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15 minutes ago, Satchel said:

Good:

https://apnews.com/article/health-california-diabetes-government-and-politics-f846c58d4cb327578d1c7b3a9495d496

Now, with several insulin patents nearing their expiration dates, California is looking to disrupt that market by making its own insulin and selling it for a much cheaper price. Last month, after a few years of study, state lawmakers approved $100 million for the project, with $50 million dedicated to developing three types of insulin and the rest set aside to invest in a manufacturing facility.

This is great news for Cali residents. Bravo, Cali. Taking care of its people.

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39 minutes ago, Satchel said:

Good:

https://apnews.com/article/health-california-diabetes-government-and-politics-f846c58d4cb327578d1c7b3a9495d496

Now, with several insulin patents nearing their expiration dates, California is looking to disrupt that market by making its own insulin and selling it for a much cheaper price. Last month, after a few years of study, state lawmakers approved $100 million for the project, with $50 million dedicated to developing three types of insulin and the rest set aside to invest in a manufacturing facility.

This will be interesting.

I learned something about insulin that I didn't know.  The original, synthetic human insulin, was patented in the 20s and the patent expired in the 40s.  I thought that was the basic stuff we were talking about.

Turns out, the current "insulins" are actually insulin analogs, made by genetic engineering and patented in the 90s.  This apparently is not just dicking around with insulin by pharma, it's a major improvement over synthetic human insulin in efficacy and is the standard of care for good reason (not just pharma marketing).  There are fast and slow-acting variants, whose basic patents expired not quite 10 years ago.  At this point, I think it's FDA regs regarding generics and manufacturing that are in the way.  For example, Lilly invented and patented the fast-acting analog, insulin lispro; and Sanofi patented the slow-acting insulin glargine.  The approved generic manufacturers for lispro and glargine are Sanofi, and Lilly, respectively.

The foregoing seems to imply that manufacturing insulin analogs is not simple, although it may be relatively low cost.  California is going to have to have its manufacturing facilities certified by the FDA, and is probably going to have to make a biosimilar ANDA to the FDA before any of this comes to pass.

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4 minutes ago, TwiceHorn said:

The foregoing seems to imply that manufacturing insulin analogs is not simple, although it may be relatively low cost.  California is going to have to have its manufacturing facilities certified by the FDA, and is probably going to have to make a biosimilar ANDA to the FDA before any of this comes to pass.

Right, insulin is a biologic and has a different regulatory framework than small molecule drugs. Here's a review on the topic for those interested. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6313268/ It also gets in to how the prescribing and dispensing requirements differ wrt interchange.

I think that CA has an uphill climb here and they will end up pouring a lot of money into standing up their alternative, but fully in favor of them giving it a go. Of course the much easier thing to do, imo, would be to just enforce some negotiated price controls directly on the current manufacturers. 

 

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18 minutes ago, TwiceHorn said:

This will be interesting.

I learned something about insulin that I didn't know.  The original, synthetic human insulin, was patented in the 20s and the patent expired in the 40s.  I thought that was the basic stuff we were talking about.

Turns out, the current "insulins" are actually insulin analogs, made by genetic engineering and patented in the 90s.  This apparently is not just dicking around with insulin by pharma, it's a major improvement over synthetic human insulin in efficacy and is the standard of care for good reason (not just pharma marketing).  There are fast and slow-acting variants, whose basic patents expired not quite 10 years ago.  At this point, I think it's FDA regs regarding generics and manufacturing that are in the way.  For example, Lilly invented and patented the fast-acting analog, insulin lispro; and Sanofi patented the slow-acting insulin glargine.  The approved generic manufacturers for lispro and glargine are Sanofi, and Lilly, respectively.

The foregoing seems to imply that manufacturing insulin analogs is not simple, although it may be relatively low cost.  California is going to have to have its manufacturing facilities certified by the FDA, and is probably going to have to make a biosimilar ANDA to the FDA before any of this comes to pass.

The human variants patented way back were what I started taking in the 80’s. It went by the names Humulin R and NPH. 

I considered myself a pretty durable type 1. Other type 1’s aren’t so fortunate. Two high school classmates of mine died before age of 30 due to complications from type 1 diabetes. One of them went blind around age 25.

My physiology changed around age 30, I became more brittle. Humulin R sent me into insulin shock several times, and I wound up in the ER to revive me. Basically the brain powers down in insulin shock.

I now take levemir (long lasting) once per day and lispro (short acting) 5 or so times per day. No episodes of insulin shock for years.

The biggest breakthrough in type 1 treatment I’ve seen in recent years is a device you attach to your arm that pairs with your phone. The device has probes that go just under the skin. You use an app to get your blood sugar reading. People normally do like 20 readings per day. No more finger sticks. Game changer. The device lasts 14 days and it’s quirky at times. There’s opportunity for improvement but it’s a huge improvement over finger sticks. It is expensive though.

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6 hours ago, GenXer said:

The human variants patented way back were what I started taking in the 80’s. It went by the names Humulin R and NPH. 

I considered myself a pretty durable type 1. Other type 1’s aren’t so fortunate. Two high school classmates of mine died before age of 30 due to complications from type 1 diabetes. One of them went blind around age 25.

My physiology changed around age 30, I became more brittle. Humulin R sent me into insulin shock several times, and I wound up in the ER to revive me. Basically the brain powers down in insulin shock.

I now take levemir (long lasting) once per day and lispro (short acting) 5 or so times per day. No episodes of insulin shock for years.

The biggest breakthrough in type 1 treatment I’ve seen in recent years is a device you attach to your arm that pairs with your phone. The device has probes that go just under the skin. You use an app to get your blood sugar reading. People normally do like 20 readings per day. No more finger sticks. Game changer. The device lasts 14 days and it’s quirky at times. There’s opportunity for improvement but it’s a huge improvement over finger sticks. It is expensive though.

I was going to ask if you could corroborate the apparent differences between the "new" insulins and the old stuff.

The FDA creates a lot of barriers to entry for generics and biosimilars.  On the one hand, you don't want to fuck around with drug safety, on the other hand, the FDA seems to be captured by pharma and related interests and it seems the "height" of the barriers may be more dictated by foreclosing competition than by safety concerns.

As indicated often by the stock market, drug patent expiration should be a watershed event, almost immediately permitting competition and the concomitant lowering of prices.  It doesn't seem to work out that way that often in pharma.

I'm not sure price controls are a really good idea, but there are a lot of things going on besides patents that shelter US drugs from competition.  Like not letting Medicare negotiate prices.  That's pure corporate welfare, right there.

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50 minutes ago, TwiceHorn said:

I was going to ask if you could corroborate the apparent differences between the "new" insulins and the old stuff.

The FDA creates a lot of barriers to entry for generics and biosimilars.  On the one hand, you don't want to fuck around with drug safety, on the other hand, the FDA seems to be captured by pharma and related interests and it seems the "height" of the barriers may be more dictated by foreclosing competition than by safety concerns.

As indicated often by the stock market, drug patent expiration should be a watershed event, almost immediately permitting competition and the concomitant lowering of prices.  It doesn't seem to work out that way that often in pharma.

I'm not sure price controls are a really good idea, but there are a lot of things going on besides patents that shelter US drugs from competition.  Like not letting Medicare negotiate prices.  That's pure corporate welfare, right there.

I can’t explain the chemical differences between the old and new stuff. It’s not my field, and I didn’t stay at a holiday inn last night.

I can speak to the cost difference between the brand name and generic. In my experience, I was surprised that the cost of insulin once the patent expired didn’t have an appreciable difference. I was using lantus as my long lasting insulin when its patent expired. Lantus’ generic is glargine. My endocrinologist wrote me a prescription for glargine at my request. I expected a lower cost but didn’t notice any to speak of.  I’ve found the main difference in cost is the which health insurance you have. As a corporate drone, I’m affected by the annual decisions of HR. 
 

A quick google search shows walgreens charges the same amount for lantus and glargine ($72 for a vial).

With my insurance, I pay $50 for a vial of levemir and $30 for a vial of lispro.  $80 a month is very reasonable for me but if I’m uninsured (meaning I’m between gigs), retail is $80 for lispro and $300 for levemir).

I just checked goodrx and here’s the retail price for one vial of levemir.

 

0ED6EA5D-F70A-4E4B-BACF-FE5FF87D288E.png

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I just meant the drug itself, new prescriptions, maybe better effects, etc. compared to the "old stuff."  

Like I said, and it was possibly not explicit, but Lilly was the original patentee on lispro/Humalog and is now the only approved "generic" for Lantus, while Sanofi was the patentee for glargine/Lantus and is now the only approved generic for Humalog.  So, it's kind of a market division between the only two players.

There are a few other insulin analogs, Levemir being one, but they don't seem to be market dominant like Humalog and Lantus.

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California manufacturing their own insulin is one hell of a market disruption and a much better alternative to a copay cap. The $35/mo cap looks good on paper but it's nothing more than a cost shift to the plan sponsor. The PBM is not going to willingly eat that cost even though they get kickbacks on the list price from Sanofi, Eli Lilly, and the other manufacturers. Plan sponsors already pay below acquisition for brand name drugs and it's one of the reasons why we're dropping TRICARE at the end of the year. My patients love the dirt cheap copays but I can't subsidize them at the same time they use a health plan funded by the government that refuses to tell the pharmacy the source of their price tables on the basis that it's proprietary. 

Here's an example I can use to relate what I'm talking about. Let's say you own a home and you have a major foundation issue. Your home insurance company says they'll cover it but completed repairs can only be authorized at their contractor negotiated price of $2,000. You talk to every contractor in your zip code and the ones around it and they're all telling you that this repair is minimum $15,000. You call the insurance company to ask them where you can find this contractor who will do it for $2,000 and they tell you "Sorry, that's proprietary information. You'll just have to keep searching for that contractor we negotiated with. He's out there somewhere!". Health plans won't even give us the names of wholesalers where they contracted with to get medication prices. They don't have to give us their contract terms but they won't even give us the name of the companies where they derived this price list from. It's one of the reasons why I love the Cost Plus/Blueberry Pharmacy model. The price at the point of sale is the price of the drug. No kickbacks, no negotiated rebates, none of that stuff. If California ends up doing something like that, there will be people begging to get involved whether as a patient or a provider.

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9 hours ago, TwiceHorn said:

I just meant the drug itself, new prescriptions, maybe better effects, etc. compared to the "old stuff." 

Good question. Every type 1 diabetic reacts differently to insulin. Here’s what I’ve seen with myself. I can speak with more detail since I began using the freestyle libre device that lets me check my blood sugar with my phone. That app plots a graph of my blood sugar so I can see my level at any point over time. This helped me discover that I have the “dawn effect.” This is effect causes my blood sugar to spike overnight when I’m asleep and haven’t eaten anything for hours. Very cool tech. There’s other makers of this tech too. My endocrinologist says I’m on the “walmart” brand of the tech snd there’s a better maker out there. 

Back to your question. The old version of the short-acting humulin insulin (humulin R) caused me to go into insulin shock much too regularly after age 30. It became a real problem. When I described the problem to my endocrinologist, he prescribed humalog. This was before its patent expired around 2013. I found immediate improvement.

Until age 30, I never got severe insulin shock with humulin R. But age takes its toll.

When he switched me to humalog, he also switched me to lantus (long acting). Previously, I took Humulin NPH for long acting. I never noticed a significant difference between lantus or humulin NPH. 

At some point, my employer health insurance dropped lantus from its covered meds and my endocrinologist switched me to levemir for long acting.

In a pinch, I can buy some Humulin NPH (now it’s just Humulin N) without a prescription and still use it.

Now that I have the device and app, I’ve discovered I have the dawn effect and adjust my long acting insulin to try to counteract it.

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I see now, too, that injection devices are a big part of the patent game for these products.  Apparently, they are actually easier to use and probably safer in terms of controlling dosage than a straight up injection.

Those aren't even drug patents, per se.  They're on devices, like an oil drill bit, or microprocessor or whatever.

The patent laws have changed in the last 20 years to make it harder to fuck around and extend the term of the patent beyond the 20 years from filing.  But a device patent is best regarded as a whole 'nother patent altogether.

One of my favorite actual stories on that is the patent owner for Immodium anti-diarrheal "extended" or got a second patent on Immodium plus simethicone, the only gas-reducing drug available.  I guess their intention was after the basic patent on Immodium expired, they'd only sell the "Immodium plus" formulation.  A court considering a patent infringement case found that patent invalid, using the following reasoning:  It is notoriously well-known that diarrhea is often accompanied by gas (never trust a fart, right?); it would then be obvious and unpatentable to combine an anti-diarrheal with the only known gas-reducer, simethicone.  Boom, patent invalid.

Pharmas are notorious for "extending" or getting second patents with a slightly longer term than the first one (a couple of years), by doing little bullshit tweaks like the above.  That is much harder to do since the patent law changes starting in 1995.

But, again, these devices aren't quite the level of bullshit that Immodium + Digel is.

Do modern insulin analogs come exclusively packaged in some type of device?  Or can you refill the devices from a "bulk package" like a vial?

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16 minutes ago, TwiceHorn said:

I see now, too, that injection devices are a big part of the patent game for these products.  Apparently, they are actually easier to use and probably safer in terms of controlling dosage than a straight up injection.

Those aren't even drug patents, per se.  They're on devices, like an oil drill bit, or microprocessor or whatever.

The patent laws have changed in the last 20 years to make it harder to fuck around and extend the term of the patent beyond the 20 years from filing.  But a device patent is best regarded as a whole 'nother patent altogether.

One of my favorite actual stories on that is the patent owner for Immodium anti-diarrheal "extended" or got a second patent on Immodium plus simethicone, the only gas-reducing drug available.  I guess their intention was after the basic patent on Immodium expired, they'd only sell the "Immodium plus" formulation.  A court considering a patent infringement case found that patent invalid, using the following reasoning:  It is notoriously well-known that diarrhea is often accompanied by gas (never trust a fart, right?); it would then be obvious and unpatentable to combine an anti-diarrheal with the only known gas-reducer, simethicone.  Boom, patent invalid.

Pharmas are notorious for "extending" or getting second patents with a slightly longer term than the first one (a couple of years), by doing little bullshit tweaks like the above.  That is much harder to do since the patent law changes starting in 1995.

But, again, these devices aren't quite the level of bullshit that Immodium + Digel is.

Do modern insulin analogs come exclusively packaged in some type of device?  Or can you refill the devices from a "bulk package" like a vial?

I’ve never transitioned to pens. I’ve tried using them but it’s awkward in my opinion. Feels like hitting a nail with a sledgehammer. I’m picky about injections and like to squeeze just the right amount of skin so that I can get just the tip in (yeah, that was intentional). This technique allows for a pain free injection. You can’t even feel it go in (yep - also intentional). I don’t have that control with the pen. And, the hard click of the pen shakes the pen so I might prick something inside (damn - this reads badly). The button to inject the insulin is awkward to click and hold the pen in the same place while injecting. One of the tricks to injecting is to avoid any blood vessels. Otherwise, you get a spot of blood on your shirt. I hate that. The pen doesn’t let me get a good look at the injection site so I don’t notice quickly if I hit a blood vessel. Hence, more blood spotted shirts.

Pens are the norm so I have to specifically ask for a vial when the doc fills out my prescription. 

I don’t believe you can fill a pen from a vial. The pens are pre-packaged with a set amount of insulin; there doesn’t seem to be a way to refill them.

There are also insulin pumps. You wear these on the outside of your body. I don’t have one but my understanding is that you refill these from vials. You still have to manually click the pump to inject the desired amount of insulin. The pumps are an alternative if you don’t like sticking yourself with a needle several times per day. That’s never bothered me so I don’t see the advantage yet of a pump.

Once someone develops the tech to pair my blood sugar device with a pump and the  app tells the pump when and how insulin to inject to keep my blood sugar in range, I will likely adopt that tech. This will act as close to a pancreas as possible. I suspect that tech may already be available as all the component tech is already developed.

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1 hour ago, GenXer said:

Once someone develops the tech to pair my blood sugar device with a pump and the  app tells the pump when and how insulin to inject to keep my blood sugar in range, I will likely adopt that tech. This will act as close to a pancreas as possible. I suspect that tech may already be available as all the component tech is already developed.

wearable to monitor blood sugar feeding information to the pump seems like something that the tech is lining up for. 

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4 hours ago, HRSchenker said:

California manufacturing their own insulin is one hell of a market disruption and a much better alternative to a copay cap. The $35/mo cap looks good on paper but it's nothing more than a cost shift to the plan sponsor. The PBM is not going to willingly eat that cost even though they get kickbacks on the list price from Sanofi, Eli Lilly, and the other manufacturers. Plan sponsors already pay below acquisition for brand name drugs and it's one of the reasons why we're dropping TRICARE at the end of the year. My patients love the dirt cheap copays but I can't subsidize them at the same time they use a health plan funded by the government that refuses to tell the pharmacy the source of their price tables on the basis that it's proprietary. 

Here's an example I can use to relate what I'm talking about. Let's say you own a home and you have a major foundation issue. Your home insurance company says they'll cover it but completed repairs can only be authorized at their contractor negotiated price of $2,000. You talk to every contractor in your zip code and the ones around it and they're all telling you that this repair is minimum $15,000. You call the insurance company to ask them where you can find this contractor who will do it for $2,000 and they tell you "Sorry, that's proprietary information. You'll just have to keep searching for that contractor we negotiated with. He's out there somewhere!". Health plans won't even give us the names of wholesalers where they contracted with to get medication prices. They don't have to give us their contract terms but they won't even give us the name of the companies where they derived this price list from. It's one of the reasons why I love the Cost Plus/Blueberry Pharmacy model. The price at the point of sale is the price of the drug. No kickbacks, no negotiated rebates, none of that stuff. If California ends up doing something like that, there will be people begging to get involved whether as a patient or a provider.

See all of what you're describing just sounds like a reason to NOT treat healthcare as a profit center and some risk to hedge against. An insulin patient buying insurance for a thing they KNOW is going to happen (buying insulin) isn't buying insurance. It's buying a cost subsidy subscription, and making room for nice tidy profit margins on the basic necessities for life for these patients.

To revisit your metaphor, it's not at all like a foundation issue on a house. This isn't some possibility - it's a reality and recurring cost that isn't negotiable. Charging so much to ensure a healthy return on investment is just pure fucking exploitation for private shareholder benefit

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4 minutes ago, Captainant said:

See all of what you're describing just sounds like a reason to NOT treat healthcare as a profit center and some risk to hedge against. An insulin patient buying insurance for a thing they KNOW is going to happen (buying insulin) isn't buying insurance. It's buying a cost subsidy subscription, and making room for nice tidy profit margins on the basic necessities for life for these patients.

To revisit your metaphor, it's not at all like a foundation issue on a house. This isn't some possibility - it's a reality and recurring cost that isn't negotiable. Charging so much to ensure a healthy return on investment is just pure fucking exploitation for private shareholder benefit

And it decouples supply and demand.  And adds multiple layers of "middlemen" taking their markup.  It's just fubar.

Raises an interesting issue.  For two chronic diseases, End-Stage Renal Disease (the kind that requires dialysis) and ALS, every sufferer is eligible and mostly on Medicare.  And Medicare strangles profit from dialysis centers.  Not sure what it does regarding ALS.

Seems like other chronic diseases maybe ought to get a similar treatment.

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14 hours ago, GenXer said:

I can’t explain the chemical differences between the old and new stuff. It’s not my field, and I didn’t stay at a holiday inn last night.

I can speak to the cost difference between the brand name and generic. In my experience, I was surprised that the cost of insulin once the patent expired didn’t have an appreciable difference. I was using lantus as my long lasting insulin when its patent expired. Lantus’ generic is glargine. My endocrinologist wrote me a prescription for glargine at my request. I expected a lower cost but didn’t notice any to speak of.  I’ve found the main difference in cost is the which health insurance you have. As a corporate drone, I’m affected by the annual decisions of HR. 
 

A quick google search shows walgreens charges the same amount for lantus and glargine ($72 for a vial).

With my insurance, I pay $50 for a vial of levemir and $30 for a vial of lispro.  $80 a month is very reasonable for me but if I’m uninsured (meaning I’m between gigs), retail is $80 for lispro and $300 for levemir).

I just checked goodrx and here’s the retail price for one vial of levemir.

 

0ED6EA5D-F70A-4E4B-BACF-FE5FF87D288E.png


 

F66EA6C8-235B-421B-A0A6-170CCE521A4C.jpeg

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9 minutes ago, Captainant said:

See all of what you're describing just sounds like a reason to NOT treat healthcare as a profit center and some risk to hedge against. An insulin patient buying insurance for a thing they KNOW is going to happen (buying insulin) isn't buying insurance. It's buying a cost subsidy subscription, and making room for nice tidy profit margins on the basic necessities for life for these patients.

I’ve always considered health insurance similar to a discount card to buy insulin at a reasonable price.

The insurance part came into play when I got appendicitis and got an appendectomy.

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On 8/18/2022 at 9:43 AM, Poe It Up said:

It’s doesn’t reduce it long term. They tricked an old man, it’s ok to admit it. 

Strange how you have 10x the number of negs that I have and yet you haven't been here nearly as long.  Maybe because when shown that you were being dishonest, you decided to double down rather than take the loss and use it as a learning moment. 

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6 hours ago, HRSchenker said:

California manufacturing their own insulin is one hell of a market disruption and a much better alternative to a copay cap. The $35/mo cap looks good on paper but it's nothing more than a cost shift to the plan sponsor. The PBM is not going to willingly eat that cost even though they get kickbacks on the list price from Sanofi, Eli Lilly, and the other manufacturers. Plan sponsors already pay below acquisition for brand name drugs and it's one of the reasons why we're dropping TRICARE at the end of the year. My patients love the dirt cheap copays but I can't subsidize them at the same time they use a health plan funded by the government that refuses to tell the pharmacy the source of their price tables on the basis that it's proprietary. 

Here's an example I can use to relate what I'm talking about. Let's say you own a home and you have a major foundation issue. Your home insurance company says they'll cover it but completed repairs can only be authorized at their contractor negotiated price of $2,000. You talk to every contractor in your zip code and the ones around it and they're all telling you that this repair is minimum $15,000. You call the insurance company to ask them where you can find this contractor who will do it for $2,000 and they tell you "Sorry, that's proprietary information. You'll just have to keep searching for that contractor we negotiated with. He's out there somewhere!". Health plans won't even give us the names of wholesalers where they contracted with to get medication prices. They don't have to give us their contract terms but they won't even give us the name of the companies where they derived this price list from. It's one of the reasons why I love the Cost Plus/Blueberry Pharmacy model. The price at the point of sale is the price of the drug. No kickbacks, no negotiated rebates, none of that stuff. If California ends up doing something like that, there will be people begging to get involved whether as a patient or a provider.

Amazingly, insulin is really cheap to produce.

”Yes, insulin costs about $10 to make but sells for nearly $300.” In 2018 there were three producers..

https://www.wusa9.com/amp/article/news/verify/insulin-costs-about-10-to-make-but-retails-for-nearly-300-pharmaceutical-companies-eli-lilly-novo-nordisk-sanofi-pbms-insuli/65-73a3cafd-3340-45cd-8324-a5e3e1c78fa5

This link is older, but much more thorough.

https://www.singlecare.com/blog/insulin-prices/

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1 hour ago, Willfully Horn said:

Amazingly, insulin is really cheap to produce.

”Yes, insulin costs about $10 to make but sells for nearly $300.” In 2018 there were three producers..

https://www.wusa9.com/amp/article/news/verify/insulin-costs-about-10-to-make-but-retails-for-nearly-300-pharmaceutical-companies-eli-lilly-novo-nordisk-sanofi-pbms-insuli/65-73a3cafd-3340-45cd-8324-a5e3e1c78fa5

This link is older, but much more thorough.

https://www.singlecare.com/blog/insulin-prices/

I’ve read the anecdote in your link before; it always breaks my heart. 

Some people are also rationing their insulin by either splitting or skipping doses. Both have serious health consequences. After aging out of his mother’s health insurance, one 26-year-old manwas informed by his pharmacist that his insulin and supplies would be $1,300 per month. It was more than he could afford on his restaurant manager’s salary. Less than a month after losing his insurance, he died. His family believes he started rationing his insulin, and that is what killed him.


I know what this young man was feeling physically. The best way I can describe is that it feels like a rotting fruit. Your body feels disconnected; muscles and joints are oddly disconnected. Running feels like you’re doing it for the first time. Walking up a flight of stairs takes away your breath away. You’re constantly parched and drinking water but you’re never satisfied. You’re constantly urinating to get the sugar out of you. I had no idea what was happening to me as I was yet undiagnosed. This young man knew he was dying but couldn’t afford the fix. Breaks my heart.

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