From "Out of Stock" to Fulfillment: How Mark Cuban Cost Plus Drug Company's 2023 HealthDyne Deal Improved Drug Distribution

Several years ago, I blogged about a PBM-powered coupon-generating app and website operated by WellDyne, which was from one of the smaller Pharmacy Benefit Managers (PBMs) and the coupon-generating app was known as WellCardRx. WellDyne is a smaller, more-transparent PBM which says it avoids rebates which defines its bigger PBM rivals. At the time, nearly every major PBM—except for CVS Caremark—had its own discount card platform. That trend has since faded. For example, United Healthcare's OptumRx sold OptumPerks to RVO Health, LLC in 2023, and Cigna's Express Scripts stopped using its mail-order pharmacy to fulfill orders from its own InsideRx coupon platform. 

WellDyne, however, continues to operate its own mail-order pharmacy business called HealthDyne. The branding between WellDyne and HealthDyne is quite similar (for example, the names for both are in lower-case letters, and use a similar color scheme), underscoring their shared corporate identity. HealthDyne is based in Lakeland, Florida (between Tampa and Orlando) and serves as the pharmacy fulfillment arm of WellDyne, a PBM which was originally founded in 1990 as WellDyne Rx, Inc. and WellDyneRx, LLC. In 2016, WellDyne was acquired by the private equity firm known as The Carlyle Group. 

Although data on WellDyne's PBM operations is rather limited, the Drug Channels Institute (DCI) reported in 2021 that as a PBM, it covered about 2.5 million lives, including roughly 700,000 commercial lives. DCI—itself now owned by HMP Global—was previously run by Pembroke Consulting, whose founder Adam J. Fein and his wife Paula still contribute to the blog. For comparison, Navitus Health Solutions, another smaller PBM co-owned by SSM Health and Costco Wholesale, had about 7 million covered lives, including 2.5 million commercial lives in 2021.

Fast forward to June 7, 2023: HealthDyne and Mark Cuban Cost Plus Drug Company (MCCPDC) announced a new pharmacy fulfillment partnership (see the press release at https://www.prnewswire.com/news-releases/mark-cuban-cost-plus-drug-company-and-healthdyne-announce-pharmacy-partnership-301844354.html). The deal positioned HealthDyne to expand Cost Plus Drugs' pharmacy operations, by leveraging HealthDyne's underlying infrastructure, technology and expertise.

While the press release never mentioned MCCPDC's previous fulfillment vendor known as TruePill, the timing suggests a transition. TruePill had previously fulfilled orders for Cost Plus Drugs, but it merged into a new entity called Fuze Health by mid-2023. Fuze Health also now owns the mail order pharmacy known as Aalto Pharmacy (which originally claimed to serve people with conditions such as diabetes) and LetsGetChecked. With Cost Plus Drugs growing so rapidly, the company likely sought a new fulfillment partner better suited to its evolving needs.

This transition may explain an order disruption I personally experienced when buying from Mark Cuban Cost Plus Drug Company. Back in August 2023, I blogged about how Mark Cuban Cost Plus Drug Company had taken my order, then unexpectedly listed my prescription as "Out of stock" (catch my post about that at  https://blog.sstrumello.com/2023/08/when-mark-cuban-cost-plus-drug-company.html for more details) when it had already accepted my reorder request. The lack of an ETA and sudden unavailability was frustrating at the time, but now it appears that the shift from TruePill to HealthDyne as the fulfillment source may have been the underlying cause.

Mark Cuban Cost Plus Drug Company has frequently been cited (including by me personally) as a disruptive force for good in the deeply dysfunctional U.S. prescription drug distribution system. By eliminating middlemen and offering transparent pricing—actual drug costs plus a 15% markup, $5 pharmacy fee, and $5 shipping—the company has challenged entrenched PBM practices and made many medications vastly more affordable for millions of Americans. For people with chronic conditions like Type 1 diabetes, where access to insulin and other life-saving medications and things like testing supplies is non-negotiable, partnerships like the one with HealthDyne appears to played a meaningful role toward better patient access and affordability. While I wish there had been more transparency about what I was experiencing at the time, this appears to be the likely explanation.

After 50 Years with T1D, I Still Have Advocacy Work to Do

In July 2026, I'll become eligible for Joslin's Half-Century Medal, awarded to those who have lived with Type 1 diabetes (T1D) for 50 years. I still haven't decided whether I'll apply for it or not, but the milestone marks something noteworthy: a half-century of survival—more importantly, endurance—and learning to navigate life with a condition and a U.S. healthcare system that prioritizes corporate insurance company profits over patients, both of which have shaped a big part of my life. 

Although I no longer involve myself in every advocacy initiative that comes along, I'm still not done with advocacy yet. I've simply become more deliberate about how—and where—I invest my advocacy time and energy. 

Choosing My Battles 

For years, I participated in the JDRF (now Breakthrough T1D) Walks to Cure Diabetes and raised thousands of dollars for the organization. I still support the cause, but I don't participate as regularly as I once did. Sometimes I have other plans, and that's fine (after all, diabetes certainly isn't my whole life). Children with diabetes often take center stage in fundraising campaigns, and lobbying events such as Breakthrough T1D's Children's Congress, and they probably should—kids are pretty persuasive spokespeople. But we as adults with T1D actually vote. Adults with T1D bring a different kind of power to the table, and our perspectives matter too (although it might be nice if Breakthrough T1D acknowledged that, and also made more of an effort to actually harness it, and maybe someday, it actually will do so). 

My advocacy these days is more focused, personal, and often rooted in my efforts to correct the historical wrongs I've endured first-hand of living with T1D. That includes pushing for accountability at both federal and state levels—whether through formal complaints to the FTC, or urging New York's Attorney General to enforce the violations of the state antitrust law known as the Donnelly Act against PBMs operating with impunity. To the best of my knowledge, I was one of only a few patients instigators in the diabetes community advocating for FTC action (during its 6[b] study, I even emailed back and forth with then FTC chairwoman Lina Khan), and I wrote about that effort in great detail here: https://blog.sstrumello.com/2025/01/why-i-pushed-for-ftc-litigation-against.html and pushed for litigation which is now on hold. 

The Pain of Enduring Repeated, Forced Non-Medical Switching

One of the most traumatic experiences in my early years with diabetes came during the involuntary shift from animal-derived insulins to the so-called "human" biosynthetic insulins, produced via recombinant DNA technology. These were promoted as advancements, but in truth, they offered NO therapeutic advantage over what came before—and up to ten percent of patients globally experienced serious adverse effects such as hypoglycemia unawareness according to a number of different peer-reviewed journal articles. 

I was one of those patients. 

Around the age of nine, I started experiencing terrifying low blood sugar episodes that often came out of nowhere—no warning signs, no symptoms, just sudden, dangerous crashes. And remember: back in those days, we didn't even have blood glucose meters to determine what was happening, and CGMs didn't exist. When I tried to explain what I experienced, instead of being heard, I was blamed—as if I was somehow making it all up, or else I was to be blamed for doing something wrong. It was incredibly isolating. Years later, I discovered I wasn't alone. People from all over the world—Canada, Australia, the UK, Germany, Switzerland, the U.S.—described going through the exact same thing when they were involuntarily switched to these so-called "human" insulins. We weren't imagining it. We were collateral damage in a system more concerned with profits than patients. 

After the discontinuation of Iletin S and L, the cycle continued: next, Humulin S and L eventually disappeared too, and for a time, we were stuck with the same inferior alternative products such as isophane (NPH) until those were eventually replaced by analogue insulins a number of years later. These new products were marketed as superior, although their timing always just happened to align with expiring patents. Years later, I suffered routine non-medical switching from one prandial insulin to another each time my insurance company's PBM changed formularies having been non-medically switched four times in one calendar year. I promised myself that if this kind of forced, non-medical switching resulting from manufacturers "retiring" insulin was to happen again, I'd push back. 

Levemir's "Retirement" and the Next Fight 

In November 2024, it happened again. Novo Nordisk announced it would discontinue Levemir (insulin detemir). I wasn't using it at the time, but I knew the business playbook extremely well, having been through it multiple times. I also knew that no company was developing a biosimilar for detemir—not Sanofi, Biocon Biologics, Sandoz/Gan & Lee, Amphastar/ANP, Lannett/HEC, Meitheal/THDB, or even CivicaScripts insulin efforts (GeneSys Biologics for glargine and lispro, Biocon Biologics for aspart), all of whom were known to be developing biosimilar insulins (and many were publicly-held corporations which listed the insulin biosimilars in their drug development pipelines, so it was not kept secret). It was an opportunity for a creative entity willing to think outside of the proverbial box; they would effectively OWN the still substantial market for insulin detemir and their competitors were ignoring. 

While Novo Nordisk tried to suggest that Levemir was a rapidly-dying product, sales data suggest otherwise. Also, the rebate-contracting commercialization model favored by Novo Nordisk enabled Levemir to co-exist on a majority of commercial insurance drug formularies where Novo Nordisk insulins were preferred over those from Lilly, Sanofi or Biocon.

2022 Estimated U.S. Insulin Market Share & Revenue

First, let's look at the actual data rather than listening to statements made in Congressional testimony from a now-terminated CEO. In 2022, over 4.8 million prescriptions for insulin detemir (Levemir) were filled for nearly 1 million patients, according to the Medical Expenditure Panel Survey (MEPS) from the Agency for Healthcare Research and Quality (AHRQ) sourced from ClinCalc Drug Stats Database. Levemir's revenue figure is from Close Concerns/diaTribe News; while other estimates are derived from market share data. The pie chart and table below show selected insulin market share data (the bestsellers) and are not fully comprehensive. Data sources: AHRQ MEPS via ClinCalc DrugStats Database and Close Concerns/diaTribe News.

While the pie chart illustrates market share, it masks the fragmentation caused by multiple biosimilars and follow-on biologics—especially for glargine (the dark blue slice), lispro (the orange slice), and aspart (the yellow slice). In contrast, detemir's (the green slice) share came from a single now-discontinued product—a gap we aim to fill. The key question: how many patients will return once non-medically switched to alternatives?

Alliance to Protect Insulin Choice

That's when I was connected with Alison Smart, who founded the Alliance to Protect Insulin Choice https://alliancetoprotectinsulinchoice.org/. We teamed up to do something about it. Alison has been much more involved in day-to-day efforts (I said I would not be doing any "heavy-lifting" but would offer relevant perspective on issues as they developed), I've been able to share strategic insight and perhaps equally important, important information. Instead of waiting for a major manufacturer, we connected with a biotech startup—one with no current products but a willingness to engage. Novo Nordisk initially stonewalled, falsely claiming that no company had reached out. Eventually, they agreed to speak with the startup, although it has not offered much help since. In other words, Novo Nordisk did as little as they could get away with doing. 

It also suggested that Levemir was a rapidly-dying product. That's at best misleading. Thanks to the PBM sponsored rebate-contracting commercialization model, Levemir and Tresiba were able to coexist for many years, thus necessitating Novo's discontinuing Levemir in order to force patients who were not Tresiba users to switch against their will. Big PBM formularies don't usually prefer specific drugs—they prefer manufacturers who offer them fat rebates, enabling Levemir and Tresiba to coexist on most drug formularies where Novo Nordisk insulins were preferred. As long as Novo Nordisk's products are preferred, its older products remained available on-formulary in most cases. 

We've explored a few possible paths forward. One is a potential FDA Rx-to-OTC reclassification for insulin detemir, much like how older human insulins are already being sold—enabling patients to buy them directly from a pharmacist without a doctor's prescription. Another is a low-cost, cash-pay prescription model through retail pharmacies or sellers like Mark Cuban Cost Plus Drug Company. Both are likely scenarios. But success will really depend on fresh thinking—free from deeply corrupt rebate entanglements and outdated assumptions about how insulin must be marketed and commercialized. 

Quiet Influence and Strategic Nudges 

My recent advocacy isn't only about insulin. 

I've also followed the financial and strategic shifts happening in the diabetes technology space. In 2018, Johnson & Johnson sold its LifeScan blood glucose monitoring business to Platinum Equity for $2.1 billion. This past July, I wrote about how LifeScan quietly entered a Chapter 11 bankruptcy through a restructuring support agreement https://blog.sstrumello.com/2025/08/platinum-equity-plans-to-reorganize.html. 

Meanwhile, Haleon—a consumer health spinoff from GSK—is now looking to acquire new assets https://www.thisismoney.co.uk/money/markets/article-15117131/GSK-spin-Haleon-eyes-Tylenol-takeover.html. LifeScan may not be a growth rocket, but it remains a cash-generating business. Despite the hype, CGMs still aren't covered by most insurers for patients with Type 2 diabetes who don't use insulin. That's why Dexcom is selling its new CGM, branded as Stelo, over-the-counter—and why Abbott sells an OTC version of its CGM known as Libre Rio. But these products haven't exactly taken off. Many consumers try the OTC CGMs briefly, then stop using them once they learn how their behavior affects their glucose levels. Low repeat purchases is not a great business model. 

I don't know anyone at Haleon, but I still think if it is looking for acquisitions, then making a bid for what remains of LifeScan could be a good idea, therefore I sent a blind email to a half-dozen employees pitching the idea of LifeScan as a potential acquisition target—not because it's a rapid-growth business, but because its neither obsolete, and the business remains cash-generative. I'm not trying to close a deal—I just want to plant the seed of an idea in someone's mind who has the potential to tell colleagues who might be in a position to make something happen. That's what advocacy sometimes looks like: small, quiet nudges that might help shift the future. Whether it's a blind email to a potential acquirer or a formal complaint to the FTC, I've found that even subtle actions can plant seeds that grow into real accountability and change—especially when state laws like the Donnelly Act (New York State's antitrust law) offer tools when federal regulators ignore gross violations of fair trade and antitrust laws. 

Still in It, But On My Own Terms 

After nearly 50 years with T1D, I don't show up for every walk or respond to every campaign—but that's not retreat, and it's certainly not giving up. It's an evolution. I advocate differently now: more focused, more strategic, and informed by decades of hard-won experience. I know the battles that matter to me, and I've learned how—and where—I can make an impact. That's the diabetes advocacy work I continue to do after a half-century of Type 1 Diabetes (T1D). 

Dexcom's Management Obscures Receivables, Hides Days Sales Outstanding (DSO), and Spins a Narrative Investors Shouldn't Trust

This is certainly a "Business of Diabetes" story. Dexcom Inc., once the undisputed leader in continuous glucose monitoring, now finds itself at a troubling inflection point. What else would you call a company that rushes a new product to market using inferior materials to match a competitor's launch date, while its CEO quietly takes an extended leave before announcing his departure, and its senior executives exit en masse? Management textbooks might call it a case study in corporate short-termism, poor governance, and cultural toxicity. These aren't isolated missteps; they're symptoms of deeper management dysfunction at Dexcom, Inc.

For years, Dexcom enjoyed a stellar run. Its G6 sensor was praised, its margins were strong, and its reputation among patients and clinicians was enviable. But cracks have begun to show. In July 2025, CEO Kevin Sayer announced he would step down on January 1, 2026 (contained in the quarterly earnings release found at https://www.businesswire.com/news/home/20250730050482/en/Dexcom-Reports-Second-Quarter-2025-Financial-Results-Updates-Full-Year-2025-Guidance-and-Announces-CEO-Succession-Plan/ for details), after a decade at the helm. His successor, Jake Leach, currently serves as President and COO. Yet Sayer's extended absence (see https://www.drugdeliverybusiness.com/dexcom-ceo-takes-temporary-leave-absence/ for the news) before the announcement raised eyebrows, and the leadership transition comes amid troubling signs.

Perhaps the most telling indicator of Dexcom's decline is its over-reliance on questionable accounting maneuvers—gimmicks that forensic accountants can spot with ease. According to Nick Gibbons, an Adjunct Assistant Professor of Accounting at NYU Stern and contributor to Hunterbrook Media, Dexcom used similar tactics back in early 2024. Specifically, the quarter after Dexcom's Days Sales Outstanding (DSO's) spiked near 100 in early 2024 — an issue flagged at the time by the accounting group — the company's stock fell around 40%. The DSO number obscures weaker-than-expected earnings. Gibbons, an alumnus of ASU's Thunderbird School of Global Management, who also teaches courses on financial statement fraud for NYU, and recently dissected Dexcom's filings in a critical Hunterbrook article (see https://hntrbrk.com/dexcom/ for the article).

His analysis coincides with a wave of senior executive departures at Dexcom. 

In October 2024, EVP and Chief Commercial Officer Teri Lawver announced her retirement (see the MedTech Dive article on Teri Lawver's retirement at https://www.medtechdive.com/news/dexcom-chief-commercial-officer-retire-earnings/731135/). Hers was a high-profile exit, but it was hardly the only one. Barry Regan (EVP of Global Operations), Paul Flynn (EVP of Global Revenue), Steven Pacelli (EVP and Managing Director of Dexcom Ventures), Laura Endres (SVP of North American Channels and Payors), Andre Hoth (Head of Engineering for pump integration), and John Alvio (Treasury Supervisor) have all left the company within the past year. This exodus suggests internal instability, not just routine turnover.

Adding to the growing list of concerns, Dexcom is now facing a surge in customer complaints about its newer G7 sensor.  And, I'm not even mentioning Dexcom's over-reliance upon legally-exempted rebate kickbacks paid to PBMs contingent-upon "formulary-exemption" which aims to prevent patients from having access to rival CGM products such as Abbott's Freestyle Libre products, although I have written about that in the past (catch my coverage of the Nick Jonas Superbowl ad fiasco HERE).

Dexcom's G7 CGM sensor with built-in transmitter

That product, rushed to market, has been plagued by (in)accuracy issues and regulatory scrutiny. According to FDA documents published by Hunterbrook (see FDA warning letter at  https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dexcom-inc-700835-03042025/ for more detail), Dexcom made unauthorized changes to a critical component: the membrane coating on the sensor filament. Originally sourced from a third-party silicone compound, the coating was designed to block chemical interference—especially from acetaminophen—and to help ensure accurate glucose readings. Dexcom replaced it with an in-house formulation, developed by individuals with questionable scientific credentials. The FDA privately warned Dexcom that its own tests showed the new coating performed worse.

This isn't just a technical hiccup. 

It reflects a corporate culture that consistently prioritizes commercial speed over science. Only the financial consequences of that are just starting to become evident. For example, Dexcom's gross margin has declined for 15 consecutive quarters, falling to 59.5% in Q2 2025. While the company offered various explanations or excuses, analysts at Goldman Sachs and JPMorgan have flagged the Dexcom margin pressure as structural. Excess and obsolete inventory charges, likely tied to product flaws and returns, are weighing heavily.

Hunterbrook's article (again, see https://hntrbrk.com/dexcom/ for the article), provocatively titled "Dexcom's Fatal Flaws," may lean toward some hyperbole, yet the underlying concerns are genuine. Many newly diagosed patients do not realize that CGMs don't actually measure blood glucose directly; they measure correlated substances found in interstitial fluid. That's why clinicians recommend verifying suspected erroneous CGM readings with a fingerstick test. Yet many newly diagnosed patients and caregivers don't even realize this and rely upon Dexcom readings as if they were not subject to error, and yet the G7's inaccuracies have led some to abandon Dexcom altogether. Longer-term patients have the luxury of knowing how flawed CGMs actually are.

Riva Greenberg, a longtime diabetes advocate and writer for Huffington Post and diaTribe News, blogged earlier in 2025 how she switched to Abbott's Freestyle Libre 3/Libre 3 Plus. Covered by traditional Medicare with a Medigap supplement, hence she made the transition after frustrations with the G7. In her blog, Diabetes Stories, she candidly described her disappointment with Dexcom's latest offering (see https://diabetesstories.com/2023/07/21/im-sorry-to-say-im-not-loving-dexcoms-g7/ for her post).

Others have conducted side-by-side comparisons of the G6 and G7. Among them include Dan Heller, a former CEO of a molecular diagnostics firm based in the Bay Area, who happens to be a person living with T1D himself, ran both sensors concurrently and documented the discrepancies. His Substack article, which draws heavily from Hunterbrook's reporting, adds a personal layer to his technical critique demonstrating the G7's flaws. His Substack article chronicling those comparisons can be read at https://danheller.substack.com/p/dexcoms-tumble-and-the-ill-fated-g7-sensor/.

Taken together, these developments paint a picture of a company (Dexcom) in trouble—not just operationally, but culturally and financially. Whether Jake Leach can reverse the tide remains to be seen. But the warning signs are no longer subtle. Dexcom's reputation, once built on trust and innovation, is now being tested by the very patients it was meant to serve.

On the upside, even while my own insurance company's PBM is collecting kickbacks from Dexcom contingent upon "formulary exclusion" of competing CGMs, and even while Aetna/Caremark cover about 37% to 40% of Dexcom sensor costs pre-deductible to ensure that kickback cash continues to flow to Caremark, as I blogged back in December 2023 (catch my coverage at https://blog.sstrumello.com/2023/12/abbott-gets-real-about-formulary.html for more), patients can use a manufacturer coupon from Abbott even if their insurance company tries to prevent you from using any CGM other than Dexcom. 

Below is Hunterbrook Media's video of its article "Dexcom's Fatal Flaws" which can be seen at https://youtu.be/_ogUlKUEVmQ?si=d3lmMOQhfvS8S8Tq or below. 

On Immunization, Blue & Purple States Declare Independence from Disproven Federal Anti-Vax Policies Imposed by Trump HHS Secretary

This was both predictable and inevitable.

The United States now finds itself navigating a fractured public health landscape, a direct consequence of the Trump administration's appointment of Robert F. Kennedy, Jr. (RFK Jr.) as Secretary of Health and Human Services (HHS). Mr. Kennedy is a lawyer with no medical training and a long history of promoting anti-vaccine misinformation. Under RFK Jr's leadership of HHS, he discontinued Emergency Use Authorization for COVID vaccines, and while the FDA has approved new ones with narrower eligibility similar to what were in place before the pandemic, plus he has also dismantled federal immunization guidance by firing the independent panel who make public recommendations. In doing so, that has left local health departments scrambling to respond to a crisis manufactured not by science, but by political ideology. The result is a nation where residents of states with competent public health leadership are likely to remain protected, while those in states governed by underfunded, incompetent, or politically-compromised agencies face renewed vulnerability to largely preventable infectious diseases.

For decades, public school districts across the country have required students to be immunized against a host of transmissible illnesses—polio, measles, mumps, rubella (the preceding three are just a single immunization!), hepatitis B, chickenpox, diphtheria, tetanus, and pertussis among them—before attending taxpayer-funded schools. These policies have not only proven effective, but have also enjoyed widespread support from public health officials and the general public. Parents opposed to vaccination have always retained the right to homeschool their children, although those children may still be subject to standardized testing. Alternatively, some families have opted for private religious schools that offer exemptions, though these come at a financial cost many cannot afford.

The principle behind these policies has always been clear: individuals may make personal health choices, but they do not have the right to endanger others in public institutions. If parents wish to avoid immunizing their children, they must seek alternatives outside the public system. Otherwise, they are expected to comply with established public health requirements.

That clarity has now been upended. 

In states like Florida, Republican-led efforts to eliminate vaccine mandates for school children threaten to reverse decades of progress. Florida's Surgeon General Joseph Ladapo has championed these changes, despite pushback from qualified medical professionals within the state. If Florida proceeds with its plan to dismantle vaccine requirements, it will not only expose its own children to preventable diseases, but also risk exporting contagions to other states and countries. In order to protect their children, parents in Florida should consult with pediatricians rather than relying on state guidance, as the science remains unequivocal: immunizations work, and children in public schools should be protected.

The broader national immunization system—once a model of consistency—has become unsustainable under Kennedy's leadership. His tenure has been marked by the removal of CDC Director Susan Monarez, the replacement of the CDC's independent vaccine advisory committee with known vaccine denialists, and the imposition of more restrictive policies that limit access to COVID booster shots. Even eligible individuals have struggled to obtain vaccines due to new prescription requirements and supply chain disruptions. Senator Bill Cassidy, himself a physician, has accused Kennedy of "effectively denying people vaccines," a charge Secretary Kennedy has been unable to refute with evidence.

The consequences have been swift and severe. Measles, once considered eliminated in the United States since 2000, has reemerged in outbreak clusters among unvaccinated populations. More than 1,400 cases have been confirmed, a grim milestone that underscores the dangers of abandoning science-based policy.

Kennedy's appointment was always controversial. His questionable background includes a decade of work for the anti-vaccine organization Children's Health Defense, and he has also publicly admitted to long-term heroin abuse. His advocacy for disproven COVID treatments like ivermectin and hydroxychloroquine—neither of which has demonstrated efficacy, and both of which pose potential harm—further discredits his leadership. As Pete Buttigieg aptly noted in a recent Substack article (see https://petebuttigieg.substack.com/p/what-rfk-jr-is-taking-away-from-you/ for more), "Robert F. Kennedy, Jr. is not just a quack; he is a quack with power, and he is using that power to undermine public health."

Mother Jones magazine offered a similarly scathing assessment (see https://www.motherjones.com/politics/2025/09/rfk-jr-is-living-in-a-pretend-anti-vax-world/ for detail), while Axios reported on the growing resistance among Democratic-led states (refer to https://www.axios.com/2025/09/05/rfk-vaccine-rule-states-democrats-vaccine-rules/ for more). That resistance has now crystallized into action. NPR offered another article about actions being taken at the state-level found at https://www.npr.org/sections/shots-health-news/2025/09/06/nx-s1-5532121/states-vaccine-guidance-washington-oregon-new-mexico.

States Seeking Alternatives to Federal Immunization Guidance

In early September 2025, the governors of California, Oregon, Washington (and subsequently joined by the State of Hawaii) announced the formation of what they are calling the "West Coast Health Alliance", a multistate coalition to coordinate public health guidelines separate from the CDC, with a commitment to upholding scientific integrity in public health. Their joint statement (https://governor.wa.gov/news/2025/washington-california-and-oregon-launch-new-west-coast-health-alliance-uphold-scientific-integrity/) condemned the politicization of the CDC and pledged to restore evidence-based policy.

Colorado, often considered a purple state, joined the movement. Governor Jared Polis issued Public Health Order 25-01, directing state agencies to ensure access to updated COVID-19 vaccines (see https://governorsoffice.colorado.gov/governor/news/governor-polis-cdphe-take-swift-action-ensure-easy-access-covid-19-vaccines-coloradans-fall/).

Pennsylvania followed suit. Governor Josh Shapiro empowered pharmacists to follow guidance from trusted medical organizations like ACOG, AAP, AAFP, and the FDA, rather than relying solely on the CDC (https://www.pa.gov/governor/newsroom/2025-press-releases/state-board-of-pharmacy-votes-to-protect-vaccine-access-across-p/).

Massachusetts Governor Maura Healey issued a standing order allowing pharmacists to administer COVID boosters to residents aged five and older, and mandated that insurers cover all state-recommended vaccines without out-of-pocket costs for people in Massachusetts (refer to https://www.mass.gov/news/governor-healey-announces-immediate-steps-to-ensure-vaccine-availability-in-massachusetts-amid-trump-rfk-rollbacks/).

New Mexico's Health Secretary Gina DeBlassie issued a public health order to remove barriers and expand access to COVID vaccines statewide (see https://cv.nmhealth.org/wp-content/uploads/2025/08/PublicHealthOrderCOVID19Vaccine-20250830.pdf).

New York Governor Kathy Hochul signed an Executive Order (EO) allowing pharmacists to administer COVID vaccines to eligible patients without a prescription, with plans to renew the order until the legislature modifies state laws to reduce reliance on federal guidance (https://www.governor.ny.gov/news/governor-hochul-signs-executive-order-expanding-access-vaccines-amid-uncertainty-washington/). She said she intends to renew the EO every 30 days until the State legislature can reconvene and change state laws to offer credible alternatives to CDC guidance on immunizations, and the legislation is expected to also expand the ability for pharmacists to prescribe the COVID vaccines off-label even for those who are not currently eligible in accordance with the existing FDA label.

Connecticut and Maine have also reaffirmed their commitment to broad vaccine access. Governor Lamont issued a statement (https://portal.ct.gov/governor/news/press-releases/2025/09-2025/governor-lamont-statement-on-access-to-vaccines/), while the Maine CDC emphasized the importance of timely, safe, and effective immunizations (https://www.maine.gov/dhhs/mecdc/diseases-conditions/immunization/).

In sum, a number of blue and purple states are now doing what the federal government under Secretary Robert F. Kennedy, Jr. refuses to do: protect their residents from infectious illness. By asserting their independence and restoring access to life-saving vaccines, they are not just defying a quack—they are defending public health itself.

Author P.S., September 18, 2025: In a move very similar to the West Coast Health Alliance, a Northeast Public Health Collaborative was formally announced on September 18, 2025 which includes the states of Connecticut, Maine, Massachusetts, New Jersey, New York State, Pennsylvania, Rhode Island, as well as the City of New York (NYC) which was documented in a press release from the NYC Health Department found at https://www.nyc.gov/site/doh/about/press/pr2025/announce-northeast-public-health-collaborative.page — its objectives are very similar to those of the West Coast Health Alliance, which is to coordinate public health guidelines separate from the CDC, with a commitment to upholding scientific integrity in public health. It can follow CDC guidance if the science is valid, but it can also rely on viable alternatives to CDC guidance which has become politicized rather than based upon scientific integrity under HHS Secretary Robert F. Kennedy, Jr., a known vaccine denialist. New York State Governor Kathy Hochul said that the Northeast coalition had agreed that updated COVID-19 vaccines should be given to children ages six months to 18 years, older children and adults with certain risk factors and adults older than 64. The group also said that all adults are recommended to be vaccinated.

Diabetes Mine Innovation Project Study on GLP-1 Therapies and T1D

Some of my followers may recall that once upon a time, there was a diabetes blog started by Amy Tenderich which was called "Diabetes Mine" and it described itself as "a gold mine of straight talk and encouragement for people touched by diabetes. We offer a unique mix of the latest diabetes news, views, and reviews. We also act as a strong voice of patient advocacy, working to foster innovation in diabetes care."

Amy subsequently hired people to manage the content published on the diabetes blog she had started, hence it was run by people who were paid to report on topics relevant to people diabetes, and all of the authors all had diabetes themselves so they shared that perspective which so few publications share (most articles about diabetes are written by people who have no clue what is important to people with diabetes, yet they assert things to be the biggest new improvement when those news items are rarely big or even improvements. But Amy decided to sell the Diabetes Mine blog to an entity known as Healthline back in 2015, which continued publishing and updating it until 2022, at which point, Healthline decided to discontinue updates to Diabetes Mine. No updates have been made to Diabetes Mine since that time.

The decision to discontinue publishing on Diabetes Mine was made in early 2022, with the closure taking effect in April 2022 after 17 years online, according to DiabetesMine.com's Facebook page. Amy Tenderich, the founder of Diabetes Mine, is now focusing on the Diabetes Mine Innovation Project, while Mike Hoskins was to remain with Healthline's broader editorial team.

Anyway, Amy Tenderich continued something she calls the Diabetes Mine Innovation Project https://ddataexchange.com/ if episodically. Earlier in 2025, the Diabetes Mine Innovation Project conducted a nationwide survey of nearly 200 people (technically, 186 respondents) living with Type 1 diabetes to better understand real-world use of GLP-1 receptor agonists (referred to as GLP-1 therapies henceforth) GLP-1 therapies. From access challenges to clinical outcomes, the findings highlight how patients are currently navigating off-label use — and what's working (or not) in daily life. That study has been published at https://drive.google.com/file/d/1WD5LCh07-fbCKR1t3tdjkaojJiG1Zb3W/

The findings, while interesting, remain fairly limited.

The biggest limitation is that it was a survey conducted using a non-scientific "convenience" sample rather than a truly representative sample of adults with T1D, which means that the survey findings may help researchers to better understand off-label usage of GLP-1s among patients with T1D, but they are not truly representative of anything other than the opinions of a few people who answered the survey questions. Right now, there is little quantitative data on T1D GLP-1 usage.

There is also another limitation: the survey itself: it refers to GLP-1s generically, without specifying any particular brand or version of GLP-1 treatment. Novo Nordisk previously tried unsuccessfully to attain FDA "label extensions" on its GLP-1s, but the FDA denied those attempts as little more than an effort to sell the expensive products to a larger audience. Most "studies" have involved only the newest, patent-protected and overpriced GLP-1 treatments, rather than generics.

But, since 2024, the FDA has approved three generics of liraglutide, and even more generics of that product (and others, does anyone remember Lilly's Trulicity?) are currently pending FDA approval decisions. With each new generic that hits the market, prices on all of the others tend to fall even further. The advent of cheaper generics should assuredly be explored, in part, not only because the branded GLP-1 treatments are expensive, but their biggest innovation is they are extended-release products, while generics are dosed daily. But daily dosage offers T1D patients a major advantage of being able to adjust therapy daily based on how glucose levels are impacted. With the newest GLP-1s, patients can only adjust insulin because the GLP-1 lasts all week. That is a limitation of the GLP-1 treatment being commercialized. But generics are readily available now and cost vastly less money.

Key Reasons for Previous FDA Denial or Lack of Label Expansion on GLP-1 Products such as Victoza (liraglutide) in T1D:

• Mechanistic Limitations: GLP-1 agonists help to stimulate insulin secretion from functioning beta cells. In autoimmune T1D, complete beta-cell destruction limits this mechanism, thereby making GLP-1s less effective as a monotherapy. However, many of the Type 2 studies which were combined with insulin were not a basal/bolus regimen, but were conducted on GLP-1s with basal-only insulin which is unheard of in Type 1 diabetes. A well-designed study should be a GLP-1 with a basal/bolus regimen but never with basal-only insulin.

Safety Concerns:

• Increased risk of hypoglycemia when used adjunctively with insulin.
• Gastrointestinal side effects (e.g., nausea, vomiting) may complicate glucose management in T1D.
• Insufficient Efficacy Data:
• Trials have shown modest improvements in weight and insulin dose reduction, but not enough to justify label expansion.
• No consistent evidence of improved glycemic control or reduced complications in T1D populations.

Regulatory Caution:

• The FDA has emphasized the need for far more robust, T1D-specific Phase III data before it would even consider label changes and Novo Nordisk did not want to undertake separate studies on T1D, merely as a leg of a study for T2D and/or obesity. As a result, Novo Nordisk has not submitted a formal supplemental Biologics License Application (sBLA) for its GLP-1s in T1D.
  
  The thinking at the company was that it was already having severe difficulty keeping up with demand among the obese populations without any form of diabetes, so the company never bothered (although it could). That opens an opportunity for peer-reviewed studies not designed by the drug manufacturer which are much more objective (and less tainted by the sponsor company) in nature aiming to sell more of a particular treatment, including those which study different GLP-1 therapies including generic GLP-1 products such as liraglutide from Teva, Hikma or Meitheal Pharmaceuticals, respectively. Academic reseach would appear to be the best vehicle to undertake such objective research.

While the Diabetes Mine Innovation Project study does answer some important, unanswered questions, much more robust and well-designed research is clearly needed. So far, however, these are not on generic GLP-1 products, only the newest, most expensive new GLP-1 therapies. But generics offer an advantage in that they are not extended-release products, enabling more adjustment by the patients either on the GLP-1 or the accompanying insulin dosages.

Biocon's Kirsty Becomes Second Insulin Aspart Biosimilar to Receive U.S. FDA Approval

Just a few weeks ago, on July 15, 2025, Biocon Biologics announced that the U.S. Food and Drug Administration (FDA) had formally approved its Biologics License Application (BLA) for Kirsty™ (insulin aspart-xjhz), a biosimilar copy of Novo Nordisk's first-generation prandial insulin analogue branded as Novolog® (insulin aspart). The Biocon insulin aspart product will also be sold under other brand names through different marketing partnerships which Biocon has established. This means Kirsty joins Sanofi's Merilog as the second FDA-approved biosimilar insulin aspart in the U.S. in 2025, however, Kirsty has the distinction of being the first biosimilar of insulin aspart which has the FDA distinction of being "interchangeable" with the innovator product, meaning pharmacists can substitute Kirsty for Novolog unless the doctor writes "No subsitutions" on the prescription. FDA has approved several copies of the basal insulin analogue Lantus already, and now Novolog, as well as one follow-on biologic copy of Humalog (specifically, Sanofi's Admelog). But, there are quite a few other biosimilar insulins which have yet to receive FDA approval decisions. I expected those to have decisions already, so FDA is running behind schedule rendering decisions on those products.

When Sanofi's insulin aspart biosimilar was approved earlier this year, FDA actually issued its own press release on the decision (see that release at https://www.prnewswire.com/news-releases/fda-approves-first-rapid-acting-insulin-biosimilar-product-for-treatment-of-diabetes-302377321.html for more), but since then, there have been unprecedented staff cuts at FDA which means no more FDA press releases about biosimilar insulins until the Trump/DOGE era with massive staff cuts is over. 

As a result, Biocon decided to issue its own press release on the FDA's approval of its insulin aspart biosimilar, and you can read Biocon's official announcement at https://www.globenewswire.com/news-release/2025/07/15/3115973/0/en/Biocon-Biologics-Expands-Diabetes-Portfolio-with-FDA-Approval-of-Kirsty-the-First-and-Only-Interchangeable-Rapid-Acting-Insulin-Aspart-in-the-United-States.html. The FDA notice of approval and letter which was sent to Biocon Biologics for Kirsty can be viewed at https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761188Orig1s000ltr.pdf. 

Shreehas Tambe, CEO and managing director of Biocon Biologics, said in a news release "With Kirsty, we are expanding treatment choices for people living with diabetes and advancing our ambition to be a global leader in addressing unmet needs in diabetes care."

Biocon originally submitted Kirsty for FDA approval back on July 16, 2020, but in early 2023, the FDA issued a Complete Response Letter (CRL) to Biocon Biologics due to manufacturing concerns at its Johor, Malaysia facility. The FDA's feedback did not question the insulin aspart biosimilar's clinical data, but it cited procedural deficiencies related to the company's adherence to Good Manufacturing Protocol (GMP), particularly issues identified during an earlier inspection of the Johor, Malaysia facility where the insulin is actually manufactured. Until those issues were resolved to FDA's satisfaction, and the site was re-inspected by FDA, no other FDA approvals would be issued for any other insulin products made there. Biocon's 2023 CRL disclosure to shareholders can be viewed at https://www.biocon.com/biocon-biologics-receives-complete-response-letter-from-us-fda-for-biosimilar-insulin-aspart/. 

The successful 2025 insulin aspart FDA approval demonstrates Biocon's ability to successfully resolve those compliance issues without support from Viatris (formerly Mylan), which previously handled regulatory operations for the company's biosimilar joint venture. Biocon acquired Viatris' half of their biosimilar collaboration on November 29, 2022, assuming full responsibility for the regulatory process. The acquisition details are at https://www.prnewswire.com/news-releases/viatris-completes-biosimilars-transaction-with-biocon-biologics-301688467.html. 

Kirsty has already received regulatory approval for sale in more than 40 countries, including Canada, Japan, Australia, and across most of Europe. Health Canada granted its approval on October 12, 2021, and the insulin aspart biosimilar entered the Canadian market in 2022. It has also been approved in markets such as Germany, the UK, France, Spain, Portugal, the Netherlands, Norway, Denmark, Sweden, Finland, and Iceland. Documentation of Health Canada's approval is available at https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00570.

In the United States, since March 6, 2025, Biocon has a commercial agreement with Civica, Inc., a nonprofit pharmaceutical organization and that organization will procure insulin aspart from Biocon Biologics. Under that deal, Biocon will exclusively supply insulin aspart for Civica's U.S. insulin program. The other two insulins included in Civica's biosimilar insulin initiative — insulin glargine and insulin lispro — will presumably still continue to be manufactured by GeneSys Biologics of India. 

Civica will carry out its own "fill and finish" manufacturing operations at its newly built manufacturing facility in Petersburg, Virginia. It also has a confirmed device supply agreement for the UnoPen disposable insulin pen with Swiss company Ypsomed, which will be used across all three of Civica's insulin biosimilar offerings. Civica and Biocon's collaboration announcement can be viewed at https://www.prnewswire.com/news-releases/biocon-biologics-and-civica-inc-collaborate-to-expand-insulin-aspart-access-in-the-united-states-302394010.html. 

While Biocon has not publicly disclosed the specific injection pen device used for its branded Kirsty insulin pens (it already sells the glargine biosimilar Semglee in a pen device and presumably it will be the same model), regulatory filings and manufacturing locations suggest that the likely source is SHL Medical, which is a Swiss company that produces disposable insulin pens in Malaysia. SHL's Madie® device is the candidate that may be used for both Semglee and Kirsty pens. Information about SHL Medical and its Madie® pen can be seen at https://www.medicalexpo.com/prod/shl-healthcare/product-118709-835950.html. 

Although it has been selling Semglee since 2021, navigating the U.S. insulin market may still prove challenging for Biocon. The entrenched rebate-driven pricing system controlled by Pharmacy Benefit Managers (PBMs) means that companies must offer steep rebates to gain favorable formulary placement. When Viatris introduced Semglee on behalf of Biocon back in 2021, it had to dramatically raise the U.S. list price (by more that sixty-five per cent!) in order to meet the 75%+ rebate demands from PBM's such as Express Scripts and Prime Therapeutics. An overview of those rebate dynamics can be found at https://www.drugchannels.net/2021/11/why-pbms-and-payers-are-embracing.html. 

However, the insulin pricing landscape in the U.S. is now shifting. The American Rescue Plan of 2021 removed the cap on Medicaid rebates for drugs whose list prices outpace inflation, which historically allowed insulin makers to keep increasing prices to fund PBM rebates without having to pay any more to Medicaid. Simultaneously, the Federal Trade Commission (FTC) launched litigation against major PBM's over anticompetitive contracting and formulary practices along with subsequent litigation against the PBM's. Discussion of these policy changes appears at https://progressivepolicyinstitute.medium.com/are-we-on-the-cusp-of-a-new-drug-pricing-paradigm-fdf611c009b3 and my own blog post found at https://blog.sstrumello.com/2025/01/why-i-pushed-for-ftc-litigation-against.html. 

Meanwhile, Civica's nonprofit insulin initiative, supported by funding from Breakthrough T1D (formerly known as JDRF), aims to bypass the PBM rebate model entirely by offering insulin aspart, glargine, and lispro at a maximum retail price of $30 per vial or $55 per box of five pens. The pricing strategy is meant to provide transparent, low-cost alternatives without formulary restrictions. More on Civica's insulin initiative is at https://blog.sstrumello.com/2022/03/civica-rx-were-entering-us-insulin.html, while Breakthrough T1D/JDRF's announcement of Civica's price commitments is available at https://www.prnewswire.com/news-releases/jdrf-announces-support-of-civica-to-manufacture-and-distribute-low-cost-insulin-301495050.html and Civica's own statement is at https://www.businesswire.com/news/home/20220303005321/en/Civica-to-Manufacture-and-Distribute-Affordable-Insulin. 

Following the FDA's approval of Biocon's Kirsty insulin aspart biosimilar, Novolog now becomes the second insulin analogue — after Sanofi's Lantus — to face competition from more than one biosimilar and/or follow-on biologic product from several different manufacturers in the U.S. In February 2025, Sanofi's Merilog became the first FDA-approved biosimilar of Novolog. Several more biosimilar versions of insulin aspart are still awaiting regulatory decisions, with applications currently pending from Sandoz/Gan & Lee, Amphastar/ANP, Lannett/HEC, and Meitheal/THDB a few years later. 

Commentary on my assessment of the backlog of biosimilar insulin drug decisions is available at https://blog.sstrumello.com/2025/01/ask-fda-why-arent-insulin-biosimilars.html. Reporting on recent major FDA staffing disruptions attributed to DOGE and current Department of HHS leadership can be seen at https://www.nytimes.com/2025/07/08/magazine/fda-collapse-rfk-kennedy.html. 

Just as it did with its glargine insulin biosimilar which is branded as Semglee, Biocon could theoretically offer both branded Kirsty sold via PBMs and a separate unbranded insulin aspart product in the U.S. (although with insulin list prices falling on all insulins in the U.S., see https://www.drugchannels.net/2025/01/inflation-adjusted-us-brand-name-drug.html for more on that development), an unbranded insulin aspart product may no longer be a necessity for Biocon; for example, Novo Nordisk announced it will be discontinuing its unbranded insulin products by the end of 2025), in multiple delivery formats including 10 mL vials as well as in disposable insulin pens. Although Biocon has not announced that it intends to sell Kirsty in a package of five 3 mL cartridges as an option for patients who prefer to use refillable smart pens such as the Medtronic InPen (a smart pen which logs insulin dosages and tracks insulin-on-board), theoretically 3 mL cartridges might have demand in the U.S. However, there was news that a self-filled injection device called the Go-Pen ApS quite recently received FDA clearance, and the fillable 3 mL cartridges used with that product could potentially be a work-around for that, although that product has not yet launched in the U.S. (see https://www.drugdeliverybusiness.com/go-pen-fda-nod-user-filled-insulin-pen/ for more). 

With rising pressure on insulin list pricing, increased regulatory scrutiny of PBM's unlawful behavior, including from the Federal Trade Commission which is now suing the big PBMs and their rebate-contracting pharmaceutical sales model in the U.S., and the emergence of nonprofit options such as those from Civica, the dynamics of insulin pricing in the U.S. are finally shifting and list prices are falling in the U.S. The entry of multiple biosimilar insulin aspart products — especially those developed outside of (or working around) the rebate-contracting sales model — could mark a long-awaited turning point for U.S. insulin affordability. 

In my opinion, it is about time.

Platinum Equity Plans to Reorganize LifeScan Diabetes Testing Business in Chapter 11 Filing

As a person living with Type 1 diabetes (T1D) and hypoglycemia unawareness, I rely on traditional fingerstick blood glucose monitoring (BGM) to stay safe. CGMs may be the future for some, but they're not a reliable replacement for patients like me. CGMs can miss dangerous lows until it is too late, or report erroneous data at critical moments. The collapse of a major Blood Glucose Monitoring (BGM) supplier like LifeScan isn't just a financial story — it's a potential threat to patient safety.

Back in 2017, Johnson & Johnson (J&J) began retreating from its diabetes business. First came the shutdown of Animas Corp., its insulin pump unit. Then it offloaded Calibra Medical, maker of a wearable insulin patch, to CeQur. Finally, in 2018, J&J sold LifeScan https://www.prnewswire.com/in/news-releases/johnson--johnson-announces-binding-offer-from-platinum-equity-to-acquire-lifescan-inc-677074533.html — maker of the OneTouch blood glucose meters and test strips — to the private equity firm Platinum Equity for $2.1 billion https://www.globenewswire.com/news-release/2018/10/02/1588268/0/en/Platinum-Equity-Completes-2-1-Billion-Acquisition-of-LifeScan-From-Johnson-Johnson.html.

I'm not a big fan of the idea of private equity in the healthcare space, but the reality is that Platinum failed to cut LifeScan's expenses or grow its revenues, while also increasing rebates paid to Pharmacy Benefit Managers (PBMs) contingent upon "formulary exclusion" of all competing BGM brands.

At the time of sale, LifeScan held about 45% of the traditional fingerstick testing market. But even then, the future was clear: Continuous Glucose Monitors (CGMs) were ascendant among insulin users, and BGM was already being commoditized thanks to PBM profiteering.

Fast-forward to 2025, and Platinum's LifeScan acquisition has hit a wall. On July 7, 2025, the firm announced plans to restructure the business through a Chapter 11 bankruptcy filing https://www.businesswire.com/news/home/20250715827575/en/LifeScan-Reaches-Milestone-Transaction-to-Improve-Financial-Flexibility-and-Enable-Future-Focused-Investments/.

LifeScan's restructuring plan has support from its first- and second-lien lenders, meaning Platinum keeps control without putting in another dime. But third-lien creditors — namely insurance company–owned PBMs — are still waiting for a bankruptcy court to decide what, if anything, they'll get.

According to Bondoro Insights https://bondoro.com/lifescan/, LifeScan owes nearly $676 million in unpaid rebates to the three biggest PBMs: 

• CVS Caremark (Aetna): $244.7 million
• OptumRx (UnitedHealthcare): $234.9 million
• Express Scripts (Cigna): $196.3 million

And here's the kicker: the PBMs might walk away with nothing.

A commenter on my blog summed it up perfectly: "I find it highly amusing that PBMs are getting the shaft from private equity. Is there no honor among thieves?"

It's hard not to chuckle. PBMs are notorious for pocketing manufacturer rebates intended to reduce patient out-of-pocket costs, only to use those funds to enrich themselves — and their commercial health insurance company parent companies. Now they're on the losing end of a financial shell game they usually run.

Max Frumes of 9fin, who oversees global coverage of distressed debt and restructuring, called LifeScan's BGM business a "melting ice cube" https://9fin.com/insights/lifescan-deal-platinum-equity/  — a fading revenue stream in a CGM-dominated world. Still, fingerstick testing isn't obsolete. Most insurance plans still don't cover CGMs for non–insulin users (which explains Dexcom's big announcement that its Stelo product would be sold OTC; rival Abbott also sells an OTC CGM which is branded as the Libre Rio), plus most doctor's offices still use BGM for triage.

Again, for patients like me, CGMs are not an entirely dependable substitute. I need fingerstick tests to detect and confirm hypoglycemia that CGMs can be too slow to pick-up or even miss completely. This isn't a matter of convenience — it's a matter of survival.

Interestingly, while LifeScan was circling the drain, Roche — another BGM heavyweight — took a different approach. Unable to sell its own BGM business and not being on many insurance company preferred formularies, Roche partnered with Mark Cuban's Cost Plus Drug Company back in 2022 to offer Accu-Chek supplies directly to consumers https://www.accu-chek.com/news/roche-and-mark-cuban-cost-plus-drug-company-team-deliver-affordable-access-diabetes-testing/. That partnership bypassed PBMs entirely, offering patients far more affordable prices without the rebate games.

The cash-pay model had its roots in a fiery 2009 patient summit with Roche, where I was present. Patients challenged the company's presumption that insurance always covered test strips — ignoring growing deductibles and cost-sharing. Roche eventually realized that rebate contracts weren't the only viable route to market.

That insight proved prescient. In May 2025, Aetna/CVS Caremark informed patients it was dropping OneTouch in favor of Accu-Chek as its preferred BGM brand — effective around the same time LifeScan filed for bankruptcy. Now, those same PBMs may get $0.40 on each dollar they're owed, although it's also a possibility they'll never collect a cent of the rebates LifeScan owes them.

Some analysts argue PBM rebates should be prioritized in bankruptcy because they're "essential" to the business. But let's be honest: PBMs are more like financial parasites than partners. Their rebate-driven sales model has distorted prices, stifled competition, and hurt patients for years. Maybe it's about time their influence shrinks.

What's next for LifeScan?

Realistically, Platinum overpaid in 2018. Ideally, the LifeScan business would have been included as part of its spinoff of former businesses including Band-Aids and Tylenol called Kenvue, but Platinum Equity offered the company more money, so that's where things are now. LifeScan entering the CGM market now would be a long-shot, with Abbott and Dexcom dominating that space — and it would eat into LifeScan's already slim margins. LifeScan's time is running out — and private equity doesn't tend to play the long game.

For now, it seems the PBMs — long the masters of the rebate racket — have finally been outmaneuvered.

Could There Be Trouble In Civica's Insulin Biosimilar Paradise?

It is possible you might not have caught an obscure press release (see the press release at https://www.prnewswire.com/news-releases/biocon-biologics-and-civica-inc-collaborate-to-expand-insulin-aspart-access-in-the-united-states-302394010.html for more details) from March 6, 2025 released by Biocon Biologics Ltd. which had announced a deal with the U.S. nonprofit drug company Civica, Inc. for insulin aspart only. 

Under the terms of that particular agreement, Biocon Biologics agreed to supply insulin aspart drug substance to Civica, Inc., who will use that drug substance to produce its own insulin aspart drug product at its "fill & finish" manufacturing facility in Petersburg, Virginia (located near the state capital of Richmond). Civica will commercialize that medicine for patients in the United States, "after completion of development work and clinical trials". The latter's insulin Biologics License Applications (BLAs) are complete, except that Civica (as well as Biocon) awaits FDA approval decisions which have yet to be rendered as I write this. When Civica announced on March 3, 2022 that it was entering the U.S. biosimilars insulin space, the company revealed it would procure the insulin aspart Active Pharmaceutical Ingredient (API) from a firm known as GeneSys Biologics (see http://dlvr.it/SL0QZV for the original news release). Now, it has a new supplier, but [so far] only for insulin aspart.

In fact, while FDA finally approved Sanofi's biosimilar copy of insulin aspart on February 14, 2025 (catch my coverage of that at https://blog.sstrumello.com/2025/02/fda-approves-merilog-insulin-aspart.html for more), becoming the first biosimilar insulin FDA rendered a decision on in over three years, that lead me to question the reason FDA has a substantial backlog of insulin biosimilars which it has not yet rendered decisions on (see https://blog.sstrumello.com/2025/01/ask-fda-why-arent-insulin-biosimilars.html for my coverage of that). 

Let me add that we are now more than halfway through 2025, and FDA has approved only one insulin biosimilar, and yet we know at least ten others are pending from Sandoz/Gan & Lee, Lannett Company/HEC, Amphastar Pharmaceuticals/ANP as well as Civica and whomever the company procures the insulin APIs from. Those include more biosimilars of glargine, aspart and a few of lispro. And, we know another three more are a few years behind those, including three from Meitheal Pharmaceuticals/THDB (which has copies of glargine, aspart and lispro in development). Originally, I presumed some of the delays were attributed to worldwide Covid-19 lockdowns, but there are hints of more problems at FDA and potentially with some of the companies developing insulin biosimilars more broadly. 

The reason the March 6, 2025 news release from Biocon and Civica on insulin aspart was so surprising is because when Civica first announced that it intended to sell biosimilars of insulin glargine, insulin aspart and insulin lispro (to be sold at a price of no more than $30/vial or $55/box of five prefilled insulin pens), is because when Civica (along with Breakthrough T1D/JDRF) made the original announcement about three years earlier (back on March 3, 2022) that Civica would be entering the biosimilar insulin business, Civica revealed that it would procure the insulin Active Pharmaceutical Ingredients for each from a Hyderabad, India-based biotechnology firm known as GeneSys Biologics, Ltd., but not from Biocon. One additional peculiarity is that the March 6, 2025 announcement was the agreement was only for insulin aspart, but not for the insulin glargine or for insulin lispro biosimilars. 

The original 2022 Civica press release stated: "Civica has entered into co-development and commercial agreement with GeneSys Biologics for these three insulin biosimilars." You may read the company 2022 press release at https://www.businesswire.com/news/home/20220303005321/en/Civica-to-Manufacture-and-Distribute-Affordable-Insulin/ along with the concurrent JDRF (now Breakthrough T1D) press release at https://www.prnewswire.com/news-releases/jdrf-announces-support-of-civica-to-manufacture-and-distribute-low-cost-insulin-301495050.html, although I covered news about the 2022 announcement on my blog in a post found at https://blog.sstrumello.com/2022/03/civica-rx-were-entering-us-insulin.html for more details. Originally, I presumed FDA had a slight backlog which might be attributed to worldwide Covid-19 lockdowns, but I think because FDA collects user-fees from these companies, it has an obligation to render decisions (which it has not yet made), and it can use the user-fees which it collects to pay for the staff needed to make those decisions. 

There is something else peculiar about the 2025 Biocon Biologics/Civica announcement on insulin aspart. On January 7, 2022, Biocon Biologics revealed to investors that the U.S. FDA had denied the company's insulin aspart application by issuing a Complete Response Letter (CRL). However, Biocon told investors "This CRL did not identify scientific issues with the product but referenced Form 483 observations (which are Inspectional Observations at the conclusion of a manufacturing facility inspection. It lists conditions or practices observed during the inspection that, in the investigator's judgment, may constitute violations of the Food, Drug, and Cosmetic Act or other relevant FDA regulations.) from a pre-approval inspection of their [Johor,] Malaysia facility." (see https://www.bioconbiologics.com/the-usfda-issues-a-complete-response-letter-for-the-biologics-license-application-bla-for-insulin-aspart/ for more). Still, in the three years since then, FDA did not move on any insulin biosimilars until its Valentine's Day approval of Sanofi's Merilog biosimilar of Novo Nordisk's Novolog. Three years, user fees, and no decisions? That strikes me as pushing the limits on decisions. Its not as if taxpayers are paying for the staff needed to make these decisions, the applicants are paying for that. 

What this means is that effective as of March 6, 2025, Civica announced a new supply agreement for a Novolog biosimilar from a company which does not even have FDA approval to sell an insulin aspart biosimilar. But this could suggest that the biotech partner Civica originally announced an agreement with back in March 2022 known as GeneSys Biologics might be having some issues in replicating the insulin aspart molecule, effectively prompting the company to find a new supplier for that, and the supplier the company chose is Biocon Biologics (which does not yet have FDA approval to sell an insulin aspart biosimilar). 

We should be asking whether Civica might have observed problems with GeneSys Biologics making copies of Novolog specifically, and sought to resolve that with a more experienced partner who had the ability to deliver. Remember: Biocon's aspart biosimilar was denied by FDA not for scientific reasons, but because previous citations by FDA at its Johor, Malaysia manufacturing facility had not yet been resolved. FDA won't approve any others until existing problems are fixed to its satisfaction. 

So far, we have not yet heard any particular problems on copies of Lantus or Humalog, although if the partner cannot deliver on them all, that is not very reassuring. And, Civica might remain committed to its original contract with GeneSys Biologics on glargine and lispro suggesting that the main difficulties were with aspart.

Maybe. But there is a sense in the biotechnology industry that making copies of insulin analogues might be easier than it really is. That's where having a competent biotech partner can help, and also a partner which can manage those relationships. 

Sandoz has a Chinese lab partner named Gan & Lee making its insulin biosimilars (catch some of my prior coverage HERE and HERE), and in 2023, Gan & Lee has regularly reported via LinkedIn when the company had submitted BLA's (Biologics License Applications) for glargine https://www.ganlee.com/detail/683.html, lispro https://www.ganlee.com/detail/690.html, and insulin aspart https://www.ganlee.com/detail/691.html. My impression is that even while Gan & Lee is based in China, Sandoz is managing its partners' development timeframes and milestones quite closely. And yet, FDA hasn't (yet) rendered any decisions on those, either. 

We should demand that our lawmakers ensure the FDA makes some decisions. Covid is over, so excuses for not rendering those decisions is unacceptable and they have had several years to consider them.

Mark Cuban Cost Plus Drug Company Enters the Telehealth Arena for Generic GLP-1s

On June 17, 2025, Mark Cuban Cost Plus Drug Company PBC announced a collaboration with a telehealth company known as 9amHealth (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, and one article at https://www.fiercehealthcare.com/payers/mark-cubans-cost-plus-drugs-partners-virtual-obesity-clinic for more details). It is worth acknowledging that 9amHealth is a startup begun Frank Westermann and Anton Kittelberger, and as FierceHealthcare documented, both of those guys happen live with Type 1 diabetes themselves even though their business is primarily focused on T2D and obesity [9amHealth is also the telehealth company which Lilly's LillyDirect uses]. 9amHealth's services are anything but cheap; membership costs $149 per month, which is why the Mark Cuban Cost Plus Drug Company/9amHealth telehealth collaboration will initially focus on employers.

You may recall that STAT News reported back in October 2024 (the article is behind a paywall, but if you have access, visit https://www.statnews.com/2024/10/17/telehealth-online-compounded-glp1-prescriptions-medical-groups/ for more) that "sketchy" telehealth firms were responsible for a vast majority of the GLP-1 prescriptions. Not surprisingly, all of those prescriptions have been for the newest, most expensive GLP-1 products, never for less costly generic products (as I write this, the U.S. Food and Drug Administration [FDA] has approved three generic GLP-1 medicines, all of which are for the drug known generically as liraglutide [fka Victoza/Saxenda]). You may also recall that I blogged that researchers from Cedars-Sinai Medical Center in Los Angeles showed an overwhelming majority of those GLP-1 prescriptions were for weight-loss instead of for Type 2 diabetes. Regardless, being denied access to less-costly GLP-1s whether for T2D or obesity is an issue, which is why the Mark Cuban Cost Plus Drug Company PBC/9amHealth could potentially be disruptive.

Teva Pharmaceuticals introduced the first generic GLP-1 on June 24, 2024 (I blogged about that at https://blog.sstrumello.com/2024/07/tevas-biosimilar-of-liraglutide-will-be.html). However, I discovered that most of the same companies which are working on bringing biosimilar insulins to market all also have generic versions of liraglutide pending approval decisions. Teva's copy of Victoza was followed by another copy from Hikma Pharmaceuticals USA, which was approved on December 23, 2024 and then another copy from Meitheal Pharmaceuticals on April 3, 2025 (catch my coverage of those at https://blog.sstrumello.com/2024/12/fda-approves-second-generic-glp-1.html for more). More copies of liraglutide from Biocon, Sandoz, Amphastar Pharmaceuticals, and Lannett Company are known to be in development.

There are a few items worth pointing out. 

First, these are hardly the only generics, these are merely the first ones to receive FDA approvals. But a bunch more copies now await approval decisions, and with each new generic to hit the market, prices tend to fall even further. The initial discounts were modest at best, so the more that come to market, the more prices are expected to fall.

Second, it is worth acknowledging that the first three copies of liraglutide are currently only approved for the treatment of Type 2 diabetes (fka Victoza). Just as Novo Nordisk did originally, the generics companies will need to successfully apply for an FDA "label extension" for the indication of obesity without Type 2 diabetes (fka Saxenda). Those label extensions have not yet happened, but are widely expected to happen. That's when the real gold-rush on less costly generic products is anticipated to start.

Nevertheless, the Mark Cuban Cost Plus Drug Company/9amHealth collaboration is a new dynamic which should likely send shivers down the spines of executives working in Bagsværd, Denmark where Novo Nordisk is headquartered. The reason is because a generic GLP-1 suddenly has a telehealth entity which can prescribe the generic product as freely as the overpriced branded drugs do, opening access to a much wider audience. That dynamic was assuredly never in Novo Nordisk's business plan.

You might also recall that Novo Nordisk's CEO Lars Fruergaard Jørgensen was recently asked to step down (he was essentially fired, although the company Board of Directors instead asked for him to comply with their request that he leaves, or else they would terminate his employment for him, see https://www.fiercepharma.com/pharma/novo-part-ways-longtime-ceo-lars-fruergaard-jorgensen-citing-weight-market-pressures for more). Although the articles on Jørgensen's termination cited competitive pressures in the obesity drug market, that really wasn't the whole story at all.

Novo Nordisk is currently paying big Pharmacy Benefit Managers (PBMs) billions of dollars for "formulary exclusion" of all competing GLP-1 products, which also includes cheaper generics. 

Ironically, it was because of magnitude of Novo Nordisk's U.S. rebating practices to PBMs for insulin that Mr. Jørgensen's predecessor named Lars Rebien Sørensen, who "retired" in 2016, leaving behind shareholder litigation over the magnitude of the company's exposure to legally-exempted rebate kickbacks paid for "formulary exclusion" of all competing insulin products that Lars Fruergaard Jørgensen even became CEO of the company (his predecessor was pushed out of the job, too, which should have been a warning which he ignored). 

It was under the leadership of Lars Fruergaard Jørgensen that Novo Nordisk quietly settled that shareholder lawsuit out-of-court without admission of any wrongdoing (see https://www.bloomberg.com/news/articles/2017-04-28/novo-nordisk-is-sued-over-diabetes-drug-sales-practices for more). Sadly, Mr. Sørensen's successor Mr. Jørgensen not only doubled-down on those kickbacks, but he actually accelerated them, except the bribes were no longer being paid on the insulin therapeutic class of drugs, but on GLP-1s instead (as if that made the practice any different?).

Perhaps it's not at all surprising that Lars Fruergaard Jørgensen got himself fired. He repeated the same ethically-challenged business practices as his predecessor, while he also accelerated those practices. But this post is not about the weakness of Novo Nordisk corporate executives or their lack of ethics. Instead, it is about a marketplace disruptor known as Mark Cuban and his Cost Plus Drug Company deploying the very tactic which sent Wegovy/Ozempic U.S. sales through the roof: telehealth prescribers and suddenly the ability to do this for a cheaper generic product. I've addressed Mark Cuban Cost Plus Drug Company as a disruptive force in the pharmaceutical industry in several previous posts, including the following:

• https://blog.sstrumello.com/2022/10/podcast-recommendation-global-healthy_21.html,
• https://blog.sstrumello.com/2022/10/podcast-episde-recommendation-twist.html,
• https://blog.sstrumello.com/2023/02/mark-cuban-cost-plus-drug-company.html,
• https://blog.sstrumello.com/2023/04/podcast-episode-recommendation-pulse-by.html, 
• https://blog.sstrumello.com/2025/03/sanofi-gets-creative-now-that-pbm.html, 
• https://blog.sstrumello.com/2025/05/cvs-caremarks-preferred-brand-switch.html

While Mark Cuban Cost Plus Drug Company has partnered with a telehealth company of its own and will target employer organizations as a way for them to slash their costs on GLP-1s as obesity drugs, there is now little which would stop an enterprising company from establishing a mail-order business to sell less costly versions of Saxenda. But telehealth is a key to making it happen. 

That also means that unlawful compounders of newer GLP-1s such as semaglutide (Ozempic/Wegovy) which have witnessed Novo Nordisk terminating relationships with companies such as Hims & Hers Health, Inc. (see HERE for more) might instead consider selling legitimate generics of the GLP-1 known as liraglutide, although it might wait until one of them receives an FDA label-extension for the indication of obesity which is widely expected to happen rather soon. Just imagine a company like Hims & Hers pushing generics of Saxenda!

That ought to make executives in Bagsværd justifiably nervous (and deservedly so).