Harness AI (artificial intelligence) to Beat Health Insurance Company Claim Denials

Let's face it: U.S. commercial healthcare insurance companies are incredibly greedy and they don't fundamentally give a $#!+ about patients' health. Their only concern is collecting as much money as possible in premiums while minimizing the amount of money in claims they pay, screwing the Federal government out of billions of dollars by administering Medicare with so-called "Medicare Advantage" plans known as Medicare Part C (for which they make money on/by denying care that regular Medicare would have paid without question), and collecting legally-exempted rebate kickbacks from drug companies which are paid in cash to their PBM units for preferred drug formulary placement or to prevent coverage of cheaper alternative drugs (like generics and biosimilars) via inappropriate, kickback-driven "formulary exclusions". 

As healthcare insurance company whistle-blower Wendell Potter (see https://healthcareuncovered.substack.com/p/unitedhealth-group-the-biggest-private for his write-up) reported:

UnitedHealth's total revenues for the first three months of 2024 were just shy of $100 billion, an increase of 8.6% from the $91.9 billion the company reported for the first quarter of 2023. Revenues have more than tripled over the past decade as the company has moved aggressively into health care delivery, government programs and the pharmacy benefits [management] space. During the same months in 2014, revenues totaled just $31.7 billion. Back then UnitedHealth was the 14th largest U.S. company. It is now the fifth largest, having leapfrogged over companies like Ford and General Motors.

A big driver of United Health's growth has been the taxpayer-supported Medicaid and Medicare programs. Enrollment in the Medicaid plans managed by UnitedHealth has increased nearly 80% since 2014, from 4.3 million to 7.7 million. Enrollment in its Medicare Advantage plans has more than doubled over the same period, from 2.99 million in 2014 to 7.76 million. While the growth in Medicare Advantage slowed this year, UnitedHealth, along with Humana and CVS/Aetna, have captured 86% of new enrollees in the privatized version of Medicare so far this year. Medicaid enrollment declined by 165,000 as states began eliminating coverage for many low-income families that had been covered temporarily with increased federal funding during the pandemic.

In a different article, (see https://healthcareuncovered.substack.com/p/unitedhealths-self-dealing-is-accelerating for that write-up), Wendell Potter added:

Optum is a dominant provider of [which includes Optum's physicians, PBM, claims integrity processing, and revenue cycle management] all these other services. One subdivision, Optum Health, acquired or hired 20,000 physicians [practices] over the past year and now has 90,000 on its roster, or about 10% of all doctors in the U.S. Another subdivision, OptumRx, is the third-largest PBM, a kind of company that comes up with and administers drug benefit plans for insurers, or about 22% of the market. It's also the fourth-largest pharmacy, with about 7% of the market.

Of course, the preceding three paragraphs are exclusively about UnitedHealth, but its big rivals include CVS Health's retail pharmacy chain (the country's biggest) and its Aetna insurance business as well as its Caremark PBM unit plus ancillary businesses such as CVS Healthspire and Oak Street Health, while Cigna's business unit branded as Evernorth operates both the PBM Express Scripts as well as an entity known as MD Live. 

My point is that these insurance companies are giants and they don't really care about whether you receive care you're employer pays premiums for; in fact, they would prefer you did not receive any care. They make more money by denying care.

Personally, I have had routine care denied for vague and non-specific reasons such as "Not Medically Necessary" (especially when a doctor prescribed it and no one from the insurance company examined me, so who are they to question my own doctor?). Fortunately, such denial reasons tend to be fairly easy to dispute, but appeals are a time-consuming hassle to deal with and many people do not bother.

What if there was a way to make that process easier?

Meet the "Fight Health Insurance" AI Tool

Well, now there is something which harnesses the power of artificial intelligence (AI) which is still in beta, but may be poised to make the lives of covered individuals easier.

On August 23, 2024, The San Francisco Standard reported in an article entitled "'Make your health insurance company cry': One woman's fight to turn the tables on insurers" (see https://sfstandard.com/2024/08/23/holden-karau-fight-health-insurance-appeal-claims-denials/ for the article) about a San Francisco tech worker named Holden Karau's efforts to harness AI to manage the laborious task of writing appeals letters.

"Instead of passively accepting the providers' decisions, she'd spend hours writing letters and filling out forms to appeal. It usually worked: Out of roughly 40 denials, she won more than 90% of her appeals, she estimates.

She began helping friends file appeals, too, then asked herself a question that's typical for engineers: Could she figure out a way to automate the process?"

After a year of tinkering, she just launched her answer: Fight Health Insurance https://fighthealthinsurance.com/, an open-source platform that takes advantage of large language models to help users generate health insurance appeals with AI.

 

Today, Fight Health Insurance's "About Us" page describes itself this way:

"We at Totally Legit Co (of Delaware) decided to create 'Fight Health Insurance' (sometimes called by...more colorful names) because we're tired of dealing with health insurance denials. In our opinion, many health insurance denials are bogus, and the insurance companies depend on us not appealing them. We hope that by making it easier to appeal medical health insurance denials, we can change that calculus on insurance companies' part."

It added: 

"Fight Health Insurance is currently a passion project. We have day jobs, but most of us have had terrible experiences with health insurance and we're tired of watching health insurance companies grind down our friends (and tired of being ground down by them ourselves)."

"Fight Health Insurance" even references Breakthrough T1D (fka JDRF) on the website under the category of "Other Resources" specifically for diabetes. I wonder if Breakthrough T1D knows they are referenced here? If so, it would seem to be a good talking point for the organization.

In order to use the "Fight Health Insurance" AI tool, the first step involves scanning your denial letter. This can be done through optical character recognition (OCR) software either on your device/phone (recommended for increased privacy) or on "Fight Health Insurance" servers. OCR makes the text in the denial letters understandable to machines, allowing its generative AI model to produce potential appeals letters for the patient to choose from.

As for OCR tools, there are quite a number of those out there. My preference is to use free tools when possible. Google has several OCR tools of its own, but I also have Microsoft Office (these days, Microsoft sells a subscription-based software model for Office software [Word, Excel, PowerPoint]), but somehow I managed to find a one-time purchase version which I prefer), hence I went with the Microsoft OCR tool which is known as "Microsoft Lens" because it was free with MS Office (and I trust Microsoft slightly more than I trust Google with such info), hence I downloaded that on my iPhone which is where I typically take pictures of printed denial letters from my insurance.

"Fight Health Insurance" Outlines Steps to Overturn Insurance Denial

1. Gather all necessary documents related to the denied claim.
   
   
2. Thoroughly review the denial letter to understand the reasons provided by the insurance company.
   
   
3. Compile pertinent medical records, recommendations, and any additional documentation that supports your case.
   
   
4. Draft a comprehensive appeal letter, addressing each point of denial with factual and supportive evidence. This is the step where "Fight Health Insurance" can help the most.
   
   
5. Submit the appeal letter along with the compiled documents to the insurance company.
   
   
6. Follow up with the insurance company regularly to track the status of your appeal. Often they're required [under state insurance laws] to respond in reasonable [sometimes defined by state law; in the state where I now live, healthcare insurance companies are mandated to issue a decision within 60 days of the receipt of all necessary information].

I recently discovered she was interviewed by the news startup NewsNation, and the interview can be found below, or at https://youtu.be/lI26LrDU2dg?si=wdyV5UPHiRuNUnze:

To be sure, these are six steps which still involves a fair amount of work, although the AI part makes it easier and more efficient for patients. Plus, the use of AI in dealing with commercial healthcare insurance company coverage [or denial] decisions is still very new. But perhaps it is not ironic that the commercial healthcare insurance companies are reportedly rendering decisions on denials using AI themselves, hence it seems to me that patients being able to deploy similar technology in order to fight seemingly baseless denials (like "Not Medically Necessary") is an appropriate use for this new technology. 

GLP-1 Inhibitor Demand Shows Strong Growth Among Those Looking to Lose Weight, Less Robust Growth Among Patients with Type 2 Diabetes

There is no denying the explosive growth in GLP-1 inhibitors, especially among those using the drugs to lose weight but do not have a clinical diagnosis of Type 2 diabetes. But we need to consider exactly where the demand is growing most. It is mostly from people just looking for pharmacologic help to lose weight, and less among those with more serious co-morbid medical conditions. 

For example, back in November 2023, research analysts from J.P. Morgan forecast (see their report at https://www.jpmorgan.com/insights/global-research/current-events/obesity-drugs for details) that the GLP-1 therapeutic category of drug would exceed $100 bn by 2030, which it predicted would be driven equally by Type 2 diabetes and obesity usage. However, the spit between T2D and obesity was a flawed assumption.

One of the J.P. Morgan authors Chris Schott, a Senior Analyst covering the U.S. Diversified Biopharma sector at J.P. Morgan, acknowledged that his company merely made an assumption when it was developing its financial model. All financial models are required to make various assumptions. Today, GLP-1s are only used by around 10-12% of T2D patients in the U.S. 

Schott noted "We model GLP-1 usage expanding to around 35% of diabetics in the U.S. in 2030, and would not be surprised to see upside to this number, especially as outcomes data continues to emerge". But its GLP-1 inhibitor forecast could account for around 9% of the total U.S. population, but the T2D/obesity split could easily shift. Doctors who treat Type 2 diabetes aren't as enamored with the drug class.

But since that time, U.S. demand has particularly shifted away from Type 2 diabetes and more towards obesity without Type 2 diabetes. Demand among Type 2 users has not grown robustly and even declined slightly, while demand has exploded among those looking for phamacologic assistance to lose weight.

According to a study published in July 2024 in the Annals of Internal Medicine (see the study [behind a paywall] at https://www.acpjournals.org/doi/10.7326/M24-0019 and two articles related to the study itself at https://www.cedars-sinai.org/newsroom/new-cedars-sinai-study-investigates-shifting-trends-in-glp-1ra-prescription/ and also at https://www.forbes.com/sites/ariannajohnson/2024/07/22/glp-1s-are-growing-in-popularity-as-weight-loss-drugs-but-losing-steam-among-diabetics-study-suggests/ for more information), researchers from Cedars-Sinai Medical Center in Los Angeles had examined 1 million first-time GLP-1 prescriptions in the U.S. between 2011 and 2023, but they separated patients by those who took GLP-1s to treat Type 2 diabetes, and those who didn't have Type 2 diabetes, but took the drugs for obesity (or obesity-related health conditions including high blood pressure and heart disease).

That study found that those who were prescribed the drugs for obesity or other obesity-related conditions had more than doubled between 2011 and 2023, particularly since 2020, while the amount of new patients prescribed GLP-1s for Type 2 diabetes decreased by almost 10% during the same period.

We are also seeing many obese people being prescribed Novo Nordisk's semglutide branded as Ozempic which is not even FDA-labeled for the indication of obesity, but for Type 2 diabetes, whereas its Wegovy brand which is labeled for obesity has struggled with a combination of over-exposure due to mass media advertising due to the company's prepaid media buys intended to stimulate demand even while the product has been in shortage, a sky-high price-tag for the drugs, and a somewhat less enthusiastic reception from practicing endocrinologists who have seen their patients struggle to get insurance coverage for the latest overpriced version of these drugs, along with less-than-overwhelming secondary benefits. 

By comparison, the cardiovascular benefits with Lilly/Boehringer Ingelheim's sodium-glucose cotransporter-2 (SGLT2) inhibitor known as Jardiance (empagliflozin) has better cardiovascular benefits than GLP-1 medicines, and it can be taken as a pill. There are a number of rival SGLT2 inhibitors (many are less costly) including Farxiga (dapagliflozin) from AstraZeneca, Invokana (canagliflozin) from J&J's Janssen Pharmaceuticals unit, and Brenzavvy (bexagliflozin) made by TheracosBio and sold by the Mark Cuban Cost Plus Drug Company and costs significantly less by having patients just pay cash instead. Mark Cuban Cost Plus Drug Company's cash-only pharmacy also now sells branded Farxiga [dapagliflozin]). On top of that, FDA has already approved one true generic of Jardiance (empagliflozin) from Zydus Pharmaceuticals, although Lilly/Boehringer Ingelheim sued and Zydus settled out-of-court with Lilly/Boehringer Ingelheim agreeing to keep its approved generic off-market until 2025 in a classic pay-to-delay example. 

On the secondary cardiovascular benefits of GLP-1 inhibitors, those were essentially pre-determined by Novo Nordisk in which trials appear to have been designed to prove a specific outcome, rather than truly randomized blind sampling in its effort to secure CMS (Medicare) coverage for the overpriced drugs. Guess what? weight-loss does improve cardiosvascular outcomes, but it is the weigh-loss and not a specific drug which causes those benefits. But no academic research have replicated those secondary benefits, although few studies have specifically looked for them either. But the U.S. Centers for Medicare and Medicaid Services (CMS) did not give Novo Nordisk a free gift; in order for Medicare to pay for Novo Nordisk's semaglutide products for obesity, a patient must have a clinical diagnosis of cardiovascular disease from a cardiologist (a CV disease diagnosis code must be indicated a prescription, making it very difficult to secure widespread prescriptions for vanity purposes as the drugs are being marketed).

Much of the obesity demand for these drugs is being driven by doctors willing to prescribe the overpriced medications by telephone or online without so much as an examination (so-called "drive-by" doctoring). 

Right now, the news cannot stop talking about GLP-1s and the growth trajectory is good. But remember: cheaper versions are already on the market (Teva's version of liraglutide [fka Victoza/Saxenda] has been available since June, and a bevvy of rival biosimilars of liraglutide are poised to hit the market starting December 26, 2024). We know that biosimilars of liraglutide are pending FDA approval decisions from Biocon, Sandoz, Amphastar Pharmaceuticals, and Lannett Company in addition to Hikma Pharmaceuticals which already has FDA approval, but is awaiting Teva's 6 month exclusivity to expire on December 26, 2024 when Teva's 6-month exclusivity period ends.

Medtronic Launches a New CGM known as "Simplera", the company also announces it is exiting the CGM business and outsourcing that to Abbott

This morning, there were press releases from both Medtronic (see Medtronic's release at https://www.prnewswire.com/news-releases/medtronic-announces-fda-approval-of-simplera-cgm-and-global-partnership-with-abbott-302216165.html for details) and Abbott Laboratories which were worth some attention.

Medtronic's press release was that the Food and Drug Administration had approved the company's "Simplera" CGM device, which it says will be the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs.

Medtronic's New Simplera CGM

But buried halfway through the Medtronic press release was this not-so-little tidbit:

Medtronic is excited to announce a global partnership with Abbott to expand CGM options for people living with diabetes. Under this unique agreement, the companies will collaborate on an integrated CGM based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and Smart MDI systems. These systems, including the Abbott-based CGM, will be sold exclusively by Medtronic.

Financial terms of the partnership and timing for commercial availability were not disclosed. In other words, going forward Medtronic will no longer even be manufacturing its own CGMs as it previously did, instead the company will outsource the manufacture of Medtronic-branded CGM sensors to Abbott. Abbott will make a CGM sensor version that is designed specifically to work with Medtronic insulin pumps and with the Medtronic/Companion Medical InPen smart insulin pen system.

Announced on August 7, 2024, the Simplera CGM's approval was accompanied by the introduction of a global partnership with Abbott to expand CGM options for individuals with diabetes. Under this agreement, the companies will collaborate on an integrated CGM based on Abbott's more advanced CGM platform and Medtronic Automated Insulin Delivery (AID) software which works with a CGM.

Separately, Abbott had its own press release (see the Abbott release at https://www.prnewswire.com/news-releases/abbott-enters-global-partnership-to-connect-its-world-leading-continuous-glucose-monitoring-system-with-medtronics-insulin-delivery-devices-302216439.html).

To be sure, the Medtronic/Abbott collaboration is a mutually-beneficial deal for both companies. Medtronic was a high-cost CGM manufacturer which could not match the Abbott's lower cost of making CGM sensors. But it is also kind of a slap in the face to Dexcom which tells everyone it is the only CGM brand which works with AID systems in the U.S. Dexcom, for its part, has partnerships for a number of insulin AID systems, although several are "non-exclusive" partnerships (including both Insulet/Omnipod as well as Tandem's pumps, although they both have more work to finish before their AID systems will work with Abbott's newest Freestyle Libre 3 model in the U.S. 

Recall that the reason for Dexcom's current domination in AID systems is because Dexcom currently pays CVS Caremark/Aetna and United Healthcare's OptumRx legally-exempted rebate kickbacks for "formulary exclusion" of CGMs sold via the retail pharmacy channel which exclude "All other continuous glucose monitoring systems that are not DEXCOM brand". For its part, Abbott has a work-around to that, by introducing a cash-pay manufacturer coupon which I blogged about in December 2023. Unfortunately, most U.S. patients are clueless about their true out-of-pocket costs for CGM sensors. Otherwise, they would conclude Abbott's Freestyle Libre with its 14 day wear-time is significantly less costly than Dexcom's CGM sensors which only offer 10 day wear-time.

Abbott's "Freestyle Libre 3 Plus" May Push U.S. CGM Prices Down Further

In recent years, I have been underwhelmed with the American Diabetes Association's Scientific Sessions. This year's event was known officially as the ADA 84th Scientific Sessions and was held at the Orange County Convention Center in Orlando, Florida from June 21–24, 2024. But this year, like several of these events from preceding years, there has been less-and-less news which is fundamentally new at all; instead the research and the product announcements have typically already been known for quite some time. Product launches have been in publicly-held companies' investor releases for years. Most of what they are calling news is tired old repeats and more validation studies which don't address much which is fundamentally new research. But occasionally we learn unexpected new things.

Flying somewhat under the radar last month at the 84th Annual ADA Scientific Sessions was news from Abbott Laboratories that the company is planning to introduce a new "Freestyle Libre 3 Plus" sensor (see more on the news at https://hitconsultant.net/2024/06/27/abbott-unveils-freestyle-libre-3-plus/ for more). The "Freestyle Libre 3 Plus" (like the Freestyle Libre 3) is cleared by the FDA for compatibility with automated insulin delivery (AID) systems. While Libre currently lacks U.S. pump partners, several pump manufacturers operating in the U.S. including Insulet Omnipod and Tandem's pumps are officially "CGM platform neutral") meaning neither has an exclusive partnership with Dexcom.

Beyond Insulet and Tandem, Abbott Freestyle Libre 3, and I presume the newer "Freestyle Libre 3 Plus", is compatible with the mylife Loop AID system from Ypsomed and CamDiab Automated Insulin Delivery (AID) system sold in European countries including Germany, although it does not currently have a U.S. pump partner. Ypsomed has attained U.S. FDA clearance for the mylife Loop pump system. Originally, Ypsomed had signed a deal with Eli Lilly & Company, then in December 2022, Lilly backed out of the partnership, leaving Ypsomed without an established U.S. partner. The mylife Loop system was covered in Drug Delivery Business News https://www.drugdeliverybusiness.com/abbott-freestyle-libre-3-automated-insulin-delivery/ on December 21, 2022. 

At present, neither Insulet nor Tandem have any pumps sold in the U.S. which are calibrated to work with Libre 3 because Dexcom pays the big PBMs legally-exempted rebate kickbacks for "formulary exclusion" of all competing CGMs (including most notably) Abbott Freestyle Libre. Nevertheless, these pump companies also sell their products in Europe where Abbott CGMs dominate the local CGM market share landscape, which means they could easily sell their AID systems compatible with Libre and it would be a fairly routine matter to do so.

Justin Eastzer, Host & Founder of Diabetech YouTube and podcast covered the "Freestyle Libre 3 Plus" as the first item he covered in his ADA Scientific Sessions highlights. Catch his coverage podcast at https://www.diabetechpodcast.com/e/future-of-diabetes-tech-takeaways-from-ada-2024/ or on his YouTube channel at https://youtu.be/FTjeMorMY30?si=9X0SbDEfZ7li4jqE. I kind of stole the image in this post from him. 

One of the more important things which differentiates Abbott Freestyle Libre CGMs in the U.S. is the lower cost. According to the Costco Member Prescription Program https://www.costco.com/cmpp, the retail price differences between Abbott and Dexcom sensors are negligible. For example, Costco Pharmacy's prices for CGM sensors are as follows:

• Dexcom G6 price for each sensor is $67.09 (note: Dexcom only sells boxes of three G6 sensors, which must be divided to derive a per-sensor cost)
• Abbott Freestyle Libre 2 price for each sensor is $63.66
• Abbott Freestyle Libre 3 price for each sensor is $63.66
• Dexcom G7 price for each sensor is $59.02

That means all sensors range in price from $59.02 to $67.09, or at most $8.07 difference for the older Dexcom G6 model which is being phased-out anyway. But that's merely the cash price for these CGM sensors. The true cost must be divided by the number of days which each sensor can actually be worn. Longer wear-time means the cost/day of usage is lower unless a patient's insurance subsidizes the cost with partial coverage. Still, using this methodology, below are the costs per day of usage for each CGM sensor model/brand when purchased from Costco Pharmacy:

• Dexcom G6 cost per day of usage is $6.70
• Dexcom G7 cost per day of usage is $5.90
• Abbott Freestyle Libre 2/3 cost per day of usage is $4.55

Clearly, with its 14-day wear-time compared to Dexcom's 10-day wear-time means that Abbott Freestyle Libre sensors are less costly on a cost per day basis. With 15-day wear-time for Abbott Freestyle Libre Plus (assuming the cost is the same as the regular Libre 3 model), the cost per day of usage would be $4.24/day of wear, daily savings of an additional $0.30. Insurance company PBMs have inserted themselves into the cost-benefit equation. United Healthcare's OptumRx and Aetna/CVS Caremark both collect legally-exempted rebate kickbacks from Dexcom to keep Abbott Freestyle Libre "off-formulary". In order to keep the kickback cash flowing to the PBMs, both of them now cover about 37% of the cost of Dexcom sensors even prior to satisfying any deductible. They aren't covering it because they are benevolent or because Dexcom persuaded them to do so; it's all about the PBM kickbacks. 

Only CGM manufacturers now offer coupons enabling patients to bypass their insurance company's Pharmacy Benefit Manager to buy CGMs, and in more than a few cases, it makes financial sense for them to do the math and make economic choices based upon THEIR out-of-pocket costs. The myth is that paying artificially-inflated prices will contribute meaningfully towards satisfying a deductible, but insurance companies never disclose to covered individuals that the amount being applied towards deductibles for all pharmacy purchases amounts to pennies on the dollar being spent.

Dexcom's manufacturer coupon enables patients to save $200 per 30-day supply of sensors (and an additional $200 on each 3-month transmitter on the G6 model). Their coupon can be downloaded at https://dexcompdf.s3.us-west-2.amazonaws.com/g7-g6-cash-pay-tearpad.pdf.

Abbott was later to the cash-pay coupon, but as I covered in December at https://blog.sstrumello.com/2023/12/abbott-gets-real-about-formulary.html, if you're commercially insured and asked to pay more than $75 for two Freestyle Libre 3 sensors, the company says to call Abbott customer care at 1-855-632-8658 (M-F from 8-8 ET) to ask them for an eSavings voucher. Abbott manufacturer vouchers expire at the end of each calendar year and patients must call each January to request a new voucher for the new year. For more general info, visit https://www.freestyle.abbott/us-en/private-insurance.html.

But here's what makes the new "Freestyle Libre 3 Plus" different: "Freestyle Libre 3 Plus" will offer a wear-time of 15 days vs. only 14 days on Libre 3. Assuming the sensors cost the same amount as Freestyle Libre 3 (right now, the Libre 2 and Libre 3 cost the same), that means the extra day will translate into even more patient cost-savings. Whether the adhesive on the sensor lasts 15 days is a very big unknown. Some patients find using adhesives like Skin Tac solves that problem.

Another big unknown will be what the impact might be once the Federal Trade Commission (FTC) sues the big Pharmacy Benefit Managers (PBMs) over their anticompetitive business practices. We know FTC intends to sue (see the Politico coverage at https://www.politico.com/news/2024/07/10/ftc-pharmacy-insulin-drug-00167342 for more). Its Interim Report from its 6(b) study on PBM business practices (see HERE for the news release, and https://www.ftc.gov/system/files/ftc_gov/pdf/pharmacy-benefit-managers-staff-report.pdf for the Interim Report itself). In theory, this litigation might result in PBM kickbacks paid in order to keep less costly competing products "off formulary" ruled by a court as illegal, and restitution would likely mean that Dexcom would no longer be able to pay bribes to PBMs keep Abbott Freestyle Libre CGMs "off-formulary". We'll have to wait for the outcome of that, but it seems clear in my mind that could be coming.

For its part, rival Dexcom is trying to have things both ways in order to maximize company profits at the expense of patients and employee healthcare plan sponsors. In an interview with MedTechDive, Dexcom CEO Kevin Sayer answered the following question this way:

MEDTECHDIVE: I've read about a potential "G7 Plus", where the life of the sensor would be extended from 10 days to 15 days. Is that something Dexcom is working on?

SAYER: It's absolutely something we would work towards. We stopped at 10 days at this point in time because we want to maximize the patient experience. Meaning, we want to make sure these devices last their entire useful life, and patients are getting what they signed up for.

Left unsaid was that while Dexcom makes sure the 15-day G7 Plus sensor lasts its entire useful life, the company also very recently changed its sensor replacement policy so the company will only replace 3 sensors each year. It also gets to charge more money. I'm calling Keven Sayer on a bull$#!t alert for that bad, dumb answer. It's all about the extra 40% more money Dexcom earns with the 10-day sensor.

In the meantime, we know according to Reuters (see https://www.reuters.com/business/healthcare-pharmaceuticals/abbott-plans-marketing-push-glucose-monitors-beyond-diabetes-2024-07-18/ for more) that Abbott management has told investors that the company plans to use a mix of mass market "TV advertisements and guerilla marketing" in the U.S. to grow the company's fairly miniscule CGM market share in the coming years. Like rival Dexcom's newly-launched Stelo, Abbott will also sell an OTC CGM aimed at Type 2 diabetes patients known as Lingo and Libre Rio to help grow the company's share, although neither product has hypoglycemia alarms or data-sharing, so I don't anticipate them changing the market for T1D patients.

But the new, coming Abbott "Freestyle Libre 3 Plus" is poised to cut CGM costs even further with one additional day of wear-time. Remember: while Dexcom's G7 and Stelo use the exact same CGM sensor, but the wear-time is 15 days for Stelo and only 10 days for G7. Evidently, the hypoglycemia alarms and data sharing is intended to cost patients 40% more money. But with Libre actually INCREASING its wear-time, that is something patients should look forward to!

More Ammo from the American Postal Workers Union Health Plan Audit Could Strengthen FTC's PBM Litigation on Insulin

Some may recall that on July 10, 2024, the Wall Street Journal, Politico and Axios all reported that the U.S. Federal Trade Commission ("FTC") intends to sue the largest Pharmacy Benefit Managers (PBMs) perhaps by the end of July 2024 (although the exact date remains to be seen), and specifically over its business practices related to insulin for "allegedly using negotiating tactics in order to steer patients to use more expensive drugs" (such as heavily-rebated brand-name versions of insulin, rather than less-costly unbranded insulins or even genuine biosimilars where they exist; so far, most are Lantus biosimilars, with only Sanofi's biosimilar of Lilly's Humalog which is branded as Admelog have been approved by FDA as of the date this particular post is published). Politico's version of the article was free; hence I will refer you to its coverage at https://www.politico.com/news/2024/07/10/ftc-pharmacy-insulin-drug-00167342 for details.

While the PBM's and its trade organization known as the Pharmaceutical Care Management Association (PCMA) have cited what they argue are insufficiencies in the FTC Interim report's data, while conveniently overlooking the reality that there's already a robust set of data on insulin from the Senate Finance Committee, and from academic sources including from the University of Southern California which FTC can include and cite in any FTC litigation against the PBMs on insulin. 

Now, yet another piece of publicly-available data emerged at the end of March 2024 from a report from an audit (see the report at https://www.oversight.gov/sites/default/files/oig-reports/OPM/2022-SAG-029_0.pdf for complete details) undertaken by the American Postal Workers Union Health Plan's pharmacy operations as administered by Cigna's Express Scripts business for contract years 2016 through 2021. The audit was undertaken by the U.S. Office of Personnel Management Office of the Inspector General's Office of Audits, which rather quietly released the result of a comprehensive audit.

While the Postal Workers Pharmacy Benefit Manager (PBM) audit and its accompanying report received little if any public attention at the time, it examined drug spending between 2016 and 2021 within the health plan that covers more than 200,000 unionized U.S. Postal Service mail carriers and post office workers, as well as retirees. The audit revealed that Cigna's Express Scripts PBM unit had overcharged U.S. Postal Service employees a stunning $45 million for their prescription drugs during that five-year period. 

STAT News reporters Ed Silverman and his colleague Bob Herman commented (if you subscribe to STAT, see the complete article at https://www.statnews.com/2024/07/22/express-scripts-overcharged-postal-workers-by-45-million-audit-says/ — I'm not a paid subscriber to STAT News, but I am on the free email Newsletters distribution list for both Ed Silverman and for Bob Herman and their STAT News reporting, so I occasionally receive emails with their coverage and can read their articles using the links contained in their emailed Newsletters at no charge. Alas there's no way for new subscribers to go back to already-distributed Newsletters), when they wrote:

"This part really caught our eyes: The biggest source of overcharges was tied to drug rebates that should not have been kept by [Cigna's/Evernorth's/Express Scripts'] Ascent Health Services, the opaque, Swiss-based group purchasing organization that is a sister organization to Express Scripts. (FYI "GPO" which is another entity aside from PBMs which receives a controversial "safe-harbor" exemption to the federal Antikickback Statute which effectively renders them able to collect legally-exempted rebate kickbacks)."

They added:

"Notably, nearly half of the overcharges stemmed from drug rebates that Express Scripts negotiated with pharmaceutical companies. But instead of passing back 100% of that money to the health plan, as the contract required, the PBM skimmed millions for itself, according to the audit, which was conducted by the Office of Inspector General for the Office of Personnel Management." 

Note that the choice of the word "skimmed" is rather curious to me. 

The term "skim" implies that Express Scripts took just a little bit as if to cover their expenses, but really, it is a question of magnitude. When the amount "skimmed" amounts to more than $45 million dollars, that means it wasn't "skimmed" — it was stolen. And thievery implies a lawsuit to get the money which was stolen returned by a Court of Law. Hence the next reveal was really interesting: STAT News acknowledged that the company [Express Scripts] agreed to fully refund all of those wrongly-retained rebates. 

But, more importantly, the point is that PBMs operate as if their "safe-harbor" exemption also somehow exempts the PBMs' from being sued for breaking a contract which they signed and agreed to, and that is completely untrue. 

The only reasons Express Scripts' and its Ascent Health Services GPO unit agreed to refund the $45 million in money to the American Postal Workers Union Health Plan is because: 

1. the American Postal Workers Union Health Plan had conducted a legitimate audit, which means it had legitimate grounds for a lawsuit against Express Scripts, and Express Scripts would likely have lost any litigation if the American Postal Workers Union Health Plan actually took them to court and 
   
   
2. the only thing PBMs want to do less than refund cash they had effectively stolen (skimmed being a euphemism for stolen) is to go to court and open their business practices and records up to a court docket which then becomes public record

Express Scripts simply opted to take the easier and safer way out and just refund the $45 million which it had effectively stolen from the American Postal Workers Union Health Plan without admitting they did anything wrong. There was nothing benevolent about the Express Scripts decision; it was a very calculated business decision, and nothing more. 

Note that in my previous blog post (see it at https://blog.sstrumello.com/2024/07/let-litigation-against-pharmacy-benefit.html if you want to read it in its entirety) that I had hinted that the FTC does not even need all the data the PBMs have yet to legally provide to the FTC in order to win litigation on the insulin therapeutic class of drugs. The reason is because there is already sufficient data in the public domain from the Senate Finance Committee, as well as from the University of Southern California, and now, the American Postal Workers Union Health Plan which practically guarantees the FTC has more than enough data to secure a victory for the Federal Trade Commission and potentially the U.S. Department of Justice. We still await the details when that lawsuit is filed. 

One reason the big, vertically-integrated (with the big commercial healthcare insurance companies) PBMs should be quite worried about the FTC litigation is that FTC can include any data derived from the public domain if it chooses to sue the big PBMs. And, with the insulin therapeutic class in particular, as I have noted previously, there is already a robust dataset within the public domain upon which the FTC (and/or the DOJ) can potentially cite in their litigation against the big PBMs.

The American Postal Workers Union Health Plan audit results also has potential to improve the odds of bipartisan legislation governing PBMs, although with a completely dysfunctional U.S. House of Representatives (which has had drama in naming and keeping a House Speaker in just two years it secured the narrowest majority in decades), I would not be willing to make any predictions. But the point is that PBMs don't really have many reliable friends in Congress these days from either political party.  

Let the Litigation Against Pharmacy Benefit Managers Begin!

Perhaps you recall that on June 7, 2022, the U.S. Federal Trade Commission (FTC), which is required by law to be staffed with Commissioners appointed from both major political parties, voted unanimously (see https://www.ftc.gov/news-events/news/press-releases/2022/06/ftc-launches-inquiry-prescription-drug-middlemen-industry for details) to initiate a comprehensive 6(b) study on the Impact of Vertically Integrated Pharmacy Benefit Managers on the Access and Affordability of Medicine (FTC Matter No. P221200). The study almost never happened, but ultimately with the Senate confirmation of FTC Commissioner Alvaro Bedoya who was sworn in on May 16, 2022, that study formally began. Then we did not hear much more as the FTC began the earnest work of collecting data and studying what was happening.

That was until July 10, 2024, when we got news from the (Murdoch-owned) Wall Street Journal ("WSJ" if you subscribe, you can view the article at https://www.wsj.com/health/pharma/ftc-to-sue-drug-managers-over-insulin-prices-b46af71f but it requires a paid subscription to read the entirety of the article) that the FTC intends to sue the largest Pharmacy Benefit Managers (PBMs). Because the WSJ article is hidden behind a paywall, instead I relied upon Politico's FREE article (see https://www.politico.com/news/2024/07/10/ftc-pharmacy-insulin-drug-00167342 for the Politico article) on the same topic. 

In recent years, the Wall Street Journal has been on something of a crusade to discredit the Federal Trade Commission because as a bipartisan organization, its move to protect competition threatens the existence of monopolies. That said, there was really nothing in the very short WSJ article which was really opinion-based as many of the WSJ's various anti-FTC articles in recent years have been (the article was not an opinion-based diatribe as if the FTC was somehow overreaching; rather this particular WSJ stuck pretty much to the facts). 

Politico's article reports: "A lawsuit could be filed as soon as this month, said the four people, granted anonymity to discuss a confidential matter, though no final decision has been made." 

Just two days earlier (on July 8, 2024), the FTC published an "interim report" (see https://www.ftc.gov/reports/pharmacy-benefit-managers-report for access to the interim report) "on the prescription drug middleman industry that underscores the impact pharmacy benefit managers (PBMs) have on the accessibility and affordability of prescription drugs". Interim reports are somewhat atypical, but not completely unheard of from government agencies. In the case of the FTC, it likely means the Commission intends to sue. The decision to publish an interim report rather than the full report is attributed, in part, because the biggest PBMs have refused to supply the data the FTC subpoenaed from them in the first place. The biggest PBMs have a LOT they would prefer to keep hidden.

As for the FTC's legal authorities to require data, former FTC Commissioner Rohit Chopra (before he resigned to accept a more senior position leading the Consumer Financial Protection Bureau "CFPB") said it best when he wrote: "FTC orders are not suggestions." 

In fact, federal law has long recognized that FTC as the only government entity which is explicitly, legally-entitled to subpoena information without having a specific law enforcement intent; there is considerable legal precedent upholding that. But big PBMs have long behaved in a lawless manner, relying on a peculiar "safe harbor exemption" to the Federal Antikickback Statute and the industry trade organization known as the Pharmaceutical Care Management Association (PCMA) has sued relentlessly to preserve that special exemption from laws which prohibit commercial bribery. Unfortunately, lawmakers seem vaguely clueless about their own role in enabling that lawless behavior, but it is clear that there is a long history of bipartisan wrongdoing due to willful ignorance about the actions of both political parties.

And yet, CVS Health/Caremark (Aetna), United Healthcare's OptumRx and Cigna's Express Scripts have been the biggest hold-outs by refusing to comply with the FTC subpoenas for data or only providing pieces of data instead of all that was demanded. 

Which is a good reason to believe the FTC is likely to sue them soon. But the point about insulin prices kind of explains why that could become a centerpiece of the litigation. The reason is because a robust public data-set already exists for prices in the insulin therapeutic class of drugs. Right now executives from the big three PBMs should be worried the FTC will WIN its pending lawsuit. A victory there would no doubt make it easier to break-up the vertically-integrated (with commercial healthcare insurance companies) PBMs.

Think about what it means when businesses must rely upon a special "safe-harbor exemption" to a bribery law as the PBMs now do; it seems clear that the PBMs are merely attempting to delay the inevitable.

According to the July 10, 2024 article(s), the FTC intends to sue CVS Caremark, Express Scripts and OptumRx over their "negotiating tactics" for drugs in the insulin therapeutic class of drugs specifically. We will have to wait until a lawsuit has been legally filed to read the details, but it seems very clear that sufficient data is already known about PBM game-playing on insulin (including from the Senate Finance Committee as well as University of Southern California researchers) that it could potentially be applied to the litigation (and indeed on virtually any drug or device sold by retail pharmacies) even if the PBMs fail to supply the data they are withholding. The reason is because data exists in the public domain about the PBM impact on insulin prices which FTC can use instead. So, for now, the FTC will sue over insulin. A victory there would likely boost cases down the road to force big insurance companies to choose between their health insurance businesses or their PBM businesses leading to divestitures of one or the other.

Recall that back on March 4, 2024, FTC Chair Lina Khan spoke at a White House Roundtable on PBMs (see her prepared remarks at https://www.ftc.gov/system/files/ftc_gov/pdf/2024.03.04-chair-khan-remarks-at-the-white-house-roundtable-on-pbms.pdf for more) stated unequivocally: "So far, the PBMs have not fully complied with our orders to turn over documents and data. FTC orders are not suggestions, and we won't hesitate to use the full extent of our legal authorities to mandate compliance."

According to the WSJ, Politico and Axios among others, the FTC intends to sue the three largest PBMs for "allegedly using negotiating tactics to steer patients to use more expensive drugs" which is a violation of the FTC Act, the Sherman Act, and the Clayton Act to name a few. It may also violate other laws. Perhaps unsurprisingly, insulin was cited as a specific example, with markups on that becoming a poster-child for a dysfunctional market in recent years.

FTC is unique in that by law, it is required to be staffed in a bipartisan manner, consisting of Commissioners from both major political parties. Commissioners serve seven year terms although their terms can potentially be renewed by Congress. Oddly, two of the FTC Commissioners named by Donald Trump (Noah Philips and Christine Wilson) both resigned, which left President Biden in a unique position to name the Republican Commissioners of HIS own choosing. So far, the Senate has been in no particular hurry to confirm the Biden-named Republican FTC replacement Commissioners even if doing so could assist the Commission's longer-term goals by ensuring the selection of FTC Commissioners who take the role of genuine antitrust enforcement seriously, rather than being little more than undisciplined partisan hacks whose only aim is to stymie anything FTC aims to do, which apparently was all the Trump-named FTC Commissioners aimed to do.

As the Guardian author and research director of the American Economic Liberties Project (see https://www.theguardian.com/us-news/2024/mar/09/lina-khan-federal-trade-commission-antitrust-monopolies for the article) eloquently wrote:

"Charged with enforcing antitrust law and promoting consumer protection, the FTC is nominally the regulator charged with stopping deals that will harm consumers. But under successive administrations – Republican and Democratic – some critics charge the FTC stood by as industry after industry consolidated power in the hands of fewer and fewer companies."

The steady monopolization of market after market arguably began during the Reagan administration, but for the past 40 years, as one industry after another has consolidated, it has really been only in more recent years that average Americans have really suffered direct consequences of a failed, ideological policy decision which had prevailed for 40 years. But it is also the reason for consumer price inflation at the supermarket has occurred in spite of economic data that would suggest inflation should not really exist. Instead, massive supermarket retailers have steadily raised their prices on goods Americans buy in order to meet their quarterly earnings numbers even while their cost of acquiring goods have fallen.

In the supermarket space, for example, in February 2024, the FTC joined with the attorneys general of a number of states and sued to block the largest proposed supermarket merger in U.S. history — Kroger Company's $24.6 billion acquisition of the Albertsons Companies, Inc. — alleging that the deal was anticompetitive. The FTC actually filed two cases against the Kroger acquisition, including one with the State of Oregon's Attorney General against that acquisition.

Monopolists do not like antitrust enforcement (see the American Economics Liberty Project's tracking of the Wall Street Journal articles against FTC Chair Lina Khan at https://www.economicliberties.us/press-release/economic-liberties-launches-new-tracker-exposing-wsjs-unhealthy-obsession-with-chair-lina-khan/ for more), but it can indeed be very effective when the antitrust laws are actually enforced. Some companies (including in the pharmaceutical space) have opted to call off their planned mergers, while others decided to fight the legal challenges against their acquisitions/mergers in court. Beyond that, however, is the underlying message that antitrust enforcement has potential to work, if and when the federal government actually chooses to enforce antitrust laws (including the Clayton Act, the Sherman Act and the FTC Act) which are already on the books.

The litigation on the PBMs is likely to be one such example (hopefully we will see more when the lawsuit happens). The insurance company-owned PBMs (with CVS Health's acquisition of Aetna being an ever-so-slight role-reversal) will fight to delay this as long as possible. 

Teva's Biosimilar of Liraglutide will be Made by Novo Nordisk (at least initially)

On June 24, 2024, Teva Pharmaceuticals, Inc. (the U.S.-based subsidiary of Israel-based big pharma company Teva Pharmaceuticals Ltd.) became the first company operating in the U.S. to receive FDA approval for a biosimilar version of the GLP-1 inhibitor medicine known generically as liraglutide. Liraglutide is the generic drug name for Novo Nordisk's drug which was branded as Victoza and later subsequently received an FDA label-extension for the indication of obesity which it branded as Saxenda. In other words, it's approved for Type 2 diabetes as well as for obesity. However, when Novo Nordisk's "new & improved" GLP-1 inhibitor product known generically as semaglutide (sold under several different brand-names including Ozempic and Wegovy) came to market, Novo Nordisk stopped selling liraglutide on the U.S. market and shifted its marketing focus to its newer and improved, plus still patent-protected and vastly more-expensive drug. 

Back in 2017, Teva revealed to investors (see https://www.businesswire.com/news/home/20170202005454/en/Teva-Confirms-Generic-Victoza%C2%AE-Patent-Challenge-in-the-United-States for more) that the U.S. business unit of the Israel-based company had applied for an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a biosimilar version of Novo Nordisk's Victoza (liraglutide) injection, and not long after, Novo Nordisk immediately sued the company over various patents. Most of the Novo Nordisk patent challenges against Teva were completely baseless, but because pharmaceutical companies employ more lawyers than they do scientists, and because both Novo Nordisk and Teva are aware that is just how the industry operates, the dispute was merely a speed bump, and Teva was well-prepared for it. Novo Nordisk was hoping its litigation might delay the inevitable copies of its older but still efficacious medicine from coming to market, but Teva knew it, and Teva also knew Novo Nordisk had no case to be made on patent infringements. The publication known as Pharmaceutical Technology had an article about the patent litigation at https://www.pharmaceutical-technology.com/news/novo-teva-victoza-patent-dispute/?cf-view which covered some of the legalities involved.

However, because Teva is not a novice in the U.S. prescription drug market, and the company fought the patent disputes - even threatening to have a judge rule on the actual merits which Novo Nordisk did not want to happen because it knew it really did not have a case. So in 2019, Novo Nordisk quietly reached an agreement with Teva Pharmaceuticals USA to effectively settle its baseless patent dispute with Novo Nordisk over liraglutide. By settling with Novo Nordisk, Teva became eligible by the courts to introduce a biosimilar copy of Victoza starting as soon as December 22, 2023, although the biosimilar first had to receive FDA approval which took several more months to attain. 

Also, by settling with Novo Nordisk, Teva effectively gained permission from Novo Nordisk to sell a copy of the company's now discontinued drug. So Novo Nordisk offered Teva a different deal: sign a deal with us and become an "authorized generic" with Novo Nordisk (since Novo Nordisk no longer sells Victoza the U.S. anyway) supplying the drug rather than Teva being forced to sell a biosimilar copy it has to make and package itself, and Novo Nordisk would make the drug and supply it to Teva in bulk. That arrangement meant that Teva did not technically even require FDA approval since it would effectively be selling Novo Nordisk's actual Victoza (and yes, Saxenda) under the generic drug name. Truthfully, the distinction is largely irrelevant as long as the FDA approves biosimilar copies, except that for the very first 6 months, Teva's version or liraglutide will be the only copy allowed to be available. That means until December 26, 2024, but then the floodgates of copies are expected to come to market.

We do not know exactly what the terms of the Novo Nordisk-Teva settlement entailed. Right now, manufacturers of GLP-1 inhibitors including Novo Nordisk are struggling to keep up with demand on weight-loss drugs at the moment (although it is mostly on the final part of the manufacturing process known as "fill & finish" whereby the product is placed into injection pen devices. To deal with that, in November 2023, Novo Nordisk announced it would stop selling the patent-expired basal insulin Levemir (insulin detemir) so it could instead re-deploy "fill & finish" manufacturing capacity to weight-loss and Type 2 diabetes drugs instead. Then, in February 2024, Novo Nordisk announced a plan to acquire the contract manufacturer Catalent for $16.5 billion (see https://www.cnbc.com/2024/02/05/novo-nordisk-parent-to-buy-catalent-to-expand-wegovy-supply.html for more) to keep up with demand. 

According to diaTribe (see https://diatribe.org/diabetes-medications/generic-victoza-now-available-us for the diatribe news article), The price of Teva's authorized generic version of liraglutide amounts to about a 16% to 17% reduction in price compared to branded Victoza, which truthfully, is an extremely modest price reduction. diaTribe also noted that Victoza leads to a more modest HbA1c lowering and weight loss, citing the SUSTAIN 10 https://www.sciencedirect.com/science/article/abs/pii/S1262363619301326 study, in which Victoza reduced A1c by 1%, while Ozempic reduced A1c by 1.7%, while participants lost about 4 pounds on Victoza, compared to 13 pounds on Ozempic. Left unsaid was that patients who continued using the older version of the medicine tended to continue losing weight over time. And, not everyone who might use the drug for weight-loss is morbidly obese.

The real elephant in the room is the price of these drugs (and no one except me is talking about that), and Novo Nordisk's newer, second-generation GLP-1 inhibitor retails for over $1,003 for just one pen according to RxSaver, compared to $469.60 for a 2-pack and $704.40 for a three-pack of pens of liraglutide, meaning the older GLP-1 inhibitors are one-fourth the price of the newer products. Although the weight-loss is slightly more modest with Victoza/Saxenda, shedding pounds quickly costs money (which many hope they can get insurance to pay for, but so far, insurance is balking). People content to use the older medicine for slightly longer tend to achieve sustained weight-loss without breaking the bank. And they could afford to use the first-generation drug for much longer and still not spend as much as a single pen of Ozempic would necessarily cost them.

Meanwhile, third-party suppliers in the injector pen business (one of the biggest being Ypsomed AG) have been ramping up production for several years in anticipation of strong demand for their UnoPen disposable injector pens. There are alternative suppliers of pen injector devices, but the other suppliers exist (based in India, for example, though some may not have U.S. FDA, Health Canada or European Medicines Agency authorization at this time which Ypsomed has at the moment). The point is there are other approved pen suppliers.

But as part of Teva's settlement with Novo Nordisk over its patent litigation, the short version of the story is that Teva will start selling an unbranded version "Victoza" within weeks and they will be packaged by Novo Nordisk in Novo Nordisk injection pen devices. In theory, the same drug could also be used as a generic Saxenda. FDA is poised to have a busy end-of-year on biosimilars for liraglutide. Reuters reported (see https://www.reuters.com/business/healthcare-pharmaceuticals/teva-launches-generic-version-novo-nordisks-diabetes-drug-victoza-2024-06-24/ for details) "Teva's generic launch [of Victoza (liraglutide)] comes days after the U.S. Food and Drug Administration tentatively approved London-based Hikma Pharmaceuticals' generic version of Victoza, according to the agency's website." 

However, my own research into the topic of biosimilar insulins revealed that a bunch of companies that intend to sell biosimilar insulins also plan copies of liraglutide, including Biocon, Amphastar Pharmaceuticals, Sandoz and Lannett Company to name a few others. And, thanks to the FTC challenging 36 of Novo Nordisk's inappropriate device patents in the FDA Orange Book, those are poised to come to market right after Christmas 2024 assuming FDA approves them.

One biosimilar manufacturer, Sandoz, told investors in April that management expects GLP-1 inhibitors could account for as much as 69% of new product sales by 2029.

Meanwhile, GoodRx reports (see https://www.goodrx.com/victoza/when-will-generic-victoza-be-available for more) added "Of these, the FDA tentatively approved a generic version of Victoza from Hikma Pharmaceuticals on June 21, 2024." The Hikma Pharmaceuticals product will be different from the authorized generic marketed by Teva Pharmaceuticals in one key way: according to the patient package insert from Teva's version will actually be actual Victoza sold under the generic drug name liraglutide which is being made by Novo Nordisk, packaged into FlexPens and simply commercialized by Teva.

According to the FDA (see https://www.tevausa.com/globalassets/us/teva-generics/products/pi/liraglutide-injection_pi.pdf for more) full Prescribing Information including Boxed Warning and Medication Guide for this medication, a so-called "authorized generic" version of Victoza, the product (at least initially) will actually be manufactured by "Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark" and the company will be doing so "for Teva Pharmaceuticals, Parsippany, NJ 07054". 

For Novo Nordisk, the agreement with Teva solves two issues: First, it will be able to sell any outstanding inventory already made and put into pens and packages for Victoza before it would otherwise be forced to discard the inventory. It also will be marketed (at least initially) as a Type 2 diabetes drug, rather than a hotly-contested obesity drug such as Saxenda. For Teva, it also saves any scientific issues which might arise in trying to make and sell a genuine biosimilar copy plus Teva will be able to answer any questions with Novo Nordisk about making the product itself, and it enables the product to come to market right now, plus it will be the only copy on the market for six months. But that also means just after Christmas 2024, a whole slew of copies of liraglutide are poised to hit the market.

At that point, my expectation is that we could see cash-only pharmacies like Mark Cuban Cost Plus Drug Company sell the less costly GLP-1 inhibitor product for those seeking a less costly weight-loss product. Will patients discover them? When the cost is $0.25 on the dollar, I suspect they WILL.

Catch My Two Recent Podcast Interviews!

I'm not exactly a stranger to the world of podcasting although I have concluded that while I might ask probing questions as an interviewer, I really don't have interest in hosting a podcast of my own. Still, over the years, I've been a guest on a few podcasts related to diabetes. For example, quite a number of years ago, I was a guest on the DiabetesPowerShow with host Charlie Cherry in which we just "talked shop" about issues related to diabetes. I'm not even sure if the archives of those shows even exist anymore, perhaps they might still be around on a place like the Internet Archive. 

More recently than that, I was a guest on TWO of Diabetic Investor David Kliff's different podcasts in 2021 and 2022. For example, in September 2021, I was featured on the "Wacky World of Diabetes" podcast with David Kliff and that episode can still be found and listened to at https://diabeticinvestor.com/its-podcast-day/. 

In March 2022, David Kliff invited me back for a newer podcast he had introduced called the "Dave and Amber Show" which I shared on this blog at https://blog.sstrumello.com/2022/03/my-recent-podcast-on-diabetes-way.html. Again, my interview can be listened to there. 

However, in June 2024, I happened to be a guest on TWO completely different diabetes podcasts. Both kind of happened by chance.

First up was an interview I did with Stacey Simms on her podcast Diabetes Connections with Stacey Simms. We had the conversation a few weeks earlier, but she released the episode in which I was interviewed as the guest on an episode on June 18, 2024. The topic of that particular episode was on the broader subject of the "Business of Diabetes", which was something I have long featured on this diabetes blog. The episode link for that episode can be found (and listened to) at https://diabetes-connections.com/the-business-of-diabetes-scott-strumellos-perspective-after-50-years-of-t1d/. For convenience, I am embedding a copy of that episode below.

   

Around the same time, I had published an article on something the Federal Trade Commission did which opened the doors to a whole bunch of less costly biosimilar GLP-1 inhibitors including those used for weight-loss (Novo Nordisk called its first-generation GLP-1 inhibitor for Type 2 medicine Victoza, and another version of the drug for obesity which was branded as Saxenda). I self-published my article entitled "FTC Challenge to Pharma's Improper FDA Orange Book Patent Listings Poised to Open the Door to Cheaper Weight-Loss Drugs" on LinkedIn on May 9, 2024 which can be seen at https://www.linkedin.com/pulse/ftc-challenge-pharmas-improper-fda-orange-book-patent-scott-strumello-h6ede/ (I originally posted it on my blog as a first draft, but the LinkedIn version was edited to be more concise, so I went back my blog post and also edited it here which you see on a blog at https://blog.sstrumello.com/2024/04/ftc-again-polices-fdas-laziness-with.html — the article on my blog is now exactly the same as the more concise article which I published on LinkedIn). 

One of the reasons I opted to self-publish an article about GLP-1 inhibitors being sold as weight-loss drugs is because corporate media had completely missed the story, and I wanted to ensure an important story was covered, so I took matters into my own hands. Most of the corporate media stories about weight-loss drugs are hyperbolic nonsense with stupid headlines on topics as idiotic as "Ozempic Babies" (see one at https://www.usatoday.com/story/life/health-wellness/2024/04/17/ozempic-withdrawal-surprise-pregnancy/73340586007/ if you need convincing) while ignoring the elephant in the room: the price of those drugs. 

Anyway, my LinkedIn article had caught the attention of another diabetes podcaster, specifically Scott Benner who hosts the Juicebox Podcast. Scott asked if I would talk to him about my LinkedIn article on his podcast, so a few weeks later, he reached out to me to talk about my article. He released the episode on June 12 (or 13), 2024 in which he named it Episode #1224 "Orange Book Chronicles". The episode link is at https://www.juiceboxpodcast.com/episodes/jbp1224. Again, for your convenience, I have embedded the episode below so you can listen to it here.

Amphastar Pharmaceuticals Will Bring a Tresiba Insulin Biosimilar to Market

While I have gone on record as saying that the PBM rebate-contracting commercialization model is badly broken, in 2023, we saw in rapid succession each of the big three branded insulin suppliers abandon that sales model.

While many lawmakers are now telling everyone that it was the passage of the Inflation Reduction Act (IRA) which helped bring insulin prices back down to earth, the thing is, unless you are on Medicare, the IRA had almost NO impact on insulin prices so far. 

In fact, it was really the passage of the American Rescue Plan Act (ARP) of 2021 which is helping to bring U.S. insulin prices down for everyone not on Medicare. On top of that, the Inflation Reduction Act contained a toxic provision which EXTENDED the safe-harbor exemption for rebates paid to Pharmacy Benefit Managers (PBMs) from prosecution for bribery under the federal Antikickback Statute until Jan. 1, 2032 (the House version of that bill was only until Jan. 1, 2027, but upon reconciliation with the Senate version of the bill, another five years were added). That was a very bad thing. Lawmakers did that in order to boost the Congressional Budget Office (CBO) score given to the Inflation Reduction Act. But it also threw anyone covered under employer-sponsored commercial healthcare insurance plans under the bus.

The Kaiser Family Foundation had an excellent overview of exactly how American Rescue Plan of 2021 impacted many older but heavily-rebated drugs including insulin which can be read at https://www.kff.org/policy-watch/what-are-the-implications-of-the-recent-elimination-of-the-medicaid-prescription-drug-rebate-cap/.

To get around the problem which Novo Nordisk had helped to perpetuate, in 2022, the company quietly introduced an unbranded (sold under the generic drug name) version of its basal insulin Tresiba since it had already seen success with an unbranded version of Novolog which reportedly reached more than 1 million American patients according to the company's annual report (see the company press release HERE for details on the launch of Novo Nordisk's unbranded version of Tresiba). A photo of the vial form of that insulin is pictured below.

But with the unbranded product offerings being so successful without much in the way of marketing, combined with the Civica/CivicaScript-JDRF biosimilar insulin announcement which arguably set a ceiling on biosimilar insulin prices, those things essentially FORCED Lilly, Novo Nordisk and Sanofi collectively to simply abandon the rebate-contracting sales model for insulin, and those 70%+ price cuts were accomplished with zero impact to the manufacturers' bottom lines; they did so by disintermediating the legally exempted rebate kickbacks (bribes) paid to PBMs for exclusive formulary placement. I've covered that at various times recently, but one post summarized it nicely at https://blog.sstrumello.com/2023/06/what-happens-when-rx-price-bubbles-such.html. 

Anyway, at the 23rd Annual Needham Virtual Healthcare Conference which took place on April 8-11, 2024, we learned from Amphastar Pharmaceuticals that the company has been expanding its diabetes business in recent years. If you visit slide #15 (see the presentation at https://ir.amphastar.com/download/companies/270152a/Presentations/Needham.pdf for more), we see Amphastar has a biosimilar of insulin aspart (fka Novolog) currently pending an FDA approval decision. For the company's aspart biosimilar, the company previously told investors it had received an FDA "Complete Response Letter" which means it was not approved, but upon addressing FDA-cited deficiencies, it will be able to resubmit that for approval (hence the designation "AMP-004m"). The slide indicates the resubmission was "in progress" as of April 8, 2024. But also look at what I circled in the image below taken from one slide of that that particular investor presentation.

But we also learned that it has now has biosimilars not only of insulin aspart, as well as regular insulin (the innovators are branded as Humulin R or Novolin R), with a version of 100 units/mL (U-100) as well as a version with 500 units/mL (U-500) for which Lilly's U-500 Humulin R insulin had quietly become a bestseller thanks to growing incidence of Type 2 diabetes patients with very high insulin requirements.

In addition to those, we also learned that Amphastar also has a copy of insulin degludec, better known by its brand-name Tresiba from Novo Nordisk. I mistakenly believed that Tresiba had patent protections still remaining. While I thought it had patent protections until 2032, according to the U.S. Patent and Trademark Office (see https://www.uspto.gov/patents/laws/patent-term-extension/patent-terms-extended-under-35-usc-156 for more), it reports that insulin degludec patent terms (which were extended already) will officially expire on July 22, 2024 which is about 8 years of patent exclusivity.

Overall, branded insulin manufacturers secured a median of 16 years of protection on their insulin products through patents and exclusiveness, surpassing the median of 14 years observed in other studies of top-selling small-molecule drugs. Keep in mind that insulins were regulated and approved as small molecule drugs at the time and that Tresiba was approved in 2016 as a "drug". Some of the most widely used insulins, such as glargine and degludec, were among those with the longest periods of market exclusivity. (refer to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10653475/pdf/pmed.1004309.pdf for the published paper which reported this). We know that FDA first approved Tresiba (insulin degludec) in 2016. 

Regardless, we know with absolute certainty that Novo Nordisk's second attempt at a "Lantus killer" known as Tresiba was expected to be its winner, but without legally-exempted rebate kickbacks paid to vertically-integrated (with commercial healthcare insurance companies) Pharmacy Benefit Managers ("PBMs"), Tresiba never really killed Lantus, and now no fewer than about 4 more biosimilar copies of insulin glargine expect approval decisions in 2024 (in addition to the two already on the market). And, thanks to the FDA revised policy decision on insulins which went into effect in 2020, the approved marketing applications for the small subset of "biological products" (medicines) including insulin and human growth hormone – which for complex historical reasons were previously generally approved as drugs under section 505 of the FD&C Act – will be deemed to be biologics licenses under section 351 of the PHSA. That meant these products, even though approved as "drugs" would be recognized as biologics and therefore eligible for biosimilars and governed as such.

For its part, Novo Nordisk had hoped its once-weekly basal insulin to be branded as Awiqli (pronounced like "A Weekly") known generically as icodec insulin injection would help it win in the basal insulin market. But that was dealt a severe blow by the FDA on May 28, 2024 when the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted against the approval of Novo Nordisk's once-weekly insulin icodec injection for Type 1 diabetes. The FDA's internal reviewers flagged its risk, noting in its briefing document https://www.fda.gov/media/178821/download that while hypoglycemia is an expected side effect of insulin products generally, insulin icodec did not yield "additional glycemic control or other benefit" in Type 1 diabetes patients. In a 7-4 vote, the panel of external experts found that insulin icodec's benefits do not outweigh its risks. That also means that the Awiqli product would not be FDA approved by the vast majority of U.S. insulin users who have Type 1 diabetes (Type 2 patients use significantly more insulin, but are fewer in number than Type 1 patients). 

In particular, there were serious concerns about how emergency personnel would deal with the inevitable insulin icodec overdoses. For patients with Type 1 diabetes, a weekly basal insulin was described by some commenters as "a solution in search of a problem to solve" since it did nothing to mitigate a need for injected prandial insulin.

The bottom line is this: we now have biosimilars for the basal insulin Lantus already on the market with a whole bunch more coming soon, plus the basal insulin Tresiba, as well as for the prandial insulins Novolog, Humalog and even the old-school rDNA Regular insulin (with the 500 units per mL or "U-500" version expected to be the bigger seller compared to the less concentrated U-100 version) all coming to market soon. That explains why Novo Nordisk tried very hard to extend its GLP-1 patents to get an extra 30 months by inappropriately listing injector devices in the FDA Orange Book (which was illegal, incidentally). But the Federal Trade Commission noticed those patents and filed a complaint with the FDA about how those patents did not belong in the Orange Book, meaning copies of patent-expired liraglutide (fka Novo Nordisk Victoza/Sexenda) are now already on the market (Teva's authorized generic is the first, but even more are expected to receive FDA approval decisions later this year, and permitted to come to market after December 26, 2024, meaning they'll hit the market soon after the New Year).

JDRF's Rebrand to "Breakthrough T1D" Is The Org's Third Rebrand Since My T1D Diagnosis in 1976

On June 4, 2024, the Type 1 diabetes nonprofit organization formerly known as JDRF (itself an acronym which stood for the Juvenile Diabetes Research Foundation) officially renamed itself "Breakthrough T1D". 

See the press release at https://www.prnewswire.com/news-releases/jdrf-is-now-breakthrough-t1d-302163068.html for more). The organization also announced it on video below, or at https://youtu.be/X_kpioCJKXg?si=bTeDbHkUz1e21fJj 

It will take me some time to get used to the new name, but in fact, I have lived through at least three of the same organization's name-changes over my lifetime of living with Type 1 diabetes mellitus.

The publication known as Ad Age (fka Advertising Age) ran an article about the re-brand entitled "Behind a Leading Diabetes Research Foundation's Rebrand" at https://adage.com/article/marketing-news-strategy/jdrf-rebrands-breakthrough-t1d-diabetes-research-foundations-new-name/2563581.

The migration to acronyms is at least part of the rebranding initiative although I have mixed feelings about those. "T1D" is not a particularly good name, but it does very clearly distinguish the autoimmune form of diabetes (Type 1 diabetes mellitus) from the far more common form known as Type 2 diabetes mellitus. The lack of understanding of the unique etiologies of different forms of diabetes has made accomplishing some public policy changes more difficult to attain, such as price containment for insulin. 

People hear the term "diabetes" and automatically and immediately presume themselves to be experts because a distant relative or friend had "diabetes" and inevitably, the person thinks that if you merely lost a few pounds, your disease would simply disappear without any comprehension that a) no amount of weight-loss will eliminate a patient with Type 1's need for exogenous insulin and b) none of the "new" treatments which have emerged are even FDA approved for Type 1 diabetes (its insulin replacement therapy or death); all of them are only for Type 2.

When I was first diagnosed, "Breakthrough T1D" was still relatively new (in existence for a few years) known as the Juvenile Diabetes Foundation, or simply the acronym "JDF". At that time, Type 1 diabetes was still routinely described as "Juvenile" diabetes because an overwhelming majority of those who were diagnosed with the autoimmune disease were children (hence the term "juvenile" being part of its name). In fact, it wasn't until around 1973 that scientists even understood that Type 1 diabetes had a very different cause or disease etiology than Type 2 diabetes, and were not, in fact, the same disease, but unique diseases that shared similar symptoms.

In 2012, the JDF added the term "Research" to the organization name. At the time, the JDF Board of Directors Felt it was necessary to  add "Research" to the name so they could more effectively lobby lawmakers in Washington by acknowledging that the JDRF was primarily focused on "research" and that was an effective name revision.

However, the old vestige of the old term "juvenile" term has come at some costs. In addition to adults too often being frequently misdiagnosed mainly because of their age, it also neglects the core reality that eventually, all those children with diabetes will grow up to become adults who are still living with autoimmune Type 1 diabetes mellitus.

That said, the original focus for JDF, JDRF or Breakthrough T1D was primarily on finding a cure. Improved treatments was intended as a stop-gap until curative therapies were developed and came to market. However, I was diagnosed with Type 1 diabetes mellitus (T1D) at age 7 in 1976. I will be eligible for a Joslin 50 year medal (should I choose to claim one) in just two years (2026). And yet in my assessment, there have been few true "breakthroughs" in my lifetime.

For example, around 1980 or so, we as patients were able to test our own blood glucose levels for the very first time when fingerstick glucose test strips and meters became available. It would take nearly another twenty years until the first continuous glucose monitor (CGM) came to market in 1999, and it took another decade until what was then JDRF bankrolled the peer-reviewed studies which laid the groundwork for widespread insurance coverage of the devices.

However, a persuasive business case for CGM in Type 2 diabetes has yet to be established for insurance company payers and that is not Breakthrough T1D's responsibility; it already did the work needed in T1D, but Dexcom and Abbott are on their own to make it happen for the more common form of diabetes. 

The cost-benefit analysis is simply not there for improved glycemic control in T2D; the hypoglycemia alarms is what sold insurers on covering them for Type 1, but it came at a huge cost: CGM's cost payers nearly four times as much money, although the savings from ER treatments for hypoglycemia justified their coverage. But on Type 2, the cost-benefit of paying 4 times as much money over fingerstick testing for a patient who is likely to be covered by another company or Medicare by the time complications set-in mean the business case is not as compelling for Type 2 diabetes at this time. Dexcom and Abbott have shifted strategy, introducing a lower-priced CGM for Type 2 accomplished mainly by having longer wear-times for each CGM sensor. We shall see if the business case for CGM coverage of CGMs for Type 2 changes with lower prices. That is not Breakthrough T1D's issue to solve (it is for Dexcom or Abbott).

While insulin manufacturers will claim that the advent of recombinant DNA manufacturing was a "breakthrough", the peer-reviewed scientific evidence from Cochrane and IQWiG among others have unequivocally proven biosynthetic insulins was no breakthrough. At the time, the only way to encourage widespread adoption of the newer biosynthetic "human" insulins was by discontinuing the older, widely-used insulins. The biosynthetic insulins offered absolutely no therapeutic benefit whatsoever and a number of patients developed hypoglycemia unawareness from the biotech-made insulins which manufacturers attempted to claim was due to "patient error". In fact, it wasn't until 1996 that the Food and Drug Administration even approved the first insulin analogue which had a significantly faster time-activity profile and a few years later, approving a longer-acting basal insulin with less pronounced peak of activity emerged.

At the same time, the U.S. medical industry being driven primarily by legally-exempted kickbacks which cause Americans to pay more for the exact same treatments than every other developed country on earth pays has ballooned into a massive problem which the free markets have largely failed to address (although startups such as Mark Cuban Cost Plus Drug Company are starting to have an impact). So far, policy-makers have done nothing to address runaway costs, while big commercial healthcare insurance companies like United Healthcare have become unmanageable, money-sucking behemoths. At some point, lawmakers need to fix that mess, but until they do, Americans will continue to pay vastly more for healthcare than Mexicans, Canadians, Europeans, Australians and everyone else on earth for the exact same treatments. There, Breakthrough T1D can and arguably should play a bigger role.

Anyway, as for the rebranded "Breakthrough T1D", as I said, I am hardly new to the organization's name changes; this one is my third name-change so far. 

My expectation is as it shifts focus away from the ever-elusive curative therapies, that the organization will step up its lobbying for effective policy solutions to ensure the overpriced treatment advances reach mass-audiences (and that means letting Dexcom and Abbott work on securing coverage for Type 2 diabetes without the help of Breakthrough T1D as they did in securing more widespread coverage for people with T1D), and instead address issues such as having a detailed action plan if one or all of the large, branded insulin manufacturers (Novo Nordisk, Lilly, Sanofi) decide it is in the best interest of their shareholders to simply abandon the commoditized insulin business. Having an action plan ready to implement immediately should that happen will enable us to raise capital quickly to acquire the insulin manufacturing business should that happen. We cannot risk losing any of them, even while shareholders may encourage divestiture.

I will trust Breakthrough T1D at its word when it says it will work for greater access to treatments and therapies for the T1D community. But I want to see proof of that!