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 (subsequently renamed Breakthrough T1D) but then dropped it to designate a separation, suggesting there was some type of relationship with the T1D nonprofit, 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) Injection, Making It the 3rd Insulin Aspart Biosimilar Approved in 2026

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. Observe that 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/. 

Observe that I do believe that Emerge Bioscience Pte Ltd. is a 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.

FDA Approves Yet Another Glargine Insulin Biosimilar from Lannett Company/HEC

Today, there was a press release (see 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 for more) that another glargine insulin biosimilar had received FDA approval and will be coming to market soon. In this case, it will be branded as LANGLARA™ (insulin glargine-aldy) as a biosimilar to Sanofi's Lantus® (insulin glargine), for the treatment of adults and pediatric patients with Type 1 diabetes mellitus and adults with Type 2 diabetes mellitus. The FDA has also determined that LANGLARA is "interchangeable" with the reference drug, enabling pharmacists to substitute LANGLARA for Lantus without prescriber intervention in states that permit such substitution. You may recall that I first mentioned Lannett Company's biosimilar insulin biosimilars back in 2022.

Depending on if you count different NDC numbers of the same molecule as genuinely separate products or not, with this copy of the basal insulin Lantus, there are now nine (9) different glargine products for sale in the U.S. market, including several sold at prices which are capped with a MaxRP (Maximum Retail Price). Among them are the following: 

• Sanofi Lantus (insulin glargine injection, 100 units/mL) 
• Winthrop by Sanofi Insulin Glargine [unbranded product] (insulin glargine injection, 100 units/mL) 
• Sanofi Toujeo (insulin glargine injection, 300 units/mL) very high-concentration insulin
• Lilly Basaglar (insulin glargine injection, 100 units/mL) approved as a follow-on biologic product
• Lilly Rezvolgar (insulin glargine-aglr injection, 100 units/mL) approved as an interchangeable biosimilar product 
• Biocon Biologics Semglee (insulin glargine-yfgn injection, 100 units/mL) approved as an interchangeable biosimilar product 
• CivicaScript Insulin Glargine (note: insulin glargine-yfgn injection, 100 units/mL)
• CalRx Insulin Glargine (note: insulin glargine-yfgn injection, 100 units/mL) 
• Lannett Company/HEC (note: insulin glargine-aldy injection, 100 units/mL) 

Now, I cannot really say whether all of these products still remain on the market at this time (for example, whether the "unbanded" version of Lantus from Sanofi's Winthrop business remains for sale or whether it has since been discontinued; I have not heard whether it's been discontinued, although rival Novo Nordisk discontinued all of its unbranded insulin products on December 31, 2025, and the need for unbranded insulin products from the major insulin manufacturers has fallen), and we also know Civica's/CalRx's glargine products are now being sold as part of a broader distribution plan, even while these products are technically the exact same biosimilar products sold by different entities. However, it appears that the unbranded version of Lantus was withdrawn from the market effective as of March 31, 2026 (which was the End Marketing Date) reported in FDA-linked NDC databases. It was reported at https://healthprovidersdata.com/hipaa/codes/NDC_0955-1729.aspx (meaning I learned something new as I was writing this blog post).

Biocon Biologics refers to this as "white labeling" its insulin biosimilars. There is a similar concept which exists in the retail segment, whereby retailers sell products under their "house" brand also referred to as private label products. It's the same concept with pharma.

And, to some extent, while they are indicative of a seemingly robust market for biosimilar insulin products in the U.S. (I think), even while the number of Lantus copies grows ever-larger, we know definitively because the companies bringing more copies to market report these details in their SEC filings are now pending FDA decisions from Sandoz/Gan & Lee, Amphastar Pharmaceuticals/ANP as well as Meitheal/THDB.

GoodRx Research published on January 15, 2025 showed (see the article at https://www.goodrx.com/healthcare-access/research/how-much-does-insulin-cost-compare-brands/ for details) that retail prices of virtually all insulin products had collectively declined by over 40%. It also acknowledged that most of the decline was due to recent approvals of generics and biosimilars.

I prefer seeing the underlying data for myself as proof. To do so, I turned to 46brooklyn Research's "Brand Drug List Price Change Box Score" accessible (at no charge) at https://www.46brooklyn.com/branddrug-boxscore, and there, I saw that between 2024 and 2026, the list price for Sanofi's brand-name Lantus had indeed fallen by a stunning 78% (the price reductions applied to both the 10 mL vial format, and also for the SoloStar pen devices which cost more money on a per-unit of insulin basis) in 2024. Meanwhile, prices for the slower-selling 300 units/mL version of Lantus which is branded as Toujeo fell by just 5%. I suspect that biosimilars may target the Toujeo product with lower prices, although keep in mind that because each unit of Toujeo contains three times as much insulin as Lantus (making it equivalent of 3 vials of Lantus, or 15 SoloStar pens), patients who use Toujeo can nevertheless anticipate more modest price reductions on biosimilars because they are using significantly more insulin.

According to FDA 2019 FDA (CDER) analysis, which examined the correlation between the number of generic entrants and market price, the more generics on the market, the lower prices fall. The data confirms that while the first generic offers only a moderate discount, the entry of 6 or more rivals triggers a price collapse of 95% or more relative to the brand price. The FDA conducts this research to measure the impact of the Drug Competition Action Plan (DCAP). The agency used these findings to identify "saturated" markets and to justify prioritizing the review of generic applications for "uncontested" molecules where competition—and therefore patient savings—was or is currently lacking. There is an archived copy of the FDA Press Release (Internet Archive) found at https://www.fda.gov/news-events/fda-brief/fda-brief-new-analysis-highlights-link-between-generic-drug-competition-and-lower-drug-prices while the Full Economic Study (PDF) can be found at https://www.fda.gov/media/133509/download.

So that's where we are now with Lantus. Prices on that are going to stay low, although the innovator Sanofi appears to be holding on to its share with biosimilars from companies like Biocon Biologics fighting over the remainder. I also question the necessity for insulin pens, which adds an additional 40% to the price of the insulin, is truly necessary for a basal insulin which is only injected once daily. Pens were created in order to dose PRANDIAL insulin while the patient is outside a home environment. To that end, insulin pens have become a marketing crutch which basal insulin makers rely on to make their products more palatable to insulin-naive Type 2 patients. There is not a necessity for a pen, although if these patients are willing to spend 40% more money, then let them do so.

We also now have two FDA approved copies of insulin aspart (Novolog/Fiasp), with Sanofi's Merilog biosimilar approved last February, followed by Biocon Biologics' Kirsty approved last July, More copies of that are also now pending, many from the same companies.

The Lannett Company press release contained some additional information of note. First, Lannett newly established a subsidiary known as Lanexa Biologics LLC to sell the company's biosimilar products including the newly approved LANGLARA glargine product. 

Second, on July 31, 2025, India-based Aurobindo Pharma announced its intent to acquire Lannett Company, Inc. and upon close of the acquisition, Lanexa will become a stand-alone company. 

Finally, the press release also said this: Chinese partner HEC established a U.S. subsidiary known as Sunshine Lake Pharma, which Lannett says will also continue to collaborate on a short acting insulin aspart which is now in development. Lannett Company initiated a process to commercialize a glargine biosimilar in 2016, and Lannett later expanded its strategic relationship with HEC in 2021, adding a new co-development agreement for an insulin aspart biosimilar.

Currently, aside from the image in the press release, I do not have an NDC number (or numbers) for LANGLARA, and we don't know if it will be sold in 10 mL vial format, either. No one really knows with certainty whether all these copies of Lantus can survive, especially since the selling prices are poised to plummet with each new biosimilar copy hitting the market. Meanwhile, the market for alternative basal insulins also eligible for biosimilar copies such as Levemir are being ignored. But they may ignore the market at their own peril. 

PBM Formulary Exclusions Are Going Away, Ending "Not Covered" By Your Insurance

For years, people with Type 1 diabetes in the United States have been told some version of the same thing at the pharmacy counter: that's not covered [by your insurance].

It didn't matter whether it was the insulin that worked best for your body or the continuous glucose monitor you relied on most. If it wasn't on your insurance company's formulary, it was effectively off-limits, unless you were willing to fight, appeal, or pay out of pocket.

That system, known as "formulary exclusion", is starting to disappear. And it is not because insurers suddenly decided to be more flexible. It is because they are being forced to change.

What's Changing, and Why It Matters

At the center of this shift is action by the U.S. Federal Trade Commission (FTC), which investigated how Pharmacy Benefit Managers (PBMs) decide which drugs and devices are covered. As you may realize, PBMs are the middlemen that create and manage formularies for insurance plans, and for years they have had enormous control over what patients can and cannot access, and what they are charged.

The FTC subpoenaed data from the PBMs, and learned that the decisions were driven primarily by legally-exempted rebate kickbacks from drug manufacturers. In simple terms, the products that paid the largest kickbacks were the ones most likely to be covered, while others were excluded even if they were generics with lower costs or worked better for certain patients.

After suing the largest PBMs, the FTC has since forced major changes. PBM companies like Express Scripts (owned by Cigna) and CVS Caremark/Aetna have already agreed to settlements that will fundamentally alter how formularies work. One of the most important outcomes is this: PBMs will no longer be allowed to maintain "exclusionary formularies" that block clinically appropriate alternatives simply because they do not generate large rebate kickbacks for the PBMs. Patients will now have access to a wider range of insulins, CGMs, test strips, glucagon rescue treatments and other diabetes-related treatments. Non-preferred products may still cost slightly more out-of-pocket, but coverage will no longer be outright denied, restoring real therapeutic choice.

What This Means for Insulin

For people with Type 1 diabetes, this change is especially important when it comes to insulin.

Many patients have been forced to non-medically switch between different rapid-acting insulins because of formulary changes. If your plan "preferred" one product over another, that was usually the end of the discussion, even if your blood sugars were better managed using something else.

As formulary exclusions go away, that dynamic begins to shift. When your doctor prescribes a specific insulin, your insurance will be more likely to cover it. Instead of being limited to a single "preferred" option, patients will soon be able to choose from multiple insulins within the same therapeutic category. Some covered options may still cost slightly more out-of-pocket, but the key difference is that your choice is no longer completely blocked by rebate-driven restrictions.

This means you'll be able to select based on how the insulin actually works for you, such as how fast it acts, how predictable it works, and how well it matches your physiology rather than which manufacturer paid the PBM the biggest kickback. For many patients, that level of choice simply has not existed.

It Doesn't Stop at Insulin

The same changes apply to diabetes technology. CGMs only became available under patients' pharmacy benefits starting around 2021, and since then, formulary design has increasingly influenced which systems are covered. In some cases, patients have been steered toward one system over another not because of clinical differences, but because of how contracts and rebate arrangements were structured.

If your insurance plan favored a system from Dexcom, then alternative options such as Freestyle Libre from Abbott might have been effectively unavailable, and vice versa.

With the FTC litigation and settlements dismantling these exclusionary formulary practices, patients can now potentially access a wider range of CGMs, even if some may still have slightly higher out-of-pocket costs. This expands therapeutic choice, allowing patients to select devices based on factors other than rebate arrangements with their insurance company's PBM. The same principle applies to other parts of diabetes care, including glucagon, test strips, and certain medications that were historically excluded for financial rather than clinical reasons.

A Shift Toward More Choice

At the same time that exclusions are going away, pricing is becoming more transparent.

Programs like TrumpRx (which is powered by GoodRx https://www.businesswire.com/news/home/20260205677365/en/GoodRx-Powers-Pricing-for-Leading-Brand-Medications-on-TrumpRx/), make it possible to access certain medications at straightforward cash prices that may be lower than what insurance has historically offered. Importantly, under the FTC settlement agreement with Express Scripts, payments made through TrumpRx will be required to count toward your deductible and out-of-pocket maximums. This means that using TrumpRx won't just save money upfront—it also counts toward your overall insurance protections, giving patients both more choice as well as meaningful financial credit.

This creates a new layer of flexibility and complexity. In some cases, patients may still choose to use their insurance. In others, they may decide it is preferable to pay cash due to lower prices, or they prefer unbranded Lilly Insulin Lispro offered through TrumpRx instead of the Novo Nordisk insulin preferred due to kickbacks paid to their insurance company's PBM. Either way, the key difference is that there are now real options that respect both patient choice and offer financial protections.

What About Medicare?

For people on Medicare, these changes still matter, but come with some added complexity.

Insulin costs are currently capped at $35 per month for Medicare Part D, which provides important protection. But as lower cash prices on different insulins become more widely available, some patients may face a choice between using that cap, or paying less through a direct pricing option (instead of using a "preferred" insulin on their formulary, meaning the one paying the biggest kickback to their Part D administrator), they'll be given an option to use coupons and paying cash. Maybe their Part D plan administrator prefers Novo Nordisk or even Biocon Biologics insulins, but the patient prefers a Lilly insulin; this will become available.

The trade-off is that cash purchases do not count toward annual out-of-pocket limits under Part D. While you might save money in the short-term, although it could affect your overall costs later in the year. It is not a simple decision, but it is also not a choice most patients have ever had before.

The Bigger Picture

You may hear about new legislative proposals, like the INSULIN Act of 2026, which aims to lower insulin costs for patients covered by commercial health insurance. But one of the biggest barriers patients have faced, specifically "formulary exclusions", is already being dismantled through government litigation led by the FTC. Nevertheless, by disabling "formulary exclusions" will result in more therapeutic options being available to patients.

Earlier laws like the American Rescue Plan Act of 2021 also played a key role by removing an arbitrary cap on rebates reimbursable to Medicaid, helped to make insulin more affordable for everyone, and improved price transparency for patients.

For years, access to diabetes treatments in the U.S. was shaped by a system that limited choice so much that many came to accept that as normal. That system is now changing.

For years, decisions about your diabetes care have often been made by someone you have never met, based on financial incentives you were never shown. That is starting to change. As formulary exclusions are dismantled, the ability to choose your insulin, your CGM, and your overall treatment approach is moving back where it belongs: with you and your doctor. For many people living with Type 1 diabetes, that kind of control has been out of reach. Now, it is becoming possible.

Unbranded Humalog Is Cheap on TrumpRx—And GoodRx Enables It.

 

Back on January 27, 2026, the Office of Inspector General ("OIG") for the U.S. Department of Health and Human Services ("HHS") released a Special Advisory Bulletin (the "Bulletin", see https://oig.hhs.gov/documents/special-advisory-bulletins/11450/OIG--FINAL--Special-Advisory-Bulletin.pdf for the bulletin) addressing exactly how the federal government would apply the application of the federal Anti-Kickback Statute ("AKS") to direct-to-consumer ("DTC") prescription drug sales, essentially saying that while it is not a "safe-harbor" exemption to AKS, pharmaceutical manufacturers can sell directly to a Medicare/Medicaid beneficiary without automatically triggering AKS concerns, provided the structure avoids what is referred to as "inducement" and "seeding" risks. 

That coincided with the subsequent establishment of TrumpRx by HHS (see the HHS announcement at https://www.hhs.gov/press-room/oig-clears-path-for-lower-cost-prescription-drugs.html for more), and TrumpRx was a a platform with the President's name and an ugly gold eagle logo on it through which American patients can buy selected prescription drugs directly from pharmaceutical manufacturers at what they referred to as a "Most-Favored-Nation" price, effectively bypassing profiteering middlemen including drug wholesalers (including McKesson, Cencora and Cardinal Health) and vertically-integrated (with commercial health insurance companies) Pharmacy Benefit Managers ("PBMs"). 

At a White House news conference held for launching the website which occurred on February 5, 2026, Donald Trump immediately hyperbolically boasted about the initiative, and was quoted saying:

"This launch represents the largest reduction in prescription drug prices in history by many many times, and it's not even close." 

He added: 

"You're going to save a fortune. And this is also so good for overall health care." 

However, TrumpRx.gov was quickly panned by critics. NBC News, for example (see the news story at https://www.nbcnews.com/health/health-news/trumprx-isnt-much-drug-prices-take-change-rcna263944 for details), claimed that at least 18 brand-name drugs on TrumpRx had cheaper generics available via GoodRx or Mark Cuban's Cost Plus Drugs. In some cases, consumers could save hundreds of dollars by going with the exact same generic medicine, instead of using TrumpRx's price. Because the TrumpRx website promised to offer the least costly prices in the world for 43 brand-name drugs, yet about half of those branded drugs were already available as less costly generics (usually for substantially less money), there was legitimate reason for skepticism. 

We also learned that TrumpRx is actually powered by GoodRx. In other words, it was an initiative with Trump's name all over it, and yet it was powered by the Santa Monica, California-based coupon-generating website and app known as GoodRx. We know this because on February 5, 2026, GoodRx Holdings, Inc. quietly announced that it was a "key integration partner for pharmaceutical companies offering discounted cash prices on TrumpRx" (see the GoodRx press release at https://www.businesswire.com/news/home/20260205677365/en/GoodRx-Powers-Pricing-for-Leading-Brand-Medications-on-TrumpRx for details).

Indeed, we know that TrumpRx relies on GoodRx's pricing data and technology to power many of its listings, according to Antonio Ciaccia (see HERE), CEO of 46brooklyn Research, a nonprofit group that tracks prescription drug prices: The coupon cards are processed through GoodRx's network, using the same BIN and PCN numbers — the codes pharmacies use to process drug discounts at the pharmacy counter. However, the "Member ID" points to a different "formulary" enabling the TrumpRx cards to offer slightly different prices on the same medicines.

Yet even while his own company was beating the prices on many branded drugs at TrumpRx, Mark Cuban Cost Plus Drug Company co-founder Mark Cuban was not among the people echoing the NBC critique, and in response, Mr. Cuban wrote: 

"Everyone wants me to rip on TrumpRx. Reality is, it's saving patients money on IVF and a few other drugs. A lot of money," wrote the Shark Tank star.

He praised the team behind TrumpRx, mentioning names like the Director of Medicare, Chris Klomp, Deputy National Coordinator at HHS, Mark Atalla, and Director of CMS Innovation Center, Abe Sutton. 

Mark Cuban added: 

"TrumpRx is just getting started."

To be sure, TrumpRx is still far from the ideal solution to America's many healthcare problems, including the big spike in Obamacare insurance premiums which Donald Trump was directly responsible for helping to create.

That said, on the insulin front, TrumpRx is nevertheless offering a bit of a deal (at prices which are up to 65% lower than list prices), at least for the only insulin product currently being offered on TrumpRx website as I write this. On the TrumpRx website https://trumprx.gov/p/insulin-lispro/, Lilly's unbranded version of Humalog currently sells for slightly less on TrumpRx than unbranded Humalog sells for most anywhere else ($25 for 1 vial, a maximum of $35 for up to four vials), which is lower than any alternatives I've encountered so far including Lilly's own manufacturer coupons or on LillyDirect (though the latter options offer discounts on disposable pens and pen-fill cartridges, while TrumpRx only offers discounts on 10 mL vials). 

So far, there are also a handful of medications which are approved for the indication of Type 2 diabetes on TrumpRx, including the AstraZeneca SGLT2 inhibitor known generically as dapagliflozin sold under the trade name Farxiga, and the Boehringer Ingelheim combination drug consisting of a DPP-4 inhibitor known generically as linagliptin along with the biguanide known generically as metformin which is sold under the trade name Jentadueto (or an extended-release version branded as Jentadueto XR). That particular product has less brand recognition, yet is considered a direct competitor to Merck's Januvia/Janumet products. DPP-4 inhibitors have been found to work very well together in combination with widely-prescribed metformin, but the runaway list prices on these combination medicines have proven to be problematic for patients on a budget. To search prices on some of these non-insulin medications, visit https://trumprx.gov/browse/.

One other not-so-minor tidbit: The recently-announced settlement agreement between the U.S. Federal Trade Commission and Cigna's Express Scripts (see the agreement at https://www.ftc.gov/system/files/ftc_gov/pdf/d09437caremarkproporder-esiresps.pdf for more) contains a provision which effectively states that plans and beneficiaries will also have access to direct-to-consumer pricing via TrumpRx and that purchases from that "Member payments made through the TrumpRx platform shall count toward Member deductible and Out-Of-Pocket Cost maximum accumulations". This helps restore therapeutic choice to doctors and patients.

This means because Lilly's unbranded version of Humalog is sold via TrumpRx, even if you're on an insurance plan which "prefers" Novo Nordisk's prandial insulins (such as CVS Health's Aetna plans, which currently prefer Novo Nordisk insulin products), you can buy unbranded Humalog bought using a TrumpRx coupon, and have it apply towards your deductible and/or out-of-pocket maximum. Of course, this may not apply right now, but the legal agreement means it will be required by the "implementation date" which is January 1, 2027. I would also add that CVS Health's Caremark/Aetna also recently agreed to a similar FTC settlement agreement, which means the same likely rules apply. It means patients who were forced to use Novo Nordisk prandial insulins will be free to switch to a Lilly prandial insulin by January 1, 2027.

There is at least one major caveat which is contained in the terms which users must accept (yet few people actually read) in order to receive their TrumpRx coupon. Specifically, the patient is limited to 13 prescription fills per calendar year using the TrumpRx coupon; if a patient's dosage requires more frequent refills, their TrumpRx discount may cut off. The TrumpRx coupons also have an expiration date on the last day of each calendar year.

So far, TrumpRx only sells Lilly's unbranded prandial insulin product (Novo discontinued its unbranded Novolog and Tresiba products already; I'm not really sure about Winthrop by Sanofi, and I believe that Biocon Biologics is now effectively using the company's new supply relationship with the CivicaScript operating unit of CivicaRx for insulin glargine and soon, also for insulin aspart; although no announcement has yet been made on lispro because Biocon Biologics does not yet have a biosimilar of that product approved for sale in the U.S., but is believed to be developing one as I write this. Rival Sanofi's insulin products also appears to offer coupons on TrumpRx, although the price for Sanofi's insulin lispro follow-on biologic product costs $10 more than Lilly's insulin lispro product.

However, my perspective is that a discount is still a discount, and it really does not matter where it comes from. Just use and enjoy it. 

Author P.S., May 18, 2026: Major media outlets (see https://thehill.com/policy/healthcare/5884064-trump-adds-600-generic-drugs/ for one such article) reported that the Federal government's drug coupon platform known currently as TrumpRx will soon be adding an estimated 600 generic drugs from Mark Cuban's Cost Plus Drug Company (MCCPDC). One early criticism of TrumpRx was that many of the coupons were for branded drugs, yet there are less expensive generic versions of the same drugs available, hence this move will address that core weakness by introducing less costly generic products into the mix. In theory, due to FTC settlements with the major PBMs, this could mean that MCCPDC purchases using a TrumpRx coupon referral should apply towards patient deductibles and out of pocket maximums. However, the underlying machinery of these settlements has yet to be implemented at this time, so patients may need to persistently ask about this provision. Since that time, TrumpRx has also added Sanofi insulin products, and also Novo Nordisk insulin product coupons.

Comment until March 16, 2026 on FTC-Express Scripts Proposed Settlement Agreement

Today, I am opining on the recent proposed "settlement" agreement with the Federal Trade Commission (FTC) and Cigna's Evernorth/Express Scripts Pharmacy Benefit Manager (PBM) business. I have long advocated for FTC action on this; if you care to read my summary of what happened, catch my post at https://blog.sstrumello.com/2025/01/why-i-pushed-for-ftc-litigation-against.html.

Make no mistake, the FTC sued, and FTC had substantial evidence against Express Scripts, so the company opted to simply settle, essentially agreeing to the FTC's "Intended Relief" which is assuredly a good thing. On February 4, 2026, Drug Channels' former owner Adam J. Fein covered the proposed FTC settlement with Express Scripts which is well worth a read. See his coverage at https://www.drugchannels.net/2026/02/the-ftc-blows-up-express-scripts-pbm.html for more.

Adam J. Fein's notable concern pertains specifically to the fact that the settlement seemingly enables employer healthcare "plan sponsors" with a potential big loophole for business-as-usual. (See Section XI of the settlement agreement at https://www.ftc.gov/system/files/ftc_gov/pdf/d09437caremarkproporder-esiresps.pdf for details).

To be certain, regardless of what Express Scripts is doing, we still need for CVS Health/Caremark/Aetna and United Healthcare/OptumRx to settle, and until those vertically-integrated entities agree to settle with FTC, the job is anything but complete, but it's still a good start. It will meaningfully implement some much-needed changes to a very corrupt industry (PBMs) which has persistently resisted them. With one big PBM settling, it also makes it rather difficult for CVS Health/Caremark/Aetna and United Healthcare's OptumRx to do nothing.

But as former Cigna exec-turned whistle-blower Wendell Potter's "Health Care Un-Covered" Substack correctly observed (see https://healthcareuncovered.substack.com/p/in-ftc-settlement-cigna-agrees-to/ for its coverage), there will be a 30-day public comment period on the settlement package before it moves toward final settlement. Those anyone wishing to weigh-in on the settlement can do so at regulations.gov to find the proposed settlement. To spare you the trouble of finding it, see below:

The settlement agreement is designated "Express Scripts, Inc., et al.; Analysis of Agreement Containing Consent Order To Aid Public Comment" which was posted by the Federal Trade Commission on February 12, 2026. Observe that the public comment period on the "Proposed Settlement" ends on March 16, 2026 at 11:59 PM EDT. Visit https://www.regulations.gov/document/FTC-2026-0134-0001 until March 15, 2026 in order to comment.

Below was the letter which I wrote to FTC. I used AI tools to help compose it, but I feel it addresses the major weakness of the proposed settlement agreement with FTC and Cigna's Express Scripts and gives FTC direction on what still needs to change before it finalizes the agreement. Feel free to use it yourself!

SUGGESTED COMMENTARY ON FTC SETTLEMENT AGREEMENT WITH EXPRESS SCRIPTS:

To FTC Staff:

Thank you for the work that has gone into this settlement. As a patient who has been directly adversely affected by PBM "business" practices, I appreciate that the FTC is finally taking steps to fix a system that has enabled drug costs rise higher for years. This settlement is the result of years of advocacy from patients, pharmacists, and others who have been calling attention to these problems. 

However, I remain very concerned about Section XI ("Meeting Competition") of the proposed order. As written, this section appears to allow employer health plan sponsors to continue requesting special terms that differ from the "Standard Offering." In practice, this could allow employers to keep receiving "premium offsets"—payments or credits funded by the large prescription drug rebates tied to high (artificially-inflated) list‑price drugs. 

This is one of the most harmful "misaligned" incentives in the current PBM system. These premium offsets are not free money. They are funded by the sickest patients who use heavily-rebated prescription medicines, and pay out‑of‑pocket costs based on artificially-inflated list prices. Meanwhile, employers benefit from lower premiums that are effectively subsidized by those same patients. This is a deeply unfair cost‑shift, and it is one of the main reasons U.S. prescription drug prices have stayed artificially high. 

If Section XI enables employer healthcare plan sponsors to continue choosing terms that preserve these offsets, then the core problem remains in place. The settlement will not achieve its goal of lowering drug costs for patients if employers can still benefit financially from inflated list prices and fat rebates subsidized by patients who require heavily-rebated prescription drugs. 

For that reason, I urge the FTC to close this loophole before finalizing the order. Specifically: 

Plan sponsors should NOT be allowed to receive premium offsets or similar financial benefits that depend on inflated list prices or rebates.  

Any deviation from the Standard Offering should NOT include terms that recreate the same misaligned incentives the settlement is meant to eliminate.  

The final order should make absolutely certain that employers cannot continue benefiting at the expense of the sickest patients. 

Without fixing this, the settlement risks leaving the most harmful part of the PBM model intact. Patients including me and others like me will continue to bear the highest costs, while others benefit from the system that created those inflated costs in the first place. 

Thank you for considering this comment and for your continued work to protect patients and bring more fairness to the U.S. prescription drug market. 

Sincerely,

[YOUR NAME HERE] 

So, this is an important advocacy action that I strongly encourage my readers to act on before the comment period expires on March 16, 2026.

We Already Have Generic GLP-1s. Why Don't Prices Reflect That? Answer: PBM Pricing Arbitrage.

The focus of this blog is the autoimmune form of diabetes known as Type 1 diabetes (T1D), which has exactly one FDA-approved treatment (insulin replacement therapy), and also has no proven way of prevention or inducing remission (certainly not sustainably), hence I don't typically address Type 2 diabetes because it is not of personal interest to me. 

However, because insulin manufacturers have shifted their business focus away from insulin to GLP-1 inhibitors (which are not approved for T1D), it remains an area of tangential interest for me, which I have episodically covered at https://blog.sstrumello.com/2024/07/tevas-biosimilar-of-liraglutide-will-be.html, and also at https://blog.sstrumello.com/2024/12/fda-approves-second-generic-glp-1.html and perhaps most recently at https://blog.sstrumello.com/2025/08/diabetes-mine-innovation-project-study.html. 

The headline tells you much of the story. However, because of my deep knowledge of how the prescription drug market works (which many don't understand), I can explain beyond the headline, and provide readers with information which may be of interest. Like the fact that we already have a bunch of generic GLP-1s.

It's true: there are already quite a few legitimate, FDA-approved generics of the GLP-1 inhibitors; there are currently a number of them already being sold for treatment of Type 2 diabetes, and even more in the pipeline from other companies which will cause prices to drop further, and at least one of the generics now already has the FDA "label-extension" for the stand-alone indication of obesity. Simply stated, there is NO reason for "compounded" versions of GLP-1 inhibitors, and that's because we already have efficacious generic GLP-1s on the market, plus many (if not all) of the compounded products are less likely to be effective because they're largely unregulated and the telehealth providers selling them do not truly care if they are effective.

GLP-1s are not new, and FDA-approved generics already exist

For people without any form of diabetes, the short story about GLP-1 drugs is that they first emerged as a treatment for the most common form of diabetes, specifically Type 2 diabetes, more than twenty years ago. Since April 28, 2005, which was when the U.S. Food and Drug Administration approved the very first GLP-1 inhibitor these meds have been sold, so they are assuredly not new. This class of drug has been safely used (and sold) since then, and all of the side-effects are already very well-established. Don't believe hyperbole about undiscovered adverse events; because there are none. 

For anyone who's blogged in the diabetes space for as long as I have, they may recall some of the early stories from patients who had fantastic results with the first-generation GLP-1 drugs. For example, the late David Mendosa, blogged extensively on his positive experiences with GLP-1s and how those assisted him in losing weight which he was unable to lose using any other diabetes drugs (see one of his posts from July 31, 2006 at https://mendosa.com/my_byetta.htm for some documentation of his experience). 

More than twenty years of experience

The first-ever GLP-1 inhibitor was originally a product sold under the trade name Byetta (exenatide) from a San Diego-based company known as Amylin Pharmaceuticals, Inc., which turned to big-pharma partner Eli Lilly & Company, Inc. to make and package the medicine in sufficient quantities to keep up with rapidly-rising demand for the product. Lilly did so because it earned the company money; and sales grew rapidly due to the Amylin partnership, which also helped to solidify Lilly's leadership in the diabetes treatment space.

Byetta, however, was approved only for the "indication" of Type 2 diabetes. About five years later, on January 25, 2010, rival Novo Nordisk introduced a newer GLP-1 inhibitor branded as Victoza (liraglutide). Liraglutide wasn't superior to Byetta, but because of legally-exempted rebate kickbacks which Novo Nordisk was paying to PBMs, its version became the "preferred" GLP-1 product for many covered patients. 

Both Byetta and Victoza had to be injected daily. However, both delivered not only adequate glycemic control, but unlike a vast majority of other Type 2 diabetes drugs, the GLP-1 class of drugs also had an atypical side-effect (compared to all other diabetes drugs sold at the time): most users also experienced impressive weight-loss over time. Most patients who used these drugs were able to lose weight, while also restoring themselves to HbA1c's which were considered close to being "within [target] range" or reasonably close. 

But the GLP-1s themselves were only FDA approved for the "indication" of Type 2 diabetes. Type 1 diabetes (T1D) is a condition which is etiologically unrelated, and is characterized by an absolute deficiency of insulin, as opposed to a relative deficiency of insulin which exists in Type 2 diabetes. Also, the only approved treatment for T1D is lifelong insulin replacement therapy. Novo Nordisk did try to get a T1D FDA "label-extension" for Victoza, except that the FDA denied the application, concluding that it simply did not work in T1D and there was insufficient evidence to approve it. I disclosed some of the reasons FDA denied GLP-1s for T1D in a post at https://blog.sstrumello.com/2025/08/diabetes-mine-innovation-project-study.html, but suffice to say, there really was no valid reason to approve it because it was not efficacious in T1D.

GLP-1s for the indication of "obesity" happened via an FDA "label-exension"

It later occurred to execs at Novo Nordisk that maybe its blockbuster GLP-1 could also work for patients who do not have diabetes, but they just want to lose weight. So, Novo Nordisk conducted clinical trials, and found that indeed, liraglutide did result in appreciable weight reduction among people who took it (even if they did NOT have any form of diabetes), so it applied for what's referred to as an FDA "label-extension" for the stand-alone "indication" of obesity. The history of weight-loss drugs has been one of repeated failure, so the advent of a treatment which actually worked was indeed a new development. And, on December 23, 2014, Novo Nordisk's liraglutide received FDA approval for the stand-alone indication of obesity, but it sold the obesity version of the drug under the trade name Saxenda.

Around the same time, Amylin Pharmaceuticals applied for regulatory approval for an "extended-release" version of the drug it had branded as Byetta. The extended-release version only required the drug to be injected once per week, rather than daily. On January 27, 2012, the FDA approved the extended-release version which Amylin Pharmaceuticals branded as Bydureon (exenatide extended-release for injectable suspension). Extended-release, which is one of the biggest "innovations" of the newest iterations of GLP-1 inhibitors, isn't really much of an innovation at all. By that time, however, Amylin Pharmaceuticals and Eli Lilly & Company were having something of a partnership disagreement. 

The Amylin/Lilly partnership was harmed by Lilly's decision to partner with another drug firm known as Boehringer Ingelheim which was responsible for much of the R&D development of the drug Jardiance (empagliflozin), a small-molecule drug in the Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor class of drug. Jardiance was proven to provide cardiovascular benefits, primarily by reducing the risk of CV death and hospitalization for heart failure in adults with heart failure, and also by reducing CV death in adults with Type 2 diabetes plus established CV disease; hence it was a big advancement in treating heart failure and CV disease risk in people with Type 2 diabetes, plus it became the first diabetes drug which also had a CV benefit to patients who used it. Since then, several other drugs in the same SGLT2 inhibitor drug class, including dapagliflozin (Farxiga), canagliflozin (Invokana), ertugliflozin (Steglatro), and bexagliflozin (Brenzavvy) have been proven to share similar CV benefits (to varying degrees), and one of those, specifically TheracosBio's Brenzavvy (bexagliflozin) sells for a remarkably affordable price compared to all the others in the same drug class, and that is sold via Mark Cuban Cost Plus Drug Company (see https://www.costplusdrugs.com/medications/brenzavvy-20mg/ for more on that).

As a result, a decade-long partnership between Amylin Pharmaceuticals and Eli Lilly unceremoniously ended (and rather unhappily) in November 2011, driven by intense litigation between the two companies, slowing Byetta sales, and conflicts-of-interest arising from Lilly's new alliance with Boehringer Ingelheim. For its part, in July 2012, Bristol-Myers Squibb announced it would acquire Amylin Pharmaceuticals for $5.3 billion. In April 2013, Bristol-Myers Squibb announced it was closing Amylin's San Diego HQ operations by the end of 2014, and would merge an Amylin manufacturing facility in West Chester, Ohio, plus combine all of Amylin's field-based sales personnel into Bristol-Myers Squibb's operations.

Of course, Lilly did not simply accept the end of the Amylin Pharmaceuticals partnership (which was a result of its signing a deal with a rival) by exiting the GLP-1 space, therefore in July 2013, Lilly applied for FDA approval of its own extended-release GLP-1 inhibitor product for Type 2 diabetes, which was subsequently cleared by regulators on September 18, 2014, and Lilly branded that product as Trulicity (dulaglutide). Of course, by then, Amylin's Bydureon product was already struggling not only with new competition from Lilly, but also from Novo Nordisk's kickback-driven sales of Victoza, which had established a commanding share of the new GLP-1 inhibitor market. 

Lilly was well aware of rival Novo Nordisk's strategy with liraglutide, and how an FDA label-extension for obesity allowed that drug to be prescribed to virtually anyone. Rather than seeking a similar extension for its own Trulicity product, Lilly planned to launch a newer GLP-1 product, known generically as tirzepatide, under a new brand name. To compete effectively, Lilly aimed for dual FDA approvals for tirzepatide to cover both Type 2 diabetes and the standalone indication of obesity. The new, extended-release product was branded as Mounjaro (tirzepatide) which received FDA-approval for Type 2 diabetes on May 13, 2022, and about a year later, the same drug sold under the trade name Zepbound (tirzepatide) received a separate FDA approval for the "obesity" indication on November 8, 2023.

The 2024 advent of FDA-approved generic GLP-1 inhibitors

Of course, since then, generic versions of both exenatide (Byetta), and liraglutide (Victoza for Type 2 diabetes, plus Saxenda for obesity) have since won regulatory approvals. Below is a list of different press releases on each of the generics' FDA approvals or subsequent "label extensions":

• Teva Announces Launch of Authorized Generic of Victoza^® (liraglutide injection 1.8mg), in the United States, June 24, 2024 https://www.businesswire.com/news/home/20240623654311/en/Teva-Announces-Launch-of-Authorized-Generic-of-Victoza-liraglutide-injection-1.8mg-in-the-United-States  
  
  
• Amneal Resubmits DHE Autoinjector New Drug Application and Receives U.S. FDA Approval of Exenatide, its First Generic Injectable GLP-1 Agonist, November 21, 2024 https://www.businesswire.com/news/home/20241121053036/en/Amneal-Resubmits-DHE-Autoinjector-New-Drug-Application-and-Receives-U.S.-FDA-Approval-of-Exenatide-its-First-Generic-Injectable-GLP-1-Agonist   

• Hikma receives FDA approval and launches the generic version of Victoza^®, Liraglutide, in the US, December 26, 2024 https://www.hikma.com/news/hikma-receives-fda-approval-and-launches-the-generic-version-of-victoza-liraglutide-in-the-us/  

• Meitheal Pharmaceuticals Announces Approval and Launch of Liraglutide Injection in the United States, April 3, 2025 https://www.businesswire.com/news/home/20250403499155/en/Meitheal-Pharmaceuticals-Announces-Approval-and-Launch-of-Liraglutide-Injection-in-the-United-States  

• Teva Announces FDA Approval and Launch of Generic Saxenda^® (liraglutide injection) – First Generic GLP-1 Indicated for Weight Loss, August 28, 2025 https://www.globenewswire.com/news-release/2025/08/28/3140801/0/en/Teva-Announces-FDA-Approval-and-Launch-of-Generic-Saxenda-liraglutide-injection-First-Generic-GLP-1-Indicated-for-Weight-Loss.html  
  
  
• Biocon obtains approval for weight management drug, Liraglutide, in the United States, February 24, 2026
  https://www.biocon.com/biocon-obtains-approval-for-weight-management-drug-liraglutide-in-the-united-states/   

Observe that Biocon Biologics' version of liraglutide does not, to the best of my knowledge, even have FDA approval for the "indication" of Type 2 diabetes, only for the indication of obesity, suggesting that it has prioritized the obesity version of that particular drug. Generics of liraglutide are forecast to be big because they can easily attain an FDA "label-extension" for the stand-alone indication of "obesity", hence a bunch of generics are expected to come to market.

Nevertheless, Novo Nordisk's liraglutide (Victoza/Saxenda) molecule is popular because it can be prescribed for both the Type 2 diabetes indication, as well as for the obesity indication. And the first generic of that particular GLP-1 drug was Teva's copy, which received approval for Type 2 diabetes on June 24, 2024. The obesity version received FDA approval on August 28, 2025. Biocon's copy received FDA approval for the indication of obesity on February 24, 2026. Note that most generics must be injected daily as opposed to weekly. 

Teva's press release said something interesting: Teva was careful to refer to the approval as an "Authorized Generic of Victoza" and the reason for that terminology was simple: Teva planned to sell its own copies of Novo's Victoza/Saxenda (and Novo Nordisk knew it was capable of doing so), and the companies ended up in court, but Novo Nordisk was unsuccessful in winning any of its patent infringement lawsuits against Teva. So, Novo tried a slightly different approach: allow it to make the original product which Teva could then merchandise, and simply call it a "generic". Teva agreed, but was clear with Novo that it was not seeking, nor did it NEED, Novo Nordisk's help, and Teva was more than prepared to start selling its own generic copies. Instead, Novo offered Teva a price on liraglutide which was cheap enough that Teva really could not refuse, plus it helped Novo Nordisk to get rid of its existing inventory of the older drug, thereby helping both companies in the process. 

A flood of generic weight-loss drugs is coming, yet almost no one knows they exist. We know, thanks to FDA research, that the more generics which are approved for a given drug, prices on those generics tends to fall even more.

As I write this, Teva's copy of Victoza is the only generic copy which has subsequently received the FDA label-extension for the "obesity" indication (becoming a copy of Saxenda in the process)...but we can expect a whole bunch more to eventually attain those label-extensions for obesity before very long. Biocon's copy received the label-extension for obesity on February 24, 2026.

We know it because they're in pipelines of publicly-traded companies which reveal their drug development pipelines in their SEC filings. The FDA label-extensions for the obesity indication typically occurs about a year following the Type 2 diabetes indication approval. And the Type 2 indications have been on the market since the latter part of 2024.

While the media talk nonstop about the newest obesity drugs, the reality is the old ones have already gone generic. And even more generics are pending approvals at this very moment.

Since then, we've seen several copies of liraglutide gain FDA approval, including from Hikma Pharmaceuticals and Meitheal Pharmaceuticals. Biocon Biologics has one pending for the indication of obesity, so does Sandoz (with collaboration partner Gan & Lee), Amphastar Pharmaceuticals/ANP, plus Lannett Co./HEC. And, remember Amylin Pharmaceutical's successful Byetta/Bydureon (exenatide) products? Well, Amneal Pharmaceuticals now sells a copy of that GLP-1 too (or maybe it's a copy of the extended-release Bydureon product; I'm unsure which on that molecule), though that product always lacked an FDA label-extension for the stand-alone indication of obesity. Also, the prices of the generics are hardly bargains right now. But the more that hit the market means prices will fall even more.

But one of the reasons the obesity drugs are selling like hotcakes is not because everyone who uses the drugs meets the clinical definition of "obese", but thanks to sketchy "telehealth" providers who are willing to prescribe the drugs without so much as an examination (see https://www.statnews.com/2024/10/17/telehealth-online-compounded-glp1-prescriptions-medical-groups/ for more details) by phone or online, almost anyone can get a prescription. Just call or chat, and an e-script is sent instantly to the pharmacy or drug company's in-house drug fulfillment center (such as LillyDirect), all while the prescriber is still on the phone or online. In other words, Novo Nordisk and Lilly rely on questionable telehealth companies to get around the need for a doctor to declare someone is clinically obese. 

Most big telehealth prescribers consist of a small number of largely unseen clinician networks (including doctors licensed to practice medicine in the U.S., but they may be based offshore in places such as India or the Philippines, plus many domestic nurse practitioners who want the predictable hours that working for telehealth providers provide, and they also have the ability to prescribe most drugs (with the exception of controlled-substances) that handle mass prescriptions at scale.

In June 2025, sensing that telehealth prescribers were driving the GLP-1 prescription bonanza for weight-loss drugs, a telehealth company known as 9amHealth and Mark Cuban Cost Plus Drug Company PBC partnered to provide employers with a more cost-efficient obesity management solution (see the press release at https://www.prnewswire.com/news-releases/mark-cuban-cost-plus-drug-company-pbc-and-9amhealth-join-forces-to-expand-access-to-affordable-obesity-care-302482628.html for details). The Mark Cuban-9amHealth collaboration integrates low-cost generic medications, transparently-priced GLP-1 inhibitors into a comprehensive clinical program for treating weight and related chronic conditions. As I write this, Mark Cuban's price for liraglutide prescribed for Type 2 diabetes is $118.33 for 1 Box (2 x 3ml Prefilled Pens), while the cost for liraglutide prescribed for obesity is $590.75 for 1 Box (5 x 3ml Prefilled Pens), although the cost is still slightly less than Novo Nordisk's Wegovy or Eli Lilly's Zepbound. 

But remember with every additional generic which is approved, prices will fall even further. The threshold is that with 2-4 generic entrants, prices fall to about ~50% of branded drug, and once there are 6+ generic entrants, prices fall to 10% or less of the branded drug.  The FDA conducts research to measure the impact of the Drug Competition Action Plan (DCAP), and uses those findings to identify "saturated" markets, in order to justify prioritizing its review of generic applications for more "uncontested" molecules where competition—and therefore patient savings—is currently lacking. 

A 2019 FDA (CDER) analysis examined the correlation between the number of generic entrants and market price, press release (found on the Internet Archive): https://web.archive.org/web/20221007032321/https://www.fda.gov/news-events/fda-brief/fda-brief-new-analysis-highlights-link-between-generic-drug-competition-and-lower-drug-prices/, while the Full Economic Study (PDF) remains accessible at https://www.fda.gov/media/133509/download if you want to see the data. Suffice to say, the data confirms that while the first generic offers a moderate discount, the entry of 6 or more rivals triggers a price collapse of 95% or more relative to the brand price. 

Currently, many employer-sponsored health plans don't cover drugs prescribed for obesity at all because they are so expensive; in fact, its usually only if the patient has a diagnosis code for Type 2 diabetes. The same is true for Medicare, generally, as there are very specific eligibility rules that must be met in order to receive Medicare coverage of obesity drugs, typically involving concurrent heart disease (such as the patient has already suffered a heart-attack). 

But vanity has nevertheless pushed a prescription boom for the GLP-1 drug class, but so far, for the heavily-rebated branded drugs, there are PBM "formulary exclusions" for all other brands (including any and all generic medicines) which seemingly defies logic. This is referred to by the Pharmacy Benefit Manager (PBM) industry as Patient "Price Arbitrage", which is a standard business procedure for the PBM industry (I first mentioned the term in 2022, see it HERE). It occurs when a Pharmacy Benefit Manager (PBM) charges an insurance plan (and/or a covered patient) a higher price for a drug than they actually pay the pharmacy to dispense it, thereby pocketing the difference (the "spread") as profit. This is "spread pricing" and it's become a big problem, especially on what should be cheap generic drugs. 

According to 2022 research from the University of Southern California's (USC) Schaeffer Center for Health Policy & Economics, when USC conducted a first-of-its-kind study to see how often this happens, they learned that patients overpaid for their prescriptions about 23% of the time (see https://kffhealthnews.org/news/paying-cash-for-prescriptions-could-save-you-money-23-of-the-time-analysis-shows/ for more), and this occurred frequently on what should ordinarily be considered "inexpensive" generic medicines. 

However, patients have started to figure this out, which explains why in 2020, the giant coupon-generating app GoodRx revealed in its "Payer Mix" that three out of four consumers who actually used the GoodRx app already had commercial, Medicare, or Medicaid insurance. This means that someone—the consumer, their employer, and/or the government—paid insurance premiums for a pharmacy benefit managed by a PBM. Yet it was still worthwhile for people to bypass their own health plan's out-of-pocket costs and PBM network rates in favor of a different PBM's rates...such arbitrage creates potent conflicts between PBM's and their employer healthcare plan sponsor clients (catch my previous coverage of that at https://blog.sstrumello.com/2022/07/turning-pbm-arbitrage-on-its-head.html; suffice to say it is a stunning indictment of the corrupt PBM business model, and the FTC has sued them over unlawful business practices. 

Put simply, the existence of generics (even in "hot" drug categories like GLP-1 inhibitors) alone does not necessarily guarantee lower prices. When PBM formulary design, rebates, and utilization channels favor high-list-price brands so the PBM can collect multimillion dollar rebates, the market irrationally behaves as if competition does not exist. PBM pricing "arbitrage" is at the heart of today’s GLP-1 market: while the FTC has sued over that (and Express Scripts has agreed to settle), there remains a major loophole in the proposed settlement agreement which I intend to ask the FTC to reconsider before accepting the settlement agreement.

However, patients seeking GLP-1s at lower prices should base their decisions on where they can get these overpriced medicines at the lowest sustainable cost. Less costly generics are available, but they are often excluded from preferred drug formularies. Sometimes. Or sometimes, entities like Mark Cuban which is known to reduce its prices when it can get a lower price, may be able to help. But the Latin saying "caveat emptor" (let the buyer beware) remains the rule of the day when it comes to GLP-1s (and most other drug categories). Just beware that generic GLP-1s for the indication of obesity are now just starting to emerge.