Wednesday, December 07, 2022

My Trial of the New Abbott Freestyle Libre 3

There are many compelling features on the new Abbott Freestyle Libre 3 and I may decide to switch; but I may wish to first try the new Dexcom G7 once it's FDA-approved. But I won't wait forever...

In my 15 years of writing this blog, one thing I have never done is something I occasionally see some younger, less-discerning members of the blogging community do: which is to pimp their blogs (and themselves) out to receive free so-called "blog-ola". I've been blogging since 2005, and I have never endorsed a product in order to get free things, nor have I ever used my blog to even solicit free stuff from companies which aim to market their products to the autoimmune Type 1 diabetes (T1D) patient community by using me as an "influencer". I tend to view myself as more of a journalist covering the T1D space rather than someone blogging to get free $#!t.

Still, I very recently had what I consider to be a most unusual opportunity: to "test drive" the new Abbott Freestyle Libre 3 CGM for six weeks, which was formally FDA approved on May 31, 2022, just ahead of the ADA's 82nd Scientific Sessions which took place June 3–7, 2022. See Abbott's company press release about the FDA approval at 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 detail). I also wish to extend special thanks to my friend Riva Greenberg http://diabetesbydesign.com/ for introducing me to people at Abbott to make my Libre 3 trial possible!

 


 

 

 

 

 

 

 

 

 






In May 2022, I blogged about the formal FDA approval of the new Freestyle Libre 3 CGM at https://blog.sstrumello.com/2022/05/abbotts-freestyle-libre-3-finally.html if you're interested in reading my coverage of the FDA approval for the product), and at one point last year, I also seriously considered switching to the older Freestyle Libre 2 model (catch my post at https://blog.sstrumello.com/2021/06/should-i-say-adios-to-dexcom-g7-hello.html for that) due to my utter frustration with Dexcom.


At the time I wrote about thinking of switching to Libre 2, I was incredibly frustrated with my Dexcom G6 having repeated "signal loss" errors on brand-new sensors which pissed me off considering the prices they charge for CGM sensors, and a lack of instruction on how to fix the problem. But switching to Libre 2 meant a convoluted process to get the alarms and data-sharing which I considered a necessity. Ultimately, I resolved my Dexcom G6 "signal loss" issues on brand-new sensors by calling Dexcom's tech support to complain.

The recommendation Dexcom provided me actually worked; they told me to power my iPhone off, wait for 5 full minutes, and then power it back on again. Voila: no more signal loss messages on brand-new sensors. Still, that persuaded me to consider becoming a defector to a rival product. My impression as a patient is that Dexcom no longer really values my business very much as the company once did; the company presumes my business will always be there for them, and I don't believe they can afford to do so; as their product is far from perfect. 






The new Abbott Freestyle Libre 3 is now formally available in the U.S., though as I write this, the company is still mass-advertising (via costly TV commercials) the older Libre 2 device which requires scanning for wearers to get a reading. The ads for Libre contain messaging clearly aimed at Type 2 diabetes patients who simply don't like fingerstick testing. Of course, insurance company payers don't really care about whether patients like it or not, but that's the direction both Abbott and Dexcom are now pursuing: to try and convert many Type 2 patients into CGM users. Whether they can successfully persuade insurance company payers on that remains to be seen; the results have been mixed so far. 

Abbott Officially Launched Freestyle Libre 3 in U.S. During Q3 2022; Medicare Forecast to Launch in the Second Half of 2023

In Abbott's Q3 2022 quarterly earnings release, the company told investors "we initiated the full [U.S.] launch of Libre 3". In the investor Q&A following the Q3 2022 earnings release, Abbott CEO Robert Ford also told a Wells Fargo analyst that CMS/Medicare introduction for Libre 3 wasn't expected to happen until the "second half of 2023", although he added that commercial insurance will definitely happen sooner. Abbott is planning to pursue the pharmacy benefit model as the primary means of distribution, although it will also be sold on a more limited basis via DME suppliers, much like it is already doing with Libre 2. Rival Dexcom has an identical commercialization strategy, having migrated most of its sales to the pharmacy benefit channel.

As noted, I recently had an opportunity to test-drive the new Freestyle Libre 3 model for 6 weeks. Abbott invites patients on its website (see https://www.freestyle.abbott/us-en/myfreestyle-freestyle-libre-3.html for details) to arrange a free trial of Libre 3. The disclosures says "Eligible patients will receive one [1] FreeStyle Libre 3 sensor for users with a compatible mobile phone operating system at $0 copay. The expiration date of the voucher is 60 days from the issue date. This program is available for patients with Type 1 and Type 2 diabetes; it is not available for patients with gestational diabetes." Still, I highly recommend doing a trial if you can arrange it. Two weeks (the life of a single Libre 3 sensor) gives you a pretty good idea of what its like to wear it on an ongoing basis. That also gives you an opportunity to actually try the Libre 3 as opposed to hearing about it from a third-party like me.  

For me, the automated alarms and data sharing were the main reasons I stuck with Dexcom's CGM devices as long as I did, but now that Freestyle Libre 3 has those exact same features as well, the reasons for sticking with Dexcom are no longer quite as compelling (for me, anyway) as they once were, plus there are a few very compelling reasons to consider switching. Read on for more about my experience.

Abbott Is a CGM Giant; It Is Even Bigger Than Dexcom

Also during its Q3 2022 earnings release, Abbott told investors that the company's Libre CGM now has an installed user-base that was disclosed as "approximately 4.5 million" people globally. That means that Abbott (not Dexcom) is the worldwide market leader for CGM's (Abbott is significantly bigger as a CGM-maker than rival Dexcom in virtually every other country except for the U.S.). European users with diabetes seem to have adopted Libre, and Abbott has captured their business since they beat Dexcom to the Continent (betting that securing business from patients with universal healthcare coverage was a smart move, and it was for the company).

Rival Dexcom has attempted to limit the Abbott competitive threat in the U.S. market for Automated Insulin Delivery ("AID") systems in the U.S. For example, Dexcom has signed partnership deals with nearly every insulin delivery (pump) company, including Medtronic, Tandem and Insulet (although Tandem and Insulet also signed deals with Abbott; so they seem to be CGM platform-neutral; meaning Tandem and Omnipod users will eventually be able to use whichever CGM they [or their insurance] prefers).

Right now, many newly-diagnosed patients tend to rely upon AID systems more than longer-term patients. If I'm being frank, diabetes long-haulers like me (I will mark a half-century living with T1D in 2026) are simply more conditioned to using the crappier, older diabetes tools). Don't shoot the messenger; that's just a reality.

Libre 3: European AID Systems First, Then U.S. AID Systems

Abbott Freestyle Libre 3 was not initially cleared with the U.S. FDA for use with AID systems. I believe that path was pursued so Abbott could start selling Libre 3 in the U.S. sooner. Libre 3 is, however, already cleared in Europe for AID systems, which means the company could subsequently attain that regulatory clearance with the U.S. FDA at some point in the future by using the data from its European AID integrations without significant difficulty or delay. In the company's Q3 2022 earnings release to investors, CEO Robert Ford said "We are working on pump integrations outside the United States and we will have a pump integration launch by end of this year, beginning of next year into Europe with one of our pump partners and I think they are going to benefit a lot from our user base that we have in those countries."

Sure enough, on November 28, 2022, Switzerland-based Ypsomed announced that its mylife Loop AID system (with CamDiab's CamAPS FX and Abbott's FreeStyle Libre 3) had formally launched in Germany (Europe's largest diabetes market), with more European launches (and iOS compatibility) to follow in 2023. That partnership doesn't mean very much to U.S. patients right now, other than Abbott can use the data from the Ypsomed European AID deal when seeking U.S.FDA approval for an AID system. 

Ypsomed is a big player in the diabetes space. The company also has a collaboration with Lilly on its Tempo smart insulin pen systems (see https://www.lillytempo.com/ for more details), which is designed to be a competitive response to Novo Nordisk's NovoPen 6 & NovoPen Echo Plus, both smart-pen systems (see https://www.novonordisk.com/our-products/smart-pens/novopen-6.html for details on that) will reportedly work with Freestyle Libre 3. Branded insulin-makers are migrating to similar smart-pen systems to the Medtronic/Companion Medical InPen https://www.medtronicdiabetes.com/products/inpen-smart-insulin-pen-system system; a rival product is Bigfoot Biomedical's Unity system, but Bigfoot has a strange business model. Smart pens have been a bit slower to catch-on in the U.S. That said, since I was forced to use Novo Nordisk insulin by my insurance company (I opted for Fiasp), I have been an InPen user and I enjoy having the data on insulin on-board. I have also learned that I can use my InPen with vial and syringe injections simply by going into InPen's "Logbook" menu and manually logging a dosage, enabling tracking of my insulin on-board even without using the more costly Fiasp Penfill cartridges.

Anyway, on the previously-announced Abbott Freestyle Libre partnership with Insulet to incorporate Libre 3 into Omnipod 5, that doesn't appear to have gone anywhere ... yet. However, I suspect the reason is because Abbott was simply opting to delay that combination until FreeStyle Libre 3 had become very widely available in the U.S., which is happening now. I'm also unsure where the Tandem collaboration deal stands now.

Then, there's also Abbott's Libre collaboration with Bigfoot Biomedical. Bigfoot's Unity https://www.bigfootbiomedical.com/bigfoot-unity system is already FDA-approved, but I don’t believe its insulin pump is approved right now. Bigfoot has a very unusual commercialization strategy called "Bigfoot Clinic Hub" which requires doctors to subscribe to in order for them to prescribe Bigfoot AID systems to patients. Unfortunately, a large and growing number of endocrinologists and other doctors today actually now work as employees of large corporate entities (such as big hospital chains; including my own endo as of a few years ago), which means they cannot offer their patients Bigfoot products simply because their patients want them to; those decisions are managed by accountants within the organizations, not by doctors. Bigfoot may need to reconsider that strategy at some point.

I believe OpenApps https://openaps.org/ systems are also currently only coded to work with Dexcom because that was all that was available, but it seems likely that someone will eventually modify the OpenApps software to work with Abbott Freestyle Libre 3 as that CGM officially becomes widely-available in the U.S., which is happening now. The entire idea behind OpenApps is very much a DIY model, so it seems someone will eventually write code for Abbott Freestyle Libre 3, especially considering the Abbott CGM's much lower price-point (30% cheaper than Dexcom).

In other words, it's uncertain Dexcom's early-lead (and monopolization) of U.S. AID systems is necessarily a long-term impediment to Abbott's eventual entry in the U.S. AID space (I don't know how many of the Dexcom partnerships were exclusive; but, the market will ultimately be forced to accommodate the demand from commercial payers and patients on the market), so for now, Abbott is focused on the European AID space.

That acknowledged, as I already noted, my friend Riva Greenberg sent me (and a few others) a personal email indicating that if we were interested in trying the new Freestyle Libre 3 model, that she would put me in touch with a contact at Abbott who could facilitate a trial of the new Abbott Freestyle Libre 3 CGM system. I was interested in trying the new Freestyle Libre 3 model, so I said yes!

Abbott then sent me several documents for me to read and sign, as well as a letter to my endocrinologist requesting that they formally "prescribe" the Abbott Freestyle Libre 3 to me (Abbott advised me that particular part tends to take the longest to facilitate, so I wrote a snail-mail to my endo explaining that I was given an opportunity to try the newly-approved device and asked her to prescribe it to me to enable the trial). I also had a quick phone conversation with Abbott about the trial itself, although I wouldn't say they were overly helpful.



 


Fast forward a few weeks, and Abbott sent me a 6-week supply (3 sensors; remember each Libre 3 sensor lasts for 14 days, hence three sensors was designed to last a total of 42 days, which is about 6 weeks) of its brand-new Freestyle Libre 3 CGM. Since I was traveling in Europe just days after they arrived, I didn't want to deal with the unexpected and unknown while traveling, so I stuck with Dexcom G6 during my travels, and then it was Thanksgiving when I returned, so I didn't try the Libre 3 until I was home. As noted, the Libre 3 CGM product was just formally introduced to the U.S. market during the preceding quarter (Q3 2022).

Using the Libre 3 was actually a straightforward matter. In fact, it was easy.

Still, I relied upon the official English-language YouTube video tutorials (from the UK and Ireland; note that the readings in the videos are expressed as mmol/L used in Europe rather than in mg/dL used in the U.S.), see FreeStyle Libre 3 - How to Apply the FreeStyle Libre 3 Sensor https://youtu.be/SIu5X52kBAI to watch.

Note that the video will automatically lead into the second video in the series, and the third, and the fourth, etc.). It was actually helpful to watch all of them, and it assisted me in configuring everything to be generally comparable to what I had set-up with Dexcom G6. The Libre 3 insertion device is considerably smaller than the Dexcom G5 device, which was impressive.

For reference, links to the YouTube video library which I relied on for Freestyle Libre 3 were:

FreeStyle Libre 3 - How to Apply the FreeStyle Libre 3 Sensor
https://youtu.be/SIu5X52kBAI

How to Set Up the FreeStyle Libre 3 App & Start the Sensor
https://youtu.be/wUL5r9sDnDs

How to View Your Blood Glucose on the FreeStyle Libre 3 App
https://youtu.be/RescynltW3Y

How to Set Up Glucose Alarms | FreeStyle Libre 3 App
https://youtu.be/DCgIIhcH0-8

How to Share Data to the LibreLinkUp App | FreeStyle Libre 3 App
https://youtu.be/u0wSeruA8A0

I was really impressed that the Libre 3 sensor it is SIGNIFICANTLY smaller than the Dexcom G6; it is really TINY (about the size of a dime, but slightly thicker). I opted to put the Libre 3 sensor on my arm since the most accurate readings for Libre seem to be for arm-worn sensors. That was very easy to do; I simply unscrewed the base (the video warns users NOT to screw the base back on; as it will ruin the sensor), removed the base, held the sensor against my prepped (pre-cleaned with alcohol and dried thoroughly) arm, and pressed down and voila: the Libre 3 sensor was attached. (Incidentally, a very similar insertion device is apparently what the soon-to-be-released Dexcom G7 will feature; no more of the big sensor insertion gun devices!). My main concern is the adhesive around the sensor itself is not very big, and I have already bumped it into a doorway so I worry a little about the 14-day durability of the sensor adhesive. We shall see on that. 




For the newly-inserted Freestyle Libre 3 sensor, in order to activate it, you then need to hold your smartphone against to the sensor until the Libre 3 app chimes (the app has to be open for that to happen), and then the warmup countdown officially begins. That part took me a few attempts since it did not chime on my first try, so I had to try it a second time, and then that worked. Still, it was a fairly easy process. By comparison, to activate the Dexcom G6, I had been scanning the barcode on the sensor adhesive which seemed to work more reliably than entering the numeric codes, but the Libre 3 is even easier: just scan the sensor against your phone and that's the last time you'll ever need to scan the Libre 3 CGM sensor to get a BG reading.

Freestyle Libre 3 has a 1-hour warmup countdown (compared to 2 hours for Dexcom G6, while the not-yet-FDA-approved Dexcom G7 will be ready in just 30 minutes). Being used to a lengthy 2-hour CGM countdown, I could live with the wait; after all, it was still half the time I was used to waiting. Side note: while the countdown time of 1-hour falls in-between Dexcom G6 at 2-hours and the yet-to-be-FDA-approved Dexcom G7 model at just 30-minutes, the 

Freestyle Libre 3 CGM sensors are approved for a 14-day wear-time compared to only 10 days for Dexcom (G6 or G7). That means each Libre 3 sensor lasts 4-days longer than each Dexcom sensor, thereby saving patients money because they get more wear out of each sensor. Two Libre 3 sensors will last patients 28 days, compared to less than two full weeks with two Dexcom sensors. That, combined with a price that is 30% less, and Libre 3 could save patients a good amount of out-of-pocket dollars. That is a pretty big deal!

In order to use Freestyle Libre 3, I also had to download (and pre-install) Abbott's Freestyle Libre 3 software on my iPhone. 




 

 





Libre 3 does not currently have a stand-alone reader, so an Apple smartphone (or presumably, an Android phone) is a necessity (although it may be theoretically possible with an Apple iPod). I also had to register with LibreView which is Abbott's cloud-based platform (very similar to Dexcom's Clarity platform) enabling data-sharing with loved ones or your doctor, and use the same LibreView login info. on my iPhone app.  During my trial, I told my endo I was trialing Libre, and I needed the "Practice ID", which the office medical techs gave me. Then, I discussed the trial with my doctor, and the staff printed the records for both my Dexcom, as well as my Libre 3. Her observation was how remarkably similar and close the graphs for both Dexcom and Libre 3 appeared to her. She said she really could not discern any difference between them. Based on that, her perspective was that either CGM appears comparable, and she said she was interested in hearing more about my experience with Libre 3 trial during my next visit.

My follower also had to participate in my trial by downloading the LibreLinkUp app to their smartphone. To facilitate following my Libre 3 data, I had to go into the Libre 3 app on my phone, and open the "Connected Apps" submenu within it. I then had to enable my follower(s) "LibreLinkUp" and from there, you select "Add Connection" and you then add the person's name and email address. They'll receive an email invitation to download the LibreLinkUp app and they'll be instantly connected to my readings since I invited them. I don't know with certainty, but it appears the LibreLinkUp app is written by a third-party, so theoretically, your followers could potentially be Android users; I'm not certain about that.

While I was disappointed that Libre 3 does not currently have an Apple Watch complication to view my Libre 3 readings on my watch as I can with Dexcom, I did discover something interesting. You CAN be notified via your Apple Watch for Libre 3 low blood sugar readings. To do so, I had to add myself as a follower and install the LibreLinkUp app to my phone as well. You will receive brief low notifications on your Apple Watch if you do that, although there still isn't a complication to regularly view your Libre 3 BG readings for your Apple Watch. Still, it was a helpful notification, especially if you aren't glued to your iPhone all day.



I kind of hoped to try both Libre 3 and Dexcom G6 concurrently to test their relative accuracy compared to one another, but a single Bluetooth connection on a smartphone essentially forced me to choose either one or the other. Considering I had travel plans abroad in early November, I waited to use Libre 3 until after that happened. The last thing I wanted was to be in Iceland and run out of supplies and not have my CGM with me! 

For me, the old Libre 2's lack of automated alarms and data sharing was perhaps the main reason I stuck with Dexcom's CGM devices as long as I did, while Libre pretty much dominates the CGM market in the rest of the world (Canada is adjacent to the U.S., hence it also has a lot of Dexcom users). People with impaired hypoglycemia awareness were among the earliest adopters of Dexcom CGM's, and they were also among the product's biggest evangelists for obvious reasons. That positive word-of-mouth really helped Dexcom transform itself from a tiny med-tech startup to become a global medical device giant. But over time, the market was presumed by Dexcom to be a certainty (without any perceived risk of losing business to a competitor).

But for me, my Libre 3 trial suggests it may indeed be time for me to consider a more permanent switch to Libre 3. I really wanted to try the yet-to-be-FDA-approved Dexcom G7 to make an informed decision. Below, I acknowledge some of the reasons you might actually wish to consider switching from Dexcom to Abbott Libre 3.




Consider the following reasons:

#1): Abbott Is a Significantly Bigger CGM-Manufacturer Than Dexcom

Abbott is the worldwide market leader for CGM's (Abbott is significantly bigger than rival Dexcom in virtually every country other than the U.S.), with a user-base that was disclosed as "approximately 4.5 million" people globally as of Q3 2022. Abbott's success in the CGM market was driven by its decision to enter Europe before the U.S., where its strategy is a mass-market approach with a lower cost-point than rival CGM systems when cost may be considered as the main driver. That's especially true in Europe where government healthcare systems tend to dominate (some countries like the Netherlands and Switzerland actually rely on private healthcare insurance, but those insurance companies are much more regulated than they are in the U.S.).

#2): Abbott Freestyle Libre 3 Is Less Costly Than Rivals

Beyond global market share, today, in the U.S., the cost differential between the Abbott Freestyle Libre system and rival CGM's is that Libre 3 is priced approximately 30% less (or, as Abbott prefers to say, its rival's CGM's sell for 70% more). That's a very big deal for many payers, and it directly impacts patient out-of-pocket expenses.

As previously noted, Abbott Freestyle Libre 3 is also the longest-wearing patient-installed CGM on the market, with 14-day wear on the upper-arm compared to only 10-days with Dexcom's G6 (and the G7 model, when that eventually receives FDA approval). The longer wear-time adds to the cost-benefit Libre 3 has over Dexcom. Getting four extra days of usage per sensor, combined with a lower price-point spells major cost savings for payers, which includes nearly half of all insured people with high-deductible insurance plans who may pay completely out-of-pocket until they satisfy their deductibles. Both Abbott and Dexcom have worked to secure more widespread CGM coverage regardless of deductibles, but it's a massive job and not everyone's health plan provides that benefit yet.

#3): Freestyle Libre 3 Is MORE Accurate Than Libre 2, Dexcom G6 and G7. Sort of.

First, understand that Continuous Glucose Monitoring ("CGM") systems don't actually measure blood glucose at all, they measure correlated values taken from the interstitial fluid within tissue, while blood glucose measurements are taken directly from the blood. Hence, all CGM's remain an imperfect measure of blood glucose.

The accuracy of CGM's is expressed in a measure known as Mean Absolute Relative Difference ("MARD"), which is a measure of how far the CGM readings are from actual plasma blood glucose levels; a percentage of zero means there would be no difference from actual blood glucose, hence the lower the percentage MARD is, the more accurate the reading is. Said another way, the closer to zero the MARD is, the MORE accurate the CGM reading is because a MARD percentage of zero would mean there is NO difference between the CGM and plasma blood glucose level.

Freestyle Libre 3 is MORE accurate than both the old Libre 2, the Dexcom G6 or the yet-to-be-FDA-approved G7. Well, sort of. I'll elaborate on that in the next paragraph. The MARD percentage for the older Abbott Freestyle Libre 2 model was 9.2% compared to just 7.9% on the newer Abbott Freestyle Libre 3 model.

By comparison, the MARD percentage for Dexcom's G6 model (the current Dexcom model) is 9.0% while the MARD percentage on the yet-to-be-launched (or FDA-approved) new Dexcom G7 model is 8.1% for arm-placed sensors and 9.3% for abdomen-placed sensors.

#3b): What I Mean When I say Libre 3's MARD is 7.9%…"Sort of"

When I said the Libre 3 MARD was "sort of" 7.9%, what I meant by that is the Abbott's Freestyle Libre 3 MARD percentage varied over the CGM's 14-day period of usage, which means that its accuracy varied over time. Regulatory data submitted to the European regulators showed the MARD percentages were acknowledged to be slightly greater in variance from plasma blood glucose (11.2% MARD on day 1), while it improves slightly on days 2-6, improving further to 8.5% on days 7-12 (its MOST ACCURATE days), while the MARD percentage on days 13-14 increased slightly to 9.2%, which is about what Dexcom G6 is today. (Nerdabetic covered MARD a bit at https://youtu.be/IQVxZz0S2_A if you're interested in hearing his perspective on the subject.)

The Libre 3's overall MARD percentage was 7.9%, but that is its AVERAGE over 14-days of usage, so keep that in mind. (Perhaps we need both mean and median MARD figures?) Incidentally, I found nearly identical issues with Dexcom G6 as the first and last few days of wear tended to give more erratic numbers which differed more widely from fingerstick readings. However, unlike Dexcom, Abbott Freestyle Libre 3 does NOT offer patients the ability to calibrate their readings; you are expected to simply accept Libre's readings without trying to correct them which, if I am being honest, really bothered me. That was the one thing I really hated about Libre 3.

That said, Dexcom's most recent non-optional software update really altered how it handles calibrations compared to how the previous iteration of its software dealt with calibrations. It now tends to simply disregard patient calibrations compared to previous versions of the software, raising the question: why bother? Dexcom's conscious decision to pay less attention to patient calibrations is a pain-in-the-ass which I really dislike but I also disliked that about Freestyle Libre 3. In my mind, it means there is now practically no difference between Dexcom and Abbott Libre 3 in my opinion on my ability to keep the readings on-track. Given that, it also made me really question whether Dexcom really has ANY genuine advantage over Libre anymore? In my mind, they both are essentially saying "trust us", but I know better than to trust either of them given the scientific reality that neither Libre nor Dexcom actually measures blood glucose but correlations in interstitial fluid. Neither is perfect.

Abbott has released some conflicting data on the MARD percentages for the new Freestyle Libre 3 at several different times over the past year. Analysts questioned company executives about those differences, and the explanation given by Abbott was a bit vague and not completely persuasive, attributing the differences in calculations used by European regulators and U.S. FDA regulators, which seemed questionable. It's possible the executive answering the question simply did not have the facts handy when they were questioned, or it could have been an error in a report which the company hoped no one would notice. However, we kind of have to take the company's word that "FreeStyle Libre 3 has an overall mean absolute relative difference (MARD) of 7.9%" over 14-days of usage since that was the MARD percentage the company is reporting, and Abbott has used that MARD figure ever since.

What We Actually KNOW About MARD Percentages

It's very certain that the newer model CGM's from both Abbott and Dexcom are improvements over their older CGM models, and its perhaps best stated this way: I think we can only say that the Freestyle Libre 3 and Dexcom G7 had marginal differences in MARD percentages between the two CGM brands. In other words, Libre is more accurate, albeit by a very miniscule percentage and it really depends upon which day since you inserted your Libre 3 sensor that you're on. But I believe the same is true for Dexcom MARD variances, only I do not KNOW those figures. But I have definitely seen it in comparisons to fingerstick readings (which I ALWAYS trust more than CGM readings), so I'm certain the same MARD curve of accuracy applies to Dexcom.

That said, as noted. because CGM's rely on interstitial fluid correlated readings, they are all imperfect. I found Libre 3 often showed significantly higher BG levels than fingerstick readings after eating on the first few days (often giving me alarms for high blood sugar readings), so I simply adjusted my high alarms on Libre 3 even higher so the alarms did not bother me unnecessarily for something I already had insulin on-board to treat. That adjustment to Libre 3's high alarms worked very well for me. In my nearly half-century of living with T1D, I rarely miss dosages of insulin as some newly-diagnosed patients do, so I really do not really need high alarms at all. That's not my problem area. Fortunately, the next Libre 3 benefit kind of offsets that.

#4): Freestyle Libre 3 Updates Readings Every Minute; Dexcom Only Updates Every 5 Minutes

A critically-important Libre 3 advantage has over the existing Dexcom G6 as well as the yet-to-be-FDA-approved Dexcom G7 is that Freestyle Libre 3 sends updates to your phone EVERY MINUTE, whereas both Dexcom models only send updates every five minutes, which can save patients from irritating repeat alarms. That's a feature I really, REALLY like, and it's a definite advantage Libre 3 has over any model of Dexcom. Dexcom can be annoying at how infrequently readings are actually updated and so that's a big plus for Libre 3.

#5): Freestyle Libre 3 Can Be Worn for 4-Days Longer Than Dexcom, Saving Patients Money

The Abbott Freestyle Libre 3 says it features unsurpassed 14-day accuracy, while the new Dexcom G7 sensor is indicated to be worn for a maximum of 10 days (plus a 12-hour grace period). In other words, not only are Dexcom G6/G7 more expensive than Freestyle Libre 3, but you also get 4 fewer days of wear out of each more-expensive Dexcom sensor (described another way, patients actually get nearly a full month out of just two Freestyle Libre 3 sensors (28 days with just two Freestyle Libre 3 sensors, meaning the entire month of February), while a Dexcom system requires three sensors for 30 days. Simply put, when you can wear a CGM sensor like Libre 3 for longer, your cost of replacing sensors means spending less money out of your pocket.

Breakdown of Key Advantages and Disadvantages for Libre 3, Unapproved Dexcom G7

The Abbott Freestyle Libre 3 does have a few slight DISADVANTAGES to Dexcom on two very specific matters, specifically: Dexcom G7 wins on slightly-faster warmup time, and on compatibility with several AID systems.

The yet-to-be-FDA-approved Dexcom G7 warmup time will be just 30 minutes, while the warm-up time for the new Freestyle Libre 3 is one hour. Neither is as long as the 2 hours patients now endure with Dexcom G6, so patients would not have to wait as long with either of the new CGM's.

But the half-hour difference in warmup time doesn't really give patients any material extra usage from each sensor because Dexcom forces you change its sensors every 10 days compared to Libre 3's 14-day wear-time. In my view, that means in terms of Dexcom advantage is not as terrific as it seems. Also, since I've been using Dexcom G6, so I'm already used to waiting 2 hours for readings while the new sensors warm-up. Sure, shorter is better, but a half-hour isn't a deal-breaker in my opinion if it means paying much more out-of-pocket.

For some patients, Dexcom also retains a slight advantage over Freestyle Libre 3 on AID (Automated Insulin Delivery) systems because of the number of deals Dexcom has already signed with pump and smart-pen companies operating in the U.S. I do not necessarily envision those will be long-term threats to Abbott because its CGM sells for 30% less money, and as the saying goes: money talks and bull$#!t walks. Abbott's cost differential means it is conceivable that Abbott could persuade enough insurance company payers to start "preferring" Libre 3 over Dexcom G7. 

We shall see on whether Abbott tries it. In the past, some medical device companies tried to seal a "preferred" placement for insulin pumps with United Healthcare, and it blew up in Medtronic's and United Healthcare's faces. People absolutely hated being told which device they had to use if insurance paid for it, and that preference later ended with a whimper. It's one matter to do it on insulin or test strips, but with a device which patients have physically attached to their bodies, that was a rather different concept.


For the time being, I am really enjoying Libre 3. And, I may opt to continue it permanently in 2023 depending out my out-of-pocket costs for Dexcom when the deductible resets.




 

 




#6: Freestyle Libre 3 is Tiny

Like really tiny. 

Even I was impressed at how small it was. It's like the size of a dime, only a little thicker (I bruised my arm with the first sensor installation, but I wanted to ensure it stuck because of how small it was!). There isn't much adhesive surrounding each sensor, hence over-patches may not be feasible (although standard medical tape would work). 

Enjoying the Silence!

But more importantly, the Libre 3 alarms seem to be far less needy and demanding for me, which is actually really good. Dexcom updates its readings every five minutes, which means recoveries from hypos can take a good 20-30 minutes for the recoveries to even show up on my Dexcom G6, and sometimes the damn thing repeats its annoying alarms after 15 minutes even after I have treated the hypo already which is incredibly annoying. After 46 years of living with T1D, I don't want diabetes to interrupt me constantly as it too often does with Dexcom G6. I also don't know if Dexcom G7 will prove less needy and demanding with alarms than the Dexcom G6 does. I certainly hope not.

Libre 3 has given me some much-needed alarm silence which is priceless!

Beyond that, I may be ready to give Libre 3 a more permanent try and save myself cash in the process. However, I really want to try the new Dexcom G7 to truly compare the features/benefits of the new CGM's to get an informed perspective. That said, insurance deductibles reset to zero on January 1, 2022, so enjoying lower out-of-pocket costs could be very persuasive while satisfying deductibles. Watch this space!

Sunday, November 27, 2022

Podcast Recommendation: The Edutainer with Dr. Erin L. Albert



Dr. Erin L. Albert is currently the VP Trade Relations and General Counsel at the Mark Cuban Cost Plus Drug Company PBC, and like her colleague and company founder Alex Oshmyansky, as well as Mr. Cuban himself, she has become a public face of the startup since communication is largely word-of-mouth and via social media (Facebook, Twitter, LinkedIn, etc.). Her Twitter feed, for example, had nearly 4,000 followers @ErinLAlbert although some have found that changes implemented since Mr. Musk acquired the company via a massive loan that some of their follower numbers have been adversely impacted. She doesn't have as many as Mark Cuban himself, but she often breaks news on new drugs carried or price reductions, and Mark Cuban himself will often re-Tweet her posts.

Back in May 2022, Erin Albert wrote a LinkedIn article entitled "Bit by a Shark: 5 Reasons Why I Joined Mark Cuban Cost Plus Drug Company, PBC" https://www.linkedin.com/pulse/bit-shark-5-reasons-why-i-joined-mark-cuban-cost-plus-erin-l-/ explaining her decision to join the company.

But today's post has little to do with Dr. Albert's corporate role.

Instead, it's about her role as a podcaster.

She was an active podcaster at "The Edutainer with Dr. Erin L. Albert" https://anchor.fm/theedutainer although her last podcast there was released on July 31, 2022. It may be based on how much time she has to dedicate to it.

For the month of July 2022, she ran a podcast series which she called "Red, Blue and You: Ways to Save on Rx Drugs in the USA". Initially, I wasn't sure I even wanted to listen to a podcast on the subject. But after listening to the first episode, I was persuaded. The "Red, Blue and You" podcast featured a series of interesting yet incredibly short podcasts (only about 10 minutes per episode), yet they were still pretty informative.

Her first tip was to obtain what's called the "SBC" from your employer. SBC means "Summary of Benefits & Coverage" (she shared a sample (blanked out) at https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/SBC-Template.pdf

That proved pretty useful, and yet in my 30-year career, I can honestly say that not one human resource person ever mentioned the document, and in fact, some had never heard of such a thing and looked at me like I was an alien from another planet when I asked. But she rightly observes that having the SBC actually documents specifics you'll likely need to understand the pharmacy benefit component of your employer-sponsored healthcare insurance plan.

I won't list all of the "Red, Blue and You" episodes here, but instead, below is the first episode of that "mini-series" and is a good place to start. The episode is below, or you can visit the podcast website at https://anchor.fm/theedutainer/episodes/S6-5---Red--Blue-and-You-Ways-to-Save-on-Rx-Drugs-in-the-USA-part-22-e1lahjp/a-a874ats
 

Sunday, November 20, 2022

Cigna-Express Scripts by InsideRx Strategy Modification, Mark Cuban Cost Plus Insulin Trial

Two years ago, I made a very well-informed decision to simply bypass our own healthcare insurance for a number of prescriptions used in my household because we were paying out-of-pocket until the deductible was satisfied anyway (which was about half the year), and our new insurance carrier Aetna and its PBM Caremark was obviously ripping us off by a fairly wide margin. In fact, the financial gamesmanship (or as the PBM's call it, "Price Arbitrage") was so overt, that it would have been financially foolish to stick with insurance under the presumption that it contributed toward satisfying the deductible (a falsehood; they only credit people for the PBM-negotiated price, not the artificially-inflated cash prices patients are actually charged). Bypassing our insurance saved us 56%, 70%, 75%, and 82% on a number of drugs (most of which were generics anyway, and generics which are supposed to be inexpensive, but Caremark was overcharging us by a wide margin on every one of those drugs).

Initially, my tactic was to find discount coupons powered by PBM's who offered lower prices, but it was almost always from a different PBM than the one used by our own insurance company. That worked reliably for several years. But by 2022, we started to experience some random, unexplained (and illogical) price increases on generic drugs. Then, I knew I was being gamed, so I widened my search, and was successful although it took even more work.

First, a random price-increase happened with the generic statin drug (formerly sold by AstraZeneca as Crestor). That particular drug, known generically as rosuvastatin calcium 10 mg tablets, had previously been purchased from United Healthcare Group's OptumRx PBM unit by using an OptumPerks coupon and using Optum Store. Recall that my carrier was Aetna (owned by CVS Health, which also owns/operates the PBM known as Caremark). My insurance carrier Aetna/Caremark/CVS Health was charging us $33.84 for a 90-day supply of the statin drug, and we were paying for it completely out-of-pocket for about half the year, so it was a clear money-saving move to simply bypass our insurance. By cutting Aetna/Caremark/CVS out of the transation, I saved 56% on the drug until June 2022. Then, in June 2022, Optum indicated in my purchase history that while I'd previously paid $15 for a 90-day supply of generic Crestor for an entire year, but the "new" (and not publicly announced), higher price had jumped by 40% to $21 instead. Since I had no refills after that, and $21 was still cheaper than $33.84 that Aetna/Caremark intended to charge me for the drug, I paid the new, higher price, only I vowed to find a new source for it.

My spouse also relies on a few generic drugs, including one used to treat hypertension, as well as several different eye drops which are used to manage glaucoma. On the eye drops, prices of those drugs are insanely costly for almost no product; the bottles are even tinier than a 10 mL bottle of insulin; being sized from about 2.5 mL to 5 mL, and yet the prices range from $17/bottle to $78/bottle. Yet all but one of the eye drops is a generic product, and the pharmacy changes the suppliers all the time (sometimes they come from Alcon [owned currently by Novartis Sandoz unit, though its being spun-off as a standalone company to be called Sandoz set to close during 2H 2023], other times they come from Pacific Pharma/Allergan, or Oceanside Pharmaceuticals/Valeant Pharmaceuticals. We've even received one bottle from a previously unidentified India-based pharmaceutical company. The quality of the eye-dropper bottles varies widely - some are not great quality and lead to wasting the content contained in the bottles themselves), but the point is that they are generic products which nearly any company can make except prices are ridiculous.

Curiously, the hypertension drug known as Eplerenone 50 mg tablets (previously sold under the brand-name Inspra) was selling from Aetna/Caremark/CVS for $48.40 (even after satisfying the deductible) for a 30-day supply which seemed very high for a generic pill. Initially, we used a coupon from InsideRx (InsideRx is owned by Cigna's Express Scripts PBM business known as "Evernorth"), which resulted in additional savings of $10.00 off the price we were charged for the drug at CVS (that also meant that TWO PBM's were involved in the transaction; Caremark which was our insurance company's PBM, as well as Express Scripts which powered the InsideRx coupon), so the revised total became $38.40 for 30 tablets which is no bargain for a generic drug. That still worked out to a cost of $1.28/tablet which is no bargain for a generic, but at least that enabled us to buy it with the existing refills we already had at the pharmacy, only getting a discount. However, Express Scripts Cash-Pay Mail Order Pharmacy by InsideRx's price for the same generic drug was just $8.72 for a 30 day supply! We opted to buy a 90-day supply of tablets for $25.39. Naturally, Cigna's Express Scripts self-preferenced its own mail order pharmacy over other pharmacies within its own retail pharmacy network; doing so maximizes its own profits.

To the best of my knowledge, the Express Scripts by InsideRx was "powered by" the PBM's National Preferred Flex Formulary, which tends to favor drugs with lower list prices over the high-list/high-rebate versions of drugs, rather than Express Scripts' much-bigger National Preferred Formulary (NPF) which happens to be Express Scripts' largest commercial formulary (that formulary reportedly covers more than 28 million covered patient lives) which tends to favor high-price/high-rebate drugs. Its obvious why that's their biggest formulary; it creates more opportunity for spread pricing derived from heavily-rebated brand-name drugs. Still, it had self-preferenced its own mail order pharmacy over other pharmacies in its network.

To patronize Express Scripts Cash-Pay Mail Order Pharmacy by InsideRx, they imposed a number of consumer-unfriendly policies which forced patients to have their doctors only e-prescribe drugs (no paper scripts were accepted), and they also required auto-billing to a credit card, so it wasn't the most consumer-friendly option. Still, the prices were 82% cheaper than our own insurance was, making it a smart decision.

At least that was the case until now.

But we received a peculiar letter this week.  

 

 

 

 

 

 

 

 

 

 

 

 

 

 




The letter was dated October 24, 2022, although they likely used the cheapest possible form of direct mail (sending it third-class to minimize the postage expense) so it arrived sometime between Monday, November 14, 2022 and Saturday, November 19, 2022 (we were traveling to Iceland when it arrived, so I'm not certain exactly which day the letter arrived).

But now it appears as if they are trying to discontinue cash-pay orders via InsideRx.

Maybe Express Scripts Cash-Pay Mail Order Pharmacy by InsideRx found that cash-payers were a hassle to deal with? I can only speculate.

I wasn't personally using Express Scripts for any of my own personal prescriptions, but my spouse had several scripts auto-filled with Express Scripts Cash-Pay Mail Order Pharmacy by InsideRx because their prices were lowest, but we had very marginal interaction with Express Scripts.

It began when we mailed a letter to the doctor last year and asked them to send an e-script into Express Scripts for a few prescriptions, which were billed to a credit card, and that was the extent of the interaction.

Apparently, Cigna's PBM unit known as Evernorth, which operates Express Scripts as well as the prescription drug coupon-generating website/app were FORCED to mail an old-fashioned letter to us because of their electronic-only policies designed to maximize the revenue of Express Scripts at the expense of patients doesn't really enable direct-to-patient communications. The letter was required because patients aren't likely to pay cash to Express Scripts Mail Order Pharmacy anymore.

As for what we'll end up doing, I think we'll simply switch suppliers when the refills are used up.

We discovered it was actually cheaper to buy generic Crestor (rosuvastatin calcium 10 mg) tablets from the startup known as the Mark Cuban Cost Plus Drug Company (see my post at https://blog.sstrumello.com/2022/08/generic-crestor-pricing-insanity.html for more). It was reliable and sold at a fair-price; and the company has actually been known to reduce its prices when their own costs fall. Their margins are fixed at 15% (enough to keep the business going) on every drug it sells; plus a $3 pharmacist fee and another $5 for shipping. Still, even with the $8 ($3 + $5), the price was still cheaper than the PBM's were charging for the same drug.

Not only that, but the Mark Cuban Cost Plus Drug Company anticipates it will be selling some 2,000 drugs (or more) by the end of 2022, and it's finally started selling a few branded products such as Roche Accu-Chek blood glucose testing supplies at prices which are lower than almost anywhere else. In fact, I have found the prices are so low that they're possibly even cheaper than some of the generics which work in the old OneTouch Ultra meters (truth be told, I did find Unistrip1 strips a bit cheaper, and many retailer private-label test strips work adequately for many people's needs, and those sell for less cash).

The Mark Cuban Cost Plus Drug Company also sells some eye drops, including Brimonidine Tartrate for glaucoma, but the size is 15 mL instead of the 10 mL which means with Mark Cuban Cost Plus Drug Company, we receive 50% more medicine at roughly the same price. I also found their prices on a 90-day supply of eplerenone 50 mg tablets to be $27.30 compared to the price of $25.39 we got from Express Scripts Cash-Pay Mail Order Pharmacy by InsideRx. Admittedly, it is slightly more costly than we attained via Express Scripts Cash-Pay Mail Order Pharmacy by InsideRx, but is still vastly cheaper than the price of $48.40 Aetna and Caremark intended to charge us for only a 30-day supply of the same medicine.

Above all, my feeling about doing business with the Mark Cuban Cost Plus Drug Company is that the prices are honest and it feels like patients are getting a fair deal. By comparison, PBM's are gaming  the system to their own benefit at every opportunity, and they are doing so mainly by withholding information.

Incidentally, Mark Cuban Cost Plus Drug Company is currently trialing insulin sales, perhaps the prescription best known for egregious spread pricing pocketed by PBM's and overt patient ripoffs. It is very much a trial right now. Details on the trial can be seen at https://costplusinsulin.com/




 

 

 

If your doctor his not participating in the Cost Plus Drugs' insulin pilot program, you are not currently eligible for this test and your prescription will not be filled. But they are selling a 90-day supply of the unbranded Lilly Insulin Lispro U-100 (the "authorized generic" version of branded Humalog). Patients' doctors must be a part of the trial. Its shipping and handling fee is $65 per order.

The company says because its cold shipping containers can only hold up to a certain amount of insulin, the trial is only supporting orders up to the following quantities per order:

  • 12 vials of Insulin Lispro
         OR
  • 8 packs of Five Insulin Lispro KwikPens® (40 total KwikPens®)


If patients in the insulin trial attempt to order more than 8 packs of KwikPens® or 12 vials, their order will be automatically cancelled. It's a trial, after all.

But of note, the total price for a 90-day supply of insulin is $170. The total price includes fulfillment, packaging and shipping. There may be incremental cost for shipments to Hawaii and Alaska.

The company acknowledges that for patients that only use 1 vial of Humalog per month, the Mark Cuban Cost Plus Drug Company insulin price in the trial works out to a price of $56.67/vial, which is actually HIGHER than the company wants it to be.

That said, any patient can freely download a Lilly manufacturer coupon and buy the unbranded, "authorized generic" version of Humalog for $35/vial. Coupons can be downloaded instantly at https://www.insulinaffordability.com/. Rival Sanofi also sells a biosimilar of Humalog branded as Admelog, and patients can also download a manufacturer coupon from Sanofi at  https://www.teamingupfordiabetes.com/sanofidiabetes-savings-program/ (they can also use Sanofi's proprietary prandial insulin analogue known as Apidra for the same price of $35/vial) from local pharmacies and chain pharmacies around the country.

Right now, all of these are for prandial insulin analogues, but none are for basal analogues. That said, the Sanofi ValYou coupon will work on Lantus as well as the unbranded "authorized generic" version of Lantus known as Winthrop US Insulin Glargine Injection U-100, which makes it possible to buy both basal and prandial insulin analogues at a price of $35/vial today.

To catch some of my prior blog posts related to this subject, see:

https://blog.sstrumello.com/2021/11/how-we-wrested-control-of-our-rx-drug.html

https://blog.sstrumello.com/2021/09/coupons-pbms-oh-my.html

https://blog.sstrumello.com/2022/07/turning-pbm-arbitrage-on-its-head.html

Wednesday, November 09, 2022

Podcast Recommendation: a16z's Bio+Health interviews Adam Fein

Julie Yoo, who's a General Partner at the Menlo Park, California-based venture capital firm known as Andreessen Horowitz (known by the acronym "a16z") which was co-founded by Marc Andreessen, a man perhaps best known as one of the original co-authors of Mosaic, which was the first widely-used web browser, and subsequently Netscape. Mr. Andreesen later also co-founded Ning, which was the social platform upon which the old TuDiabetes (by Diabetes Hands Foundation) ran on for years. Before merging with the nonprofit Beyond Type 1 (BT1), TuDiabetes ultimately did migrate away from Ning to different software prior to combining with BT1.



Anyway, Julie Yoo works in a16z's biology and healthcare investment business within a16z at something called Bio+Health. One of Bio+Health's projects is a podcast called Bio Eats World that explores the intersection between biology, healthcare, and technology. In that podcast, Ms. Yoo recently interviewed Adam J. Fein, the President and CEO of a pharmaceutical consulting firm known as Pembroke Consulting, Inc. whose paying clients are primarily execs at manufacturers of biopharmaceuticals. In other words, Adam Fein's business depends on him being hired to help pharma navigate the dysfunctional U.S. prescription drug distribution system to maximize their own benefit from it. Adam Fein also operates another entity on the side which he calls the "Drug Channels Institute". As a result, he seldom gives interviews with third-parties (most of what he does are in channels he can control).

Dr. Fein's company website says his consulting work with healthcare products manufacturers typically precludes him from any business consulting assignments with wholesalers, distributors, pharmacy benefit managers, and dispensers of healthcare products and pharmaceuticals. Dr. Fein is also not generally available to speak with consultants, investors or other professional services firms.

That is perhaps one reason the Bio Eats World interview with Adam Fein particularly worth listening to. The reason is because a) the interviewer Julie Yoo can more hold her own with Adam Fein, and b) her work for a venture capital firm's biotech business makes her uniquely well-positioned to ask poignant questions of Adam Fein, which too often tends to be decidedly in favor of his paying clients' best interests.

They also briefly address another topic I've had particular interest in lately: the cash-only generic drug business called the Mark Cuban Cost Plus Drug Company.

Have a listen to the podcast at https://bio-eats-world.simplecast.com/episodes/the-consolidated-drug-channel-qtgWgYbZ.

...or listen below.

Friday, November 04, 2022

Podcast Episode Recommendation: This Week Health: Conference "Mark Cuban's Cost Plus Drugs Is Solving the Equity Problem in Prescription Medicine"

My next podcast episode recommendation is another one on Mark Cuban's CostPlus Drug Company. Recall that my previous blog post was an interview with the CEO of that company, Alex Oshmyansky. In that episode, Dr. Oshmyansky not only revealed he was an insulin-dependent person with diabetes himself, but he also told the podcaster that Mark Cuban is surprisingly involved in seemingly miniscule details which he said was not only interesting and helpful, but also demonstrates just how involved Mr. Cuban himself is in the Cost Plus Drug Company startup itself. Also, Mr. Cuban likes to talk to the press about his new venture.

This podcast is one from This Week Health (which has several podcasts), specifically the one it calls "This Week Health: Conference" and more specifically, an episode released on April 8, 2022 entitled "Mark Cuban's Cost Plus Drugs Is Solving the Equity Problem in Prescription Medicine". It is clear Mark Cuban is not an absentee investor in the company, he really understands what's going on and has a solid plan to disrupt the costly status quo.

The drug industry is up against giant companies with lots of money and influence and complicated relationships with tentacles wrapped around government manufacturers, insurance companies, drug stores, pharmacists, retailers and more. There's all kinds of super complicated contract arrangements that include rebates and hardwired incentives that keep this giant self-licking ice cream cone stuck together. The participants in this cartel like the deals they have and they make good money on them. The system is built to keep others out.

This episode (not necessarily the whole podcast) is another one worth listening to. The link to the episode itself can be reached at https://thisweekhealth.com/captivate-podcast/mark-cubans-cost-plus-drugs-is-solving-the-equity-problem-in-prescription-medicine/.

My next podcast episode recommendation is another one on Mark Cuban's CostPlus Drug Company. Recall that my previous blog post was an interview with the CEO of that company, Alex Oshmyansky. In that episode, Dr. Oshmyansky not only revealed he was an insulin-dependent person with diabetes himself, but he also told the podcaster that Mark Cuban is surprisingly involved in seemingly miniscule details which he said was not only interesting and helpful, but also demonstrates just how involved Mr. Cuban himself is in the Cost Plus Drug Company startup itself. Also, Mr. Cuban likes to talk to the press about his new venture.

This podcast is one from This Week Health (which has several podcasts), specifically the one it calls "This Week Health: Conference" and more specifically, an episode released on April 8, 2022 entitled "Mark Cuban's Cost Plus Drugs Is Solving the Equity Problem in Prescription Medicine". It is clear Mark Cuban is not an absentee investor in the company, he really understands what's going on and has a solid plan to disrupt the costly status quo.




 

 

 

 

 

The drug industry is up against giant companies with lots of money and influence and complicated relationships with tentacles wrapped around government manufacturers, insurance companies, drug stores, pharmacists, retailers and more. There's all kinds of super complicated contract arrangements that include rebates and hardwired incentives that keep this giant self-licking ice cream cone stuck together. The participants in this cartel like the deals they have and they make good money on them. The system is built to keep others out.

This episode (not necessarily the whole podcast) is another one worth listening to. The link to the episode itself can be reached at https://thisweekhealth.com/captivate-podcast/mark-cubans-cost-plus-drugs-is-solving-the-equity-problem-in-prescription-medicine/.


Saturday, October 29, 2022

Podcast Episode Recommendation: TWiST Solving Prescription Drug Pricing in the U.S. with Cost Plus Drugs and Capital Rx CEOs

So next up on my recommendation for informative podcast episodes is an episode of the podcast called "This Week in Startups" (TWiST) With Jason Calacanis & Molly Wood, spoecifically an episode which interviews Mark Cuban Cost Plus Drug Company CEO and Founder Alex Oshmyansky AND the CEO of another startup aiming to disrupt the Pharmacy Benefit Manager (PBM) industry, Capital Rx CEO AJ Loiacono. Incidentally, the PBM startup offers a coupon-generating website and app of its own called CapitalRx Advantage Savings (or CRxAdvantage) https://capitalrxadvantage.com/ which is one worth saving on your smartphone.

During the interview with Alex Oshmyansky, he revealed that he is actually a person with Type 1 diabetes himself which many people might not have realized. Insulin is on the company's radar, although it may be looking at multiple-sources for those products (including biosimilars when they're approved), so while there's no commitment, it seems clear the company is looking at the huge PBM and drug wholesaler markups and sees opportunity.

While I don't necessarily recommend a subscription to this podcast itself unless you're interested in learning about startup businesses, this episode in particular is one worth listening to.

The website for the This Week in Startups (TWiST) With Jason Calacanis & Molly Wood" podcast itself can be found at https://linktr.ee/twistartups

The podcast itself can be found wherever you listen to podcasts, and the episode itself is titled "This Week in Startups With Jason Calacanis & Molly Wood Podcast: Solving Prescription Drug Pricing in the U.S. with Cost Plus Drugs and Capital Rx CEOs" and the episode itself can be found at https://anchor.fm/this-week-in-startups/episodes/Solving-prescription-drug-pricing-in-the-US-with-Cost-Plus-Drugs--Capital-RX-CEOs--E1518-e1lnu90.

However, I find that embedding their episodes easiest from their YouTube channel (you can also subscribe there, if interested), so listen and watch the episode below.

Thursday, October 27, 2022

Recommended Podcast: NPR's the "An Arm and a Leg" Show

With most of my recent podcast shares, I was pretty specific to note that I was recommending a particular podcast episode, but stopped short of recommending you subscribe to the entire podcast.

However, there are at least are a few podcasts which I actually recommend you subscribe to: one specifically is today's recommendation: a podcast known as the "Arm and a Leg" show https://armandalegshow.com/, which was started by an enterprising NPR reporter from an NPR station in Chicago by the name of Dan Weissman, who is also the podcast's creator & host, although his podcast is now produced with support from NPR, Kaiser Health News and others who believe in it and has a team of like-minded producers. 



 

 

The Arm and a Leg show podcast's origins began from the perspective was from that of actual patients, rather than industry spokespeople, doctors on the fringes of navigating the what some doctors (such as Marion Mass, see the preceding podcast recommendation HERE) who have openly described the U.S. healthcare system as "predatory"  see a report she co-authored at https://free2care.org/files/report.pdf). Part of the reason I am recommending you subscribe to "An Arm and a Leg" is the way it describes itself:

"An Arm And a Leg is a show about the cost of health care that's more entertaining, empowering, and occasionally useful than enraging, and terrifying and depressing. We may be screwed, but we're together.

Let's talk."

Without a long diatribe about why I recommend this podcast, why don't you listen to several episodes for yourself? Below is a sampling. More can be found in the podcast itself.

Season 2, Episode 4: "Why are drug prices so random? Meet Mr. PBM"
https://armandalegshow.com/episode/why-are-drug-prices-so-random-meet-mr-pbm/


Season 2, Episode 5: "The surprising history behind insulin’s absurd price (and some hopeful signs in the wild)"
https://armandalegshow.com/episode/the-insane-surprising-history-behind-insulins-crazy-price-and-some-hopeful-signs-in-the-wild/  

Season 4, Episode Originally Released March 10, 2022: "Filling a prescription means swimming with the sharks"
https://armandalegshow.com/episode/swimming-with-sharks/

Season 4, Episode 13: "A 21st-century Christmas Carol: How one Scrooge became a health-care whistleblower" in an interview with Wendell Potter, visit
https://armandalegshow.com/episode/a-21st-century-christmas-carol/ 

Monday, October 24, 2022

Recommended Podcast Wholist Health Episode 205: What You Need to Know About Healthcare Middlemen

Today on my podcast recommendation is an episode from the podcast known as "Curate Your Health with Dr. Heather Hammerstedt" http://podcast.wholisthealth.com/ and more specifically, Episode 205: "What You Need to Know About Healthcare Middlemen" and that episode can be found at http://podcast.wholisthealth.com/episode-205-what-you-need-to-know-about-healthcare-middlemen


 


 

 

 

 

 

 

 

 

 

 





It's possible some will think otherwise, but I didn't find many of the other "Curate Your Health with Dr. Heather Hammerstedt" podcasts interesting enough to recommend subscribing to it or the Wholist Health podcast generally because the content wasn't really my personal interest; it was heavily-focused on "lifestyle" health issues, which isn't related to my particular interests. They might be great for someone else (such as younger listeners; to each their own).

Anyway, the guest in this particular episode is Dr. Marion E. Mass, M.D., who's a practicing pediatrician in the Doylestown, PA area (located in Bucks County, which is really an extension of the Philadelphia suburbs), but Dr. Mass is also co-founder of an organization known as Practicing Physicians of America (PPA) https://practicingphysician.org/. More importantly, I really like the way Dr. Mass explains everything. She's a pediatrician who usually has to translate complex medical-speak for parents of young children so they understand what's going on with their children. As a result, I think she speaks with a clarity which is not only easy-to-understand, but it is also reassuring for people who don't necessarily have her understanding.

I also think its appropriate to acknowledge the role that "middlemen" have assumed in U.S. healthcare prices more broadly (and not only in pharmacy, but an equally important one is in the prices we pay if any when we need care in the hospital because there are organizations which purchase supplies ranging from syringes to bedpans, but they also get legally-exempted kickbacks, hence the bills anyone who goes to a hospital are artificially-inflated as a result). Before I recommend podcasts on PBM's and PBM reforms (and there WILL be a few of those in future recommendations), this episode is an excellent place to start.

Without getting too far off on a tangent, have a listen and maybe this will help translate some of the unnecessary complexity related to the U.S. healthcare system. So, once again, below is the actual podcast itself, while the link to this particular podcast is at http://podcast.wholisthealth.com/episode-205-what-you-need-to-know-about-healthcare-middlemen

Sunday, October 23, 2022

Mark Cuban CostPlus Drug Company Is Distributing Roche Accu-Chek Testing Supplies

Taking a bit of a break from my recent podcast recommendations, but kind of an extension of the previous post (see HERE) about the Mark Cuban CostPlus Drug Company, on October 11, 2022, Mark Cuban's startup known as the Mark Cuban CostPlus Drug Company ("MCCPDC", in different notices shared on Twitter, LinkedIn, Facebook, etc.) announced a partnership with Roche Diabetes Care to bring CostPlus Drugs patients access to buy Accu-Chek testing supplies through them at a lower price. 

 

The cost of buying Accu-Chek test strips from CostPlus is $16.79 for a quantity of 50 test strips. That works out to a cost of $0.34 per strip. Price-wise, that's actually quite low in the grand-scheme of things. 

They also sell an Accu-Chek Guide Me meter for $10.76. The meter isn't the item most patients struggle to pay for; it is the test strips used in the meter.  Beyond that, it is also selling lancets, although those are a commodity product and are available for a low price at many pharmacies nationwide.

However, they limit the quantity patients can purchase to 150 test strips (3 packages of 50 test strips).

What happens if a patient tests their blood sugar more frequently than 5x per day?

For example, patients with hypoglycemia unawareness, or women with diabetes who are pregnant may test more frequently, and yet the quantity limit appears to be a key limitation. The answer to what happens to people who want more is unclear at the moment. Currently, there's simply no way for patients to order any MORE than that quantity right now. I suppose they could potentially refill the script immediately thereafter they receive their order, but that also means paying another $5 for shipping with each order, which reduces the cost advantage. I reached out to the company about it, but so far, haven't received a response (yet), so we shall see.

Some patients (myself included) have actually found buying test strips from third-party "generic" strips which work in Lifescan OneTouch Ultra meters from firms such as UniStrip Technologies, LLC http://www.unistrip-tech.com/unistrip1/ (which sells the Unistrip1 brand of testing supplies which work in the original OneTouch Ultra meter) to be marginally less costly, although not by very much, and it very much depends on exactly WHERE the patient ends up buying the product. Some retailers offer better deals based on quantity of test strips ordered. But with a branded testing product line (and meters which are still sold; OneTouch abandoned the Ultra meters to focus on the Verio product) so close in price, that could potentially be a lower-cost option than pharmacy private label brands.

Mark Cuban CostPlus Drug Company has carved a lucrative niche for itself as a nationwide operator of cash pharmacy, selling generics for prices which are frequently much less than insurance company PBM-provided pharmacy benefits charge for the same products. However, as I acknowledge in a recent podcast recommendation, that's a function of how broken the U.S. Rx drug market has become. However, it has become an opportunity for savvy patients to turn PBM price arbitrage on its head and use that to their own financial advantage 

From Roche's perspective, it may prove to be a way of selling more test strips by avoiding insurance companies, with sales it would have to pay millions in kickbacks as "rebates" to PBM's. If bypassing insurance works well for the company, it may alter the monopoly PBM's have on discounting testing supplies, which is a big deal. In the insulin space, Lilly's now patent-expired unbranded prandial analogue now accounts for one-third of U.S. sales, up from nothing two years ago.

Still, the Roche Diabetes Care deal with the Mark Cuban CostPlus' is one of the company's first pharma partnerships, one in which Mark Cuban CostPlus Drug Company is now selling that company's Accu-Chek testing products, a leading brand in blood glucose monitors, test strips (and lancets), for less-than-the-average retail price. That's seen as a first step for the Mark Cuban CostPlus Drug Company to maybe potentially sell other branded prescriptions at lower prices than retail pharmacies, which tend to rely on PBM's to facilitate distributions and reimubursements hence prices are not within their control.

As of October 2022, the Mark Cuban CostPlus Drug Company lists more than 700 drugs (most generic; often at much lower prices than PBM's will enable patients to buy them for). The company says it hopes to have 2,000 medicines available by the end of 2022, and it is working to offer EpiPens and insulin, two of the most-heavily rebated prescription drugs (to PBM's) in existence.

The latter two products may depend on FDA approval of biosimilars, although not necessarily. For example, there are non-rebated, unbranded "authorized generic" versions of insulin already on the market from Lilly (lispro), Novo Nordisk (aspart and degludec), and Sanofi (glargine) on the market which the Mark Cuban CostPlus Drug Company could theoretically sell if they can acquire the products the right price. Currently, both Lilly and Sanofi, through manufacturer coupon programs, sell their insulins at a cost of $35/vial. But how willing will Lilly, Novo Nordisk and Sanofi be to simply bypass the PBM rebate-monster, even on unbranded insulins?

Biosimilars are coming (as I recently blogged about), too, which could change the underlying market dynamics. I know with absolute certainly that there are now biosimilar versions of Lantus, Novolog, Humalog and even old-school rDNA biosynthetic Regular and isophane/NPH "human" insulins in development from such companies as Biocon (already selling glargine and has a version of aspart now in development), Sandoz/Gan & Lee (glargine, aspart and lispro), Amphastar/ANP (glargine, aspart, rDNA regular and isophane/NPH), Lannett/HEC (glargine, U-300 glargine, and aspart), Civica/GeneSys Biologics (glargine, aspart, lispro) all currently working their way to receiving FDA approval (most of them have told investors they are pursuing FDA-designated "interchangeable" status with the innovator products). As of October 2022, there are a half-dozen Lantus biosims in development (including both U-100 and U-300 versions), and a comparable number of aspart products (Sandoz/Gan & Lee, Lannett/HEC, Amphastar/ANP, and Civica/GeneSys Biologics), at least two more lispro biosimiliars (from Sandoz and Civica, plus one already on the market from Sanofi), as well as at least one of Regular and isophane/NPH (the latter in development from Amphastar). My suspicion is its not a matter of if, but WHEN it will sell the products.

Anyway, with the MCCPDC/Accu-Chek announcement (see the following social media links):

https://twitter.com/costplusdrugs/status/1579890181246971906?s=20&t=8Nyv5L9NSR_DXZaKauUFKw

https://twitter.com/costplusdrugs/status/1579890327242276864?s=20&t=8Nyv5L9NSR_DXZaKauUFKw

https://www.linkedin.com/posts/costplusdrugs_cost-plus-drugs-now-offers-accu-chek-test-activity-6985655434346987521-yGVI

https://www.facebook.com/costplusdrugs/photos/a.404409049909907/1903332246684239/


Author P.S.: So, I reached out via social media to Mark Cuban Cost Plus Drug Company, but largely to no reply. Then I sent a direct message to the company, and was pleased to get a response to that, and the response was informative! Below was my dialogue:


So I have a practical question about the recently announced partnership with Roche Diabetes Care. I test 15x per day, which means I use a quantity of test strips of 450 test strips each month. Yet, your website says the maximum supply I can order is 150 test strips (3x50). Any suggestions on how to accommodate my needs?

I also included a link to their post in my direct message (see for https://twitter.com/costplusdrugs/status/1579890181246971906?s=20&t=goC5c0wnz-ZwMxOHmozSzw for the company's original Tweet announcing the Accu-Chek partnership)

Here was the very informative response I was given:

My team let me know we can supply up to 9 boxes every 30 days!

The doc needs to write 'test up to 15 times per day' on the directions or sig, however, so we can properly show a 30 days supply for 450 test strips.'

So you should be all set if your prescriber sends in a prescription for these.

Friday, October 21, 2022

Podcast Recommendation: "How I Built This Lab With Guy Raz" Episode With Mark Cuban on His CostPlus Drug Co.

So, next up on my podcast recommendation (and incidentally, I should note that my recommendations are for specific podcast episodes, not necessarily all episodes within a given podcast, although you may also like subscribing to certain podcasts as the content tends to be similar to an episode I'm recommending) is one I only occasionally listen to if the topic sounds interesting. 

The podcast episode I am recommending today is one created by NPR called the "How I Built This Lab With Guy Raz" podcast (Guy Raz is the name of the host) in which he interviewed billionaire Mark Cuban. Mr. Cuban was on this particular podcast previously in one of its inaugural episodes, but the particular episode I enjoyed was a recent one from June 16, 2022 in which they interviewed Mark Cuban and asked him about how his new startup business known as the Mark Cuban CostPlus Drug Company and how that came to fruition and how that business is looking to disrupt the pharmaceutical and PBM industries.

In fact, I am likely to share several other podcasts about the Mark Cuban CostPlus Drug Company because it has potential to become a disruptive force to the PBM Kickback problem responsible for prescription drug price inflation in the U.S. (BTW, I wrote an article published on LinkedIn on the subject of the PBM Kickback problem which you can read at https://www.linkedin.com/pulse/how-civica-insulin-announcement-may-disruptive-pbm-scheme-strumello/ so please feel free to read my article).

Anyway, the "HIBT" (the acronym for "How I Built This") podcast host Guy Raz acknowledged in the episode intro that Mr. Cuban had been founding and investing in different startups for decades, but he'd never put his name on a company until the CostPlus Drug Company came to be. That's an interesting story by itself, but he also shares some fascinating additional details about the actual business in this episode.

The link to the episode itself is found at https://wondery.com/shows/how-i-built-this/episode/10386-hibt-lab-mark-cuban-cost-plus-drug-company-mark-cuban/ 

 

 

 

For whatever reason, Wondery podcasts (or distributors like Apple Podcasts) doesn't technically enable sharing of podcasts they host, so in this case, I simply borrowed their episode image (it was a WebP image format which was a hassle to work with or download, so I converted it to a more usable PNG format), and if you click on the image (or the link), it will direct you to the page for the podcast itself.

Anyway, this  NPR "How I Built This" ("HIBT Lab") episode entitled "Mark Cuban CostPlus Drug Company: Mark Cuban How I Built This with Guy Raz" was one worth listening to. It provides some info. from Mark Cuban himself about this startup business, the man who pitched the idea to him Alex Oshmyansky and how he, as a multi-billionaire, doesn't aim to sell the company to "cash out" as so many pharma entrepreneurs do. That's an important point of differentiation and in my opinion, and combined with cost transparency makes MCCPDC a drug company I'm more willing to do business with if I'm paying out-of-pocket. In fact, I recently did so (although only because the cost of the drug itself was among the lowest I could find anywhere).