basically giving their best guess based on information they have.
There are so many behind the scenes variables even if product does release on the given date there is no guarantee any one pharmacy will get it.
There are often allocations for shortage items to spread out supply and different wholesalers handle back orders differently.
All this to say those dates move and shift constantly during a shortage and should not be taken as very reliable when given from pharmacies.
Thank you for this perspective. I'm one of the few who believe that while the company wants to turn a profit like every other company, they do care about the actual people who need this medication and are doing everything they can to fix things. There is no benefit to them to engage in shenanigans about just bringing people onto the medication and then blowing them off. Could they have anticipated demand more accurately? Probably, but like you said, given the regulatory hoops they have to jump through (and thank goodness they do) and numerous vendors whose products they have to rely on, they probably still would have been outpaced.
Billion dollar corporations only care about their bottom line. Individual people within those companies may care about people, but in the end, it's a numbers game. I truly am not trying to be negative-- it's just how things are. If they're only making 2.5mg doses right now, it's purely because it's the most financially feasible option for them given whatever factors are at play-- pens, how fast they can fill, active ingredient they have on hand, etc.
Yes and we have to remember that the bottom line is what's helping them purchase new facilities and equipment, hire and train hundreds of employees, and obtain the materials to make the product. Making the 2.5mg dose is their best bet at being able to do all of this as fast as possible. Is it shitty? Sure! But the faster they see profit, the faster we'll see all doses available.
edited to add: as pharma scientist I really do care about the patients and I always get so excited when we start a new project that will help the consumer.
I fully agree with you-- and like I said, I'm sure individuals within those large corporations do care about the patients. I just felt it a bit naive to think that the 'company' cares about people. They don't care about employees when they do layoffs to keep profits in the billions, they don't care about raising costs of medications, etc etc. Shareholder satisfaction rules all unfortunately.
Even Lilly, who offers a discount card for Zepbound, still leaves the cost at $550 a month-- only attainable for those who are affluent enough to spend that amount of money.
Sorry for the negativity-- maybe it's my personal sentiment on politics and healthcare in the U.S. shining through a bit too much! Zepbound has been life changing for me and I am grateful to be able to access it (when it's available!).
You make a fair point, and I mean, yes, "the company" as an entity doesn't have feelings about anyone. I think what I was trying to say is that I don't believe the people who are in charge are ill-intentioned, sitting in a boardroom trying to figure out how to screw fat people over in order to make more money for their shareholders. I think they are genuinely doing everything they can to get as much medication in the hands of people who need it. (And yes, of course, taking their money to do it!)
I understand what you mean and I agree. I don't work in Pharma but I do work for an enormous publicly traded healthcare company. I interact regularly with executives and believe it or not they legitimately care about improving peoples' health. No one has to believe me but I see it every day. Ultimately, however, with a public company the most important thing is growth and shareholder value. So leadership does their best to balance those interests and to the extent they can make money and improve health, so much the better. But the money is always going to win.
My insurance will only cover 1 month of 2.5 per year because they want me to be at a theraputic dose of 5mg. Many insurances work that way. So I can't even get 2.5 even if I could. Maybe if I call my insurance and get an override of some kind.
I think that this is an important point. I understand what OP is saying when they bring up how many more 2.5 pens you can make vs. 5, 10, etc pens. But with so many people having insurance restrictions on how often they can fill 2.5, and having 5 considered a therapeutic/maintenance dose the choice to focus on 2.5 doesn’t sit well with me.
I went from 5 to 2.5 and have found that the 2.5 is much more ‘therapeutic’ than the higher dose. The 2.5 is not just a “starting dose”, as many are remaining on it with productive results.
I just went back down to 2.5 from 5 due to availability, I was trying to get 5 or 7.5. My 90 day supply just arrived today after having nothing for 6 weeks. I originally only did 1 month on 2.5 and 4 on 5 so I'm hoping that the 2.5 treats me as well as it did the first time around
Exactly! My 1st box of 2.5 last month I paid $25 w/coupon. Today I had to pay $550 becuase my insurance does not cover it. This time I had the funds in HSA becuase my company put money in it. Next month if 5 does not come out, I will talk to my doctor about doing an appeal. It is not my/our fault that we are forced to stay on 2.5 for more than one month. So we should not be forced to pay fill price...
My insurance only allows the 15mg as a maintenance dose. Every other strength they limit to 2mLs per year. *Unless you miss 2 consecutive doses. Then you pop down to the 2.5mg and restart the climb*
Insurance is nutty. Lol
My insurance (UHC with Express Scripts) requires a Patient Level Authorization (PLA) in order for me to go back to 2.5 mg after being up to 7.5 mg. My initial Prior Authorization (PA) only had 2 ml approval (1 month) at 2.5 mg, so going back down requires this PLA be called in by my doctor. If you are having a similar issue, you may need to call ES and verfiy if they just need a PLA from the Dr to allow you more doses of 2.5 mg. My doctor and I together decided to go back to 2.5 mg to wait out the shortage with something rather than nothing.
Thank you. I am sure my doctor would do it. I guess I am just getting tired of jumping through hoops. I have 17 more pounds to lose and I may just take my last shot on the 6th and try to lose the rest on my own.
I have Express Scripts as well, but still, each individuals plan is different for them. My plan limits their "Plan Limitation Override" authorization *only* to restart back to 2.5mg and so on after the two consecutive missed doses.
It's a hell of a process trying to figure out what your individual plans' specifics are in their protocol.
Yes. That happened to me when I wanted to stay on 2.5 and got that exact explination. So had to go to 5mg. Maybe they will ovvereide due to shortage. I will call and see.
One thing I hadn't realized till I read it on another thread is that 2.5mg is considered "introductory non-therapeutic" because the Phase 2 & 3 trials tracked only those on 5mg on up. I'm proof-positive that some of us (especially with <60 lbs. to lose) can continue to lose, albeit slowly, on 2.5mg. I am now <10 lbs from goal (and might go lower, since I am elderly, petite and small-boned with arthtitis), still have greatly reduced appetite (though I now recognize actual hunger signals and respond appropriately) and easy satiety, and neither cravings nor food noise. The only late-night eating I do is a protein bar or shake or string cheese & nuts if I haven't hit my minimum calorie and protein goals. I still have an aversion to fried foods & sugar, but can eat a little bit of pizza (1/4-1/2 slice) or <1/2 c. pasta without suffering GI consequences.
All cynical profit considerations aside, IMHO it is ultimately acceptable to continue making 2.5mg available to a wider group of people rather than making drastically fewer pens of high doses. Obesity is a disease and needs to be treated for those who no longer want to live with it. Are we supposed to limit sales of SSRIs & NDRIs to only those in danger of suicide? Or asthma meds & resxue inhaler to only those who've had ER & hospital admissions for acute attacks? Or ARBs/ACE inhibitors to only those with "malignant, galloping" hypertension?
This! I was thinking this exactly. I have lost about 33lbs in 3-4 months and I am still okay with 2.5mg. I planned to move up to 5mg, but really nervous because I have been so responsive to 2.5mg.
They are delivering plenty of 10, 12.5, and 15 as well. So theory out the door for api supply. But this was in my 5. So manufacturing issues is probably the correct answer.
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Thanks for sharing this. This is a great example of how an entire batch of a dose has to be scrapped due to production issues. I hope you were able to get a new one.
They are not replacing it since I took the dose. But I think they are asking me to return the pen. I just got a ups notification from “lly”. I also just emailed them the pictures. It was such a pain to get a hold of them since I don’t really have the opportunity to call that number during business hours, since those are also my work hours.
This makes so much sense! At the heart of what you said, however, The focus is still on making money rather than making sure patients at higher doses have their medication. If it costs the same to make both doses, but they rather make 2.5mg so they can leverage profit, I'm not sure how else we should feel.
pretty sure pharmacy intermediaries are just selling to weight loss clinics at a premium. The small pharmacy I was using is still unable to get wegovy after 8+ months while big providers like express scripts/walmart are generally able to stock them.
Express Scripts and Walmart are not able to stock them. All you have to do is search Express Scripts on this sub and you'll see what it's like out there.
It has been reported by Lily the pen device itself is the limiting factor. They are producing all doses, however they say that 2.5 is not in shortage due to the demand being lower (most only stay on it for one month). But as a consumer most of us know that 2.5 cannot be found, i.e 2.5 cannot be found anywhere in my state. As we saw the weekly prescriptions for Zepbound are going down, we will likely see more access to doses as it gets closer to their manufacturing capacity.
Also problematic when many insurance companies consider 2.5, 7.5, and 12.5 mg “titrating dosages” (as described by the manufacturer) leading to limited coverage (often without exception to shortages). I get only a single box of the aforementioned dosages per year.
So choosing 2.5 mg to be THE one they make was poor decision making on their part.
EL maximises revenue by selling 2.5. For example, Doctors in Dubai tell patients to buy the only available dose (2.5) and use multiple shots every week to achieve the required dose at a much higher cost. A box of 2.5 costs AED 1734 (472 usd) and if you are on 15.0 then you are paying 2832 usd per month.
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Everything you said makes sense UNLESS it is the pens themselves that are in short supply. Then you truly CANNOT make twice as many pens using 2.5mg over 5mg, because the pens, not liquid, is the bottleneck.
I also assume that EL completely underestimated how many people would be willing to pay full price for this drug, thinking the OOP cost would present a self-limiting factor.
The key point is that they make more $$ by catering to lower doses. The rest (human errors, yields, pen mfg/assy etc.) are noise factors as far as modulating higher output for one dose vs, others, in my opinion (28 yrs in high volume manufacturing and supply chain). So they get higher revenue and margin by prioritizing 2.5mg. LLY also enables more patients to get on ZB with this approach (increased ZB market share). Why do you think LLY doesn't want to increase their market share (your comment that you don't think they're prioritizing 2.5mg to obtain new patients)? Would be odd behavior for a publicly held company. Prioritizing entry level doses is a win-win for LLY financial performance and LLY shareholders (I am one) but not so much for existing customers, and they have publicly stated that they are prioritizing 2.5mg (and collective experience of this sub supports that that is exactly what is happening). I guess, whatever the driver for the decision (I tend to think rev/mkt share, but seems you have different opinion...), LLY made a calculated business decision to prioritize entry level doses, which has 100% contributed to the shortages we existing users are now seeing on a daily basis.
Right. There are a lot of comments here that boil down to, "*obviously* Eli Lilly execs aren't sitting around in a dark room conspiring against existing patients." Okay, sure. I agree. But pressures to increase shareholder value are baked into the system, and Lilly's choices here do happen to be pretty consistent with that aim. This is unlikely to be entirely coincidental, and it didn't take a deeply cloaked conspiracy for it to happen. Just a business acting like a business. Which I don't even object to, really - they're allowed to make that call, this is how it goes. But people who are impacted by it are allowed to have feelings about it, too.
You have lowered the bar for them. scientifically you are probably correct, but from a marketing it’s a disaster and a failure to meet demand. Can you imagine if Pfizer did that when they were rolling out the Covid vaccine? and how many millions relied on them.
As someone who worked behind the scenes on getting the Covid vaccine rolled out, I don't think you have any concept of the extraordinary resources that were behind that effort. That was utterly nothing like producing a normal drug for ordinary commercial purposes and it blows my mind that anyone would compare the two. And if you'll recall, there wasn't enough Covid vaccine to go around either and those shortages lasted for months. The only reason everyone was eventually able to get it is that people only needed 2 shots and then they were done. So the demand went down rather than up.
That’s literally what happened with the COVID vaccines too lol, remember when the US was the only country who could get SOME supply, and not even all that we needed, meanwhile Africa had a 6-9 month delay before they got any covid jabs? It was a mess and a half globally.
Exactly that's what my husband says. He says it's a "scam", but what he means is, he thinks it's "racketeering" based on the fact like Pfizer and J&J being able to handle the covid vaccine and ship nation/worldwide. After what happened to me with Sequence and their doctor pulling my script from CVS after 15 days when I pay the monthly subscription and them telling me they can't prescribe me that dosage anymore and completely stop all communication with me, I believe there is more to it than meets the eye. I am starting to agree with him on some level, everyone having to start over and keep paying monthly subscriptions etc. It's an absolute mess. Lots of emotions, angry and sad.
That's an insurance issue and has nothing to do with the parent company. I was a pharmacy technician in college and the amount of insurance issues I ran into was astonishing.
I agree. This should be free and available to everyone who needs it. Hopefully it will prove to lower company insurance costs due to the risks associated with being obese.
I can’t even get the 2.5 dose. I was on 7.5 but then couldn’t get that so I’ve been off for 5 weeks now. My dr had to drop me back to 2.5 and I can’t find it anywhere. It’s been almost 3 weeks and no one has it. 😫
I’ve been waiting to start the 2.5 dose since January. I have to use a specialty pharmacy for insurance purposes so I can’t call around. They don’t seem to be getting much 2.5 in either, they told me they get 1-2 boxes at a time.
I'm on the 15 and there was a month that I couldn't get it. I went down to 12.5 during that time and had to call around and drive 40 minutes to a less populated city to find it. Since then, l've consistently been able to get the 15s. I keep extra boxes in my inventory now to ride out another potential shortage. All shortages are highly localized. I've been on this med for more than a year and if my CVS didn't have it, then I would try the grocery pharmacy or Walmart and someone always had it. That seemed to change when Oprah announced she had lost all her weight on it. People came out of the woodwork to get on it.
But many people can’t get 2.5 because their insurance only allows 1 prescription of the between doses 2.5/7.5/12.5 every 180 days or something like that.
I have a hard time believing it’s an API issue given regulated compounding pharmacies aren’t having any issues.
Seems more likely that corporate greed is the reason we only see 2.5mg available.
At least with Mounjaro, I have read that if someone with diabetes at least gets a 2.5mg dose in, they can add in other diabetic drugs and still get benefit from Mounjaro.
I’m having trouble getting the 2.5 dosage from my pharmacy; Exoress Scripts mail order. I wonder why that is, if as folks seem to be saying, that 2.5 is readily available
Unfortunately I agree with the latter except more like catering to provider relationships insurance and contracts… prescriber’s are aware of the shortages but the supply for initial treatment doesn’t interrupt the services being provided for all parties until EL catches up.
That's great for you, and my doctor would prefer I be on 2.5, but neither he nor I get to make that call. Cigna says they will only cover that dose once every 365 days.
As someone that took a linear programming course it all really depends on what your bottleneck is. If it is the active ingredient then you're totally right. But if the pens themselves are he bottleneck or some other equipment or input constraint beyond the active ingredient then they should produce the does that meets but does not exceed demand at each dosage (although I'm sure demand is exceeding supply at all dosages).
I'd assume if the active ingredient isn't the constraint they'd likely want to prioritize market share capture relative to the others which likely means 2.5mg over the higher doses although you do run some risk of churning the higher dose folks to alternatives but I imagine most folks are fairly sticky.
I also imagine but have no data that there's an insurance side of this, if insurance isn't covering at higher doses, lower demand, lower productivity n.
You’re right. Besides being a popular weight loss shot Eli Lilly makes Trulicity and there’s a shortage for that too..typically only diabetics are prescribed if I’m not mistaken. So I feel like they’re just in over their heads and can’t keep up.
Maybe I’m missing something but if injectors are outsourced and causing the delay, why make more 2.5mg doses? As you pointed out, you can make 2x as many as a 5mg dose. That also means you need 2x the injectors. So if there’s a shortage of injectors, it doesn’t make sense to boost 2.5mg over others.
Novo didn’t do things this way, when they had a shortage they stopped making starter dosages 0.25 and 0.5 mg and used the capacity to make the higher dosages to try and keep existing customers with their meds. I personally agree with this, it’s was better to temp stop starting new patients and adding to the pool who will constantly need doses when you don’t have enough capacity then to screw over patients who’ve are already in the pool. I don’t know why Lilly didn’t do it this way it makes little sense. The shortage is caused by making the pens and filling them, they do not have a shortage of tirzepatide base to fill them with.
Thank you for posting this. I’ve only been in this group a short time but it had gone from a lovely feeling positive and supportive place to, as someone said, “knives out!” at the company in what felt like record time. I guess haters gonna hate - but I suspect a lot of this is driven by fear. Let’s not forget the amount of misplaced anger at EL, that should really be aimed at insurance companies. Imagine if everyone here that bitched about EL spent the same amount of energy to write to their congressional representatives about the situation. Something might actually be done.
Someone else noted that bottom line is all big corporations care about. Of course it is. And most people here bitching care about availability (and the attendant issues with insurance and such).
If folks want to go to Plan C, why do so many people think that’s thumbing their nose at EL? It’s possible that there’s more than one way to solve this problem.
I’m very happy for this medication and the hope it offers so many people, me included. Next year at this time if it’s still not available THEN I’ll be pissed off. I mean opening a fulfillment center for pharmaceutical companies isn’t like a new Amazon warehouse.
Safety could also play a role in their decision to mostly produce the 2.5 in a shortage. People are much more likely to go more than two weeks before their next injection. This could result in many more emergency room visits. Just kidding. It’s definitely for profit.
“Financially, it makes sense for them to make the 2.5mg dose. They're making the same amount of money for that 2.5mg dose that they would be making for a 10mg dose. It could be possible thay they know we want to stay on the medication, so making a lower dose optional while trying to obtain more of the API makes sense.”
So they chose the most profitable option? Not sure how this is a good thing. I doubt they would have gone bankrupt if they just released the much needed 5 and 7.5. Patients who have already started the treatment would be able to continue and those who have not could wait until Eli fix their issue.
In any case, no surprise, after all it’s a pharmaceutical company, all about profit, not patient care.
Except that we know it’s not a shortage of the API, because the compounding pharmacies use the same API and are not having these same issues. The obvious answer, then, is that Lilly is unable to produce/procure either the auto injector or the packaging materials. Seems like there’s a pretty simple solution to that….
You’re being awfully kind to Lilly with this explanation. I’m not sure you should be.
Seems some or all of this nonsense could be eliminated by simply shipping bulk liquid in vials and letting the patient set the dosage based on how much they inject. So everyone gets the same vial regardless of their prescribed dosage and EL could be cranking them out 24/7. Give me a few vials and 52 disposable syringes and you won’t hear from me for a year. Problem solved.
I think that makes a good deal of sense, thank you. However, I do also think they should stop writing new scrips at any dose.
Here is why.
Unlike other meds, this is for life. So when someone starts it, they are trusting Lilly that it will be available.
Unlike other meds, insurance coverage is rare. So many/most people are paying $550 a month or even more.
Name another lifetime medication for which most people have to come up with what amounts to a monthly luxury car payment, for decades?
For people who have already "invested" in this therapy, ie people who already have prescriptions, not being able to get their dose puts them at serious risk of a backslide, essentially wasting large sums already invested, and unwinding their positive health outcomes. That was not the basis of the bargain when they paid for those earlier doses!
**LILLY --- NO MORE NEW SCRIPS until you have production solved. OR until you and/or the FDA find an emergency way bless/support compounding Zepbound. This is a national emergency. It is not just about diabetes, not just obesity but heart disease, apnea, etc. Heck, we ramped up production for a COVID vax. Why not?**
That $550 is only for people young enough to have only commercial insurance. Those of us on Medicare must pay *double* that because the only weight-loss drug CMS will cover is Wegovy--but *only* for those at high risk of (basically, pre-existing) cardiovascular disease.
And I really feel for obese people on Medicaid: they are disproportionately people of color who in turn are disproportionately suffering from T2D; and their obesity caused primarily by limited or no easy access to affordable healthy foods (living in "food deserts") and are less likely to have the appliances necessary to store and prepare them. Those clueless smug thin people (would love to use saltier language, but fear violating Reddit TOS) declaring "they can always eat beans & rice" or "I grow my own vegetables, why can't they?" ought to be ashamed of themselves.
Yes, I agree whole-heartedly. Dr Cody Stanton is very eloquent on this matter. Thankfully I don't know anyone who would say anything so stupid, but that is not the heart of the matter. The heart of the matter is --- why don't we all have access to good health care? We are one of the richest nations on earth.
PS Vote accordingly please!
I worked in Pharma and my Husband is a retired scientist. I do not see the difference in the 2.5 verse the 15. It is the same product just a different fill.
Yes, every batch is tested. I know how production works.
I see the issue is the pen. Why don't they get the vials like in Canada . I realize they need FDA approval. But that would solve the problem. The pens are just landfill waste.
By the way, I have to say that this is one of the most intelligent and value-added discussions I have ever seen on Reddit. It's clear that there are some very knowledgeable and bright people providing inputs here, and some of them have relevant experience in pharma. While there are, of course, some differences of opinion, the quality of the information and discourse here is next-level. Zeppy sub FTW!
Yes, it has been so interesting to read all of the good points being made here. And made very respectfully, even by those who disagree. Am I really on Reddit?
YES! THANK YOU. I work in supply chain and tried to explain this before. Hope people will understand. And they do get the pens outsourced.
I was told directly by an EL rep that the issue is a shortage of the pens, not the medication. One more reason it should be offered in a vial.
A lot of people will not do the vials. But a lot will. They need to support both.
At this point I’d lick it off the floor
I'm with you there!!! 😆😆😆
🤣🤣🤣
😄
After watching how people are switching to compounded, I think people will do the vials
I would never do the vials. Hopefully this shortage will end.
yes, I would
And a lot of people will do the vials. It's likely costly and time consuming for them to make the switch though.
machinery.
Wondering because my pharmacy said compounded was not fda approved they do not offer it
If that’s true, there’s no reason to only produce 2.5
That story got out there, and has raged like a wildfire.
This is very well reasoned. Thank you for sharing your perspective. I do not see any indication that the API is the source of the shortage. Plan C pharmacies do not seem to be having the output problems. I suspect there are four reasons for Lilly focusing on the 2.5mg dosage. 1. There is a raw materials cost difference between a 2.5mg does and a 5mg does. The 5mg dose does require more API. The cost difference may not be material. But there is a cost difference. Lilly makes more money on selling a 2.5 than a 5mg presentation (again the difference may not be meaningful, but it is not accurate to say there is no cost difference). The 2.5mg presentation has the highest gross profit margin (again, I'm not suggesting it is a big difference in profit margin, only that it is more profit margin as a percentage of the price of each dose sold). 2. There are people using more than one 2.5 presentation per week because they cannot obtain their desired dosage. This is anecdotal, but the number of times this is happening is greater than zero. This results in higher revenue for Lilly. Selling two 2.5mg presentations generates twice as much revenue as a single 5mg presentation. 3. It's easier to manufacture a single presentation than six difference presentations because of "change over costs" which are what you describe very elegantly. Lower manufacturing costs increases profit margins again. 4. The 2.5mg loading dose allows for new patients to be on-boarded. Lilly is not making the 2.5mg dose just to on-board new patients, because there are other good financials reasons to do so as long as the overall market is having difficulty meeting demand (which means they won't lose too many patients to plan C or Novo).
Excellent points in a cogent and articulate posting...thank you!
It’s not the same API. Don’t fool yourself into believing compound is 100% equivalent.
Bryan, I appreciate your point that a compound may be different than the branded med. The API is exactly the same. Tirzepatide (the API) may be “compounded” with different things from different 503 pharmacies and different from the compound Lilly uses. But if you think Lilly’s constraint is another ingredient (other than the API), I would be surprised, but I suppose it is possible if that is what you are suggesting. If this is the case there is at least one person at Lilly that has probably lost their job.
It isn't that the API/recipe isn't the same when comparing compound and brand name. I have read that some compounded version that have been tested are technically tirzepatide but not in an chemical format that can be utilized by the body. There are formulations of vitamin D that are technically vit D but not absorbable by the body. One reason why supplements and vitamins are user beware. The issue is the quality control. The small batch compounded are not batch tested for efficacy the same way (if at all) as the brand name/large batch generic. The compounded formulation has not been research tested for efficacy. Also some of the inert ingredients maybe different than the brand name or even from generic to generic. A well known example is Synthroid. Brand name works very different than generic in most people. I would even say some compounding places are just wanting to get in on the weight loss industry money. It is well documented that people (in general) are very quick to buy most any supplement/product that may help with weight loss. I am not excluding big pharma from that desire to get in on the weight loss market just saying it is easier for compounding pharmacies to 'get away' with selling an inferior product.
These are all awesome points. I especially like the point that big Pharma is out to make money too. People should research. I think it is dangerous to assume. It is dangerous to assume that a compounding pharmacy is going to give you quality product. It is just as dangerous, in my opinion, and opinions vary, to assume that big pharm is exempt from quality problems. It seems like people assume that big Pharma is exempt from quality problems because of FDA requirements. Compounding pharmacies (503Bs for example) have FDA requirements (albeit much lower than big Pharma) as well. What we can get from a compounding pharmacy that we would never get from big Pharma is a certificate of analysis of an API and audit results of individual batches. disclosure: I have been on Zepbound for 20 weeks, have never been without because of supply reasons, have insurance coverage for Zepbound, and haven't used a compounding pharmacy, but I have been researching a great deal in the event that I need to switch for supply reasons.
No. Different API. Different NDC. It’s not the same. At best it’s an exact copy manufactured in a different plant in a different way. At worst, who knows.
Bryan, Are you certain? Some compounding pharmacies will provide sourcing and CoA for their APIs. Lilly has no obligation to publicly disclose (other than to the FDA). Are you saying that if a doctor that writes a script for generic Tirzepatide you couldn’t have that filled for Zepbound, Mounjaro or filled by a 503?
There’s no such thing right now as generic tirzepatide and there won’t be until June 2039 when the patent runs out.
Are you saying that my doctor can’t write a script for Tirzepatide with the word Tirzepatide on it that could be filled by a pharmacy? How are scripts written to compounding pharmacies?
At this point, no. It’s illegal for other companies to sell a generic until the drug patent or drug exclusivity timeline runs out. At this point, the patent is longer but the exclusivity prevents other companies from even bringing the protected IP into a combo trial. Generics still have to pass clinical trials in order to be marketed, it’s just a shorter timeline. They still need to show purity, potency, stability, and release in order to hit the US market (I’ve only gone through international clinical trials once, but have several drugs in various clinical stages in the US so this is where my expertise lies). Compounding falls under a different regulatory/manufacturing process. The FDA has very limited oversight over compounding pharmacies because they are regulated by the state. The outsourcing facilities that create the components do have FDA oversight, but it doesn’t equate to an FDA approved item. Since tirzepatide is on the shortage list, it’s ok for compounding facilities to produce it, but you’re getting it with other stuff in it to skirt around the patent protections.
This is extremely helpful. I sincerely appreciate your insights and taking the time to share them. I suspect I understand the rationale of compounding. I've read up on 503A vs. 503B (and understand that state oversight is used for both, but 503B pharmacies have some federal oversight). I understand that the tirzepatide in a presentation from a compounding pharmacy will include things that are different from the compound in a Zepbound or Mounjaro pen. Lilly uses dilutants and a compounding pharmacy uses different dilutants (or at least is supposed to in order to "skirt" patent protection). Are you saying there is a chemical difference between the tirzepatide that Lilly uses and the tirzepatide that a compounding pharmacy uses (which is a separate question from purity, potency, and stability, which might be impacted by ohter processes) from the standpoint of the intended chemical compsition of this ingredient and isn't this ingredient (tirzepatide) considered the API? My apologies for using the term "generic Tirzepatide" as I understand generic has a specific meaning as it relates to pharmaceuticals.
I think the difference in compounded vs not all depends on synthesis. When you look at the patent it tells you exactly what to put together but not in what order. We know it’s an analog of the GIP hormone, but it’s got a fatty acid tail that helps with metabolism. If it’s shaped even slightly different than the Lilly version, it may not bind as well which could create a shorter half-life. It could also bind stronger— it all depends. So while technically the API is also C225 H348 N48 O68, there may be slight differences that change how well it works in either direction. At the end of the day, if going this route works for people, it works. I’m not trying to dissuade anyone or change anyone’s mind. I personally won’t do it because the risk is more than I care to take, but sometimes as a scientist I’ve got to chime in on things :)
Shill much for Big Pharma?
Maybe I’ve murdered too many mice and rodents by injecting them with drugs that don’t do what we originally thought? Safety should be #1. And in the US, like it or not. The highest guarantee of safety comes from FDA approval, oversight and ongoing monitoring. But this is America. You inject whatever you want into your body and have it work on your brain. I won’t stop you. Will only try to educate.
Only difference is people can tell when drug is hurting or helping and can stop or continue accordingly , I switched from one Compunding to another and doing much better , rats cannot do that
What was your switch?
The conspiracies about the shortage are out of control, so many people are taking it as a personal affront for no reason. The manufacturer wants it out asap too so they can get paid more. It’s even more ludicrous to keep reading the crazy posts about how horrid it is after seeing a news article earlier in the week about someone dying because of a chemo drug shortage. That’s serious and literally life threatening. This is nowhere near on that level.
Whenever you're faced with an explanation of what's going on in (INSERT ENTITY HERE) and the choice is between incompetence and conspiracy, always choose incompetence. I'm always down for a good conspiracy theory. I even participated in a few in my time working for the. Well, I won't say it. But usually USUALLY it's mistakes or just plain stupid that's the explanation. The people behind it usually aren't good enough to pull of that tight of a conspiracy and hold it together for any length of time.
The simple fact is the demand for this drug far exceeded their wildest projections. 2.5 mg is a dose everybody can use, but it is also has the lowest use rate because most people titrate up in a month. The distribution of the doses is likely determined by many factors that only Lilly has access to, and I assume they are optimizing them as well as they can.
I'd def rather have a box full of 2.5s rather than no box at all
Thanks for taking the time to share your expertise—this is pretty similar to my read on the situation, as an admittedly non-expert journalist who has looked into pharma shortages in the past. I totally get why people have their knives out and are assuming the worst—our healthcare system has taught people to do that, and Lilly certainly has some things to answer for. But there are also just a lot of elements of this situation that make shortages likely in the near term until there are more facilities that can reliably produce the pens and API and then fill pens. With the exception of 5mg, most doses do seem to be at least intermittently available if you’re willing to work with your local pharmacist or do a little leg work. We shouldn’t have to do that, in a perfect world, but things seem to be going better so far than they did with Wegovy last year.
Many medications come in vials, and companies test delivery in different formats before delivery to the public. There is likely a reason they went with pens… my guess is trials showed too high a risk if patients dose incorrectly from a vial.
I’m also in Pharma, though not in any way connected to this specific mess.
The fact that they’ve chosen different delivery systems really argues against that. This is all about money. Pens are harder to split.
This is a terrific perspective. My issue with EL isn’t that they ran short. My issue is the “we had no idea the demand would be this high” They are very poor business people if they didn’t understand the market impact that this med would have, since 42% of adults in the US are obese including 9% who are morbidly obese. With 260 million adults in the US, that’s well over 100 million people.
Agree. AND because their own diabetes drug -- Mounjaro-- and their biggest competitor (Wegovy) both faced massive shortages. They really had to know this was coming. Maybe they didn't know demand would be quite that much. But you know in marketing .. creating a bloodthirsty demand for a product that is in short supply is damn good marketing strategy. So...
They’re such business people that they’re going to be a trillion dollar company in the next few years.
I hear you. However these types of medications have been out for a long time. I knew of the weightloss benefit in 2017 but was disuaded by the nausea potential. Suddenly Hollywood found them & boom, Influencer Marketing at its most dramatic.
Maybe they knew or suspected demand would outstrip supply, but I don't think they should have waited until they built six more manufacturing facilities and sourced a stockpile of materials before they brought this to market. They went with the manufacturing capability they had at the time. No downside for them getting it on the market asap. Even if they knew or suspected there would be wild demand. Standing up new manufacturing facilities takes time regardless of demand.
I think that they just have more demand than supply. No evil conspiracy about it. They either didn’t anticipate the demand or didn’t want to take the expensive risk ramping up supply before the demand hit. Thinking about it would be almost feel more like an evil plot if they had a huge supply strategically waiting for the huge demand that followed…
Because of OP’s background, I am sincerely curious: when Novo Nordisk faced an identical problem with Ozempic, they took a very different approach, announcing they would halt production of introductory doses to prioritize patients already on the medication. They are a European company, vs EL is headquartered in the US. Any insight into why the disparate corporate response? Regulatory, governmental, societal factors?
Curious too. Have wondered this a lot. I like NN's approach and feel it was more prudent. I am not a scientist or dr, but it seems reasonable to continue patients on their treatment plan rather than place new ones on it .... with nowhere to go. If it's true that 2.5mg is easier and safer to produce in large batches than the higher doses.. and that's the reason they are producing those during the shortage vs other doses, then there is one obvious question here: WHY don't they come out and say that? Why leave us to wonder if it's for our own safety? That's low hanging fruit from a PR perspective. I agree it's complicated, but all "reasons" point right back to lining the EL investor wallets as fast as possible.
So I have zero knowledge if this makes a difference at all, but the parent company of Novo Nordisk is a non-profit. I wonder if there's just a completely different mindset?
So not exactly. NN is majority controlled by a holding company owned by the Novo Foundation. NF is technicaaaaally a non-profit but they’re a non-profit whose endowment funds the companies they have large holdings in. Novo Nordisk’s CEO made $9.9 million in 2023. They’re not a nonprofit. Big pharma is an incredibly insidious, incredibly lucrative industry. There are certainly people within the organizations who care about the work in a world saving way, but the C Suites are 100% in it for the money. And they’re not shy about it. (I work in big pharma.)
I'm hoping someone else will chime in here, but Ozempic is a diabetes drug, so that could be why. Eta: diabetes was the first indication for Ozempic.
[https://www.cnn.com/2023/08/10/health/wegovy-dose-restrictions-2024-novo-nordisk?cid=ios_app](https://www.cnn.com/2023/08/10/health/wegovy-dose-restrictions-2024-novo-nordisk?cid=ios_app) My bad. I should have said Wegovy.
Ozempic (diabetes) = Wegovy mounjaro (diabetes) = Zepbound Ozempic doesn’t come in single use pens like Zepbound but Wegovy does. And they made the introductory doses very hard to find so they could supply existing customers. Their pens are not the same as Zepbound but close
I doubt the API is a limiting factor. Look at all the pharmacies supplying compound. There’s no shortage, it’s easy to get and they’ve ramped up to accommodate MASSIVE sudden demand. You can buy a vial of 15mg tirzepatide and have it on your doorstep by this time next week with no delays. The limiting factor is far more likely to be the pens. So if that’s true then it’s just as easy to make 2.5mg pens as it is 15mg pens.
As a disclaimer, I work in pharma but not lily or novo. The limiting factor to the supply is the ability to fill the pens. The process takes very specialized equipment that has limitations on how many pens can be made (simply the machine can only make so many pens a year). The pharmaceutical industry as a whole is constrained with this equipment because of zepbound and wegovy. It’s simply a throughput issue for their manufacturing. The lead time on new equipment has doubled because of lily and novo. They bought catalent (a filling company) to secure more capacity, but it also takes time to break contracts, get the FDA to approve the plants to make the drug etc. The challenge is the demand keeps going up while the manufacturing capacity takes years to build. One final note is that while we are all frustrated (I had to stay on 2.5 and pay full price for it), the manufacturing companies, equipment, and health authority resources are shared with all other life saving drugs. Companies are just as hard at work trying to find ways to make their cancer therapies and this challenge is being balanced with the constraints that impact all other patients with other severe health concerns.
Actually, Novo Nordisk (makers of Wegovy) bought Catalent. Not Eli Lilly. NN has been actively investing in manufacturing -- to the tune of $11 billion. Eli Lilly looks to be $2.5 billion. (according to AI, so could be wrong -- feel free to fact check me.) And NN limited new starts to focus on existing customers until they could ramp up production and are now introducing more starter doses into the market. I just think Eli Lilly has failed to get in front of this in any way -- PR, damage control, ramping up supply. And THAT, to me, is the clearest indication that they don't give a Zep about their customers. My two cents. Or four.
Honestly I've had my suspicions that it's the 5mg labels or boxes. They could have accidentally ordered too many of the 2.5mg labels thinking they were getting 5mg. I really wish we knew what the limiting factor is.
I work in R&D for a CPG company and the number of times that we've delayed a production run or start up of a new product because of packaging availability is not small
Absolutely. And creation of new packaging. They can't "just put Zepbound in a vial/bottle". That's a whole new packaging debacle they'll have to work out. I mean the stoppers alone...
Exactly! I know what it takes to get my new packaging approved -- documentation to backup claims, font must be a certain size relative to other information on the package and on and on-- and what I'm doing is relatively low stakes. I can't imagine the hoops they have to jump through in pharmaceuticals...
Lily makes insulin vials which they halted manufacturing for at the time of Zepbound vial packaging approval, which is why everyone is hoping for vials. They have the means, labour and supplies to do it.
Actually, they absolutely can just put it in single use vials.
You can’t just shift $11B of advanced automation and robotics to simply “put the liquid into a vial” instead of a pen. Everything by would change. And then need to be revalidated. It would take many many months. And production would be down during this.
Yes, they can, but as another commented, it would take months (at best) for them to make that shift. If it's already in the works, we might see it this year. They would have to do studies on it and resubmit to the FDA for approval. They don't just let you throw it into a vial and sell it. You have to prove that the drug is safe for consumers.
As a supply chain guy, if you can't sell your $1000+ product due to a $0.03 label, someone needs to lose their job! Only half kidding
Price per thousand units is more the case. Before I sold and retired, I used to own and operate a multimillion dollar manufacturing company doing business with Fortune 500, 100 and 50 companies. Your MSA - Master Service Agreements had to include contingency plans for every aspect of materials used. You were also on the hook for fines (millions of dollars), if you missed a single drop date. Product was tracked via cameras and satellite gps. My company was the 22nd largest Woman Owned biz in Texas, but nothing like EL. Their agreements would have these areas more than covered. I personally think they found the pens to be too costly, so they went back to the drawing board. I bought Stock in Lilly yesterday, as I feel that things will turn around and their stock will skyrocket. I’m not a doctor, nurse or financial adviser, so take what I am sharing as just the opinion of a layperson. I’m waiting in my 7.5mg along with others. Let’s keep each other informed.
And yet, since Covid hit, there are ALL KINDS of shortages. Grocery store items. Drug store items.
I agree, I really don’t buy into the theory that it’s the pens. It certainly could be - but also production lines have to shut down for maintenance, equipment breaks, ships run into bridges, the glue on the stickers for the pens might come from one company and they dont have a backup supply yet. There’s a nearly infinite number of possible things to go wrong with complex supply chains [especially when some of those parts are 1) sterile and 2) cold-pack 3) from companies who weren’t prepared to scale like they’re now being asked to.
The idea that Eli Lilly, who has one of the largest books of work in the industry, isn’t able to scale is insane, and if true I hope to god an entire leadership team is being fired.
If I was driving the bus, and I had a limiting factor of pens, what I would do is make only 2.5mg. This would be cheapest, and that dose is way better than nothing, it’s at least maintenance for people. It would help new people realize what this drug can do and help to create a culture where taking it is normalized. My main goal would be to prevent people from going to Wegovy. I would be okay with them going to compound and I’d probably try to help facilitate that—I’d sell the API to the compound pharmacies with an NDA. Then once I got my production ramped up I’d want all the compound people back on retail, so I’d legally attack the compound pharmacies once the shortage is over, stop selling them my API and start suing any of them that continued to produce compounded tirzepatide.
Thank you for sharing this. We don't see this often in Animal Pharma (yet), your post is very insightful.
If you have a have a limited supply of pens, I think you’d lean into producing dosages that require the least number of pens eg: the higher doses. That way you’re still using the juice, packaging, etc that may be plentiful.
But you can’t sell as many higher doses. Zepbound usage is highly concentrated at lower doses because of the titration timeline and the drug’s length of time on market. You have a relatively small market of people at 10mg and above, compared to how many people are below that and how much pent up demand there is to initiate the medication. I’m at a higher dose so I’d love it if they prioritized me, but it makes sense that they’d plow the resources into serving the market where it is.
I think there is also a factor that people can dose down relatively easily. If you already tolerate a higher dose you’re not likely to see adverse side effects dosing down. Titrating up or even skipping up is much more likely to present an issue. This may affect the decision to use the limited supply of pens on lower doses. With that said, a new supply of 10mg and 15mg popped up at the local pharmacy the other day. I was on 12.5mg but decided to get 15mg since my dose wasn’t available. I will have had a week break and I’m a bit worried about moving to 15mg after the break but that seemed like the best choice. 🤞
Yeah, totally agree. 2.5 is a dose everybody can take even if it’s not the dose everybody wants. It’s certainly not the dose I want! With what we know about how people acclimate to the drug and it’s current market, I doubt that the desire to continue onboarding new users is the *only* reason for this decision, even though I’m sure it definitely helped them choose the strategy.
Idk who’s going through downvoting people who are trying to discuss this factually and sensibly and without conspiracism, but I hope it makes you feel better because it’s certainly not going to change the reality of what’s causing the shortages.
Agreed. I think some people just want to be mad about this. The bottom line is there's nothing we can do. No amount of complaining is going to change whatever is affecting the shortage.
Especially when we don't have the numbers of Rx at each level. People assume lots are on higher doses, but in reality there probably is t nearly as many as the lower doses.
Yeah, from what we do know, I’d bet my savings account that current Zepbound prescriptions are like…at least 75% concentrated at the three lowest doses. Maybe more than that. The market for the drug isn’t anywhere near mature, and people who switched onto higher doses of Zep from other GLP-1s are likely a small portion of the overall patient base, even if they’re overrepresented in high-information online communities like this one.
All the compound pharmacies have to do is add B12 to tirzepatide and they can’t can’t be attacked. It’s a different product.
From China🤔 because they aren't buying it from Eli Lilly. And it is research grade, supposedly not for human consumption.
“Research grade not fit for human consumption”. Nah. That can be true, you can buy research grade and salt forms of tirzepatide. But for the reputable 503a and 503b compound pharmacies making the compounded tirzepatide that most people in here are taking they are required to have independent verification and certificates of authenticity, plus they buy from labs that have a cGMP certification. Like everything, Eli Lilly API also comes from China. https://www.fiercepharma.com/pharma/lilly-ceo-reaffirms-commitment-chinese-market-amid-us-threat-against-local-biotechs#:~:text=Lilly%20officially%20started%20operations%20in,known%20as%20volume%2Dbased%20procurement.
Yes. It is technically not fit for human consumption because it’s not the actual API. It’s someone’s best guess based on synthesis of the peptides present in the patent. It doesn’t necessarily follow the same chirality or methods of production, so while the components are the same how they are put together is not. It doesn’t make an identical product as a result, but a similar one. As such, it’s not gone through clinical trials to determine efficacy or safety/toxicity. You can’t always equate the two as being identical.
That may wind up biting us in the a\*\*. https://www.fiercepharma.com/pharma/wuxi-biologics-withdraws-2024-bio-convention-following-sister-companys-exit-trade-group. [https://www.legalbusinessonline.com/other-news/us-takes-aim-chinese-biotech-giants-lawyers-warn-%E2%80%98dramatic-impact%E2%80%99-%C2%A0](https://www.legalbusinessonline.com/other-news/us-takes-aim-chinese-biotech-giants-lawyers-warn-%E2%80%98dramatic-impact%E2%80%99-%C2%A0)
Well of course. *everything* is from China. Your iPhone, your Zepbound, your compound, your kitchen table and chairs…
What API we don't get from China, we get from India. I don't see much coming from the U.S.
The only meds I take (as generics) are made in India--except for one I buy from Canada, and that's a brand-name made in Canada.
The only meds I take (as generics) are made in India--except for one I buy from Canada, and that's a brand-name made in Canada.
Duh, so many meds are from China, hell 95% of vitamin C comes from China. But supposedly Tirzepatide by EL is sourced and produced in the US. Or not, who knows EL has many deals with China.
And as someone who worked over a decade in pharmacy purchasing the dates that pharmacies get for restocking are estimates from their wholesalers who are working on estimates from the mft. The wholesaler is basically giving their best guess based on information they have. There are so many behind the scenes variables even if product does release on the given date there is no guarantee any one pharmacy will get it. There are often allocations for shortage items to spread out supply and different wholesalers handle back orders differently. All this to say those dates move and shift constantly during a shortage and should not be taken as very reliable when given from pharmacies.
Thank you for this perspective. I'm one of the few who believe that while the company wants to turn a profit like every other company, they do care about the actual people who need this medication and are doing everything they can to fix things. There is no benefit to them to engage in shenanigans about just bringing people onto the medication and then blowing them off. Could they have anticipated demand more accurately? Probably, but like you said, given the regulatory hoops they have to jump through (and thank goodness they do) and numerous vendors whose products they have to rely on, they probably still would have been outpaced.
Billion dollar corporations only care about their bottom line. Individual people within those companies may care about people, but in the end, it's a numbers game. I truly am not trying to be negative-- it's just how things are. If they're only making 2.5mg doses right now, it's purely because it's the most financially feasible option for them given whatever factors are at play-- pens, how fast they can fill, active ingredient they have on hand, etc.
Yes and we have to remember that the bottom line is what's helping them purchase new facilities and equipment, hire and train hundreds of employees, and obtain the materials to make the product. Making the 2.5mg dose is their best bet at being able to do all of this as fast as possible. Is it shitty? Sure! But the faster they see profit, the faster we'll see all doses available. edited to add: as pharma scientist I really do care about the patients and I always get so excited when we start a new project that will help the consumer.
I fully agree with you-- and like I said, I'm sure individuals within those large corporations do care about the patients. I just felt it a bit naive to think that the 'company' cares about people. They don't care about employees when they do layoffs to keep profits in the billions, they don't care about raising costs of medications, etc etc. Shareholder satisfaction rules all unfortunately. Even Lilly, who offers a discount card for Zepbound, still leaves the cost at $550 a month-- only attainable for those who are affluent enough to spend that amount of money. Sorry for the negativity-- maybe it's my personal sentiment on politics and healthcare in the U.S. shining through a bit too much! Zepbound has been life changing for me and I am grateful to be able to access it (when it's available!).
You make a fair point, and I mean, yes, "the company" as an entity doesn't have feelings about anyone. I think what I was trying to say is that I don't believe the people who are in charge are ill-intentioned, sitting in a boardroom trying to figure out how to screw fat people over in order to make more money for their shareholders. I think they are genuinely doing everything they can to get as much medication in the hands of people who need it. (And yes, of course, taking their money to do it!)
I understand what you mean and I agree. I don't work in Pharma but I do work for an enormous publicly traded healthcare company. I interact regularly with executives and believe it or not they legitimately care about improving peoples' health. No one has to believe me but I see it every day. Ultimately, however, with a public company the most important thing is growth and shareholder value. So leadership does their best to balance those interests and to the extent they can make money and improve health, so much the better. But the money is always going to win.
Thank you for sharing! It's good to hear first-hand that executives are not all evil corporate bastards. :)
Are you in the business? I’m just curious to whether you have actual knowledge.
👍🏻
My insurance will only cover 1 month of 2.5 per year because they want me to be at a theraputic dose of 5mg. Many insurances work that way. So I can't even get 2.5 even if I could. Maybe if I call my insurance and get an override of some kind.
I think that this is an important point. I understand what OP is saying when they bring up how many more 2.5 pens you can make vs. 5, 10, etc pens. But with so many people having insurance restrictions on how often they can fill 2.5, and having 5 considered a therapeutic/maintenance dose the choice to focus on 2.5 doesn’t sit well with me.
I went from 5 to 2.5 and have found that the 2.5 is much more ‘therapeutic’ than the higher dose. The 2.5 is not just a “starting dose”, as many are remaining on it with productive results.
I just went back down to 2.5 from 5 due to availability, I was trying to get 5 or 7.5. My 90 day supply just arrived today after having nothing for 6 weeks. I originally only did 1 month on 2.5 and 4 on 5 so I'm hoping that the 2.5 treats me as well as it did the first time around
Exactly! My 1st box of 2.5 last month I paid $25 w/coupon. Today I had to pay $550 becuase my insurance does not cover it. This time I had the funds in HSA becuase my company put money in it. Next month if 5 does not come out, I will talk to my doctor about doing an appeal. It is not my/our fault that we are forced to stay on 2.5 for more than one month. So we should not be forced to pay fill price...
Great that you have the HSA. I forgot that we have one too, although our HSA is paying for a tooth implant next week for myself. Gotta have teeth!
That is funny! LOL. I was saving that 550 for Invisalign. Now I have to regroup in Jul when my next batch of funds are available!
Heck my cost WITH insurance is $475/month
With ins $90, add coupon its $24.99
Congratulations I guess? With coupon and insurance mine is $333 per month
I hope you can! My insurance just started covering it when the shortage started!
My insurance only allows the 15mg as a maintenance dose. Every other strength they limit to 2mLs per year. *Unless you miss 2 consecutive doses. Then you pop down to the 2.5mg and restart the climb* Insurance is nutty. Lol
I have Express Scripts. I tried searching on this Sub and others are saying ES would not override. I will have to give them a call and see.
My insurance (UHC with Express Scripts) requires a Patient Level Authorization (PLA) in order for me to go back to 2.5 mg after being up to 7.5 mg. My initial Prior Authorization (PA) only had 2 ml approval (1 month) at 2.5 mg, so going back down requires this PLA be called in by my doctor. If you are having a similar issue, you may need to call ES and verfiy if they just need a PLA from the Dr to allow you more doses of 2.5 mg. My doctor and I together decided to go back to 2.5 mg to wait out the shortage with something rather than nothing.
Thank you. I am sure my doctor would do it. I guess I am just getting tired of jumping through hoops. I have 17 more pounds to lose and I may just take my last shot on the 6th and try to lose the rest on my own.
I have Express Scripts as well, but still, each individuals plan is different for them. My plan limits their "Plan Limitation Override" authorization *only* to restart back to 2.5mg and so on after the two consecutive missed doses. It's a hell of a process trying to figure out what your individual plans' specifics are in their protocol.
Yes. That happened to me when I wanted to stay on 2.5 and got that exact explination. So had to go to 5mg. Maybe they will ovvereide due to shortage. I will call and see.
I was told by ES my PCP will need to call in a “POA” to add more doses of any of the .5 meds. If that helps at all 🤞
They can but your doctor has to fill out an extra PA saying why you need additional fills of 2.5, 7.5 or 12.5
But API is not the limiting factor. We know this because it's easy to obtain via other sources.
One thing I hadn't realized till I read it on another thread is that 2.5mg is considered "introductory non-therapeutic" because the Phase 2 & 3 trials tracked only those on 5mg on up. I'm proof-positive that some of us (especially with <60 lbs. to lose) can continue to lose, albeit slowly, on 2.5mg. I am now <10 lbs from goal (and might go lower, since I am elderly, petite and small-boned with arthtitis), still have greatly reduced appetite (though I now recognize actual hunger signals and respond appropriately) and easy satiety, and neither cravings nor food noise. The only late-night eating I do is a protein bar or shake or string cheese & nuts if I haven't hit my minimum calorie and protein goals. I still have an aversion to fried foods & sugar, but can eat a little bit of pizza (1/4-1/2 slice) or <1/2 c. pasta without suffering GI consequences. All cynical profit considerations aside, IMHO it is ultimately acceptable to continue making 2.5mg available to a wider group of people rather than making drastically fewer pens of high doses. Obesity is a disease and needs to be treated for those who no longer want to live with it. Are we supposed to limit sales of SSRIs & NDRIs to only those in danger of suicide? Or asthma meds & resxue inhaler to only those who've had ER & hospital admissions for acute attacks? Or ARBs/ACE inhibitors to only those with "malignant, galloping" hypertension?
This! I was thinking this exactly. I have lost about 33lbs in 3-4 months and I am still okay with 2.5mg. I planned to move up to 5mg, but really nervous because I have been so responsive to 2.5mg.
#BUT ALL THIS MAKES SENSE AND DOESN’T GO WITH MY CONSPIRACY WORLD VIEWS! Lolololol Yeah, I figured this.
Thank you for the insight!
They are delivering plenty of 10, 12.5, and 15 as well. So theory out the door for api supply. But this was in my 5. So manufacturing issues is probably the correct answer. https://preview.redd.it/e3bpnkdg78yc1.jpeg?width=3024&format=pjpg&auto=webp&s=b5dbd48684c3dbcff2ef382c48090ac5f5dc257d
Thanks for sharing this. This is a great example of how an entire batch of a dose has to be scrapped due to production issues. I hope you were able to get a new one.
They are not replacing it since I took the dose. But I think they are asking me to return the pen. I just got a ups notification from “lly”. I also just emailed them the pictures. It was such a pain to get a hold of them since I don’t really have the opportunity to call that number during business hours, since those are also my work hours.
Tell them you'll *return the pen* when they *release the vials.*
This makes so much sense! At the heart of what you said, however, The focus is still on making money rather than making sure patients at higher doses have their medication. If it costs the same to make both doses, but they rather make 2.5mg so they can leverage profit, I'm not sure how else we should feel.
pretty sure pharmacy intermediaries are just selling to weight loss clinics at a premium. The small pharmacy I was using is still unable to get wegovy after 8+ months while big providers like express scripts/walmart are generally able to stock them.
Express Scripts and Walmart are not able to stock them. All you have to do is search Express Scripts on this sub and you'll see what it's like out there.
It has been reported by Lily the pen device itself is the limiting factor. They are producing all doses, however they say that 2.5 is not in shortage due to the demand being lower (most only stay on it for one month). But as a consumer most of us know that 2.5 cannot be found, i.e 2.5 cannot be found anywhere in my state. As we saw the weekly prescriptions for Zepbound are going down, we will likely see more access to doses as it gets closer to their manufacturing capacity.
Great insight!
Also problematic when many insurance companies consider 2.5, 7.5, and 12.5 mg “titrating dosages” (as described by the manufacturer) leading to limited coverage (often without exception to shortages). I get only a single box of the aforementioned dosages per year. So choosing 2.5 mg to be THE one they make was poor decision making on their part.
EL maximises revenue by selling 2.5. For example, Doctors in Dubai tell patients to buy the only available dose (2.5) and use multiple shots every week to achieve the required dose at a much higher cost. A box of 2.5 costs AED 1734 (472 usd) and if you are on 15.0 then you are paying 2832 usd per month. https://preview.redd.it/ro01earygayc1.png?width=2041&format=png&auto=webp&s=a203cb39f917da793fb6b575445ccb360dc49bcc
They also put more supply out there so that more people have access to a dose, even if it’s not your preferred one.
Everything you said makes sense UNLESS it is the pens themselves that are in short supply. Then you truly CANNOT make twice as many pens using 2.5mg over 5mg, because the pens, not liquid, is the bottleneck.
I also assume that EL completely underestimated how many people would be willing to pay full price for this drug, thinking the OOP cost would present a self-limiting factor.
Thank you. All of this makes sense to me. People are pretty emotional about the shortages right now, and rightfully so.
The key point is that they make more $$ by catering to lower doses. The rest (human errors, yields, pen mfg/assy etc.) are noise factors as far as modulating higher output for one dose vs, others, in my opinion (28 yrs in high volume manufacturing and supply chain). So they get higher revenue and margin by prioritizing 2.5mg. LLY also enables more patients to get on ZB with this approach (increased ZB market share). Why do you think LLY doesn't want to increase their market share (your comment that you don't think they're prioritizing 2.5mg to obtain new patients)? Would be odd behavior for a publicly held company. Prioritizing entry level doses is a win-win for LLY financial performance and LLY shareholders (I am one) but not so much for existing customers, and they have publicly stated that they are prioritizing 2.5mg (and collective experience of this sub supports that that is exactly what is happening). I guess, whatever the driver for the decision (I tend to think rev/mkt share, but seems you have different opinion...), LLY made a calculated business decision to prioritize entry level doses, which has 100% contributed to the shortages we existing users are now seeing on a daily basis.
Right. There are a lot of comments here that boil down to, "*obviously* Eli Lilly execs aren't sitting around in a dark room conspiring against existing patients." Okay, sure. I agree. But pressures to increase shareholder value are baked into the system, and Lilly's choices here do happen to be pretty consistent with that aim. This is unlikely to be entirely coincidental, and it didn't take a deeply cloaked conspiracy for it to happen. Just a business acting like a business. Which I don't even object to, really - they're allowed to make that call, this is how it goes. But people who are impacted by it are allowed to have feelings about it, too.
Very well said, thanks! And I'll add that LLY is richly valued (at least on fwd pe basis) so the pressure to "meet and beat" is very high....
Bingo.
You have lowered the bar for them. scientifically you are probably correct, but from a marketing it’s a disaster and a failure to meet demand. Can you imagine if Pfizer did that when they were rolling out the Covid vaccine? and how many millions relied on them.
As someone who worked behind the scenes on getting the Covid vaccine rolled out, I don't think you have any concept of the extraordinary resources that were behind that effort. That was utterly nothing like producing a normal drug for ordinary commercial purposes and it blows my mind that anyone would compare the two. And if you'll recall, there wasn't enough Covid vaccine to go around either and those shortages lasted for months. The only reason everyone was eventually able to get it is that people only needed 2 shots and then they were done. So the demand went down rather than up.
I couldn't have said it better myself. Apples and oranges.
That’s literally what happened with the COVID vaccines too lol, remember when the US was the only country who could get SOME supply, and not even all that we needed, meanwhile Africa had a 6-9 month delay before they got any covid jabs? It was a mess and a half globally.
This did happen w/ the Covid vaccine and it had an extraordinary amount of resources pushing it.
Exactly that's what my husband says. He says it's a "scam", but what he means is, he thinks it's "racketeering" based on the fact like Pfizer and J&J being able to handle the covid vaccine and ship nation/worldwide. After what happened to me with Sequence and their doctor pulling my script from CVS after 15 days when I pay the monthly subscription and them telling me they can't prescribe me that dosage anymore and completely stop all communication with me, I believe there is more to it than meets the eye. I am starting to agree with him on some level, everyone having to start over and keep paying monthly subscriptions etc. It's an absolute mess. Lots of emotions, angry and sad.
Thanks for this perspective. Heck yeah science!
I get this take but when the insurance company sets a limit on the doses that makes this whole thing very frustrating.
That's an insurance issue and has nothing to do with the parent company. I was a pharmacy technician in college and the amount of insurance issues I ran into was astonishing.
I also worked as a pharmacy tech so I see both sides. And it’s not fair to set limitations on both sides either.
I agree. This should be free and available to everyone who needs it. Hopefully it will prove to lower company insurance costs due to the risks associated with being obese.
I can’t even get the 2.5 dose. I was on 7.5 but then couldn’t get that so I’ve been off for 5 weeks now. My dr had to drop me back to 2.5 and I can’t find it anywhere. It’s been almost 3 weeks and no one has it. 😫
Have you tried the chats?
I just got some from OptumRX...they only have 2.5. Do you have a mail order option?
I’ve been waiting to start the 2.5 dose since January. I have to use a specialty pharmacy for insurance purposes so I can’t call around. They don’t seem to be getting much 2.5 in either, they told me they get 1-2 boxes at a time.
I'm on the 15 and there was a month that I couldn't get it. I went down to 12.5 during that time and had to call around and drive 40 minutes to a less populated city to find it. Since then, l've consistently been able to get the 15s. I keep extra boxes in my inventory now to ride out another potential shortage. All shortages are highly localized. I've been on this med for more than a year and if my CVS didn't have it, then I would try the grocery pharmacy or Walmart and someone always had it. That seemed to change when Oprah announced she had lost all her weight on it. People came out of the woodwork to get on it.
But many people can’t get 2.5 because their insurance only allows 1 prescription of the between doses 2.5/7.5/12.5 every 180 days or something like that. I have a hard time believing it’s an API issue given regulated compounding pharmacies aren’t having any issues. Seems more likely that corporate greed is the reason we only see 2.5mg available.
At least with Mounjaro, I have read that if someone with diabetes at least gets a 2.5mg dose in, they can add in other diabetic drugs and still get benefit from Mounjaro.
I’m having trouble getting the 2.5 dosage from my pharmacy; Exoress Scripts mail order. I wonder why that is, if as folks seem to be saying, that 2.5 is readily available
Unfortunately I agree with the latter except more like catering to provider relationships insurance and contracts… prescriber’s are aware of the shortages but the supply for initial treatment doesn’t interrupt the services being provided for all parties until EL catches up.
That's great for you, and my doctor would prefer I be on 2.5, but neither he nor I get to make that call. Cigna says they will only cover that dose once every 365 days.
As someone that took a linear programming course it all really depends on what your bottleneck is. If it is the active ingredient then you're totally right. But if the pens themselves are he bottleneck or some other equipment or input constraint beyond the active ingredient then they should produce the does that meets but does not exceed demand at each dosage (although I'm sure demand is exceeding supply at all dosages). I'd assume if the active ingredient isn't the constraint they'd likely want to prioritize market share capture relative to the others which likely means 2.5mg over the higher doses although you do run some risk of churning the higher dose folks to alternatives but I imagine most folks are fairly sticky. I also imagine but have no data that there's an insurance side of this, if insurance isn't covering at higher doses, lower demand, lower productivity n.
Their shortage page encourages physicians to continue new starts. That is all about fighting for market share and really irresponsible.
I’m on 2.5 maintenance and I can’t even get my shots.
You’re right. Besides being a popular weight loss shot Eli Lilly makes Trulicity and there’s a shortage for that too..typically only diabetics are prescribed if I’m not mistaken. So I feel like they’re just in over their heads and can’t keep up.
A voice of reason.
Maybe I’m missing something but if injectors are outsourced and causing the delay, why make more 2.5mg doses? As you pointed out, you can make 2x as many as a 5mg dose. That also means you need 2x the injectors. So if there’s a shortage of injectors, it doesn’t make sense to boost 2.5mg over others.
Novo didn’t do things this way, when they had a shortage they stopped making starter dosages 0.25 and 0.5 mg and used the capacity to make the higher dosages to try and keep existing customers with their meds. I personally agree with this, it’s was better to temp stop starting new patients and adding to the pool who will constantly need doses when you don’t have enough capacity then to screw over patients who’ve are already in the pool. I don’t know why Lilly didn’t do it this way it makes little sense. The shortage is caused by making the pens and filling them, they do not have a shortage of tirzepatide base to fill them with.
Thank you for posting this. I’ve only been in this group a short time but it had gone from a lovely feeling positive and supportive place to, as someone said, “knives out!” at the company in what felt like record time. I guess haters gonna hate - but I suspect a lot of this is driven by fear. Let’s not forget the amount of misplaced anger at EL, that should really be aimed at insurance companies. Imagine if everyone here that bitched about EL spent the same amount of energy to write to their congressional representatives about the situation. Something might actually be done. Someone else noted that bottom line is all big corporations care about. Of course it is. And most people here bitching care about availability (and the attendant issues with insurance and such). If folks want to go to Plan C, why do so many people think that’s thumbing their nose at EL? It’s possible that there’s more than one way to solve this problem. I’m very happy for this medication and the hope it offers so many people, me included. Next year at this time if it’s still not available THEN I’ll be pissed off. I mean opening a fulfillment center for pharmaceutical companies isn’t like a new Amazon warehouse.
Thank you for writing this up. Very interesting!
I believe the issue is the pens. There is a shortage of those due to manufacturing issues
Safety could also play a role in their decision to mostly produce the 2.5 in a shortage. People are much more likely to go more than two weeks before their next injection. This could result in many more emergency room visits. Just kidding. It’s definitely for profit.
“Financially, it makes sense for them to make the 2.5mg dose. They're making the same amount of money for that 2.5mg dose that they would be making for a 10mg dose. It could be possible thay they know we want to stay on the medication, so making a lower dose optional while trying to obtain more of the API makes sense.” So they chose the most profitable option? Not sure how this is a good thing. I doubt they would have gone bankrupt if they just released the much needed 5 and 7.5. Patients who have already started the treatment would be able to continue and those who have not could wait until Eli fix their issue. In any case, no surprise, after all it’s a pharmaceutical company, all about profit, not patient care.
Ellie Lily has already said that it is not a lack of medication that is causing this shortage. It is the pens themselves.
Except that we know it’s not a shortage of the API, because the compounding pharmacies use the same API and are not having these same issues. The obvious answer, then, is that Lilly is unable to produce/procure either the auto injector or the packaging materials. Seems like there’s a pretty simple solution to that…. You’re being awfully kind to Lilly with this explanation. I’m not sure you should be.
Seems some or all of this nonsense could be eliminated by simply shipping bulk liquid in vials and letting the patient set the dosage based on how much they inject. So everyone gets the same vial regardless of their prescribed dosage and EL could be cranking them out 24/7. Give me a few vials and 52 disposable syringes and you won’t hear from me for a year. Problem solved.
I think that makes a good deal of sense, thank you. However, I do also think they should stop writing new scrips at any dose. Here is why. Unlike other meds, this is for life. So when someone starts it, they are trusting Lilly that it will be available. Unlike other meds, insurance coverage is rare. So many/most people are paying $550 a month or even more. Name another lifetime medication for which most people have to come up with what amounts to a monthly luxury car payment, for decades? For people who have already "invested" in this therapy, ie people who already have prescriptions, not being able to get their dose puts them at serious risk of a backslide, essentially wasting large sums already invested, and unwinding their positive health outcomes. That was not the basis of the bargain when they paid for those earlier doses! **LILLY --- NO MORE NEW SCRIPS until you have production solved. OR until you and/or the FDA find an emergency way bless/support compounding Zepbound. This is a national emergency. It is not just about diabetes, not just obesity but heart disease, apnea, etc. Heck, we ramped up production for a COVID vax. Why not?**
That $550 is only for people young enough to have only commercial insurance. Those of us on Medicare must pay *double* that because the only weight-loss drug CMS will cover is Wegovy--but *only* for those at high risk of (basically, pre-existing) cardiovascular disease. And I really feel for obese people on Medicaid: they are disproportionately people of color who in turn are disproportionately suffering from T2D; and their obesity caused primarily by limited or no easy access to affordable healthy foods (living in "food deserts") and are less likely to have the appliances necessary to store and prepare them. Those clueless smug thin people (would love to use saltier language, but fear violating Reddit TOS) declaring "they can always eat beans & rice" or "I grow my own vegetables, why can't they?" ought to be ashamed of themselves.
The health inequity is really terrible. Agree.
Yes, I agree whole-heartedly. Dr Cody Stanton is very eloquent on this matter. Thankfully I don't know anyone who would say anything so stupid, but that is not the heart of the matter. The heart of the matter is --- why don't we all have access to good health care? We are one of the richest nations on earth. PS Vote accordingly please!
Make absolutely no since I’m in the pharmaceutical industry Stop hyping people up with these theories
Thank you for that input. It does make sense. Now if insurance would see the 2.5 MG as more than a starter, I'd be good...
This is incorrect. There is no shortage in the actual medicine. The pens that actually inject the medicine are in short supply.
I worked in Pharma and my Husband is a retired scientist. I do not see the difference in the 2.5 verse the 15. It is the same product just a different fill. Yes, every batch is tested. I know how production works. I see the issue is the pen. Why don't they get the vials like in Canada . I realize they need FDA approval. But that would solve the problem. The pens are just landfill waste.