Another Three Biosimilar Insulins Planned from Meitheal Pharmaceuticals, Inc.

On September 21, 2023, Chicago-based Meitheal Pharmaceuticals, Inc. (which is a subsidiary of a Chinese parent company named Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.) announced an exclusive commercial licensing agreement with a different Chinese company known as Tonghua Dongbao Pharmaceutical Co. Ltd. with intent to sell three insulin biosimilars in the U.S. market. 

 

 

 

 

The company press release can be seen at https://www.meithealpharma.com/news/61 while the pharmaceutical industry trade press covered the story at https://www.thepharmaletter.com/article/licensing-deal-to-bring-three-new-insulin-biosimilars-to-the-usa.

Meitheal announced its intent to sell biosimilars of the three bestselling insulin analogues currently sold in the U.S. (for insulin aspart, insulin lispro, and insulin glargine). The company expects to begin clinical trials necessary for the three insulin biosimilars in 2024. Meitheal will be several years later than a number of other companies currently which are have insulin biosimilars pending approval which are forecast to hit the market in 2024.

Meitheal Pharmaceuticals will follow a nearly-identical commercialization path to virtually all other insulin biosimilars (exceptions being those from the biggest branded insulin-makers, including Lilly and Sanofi; Lilly sells copies of Sanofi's Lantus, and Sanofi sells a copy of Lilly's Humalog). Aside from copies made by the big branded insulin-makers, all other insulin biosimilars will involve either a U.S.-based company or a U.S. business unit of a company based offshore (Sandoz, for example). However, all will procure the Active Pharmaceutical Ingredient (API) for the insulin from laboratory partners who are based outside the United States.

Biocon Biologics originally entered the U.S. biosimilar insulin market back on July 28, 2021 with a partner known as Viatris in a joint venture. That partnership involved Viatris navigating the FDA regulatory applications and the the bizarre peculiarities if U.S. drug distribution system with PBMs and whatnot, while Biocon focused on manufacturing and packaging done at a massive facility located in Johor, Malaysia not far from the Singapore border. However, on February  27, 2022, Biocon officially acquired Viatris' half of their joint venture although the company retained access to Viatris FDA experts and drug distribution system experts for a period of two years after the acquisition closed.

Biocon sells two identical versions of the exact same insulin biosimilar: known generically as insulin glargine-yfgn, although focused the PBM rebate-driven contract model selling branded Semglee. Specifically, in late 2021, it landed the insulin on the Express Scripts preferred drug formulary effective in early 2022, as well as those whom Express Scripts contracts on behalf, including Prime Therapeutics' PBM formularies. As a workaround, Viatris/Biocon introduced a separate, unbranded version (oddly, of a biosimilar) called Viatris U-100 Insulin Glargine Injection which had a list price which was 65% lower. Offering a branded/unbranded version of the product followed the path already established by Lilly and Novo Nordisk back in 2019 (and later, by Sanofi in 2022), except that Viatris/Biocon was selling a copy of a therapeutic originally developed by Sanofi. Biocon also applied for a biosimilar of insulin aspart (Novolog), but on January 7, 2022, the FDA denied the application for its insulin aspart biosimilar with a "Complete Response Letter" (CRL). After that, Biocon told investors that the company intended to respond to the CRL in order to satisfy the FDA's requests. Since then, that has been Biocon's focus, hence there has been little follow-up information on the status of its Novolog biosimilar. It is unclear whether Biocon also intends to sell a Humalog biosimilar.

Civica, Inc.'s CivicaScript PBC operating unit will procure insulin API's for the exact same three insulins from Hyderabad, India-based GeneSys Biologics (see https://www.businesswire.com/news/home/20220303005321/en/Civica-to-Manufacture-and-Distribute-Affordable-Insulin/ for a press release containing the API source, AND https://www.prnewswire.com/news-releases/jdrf-announces-support-of-civica-to-manufacture-and-distribute-low-cost-insulin-301495050.html for pricing details).

Even before its insulin biosimilars have FDA approval, Civica has already had a major impact on U.S. insulin pricing. The reason is because CivicaScript has a unique Unilateral Pricing Policy ("UPP") that sets a Maximum Retail Price (MaxRP) for all CivicaScript products which is printed on all packages which patients can see clearly. Violations or refusal to participate in CivicaScript's UPP could result in loss of ability to purchase CivicaScript products (see https://civicascript.com/upp/ for more). Civica intends to sell its biosimilars of Lantus, Novolog and Humalog for $30/vial or $55 for a box of five prefilled insulin pens. Civica has licensed Ypsomed AG's disposable UnoPen design (see https://www.businesswire.com/news/home/20230131005294/en/Civica-Welcomes-Ypsomed-as-Injection-Pen-Partner-for-Its-Affordable-Insulin-Initiative for more on the Ypsomed UnoPen licensing agreement).

 

Thus far, all biosimilars other than those from Civica will be procured from laboratories based in China. For example, Switzerland-based Sandoz (and its U.S. unit Sandoz, Inc.) will procure biosimilars from China-based Gan & Lee. When Sandoz announced its intent to enter the U.S. biosimilar insulin market back in December 2018, the reason Sandoz cited for partnering with Gan & Lee in its press release was revealed was as follows:

"Gan & Lee is a leading insulin supplier headquartered in China with more than 20 years' experience in insulins and production capacity with attractive cost of goods sold (COGS) structures."  

(see https://www.globenewswire.com/news-release/2018/12/19/1669194/0/en/Sandoz-enters-into-commercialization-and-supply-agreement-for-insulin-biosimilars-anticipating-growing-demand-as-diabetes-burden-rises.html).

Sandoz did not elaborate further, but since that time, the world has learned considerably more about what the underlying cost of goods sold (COGS) are which Sandoz boasted about back in December 2018 were. Notably, in Gan & Lee's 2022 annual report (see https://www.ganlee.com/uploads/files/2023/0428/ILHLDWv4RJ5kJaR1AVfVZOMa8FgQrC13lKU6VnGH.pdf), if one fast forwards to page 62 of 375, we know exactly what its biosimilar insulin prices are. Specifically, the costs were disclosed in Chinese Yuan, referred to as "CNY", so using current currency exchange rates, the U.S. Dollar (USD) amounts revealed at the time they were calculated were as follows:

• Insulin glargine injection 143.97 CNY = $20.83 USD
• Insulin lispro injection 60.00 CNY = $8.68 USD
• Insulin aspart injection 59.63 CNY = $8.62 USD

Note: There is no reason to presume that insulin glargine costs materially more to culture in a bioreactor and extract than insulin aspart or lispro costs. The manufacturing process is similar for all; the variance in prices are not based on underlying manufacturing costs, but the historical price differences between basal and prandial insulin analogues.

Other biosimilar companies will offer some (but not all) of the bestselling insulin varieties. One such firm is California-based Amphastar Pharmceuticals, Inc. which has been building its diabetes business since 2020. Amphastar introduced the first-ever old-school, mix & inject glucagon emergency kit (see https://www.globenewswire.com/news-release/2020/12/29/2151177/0/en/Amphastar-Announces-Approval-for-Glucagon-for-Injection-Kit-1mg.html for the company press release, and https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-drug-used-treat-severe-hypoglycemia for the FDA press release). 

 

 

Amphastar's rein as the only generic glucagon rescue kit manufacturer quickly ended when Fresnius Kabi US was approved by FDA and was commercialized by the Switzerland/Germany-based pharmaceutical company (see the press release for its FDA approval at https://www.businesswire.com/news/home/20200205005106/en/Fresenius-Kabi-Introduces-Glucagon-Emergency-Medicine-Kit-to-Treat-Life-Threatening-Episodes-of-Low-Blood-Sugar for more). Then, on April 23, 2023, Amphastar acquired from Lilly that company's "modern" glucagon product known as Baqsimi (see https://www.prnewswire.com/news-releases/lilly-to-divest-baqsimi-to-amphastar-301804855.html for the press release).

Amphastar has also been pursuing a number of insulin biosimilars, specifically a biosimilar of Sanofi Lantus and another biosimilar of Novo Nordisk's Novolog, and curiously, two versions of rDNA biosynethetic "human" insulins which some find surprising. I had originally suspected that would be Regular and NPH/isophane (the company only said it had TWO biosynthetic "human" insulins in development), but now I believe that those will be U-100 Regular and U-500 Regular (the latter expected to be the biggest seller) as Lilly is the only current supplier of that product in the U.S. Amphastar will procure the insulin biosimilars from an entity known as Amphastar Nanjing Pharmaceuticals, Inc. (ANP). While Amphastar claims that to be a "business unit", under Chinese law, it cannot "own" a Chinese unit, which means that ANP likely has an exclusive supplier relationship with the company. Although Amphastar does have the ability to procure insulin biosimilars from another business unit based in France, the cost equation strongly suggests the China-source will be preferred for the insulin API's, rather than a European-based source.

 

 

In 2016, Lannett Company, Inc. inititated a process to commercialize an insulin biosimilar of insulin glargine to be manufactured by YiChang HEC ChangJiang Pharmaceutical Co., Ltd., an HEC Group company. Lannett later expanded its strategic relationship with HEC in 2021, adding a new co-development agreement for second biosimilar analogue of insulin aspart. Like Civica, Lannett has licensed Ypsomed's disposable insulin pen which we know to be the UnoPen (see https://www.prnewswire.com/news-releases/lannett-announces-patent-licenses-for-the-pen-injector-delivery-device-to-be-used-for-its-insulin-glargine-and-insulin-aspart-development-program-301669481.html for more).

Anyway, while the offshore-based biosimilar insulin manufacture is the standard manner for competing in the biosimilar insulin space, the reality of multiple biosimilar-makers which can undercut branded insulin prices considerably has essentially FORCED major branded insulin manufacturers (Lilly, Novo Nordisk, and Sanofi) to slash their own insulin list prices, and to pay for that, they will simply disintermediate the PBMs from the transactions. See https://www.prnewswire.com/news-releases/lilly-cuts-insulin-prices-by-70-and-caps-patient-insulin-out-of-pocket-costs-at-35-per-month-301758946.html AND https://www.prnewswire.com/news-releases/novo-nordisk-to-lower-us-prices-of-several-pre-filled-insulin-pens-and-vials-up-to-75-for-people-living-with-diabetes-in-january-2024-301771409.html AND https://www.globenewswire.com/en/news-release/2023/03/16/2629188/0/en/Press-Release-Sanofi-cuts-U-S-list-price-of-Lantus-its-most-prescribed-insulin-by-78-and-caps-out-of-pocket-Lantus-costs-at-35-for-all-patients-with-commercial-insurance.html for more.

While the PBMs are not at all happy about their insulin kickback cash-cow being taken away from them, they have already moved on. In diabetes, for example, they now collect legally-exempted kickbacks from Dexcom paid to keep Abbott Freestyle Libre off-formulary (catch my coverage HERE). Senseonics/Ascensia's Eversense CGM bypasses those kickbacks by its coverage under patients medical rather than pharmacy benefits. The FTC's 6(b) study of PBM business practices could see litigation to end formulary exclusions, but right now it is entirely speculation.

Some patients have expressed concern with offshore-made insulins, particularly those manufactured in China since FDA inspectors cannot freely-inspect China-based biotechnology laboratories. Those concerns are legitimate. By comparison, India-based biotechnology laboratories can be freely inspected by FDA. That said, for patients struggling to afford their insulin, the advent of biosimilars regardless of where they are cultured, should bring meaningful, sustainable price relief. The advent of biosimilars forced big branded insulin-makers to reconsider the PBM commercialization model and they concluded the insulin sells itself, they shouldn't pay more than 75% of their margins to PBMs for doing absolutely nothing.

However, a report from Democratic Senators Elizabeth Warren, Richard Blumenthal, and Raphael Warnock revealed that accessing discounted insulin from pharmacies is harder than it seems https://www.warren.senate.gov/imo/media/doc/Report%20on%20Insulin%20for%20Uninsured%20Patients%20-%2007.12.2023%20(updated)1.pdf.

According to a survey of over 300 pharmacies, less than half reportedly did not even sell Lilly Insulin Lispro, Lilly's less costly unbranded prandial insulin. Meanwhile, the vast majority of pharmacies still sold branded Humalog, the more expensive brand-name version. Many people were charged more than what the drug companies had promised, according to the report. The report found that on average, people without insurance paid $97.51 for Lilly Insulin Lispro. That is nearly four times the $25 rate that Lilly set in the U.S. for its unbranded insulin. Beyond those findings, the report explained that patients must still navigate confusing resources regarding insulin pricing. As a result, many people ended up paying more than the discounted prices.

Regardless, with the addition of Meitheal insulin biosimilars in the future, we will have no fewer than six Lantus biosimilars (that explains why Sanofi finally got around to slashing its own prices on Lantus by 78%) and the same number of Novolog biosimilars. There will be four Humalog biosimilars, but Lilly has been more aggressive in price-cutting its own unbranded version of Humalog. Right now, patients can readily download coupons to buy Lilly Insulin Lispro for a price of just $35/vial from https://www.insulinaffordability.com/ while Novo Nordisk has its own manufacturer coupon program at https://www.novocare.com/diabetes/help-with-costs/savings-offers.html and Sanofi's manufacturer coupon program can be found at https://www.teamingupfordiabetes.com/sanofidiabetes-savings-program.

Abbott Acquires Bigfoot Biomedical. Unity has a new home. Some Bigfoot employees might not like it.

In mid-September 2023, the medical technology startup known as Bigfoot Biomedical, reached a definitive agreement to be acquired by Abbott Laboratories (see the official press release at https://www.prnewswire.com/news-releases/abbott-to-acquire-bigfoot-biomedical-furthering-efforts-to-develop-personalized-connected-solutions-for-people-with-diabetes-301918254.html for details). Financial terms of the deal were not disclosed. The acquisition closed just 2 weeks later (see https://www.prnewswire.com/news-releases/abbott-completes-acquisition-of-bigfoot-biomedical-301936187.html for the announcement on that), which suggests the amount of cash paid for the company did not require significant financing.

Bigfoot's CEO Was Fired from JDRF

Some people with diabetes might recall that Bigfoot Biomedical was co-founded by Jeffrey Brewer, whose previous job was as CEO of the JDRF. But Mr. Brewer was shown the door at JDRF. Jeff Brewer left JDRF in July 2014, and he became CEO of Bigfoot Biomedical in November 2014, which was roughly 4 months later. His unannounced departure from JDRF occurred rather suddenly, and yet full details on his departure were never made public. Bigfoot Biomedical began in November 2014 on the other side of the country (JDRF is based in New York, while Bigfoot was based in the San Francisco Bay Area in the Santa Clara County town of Milpitas, which is adjacent to San Jose. My only recollections of Milpitas was when the Great Mall opened back in 1994, as I was living in the Bay Area at the time). Such timing would be impossible unless Mr. Brewer was working on it while he was still employed at the JDRF. I must presume Jeff Brewer was conducting business for his startup while still on JDRF's payroll, and the JDRF Board discovered that, and therefore they wanted him fired immediately. The JDRF International Board of Directors quickly named Mr. Brewer's successor (Derrick Rapp) just weeks after his departure, which was vastly quicker than new CEOs of the JDRF had been named previously. But it is also likely that Mr. Brewer negotiated to keep the events which lead to his sudden and unexpected departure from JDRF undisclosed.

Bigfoot Biomedical CEO and Co-Founder Jeffrey Brewer

While Bigfoot was privately-held, therefore its financial statements were unavailable for any public scrutiny, there is reason to believe the company had been struggling financially. In fact, Bigfoot sells just one FDA-approved product, specifically a smart insulin pen cap system known as Unity https://www.bigfootbiomedical.com/bigfoot-unity/ which functions with Abbott's Freestyle Libre CGM system rather than with Dexcom. Unity received FDA approval on May 10, 2021. But Bigfoot was funded almost exclusively by venture capital, and honestly, those investors won't keep the cash spigot running indefinitely. On February 13, 2023, we started to see the first signs of financial distress when Bigfoot sold the company's intellectual property assets related for Bigfoot Biomedical's pump-based automated insulin delivery technologies to Insulet in order to strengthen the company's balance sheet (see https://www.businesswire.com/news/home/20230213005076/en/Insulet-Acquires-Insulin-Pump-Patents-from-Bigfoot-Biomedical-as-Both-Companies-Prioritize-Improved-Insulin-Delivery-Technologies/ for the press release), although Bigfoot (and presumably, now Abbott) retained a lifetime license to those patents, they were assets which could be sold to raise money. But that was kind of our first clue that things were not looking so healthy at Bigfoot Biomedical.

Bigfoot's decision to partner with Abbott rather than Dexcom was unusual given that in 2014, Dexcom commanded the U.S. market even though Abbott was the clear winner on a global basis, dominating markets outside the U.S. and Canada (such as Europe, which does not struggle with lack of coverage or even more endemic under-insurance issues thanks to high-deductible insurance plans which continue to plague the U.S. market; but European payers were never prohibited from negotiating process as they were in the U.S. until recently). Theoretically, Bigfoot could have done as Abbott did, which was to focus primarily on the European market, but Bigfoot did not do so, and that may have contributed to the company's decision to sell itself to Abbott in 2023.

While Bigfoot's Unity smart pen caps did something technologically impressive given that mobile devices can generally only have one Bluetooth connection working at a time and it required its technology to navigate a CGM and likely things such as smart insulin pens. But they used what's known as near-field communication (NFC) to get around that Bluetooth limitation. On the marketing side, Bigfoot's Unity caps are color-coded, so the white pen caps work for prandial insulin varieties while black pen caps work for basal insulin varieties.

According to data which is now a few years old from MedTech Insight (see https://medtech.citeline.com/MT144176/Dexcom-Abbott-File-Dueling-Lawsuits-On-Diabetes-Management-Technology/ for more), Abbott was actually the largest player in the global CGM market with a 30% market share as of 2020, followed by Dexcom with 20% market share as of 2020. The remainder belongs to companies including Medtronic and Senseonics/Ascensia.

Dexcom CEO Kevin Sayer told investors in February 2023 when Dexcom released its fourth quarter 2022 earnings data that it had a total of 1.7 million customers globally in 2022 (see https://www.medtechdive.com/news/dexcom-reports-another-record-year-of-new-customers-amid-continued-demand-f/642472/ for more), hence we can estimate that Abbott Freestyle Libre has approximately 4.5 million customers globally. Meanwhile, outside the U.S., there are several companies based in Asia which have their own native companies selling CGMs. So far, none have expanded offshore, but it's quite possible we could someday see China's Zhejiang POCTech and/or South Korea's i-SENS try to enter the U.S. CGM market. Zhejiang POCTech was planning to enter the U.S. with a partner. However, CGM developer Senseonics took a financial lifeline from Ascensia Diabetes Care a few years ago, hence POCTech was out.

Meanwhile the recent acquirer of Bigfoot Biomedical, Abbott Laboratories is kind of also approaching the U.S. market as a virtual newcomer. When the CGM market first began back in 1999, Abbott decided to focus on markets outside the U.S. (such as Europe). That strategy worked brilliantly for Abbott. Because of its focus on markets abroad, it is Abbott, not Dexcom, which dominates the global CGM market everywhere on earth except for the U.S. and Canada. Abbott also sells far more CGM's each quarter than Dexcom, and its cost of goods sold is therefore quite a bit lower. In recent quarters Dexcom has been telling investors it is now working to reduce its costs to $10 on a per sensor basis. That means Abbott Freestyle Libre sensors apparently cost less to make and sell. 

Let's be clear: Abbott and Dexcom are practically identical in terms of their accuracy. The MARD values are marginally different, and some of that may be impacted by the denominator (wear-time) in the calculations. But, for example, in comparative real-world data (included in multiple, peer-reviewed studies), Abbott's Freestyle Libre system was shown to achieve comparable reductions in HbA1c levels and acute complications (notably hypoglycemia) compared to Dexcom's CGM systems. Indeed, the studies showed there were no significant differences between Freestyle Libre and Dexcom in post-CGM diabetes events. But, critically, many payers tend to prefer Libre because of its 35% lower price-point (thanks to its 14-day wear-time compared to Dexcom's much shorter 10-day wear-time). The U.S. does not function like rational markets should, where rebate-driven, legally-exempted kickbacks are more likely to win formulary placement rather than lowest aggregate costs, and guess who pays for that? Patients and employers alike.

Abbott's newest Freestyle Libre 3 model (see https://www.prnewswire.com/news-releases/abbotts-freestyle-libre-3-receives-us-fda-clearance--features-worlds-smallest-thinnest-and-most-accurate-14-day-glucose-sensor-301557561.html for the press release on the Libre 3's FDA approval) not only matches Dexcom on its core product features (notably, it features automated alarms without scanning, as well as data-sharing with others), plus it one-ups Dexcom on a few major features, specifically Libre 3 updates readings every minute compared to Dexcom's every five minutes (which translates into Libre 3 giving users 1440 new readings every day compared to only 288 new readings from Dexcom G6/G7 each day), and its 14-day wear-time, combined with a nearly equal retail price translates into Libre 3 costing 35% LESS than Dexcom. Dexcom is aware of the price differential, but seems to be focused on bringing a less costly product to the Type 2 market as that population does not have widespread usage of CGMs because insurance companies don't see the economic benefit of paying 3x as much for CGMs vs. fingerstick tests. But the price differential may cost it business with the Type 1 population if Abbott can get around the legally-exempted kickbacks Dexcom pays CVS Caremark and United Healthcare OptumRx to keep Libre off-formulary.

As the Federal Trade Commission (FTC) noted in its June 16, 2022 revised "Policy Statement on Rebates and Fees in Exchange for Excluding Lower Cost Drug Products" (see https://www.ftc.gov/system/files/ftc_gov/pdf/Policy%20Statement%20of%20the%20Federal%20Trade%20Commission%20on%20Rebates%20and%20Fees%20in%20Exchange%20for%20Excluding%20Lower-Cost%20Drug%20Products.near%20final.pdf for more), FTC has several legal authorities that may apply to such practices deemed to be commercial bribery, including Section 5 of the FTC Act, Section 3 of the Clayton Act, Section 2 of the Robinson-Patman Act, and the Sherman Act. It noted that the FTC has a long history (dating back to the 1930's) of addressing commercial bribery and will continue to do so. It awaits the conclusion of its 6(b) study on PBM business practices before it acts.

Dexcom Tells Investors They're working to slash costs to $10/sensor. Abbott Freestyle Libre is forcing it to reduce its production costs.

Nevertheless, Dexcom knows it faces competition from Abbott and the FTC 6(b) study could eliminate its formulary exclusion for rival Abbott Freestyle Libre, hence its working on a cheaper product targeting the Type 2 patient universe with a cheaper, longer-wearing CGM product. For example, Dexcom CEO Kevin Sayer told MedTech Dive (see https://www.medtechdive.com/news/dexcom-ceo-g7-fda-15-day-sensor-ma/625013/ for more) on the G7 "To get to 15 days — we have the tools to get there. For most adults, the sensors last 15 days now. The biggest issue for 10 days often is the adhesive, and what somebody puts the adhesive through in their own life, or just how their skin reacts to our adhesive. We do have adhesive programs. We have an adhesive we picked for G7 that became quite good. We are testing a couple of others to be more sticky for a 15-day product offering." He added: "We don't have an electronics or battery problem going 15 days with G7."

Abbott Has Its Own Challenges in the U.S. CGM Market

Abbott itself faces some business challenges in growing the company's U.S. business, even though its Libre 3 model is superior to rival Dexcom's G7 model, thanks to Dexcom bankrolled "formulary exclusions" (catch my coverage HERE), Abbott cannot gain access to customers. While product prices for Abbott Freestyle Libre 3 and Dexcom G7 are generally comparable (yet Dexcom sensors cost about $3 more), because Dexcom sensors have a 10-day wear-time compared to Libre 3's 14-day wear-time, that means Dexcom COSTS 35.5% more money, which is a key point of differentiation. Dexcom is keenly aware of this, which is why it's been telling investors that the company is working feverishly to reduce its production costs to $10 per sensor. Evidently, Dexcom believes Abbott's production costs are about $10 per sensor, while Dexcom's production costs are probably closer to about $14 per sensor.

While Dexcom announced plans for a new 15-day CGM sensor designed specifically for people who don't use insulin, which the company says is about 70% of Americans living with diabetes. The longer-lasting sensors will be the same, but the software will be configured so they are not focused on alarms for rapidly declining (or rising) blood glucose leves, but to help guide patients to understand the consequences of their food or exercise choices. That's not to say the product could not be used off-label by a person with Type 1 who needs a lower cost (but without hypo alarms, its unclear how many would do so), but Dexcom views the needs for Type 1 patients and Type 2 patients as being distinct from one another. But that could potentially spell opportunity for Abbott whose Libre 3 product has a longer wear-time while the retail prices for Libre and Dexcom are practically the same if Abbott can fix its insurance coverage problems.

For its part, Abbott is squarely targeting the largely untapped (for CGMs) Type 2 patient universe, but has some problems with Dexcom paying key PBMs (notably United Healthcare's OptumRx and CVS Health/Aetna's Caremark rebates which are paid contingent upon "formulary exclusion" of Abbott Freestyle Libre CGMs. The FTC now has a comprehensive 6(b) study underway examining the business practices of the six largest PBMs. That study has been underway for over a year but was expanded this summer to also include PBM owned Group Purchasing Organizations.

As for Bigfoot Biomedical, let me make this observation: the company spent a boatload of other people's money. The company spent lavishly to hire all kinds of senior executives from other companies, it hired a firm named Health+Commerce (which was where Karrie Hawbaker ended up working; my peers may recall she previously worked for Medtronic Diabetes when many of us went to a social media event held in the Los Angeles area) to monitor social media on its behalf, and its headquarters are/were in one of the most costly markets anywhere. 

But think about this: what do venture capital investors have to show for all that? Selling the company to Abbott gives them a return on their investment. Abbott is clearly a better home for the product. Only some Bigfoot employees might not like how the change impacts them.

Glooko Solicitation: What's in it for me?

This morning, I received a peculiar email. The email was from my endocrinologist's office (well, sort of, it was actually sent from Glooko). The subject line said "New York Presbyterian Medical Group created a Glooko account for your diabetes data". 

I was actually a little creeped-out by it, but because I had a very vague idea of what Glooko actually was, I did not instantly delete it. Still, I have no connection to Glooko (in fact, I have never once given the company my email address, nor have I ever asked them for more information, which means they attained it from my endocrinologist's office).

Some of the issue is because until 2019, Glooko actually CHARGED patients a subscription fee for individuals not sponsored through their provider, health plan, or employer (see the press release at https://www.businesswire.com/news/home/20190305005039/en/Glooko-Mobile-App-Now-Free-For-All-People-with-Diabetes%21 announcing that Glooko was dropping its patient subscription fee). 

With all due respect, sorry, but I was definitely not interested in PAYING a health tech startup for its advice which may not even be useful. I saw that as a tool which might help people who are not on the cusp of getting their Joslin 50 year medal (catch my post about approaching that at https://blog.sstrumello.com/2023/04/approaching-half-century-of-life-with.html), hence it appeared to me to offer more benefit to people who are new to diabetes. I saw no real need for or benefit to using Glooko, and even less apparent benefit so that a private company could mine my personal health information in order to sell it (even if anonymized) to others.

I could potentially still be persuaded, but my expectation is that the company needs to send me a FREE Glooko universal uploader cable for capturing fingerstick meter glucose data. I'll be damned if they expect me to pay for that, while Glooko sells my personal data.

In the end, while entities like Glooko are trying to position themselves as a way to sync your devices through your smart phone or home computer without the need to visit your doctor's office, that shifts the burden to me as the patient to do all the work the medical assistants at my endo's office do on my behalf. The old Diabetes Mine had an article from 2022 written about Glooko (see https://www.healthline.com/diabetesmine/glooko-diabetes-data-company for the article). Maybe I've become an oldster with T1D, but so far, the company's FDA approval for its long-acting insulin titration app for people with Type 2 diabetes (basal only Type 2's) has zero appeal for me.

At this point, Glooko needs to do more work to persuade me that it's even worth the effort.

Podcast Episode Recommendation for Deconstructed: Medicare Drug Pricing Negotiations Advance

So, today I am going to share a podcast episode which provides an interesting history of how Medicare ended up being unable to negotiate prescription drug prices which, on its face, seems like it SHOULD make no sense, but somehow price negotiations never happened and the reasons were really absurd. 

Naturally, since the list of the first 10 drugs to get Medicare price negotiations was published, there has also been considerable discussion of insulin prices which is the poster-child for how broken the prescription drug market is, and even more interestingly was how, included in the first round of Medicare price negotiations, were Novo Nordisk's prandial insulins known as aspart, including both Novolog AND Fiasp (in vials, disposable pens and penfill cartridges), and the inclusion of those was seen as a victory not only for patient prices, as well as downstream costs which Congressional lawmakers have done absolutely nothing to address until now. 

Medicare Part D went into effect as part of the Medicare Modernization Act of 2003 and went into effect on January 1, 2006. At the time, President George W. Bush (Junior) was in office, and he enjoyed a Republican Congress (for at least part of his Presidency). The story of how that came to be was pretty interesting, and how Republicans passed that legislation, and how doing so put Democratic lawmakers into a bind, but it worked for Republicans for years, along with a huge giveaway to the pharmaceutical industry. 

Anyway, this is the story of how Democratic lawmakers finally managed to un-do that huge giveaway to the pharmaceutical industry with the Passage of the Inflation Reduction Act, and curiously how prandial insulin made it on the list of the first drugs whose prices will be negotiated by Medicare. 

For the news about how Novo Nordisk's prandial insulins managed to be among the first 10 drugs to see price negotiations by CMS/Medicare, see the official release at https://www.hhs.gov/about/news/2023/08/29/hhs-selects-the-first-drugs-for-medicare-drug-price-negotiation.html and the fact sheet at https://aspe.hhs.gov/sites/default/files/documents/705b9c384d493e442a1d4004905cf8ae/ASPE-IRA-Drug-Negotiation-Fact-Sheet.pdf 

But this post is about a podcast episode which comes from The Intercept, which is a center-left learning news organization. Pierre Omidyar, eBay founder and philanthropist, provided the funding to launch The Intercept back in 2014. One of its podcasts is known as Deconstructed. 

The Deconstructed podcast describes itself as a show that cuts through all the political drivel and media misinformation to give you a straight take on one big news story of the week.

 

 

Its explanation on how Congress managed to add Medicare price negotiations came to happen was rather fascinating. In this particular episode of Deconstructed, Alex Lawson, executive director of Social Security Works, joins Ryan Grim to discuss the decades-long struggle against the pharmaceutical lobby to lower drug prices and how the Biden administration secured Medicare drug pricing negotiations. 

The description of this episode of Deconstructed itself is as follows:

Insulin, the lifesaving drug for tens of millions of Americans, is among the 10 drugs Medicare will negotiate for lower prices, by the power vested in the White House through the Inflation Reduction Act. This week on Deconstructed, Alex Lawson, executive director of Social Security Works, joins Ryan Grim to discuss the decades-long struggle against the pharmaceutical lobby to lower drug prices and how the Biden administration secured Medicare drug pricing negotiations. Grim and Lawson discuss the pharmaceutical industry’s enormous power, their aggressive efforts to stop the legislation and water it down, the history of political infighting and betrayal that led to this moment, and what the future of drug price negotiation may look like. 

The link to the podcast is at https://theintercept.com/2023/09/01/deconstructed-medicare-drug-pricing-negotiation/ or you can simply listen to it below.

Insurance Deductibles Don't Work Well for Patients with Chronic Illnesses. Some strategies for PWD's With HDHP's to Consider.

As of 2022, the U.S. Internal Revenue Service (IRS) defined a High-Deductible Health Plan (HDHP) as a health plan with an annual deductible that is not less than $1,500 for self-only coverage or $3,000 for family coverage, and for which the annual out-of-pocket expenses (deductibles, co-payments, and other amounts) must be satisfied before coverage kicks in. About half of all Americans with employer-sponsored healthcare insurance plans have deductibles to satisfy before the insurance covers much, although some employers provide Health Reimbursement Accounts (HRAs) to help offset the deductible. That said, the IRS has also ruled that a HDHP can actually cover certain types of "preventive" care without a deductible, or with a deductible that is much less than the annual deductible applicable to all other healthcare services, which is why the 2019 IRS decision to add care for a number of chronic medical conditions including diabetes to the list of "preventive" care benefits that may be provided by HDHP's was a big deal (catch my coverage of that at https://blog.sstrumello.com/2019/09/in-2020-people-with-diabetes-may-wish.html). While HDHP's can now cover insulin and test strips and a growing number actually do, many health plans still exclude CGMs since those were not explicitly named by IRS.

Consider the cost of CGM sensors. 

One reliable source to determine the actual cost of a CGM sensor is the Costco Member Prescription Program https://www.costco.com/cmpp which provides cash prices for some CGM sensors and other prescriptions Costco Pharmacy carries. Costco reports the cash prices for CGM sensors ranges from $57.33/sensor to $61.28/sensor. But the cost calculation is NOT complete yet. The reason is because the wear-time for CGM sensors also varies. For example, Dexcom G6/G7 sensors enable users to wear the CGM sensors for 10 calendar days, while Abbott Freestyle Libre 3 sensors can be worn for 14 calendar days. More frequent CGM sensor replacement generally costs patients more money out-of-pocket unless your insurance covers a portion of the cost. Hence a true cost comparison for CGM sensors must also calculate the cost of wearing the CGM sensor on a daily basis. Using the per sensor CGM costs computed from Costco CMPP, then the cash cost per day of wearing CGM sensors is as follows:

• Dexcom G6 Sensors cost $6.13 per day of usage
• Dexcom G7 Sensors cost $5.73 per day of usage
• Abbott Freestyle Libre 3 Sensors cost $4.23 per day of usage

The cost of using the lowest-price Dexcom CGM device (G7) therefore still costs 35.5% MORE than using an Abbott Freestyle Libre 3 CGM device costs unless a patient's insurance pharmacy benefit assumes some portion of the cost which is increasingly the case. 

CVS Health which owns/operates my own insurance carrier Aetna has chosen to cover just enough (about 37%) of the cost of using a CGM device to make it more attractive for me as a covered patient to use my own employer-sponsored insurance pharmacy benefit rather than me completely bypassing my insurance. If I were paying the costs completely out-of-pocket, my cost would have been $6.13 per day for a Dexcom G6 CGM sensor if I bought it at Costco Pharmacy. But it's actually cheaper for me to use my insurance (I pay about $3.88 per day of usage). That way, CVS Caremark still gets a cash rebate kickback from Dexcom which they would not collect if I bypassed insurance and bought an Abbott Freestyle Libre 3 instead. 

Of course, patients might still consider using Dexcom anyway in spite of it having a higher cost. For example, Dexcom has the most partnerships signed on Automated Insulin Delivery ("AID") systems (see https://t1dexchange.org/status-update-automated-insulin-delivery-devices/), and peer-reviewed medical research studies have shown that patients using AID systems have generally superior glycemic control, and those systems also make life vastly easier for patients, so the higher price might still be worth it for some (not necessarily all) patients.

There's one option also worth acknowledging here, which is if you're insurance doesn't cover CGM sensors at all until your deductible is satisfied: Dexcom has a manufacturer coupon program which covers up to $200 per month. Using Costco's CMPP to check prices, its cost for 1 Box of Dexcom G6 Sensors (each box contains 3 sensors) is $183.84 (or $61.28 per sensor) while 1 Box of Dexcom G7 Sensors (each box contains 3 sensors) is $171.99 (or $57.33 per sensor), so the newer product is marginally cheaper. GoodRx distributes Dexcom manufacturer coupons, or you can easily download the coupon from Dexcom's website at https://www.dexcom.com/en-us/savings-center-cgm-without-insurance/. Disregard whether it asks if you have insurance; if you have a deductible to satisfy before your insurance covers it, then you're effectively uninsured and should therefore use the Dexcom manufacturer coupon (just don't try to use a manufacturer coupon WITH insurance; you must use one or the other but usually not both; choose the one which costs you the least. Also, if you use Medicare, beware that coupons do not generally work WITH Medicare, but might work if you pay cash for a prescription, in which case, you might want to calculate which option costs you the least. Beware that some find it easier to fill scripts using coupons at a completely different pharmacy.

Another possibility is to consider using a longer-term CGM at the end of the calendar year which will last you for six months. In theory, insurance will likely pay for it by December. You can then use the Eversense E3 CGM for six months, which will carry you until June 2024. Perhaps by next June, your deductible will already be satisfied. 

 

Interestingly, on June 2, 2023, Senseonics https://www.senseonics.com/ and its collaborating partner Ascensia https://www.ascensiadiabetes.com/eversense/ announced it had landed Eversense E3 CGM coverage from the nation's largest commercial healthcare insurance company: United Healthcare (see https://www.businesswire.com/news/home/20230602005099/en/Senseonics-Announces-UnitedHealthcare-Coverage-of-Eversense%C2%AE-E3-CGM-for-Adults-with-Diabetes for the press release) which was kind of a big deal for the CGM startup.

Eversense had gained coverage from United Healthcare even though CGM rival Dexcom pays rebates to its OptumRx PBM unit which are paid by Dexcom contingent upon "formulary exclusion" for all rival CGM systems. But the reason for that seeming oxymoronic coverage decision was because Eversense CGMs must be inserted in (and removed from) patients' arms by a medical doctor. Hence, Eversense CGM's are typically reimbursed under the patient's medical (not pharmacy) benefit. That said, Abbott's Libre CGM system is definitely excluded from United Healthcare's OptumRx formulary. Ditto for CVS Health/Aetna/Caremark, which like United Healthcare, announced in 2018 that it would cover Eversense CGMs (see https://www.businesswire.com/news/home/20181022005926/en/Senseonics-Announces-Aetna%E2%80%99s-Positive-Coverage-Decision-for-Eversense for more). Curiously, Cigna's Express Scripts does not currently have a formulary exclusion for Abbott Freestyle Libre CGMs, although I'm not certain if Eversense currently has coverage from Cigna (it might). 

I suspect the Federal Trade Commission's 6(b) study now underway on PBM business practices might play a role because Express Scripts had the longest history of data which was subpoenaed by FTC for the study, and the company likely did not want to add anymore potential wrongdoing to its already-long list of matters which the FTC could cite and sue them over. The FTC is the only government agency which has the legal authority with subpoena power that does not necessarily have a law-enforcement intent, although it could if FTC uncovers any proof of wrongdoing.

Recall that on June 16, 2022, FTC issued a revised policy statement (see https://www.ftc.gov/news-events/news/press-releases/2022/06/ftc-ramp-up-enforcement-against-illegal-rebate-schemes) that it intends to ramp up enforcement against any illegal bribes and rebate schemes that block patients' access to competing lower-cost prescriptions. However, as a practical reality, enforcement hasn't really happened until the FTC 6(b) study on the business practices of the six largest pharmacy benefit managers concludes. That 6(b) study was expanded earlier this year to also include PBM-owned Group Purchasing Organizations (GPOs), including Express Scripts Ascent Health Services GPO which is based in Switzerland, and OptumRx's Emisar Pharma Services GPO which is based in Ireland. 

For patients with diabetes who have substantial annual deductibles to satisfy, Eversense might be a compelling option if the patient coordinates having the first Eversense CGM sensor inserted in December. That would translate into no more costs for CGM sensors until the following June since replacement is done every 6-months, and presumably, many will have already satisfied their annual deductible by that time. 

The most notable downside is that Eversense E3 displays and updates real-time glucose readings every 5 minutes, just as Dexcom G6 and G7. By comparison, Abbott Freestyle Libre 3 displays and updates real-time glucose readings every minute. Eversense also enables (and indeed, requires for the first 21 days) calibrations. Because Eversense requires a small outpatient surgical procedure in a physician's office to insert and remove the sensor — that can potentially result in scar tissue. Also, you have to wear the black plastic transmitter on your upper arm over the inserted sensor, which really is not particularly discrete. The transmitter adhesive backing must also be replaced every 24 hours, plus you have to charge the transmitter for about 10 minutes every day (the charge lasts a max of roughly 42 hours); if the battery runs out, your readings will be interrupted until you charge it. By comparison, Libre 3 does not enable calibrations, but that is offset by the fact that Abbott Freestyle Libre 3 gives users 1440 new blood glucose readings per day compared to only 288 readings per day with Dexcom or Eversense. Whether more updates makes much practical difference remains open to debate, but its a factor to consider if you have a choice.

Like Dexcom, Eversense also has a patient assistance program called Eversense PASS which covers part of the cost of the system. Visit https://www.prnewswire.com/news-releases/ascensia-diabetes-care-expands-payment-assistance-and-simple-savings-program-for-eversense-e3-cgm-system-301818639.html for more on that program.

For patients who rely mainly on automated insulin delivery (AID) systems, Eversense E3 is not currently integrated with any of those systems except the DIY systems which have gained international credibility since being published in peer-reviewed medical journals; there Dexcom is the hands-down winner (although Abbott Freestyle Libre already has an AID system with Ypsomed called the mylife YpsoPump system https://www.mylife-diabetescare.com/en/ which is CGM platform-neutral, meaning it's compatible with both Abbott Freestyle Libre as well as Dexcom). Technically, CGM platform-neutrality will also potentially be true for Tandem and it was true for Insulet until February 2023 when that company acquired intellectual property rights for a closed-loop system from Bigfoot Biomedical, although even Tandem has yet to announce U.S. plans for their AID systems to work with Abbott CGMs in the U.S. Lilly abandoned its joint project with Ypsomed to enter the U.S. insulin pump market in December 2022, but Ypsomed has nevertheless told investors it still plans to submit its YpsoPump system to the U.S. FDA for approval in the second half of 2023 according to plan. It will then shop around for a new U.S. partner to help commercialize the AID system once it attains FDA approval. YpsoPump is currently used in Germany, Austria, Switzerland, the UK and other European markets, so the system is already very well-tested.

Meanwhile, the Eversense E3 medical vs. pharmacy benefit coverage is likely to be the way for Senseonics/Ascensia to get around formulary exclusions which have limited Abbott Freestyle Libre system from more rapid U.S. growth, although Senseonics/Ascensia still have a major challenge getting doctors trained to insert the Eversense sensors themselves because so few doctors are trained to insert and remove the Eversense sensors.

Eversense E3 is still relatively small in the U.S. But the team at Taking Control Of Your Diabetes (TCOYD) has a video of Dr. Steven V. Edelman getting an Eversense E3 CGM sensor inserted in his arm real-time, while his collaboration partner Dr. Jeremy H. Pettus was an observer. They also include the website link for Eversense at https://www.ascensiadiabetes.com/eversense/get-started-today/ if you're interested in learning more. In their dialogue, they mention that some patients find the Eversense E3 to be more accurate than other CGM's. A key feature is that Eversense has vibration alerts which enable patients to know if blood glucose levels are low or high and they have those without access to their phones or receivers. 

Catch the video at https://youtu.be/v6pqBiFZtow?si=t9A_QISQXTc-Gm7Z or below.

Why Amazon Pharmacy's Recent Insulin Move is Helpful, But Not Groundbreaking

On August 15, 2023, Amazon Pharmacy (fka PillPack) announced (see https://www.aboutamazon.com/news/retail/amazon-pharmacy-insulin-coupons/ for the announcement) that it would begin automatically applying various manufacturer coupons to more than 15 common insulins and diabetes devices (including Dexcom, which offers a coupon for up to $200 per month at https://www.dexcom.com/en-us/savings-center-cgm-without-insurance/ even without insurance). So far, no coupons from Abbott on Freestyle Libre 3 sensors, but the longer wear-time of 14-days means Libre 3 sensors still cost about one-third less than Dexcom's 10-day wear-time. Some products, such as blood glucose test strips, may not be as cheap with Amazon Pharmacy as by patronizing Mark Cuban Cost Plus Drug Company and buying Roche Accu-Chek test strips for just $16.79 for a vial of 50 test strips (compared to Amazon Pharmacy's cash price of $24.00 per vial of 50 Accu-Chek test strips). diaTribe News had a pretty good summary of the Amazon Pharmacy move at https://diatribe.org/amazon-pharmacy-unveils-35-monthly-insulin which is worth reading.

Several years ago, I would have applauded the Amazon Pharmacy move. Today, while I think it is helpful and I hope it prompts other pharmacies to do the same thing, but it's not really groundbreaking. The reason is because of all of the underlying work that patient advocates such as I have done to enable this over the past six years, and now Amazon Pharmacy marches in and is trying to take credit for all of the real work people like me helped to make a reality.

As the diaTribe News' summary explained, despite the recent insulin list price cuts announced by Lilly, Novo Nordisk and Sanofi, a relatively new report from Democratic Senators Elizabeth Warren, Richard Blumenthal, and Raphael Warnock (see https://www.warren.senate.gov/imo/media/doc/Report%20on%20Insulin%20for%20Uninsured%20Patients%20-%2007.12.2023%20(updated)1.pdf for access to the report) revealed that accessing discounted insulins from pharmacies is still a lot harder than it seems. 

In the Senators' report, in a survey of over 300 pharmacies, less than half did not even sell Lilly Insulin Lispro Injection (U-100), which is Lilly's less costly unbranded "authorized generic" prandial insulin. Meanwhile, the vast majority of pharmacies still sold branded Humalog, the more expensive brand-name version which tends to be heavily-rebated to PBMs. Many people were charged more than what the drug companies had promised, according to the report. On average, people without insurance paid $97.51 for Lilly Insulin Lispro. This is nearly four times the $25 rate that Lilly has set in the U.S. for its unbranded insulin. Beyond these findings, the report explained that patients must navigate confusing resources regarding insulin pricing. As a result, many people end up paying significantly more than the discounted price. 

Such is the dilemma pharma companies have created with their odd, co-dependent relationship with predatory Pharmacy Benefit Managers (PBMs). While I think the March 2023 announcements by Lilly, Novo Nordisk and Sanofi that they would further reduce insulin list prices and to pay for that, they would stop paying PBMs rebates for formulary placement was a much-needed development, we are not likely to realize the full benefit of that until 2024.

In fact, Lilly was the very first big insulin manufacturer to introduce a less-costly version of Humalog called by it's generic drug name back in March 2019 (see https://www.prnewswire.com/news-releases/lilly-to-introduce-lower-priced-insulin-300805560.html for the press release). At the time, Lilly told everyone the product would be sold for half-price of what branded Humalog cost. In essence, Lilly introduced an unbranded version of its bestselling prandial insulin in order to bypass the list price increases needed to pay ever-higher legally-exempted rebate kickbacks paid to PBMs in order to secure formulary placement. But savvy patients with diabetes very quickly discovered they could buy unbranded Lilly Insulin Lispro for even less than half-price, and simply could use a GoodRx (or rival) coupon to buy it for 75% off the price of branded Humalog. Eventually, Lilly introduced its coupons attainable from https://www.insulinaffordability.com/.

In September 2019, rival Novo Nordisk realized that Lilly was onto something, and essentially copied Lilly's strategy by introducing an unbranded version of Novolog (see the press release at https://www.prnewswire.com/news-releases/novo-nordisk-launching-additional-us-insulin-affordability-offerings-in-january-2020-300913167.html for details). The PBM rebate contracting model for insulin had been under pressure for years. In 2020, Novo Nordisk disclosed to investors that the company was paying-out 74% of its gross U.S. sales as rebates paid to PBMs required to secure formulary placement. The company offered its own coupons at https://www.novocare.com/diabetes/help-with-costs/savings-offers.html. In Novo Nordisk's 2021 Annual Report, the company revealed to investors that between 2017 and 2021, the company's realized "net" prices for insulin had fallen by an average of 16.75% per year during that period. The company also acknowledged that "more than 1 million" Americans had been reached by the company's "affordability offerings" during that year, and the single biggest component of that was its unbranded (sold under the generic drug name), un-rebated "authorized generic" version of Novolog called insulin aspart which launched in September 2019 (its unbranded basal insulin degludec was only introduced in September 2022). In other words, the company realized the PBMs were not providing any added value; the insulin sold itself.

The PBM rebate contracting model for insulin had been under pressure for years. Indeed, research undertaken by University of Southern California published in the November 2020 issue of JAMA Health Forum https://jamanetwork.com/journals/jama-health-forum/fullarticle/2785932, researchers there offered one of the most comprehensive looks at the insulin distribution chain and showed exactly which players were profiting, by how much, all from selling insulin.

The USC conclusion was that insulin's list price had indeed been going up, not down, with trade secrets and other protections preventing many researchers from pinpointing exactly who was receiving profits from its sale. Meanwhile, the realized "net" price — what manufacturers receive after accounting for all the discounts and payments to distribution system entities — had been falling. USC researchers analyzed the flow of money across all distribution system participants — manufacturers, wholesalers, pharmacies, PBMs, and health plans — and found that middlemen in the distribution process were then taking home approximately 53% of the "net" proceeds from the sale of insulin, up from 30% in 2014. Meanwhile the share going to insulin manufacturers had fallen by 33% over the same period of time.

However, big pharma wasn't completely ready to abandon the PBM commercialization model just yet. Nevertheless, effective January 1, 2022, Lilly announced it would further reduce the price of its unbranded Humalog by an additional 40% (see the press release at https://www.prnewswire.com/news-releases/lilly-again-reduces-list-price-of-insulin-lispro-injection-as-latest-change-to-affordability-options-301386117.html for detail). Presumably, Lilly realized it could sell unbranded Humalog without paying PBMs multimillion dollar kickbacks which the PBMs should have realized was a bad omen for their not-so-little kickback scheme. Novo Nordisk did not cut its unbranded insulin prices any further, but in September of that year, the company did introduce an unbranded version of its basal insulin Tresiba called Insulin Degludec Injection U-100 (and U-200) which I covered in my post HERE (catch Novo Nordisk's coverage at https://www.novonordisk-us.com/media/news-archive/news-details.html?id=133808).

Still, at the time the less costly unbranded insulins were introduced in 2019, some major pharmacy chains like CVS refused to carry the unbranded products because the company's Caremark PBM division made so much money on branded insulin rebates, and then by forcing patients to pay artificially-inflated prices for branded insulins. But rival Walgreens (which does not own a PBM) sold the unbranded products and ultimately, CVS Pharmacy was ultimately forced to carry them, too (if begrudgingly).

Rival Sanofi was a bit of a laggard on the unbranded insulin front, until two of its biggest PBM clients Express Scripts (see https://www.prnewswire.com/news-releases/express-scripts-will-unlock-20-million-in-savings-for-clients-in-2022-by-preferring-the-first-interchangeable-insulin-biosimilar-301404121.html for more) and Prime Therapeutics both dropped the Lantus reference product from their preferred drug formularies and replaced it with Viatris/Biocon Semglee instead. That essentially forced Sanofi to introduce an unbranded version of Lantus in July 2022 (catch my coverage HERE) as its rivals did (catch the press release at https://www.news.sanofi.us/2022-06-29-Sanofi-to-lower-out-of-pocket-cost-of-insulin-for-uninsured-patients-and-expand-access-in-underserved-communities/). Sanofi also offered its own coupons at https://www.teamingupfordiabetes.com/sanofidiabetes-savings-program.

Nevertheless, navigating through this highly dysfunctional mess is no small undertaking as the Senators' report correctly concluded. It is especially difficult on those who lack commercial healthcare insurance (the uninsured) who tend to be most vulnerable. Amazon Pharmacy will make it a bit easier for patients to navigate if they can get over having to buy everything via mail order. It would be really nice if a big pharmacy player like Costco or Walgreens copied the idea.

Podcast Episode Recommendation: Healthy Dose of Dialogue Episode 31 "A Dose of Prescription Drug Disruption"

Today, I am recommending a podcast episode worth listening to. Specifically, it is an episode from June 15, 2022 of the podcast known as "Healthy Dose of Dialogue" which describes its mission to "gather the brightest minds in healthcare to share their unique perspectives on transformative marketplace trends, industry insights, and their vision for the future".

This particular episode (EP31: "A Dose of Prescription Drug Disruption") is an interview with the President of CivicaScript PBC, which in case you weren't aware of it, is an affiliated business unit of the nonprofit drug company Civica, Inc. and CivicaScript is its operating unit dedicated to lowering the cost of select high-cost generic medicines. The president of CivicaScript is a woman named Gina Guinasso. 

 

 

 

 

 

 

 

 

What makes CivicaScript PBC unique from the corporation known as Civica, Inc. is that CivicaScript was established as a public benefit corporation to reach consumers directly through retail and home delivery pharmacies rather than from a hospital setting which is where most of Civica's other drug business serves. CivicaScript is unique in that the company deploys what it calls a Retail Unilateral Pricing Policy ("UPP"). The CivicaScript Unilateral Pricing Policy sets a Maximum Retail Price (MaxRP) for all CivicaScript Products. This UPP is designed to fulfill its mission to offer low cost pharmaceuticals to patients. In order to remain in good standing, CivicaScript Resellers must advertise and sell all CivicaScript Products at or below the MaxRP. Violations or refusal to participate in CivicaScript's UPP could result in loss of ability to purchase CivicaScript Products.

Recall that on March 3, 2022, CivicaScript announced the company's intention to sell biosimilar versions of the three bestselling insulins https://www.civicainsulin.org/ currently on the U.S. market: glargine (Lantus), aspart (Novolog) and lispro (Humalog). 

While Civica will follow an identical business model to other biosimilar insulin companies (Sandoz/Gan & Lee, Lannett/HEC, Amphastar/ANP) by procuring the insulin Active Pharmaceutical Ingredients ("API") from an offshore biotech partner known as GeneSys Biologics in Hyderabad, India (see the company press release at https://www.businesswire.com/news/home/20220303005321/en/Civica-to-Manufacture-and-Distribute-Affordable-Insulin/ for information on the GeneSys Biologics collaboration), because of CivicaScript's unique UPP, the maximum patient out-of-pocket price patients will be charged will be $30/vial or $55/box of 5 prefilled insulin pens which was disclosed in the concurrent JDRF press release (see https://www.prnewswire.com/news-releases/jdrf-announces-support-of-civica-to-manufacture-and-distribute-low-cost-insulin-301495050.html for pricing info) on the same news.

Also of note is that Civica signed a licensing agreement with Switzerland-based Ypsomed AG to use that company's disposable insulin pen (see https://www.businesswire.com/news/home/20230131005294/en/Civica-Welcomes-Ypsomed-as-Injection-Pen-Partner-for-Its-Affordable-Insulin-Initiative/ for a bit more on the pen licensing agreement), and we later learned from Ypsomed's investor presentations that will be the company's UnoPen design (download the presentation at https://www.ypsomed.com/en/media-investors/presentations.html?file=files/media/03_Documents/04_Presentations/2022_23/Ypsomed%20Full-Year%20Results%202023.pdf and visit slide #13 for more).

CivicaScript President Gina Guinasso originally started on the drug company side of the pharmaceutical business, and then later moved to the PBM side of the business with the OptumRx business of United Healthcare, where she was a senior executive. She admits that she never would even have been considered for or gotten the job with Civica had it not been for her prior experience on the OptumRx PBM side of the prescription drug business. But as it turned out, that particular PBM experience made her especially well-suited to lead the CivicaScript business because she really understands what the business practices of both pharma and PBM's are.

In the interview, Gina Guinasso is interviewed by host Andy Chasin, who is Blue Shield of California's Vice President of Federal Policy and Advocacy. The podcast episode itself can be accessed at at https://www.doseofdialogue.com/episodes/31. However, I am embedding the podcast episode here for convenience. Just beware that the website also includes a transcript for the episode, so you can refer back to it if you want to read the episode transcript itself. Even though this episode is a year old, its one definitely worth a listen!

Campaign to End Diabetes Stigma

Currently, there is a global effort to pledge to make the world a more supportive, understanding, informed and caring place for people living with diabetes by eradicating "diabetes stigma". This has been a matter which Renza Scibilia has invested considerable effort to address (catch her post at https://diabetogenic.blog/2023/07/31/sign-the-pledge-to-end-diabetes-stigma/ for details) and I wish her well in the venture. To sign the pledge, visit https://enddiabetesstigma.org/.

 

Diabetes stigma is something I've been forced to endure for nearly a half-century (I was diagnosed with T1D in 1976; you do the math). When it comes to diabetes, ignorant people feel entitled to shame, blame, and disrespect people with diabetes of all types. These are the same people who use diabetes as a lame punchline in bad jokes on TV, or make irrelevant comments like if a T1D just ate better they could go off insulin which is a falsehood because of the etiology of their disease.

Make no mistake: I'm as sick of d-stigma as many seasoned diabetes veterans are because I've endured it for nearly 5 decades, but I have also grown to disregard lack of support or understanding because no one fixed the issue for me. Hence, I no longer care what other people think of people with diabetes. Its also no longer a top priority for me to fix personally. I care about the issue, but its just that as an issue, it's going to have to be something the younger crowd of diabetes advocates work to fix and they have my support in doing so. I just can't and won't personally do any heavy lifting on the matter.

D-Shaming Sucks, But I've Already Done Plenty for the Community, So Others Can Fix It

Over the past 40 years, I've done a LOT of advocacy work for the diabetes community. Although insulin has been on WHO's List of "essential medicines" since that list was first published in 1977, I did take on getting insulin analogues added to the World Health Organization's (WHO) list of "essential medicines" in the 1990's. And yet, since then, we have seen repeated accessibility problems on a worldwide basis due largely to prices. I can recall when Novo Nordisk went on a global acquisition spree, buying-up many formerly independent insulin manufacturers from Brazil to Eastern Europe. That really should never have happened, but it did. Access remains an issue on a worldwide basis, including developed economies like the U.S.

People outside the U.S. were actually surprised to discover that in the U.S., patients faced a severe insulin affordability crisis until very recently (see HERE and HERE for more). As advocates, we were able to get insulin reclassified by health plans as a "preventative treatment" classified by the Internal Revenue Service which only happened in 2019. That made insulin, for the first time, eligible for pre-deductible coverage which was not true before that, but it then took several more years to see that adopted on a more widespread basis as health plans were renewed.

Since then, I've also invested considerable effort working to partially dismantle a crooked, profit-driven healthcare U.S. system whereby patients with deductibles to satisfy were charged hundreds of U.S. dollars for a single vial of insulin which was far more than their own health care plans paid. I'm pleased to say, in March 2023, that not-so-little kickback scheme finally started falling apart before our eyes, but none of that just happened. It took a lot of behind-the-scenes work to make that happen, and unfortunately, the patient community does not always appreciate just how much underlying work was involved in accomplishing those things. But you need to be satisfied that you have accomplished something (even if its only incremental) which needed to be addressed.

But, as I said, it took a lot of behind-the-scenes work to make it happen. Countless people were involved in fixing that problem in the U.S. We can really thank the advent of a bunch of biosimilars expected to receive FDA approval in 2024 (Sandoz' partner Gan & Lee even revealed what its Cost of Goods Sold was!) including three from a nonprofit drug company which said it would charge no more than $30/via or $55/box of 5 prefilled insulin pens) before they even had the courage to tell corrupt PBM rebate aggregators to go fuck themselves which occurred in March 2023.

That was enabled when in mid-2022, the U.S. Federal Trade Commission began formally studying the PBM industry which emboldened big insulin makers to slash prices without fear of petty formulary exclusions by PBMs. But big insulin makers fed that with quarter-after-quarter increases in rebates paid to secure formulary placement for years. In 2020, Novo Nordisk revealed to investors that it was paying-out 74% of its gross U.S. margins as rebates paid to PBMs required to secure formulary placement. Come on! How stupid does a company have to be to enable PBM formulary managers just have 74% of its gross margins? And, at the same time, the company's U.S. insulin margins had fallen, on average, by 12% per year between 2017 and 2021. You don't have to be an accountant to realize that's really stupid, bordering on incompetent or worse, corrupt.

Since then, we have seen an obvious shift in PBMs who previously enriched themselves on enormous insulin rebates, and instead start collecting rebate kickbacks from Dexcom paid to them in order to "exclude" rival CGMs like Abbott Freestyle Libre 3 which many would argue is far superior to Dexcom G7 both in terms of functionality, and patient out-of-pocket costs because of its longer wear-time means it is less costly for patients to use.

Before that, from 2016-2017, I worked tirelessly to get the FDA to relabel CGM devices from "adjunctive" to "therapeutic" for which insulin dosages could be made with the ultimate goal of securing CMS/Medicare coverage for CGM's for seniors on Medicare which CMS ultimately did. Truthfully, I anticipated before too long, I'd be a senior covered by Medicare and I wanted to be damn certain I could still get coverage for a CGM device given that all insulin on the market has an efficacy failure known as hypoglycemia. Many seniors aged into Medicare and had to say goodbye to their CGM unless they paid cash for them. Its not that CGMs are so reliably accurate (because they are NOT), but the devices provide a lot more data-points upon which dosage decisions can be made. And, Libre 3 provides even more data points than Dexcom 7 because it updates readings every minute compared to only every five minutes for Dexcom.

For me, battling the "stigma" issue is a priority I feel comfortable in entrusting to a younger generation of people with diabetes to help fix. I've lived for a half-century with stigma, so I'm pleased to let a younger generation try and fix that problem.

To be sure, there's a LOT about diabetes treatment that remains broken. A messed-up naming convention is a core part of the problem. For example, why not abandon diabetes "types" and instead come up with disease names based on etiology? That way, Type 1 diabetes (T1D) could and SHOULD be called "autoimmune diabetes" to make it unequivocal how the disease originated in the person. Today, I avoid using dumb acronyms like T1D and describe myself as having autoimmune Type 1 diabetes. No medical professional can possibly fuck that up.

Blame and shame are currently a central part of diabetes management because the reality is that doctors have discovered a lot about the illness as time passed. Prior to that, they merely stated their non-scientifically validated opinions, some of which were later proven to be false. But after nearly 50 years (in 2026!), I have learned to ignore the ill-informed comments from people who are clueless about diabetes and don't really care to learn anything, hence I avoid the entire education process because I'm just tired of being forced to teach everyone (including those who don't even care to listen) the facts all the time -- frankly, I'm sick of it and would rather live my life and be left alone.

That said, if someone who aims to fight diabetes stigma would like me to share some diabetes war stories, I'm happy to share some of what we endured (and maybe learned) with previous battles hopefully to better prepare them for what to do when things don't work out the way they hope (and there will be some battles that do not work out; its part of the learning process). The main point I would share is the reality is that the advocacy is always going to be an ongoing effort; its never just cross the finish-line and its done. But this is a good place to begin!