MiniMed Go Could Turn Expiring InPen Users into Lost Customers

Back on July 27, 2016, a diabetes startup based in San Diego known as Companion Medical received FDA approval for a wireless-enabled insulin pen and proprietary mobile application branded as the InPen® system. The announcement is available at https://www.prnewswire.com/news-releases/companion-medical-receives-fda-clearance-for-smart-insulin-delivery-system-300304933.html. 

The InPen was the first, and is (so far the only) FDA-cleared smart insulin pen that includes technology to: 

• Calculate and recommend optimal dosing;
• Track history and timing of insulin doses; 
• Display the time of the last dose and current insulin-on-board; 
• Track and report to the health care provider; and
• Monitor insulin temperature.

Insulin pumps provide many of these features, and are typically most beneficial for people whose basal insulin requirements vary throughout the day. However, some patients do not want to manage routine infusion-set or pod changes, pay the additional costs associated with pump therapy, or remain attached to multiple devices. For those patients, a smart insulin pen can offer some of the benefits of connected diabetes technology without requiring an insulin pump. That is the market for InPen.

Companion Medical subsequently expanded InPen availability. The company announced FDA clearance for the Android version in 2018: https://www.prnewswire.com/news-releases/companion-medical-announces-fda-clearance-for-the-inpen-system-for-android-300677274.html. It later received FDA clearance for expanded pediatric use: https://www.prnewswire.com/news-releases/companion-medical-inpen-receives-fda-clearance-for-expanded-pediatric-use-301081939.html. Companion Medical also expanded its commercial operations, as described here: https://www.prnewswire.com/news-releases/companion-medical-announces-expansion-of-commercial-operations-300830663.html.

On August 11, 2020, Medtronic announced that it would acquire Companion Medical: https://www.nasdaq.com/press-release/medtronic-to-acquire-smart-insulin-pen-company-companion-medical-2020-08-11. Medtronic has since completed the separation of MiniMed Group Inc. The October 15, 2026, announcement is available at https://www.prnewswire.com/news-releases/medtronic-completes-separation-of-minimed-group-inc-302910198.html.

The InPen Itself

The InPen's underlying reusable pen mechanism is believed to have been supplied by Haselmeier GmbH, a German medical-device manufacturer based in Stuttgart. Companion Medical added its own Bluetooth electronics, sensor array, and software to create the connected insulin delivery system.

Haselmeier was acquired in 2020 by Sulzer, the Swiss industrial group whose businesses included drug delivery systems. The company's drug delivery activities later became part of medmix. The distinction matters because the smart features of the InPen are not the same thing as the mechanical pen injector itself. The electronics and software are what make a conventional reusable pen into a connected device.

Another example of a reusable pen injector is Ypsomed's ServoPen, described here: https://www.ypsomed.com/en/products/pen-injectors/servopen. In principle, a compatible electronic system and software could be developed around a reusable pen mechanism. That possibility is worth distinguishing from the question of who currently owns or markets the InPen system.

Smart Pens Have Had Limited U.S. Competition So Far

Novo Nordisk sells its NovoPen 6 and NovoPen Echo smart insulin pens in Europe, but neither has been FDA-approved or made available in the United States. The U.S. market has relied heavily on disposable insulin pens, while smart pens have made relatively little commercial headway.

Bigfoot Biomedical developed the Bigfoot Unity system, which used a smart pen cap and associated software. Abbott Diabetes Care acquired Bigfoot Biomedical in September 2022. I discussed that transaction in an earlier blog post: https://blog.sstrumello.com/2023/09/abbott-acquires-bigfoot-biomedical.html. The Unity product was subsequently discontinued by Abbott.

It is conceivable that technology developed for Bigfoot Unity could be licensed or otherwise used in another system, but I have no evidence that Abbott intends to make that happen.

The InPen supports certain branded insulin products from both Novo Nordisk and Eli Lilly & Company. Although InPen pens are sold in three different colors, those colors do not designate whether a pen is intended for basal or prandial insulin. By contrast, Bigfoot Biomedical's Unity system used color-coded caps to distinguish insulin types. Reusable pens for mealtime insulin have been particularly associated with Novo Nordisk's products and marketing. No patient who doses basal insulin once per day (or even twice per day) requires an insulin pen which raises the cost by 40%. Basal insulin delivered in pen format has always been a marketing gimmick to persuade insulin-naive Type 2 patients to become insulin users, even if it's basal-only by making self-injections seem less threatening. But if a patient is only dosing basal insulin once a day, why do they need a pen? They certainly don't need it to be a $125 smart insulin pen. 

A five-pack of Lilly Humalog 3 mL cartridges, NDC 0002-7516-59, remain available through LillyDirect at competitive prices. Novo Nordisk, of course, was the innovator of "PenFill" cartridges and its prandial insulins are sold that way in addition to vials and disposable pens. However, aside from Novo Nordisk insulins, insulin sold in cartridges has generally not been covered by U.S. insurance plans in the same way as insulin supplied in disposable pens or vials. Lilly never invested much in the way of sales efforts to keep its Humalog in cartridge format on-formulary, and Lilly was the first to abandon the rebate-kickback sales model for insulin anyway. It's comparatively affordable to buy a box of 3 mL Humalog cartridges from LillyDirect, and the TrumpRx provision for FTC settlements with Express Scripts and CVS Caremark opens a back-door to coverage.

The Transition from InPen to MiniMed Go

MiniMed is now forcibly migrating legacy InPen users away from the original InPen application to its newer replacement application, MiniMed Go, and has announced that the legacy InPen app will be discontinued. While most functionality from the legacy app is contained in the new app, the notable item missing are Dexcom CGM readings.

The concern is that this transition does more than just replace one application with another. MiniMed has a commercial relationship with Abbott Diabetes Care, which manufactures the Instinct CGM sensor used with the MiniMed system and those are the only CGM readings included in the new MiniMed Go app, Dexcom readings are no longer offered. That relationship provides the commercial context for MiniMed's CGM sensor strategy. It should not, by itself, be taken as evidence that excluding Dexcom integration is a technical necessity.

The commercial relationship with Abbott matters because the CGM market is not simply a contest in which patients are free to choose whichever CGM sensor they prefer. Pharmacy benefit managers negotiate with manufacturers over formulary placement, and rebates and other financial arrangements can influence which CGM products a health plan prefers, restricts, or excludes. As a result, the CGM a patient can actually obtain may be determined as much by insurance formulary decisions as by the patient's own or prescribers' preferences.

That creates a problem for existing InPen customers who use Dexcom because that's what their insurance pays for. A patient whose health plan favors Dexcom may be unable to switch to an Abbott sensor just to retain the same functionality in an insulin pen app. Conversely, a patient whose plan favors Abbott may face a different set of choices. The point is that rebate-driven formulary preferences can and do constrain patient choice, and an app transition intended to persuade adoption of the Instinct CGM sensor can make those restrictions more consequential.

The technical capability to integrate Dexcom data into the InPen application already existed. By discontinuing the legacy application without maintaining that integration in the MiniMed Go app, MiniMed risks making its smart pen less useful to people whose insurance coverage favors Dexcom. That outcome aligns the app with MiniMed's commercial sensor relationships while leaving many existing customers with fewer practical options.

Conclusion

The problem is not simply that MiniMed is replacing one app with another. MiniMed has a commercial relationship with Abbott, but patients' CGM choices are also shaped by PBM negotiations and rebate-driven PBM formulary coverage. When those insurance arrangements determine which CGM a patient can obtain, limiting app compatibility can turn a commercial partnership into a loss of functionality for existing customers.

MiniMed could avoid that problem by making MiniMed Go compatible with the CGMs patients can actually obtain through their health plans. Otherwise, when their current InPens reach the end of their usable lives, some customers may decide that a disposable insulin pen paired with a third-party app is the more practical choice. MiniMed could successfully retire its legacy app while not giving existing customers a reason to abandon the InPen itself. That would be a costly way to turn a product transition into a customer-retention problem. How MiniMed opts to manage the situation remains to be seen.

Dexcom Is Out. Libre Is In. I'm Happy, Except About the Prior Authorization (PA).

I recently received notice that my employer-sponsored Aetna healthcare plan will drop Dexcom CGMs from its formulary and adopt Abbott FreeStyle Libre instead. Some might be unhappy, but I welcome the change. Based on my experience with both products, I consider Libre a superior CGM.

Libre provides new glucose readings every minute, compared with every 5 mins. with Dexcom, or 1,440 new readings/day vs. 288. Abbott also earned credit for bringing meaningful price competition to the U.S. CGM market. Libre originally offered 14 days of wear, 4 days longer than Dexcom's at the time (which meant Libre was about 30% cheaper given the comparable cost of each brand of sensor), reducing the effective cost per day of usage. Dexcom has since responded with the 15-day G7 Plus, but Abbott already had that with the Libre 3 Plus (I've shared my views Libre episodically over the years, my previous post can be read HERE). Abbott was the company that first introduced the longer wear-times which helped reduce patient out-of-pocket costs. That's what competition is supposed to do.

My good friend Riva Greenberg made the same switch from Dexcom to Libre and has been happy with her decision. She wrote about her firsthand experience with Dexcom G7 here: https://diabetesstories.com/2023/07/21/im-sorry-to-say-im-not-loving-dexcoms-g7/. 

But my formulary isn't becoming more competitive. Its simply switching the preferred brand from Dexcom to Freestyle Libre. That's not restoring patient choice. In an ideal world, both Dexcom and Libre would be covered, with differences in negotiated costs reflected in patient co-pays or other cost-sharing.

There's another wrinkle in the formulary change that caught my attention. The Libre products are not simply being substituted for Dexcom on an equivalent basis. For the Libre sensor systems, the notice specifically says: "Preauthorization required; Quantity limits apply."

The limit of 2 sensors every 25 days is not a change; the quantity limit on the number of sensors covered every 25 days is really no different from what I now have with Dexcom. But my previous Dexcom coverage didn't require Prior Authorization (PA). The PA implementation is what really makes this formulary change strange. I can keep refilling Dexcom through December, but starting January 1, 2027, Dexcom will be non-formulary and Libre will become the preferred option, with a new Prior Authorization required. So my doctor will need to get the new Libre authorization approved before I can make the switch without risking an interruption in my CGM supply. The Aetna notice does not explain how that transition is supposed to work. And that is particularly odd because Aetna has been publicly saying it is working to reduce prior authorization, not add new requirements.

That strikes me as particularly bad because PBMs and insurers have been under increasing pressure to reduce prior authorizations. CVS Health (which owns Aetna) itself said in Jan. 2026 "We continue to decrease prior authorizations" as part of its effort to make health insurance simpler and the same announcement identified Aetna as having about half as many services subject to PA as its nearest competitor. And yet here I am getting a brand new Prior Authorization requirement in addition to my switching preferred CGM brands which presumably saves the company money. I am not going to be shy about saying this is, in my opinion, complete B.S.!

So while Aetna and Caremark are giving me a CGM I consider to be superior, they appear to be taking something away at the same time by adding a new prior-authorization requirement that did not apply to Dexcom. Giving with one hand and taking away with the other while enriching themselves is a pretty good description of how I have come to view PBMs and health insurers.

There are some important differences between the two CGM companies. Dexcom currently has more established U.S. partnerships with automated insulin delivery (AID) systems, including non‑exclusive integrations with Insulet and Tandem. FreeStyle Libre also integrates with certain AID and semi‑closed loop systems, though its U.S. options appear more limited in scope and availability compared to Dexcom's, and Abbott has not invested much effort in promoting the availability of those integrations. These differences matter to patients, particularly people using AID systems. But none of that matters much to a PBM when there is money to be made from deciding which manufacturer gets preferred formulary status. 

For a long time, CVS Caremark (which owns the insurance company Aetna) maintained a formulary exclusion for any CGMs which "Are not Dexcom Brand." How Dexcom was persuaded to pay PBMs huge rebates conditioned on excluding competing CGM brands was kind of foolish in my view. Even without a formulary exclusion, Caremark was never going to cover a competing CGM, so the rebates Dexcom paid to CVS Caremark to keep Libre "off formulary" was money being pissed away for nothing.

There is, however, a glaring exception to Caremark's Freestyle Libre exclusion on my plan. Aetna also covers Senseonics' Eversense 365 CGM, but there is a simple explanation: Eversense is covered under the medical benefit rather than the pharmacy benefit because a physician must insert the Eversense sensor in a patient's arm rather than having the patient insert it themselves.

That meant Caremark could (on paper) honor its commitment to keep competing CGMs off its pharmacy formulary while Aetna also covers a competing CGM through the medical benefit. From the patient's perspective, a competing product was technically available, but only by going through a different part of the insurance plan. It is exactly the kind of disjointed, fragmented coverage structure and deceptive and opaque business practices that makes me skeptical of PBMs and the way they control access to prescription products.

The same dynamic existed with UnitedHealthcare plans, where Optum Rx collected rebates while competing CGMs were excluded from its preferred prescription formularies. Eversense covered as a medical benefit on United Healthcare plans is a work-around for the insurance companies, but the companies paying the rebates are being promised something they are not actually receiving.

This is where the Federal Trade Commission's litigation against the largest PBMs becomes relevant. In September 2024, the FTC sued Express Scripts, CVS Caremark and Optum Rx and their respective GPOs in the same underlying proceeding over alleged anticompetitive practices involving insulin pricing, rebates and formulary exclusions. The FTC subsequently negotiated separate settlement agreements with each PBM.

On July 14, 2026, CVS Caremark agreed to settle with the FTC without admitting wrongdoing and agreed to substantial changes in how its PBM business operates.

The Express Scripts and Caremark settlement agreements are largely parallel. Much of the relief had already been outlined in the FTC's contemplated relief in the underlying litigation. Adam Fein at Drug Channels summarized the practical implications of the settlement agreements: https://www.drugchannels.net/2026/02/the-ftc-blows-up-express-scripts-pbm.html 

Among the changes the FTC settlement agreements will impose include:

• Standard formularies can no longer favor high-WAC drugs over lower-WAC alternatives [WAC is the acronym for "Wholesale Acquisition Cost" which is another term for a pharmaceutical's list price]
• Patient out-of-pocket costs are to be be based on the PBM's discounted "net" price rather than the artificially-inflated list price under the applicable settlement arrangements
• Plans and beneficiaries have access to direct-to-consumer pricing through TrumpRx
• Point-of-sale rebates must be passed through to patients
• Manufacturer fees paid to PBMs must be de-linked from pharmaceutical list prices
• Employer healthcare plan sponsors receive substantially more transparency
• Retail pharmacies can receive cost-plus reimbursement

The FTC's Express Scripts settlement announcement is here:

• https://www.ftc.gov/news-events/news/press-releases/2026/02/ftc-secures-landmark-settlement-express-scripts-lower-drug-costs-american-patients 

The full Caremark settlement announcement is here:

• https://www.ftc.gov/news-events/news/press-releases/2026/07/ftc-secures-major-settlement-caremark-resolving-antitrust-case-against-second-drug-middleman

So why does this matter to me?

I am getting the CGM I would prefer to use because I think it's superior. But I have no idea whether that's because Abbott offered Aetna or CVS Caremark a better "net" price, or because of some other contractual arrangement. Patients generally are not told what actually drives these decisions.

That is the part I find interesting: The FTC is trying to change the financial incentives that have shaped PBM formularies for years, yet my own experience suggests that the fundamental structure remains unchanged so far. One manufacturer has preferred status and the competing manufacturer is effectively excluded. The only thing that has changed is which manufacturer won.

And now there is another question: insurance companies pledged in June 2025 (see https://kffhealthnews.org/insurance/prior-authorization-insurance-denials-reform-pledge-year-later/ for more) to improve a controversial practice known as "prior authorizations," which requires patients or someone on their medical team to seek prior approval from insurers before proceeding with treatments, so why is my Aetna plan apparently now adding a brand new prior auth requirement for a CGM at the same time it also changes which brand of CGM is preferred? That would seem to be a direct contradiction to the prior commitment Aetna made to end prior authorizations, which burdens patients and doctors with unnecessary delays in care.

In an ideal world, both Dexcom and Libre would both be covered (and that's how things used to be done in the past). Patients could choose the product that works best for them, while negotiated differences in cost could be reflected through patient cost-sharing rather than "formulary exclusion". Now, the settlement agreements specify "as soon as commercially feasible, but no later than the implementation date of Month DD, YYYY" so I realize these could still be modified. But knowing how Caremark operations, I won't hold my breath waiting.

In this case, I happen to be OK with the outcome because the preferred manufacturer is the one I would likely choose anyway. But that does not mean my formulary has become more competitive or transparent. It has simply switched the preferred brand from Dexcom to Libre.

Author P.S., October 9, 2026: Since publication, Aetna has quietly removed the new Prior Authorization (PA) requirement for FreeStyle Libre CGMs starting in January 2027. My post generated a dialogue among patient influencers, and Abbott Diabetes Care contacted me and others about my post before apparently raising the issue with both Aetna and CVS Caremark. The PA requirement was subsequently removed (but I saved the receipts of both notices!). I cannot say how much each intervention contributed to the decision, but the outcome demonstrates the value of patients speaking up and the importance of manufacturers taking those concerns seriously.

Why Reform Hasn't Reached the Pharmacy Counter Yet

Currently FDA approved Novolog biosimilars

Since 2025, the FDA has approved THREE (3) biosimilar copies of Novolog (depicted in the image above, [from L to R] including the newest called Garzulys which was approved in 2026, plus Kirsty as well as Merilog, which was approved in 2025), and yet few U.S. patients realize they even exist. People whose pharmacy benefits are administered by Express Scripts (and by extension, Prime Therapeutics) have been forced to adopt Biocon Biologics' insulin biosimilars, but does this necessarily mean biosimilars hold the key to affordability?

So far, biosimilars have barely made an impact.

Dr. Kasia Lipska, a professor, endocrinologist and researcher at the Yale Diabetes Center in New Haven, Connecticut co-authored a study showing that people treated there were still rationing insulin at the same rate in 2024 as in 2017. About one in four people reported rationing due to cost, but when including insurance delays and supply limits, more than one in three (38%) struggled to keep insulin on hand (see https://medicine.yale.edu/news-article/insulin-rationing-persists-despite-policy-changes-study-shows/ for news about the study, or https://pubmed.ncbi.nlm.nih.gov/41193794/ for the study itself). 

Dr. Lipska said "There's just still a lot of holes in one who is covered by various protections and then how they're covered and how they access this" adding "It's not as simple as just showing up at the pharmacy and asking for your insulin, and the sticker price is there, and that's what you pay. It's extremely complicated."

Her second statement may be an understatement which few people understand.

Thanks to more than a decade of kickback-driven (which PBMs call "rebates") formulary-exclusions, which the Federal Trade Commission (FTC) sued over in 2024, and securing settlement agreements in 2026 from several of the biggies, we are finally starting to see meaningful changes on that front, but another issue is that every existing employer contract + any contract renewal are not yet impacted by those FTC-PBM settlements. They apply only to new PBM contracts. But when employers' new PBM contracts are signed, then covered patients could finally realize a benefit from those legal consent agreements. However, this is also impacted by PBM retail pharmacy contracts, which essentially dictate that cash-paying customers end-up paying the highest prices of any payer, which means that coupons are the only work-around to that reality.

There's another wrinkle: thanks to the American Rescue Plan of 2021, that law removed a cap on rebates which are reimbursable to Medicaid, effectively forcing innovators of older, very heavily-rebated drug classes such as insulin to either slash their list prices by more than 70%, or else pay Medicaid for those drugs to be included on the Medicaid formulary. The result was branded Novolog (and its competitors') list prices have fallen significantly as of 2025. 

You can see evidence of the insulin list price reductions in the data. 46brooklyn Research offers a tool called "Brand Drug List Price Change Box Score" which is accessible at no charge to anyone at https://www.46brooklyn.com/branddrug-boxscore/, but using it takes some practice. If you don't want to look-up the numbers for yourself, it's not necessary. GoodRx published a study in January 2025 showing the same insulin list price reductions (see https://www.goodrx.com/healthcare-access/research/how-much-does-insulin-cost-compare-brands) for the GoodRx study/article which may be easier to digest). That was also the reason Sanofi felt comfortable eliminating its unbranded version of Lantus in March 2026. Its move followed rival Novo Nordisk which discontinued its unbranded insulin products around the same time. 

Only Lilly now continues selling its unbranded version of Humalog, and the reason is because Lilly revealed to investors two years after introducing the unbranded insulin product, that the unbranded version of Humalog accounted for nearly a third of domestic Humalog sales at the time. Now, the unbranded insulin lispro product outsells branded Humalog in the United States. Patients think they are using a biosimilar, when it's really just branded Humalog being sold under the generic drug name. 

Remember: many patients have yet to experience the list price reductions as the Yale research showed. Cash prices are artificially-inflated (including patients using insurance with unsatisfied deductibles) due to retail pharmacy contracts with PBMs, plus deductible credits are currently based on the deeply-discounted "net" price which the insurance company pays, effectively making covered patients pay...TWICE. The PBMs which have settled with FTC have actually agreed to substantive changes, but the settlements specify their implementation dates "as soon as commercially feasible, but no later than the implementation of Month DD, YYYY [specified in the settlement agreements]".

In essence, the U.S. prescription drug market is an incredible mess which is caused by every entity involved in distribution trying to skim some margin from it. 

And for patients, navigating this dysfunctional mess is anything but simple.

That's why the Yale University study found that people treated there were rationing insulin at the same rate in 2024 as they were in 2017.

Behind the scenes, no one can say that meaningful changes are not happening. 

But fixing this big mess is also no small undertaking and it there are a lot of different moving parts involved in resolving this. How important biosimilars end up being in the U.S. market remains an open question. 

One player, specifically the CivicaScript operating unit of Civica Rx, is attempting to bypass traditional drug wholesaler, retail pharmacy, and PBM/insurance markup schemes using a Unilateral Pricing Policy (UPP) https://civicascript.com/upp/, which establishes a strict maximum price that retail pharmacies can charge to consumers. 

Following its January 2026 introduction of a Biocon Biologics-manufactured biosimilar insulin glargine product, Civica has made a box of five prefilled pens available for no more than $55, demonstrating that transparent, capped pricing at the counter for patients is actually possible when a manufacturer intentionally limits intermediary margin. But knowing where it can be purchased remains an issue. Big chains like CVS and Walgreens benefit from inflated list prices. Also, Civica has yet to introduce its own version of Biocon Biologics' Kirsty, but we know one is coming because it was announced in 2025. 

When will patients start to see prices fall? Some covered by employer-sponsored commercial health insurance plans with deductibles are now covering insulin PRE-DEDUCTIBLE, and I am benefitting from that, except that I've been forced to non-medically switch to a different insulin brand "preferred" by my insurance plan which happens to be Novo Nordisk under my Aetna plan. At least it's covered. And with the FTC settlement agreements, a provision about TrumpRx purchases means that for all manufacturers' direct-to-patient sales efforts, the insurance plan will have to also cover insulins bought that way even if the insulin is not on-formulary. That means I will at some point be able to use Lilly's Humalog if I buy from LillyDirect, rather than Novo Nordisk's Novolog or Fiasp. It means an end to routine non-medical switching of insulins unless I agree. That, in my view, that's still a big deal. 

No one is saying this will happen quickly, but meaningful changes are underway. 

The U.S. Prescription Drug Market Has Changed, But Our Assumptions About It Did Not

The way Americans buy prescription drugs has changed so much that many of the old assumptions we still rely on now have potential to work against us. Ideas such as "health insurance is here to help lower our costs" or "generics are cheaper than brand-name drugs" were once mostly true, but today, those ideas can sometimes trick people into spending more on prescriptions than they necessarily need to spend. It's more accurate to say today that those are sometimes true, but verify those presumptions first. Notably, a major 2022 study from the University of Southern California (USC) found that paying cash with no insurance [for generic drugs] is actually cheaper about 24% of the time—a surprising reminder that insurance isn't always the bargain we were taught to believe it is. (see link: https://schaeffer.usc.edu/research/u-s-consumers-overpay-for-generic-drugs/)

In a 2018 study (see https://schaeffer.usc.edu/research/frequency-and-magnitude-of-co-payments-exceeding-prescription-drug-costs/ for more detail), USC also conducted research into pharmacy claims, analyzing 9.5 million U.S. commercial insurance pharmacy claims from 2013 and found that 28.17% of all generic drug claims involved an overpayment—meaning the patient's copay was higher than the total cost of the drug to the insurer. Collectively, the take-away from these findings is: "let the [prescription drug] buyer beware". The upside is that Americans have started to notice, and we see people at the pharmacy counter routinely checking GoodRx prices for the same prescription as a sanity-check for insurance company ripoffs.

Part of the problem is that the U.S. drug‑pricing system is confusing by design. For example, drug wholesalers and retail pharmacies can choose from a stunning nine different pricing benchmarks when answering the seemingly simple question: "What does this [drug] cost?", and most of those pricing benchmarks are created by entities with a financial stake in the outcome. Only one of the pricing benchmarks, specifically known as NADAC (the acronym for "National Average Drug Acquisition Cost"), is independently calculated. With so many different competing "prices," it can be nearly impossible for patients to know whether they're getting a fair deal or if they are being robbed. (see the glossary link at: https://www.46brooklyn.com/glossary/ for more on drug pricing terminology)

U.S. insulin pricing has been especially distorted. For years, insulin manufacturers paid Pharmacy Benefit Managers (PBMs) multimillion dollar rebates in order to keep all competing insulins "off-formulary", which drove U.S. insulin prices through the roof. In June 2022, the Federal Trade Commission (FTC) stepped in, studied PBM business practices, published several interim reports including one which focused largely on the insulin market, proceeded to sue the PBMs and secured settlement agreements (the lawsuit specified the 'contemplated relief' the FTC was seeking) that may effectively alter the legally-exempted rebate‑kickback system. However, the FTC settlements were only finalized in 2026, hence they'll apply to new PBM contracts, but not to any existing contracts or contract renewals, so it will take time before U.S. patients necessarily benefit using insurance. As a result, insulin benchmark prices since have fallen sharply, and it is now possible for anyone to buy insulin for $35 per vial [or less] simply by cutting their insurance out of the transaction and paying cash with manufacturer coupons, but it may involve consciously taking insurance or your Medicare Part D plan OUT of the equation.

Even so, many people still believe that paying artificially-inflated pharmacy prices helps them to satisfy their deductibles faster. Unfortunately, that's not how the math works. Deductible credits are based upon the insurer's deeply-discounted, realized "net" prices for a drug—not the inflated amount patients are charged at the pharmacy counter. This means paying more doesn't necessarily get you closer to meeting your deductible.

Medicare Part D adds another layer of complexity. While it's only been in place for 22 years, it continues to evolve. Despite recent changes like the adjusted $2,100 maximum annual out-of-pocket expenditure cap, prescription drug costs can still surprise seniors trying to navigate these market complexities (see https://www.linkedin.com/pulse/medicare-drug-cost-cap-surprises-2026-james-hale-rk5wc/). On top of that, plans can and do change their preferred insulins at any time without notice, forcing patients to non-medically switch to the new preferred insulin unless the patients know how to navigate exceptions.  

Meanwhile, the U.S. insulin market itself is evolving thanks to the patent expirations on the bestselling insulins, along with the advent of follow-on biologic and biosimilar copies of branded insulin molecules. The FDA's updated biosimilar approval pathway has led to a growing number of insulin copies. These products are often easier to switch to than switching to completely different analogues (such as switching to/from Novolog/Fiasp from/to Humalog/Lyumjev or vice versa), and they increase the market and pricing options by reducing dependence on just a few insulin manufacturers.

Also, coupon programs like TrumpRx.gov (which is powered by the coupon-generating website/app GoodRx, although the prices may be different) can offer even lower prices on certain insulins, including unbranded Lilly Insulin Lispro which can be attained for a price as low as $25 for a 10 mL vial. Results may vary by pharmacy, but manufacturer coupons remain a reliable fallback option for many people who require insulin.

The good news is that insulin manufacturer redundancy is now increasing. Lantus now has at least eight follow-on and biosimilar versions from different manufacturers (the most recent one was approved on July 24, 2026, catch my coverage of that HERE), Novolog/Fiasp now has three [so far, and the copies branded as Merilog, Kirsty and Garzulys were all approved in 2026], and Humalog has one copy known as Admelog which received FDA approval in 2017. Even more insulin biosimilars are on the way from companies like Biocon Biologics, Civica/CivicaScripts, CalRx, Lanexa Biologics, Meitheal Pharmaceuticals, and Amphastar Pharmaceuticals to name a few. We know this because many are from publicly-held [or formerly publicly-held] companies, and the biosims were disclosed in their drug development pipelines in the company SEC filings. Wholesale Acquisition Costs (WAC) for nearly all branded and several biosimilar insulins fell by more than 70% in 2024-2025 (GoodRx published a report showing this, which is accessible HERE, and you can see the numbers for yourself at 46brooklyn Research's "Brand Drug Box Score" tool HERE). If your out‑of‑pocket costs haven't dropped accordingly, it may be time to explore alternatives.

Conclusion

The U.S. prescription drug market is finally shifting in ways that matter to real people, but the system hasn't suddenly become simple or transparent. If anything, the recent changes make it even more important for those of us living with T1D, or caring for someone who does, to understand how prescription pricing really works and where the underlying price traps still exist. The old assumptions about insurance, deductibles, and "preferred" drug brands were created during a different era, and holding onto those beliefs now mostly benefits the entities that profit from confusion (such as insurance companies and their Pharmacy Benefit Managers or PBMs).

What's emerging instead is a landscape where patients now have more leverage than we've had in decades. Cash prices, manufacturer direct-to-patient sales, manufacturer coupons, biosimilar options, and new market entrants give us choices we never had before. The dramatic drop in insulin reference prices didn't happen because the system suddenly became benevolent; it happened because people and organizations pushed, regulators investigated and sued, and the old rebate‑driven pricing games finally began to show major cracks in its foundation. The lower prices only matter, though, if people know how to get them, compare them, and push back when insurance tries to steer them toward options that don't work for their bodies (or their wallets).

While the U.S. drug-pricing system remains opaque, the expansion of market alternatives and cash options allows informed patients to take control of their healthcare spending rather than assuming their insurance plan offers the best deal.

For a community that has spent years navigating a scarcity of manufacturers, unpredictability, and financial strain, this moment is worth claiming. We finally now have more alternatives. We finally have transparency starting to creep in. And by staying informed and connected, sharing what works, what doesn't, and what we've learned along the way, then we can make sure these changes translate into real, lasting affordability for everyone who depends on insulin to live.

Breakthrough T1D's coup d'état of the T1D Fund's Board

Remember back in 2021 when the New York Times (see the article at https://www.nytimes.com/2021/07/02/your-money/philanthropy-type-1-diabetes-research-fund.html although observe that article it is behind a paywall) covered what was, at the time, an innovative approach to Type 1 diabetes research and development? The NYT article, "Quest to Help Diabetic Son Endures With a Different Kind of Giving," was about Sean Doherty's involvement in helping to create a venture philanthropy fund known as the T1D Fund.

The article described Mr. Doherty, then a private-equity executive at Bain Capital, whose son Finn had been diagnosed with Type 1 diabetes (T1D) as a child. The T1D Fund was described as part of an emerging "venture philanthropy" model. The idea was that very wealthy parents and other donors would create a venture philanthropy fund designed to take selected risks that more conventional investors might otherwise avoid, providing financial incentives for companies to develop new and innovative therapies for T1D.

The T1D Fund was not simply another charitable organization making grants. Donors provided capital that was invested in commercial companies, hopefully generating a financial return in addition to advancing therapies intended to cure T1D.

The T1D Fund originally used the name JDRF T1D Fund (JDRF was subsequently renamed Breakthrough T1D) suggesting there was some type of relationship with the T1D nonprofit, but then dropped the prefix to suggest a separation, although the precise relationship was really known only to JDRF's Board of Directors.

We do know that the T1D Fund generated fairly substantial investment returns. According to the Fund's own disclosures, it had realized nearly $100 million in profits from portfolio returns, with those returns being reinvested into future investments.

But the most interesting part of this story is what the T1D Fund said about itself in 2021 compared with what it says about itself today.

In 2021, the T1D Fund's "About" page said the following:

"In 2015, a group of JDRF volunteers observed that there was virtually no private investment in T1D which was causing a gap between scientific advancements and the delivery of solutions to the people who need them. 

 

Our bold solution was to launch the JDRF T1D Fund—a venture philanthropy fund to create a market in T1D by using our capital and expertise to convince venture capital, biotech and pharma to make the investments needed to cure T1D. 

 

Operating as a separate company, we make compelling investments that stimulate private capital financing, whilst remaining efficient and nimble."

That description is important because it explains exactly why the T1D Fund was originally created.

The T1D Fund was explicitly a response to a perceived lack of private investment in T1D. Its purpose was to "create a market in T1D" by using philanthropic capital and expertise to convince venture capital, biotech and pharmaceutical companies to invest.

And importantly, it was described at the time as operating "as a separate company."

Now compare that with the description currently appearing on the T1D Fund's website in August 2026:

"Launched in 2016 as a wholly owned subsidiary of Breakthrough T1D, the T1D Fund is the first scaled venture fund established to catalyze the development of T1D cure-oriented therapies through investments. The Fund co-invests with venture capital firms and biopharma companies in support of early-stage companies pursuing disease-modifying therapies and potential cures for T1D. A core element of its mission is to rapidly advance promising therapies through development and ultimately regulatory approval. Led by a deeply experienced team of healthcare and investment professionals, working in partnership with an independent Investment Committee, the Fund leverages its vast research, clinical, regulatory, and medical affairs network on behalf of its portfolio companies. Funded through charitable contributions from donors and from Breakthrough T1D itself, the Fund makes investments in biotech companies and reinvests returns into new investments, thereby extending the impact of its donors’ contributions."

There are several significant changes here.

First, the original explanation of the market failure has disappeared. In 2021, the T1D Fund explicitly said that there was "virtually no private investment in T1D" and that its solution was to "create a market in T1D." 

In 2026, the T1D Fund instead describes itself as "an established venture fund whose purpose is to catalyze development of therapies and advance them through development and ultimately regulatory approval".

Second, the T1D Fund's relationship with Breakthrough T1D is now explicitly described as that of a "wholly owned subsidiary." That is materially different from the 2021 description of the Fund "operating as a separate company."

I would not interpret those words alone to mean that the T1D Fund ceased to be a separate legal entity. A subsidiary can itself be a separate legal entity. But the change from "separate company" to "wholly owned subsidiary" clearly describes a different corporate relationship between the T1D Fund and Breakthrough T1D.

That also raises a very obvious question: when and how did that relationship change?

Third, the 2026 description places much greater emphasis on the T1D Fund's institutional investment infrastructure, including its professional investment team, an independent Investment Committee, and access to Breakthrough T1D's research, clinical, regulatory and medical-affairs network.

And fourth, the 2026 description explicitly says that Breakthrough T1D itself provides charitable funding to the T1D Fund and that investment returns are reinvested into new investments.

So, something clearly changed between 2021 and 2026. The question is what?

Breakthrough T1D has provided an explanation, although in my view, it leaves some critical details unanswered.

Breakthrough T1D published a formal statement (see https://www.breakthrought1d.org/for-the-media/statements/statement-regarding-t1d-fund-governance/ for its statement regarding T1D Fund governance on June 25, 2026.

The statement says:

"On May 8, Breakthrough T1D’s International Board of Directors acted within its fiduciary responsibilities and authority under the LLC agreement governing the T1D Fund to change the composition of the board and update the LLC agreement."

It goes on to say:

"These changes were made to support the Fund’s mission and to ensure donor contributions and profits remain dedicated to their intended purpose. As the Fund’s sole member and parent organization, Breakthrough T1D has always held legal responsibility for ensuring appropriate governance, protecting donor resources, and keeping the Fund’s work aligned with its charitable mission."

Breakthrough T1D also says that the T1D Fund remains an integral part of its strategy, that the Fund continues to operate under the same mission, investment strategy and venture philanthropy model established at its founding, and that the recent governance changes "do not alter the Fund’s mission, investment strategy, or operating model."

That is Breakthrough T1D's position, and it is important to acknowledge it.

But there is an obvious tension between saying that nothing fundamental changed and the fact that Breakthrough T1D's International Board changed the composition of the T1D Fund's Board and simultaneously updated the LLC agreement. And, as Dan Heller's Substack article observed, it fired the T1D Board members via email, it did not do so in person. How brave. 

The statement tells us that Breakthrough T1D had the legal authority to do this. It does not tell us much about why it chose to exercise that authority in the manner it did.

We know that on May 8, 2026, the T1D Fund Board was changed and its governing LLC agreement was updated.

We also know that the T1D Fund's public description now characterizes it as a wholly owned subsidiary of Breakthrough T1D.

And we know that at least some of the people who had been deeply involved in the T1D Fund objected to what happened and the manner in which it happened.

Joanne Milo covered the T1D Fund board controversy at https://thesavvydiabetic.com/savvy-updates-8-10-26/ while she drew primarily from Dan Heller's Substack coverage accessible at https://danheller.substack.com/p/breakthrought1d-scraped-an-iceberg/. Both are worth a read. Another I would recommend is the Juvenile Diabetes Cure Alliance (JDCA) coverage found at https://www.thejdca.org/publications/report-library/archived-reports/2026-reports/t1d-fund-rift-expands.html. Ordinarily, I'm not really a big fan of JDCA, Fundamentally, I disagree with JDCA's definition of a "cure" hence I do not routinely see eye-to-eye with JDCA's perspectives on many issues. But in this particular case, its analysis seems fairly objective.

However, JDCA asserts that Breakthrough T1D had always held ultimate ownership and control of the T1D Fund even though we are left to believe that is true without evidence. Breakthrough T1D accused a subset of the T1D Fund's prior leadership of attempting to widen the gap between the entities, spin-off the T1D Fund as an independent 501(c)(3), and reduce parent oversight from Breakthrough T1D, and if true, that would indeed be a valid reason for Breakthrough T1D's coup. But there are too many details omitted from all parties involved, which is the main problem from my viewpoint.

Dan Heller reported that the T1D Fund's page stated that it had "realized nearly $100 million in profits from portfolio returns" since inception and that "every dollar has been reinvested to support future investments in promising T1D therapies and cures."

He also documented the departure of David Panzirer, a trustee of The Leona M. and Harry B. Helmsley Charitable Trust and one of the T1D Fund's original founders.

On June 18, 2026, David Panzirer resigned from the T1D Fund. According to an open letter that Heller reported having seen, Panzirer stated:

"What Breakthrough did by firing the Fund Board with zero notice or transparency has alienated the 4 largest families in T1D all within 48 hours. Each family has committed well over $100MM to the cause. NOTHING will happen if we don't all stand up and demand transparency."

That is an extraordinary statement from someone who was not simply a donor, but one of the people who helped create the T1D Fund.

And it raises another question:

What exactly happened to the T1D Fund's original governance structure?

Breakthrough T1D says that it acted within its authority under the LLC agreement. Former T1D Fund leaders have offered a very different account, describing the action as a unilateral dismantling of the T1D Fund's independence and a breach of trust. Both can be true at the same time. Breakthrough T1D never disclosed those details, so we really do not know with any certainty. There is therefore a genuine dispute over what happened and why. We do know: 

The T1D Fund's Board was changed.

The LLC agreement was changed.

Some longtime T1D Fund leaders were removed or subsequently resigned.

And major donors apparently learned about the changes only after they had occurred—by email!

The precise details of the revised LLC agreement are particularly important. If the T1D Fund's governance structure changed materially, then it would be useful for donors and other stakeholders to understand exactly what provisions were changed and what those changes mean for the T1D Fund's independence, investment decisions and financial resources.

That is where the current public explanation leaves me unsatisfied.

Breakthrough T1D says that donor contributions and investment profits remain dedicated to the T1D Fund's charitable purpose. It says that every dollar of the nearly $100 million in profits realized since inception has been reinvested. It says the T1D Fund continues to have its own Investment Committee and that its mission, investment strategy and operating model have not changed.

Those statements are somewhat reassuring.

But they do not answer every question raised by the abrupt change in governance. The outstanding questions in my mind are as follows: 

1. Why was the T1D Fund's Board changed so abruptly? And why did they notify the terminated T1D Fund members (via email, rather than in person)?
   
   
2. Why was the LLC agreement changed at the same time?
   
   
3. What specific provisions of the LLC agreement were changed?
   
   
4. Why were some of the Fund's largest donors apparently informed only after the changes had occurred?
   
   
5. Why did one of the T1D Fund's original founders (including a father of two grown children with T1D himself) subsequently resign?
   
   
6. And what exactly does Breakthrough T1D intend to do with the substantial capital and investment returns that have accumulated inside the T1D Fund?

Those are not unreasonable questions for donors, major fundraisers and members of the T1D community to ask.

This may have little immediate impact on people who participate in Breakthrough T1D's annual Walks to Cure Diabetes fundraising events. But it could have a more significant impact on major-donor confidence.

The T1D Fund was built on a different proposition from traditional charity. Its founders were not simply asking donors to give money. They were asking them to provide capital for an investment vehicle that could generate additional capital and thereby expand the amount of money available for T1D research and development.

That model depends heavily on trust.

If major donors believe that the governance structure of the Fund can be changed without transparency or meaningful consultation, that trust could be damaged.

And that may ultimately be the most important issue surrounding what I would call the T1D Fund Board coup d'état.

Not whether Breakthrough T1D had the legal authority to make the changes. Breakthrough says it did.

The bigger questions are why it chose to make the changes, what actually changed in the Fund's underlying governance and relationship with Breakthrough T1D, and why the people who provided much of the capital apparently learned about those changes after they had already occurred.

Breakthrough T1D has explained its legal authority.

What it has not fully explained, at least to my satisfaction, is the underlying reasoning, process and precise substance behind the reorganization.

And that leaves one final question:

Why the sudden reorganization, and is Breakthrough T1D risking major donor support with such a move? 

Breakthrough T1D's Board has become increasingly secretive in recent years (for example, in 2016, I documented about something I learned of which was referred to then as JDRF Therapeutic Ventures LLC, catch my coverage at https://blog.sstrumello.com/2016/01/just-who-is-jdrf-therapeutic-ventures.html for more on the still-unanswered questions I raised at that time), and that gives me pause to continued, unquestioned support without more transparency.

While some individuals, including Diabetic Investor David Kliff whose views I generally respect, has called for the resignation of Breakthrough T1D's CEO Aaron Kowalski (as well as ADA's President over the recent decision to call security over a researcher who was sharing an opinion piece which had been published in an actual ADA journal). He posted those views in items shared via LinkedIn. The links to each are listed below.

• https://www.linkedin.com/posts/david-kliff-78b669b_diabetic-investor-post-activity-7473019027196379136-3jqs 
  
  
• https://www.linkedin.com/posts/david-kliff-78b669b_enough-is-enough-activity-7483940736086847489-Eysy
  

I would probably stop short of such a move on calling to fire Breakthrough T1D's CEO until we have more information about what the underlying reasons were. Right now, we are left to piece together small details from desperate sources. 

I suspect that eventually those details WILL come out. 

For example, they did when Bigfoot Biomedical founder Jeffrey Brewer was fired as then CEO of JDRF (now Breakthrough T1D) when the Board learned he was raising funds for a startup while leading JDRF. Bigfoot subsequently imploded and sold the remaining intellectual property (IP) asset rights to Abbott (recall I covered that at https://blog.sstrumello.com/2023/09/abbott-acquires-bigfoot-biomedical.html which provides an instructive lesson on how details inevitably become available after-the-fact, in spite of best efforts to keep the details a secret). But keeping secrets is no way to run a diabetes nonprofit organization (or two).

Meitheal Pharmaceuticals Announces FDA Approval of Garzulys™ (insulin aspart-fsan), Becoming the 3rd Insulin Aspart Biosimilar Approved

On July 24, 2026, there was news that Chicago-based Meitheal Pharmaceuticals had received FDA approval for another (the third approved in 2026) of Novo Nordisk's Novolog prandial insulin analogue known generically as insulin aspart injection 100 units/mL which will be branded as Garzulys™. On February 14, 2025, FDA approved Sanofi's biosimilar of insulin aspart branded as Merilog, and then on July 15, 2025, FDA subsequently approved Biocon Biologics copy of insulin aspart branded as Kirsty. Collectively, with the approval of Garzulys, the FDA has (as I write this in 2026) approved three (3) biosimilar copies of insulin aspart. By comparison, FDA has so far only approved one copy of Lilly Humalog, specifically Sanofi's follow-on biologic copy branded as Admelog.

The FDA approval letter for Garzulys (insulin aspart-fsan) 100 units/mL can be viewed at for https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761497Orig1s000ltr.pdf while the company issued a press release indicating that its biosimilar copy of insulin aspart on July 30, 2026. The press release can be viewed at https://www.businesswire.com/news/home/20260730232521/en/Meitheal-Pharmaceuticals-Announces-FDA-Approval-of-Garzulys-insulin-aspart-fsan-Injection/. 

The image of a 10 mL vial package of Garzulys from the DailyMed website appears below, or by visiting https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=30c64769-d2f7-4604-ac9e-2a6bc09506c9: 

Observe that I do believe that Emerge Bioscience Pte Ltd. is a Singapore-based unit of China-based Tonghua Dongbao Pharmaceutical Co., Ltd., which actually holds the approved U.S. biologics license application for Garzulys, while Meitheal Pharmaceuticals serves as the product's U.S. regulatory agent and holds exclusive U.S. commercialization rights under a license agreement with Emerge. Emerge is the U.S. BLA holder and is responsible for key supply-chain activities associated with the product. Also know that back on September 21, 2023, Meitheal Pharmaceuticals announced its intention to sell biosimilars not only of Novolog, but also of Humalog and Lantus (catch my coverage of that announcement at https://blog.sstrumello.com/2023/09/another-three-biosimilar-insulins.html for more). So far, Garzulys has become its first of three. We anticipate seeing others in the not-too-distant future.

The Meitheal Pharmaceuticals press release stated:

"The FDA approval of Garzulys represents an important milestone in Meitheal's continued expansion beyond our established generic injectable business and into a broader portfolio of biologics and branded products," said Tom Shea, Chief Executive Officer of Meitheal. 

"We are making deliberate, long-term investments in the regulatory expertise, commercial infrastructure and strategic partnerships needed to expand patient access to high-quality biologic treatment options. Our leadership of the U.S. regulatory process for Garzulys demonstrates the strength of our platform and the disciplined execution we bring to complex products and global partnerships."

We do know that Garzulys will be sold in internationally-standardized 10 mL vials, as well as in prefilled insulin pen devices. While it is unclear what retail price will be for either, or whether Meitheal Pharmaceuticals intends to sell the product to PBMs, direct-to-patients, as private (white) label products sold under retail pharmacy partner brands, or some combination of these.

However, we do know that another biosimilar company, Sandoz, on July 2, 2026 announced a direct-to-patient model known as Sandoz Direct https://www.sandozdirect.com/, similar to Lilly's Lilly Direct platform which sells Lilly insulin products at prices vastly lower than are available elsewhere. Sandoz Direct is powered by Aalto Pharmacy. The direct-to-patient models work to enable patients to bypass insurance company and PBM rebate-driven markups, and have proven to be a valuable affordability work-around to the dysfunctional U.S. prescription drug distribution system. It is unclear whether Meitheal Pharmaceuticals will offer a direct-to-patient business model as Sandoz and Lilly now do.

The Most Lucrative Biosimilar Insulin Opportunity May Not Be the Biggest One

The race to develop biosimilar or follow-on biologic entrants in the U.S. insulin market has suffered from a fundamental strategic flaw: chasing the largest top-line market size rather than recognizing completely vacant commercial spaces. For a decade, developers viewed Sanofi's Lantus (insulin glargine) as the ultimate prize simply because it was the highest-grossing basal insulin.

The Mirage of Market Share vs. Reality
Market share looks large—until you see how many players are fighting for each molecule

The subsequent chronology illustrates how rapidly this singular focus led to an overcrowded market. On December 16, 2015, the FDA approved Lilly's Basaglar as a follow-on biologic under a pathway that's since been discontinued (the molecule remains for sale) https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205692Orig1s000ltr.pdf. Years later, on July 28, 2021, the FDA approved Viatris [fka Mylan]/Biocon's Semglee as the first interchangeable biosimilar to Lantus https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761201Orig1s000ltr.pdf, followed quickly on December 17, 2021, by Lilly's Rezvoglar https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761215Orig1s000Approv.pdf—marking Lilly's transition to the new FDA 351(k) biologic pathway.

To defend its market share, Sanofi introduced an unbranded glargine via its Winthrop unit on June 30, 2022 https://blog.sstrumello.com/2022/06/sanofi-joins-ranks-of-35vial-insulin.html. However, after a Medicaid rebate cap elimination took effect on January 1, 2024 https://www.kff.org/medicaid/what-are-the-implications-of-the-recent-elimination-of-the-medicaid-prescription-drug-rebate-cap/, Sanofi slashed branded Lantus's list price by 78% https://www.globenewswire.com/news-release/2023/03/16/2629188/0/en/Press-Release-Sanofi-cuts-U-S-list-price-of-Lantus-its-most-prescribed-insulin-by-78-and-caps-out-of-pocket-Lantus-costs-at-35-for-all-patients-with-commercial-insurance.html. Historical pricing data tracked by 46brooklyn Research https://www.46brooklyn.com/branddrug-boxscore/ (free for anyone to use) confirms these cuts, which ultimately made unbranded versions redundant; Winthrop discontinued its unbranded glargine on March 31, 2026 https://healthprovidersdata.com/hipaa/codes/NDC_0955-1729.aspx. Mirroring this shift, Novo Nordisk similarly halted its unbranded fast-acting and basal lines, while Lilly's unbranded Humalog remains a rare exception because it outsells its branded counterpart in the U.S. at the moment.

Despite this hyper-saturation, white-label arrangements like CivicaScript and CalRx continue to emerge, and on May 4, 2026, Lannett Company, Lanexa Biologics, and Sunshine Lake Pharma announced the FDA approval of LANGLARA as yet another interchangeable biosimilar of U-100 insulin glargine https://www.businesswire.com/news/home/20260504761789/en/Lannett-Company-Lanexa-Biologics-and-Sunshine-Lake-Pharma-announce-FDA-Approval-of-LANGLARA-an-Interchangeable-Biosimilar-of-Lantus-insulin-glargine/. With additional glargine pipeline entrants from Sandoz/Gan & Lee, Amphastar Pharmaceuticals/ANP, and Meitheal Pharmaceuticals/THDB all awaiting FDA approval decisions on their glargine biosimilar products in the foreseeable future, this crowded environment has forced deflationary pricing pressure and razor-thin margins. While this delivered a victory for PBM rebate-driven formularies, it hollowed out the commercial return for manufacturers and turned glargine into a low-priced commodity.

Meanwhile, a much more lucrative opportunity went completely unnoticed.

When I first learned that Levemir would be discontinued, my immediate reaction was simple:

"Again?! How many fµcking times will patients be forced to endure such egregious business practices?"

When Novo Nordisk announced it would discontinue Levemir (insulin detemir) to prioritize manufacturing capacity for its higher-margin GLP-1 weight-loss drugs, corporate narratives implied falling demand. However, publicly available data suggested otherwise. Data derived from the federal government's Medical Expenditure Panel Survey (MEPS), conducted by the U.S. Agency for Healthcare Research and Quality (AHRQ) https://meps.ahrq.gov/mepsweb/, showed that prescriptions for Levemir remained remarkably consistent over time. To analyze this underlying MEPS data, pharmacists and pharmacy technicians frequently rely on ClinCalc's DrugStats database (which is free to use) https://clincalc.com/DrugStats/. According to those figures, Levemir ranked as the 117th bestselling drug in the U.S., accounting for 5,214,067 prescription fills dispensed to 1,027,442 unique patients. Furthermore, reporting from diaTribe News https://diatribe.org/diabetes-medications/levemir-long-acting-insulin-be-discontinued-novo-nordisk indicates that Levemir generated nearly $650 million in revenue for Novo Nordisk during 2022.

Walking away from this massive, completely uncontested 10% slice of the U.S. insulin volume leaves a commercial vacuum wide open to any developer willing to step in. This is not just another commodity; it is a clinical necessity serving specific patient populations that cannot simply non-medically switch to glargine or degludec. Levemir remains a distinct clinical tool as the only basal option with an FDA label for use during pregnancy, and the only one whose formulation allows it to be safely diluted for infants and highly insulin-sensitive patients.

Historically, when a manufacturer discontinued an insulin—such as Lilly Iletin animal-source pork insulin, or Lilly's Humulin U (Ultralente)—left patients had no recourse because the legal framework did not exist to replicate them. 

Today, a viable legal playbook is firmly in place. Under the Biologics Price Competition and Innovation Act (BPCIA) and the FDA's subsequent transition of insulin to a biologic pathway https://www.fda.gov/drugs/biosimilars/deemed-be-license-provision-features-and-benefits, developers have a clear, defined 351(k) approval route to bring an abandoned molecule back to market. This structural transition is underscored by the FDA announcement at https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-agencys-continued-efforts-bring-competition-insulin/ mapping out the agency's more modern framework to streamline generic competition for biological drug products.

Recognizing this shift, the Alliance to Protect Insulin Choice https://alliancetoprotectinsulinchoice.org/ and patient advocates are rewriting the script. By highlighting these unique U.S. market dynamics and shifting PBM drug channels, advocacy is no longer just pleading for access—it is handing developers a highly predictable, zero-competition economic opportunity. The most lucrative biosimilar insulin opportunity in America isn't necessarily the biggest selling innovator molecule; it's the one everyone else abandoned. 

With UNH's Optum Rx Reforms, The Last Big PBM Domino Is Falling

Bloomberg health care reporter John Tozzi reported on LinkedIn (the link he shared is at https://www.bloomberg.com/news/articles/2026-05-11/unitedhealth-s-optum-rx-says-profits-won-t-depend-on-drug-prices/, though much of Bloomberg's content remains behind a paywall) that UnitedHealth Group stated that it will move away from having the profits from its Pharmacy Benefits Manager (PBM) unit linked to the bogus list prices of medications, the latest shift to address longstanding criticisms of its business model. United Health's Optum Rx unit continues to try challenging the legality of the FTC's legal authority, which appears now to be little more than delay tactics, but this news suggests that it seems to have given up on those ill-fated attempts.

Optum CEO Patrick Conway reportedly said in an interview: 'We want our earnings based on service to the client. We do not want any of those earnings tied to the list price of drugs, period.'

Without having full access to the paid Bloomberg content, the official company press release is available and accessible to anyone, and that can be found at https://www.businesswire.com/news/home/20260511088754/en/Optum-Rx-Introduces-Industrys-First-Transparent-Pharmacy-Care-Model/ which tells you most of what you really need to know. Below is an excerpt: 

"Under the new approach, Optum Rx clients will be offered a pricing structure with monthly, clearly defined fees per member that are independent of manufacturers' list prices or prescription volume, eliminating spread pricing and similar practices. Every client will have transparency into Optum Rx fees—including those associated with its group purchasing organization (GPO)—with clear disclosure of payments received from pharmaceutical manufacturers. By the end of 2027, group purchasing will fully transition to flat service fees."

In other words, this marks a shift from the nation's largest commercial health insurance company's PBM business unit away from spread pricing, rebate opacity, and list-price-linked economics which was precisely the "Intended Relief" the FTC was seeking in its very litigation against Optum Rx.

Optum Rx is acknowledging what the "net" pricing drug distribution system makes increasingly unavoidable:

• Simpler, fee-based pricing models will win
• Rebate-heavy strategies will lose favor
• Gross-to-net pricing arbitrage will be harder to sustain
• Transparent cash flows between will force intermediaries including PBMs to redefine their value

Make no mistake, it's not because Dr. Conway or the PBM he runs has suddenly had an epiphany about the role his company plays in runaway U.S. prescription drug price inflation, driven by Optum Rx's relentless demand for ever-higher rebates. The reality was that in 2022, the U.S. Federal Trade Commission (FTC) undertook a multi-year 6(b) study of the PBM industry "business practices" [referred to as "FTC Matter No. P221200"] and in 2024, upon its conclusion, the FTC sued the major PBMs for taking kickbacks to exclude less costly NDCs of unbranded and biosimilar insulin varieties from their formularies. And, as I have blogged before, that study did not occur by accident, patients like myself pushed for it to happen (catch my previous coverage at https://blog.sstrumello.com/2025/01/why-i-pushed-for-ftc-litigation-against.html for more).

The major PBMs had engaged in conduct that violated Section 5 of the FTC Act, 15 U.S.C. § 45, hence the FTC sued the big PBMs (see the FTC complaint at https://www.ftc.gov/system/files/ftc_gov/pdf/d9437_caremark_rx_zinc_health_services_et_al_part_3_complaint_corrected_public.pdf for more details) which gives the FTC the authority to prosecute PBMs for unfair methods of competition that inflate drug prices and distort formulary design, and the FTC had plenty of evidence proving that was precisely what the big PBMs (including Optum Rx) were doing.

To be sure, rival Cigna-owned Evernorth line of business (which consists primarily of Express Scripts; the company decided to rename it "Evernorth" because the name Express Scripts had become so toxic) and rival CVS Health/Aetna Caremark were also sued for the exact same conduct, and on February 4, 2026, Express Scripts agreed to a comprehensive settlement agreement to move away from using artificially-inflated drug list prices to its own negotiated "net" prices instead. The news of that settlement agreement can be read at https://www.ftc.gov/news-events/news/press-releases/2026/02/ftc-secures-landmark-settlement-express-scripts-lower-drug-costs-american-patients/ and is definitely worth reading if you have the time to do so; it's written in plain English so there should not be much there which an average reader would be unable to understand.

Finally, on March 24, 2026, CVS Health/Aetna/Caremark also agreed in principle to settle the litigation with the FTC (see https://www.fiercehealthcare.com/payers/cvs-caremark-ftc-reach-settlement-insulin-pricing-case/ for the news), although complete details of the CVS Caremark settlement were still being finalized.

However, note how on February 4, 2026, Drug Channels' creator Adam J. Fein (he sold that to HMP Global a few years ago, but I believe he still runs a consulting firm known as Pembroke Consulting) observed the following about the Express Scripts settlement agreement (see "The FTC Blows Up Express Scripts' PBM Model—and Launches the Net Pricing Drug Channel", published on Feb. 4, 2026 

https://www.drugchannels.net/2026/02/the-ftc-blows-up-express-scripts-pbm.html): 

"The settlement addresses virtually every warped incentive that we have been covering on Drug Channels for the past 20 years. I summarize them below, but it's worth reading the full document to appreciate just how completely the FTC has dismantled the existing PBM business model.

Taken together, these actions signal major momentum toward the 'Net Pricing Drug Channel' (NPDC)—a market environment in which [the PBMs' realized] 'net' prices, not [the artificially-inflated] list prices, determine access, economics, and competitive strategy.

The FTC settlement will help reset the relationship between list and 'net' prices, lower patient costs, and trigger sweeping changes for [employer health care] plan sponsors, [retail] pharmacies, [bio-pharmaceutical] manufacturers, and Express Scripts' PBM competitors."

So that's where things stand as of May 2026. 

One observation I really had to laugh at was because the FTC study was initiated in 2022 under the Biden Administration's FTC Chair Lina Kahn and a slight majority of the FTC Commissioners on the Federal Trade Commission at the time the study was initiated were named by Democratic Presidents. Hence, the litigation against the big PBMs was initiated while Ms. Kahn was in office as FTC Chair. And yet, in the FTC's press release, was this statement clearly sucking-up to the current administration: 

"The FTC's settlement with Express Scripts ["ESI"] is a clear testament to the Trump-Vance FTC's focus on lowering healthcare costs for American patients," said FTC Chairman Andrew N. Ferguson. "The FTC's settlement with ESI will end its business practices that have kept drug prices high, ultimately providing meaningful financial relief to American patients who depend on ESI to access life-sustaining prescription drugs as well as community pharmacies who will see new revenues each year and relief from being squeezed."

Trump-Vance had almost nothing to do with it, that was all Biden-Harris. Yet Lina Kahn stepped down as Chair of the FTC when President Biden left office. Still, it is very obvious the Trump Administration simply tried to take credit for the work his predecessor accomplished with the FTC under Biden's leadership, and this PBM litigation and the ensuing settlements with the big PBMs was the culmination of that. Trump and his administration really had nothing to do with it other than to execute the final settlement agreements, which were the result of litigation his predecessor had already initiated, and they did not really have a choice given the "Intended Relief" which the FTC had already documented in its 2024 litigation against the PBMs.

Still, with the United Health Group Optum Rx PBM moves now to alter how it does business, that means that all three of the largest PBMs have agreed to the FTC's "Intended Relief" and will stop some of their most egregious business practices of effectively stealing money intended for covered patient price relief and using that cash to sell more insurance policies. 

As the executive summary in one of the FTC interim reports on the PBM business practices stated: "As a result of drug manufacturer rebates, the net prices of drugs to payers are often substantially less than the point‑of‑sale prices that determine patient cost sharing and deductibles at the pharmacy counter."

However, with these actions on the big three PBMs and the actions the PBMs are now taking, it is looking as if these egregious (and, let me remind my readers, they are indeed unlawful) business practices will soon come to an end. It cannot come a moment too soon for patients who have been financially harmed by these practices.