Monday, June 14, 2021

Reports of the Death of Diamyd's T1D Intervention Have Been Greatly Exaggerated

Remember Diamyd Medical?  I wrote about the company and even interviewed one of the company execs (Peter Zerhouni, who was then Director of Business Development) back in 2010 (see that post at https://blog.sstrumello.com/2010/05/interview-with-diamyd-medical-ab.html). A year later, I wrote another post about it not being dead yet (see https://blog.sstrumello.com/2011/06/teplizumab-and-dpt-1-not-dead-yet.html), but it later appeared to actually be dead, and I basically lost interest.

As it turns out, the Swedish biotech firm known as Diamyd Medical isn't dead after all! Diamyd Medical was founded by the Swedish entrepreneur Anders Essen-Möller when his daughter was diagnosed with Type 1 diabetes. After a failure to meet clinical endpoints many had presumed that Diamyd Medical was, for all practical purposes, dead. But as American author Mark Twain once said "Reports of My Death Have Been Greatly Exaggerated" (meaning he wasn't really dead). Evidently, the same can be said for Diamyd Medical.

The company’s diabetes vaccine Diamyd is, scientifically speaking, glutamic acid decarboxylase, but most people just refer to that by the acronym GAD. GAD is an enzyme which plays several roles in the human body, including in the brain and the pancreas. As an enzyme, it converts the excitatory amino acid known as glutamate into the inhibitory neurotransmitter GABA, which cells use to communicate. But it also has a less helpful role as an autoantigen (an element of self that provokes the generation of antibodies, or a process whereby the body's immune system attacks the body it is supposed to protect) in autoimmune Type 1 diabetes. 

Most people with Type 1 diabetes also have antibodies to GAD. But the most interesting of GAD's attributes is that when it is given as a therapeutic, it seems to interrupt the immune system's attacking of the beta cells in the pancreas, although we now know from earlier clinical trials that it only seems to work in certain people. More specifically, in newly diagnosed people with Type 1 diabetes with specific HLA haplotypes (aka genotypes).

There is another particular example worthy of mention in this dialogue because it ended up being a similar story. Another once-promising Type 1 diabetes cure-like treatment designed to arrest the autoimmune process which causes the Type 1 diabetes disease to occur, specifically the humanized anti-CD3 monoclonal antibody known as teplizumab, was also presumed dead. Insulin giant Lilly made an investment in a Maryland-based company named Macrogenics thinking that the candidate known as teplizumab would be an imminent blockbuster. But when teplizumab bombed out in clinical trials, Lilly (and its cash) disappeared. Lilly concluded it did not have a potential blockbuster on its hands, so it cut its losses and exited.

Both are relevant because both treatments failed in widespread human clinical trials, but the underlying science revealed in those trials that the treatments worked in certain patients, just not everyone. As it turns out, neither Diamyd nor teplizumab are really dead after all. Teplizumab has changed hands more than a few times, and today it is being pursued by a New Jersey-based company known as Provention Bio, Inc. which is working on bringing that treatment to commercialization. It was originally a Maryland-based biotech firm known as Macrogenics working on it, then Lilly came in with cash for large clinical trials, but when the trial result failed to meet its pre-defined milestones, Lilly and its cash disappeared. 

There are very close parallels between the two, but I've talked enough about Teplimuzab. That's a story for another day and I probably won't be telling it. Today, I'm talking about Diamyd Medical. The company is different in that it retained ownership of the intellectual property, whereas teplizumab was sold, dumped, and picked up by another company, while Diamyd Medical’s assets have stayed in the same hands all along.

Like Teplimuzab and Lilly's abandonment of that particular treatment, Diamyd Medical originally attracted major investment from J&J's Janssen unit, which entered the picture in Phase 3. But after a large-scale clinical trial failed to meet a clinical milestone, J&J exited fast. The main difference seems to be that Lilly and J&J both marched in with big money to do large clinical trials, but then both skipped town when the milestones were not met.

Diamyd Medical has endured because the company is driven by its founder's desire to see his daughter with T1D (and now a granddaughter too) cured which is touching. That said, sometimes that's not enough to bring back a failed treatment to life. But Diamyd Medical seems to be defying the odds because of the underlying science which, in spite of failing to become a mass-market cure actually DID work — just in certain subgroups of patients.  It doesn't seem to work for everyone with Type 1 diabetes, but did work for some, about half of all newly diagnosed Type 1 diabetes patients, and for those lucky patients, it might be the difference between a lifetime of ever-rising prices for insulin and all the other supplies (CGM sensors, test strips, syringes or pen needles, insulin pumps, infusion sets and all the other stuff that goes with it which lines the pockets of diabusiness).

But neither Diamyd Medical nor the developer of teplizumab were complete failures, but the big drug companies were expecting a blockbuster to come from their initial investment. But, as it turned out, both treatments appear to work in more-narrowly defined populations. 

The bright spot seems to be that the original J&J investment in Diamyd Medical wasn't a complete bust, because it proved in a very large clinical trial that the Diamyd GAD vaccine was safe. In addition, the clinical trial provided the company with valuable data that turned out to be instrumental for its future. More specifically, in 2019 an analysis of data from more than 500 individual patients that had participated in previous clinical trials showed that the genetic profile of the individual significantly influences the effect of the vaccine. These new findings were incorporated into the ongoing Phase 2b clinical trial and when the results were released in the autumn of 2020, they showed that the GAD vaccine indeed seems to work in individuals that carry the HLA DR3-DQ2 haplotype (which can be up to 50% of all Type 1's). The upcoming Phase III Diamyd 'DIAGNODE' Trial starting up in the coming months here in the U.S. and Europe will answer that. 

Big pharma investments from Lilly, J&J or others often means the death of a promising intervention when it fails to deliver widespread efficacy for the masses in clinical trials. But closer examination of the underlying data may reveal that the treatments MAY work after all in smaller groups with more precise defining characteristics. Call it precision medicine on the cure front. 

The lesson seems to be that it's possible we may yet see different T1D "cures" (even if they are not permanent, a periodic treatment with an intervention seems a decent price to pay for fully-functional Islets of Langerhans because anyone with T1D knows what life is like living with the disease, including some not-so-fun side-effects such as hypoglycemia unawareness caused by defective counter-regulatory response to imprecise insulin dosages which comes with all insulin replacement therapy because dosing insulin is assuredly not precision medicine) which either extend the honeymoon period for a much longer period, or may even do so indefinitely with ongoing treatments. As I said, it would seem that a periodic treatment with Diamyd (or teplizumab) might be preferable to multiple daily treatments with insulin and endless testing to ensure the dosages are correct since insulin replacement therapy is deeply-flawed in spite of whatever improvements pharma likes to claim. As long as dosages of insulin remain best estimates instead of precision dosages based upon plasma blood glucose levels, insulin replacement therapy will remain a deeply imprecise dosage requirement.

So, its worth staying tuned to Diamyd see what happens next on the horizon with a new trial set to begin soon. This is one of a number of trials available to those newly-diagnosed with Type 1 diabetes — and remains an opportunity to intercede in the disease process early on. As a side note, Diamyd Medical also has another interesting product now in development, called Remygen, which may make a difference for those of us who have been living with T1D for more years than we care to remember. It is being tested for its' ability to regenerate beta cells. You can check that out, and more, on Diamyd Medical's website: https://www.diamyd.com/.

Monday, June 07, 2021

Should I Say Adios to Dexcom G7, Hello Abbott Freestyle Libre 2? Maybe.

Dexcom recently announced new features to be part of its new G7 CGM system which is anticipated to be available by late 2021 for most of the U.S.  Among the new features and supposed improvements will be a reduction in the sensor warm-up time from a lengthy 2 hours (on the G6) to just a half-hour (on the G7), and the company will also be making its sensors and transmitters all-in-one, with the automated inserter device handling regular replacements as the G6 does. Unlike the G6 which requires a separate transmitter,  the new G7 will contain everything. My guess is that will mean a big price increase to the device, and the added value seems less thrilling to me. 

I'd rather have my costs reduced. since I, like more than 55% of all Americans, have a high-deductible insurance plan which means they're forced to pay the bloated higher price for Dexcom's G7 sensors out-of-pocket, at least until mid-year when many usually satisfy the annual deductible. 

Although I won't have to make a decision until Dexcom actually discontinues the G6, I am now seriously considering a different CGM. 

I have been annoyed by repeated "Signal Loss" errors on my Dexcom G6, which is annoying and disruptive and due to no fault of my own. One CGM on my radar is the Abbott Freestyle Libre https://www.freestyle.abbott/us-en/home.html system, which I had not expected. Also, since the latest version of Dexcom G6 software came out, it repeatedly rejects my calibration attempts. I rely upon calibrations to keep the Dexcom readings accurate. The reality is I will always trust a fingerstick reading of actual plasma blood glucose more than a reading from a CGM which isn't a blood glucose reading, but a correlation to blood glucose based on molecules found in interstitial fluid. That's a proven scientific reality. Also, while the Dexcom G6 bulky insertion devices are assuredly easier than the old G5 inserters ever were, they add a ton of plastic and other shit into the waste disposal system, which is annoying. The other thing is the accuracy on the Dexcom G6 really sucks. It alerts me to impending lows which I love, but it seemingly never returns to normal readings after treating a low, it keeps alarming and alarming unless I calibrate the Dexcom app to force it to show a reading that accurately reflects a normalized fingerstick reading, effectively forcing it to do so, which sucks. Perhaps the next iteration will also slim the enormous medical waste of the inserter down, but I'm guessing Dexcom isn't even considering that in its decision-making.

I'm sort of in a state of suspension on the matter whether I wish to switch. Right now, I hope to try it soon so I can decide what I want to do headed into 2022.

The reality is with my current healthcare plan, whenever I pick-up my Dexcom G6 Sensors, my cost has steadily been $35 each month, which is well below the actual retail price of $350.00 for a package of three Dexcom G6 sensors sold at CVS. The reason is because apparently, my insurance plan, which was a relatively new plan, actually adopted the new IRS standards for diabetes supplies offering them at discounted prices prior to patients having satisfied the deductible rather than the bloated full cash retail prices. We as American taxpayers are paying the insurance company to do that, so its not insurance benevolence driving that move. 

I still can't believe that part. 

I was originally expecting the cost to be thousands, and thanks to a change by the U.S. Department of the Treasury and the IRS, its been MUCH less. I thank the IRS for reclassifying certain medical care services received and items purchased, including prescription drugs and a few medical devices for certain chronic conditions which are now be re-classified as "preventive care" for people living with chronic conditions. Diabetes (all types), asthma and depression were among the major chronic conditions which were recently added to that list, thereby making many diabetes treatments and supplies eligible for pre-deductible coverage which was announced in 2019. I blogged about that at http://blog.sstrumello.com/2019/09/in-2020-people-with-diabetes-may-wish.html, but I first called on Federal lawmakers to do it in 2018 http://blog.sstrumello.com/2018/11/we-need-get-insulin-added-to-national.html. Of course, no insurance company applied the new U.S. Treasury Department and IRS rule to any existing plans, only to new plans which were to employers sold since the IRS changed the rules. 

That may leave me in an enviable position to switch CGM's by choice rather than by economic necessity.

Right now, Dexcom has been losing in my opinion. The endless "Signal Loss" errors I experience on my Dexcom G6 are an efficacy failure and are endlessly irritating. Maybe the G7 will fix that and maybe it won't. But the software also often rejects my calibration efforts even though the Dexcom readings are  >75 mg/dL off. I cannot help but wonder if I'd be better off with a rival CGM instead. I'm seriously looking at Abbott Freestyle Libre due to my growing dissatisfaction with the accuracy of Dexcom G6.

Technically, although the Abbott Freestyle Libre 2 is often referred to as a CGM, it is in fact a "flash glucose monitoring system" as it relies upon the user to scan the sensor in order to receive the glucose readings stored in the sensor. The difference between a "flash glucose monitoring system" and a true CGM are 3 key (but relevant) features which are 'missing' when using the Libre sensor as-is:

  1. Alarms - crucial to many wearers and their caregivers to alert them to lows (and highs) -- many users consider the alarms to be a CGM requirement;
  2. The ability to share patient glucose reading info with another person/caregiver, for similar reasons as the alarms;
  3. Continuity of seeing readings - without a need to scan for them

The absence of these key features enables Abbott to sell a device which is a lot less costly than more traditional CGM devices because there's no transmitter, receiver, or smartphone software application or the costly clinical trials needed to prove their validity. In fact, Abbott's Libre 2 sensors sell for about a third less than Dexcom's (or Medtronic's) sensors do, and they last for 14-days (although likely could work for an even longer period of time if the adhesive lasted) compared to only 10-days associated with Dexcom's G6 system. But the company released trial data on its Freestyle Libre 3 sensor, and promises that its new product will offer full-CGM functionality because it will no longer require any sensor scanning to provide real-time glucose readings. The new Libre 3 will generate real-time glucose readings each minute, displaying that result on the compatible mobile app on iPhone or Android. This continuous stream of data allows optional alerts for high and low blood sugars, along with glucose results. This is a big leap forward compared to Libre 2 that still requires a confirmation scan to get a numeric reading, and doesn’t offer any alerts. Like Dexcom, Abbott boasts about the size reduction for the Libre 3 which will smaller and thinner, about the thickness of just two pennies (rather than two stacked quarters in earlier versions). Per Abbott, that is a more than 70% size reduction that uses 41% less plastic. We don't know for certain, but after delays due to COVID-19, it is believed we should expect a launch date for the product sometime later in 2021 or early 2022. This revision will make the Abbott Freestyle Libre a more direct competitor to Dexcom.

Medtronic also has its Guardian Connect CGM system https://www.medtronicdiabetes.com/products/guardian-connect-continuous-glucose-monitoring-system which is primarily used by Medtronic insulin pump users (not all, but many). It has started selling a standalone Guardian Connect System to work with its smart insulin pen known as InPen (see the Medtronic sight at https://www.medtronicdiabetes.com/products/inpen-smart-insulin-pen-system) since the company acquired Companion Medical Systems of San Diego a few years ago.

The other major CGM is Senseonics' https://www.senseonics.com/ Eversense https://www.eversensediabetes.com/ CGM system. However, technologically, the Senseonics CGM sensors require a doctor's insertion into the patients' arms, and are therefore even longer-lasting than all of the self-inserted varieties are. It is therefore more costly because of the doctor-required insertion and it lasts like six months, although loyal patients believe the underlying Eversense sensor technology provides much more accurate CGM readings and they like the freedom of being able to disconnect and reconnect as frequently as they desire. My own endo has never inserted one before, so that makes me less thrilled since it requires me as a patient to get a Senseonics instructor to come to the doctor's office, using ME as the guinea pig teaching her how to do it. Scheduling that is a hassle, and the cost-savings seems sketchy at best.

On the Freestyle Libre 2 model, Abbott (as a company) was able to skip the additional clinical trials and associated equipment and software (along with a host of different operating system versions and the problems associated with all of those) which are an added layer of complexity which requires additional testing and FDA regulatory approval. Instead, its system enables tech firms to do the work on genuine CGM functionality. Its not perfect, but the model has worked well for the company. It means Freestyle Libre sensors are considerably cheaper than those from Medtronic and Dexcom. That, combined with 2-week usage enables a genuine pricing differential. Meanwhile, the Senseonics Eversense sensor is a slightly different variety (technically, some human clinical trials conducted in Europe revealed that the Senseonics Eversense CGM sensors could work reliably for a year or longer, but that's a terrible business model, hence we can expect them to require more frequent sensor changes to pad the company's bottom line). Senseonics had a near-death experience until the glucose monitoring company Ascensia rescued it with a cash infusion last year, so some decisions are now driven by the bottom line.

NFC Enables Abbott Freestyle Libre to Be a True CGM (If It Wants)

It's not that Abbott's Freestyle Libre 2 is incapable of being a true CGM. Specifically, the Freestyle Libre sensors emits what's called NFC (Near Field Communications) signal of readings which enable genuine CGM functionality. The company has said that its next generation system (the Freestyle Libre 3 model) will include transmitters that many American patients have come to expect from a CGM. In the meantime, Abbott is selling its Libre 2 sensors in the U.S. for about $75.00 per sensor. They are sold in packages of two at retail pharmacies across the country (a box of 2 sensors sells for $150.00/box), although patients satisfying deductibles can get GoodRx coupons to buy them for about $65.00/sensor or about $116.00 for a box of 2 sensors. Cost-wise, it is cheaper than rival most other CGM's are.

In fact, Abbott as a company seemed content with its commanding global lead in sensor sales in Europe and elsewhere in the world. The reality is that as a company, Abbott is a LOT bigger than rival Dexcom is in terms of global sensor sales. Its production of those sensors is done on a mass-market scale, further enhancing the company's low-cost differential. Some worry the transmitter model might mess up the company's cost differential in an upwards direction, but its currently just speculation, because Dexcom's new model will be an all-in-one sensor and transmitter, hence making it easier but also even more expensive than that is now. That means Abbott's Freestyle Libre may yet be even less costly given Dexcom's decision which will inevitably bloat the price tag. But I question whether Dexcom is worth the premium price. More on that in a minute.

The Freestyle Libre 2 sensor never required calibration or warm-up so its fast (though some users say their readings on the first and/or last day are suspect, which is a similar issue on other CGM's), while a true CGM may need the user to calibrate it by carrying out a finger stick test, to ensure the levels it gives are 'accurate'. In fact, newer generation CGM are trying to eliminate the calibration requirements (Dexcom G6 often rejects my calibrations, which I used to keep the readings accurate), but the reality is most sensors' accuracy simply isn't good enough to enable that. My personal perspective is that Dexcom's G6 sensors are NOT terribly accurate, often being off by more than 50 mg/dL or more on the very first reading, so I think there's a lot of room for more precision. When it comes to accuracy, Dexcom isn't great. Call me less-than impressed with Dexcom's sensor readings.

Anyway, Abbott's strategic decision to avoid the U.S. market while it was establishing itself as a global sensor leader around the world means in the U.S., its currently an also-ran. The company now uses its lower-cost differential, yet many patients remain unpersuaded. I understand it. But if you're dealing with costs, there are some convenient accessory devices which read the Abbott Freestyle Libre NFC (Near Field Communications) and solve a huge issue many believe to be its biggest deficit, a lack of alarms and share function with caregivers.

Add-On Transmitters Turns Libre 2 into CGM Now. Beware: FDA Approval Not Required. But Bigfoot Unity (and Soon Its Pumps) Has FDA Approval. 

In addition to the Abbott decision to dominate the rest of the world, even today, Abbott's Freestyle Libre 2 DOES in fact have the ability to work right now as a genuine CGM by using add-on devices and software. There are a handful of such add-on transmitter packages on the market. Some operate primarily in Europe, where Abbott's Freestyle Libre 2 dominates the "CGM" market already. Most are from scrappy startups with a handful of smart techies. That enables them to keep their products affordable, although they often lack a customer service infrastructure which sometimes can leave leaves users frustrated that the apps aren't working on whatever operating system iteration the patient is using. That's attributed to technology in general and is less a function of the companies which develop it. Also  Beware of the downside, which is that its products are add-ons and are not required to get FDA approval, so if they do not work, the company has no obligation to help. Abbott plays no role in these add-ons other than its product emits NFC signals which are open to others to work on.

Bigfoot Unity: SmartPen Cap + Freestyle Libre 2 Transmitter All In-One

There are a handful of these add-ons around the world, but since I'm in the U.S., my main concern is the U.S. and Canada. The Libre 2's NFC (Near Field Communications) signal is openly accessible to be read by other devices and software. Bigfoot Biomedical's "smart" insulin pens dubbed Unity https://www.bigfootbiomedical.com/bigfoot-unity will do just that. But Bigfoot is currently not working directly with patients, but with medical practices, which might be a unique model, but means hardly anyone in the U.S. has a Bigfoot Unity pen cap, and that model is largely inaccessible, leaving patients like myself to turn to rival Companion Medical Systems, which is now in Medtronic Diabetes' stable of products. Their insulin pens are attractive and they work pretty well although many insurance companies refuse to cover the insulin pen cartridges leaving it out of reach for many. Bigfoot's Unity pen cap system is much less bulky and has a lot more features, most notably the ability to turn the Freestyle Libre 2 system into a true CGM. In effect, the presence of a Unity smart pen cap to read the Libre's NFC signal turns the Libre 2 into a true CGM. Bigfoot also plans to do the same for its insulin pumps (now in development), but those systems are not yet FDA approved. 

I'm personally very annoyed by Bigfoot's shitty distribution model for Unity. It is sold as a subscription to doctor's practices, who are then supposed to charge their patients for it. It means the Unity system is virtually unavailable except for those whose doctors' subscribe and offer it to their patients, and the handful of practices they have teamed up with seem to in the immediate area of the company's Milpitas California headquarters (also in the South Bay area bordering on Silicon Valley, but also bordering on the East Bay near Fremont) right now. I likely will not be among Bigfoot's clients unless it changes its marketing model. Its an annoying business model and I kind of question whether they're really serious about selling the product with a business model that leaves many thousands of patients completely out-of-reach. Bigfoot Unity could reach many more with a more traditional model of targeting insurance companies directly, but they will instead merchandise themselves at the ADA Scientific Sessions hoping to sign up doctors at events like that instead of working with insurance companies. Its anyone's guess whether it will be successful, but I suspect it will not be, although it will help the company to establish relationships with endocrinologists and CDE's which it envisions will be necessary to compete in the insulin pump space when its device is finally approved.

MiaoMiao Transmitter and Its Tomato Smartphone Software

Aside from Bigfoot, a lesser-known company also sells add-on Freestyle Libre 2 transmitters. One is from a Toronto-based startup named MiaoMiao https://miaomiao.cool/ (whose app is called Tomato, which is available to download on both the Google Play [Android] store and Apple's iOS App store) . I have no experience with the company, but as I understand it, its software is quite well-liked by many users, which means that even though its transmitter add-on appears a little bit bulky and annoying to wear, other companies' transmitters are also capable of working with the Tomato smartphone software which is a plus. Their products are legally considered add-ons to the FDA-approved Abbott Freestyle Libre sensor, and is therefore not legally required to get FDA approval, so if they do not work, the company has no obligation to help and you can't report it to the FDA. That said, users can use MiaoMiao's Tomato software with another company's add-on Libre transmitter (another add-on which bypasses FDA). Many users praise this company's software and it remains a popular one on the global market.

Ambrosia Systems BluCon Transmitter

Another of the add-on transmitter devices for Freestyle Libre 2 are the relatively inexpensive (about $150 for a waterproof model, but some this one appears to enable the batteries to reportedly be changed by the patient, so I think it is often a one-time expense, unless the transmitter dies) which is from a Newark, CA (which is located in the San Francisco Bay Area's East Bay region, although the company was originally based in the Silicon Valley town of Sunnyvale) known as Ambrosia Systems, Inc. https://www.ambrosiasys.com/ whose add-on transmitter and software package is called BluCon. The company offers different varieties of transmitters, including a slightly cheaper non-waterproof model, but I think the difference in price between that and the waterproof model is comparatively small.

BluCon is a BLE (Bluetooth Low Energy) electronic transmitter which also works with smartphone software developed by Ambrosia Systems. Bluetooth can be a bit messy from my perspective and that's a key reason why Bigfoot's Unity product is so impressive, because it links so many different pieces together in spite of a limit of a single bluetooth connection to exist. Still, I admire the way the Ambrosia's reader physically attaches to the Abbott Freestyle Libre's sensor as well as it appears to, the fact that the company is based in the United States, and its apps appear functional (at least on Apple iOS devices; so many fail on the Android side because there are so many operating system iterations which exist and phone hardware makers can choose whichever version they want, making Android devices a much more challenging nut for them to crack effectively). That also bedevils far too many reputable medical device-makers including Dexcom. 

Ambrosia's BluCon offers software which works on different smartphone operating systems software enabling the product to receive and share the Freestyle Libre readings data with another app giving caregivers access to receive Libre readings and they are available right now. Beware of the downside, which is that its products are add-ons and are not required to even seek FDA approval, so if they do not work, the company has no obligation to help. I cannot speak from experience with Ambrosia, but it has several positive things going for it, including most notably it's here and it exists now, it's comparatively inexpensive, and it is from a domestic supplier. The downside is its from a small startup with few employees and similar to MiaoMiao, it bypasses the FDA completely. A biggest downside is that its products are add-ons and are not required to get FDA approval, so if they do not work, the company has no obligation to help and you can't report it to the FDA.

Bubble Smart Reader

A third option for Freestyle Libre 2 is known as the Bubble Smart Reader https://www.bubblesmartreader.com/. I cannot really tell where this firm is even based. It could be in a former Soviet republic for all I know, although some Europeans seem to like it. I am less enamored with a company which I cannot even identify a headquarters location for and whose website has a few obvious English language errors. Remember: Americans are not even the target market for their work, so the company really does not care, but the important thing is for users to know that the company exists and it remains yet another option if they are underwhelmed with the others.

Conclusion

In the end, I'm getting sick of Dexcom and its product. I feel as if the company's initial focus on patients has declined, and the company now takes its patients for granted as it pushes for events to drive its share price up, and while its retail model has made getting the product to consumers vastly easier, but its basic product has not improved much. The new G7 model will make some modest changes, along with reducing the number of SKU's needed for the company to commercialize the product, which is less of a patient benefit and more about making distribution to retail pharmacies easier for the company. That should theoretically result in lower prices, but because it combines sensor and transmitter functions into a single item, patients can basically count on higher prices. That means Dexcom views patients as little more than a revenue source. Is that really worth a slightly shorter warm-up? That depends on if it fixes the countless problems I've experienced over the past few years with "Signal Loss" and calibrations being rejected. Sorry, but I trust fingerstick readings much more than I do CGM interstitial fluid correlations. If Dexcom fixes those problems, I'll be pleased. 

These things have me seriously considering alternatives to Dexcom. And Abbott's Freestyle Libre 2 is one of them I'm considering because of its simplicity and add-on functionality. Then again, the Libre 3 model could be commercialized before too long. Watch this space.

Monday, March 08, 2021

GoodRx Upends Healthcare Price Obfuscation

As Dr. Elisabeth Rosenthal told NPR in 2017 (listen to or read the interview at https://n.pr/2OgsDMt -- it was fascinating), Americans are told over and over again that they need to be  good consumers of healthcare services. But she explained that in order to be a good consumer, you need to know a price. Healthcare in the U.S. is one of the few markets in which no one can tell the consumer what the prices for their services actually are. (And she added "P.S., a lot of medicine isn't so elective. Your doctor says hey, you need to have your hip replaced. Or your doctor says, I'm going to fill out a requisition for this blood test. Here's the lab I'm sending it to. You don't really have a lot of choice").

Dr. Rosenthal gave the example, if a doctor tells you that you need to get that your wrist X-rayed after you fall, you can call 10 different X-ray centers. But no one can tell you what the price for those services are. Instead, they're all going to tell you that "it depends on your insurance" or "we don't know".

That's the very definition of a failed marketplace. 

If lawmakers expect to reform it, there has to be a lot more transparency. But transparency alone won't fix it because so many entities involved have grown accustomed to collecting money they have not earned, but it needs to be there. Hidden or secret prices does not enable consumers to comparison shop or to be good consumers of healthcare services. In prescription drugs, the amount spent on discounts given to healthcare insurance company payers is routinely defended by pharma as "trade secrets".

Prescription Drugs: The Definition of Healthcare Price Obfuscation

Picking up a prescription from the pharmacy seems like it should be a straightforward process from a consumer perspective: the doctor writes the prescription, the pharmacy fills it, and when it's ready to be picked up, the consumer shows up. 

In the background, however, the process is anything but straightforward. And virtually none of the decisions that have an economic impact on the consumer are made by any of the stakeholders involved in the prescription-fulfillment process: few doctors will know the out-of-pocket costs the consumer will face, the pharmacy doesn't set the price, and consumers often face sticker shock when they arrive, unaware that the same prescription may be available at a lower cost at another pharmacy down the street.  

Behind the curtain are actors and forces that in general seek to reduce healthcare costs at a system level but, as each has its own set of incentives, whose efforts frequently conspire to put consumers at a disadvantage. 

That's why a Los Angeles-based digital health company known as GoodRx (founded in 2011) which successfully went public September 2020 is a rarity because it actually shows how price transparency in healthcare can be very profitable and serve the public interest, too. The nine year-old company is already very profitable, with $388 million in 2019 revenue and, more surprisingly, $139 million in operating profit.

GoodRx is perhaps best known for making prescription drug pricing transparent and offering discount coupons to consumers, allowing consumers to shop for which pharmacy provides the best combination of price and convenience. The company earns revenue only when it saves people money. Thus far, the company estimates it has helped Americans realize $20 billion in savings.

GoodRx fits in by helping different groups of consumers save money on prescription drugs:

  1. For uninsured or underinsured consumers, GoodRx allows consumers to tap into and leverage PBMs' scale and purchasing power to negotiate drug prices down from pharmacies' bogus "usual and customary" prices'
  2. For commercially-insured consumers, GoodRx still allows consumers to access PBMs' discounts (which are often denied to patients unless they have satisfied a deductible) to identify when discount card options are actually lower cost than the consumers' own insurance copays are for a given drug. For patients still satisfying insurance deductibles, many find the GoodRx prices are cheaper - often by a substantial amount. 

With insulin, for example, patients can get coupons to buy it for roughly 75% off the pharmacy cash price with a GoodRx coupon (in fact, insulin maker Novo Nordisk A/S revealed in its Q3 2020 earnings presentation on slide #103 to investors that it is now spending 74% of its gross insulin sales on rebates paid to PBM's). 

In fact, while logic might suggest that the majority of GoodRx users are in the uninsured group, in fact GoodRx reports that almost 75% of its users are actually insured. 









All that money is going someplace, and in the post I did on the Right Care Alliance presentation I recently gave, we know where the money is going. Insurance companies are taking the Rx rebates and giving them to employers as "premium offsets" so they can sell more new policies. It is, in effect, a system whereby the sick are subsidizing the healthy, which is not something a functioning healthcare system does because it makes no sense.








GoodRx isn't alone. Like all good ideas, others have copied it. There are now more than a dozen competitors. Not all offer the best discounts, but patients can do their price-shopping before even going to the pharmacy and bring the coupon that offers the price they want to pay with them to the checkout.

That explains why at the 2021 J.P. Morgan Healthcare Conference Pfizer's CEO Albert Bourla spoke with someone from J.P. Morgan. Although I think Mr. Bourla lacks the polish and finesse of his predecessor Ken Frazier, he didn't get the brass ring because he's clueless about how Pfizer runs. Towards the end the session at J.P. Morgan 2021, Mr. Bourla shared an interesting thought on the future of U.S. healthcare reform: 

"I think [rising out-of-pocket cost] has become a unanimous concern for all of us. If you ask any of my peers, and good friends, they'll tell you that one of the highest concerns is that in the U.S., patients are getting their medicines like if they DON'T have insurance, even if they DO have it. That's the result of a system that was driven by rebates, and we're stimulating wrong behaviors. We've arrived at a situation where we need reform – that needs to change ... We believe that the #1 priority of any healthcare reform is to reduce the out-of-pocket cost for patients. That's #1. Everybody should contribute to that. But we should contribute, insurance companies should contribute, the state should contribute – everyone should contribute. This is a must because it's not a sustainable situation and that creates a lot of animosity. It is the fundamental base of why things are so tense in the healthcare section..." 

Of course, the animosity towards pharma is due to the fact that it defends the $185 billion in prescription drug rebates which the industry spent in 2019. Beyond that, the "state" as he refers to it already contributes a LOT more than anyone realizes which Bourla fails to acknowledge. For example, the Congressional Budget Office (CBO) revealed in 2019 that U.S. taxpayer subsidies for employer-sponsored healthcare insurance plans was $567 billion. Mr. Bourla may be right that all parties need to contribute, there is no denying that the drug industry has defended its use of prescription drug rebates as "trade secrets" and that patients end up paying for it.

Forbes had an interesting article about GoodRx which is worth having a look at, see it at https://www.forbes.com/sites/sethjoseph/2021/01/12/what-could-a-healthcare-marketplace-look-like-goodrx-is-trying-to-show-us/.

Monday, February 08, 2021

How to Navigate Life with a Chronic Disease Like T1D and High-Deductible Insurance Plans

Over the years, I've learned (based on my personal experience) some useful money-saving ways to navigate high-deductible insurance plans when you live with autoimmune Type 1 diabetes. One is that it helps to take advantage of any tax-advantaged (pre-tax) employee benefits offered by your employer including Flexible Spending Accounts (FSA's) and/or Healthcare Savings Accounts (HSA's) if you have access. There are differences between them, but they're both governed by IRS rules. They enable you to use pre-tax dollars for eligible healthcare expenses and reduce your taxable income. There's another FSA benefit: your employer is obliged to pre-fund the entire FSA amount you select on January 1, but if you resign on February 1, you can still use all the money even if your pay hasn't funded it yet. 


There are nuances between HSA's and FSA's, and some people actually use both. Charles Schwab had an interesting article entitled "Are HSA's the New IRA's?" (see the article at https://www.schwab.com/resource-center/insights/content/are-hsas-new-iras) which you can review if you're interested in reading more on the subject. Although FSA dollars are "Use it, or lose it", that was never a problem for me as a person with a chronic illness like Type 1 diabetes. When I knew I was leaving my employer, I simply purchased of several Dexcom CGM sensors and bought them using the Visa card accessing my FSA. When my last day at the employer happened, I had just $0.03 remaining in the account, but I left the company in March, meaning it was my employer's money, because I hadn't been paid enough to fund it completely by March. Those are the IRS rules, so I was entitled to do it -- but it was kind of a parting gift from a former employer which THEY paid for, not me!

Bypass Insurance When Buying Prescriptions Until You've Satisfied a Deductible

But perhaps the most powerful financial tool is to simply bypass insurance completely until you have satisfied your insurance deductible. The short explanation is that your healthcare insurance company is working to screw you. If you have a high-deductible insurance plan, a crude analogy is that your insurance company is trying to screw you from both the front and the back. That means you need to learn to play the game correctly, or you'll end up paying thousands of dollars more than you need to. 

The reason I made such a crude analogy is because today, health insurance companies are receiving massive discounts of more than 70% on life-sustaining insulin, yet they are allowing patients to pay the bogus pharmacy "list" prices (calling that the "plan cost" for insulin) — even when the patient uses the PBM's mail-order pharmacy which is supposed to save the insurance company money. In fact, Novo Nordisk revealed during its Q4 2020 Earnings Presentation to investors (found on slide #103 of the presentation archived at https://seekingalpha.com/article/4403040-novo-nordisk-s-2020-q4-results-earnings-call-presentation if you're interested) that the company was paying 74% of the company's U.S. gross insulin sales as rebates paid to Pharmacy Benefits Managers (PBM's), who are contractually obliged to pass-thru 100% of all Rx rebates received to the insurance company which owns them or hires them. On top of all that, even while patients are paying like $250/vial for insulin, your insurance company only gives you credit applied towards your deductible of about $70 (which works out to like 25% of what you're paying).

The bogus prescription "list" price is also often used as the pharmacy's Usual & Customary (U&C) price given to cash-paying customers (plus a small markup that the pharmacy adds as its profit margin, only their contracts with third-party Pharmacy Benefits Managers [or PBM's] don't allow pharmacies to really markup Rx drug prices, instead they are paid a small transaction processing fee on each Rx script handled thru insurance). But there is nothing that requires anyone to use insurance and it may prove more beneficial to bypass insurance because they are not giving you nearly as much credit applied towards your deductible that way. 

My Right Care Alliance Presentation 

On November 15, 2020, I did a presentation for the nonprofit Right Care Alliance in which I revealed how anyone (ANYONE) can get rapid-acting insulin analogues for 75% off the bogus list price with modern, coupon generating websites/smartphone apps. There's a lot of relevant information in my presentation so I encourage you to read it. The presentation itself is only about 15 pages and there are plenty of graphics. I recommend you have a look below, or by visiting https://www.slideshare.net/sstrumello/right-care-alliance-presentation.


Coupon-Generating Apps/Websites 

Coupon-generating websites/apps are a new wrinkle in a not-at-all transparent but dysfunctional cash-flow behind the runaway U.S. prescription drug pricing mess. These work on drugs like insulin as well as medical devices such as blood glucose test strips and CGM sensors. However, the latter tend to be far less-heavily rebated than insulin is, so the discounts are not as big. I should also acknowledge that these are not only for those with high-deductible insurance plans, those in the Medicare donut hole or those without insurance can also use these tools. 

Best Tools for Insulin Discounts of 75% Off

The number of such websites/apps continues to grow, and while not all websites/apps offer discounts on insulin, some do. In my assessment, the most reputable and relevant ones are GoodRx https://www.goodrx.com/ and RxSaver https://www.rxsaver.com/. A third is ScriptSave WellRx https://www.wellrx.com/. Each of these offer discounts for rapid-acting insulin analogues which is among the most heavily-rebated prescription drugs in existence. Beware that prices for insulin pens are slightly higher, whereas if you fill a 90-day supply of insulin, the price per vial is slightly less.

These websites/apps all offer discounts on the authorized generic versions of rapid acting insulin analogues; but long-acting analogues seem to be the exception. Some do refer patients to manufacturer discount programs. Sanofi's Lantus, for example, is offering coupons to buy it without insurance for $99/vial. Biosimilar versions of insulin glargine also exist and might be worth considering if the price is right, including Lilly Basaglar and Viatris/Mylan (Biocon) Semglee which may also offer meaningful manufacturer discounts. So far, other basal insulin varieties do not yet have biosimilars since patents have different expiration dates and some of Novo Nordisk's patents on basal insulins have yet to expire. Beware that some coupon-generating websites/apps seem to default to the most costly packages (notably insulin pens, which are significantly more expensive than vials and syringes so I would never recommend using those if you're paying cash), but just beware of exactly what form of the drug the site/app is searching for (some offer the ability to change from boxes of insulin pens to 10 ml vials, for example).

Other discount websites/apps worth investigating could also get you discounts on things like test strips, syringes, and other types of prescriptions including cholesterol-lowering drugs, blood pressure medications, and even CGM sensors which have transitioned from being classified as durable medical equipment (DME) to a prescription now sold in pharmacies. Check out BlinkHealth https://www.blinkhealth.com/, SingleCare https://www.singlecare.com/, Americas Pharmacy https://www.americaspharmacy.com/, and others such as United Healthcare's OptumRx offers something it calls OptumPerks https://perks.optum.com/ which also has potential to help with some non-diabetes prescriptions. But I haven't found OptumPerks to provide any meaningful discounts I have found useful, but it's an option that's available and things change all the time. I should acknowledge that using these apps adds a new layer of complexity to the prescription purchase process in the U.S. 

Shop for Discount Prices Before Going to the Pharmacy

My advice is to check out all of them before you even visit the pharmacy. Be sure to search under the generic drug name (in addition to the brand-name) because each one has different search logic and may miss a discount if you enter the brand-name and/or the generic drug name, and identify both the lowest price at a pharmacy located near you, and then print a copy of the coupon to take with you for each script. In my experience, Walgreens is the place where I have found the lowest prices on authorized generic versions of insulin, at less than $70/vial. Once the coupon is entered into your pharmacy's system, it will remember it (so when you refill it, they will default to the coupon). Once you have satisfied your deductible, you will also need to keep this in mind and tell them to process it using the correct payment method: your insurance card. 

I should note that for things like statin drugs, which is now a generic, the price circus is beyond strange. There, I found the deepest discounts at my local supermarket's pharmacy, which I don't ordinarily use.

Consider Using "Generic" Test Strips 

Aside from those tools enabling people who have not yet satisfied a deductible (or those who lack healthcare insurance) to access deeply-discounted, PBM-negotiated prescription drug prices (as well as discounts on test strips and CGM sensors), I also view startups selling generic test strips as another rather useful tool. I chose generic test strips because they were much cheaper. 

I'm not talking about a store-branded meter and strips made by some unnamed Chinese entity, but U.S.-based companies selling test strips which work in meters made by big manufacturers like Lifescan. Some have concerns about accuracy, and if that is a concern for you, you might consider using coupon-generating apps/websites instead. My readers may recall (see my post HERE) I test-drove use of these generics during the pandemic. I was pleased enough to make it an ongoing strategy while I stocked inventory of the preferred formulary brand. In a comparison of the brand-name strips and the generics, the results were very close. Plus, I still have access to my Dexcom readings, so I can use the test strips as an adjunct to that (and I'm old enough to recall when the FDA considered CGM's as an "adjunct" to traditional fingerstick tests). 

Luckily, I also have a stash of many different old meters still in my possession (most brands since insurance plans and/or new insurance carriers have forced me to switch brands often), including my trusty old OneTouch Ultra meter (the original model, not the Ultra II model) which served me well for many years. With a single replacement #2032 battery acquired from my local dollar store, it was ready to work again. If you do not have one but want to go this route, you can buy the Ultra II or Mini models in most pharmacies, or you can always try eBay. 

Currently, there are 2 generic brands: Unistrip1 from Charlotte, NC-based Unistrip Technologies, Inc. http://www.unistrip-tech.com/ and GenUltimate! http://genultimate.com/ from Westlake Village, CA-based PharmaTech Solutions, Inc. Unistrip1's test strips are made in Taiwan, whereas PharmaTech Solution, Inc's GenUltimate! test strips are made in South Korea. 

Neither appears to operate an online store of their own (although they do refer you to a preferred retail partner), but there are plenty of sellers in the online space. But the cost for their products are a lot less than Lifescan's OneTouch Ultra test strips cost. As a practical reality, that means patients can buy generic strips which work in OneTouch Ultra meters at a cost of about $50.00 for 300 test strips vs. only 50 strips for about the same price as the brand-name product. It means more strips per dollar spent. On a per-strip basis, the cost works out to be about $0.16 per strip. If I bought the brand-name in the pharmacy, it would cost about $0.90 per strip, or maybe as low as $0.86 per strip with a GoodRx coupon. My preference is the Unistrip1 product since I think it requires a marginally-smaller blood sample, but I was happy to buy some GenUltimate! strips on clearance (because the expiration dates were < 1 yr away) for $7.95 for a vial of 50, so I bought 300 of them. That was just a happy accident.

However, in general, the more generic strips you buy from online sellers, the lower your cost on a per-strip basis becomes. That does not usually happen when you patronize a brick-and-mortar store or use your insurance company mail-order pharmacy. 

My Recent High-Deductible Experience Has Changed Due to New(ish) IRS Rules

Recall that in 2019, I blogged about a long-overdue change implemented by the U.S. Internal Revenue Service (IRS) which expanded the list of medicines and devices eligible for pre-deductible insurance coverage (see my post HERE to read that). Even though that rule will eventually benefit many more people, insurance companies are fine taking the taxpayer subsidies without passing them on to patients covered by the plans. None chose to change any existing plans, only new plans they sold. Eventually, they'll have to or risk an IRS audit, but they can cite different "plan years" for a while, which means they weren't going to do it with any existing plans, only new plans. 

Still, with my most recent insurance carrier switch came its long-overdue adoption of the 2019 IRS rule change which made insulin a "preventative" medical treatment meaning patients no longer need to satisfy a deductible to get insurance to pay for it. For some reason, they exclude glucometers even though they are included on the IRS list, and they also only cover one brand of statin. Another downside: unlike the last time I was covered by Aetna in 2016, they no longer have Lilly insulin on their preferred drug formulary, now its Novo Nordisk insulins. They also switched me from OneTouch meters to Accu-Check meters. I'm not a fan of Novo Nordisk insulins. They have never worked well for me personally, even though I've been forced to use them on occasion. I found Novolog was not much more rapid than regular. At least that was true for Novolog. But I've been OK with Fiasp as long as it's being paid for by insurance. But if I was paying out-of-pocket (as many are when they are satisfying a healthcare insurance deductible), I would be choosing Lilly Insulin Lispro. But for those who find Novo Nordisk Insulin Aspart their preferred brand, if you ask your doctor to prescribe a generic-named insulin variety, you can easily switch to the brand-name once you've met your deductible amount, enabling you to switch seamlessly at the pharmacy checkout counter.

Conclusion:

So, this is a method to survive a high-deductible insurance plan without breaking the bank. I have done it, so I know it works. Keep in mind: insurance companies feel entitled to screw patients (you are not their customer, your employer is). Don't let them do it to you!

Tuesday, October 13, 2020

Get Humalog or Novolog for About $50/vial TODAY

First, this is NOT another page dedicated to bogus manufacturer Patient Assistance Programs. Having lived with Type 1 diabetes for nearly 50 years, I can honestly tell you I have never met a person who qualified for those fake programs. Ever. 

Yet as we head into a new year, for people with high-deductible insurance plans, the deductible reset dates often start at "open enrollment" which is in November at many organizations (although some plans use the calendar year as the reset date for deductibles, which means January 1 -- a lousy way to wish patients a happy new year and that's slightly over a month away). Other companies have different plan dates, so if you have employer-based insurance coverage, you can verify with HR to determine the start date for your particular healthcare plan. 

In recent years, we've heard of horror stories about caravans of Americans headed to Canada or Mexico to buy less-costly insulin because prices in the U.S. are so out-of-control. It finally became a PR disaster for manufacturers like Eli Lilly & Co., Novo Nordisk and Sanofi. Even while those same companies bankrolled trade groups like PhRMA to fight/litigate any and all state initiatives to regulate what they were doing behind-the-scenes, enough pressure forced the two biggest insulin manufacturers (Lilly and Novo Nordisk) to offer a response to a problem they had created. Their solution: to introduce supposedly half-priced versions which they call "authorized generics". Although the nation's largest pharmacy chain CVS simply refuses to even carry the cheaper versions, its biggest rival Walgreens (which recently acquired another chain known as Rite Aid) does sell them. The curious thing is that in spite of Lilly and Novo Nordisk slashing insulin prices in half, their own bottom lines were not impacted at all. 

Nada. Zilch. 

To be sure, insulin-makers aren't exactly sitting pretty. We know that the realized "net" prices that Lilly, Novo Nordisk and Sanofi make on insulin have not risen after all the big fat rebates of  >70% given to some entity other than patients (see an article published in the Wall Street Journal on March 4, 2020 entitled "Sanofi, Fighting Back in Insulin Price Debate, Says Its Net Prices Fell 11%" at https://www.wsj.com/articles/sanofi-fighting-back-in-insulin-price-debate-says-its-net-prices-fell-11-11583340721 for detail) to pharmacy benefits managers ("PBM's") hired by or owned outright by the largest healthcare insurance companies. I described that in a recent post I did entitled "It's the Rebates, Stupid". 

Rebates are a problem of pharma's own creation, yet ironically, they seem to defend the practice. I suspect they likely could fix it if they really wanted to, so its odd, but its not patients' problem to worry about pharma's problem with rebates. The problem is that mergers have created insurance companies who are as big as pharma and now the shoe's on the other foot. But pharma has been more than willing to take care of themselves while patients have suffered from runaway prices. Price caps simply force insurance companies to give the rebates to the individual who generated those rebates. I don't necessarily think they are the best solution, but many red and blue states are doing them, and they work. 

But what if you live in a place that hasn't capped insulin prices and your deductible resets in November or January? 

The good news is that you can readily get the "authorized generics" of  rapid-acting insulin analogs for about $67/vial or $68/vial with coupons. Today, I found a coupon to get the authorized generic version of Novolog (insulin aspart) for about $67/vial. Key is to search using "insulin aspart" not Novolog. RxSaver (which was acquired by RetailMeNot in 2018) seems to be the low-price winner for that type of insulin. Its sold in Walgreens and some smaller pharmacies, just not at CVS because that pharmacy chain refuses to even carry the lower-priced versions, which means you should go to Walgreens instead (at least until you've satisfied your deductible). Just be sure to ask your doctor to prescribe your insulin with the generic drug name rather than the brand-name (ask them to prescribe either U-100 Insulin Lispro or U-100 Insulin Aspart).


Rival Humalog (insulin lispro) also sells for $68/vial today with a readily-available coupon. I first found a coupon at that price available from GoodRx today (also at Walgreens, Rite Aid or some other pharmacies, just not CVS). The low-priced GoodRx coupon for "insulin lispro" is pictured below.


For insulin aspart at GoodRx was a mere $4 higher, but why pay that much for it? Just use the app that offers the lowest-cost insulin product for your needs. The prices for both authorized generics are quite a bit less than the "half-price" advertised by the insulin makers (Novo Nordisk introduced its version with hardly any fanfare, but the fact that it copied Lilly's move is validation that it concluded that was the best way to respond to the pricing price crisis it perpetuates, but you will need a free coupon from either GoodRx.com or RxSaver by RetailMeNot. 

The apps (or online using a browser) are free and they work. Catch my post about the first time I discovered them at https://blog.sstrumello.com/2020/09/more-games-more-games-with-us-insulin.html if you want more background about how they work. But the key to it is the coupon. there are a lot out there including some advertising on TV, but some don't offer insulin discounts, so you have to do some homework, but these are readily available in the U.S. today without having to provide any personal info (unless you want them to email or text it to you).

Author P.S., May 13, 2021

On May 13, 2021, Bloomberg News reported that GoodRx Holdings had acquired the discount drug company known as RxSaver which was owned by the marketing firm Vericast for $50 million, citing people with knowledge of the matter. Vericast is controlled by billionaire Ronald Perelman. The actual sale took place in April 2021, GoodRx revealed to investors on a private call. 

The digital coupon firm RetailMeNot, which had been previously owned by Vericast, acquired RxSaver three years earlier as part of a plan to move into healthcare services. It was backed by MacAndrews & Forbes (a holding company owned by Ronald Perelman). Vericast used the money from its RetailMeNot sale in order to pay down some of its debt by buying back roughly $336 million of bonds, Bloomberg had previously reported. Several media outlets reported that Vericast had debt totaling some $2.7 billion at the time, but only about $60 million in cash, according to sources. That means that it is likely that it was forced to sell RxSaver in order to meet the firm's financial obligations.

Since the GoodRx acquisition of RxSaver, the impact on people with diabetes is that GoodRx is now offering even deeper discount coupons for Novo Nordisk Insulin Aspart (at a retail price of $52.78/vial when purchased from Walgreens, which is an additional discount of about 22% off the previously discounted price of $67/vial), which is the company's "authorized generic" (which Novo calls an "Unbranded Biologic") version of its heavily-rebated Novolog insulin analog being sold via its Novo Nordisk Pharma unit. The current coupon can be viewed below:


It is widely believed that Novo Nordisk is planning to discontinue making (or "retire") Novolog, which is no longer patent-protected, and at least three companies have announced plans to introduce Insulin Aspart biosimilars (among them: Viatris/Biocon, Lannett/HEC, and Novartis Sandoz/Gan & Lee).

Separately, Novo Nordisk told investors in its Q4 2020 investor presentation that rebates paid to pharmacy benefits managers (so-called "PBM's", who are contractually obliged to pass on all rebates to the commercial healthcare insurance companies which hire them, or own them outright) now consume 74% of Novo Nordisk's gross insulin sales in the U.S.

As an added benefit, GoodRx now offers discount coupons to purchase rival "authorized generic" insulin product from Lilly called Lilly Insulin Lispro, and the price on that is now $48.07/vial, which is even better! Users may recall that it was Lilly who originated selling a less costly "authorized generic" in response to growing public outrage over runaway prices for the now out-of-patent medicine.


As always, there are a few things patients should beware of. First, insulin pens are always more costly than a vial of insulin, and second, if they buy a larger quantity of insulin, the cost per vial does decrease slightly.

Tuesday, September 29, 2020

"It's the Rx rebates, stupid!"

Although my last post addressed one realistic solution to an embedded problem in the U.S. healthcare system related to prescriptions of life-sustaining essentials like insulin (which isn't a NEW drug; it was discovered in 1921), the problem has never really been explained which is necessary when interacting with lawmakers about potential legislative solutions to the problem of runaway insulin prices. So, this post aims to be an explainer. 

Insulin is today a prescription medicine (it used to be OTC, and early-generations still are, but with the advent of analog insulin, the drug companies persuaded the FDA to reclassify insulin as a prescription drug rather than OTC, which was the first step towards runaway prices) and there are only a handful of manufacturers worldwide. That is the root of the problem, but not due to a lack of competition, but because of the primary way insulin makers compete on price. Instead of price transparency, they rely on secret deals and discounts are awarded through rebates offered to payers rather than reducing the prices up-front. They artificially raise the list price of insulin so they can give ever-bigger rebates to insurance companies who pay for most prescriptions.

The Rx rebates ARE the problem, and it's an enormous problem!

According to the June 29, 2020 report entitled "Diabetes Costs and Affordability in the United States" by the IQVIA Institute for Human Data Science (see https://www.iqvia.com/insights/the-iqvia-institute/reports/diabetes-costs-and-affordability-in-the-united-states for the free report if you provide an email address), invoice prices for diabetes medicines have been growing above the rate of inflation while "net" prices paid to the drug companies have been declining-to-flat for five years. Stated another way, "net" realized prices for insulin paid for by insurance companies after rebates have declined, yet patient out-of-pocket costs have increased dramatically. This dichotomy is explained by several important factors documented here.

Changes in Health Insurance Benefit Designs and High-Deductible Insurance Plans

The single most important factor behind dramatic price increases experienced by patients is changes in healthcare insurance benefit designs, most notably high-deductible insurance plans (HDIP). According to several reputable third-parties including the Commonwealth Fund, HDIP today account for more than half of all insurance benefits which Americans receive through their employers. The incidence of HDIP has increased steadily in recent years and now constitutes a majority of all healthcare plans in 2020. That explains why more Americans are acutely more sensitive to prescription drug prices than they were in the past.

Of course, the decision to charge insured patients the artificially-inflated wholesale acquisition cost (better known as a drug's "list price") for prescriptions including insulin depends on each particular insurance plan. But, when all is said and done, all of that money (and it's a LOT, noted below) is going someplace. I will map out exactly WHERE that money is going for consideration in policy changes needed for Congress. We know the amount of dollars involved, and we know where it is going. In 2018, we know that pharmaceutical manufacturers paid $166 billion in rebates and discounts. Certain essential drug categories including insulin sell at even deeper discounts

The image below appears to be one of the most accurate visual depictions of the U.S. insulin distribution and cash-flow published to-date. It is courtesy of the American Diabetes Association. There is, however, ONE missing component to this depiction which is critical and relevant: employers who actually play a role today. But the bottom line is that in virtually all cases, insurers (which includes entities like Medicare) control that cash-flow. 

Click on image to enlage
Click on image to enlarge

http://www.diabetesforecast.org/2016/mar-apr/images/insulin-costs-infographic.gif 
http://www.diabetesforecast.org/2016/mar-apr/rising-costs-insulin.html 

So, the most obvious question is WHERE are all those Billions of Rx rebate dollars going?

On March 4, 2020, insulin maker Sanofi revealed in a Wall Street Journal article entitled "Sanofi, Fighting Back in Insulin Price Debate, Says Its Net Prices Fell 11%" (see that article at https://www.wsj.com/articles/sanofi-fighting-back-in-insulin-price-debate-says-its-net-prices-fell-11-11583340721 for more detail) the amount of those rebates. The WSJ article revealed that because of the large and ever-growing rebates necessary to secure formulary placement in the U.S., and those insulin rebates amount to approximately 70% of the artificially-inflated list price for insulin which is rebated back to payers (in this case, meaning healthcare insurance companies who either own outright or else hire third-party pharmacy benefits managers known as "PBM's") as volume-based price concessions (e.g. a higher percentage rebate for more sales volume of a given Rx drug). Rival Novo Nordisk disclosed that it pays about 71% of the bogus list price (see slides #99 and #101) as Rx rebates paid to PBM"s (most of which are OWNED by the largest insurance companies). But it doesn't mean insurance companies are keeping those dollars. 

Unfortunately, determining the destination for all that money is no small undertaking thanks to a change to ordinary net cost accounting standards typically used in financial statements. About 25 years ago, the healthcare insurance industry lobbied the Financial Accounting Standards Board (FASB) for an exemption to normal net cost accounting standards for prescription drug rebates indirectly received from pharmaceutical manufacturers. 

Today, insurance companies erroneously misclassify this money as "general revenue" and do not itemize it as a specific line-item in their financial statements. This makes following the money difficult for even forensic accountants. At the time rebates first emerged, the dollars were not large and there were hundreds of insurance plans, but thanks to relentless mergers and acquisitions, today, only a handful of national healthcare insurance plans remain and the rebates themselves have ballooned into billions of dollars. Hence, although Rx rebates began innocently enough, over time, they ballooned into a massive dollar amount. That now needs serious reform.

Following the Money

But we now KNOW where those dollars are going. According to the Commonwealth Fund https://www.commonwealthfund.org/publications/issue-briefs/2019/mar/pharmacy-benefit-managers-practices-controversies-what-lies-ahead/, pharmacy benefit managers (PBM's) "report that in many of their contracts, 90% of rebates are passed on to health plans and payers." 

Beyond that, Adam Fein of the Drug Channels Institute and Pembroke Consulting cited reporting from the Pharmacy Benefit Management Institute (PBMI). The data in their reporting (see Adam Fein's posts HERE and HERE for details) suggest that employers admit that they are 'hoarding' Rx rebates rather than sharing the savings with the employees whose prescriptions generated the rebates. He specifically cites specific data reported by Bloomberg on Humalog insulin in the second post. I think its less of a conscious move, rather than a decision to ignore where the money is coming from.

In other words, its EMPLOYERS who are receiving most of the insulin rebate dollars. That’s why the omission in the ADA flow-chart above is so notable. Employers are justifiably happy to receive any offset to rising insurance premiums, hence many do not ponder WHO is bankrolling that. And, for the insurance companies, they are able to give premium offset discounts because it's not their money in the first place. That's great for insurance companies, but it is patients who end up paying for it. Not only are patients with diabetes paying more with high-deductibles, but they are also also subsidizing premiums paid by their employers!

Insurance plans could choose to use these Rx rebates to lower the costs of the sickest patients, whose frequent purchases of expensive drugs allow manufacturers to give rebates in the first place. Instead, health plans prefer to apply the rebates to the price of average plans, hoping to compete for new business through lower premiums paid for by patients with illnesses. 

FDA to Insurers: "You're Doing It Wrong!"

This is precisely why former commissioner of the U.S. Food and Drug Administration (FDA) Dr. Scott Gottlieb made headlines at a conference organized by the health insurance industry known as the National Health Policy Conference of AHIP on March 7, 2018 when he told the attendees (see https://cnb.cx/2y51uEb for details): 

"Sick people aren't supposed to be subsidizing the healthy. That's exactly the opposite of what most people thought they were buying when they bought into the notion of having insurance." 

And yet, that is exactly what is happening today. 

Aaron Kowalski, PhD, the CEO of the JDRF, wrote in a journal submission to the American Journal of Managed Care  (see https://www.ajmc.com/journals/evidence-based-diabetes-management/2019/september-2019/jdrfs-kowalski-sees-hope-in-bipartisan-support-for-insulin-pricing-reform):

"We see the issues related to the rebate system as being the biggest challenge for us right now. In a normal capital market where you have at least 3 similar products, as we do for most types of insulin, you’d see competition driving retail prices down. The rebate system lets the 3 insulin makers chase the prices up rather than chase them down. It hurts everyone, but it is extremely painful to people who are uninsured, who are underinsured, and who have high deductibles or copays."

Insulin Price Caps Work, But Don't Fix the Underlying Rebate Problem

Insulin price-caps have been debated by the legislatures in over a dozen states from blue to red, from Illinois and Oregon to Utah and Tennessee (catch my post on that HERE). A number have passed price caps into law, and more are doing so all the time. The reason is because it impacts millions of people, and it's a solution that works, although it does not really disrupt the system as it works today and that system is so dysfunctional and badly in need of reform.

The reason legislation that caps out-of-pocket spending on insulin works is because it forces healthcare plans to give patients the benefit of their realized lower "net" costs on prescription drugs such as insulin rather than passing that savings on to employers as premium offsets, which is what happens today. This observation is consistent with the fact that an out-of-pocket insulin cap had a negligible impact on overall healthcare insurance premiums in the State of Colorado (see an article at https://coloradosun.com/2019/09/11/colorado-insulin-price-insurance/).

But capping prices at a specific dollar amount isn't the best way to do it. Prices change over time, but legislation that caps prices at specific dollar amounts won't change. Instead, it should be capped at the "net" realized price attained by healthcare insurance plans licensed in a state.

I should also note that insulin price caps solves the problem for only ONE prescription drug (insulin is one of the most-heavily rebated drugs in existence, if not THE most heavily-rebated, so it's a useful place to start to help millions of people). But other prescriptions, including blood glucose testing supplies is excluded, so the problem continues unabated. Price caps are a Band-Aid applied to massive problem of prescription drug rebate reform which lawmakers are likely to face voter complaints for failure to fix a broader problem of runaway prices for prescription drugs. But the real solution is not necessarily price caps (there will be inevitable efforts to adjust the dollar amount of the cap over time), but prescription drug rebate reform.

Wednesday, September 23, 2020

More Games With U.S. Insulin Prices and Coupons (or why GoodRx works)

This week, I did something unplanned: I bought a vial of Lilly's "authorized generic" of its brand-name U-100 insulin analog usually branded as Humalog (insulin lispro rDNA origin) at my neighborhood Walgreens for just $68.38! The reason it was unplanned is because I already met the deductible for my insurance plan, so I hadn't expected to deal with this until it resets in January (maybe, I think my new plan covers it without having met the deductible but we'll see). But I had a script I last filled before I met the deductible, and the pharmacy sent a text telling me it was time to refill. In reality, I have insulin but its a different brand and a different pharmacy. But Walgreens wants a sale so it was telling me it is time to refill. I had a coupon to get it for a price comparable to what it sells for in Europe, Canada and elsewhere and I wanted to see if it really worked. It did!

According to insulin manufacturer Eli Lilly & Company, Inc. the price of its "authorized generic" of U-100 insulin lispro product is supposedly half-price of the "list price" for the branded version known as Humalog (U-100 insulin lispro rDNA origin). Both are made by Lilly. I bought it since I was able to get it for >$30 less than I had paid out-of-pocket last time (and that was a big discount without insurance), and I wanted to ensure I really could pay that price for insulin, and I discovered it worked!

According to the Lilly press release, the list price for a vial of the "authorized generic" version of Humalog is $137.35 per vial which it asserts is half-price. Back-of-the-envelope math means that the price for a vial of the brand-name version of the product known as Humalog should theoretically be $274.70 per vial. I don't know if that's truly the price, when I was paying for it out-of-pocket, I actually paid MORE than that amount, at least once. I now have a different insurance plan (its become an almost annual tradition, which means I've been covered by Aetna, Anthem, Cigna, Emblem Health, and United Healthcare over the past few years, and each time it means non-medical switching to whichever insulin brand pays the insurance company the most money in rebates). But that was WITH an insurance card. Truth be told, I stopped paying for insulin through insurance when I was paying my deductible because not only did my insurance give me less credit applied towards my deductible than I actually paid, but I also discovered that I could pay LESS for the product, too -- meaning only a fool pays that price. 

But it also raises big questions about what the real price for insulin sold in the U.S. actually is?

If you're paying out-of-pocket, the prices become even more obfuscated and they're already pretty hidden with insurance. That means either someone isn't being truthful, or even when patients are in deductible phase, many are actually being overcharged for the product. We know that most of that money is benefiting insurance plan sponsors (employers) who pay premiums for insurance plans. That's because most insurance plans pass 90% or  100% of Rx rebates they receive onto plan sponsors who take that money as an offset to premiums without considering who's actually bankrolling that. After all, its not THEIR money, so it costs insurance nothing to give it to employers in order to sell a new insurance policy.

In reality, $137.35 may not be quite a half-price for a vial of the brand-name product of Humalog insulin. Because no one ever discloses what the true price really is, so we're left to take the word of parties who have never been exactly truthful about prices. However, I discovered that with GoodRx, the price patients pay was $68.38/vial at my local Walgreens, which I think is actually about half-price. (Although rival Novo Nordisk has also promised a half-price version of its rapid-acting insulins, so far, their cheaper products are not yet widely available). The reason I think GoodRx's $68.38 is probably the true half-price is according to an article written by  Dr. Elisabeth Rosenthal (now the editor-in-chief at Kaiser Health News, and author of "An American Sickness: How Healthcare Became Big Business and How You Can Take it Back") when Lilly announced its half-price "authorized generic" earlier this year, she wrote "In Germany, the list price of a vial of Humalog is about $55 — or $45 if you buy 5 at a time — and that includes some taxes and markup fees." Therefore, Americans shouldn't feel grateful for $137 Insulin.

But in order for me to even get that price, I needed a coupon. As it turns out, there are a variety of different coupons available — you just need to know where to get them. The only thing is you cannot fill a script for Lilly's "authorized generic" of insulin lispro at a CVS Pharmacy because that company simply refuses to even carry it. The reason is because it makes too much money on the rebates paid on the brand-name product.

Fortunately, I asked my doctor to write the script for a vial of "insulin lispro" which I initially filled for with Sanofi's Humalog biosimilar known as Admelog (I went to Walgreens, not CVS because there's one closer to where I live, and in the midst of the Covid-19 pandemic in NYC, I could simply walk around the corner and wait in line for 3 hours) because I had a coupon to get it for $99.00 per vial, which was vastly cheaper than the alternatives (at least at the time; today there are alternatives). My experience with using Admelog was very good; I did not have to make any adjustments to insulin-to-carb or correction ratios, so in my opinion, that was as close to interchangeable as it comes. 

By comparison, with "therapeutically equivalent" products such as Novo Nordisk insulin aspart (branded as either Novolog or Fiasp) or Sanofi's Apridra (U-100 insulin glulisine rDNA origin), that never happens. It always requires me to test and test again to come up with brand new ratios. Of course, insurance never provides any additional test strips when doing a non-medical brand switch of this type, which they should. Plus the product never works quite the same as the one it replaces. The peak hits at different times, and the "tail" lasts for different durations. Today, my insurance only covers Novo Nordisk insulin varieties, so I've been using Fiasp. Fortunately, its a new plan which means insurance actually charges the copay amount to patients even still in deductible phase. They should be doing so; they are getting generous tax benefits from U.S. taxpayers via the IRS in order to do so.

Because my doctor wrote the script for "insulin lispro", I discovered Walgreens could fill my script with brand-name Lilly Humalog, Sanofi Admelog, or Lilly Lispro (the "authorized generic") and potentially others from companies like Mylan and co-development partner Biocon, as well as Novartis' Sandoz unit in the future — the difference is what price will be charged. With coupons, that's another layer to the murky price patients are charged. In the end, for this go-around, the pharmacist told me that with the coupon from GoodRx for the 'authorized' Lilly Lispro, I'd pay about $131.00 for 2 vials, which works out to be about $65.00/vial. GoodRx notes: "You may find that filling a 90-day supply will reduce your total cost for this prescription." But I bought just 1 for exactly $68.38 which was vastly different in price from what I would have paid without a coupon.

So, take your pick. But take my advice: don't dare pay full price for insulin if you can avoid it with an app like GoodRx. Almost no one does. Even if you're paying down towards a deductible, it will cost you less money to use one of the coupons than it will to buy it with insurance involved. Insurance only gives you credit for their deeply-discounted price applied towards your deductible amount. The only exception is when you're getting close to satisfying the deductible and need an insulin refill. That could push you towards satisfying the deductible amount (maybe).

For Sanofi's coupon, in order to get its $99.00/vial of Admelog (U-100 insulin lispro rDNA origin), you should visit https://www.admelog.com/savings. Unlike many bogus "patient assistance programs" which hardly anyone qualifies for, you can actually get this discount coupon today. 

But you'll be asked to answer a few 'eligibility' questions. Just be sure to answer those questions correctly, or they could respond by telling you that you're somehow ineligible for the discount coupon. Don't believe it. They will ask you to answer the following questions; I've provided the answers you must give in order to get the coupon.

1. Are you a current resident of the United States, Puerto Rico, Guam, or the U.S. Virgin Islands? Answer "Yes" to this question (side-note: if you lived in any other place on earth, you would be paying a fraction of what you do in the U.S. and territories!).

2. Are you a patient 18 years of age or older? Answer "Yes" to this question.

3. Do you currently receive Medicaid? Answer "No" to this question.

4. Are you currently serving in the U.S. military? Answer "No" to this question.

5. Do you qualify for Medicare? Answer "No" to this question.

6. Do you have commercial/private insurance? Answer "No" to this question.

7. Do any of the following apply: 

  • You are 65 years of age or older and neither you nor your spouse is working, 
  • You are receiving Social Security payments because of a disability,  
  • You have end-stage renal disease 

Again, you must answer "No" to this question. 

Questions about serving in the U.S. military, or whether you're eligible for Medicaid or Medicare are irrelevant and Sanofi isn't really entitled to know that. Whether you qualify for any of those government insurance plans is not relevant to how you are actually PAYING for their insulin. The reason is because you will not be not using any of those to actually FILL your prescription, hence you are paying out-of-pocket and are therefore entitled to the discount offered with the coupon. 

GoodRx is different, but you should know about it. It's free. The company is a Los Angeles-based (technically, its based in the beach town of Santa Monica, but its still Los Angeles County) and recently filed paperwork with the Securities and Exchange Commission (SEC) in anticipation of becoming a publicly-traded company. Adam Fein, a consultant who runs the Drug Channels Institute, which is a consulting firm which makes money by advising clients (either pharmacy chains, drug manufacturers or drug distribution system entitites like PBM's and drug wholesalers) to maximize their own profits from the dysfunctional U.S. prescription drug system (the word "system" is a misnomer, but whatever) recently addressed GoodRx in a blog post. 

Adam Fein likes to refer to himself as a doctor, and technically-speaking that's true. But he has a PhD, not an MD which is a bit of misrepresentation of his actual qualifications. Self-important people tend to do that. Adam never went to med school and he's never taken any medical boards. Instead, he's more of a bean counter for an obscure niche of the U.S. healthcare system. I worked for a mathematician with a PhD for years, but she never called herself a doctor even in proposals because she felt it was misleading and didn't want to have to explain the reality that she knew absolutely nothing about medicine, so she just used her name. But Adam thinks you'll be more impressed when he calls himself Dr. Adam J. Fein. I could care less; but I do think his explanation about how GoodRx works is useful background info. He wrote a post called "How GoodRx Profits from Our Broken Pharmacy Pricing System" (see https://www.drugchannels.net/2020/08/how-goodrx-profits-from-our-broken.html for more). 

He said: "The company [GoodRx] is insanely profitable. Its adjusted net income—earnings before interest, taxes, depreciation, and amortization (EBITDA)—is an astonishing 40%."

Fein summarizes the GoodRx revenue model as follows:

  1. Start with the pharmacy's bogus cash prescription price (YES, he used the word BOGUS, except its not bogus for many)
  2. Save money for consumers by providing easy access to a PBM's network rates (he adds: "GoodRx partners with multiple PBM's, including Express Scripts, OptumRx, MedImpact, and Navitus")
  3. Collect a portion of the fee that the pharmacy pays the PBM

He says "The GoodRx team has built and scaled a robust platform for monetizing the three steps above" adding "Think about it this way: GoodRx profits by helping consumers avoid the U.S. pharmacy industry's historical cash pricing models."

Fair enough. But the reality is that as long as the U.S. prescription drug market is so dysfunctional, it is up to the individual paying the bills to figure out how to help themselves navigate through it. For anyone trying to satisfy a healthcare insurance plan deductible, it means YOU are the one paying the bill for at least part of the year. And, because insulin happens to be one of the most heavily-rebated prescription medicines in existence, that means people with diabetes need to learn enough about it to avoid paying too much. As it turns out, Lilly's Insulin Lispro product can be attained at prices at least comparable to what people in places like Canada or Germany pay. 

Note that GoodRx also has a coupon for $71.72 at Walgreens for Novo Nordisk insulin aspart (which is the "authorized generic" version of Novolog). Its not quite as deeply-discounted as the "authorized generic" of Humalog is, but its a mere $3.34 more, so its only marginally more costly if you're a person who does better with Novo Nordisk's products rather than Lilly's. Note that there's no coupon for Fiasp. If you're struggling to pay for insulin, I'd say have your doctor prescribe insulin lispro because its cheaper, but I do think the coupons for either are a meaningful enough discount to help many patients as we head into the 2021 deductible reset.

Biosimilars are one option. Sanofi makes a version of Humalog and offers coupons to get that for $99.00/vial which isn't terrible. But GoodRx offers the so-called Lilly "Half-Priced" Humalog for $68.38, or the half-priced version of Novolog for $71.72. As of today, the Lilly version is the least-costly rapid-acting insulin analog GoodRx is offering at that price, but the prices are low enough to make a worthwhile difference as we head into 2021 and insurance deductibles reset. 

Long-acting insulin analog varieties such as Sanofi Lantus, or biosimilars of that known as Lilly Basaglar and Mylan and Biocon's Semglee seemed to be less-heavily discounted perhaps because it is so widely used by many patients with Type 2. That said, biosimilar copies of Lantus including Lilly's Basaglar or Semglee may offer coupons for even deeper discounts. In general, competition for the exact same insulin (for which, there are now at least 3 brands) tends to result in greater discounting.

Even amongst those, a seach for Semglee revealed GoodRx had coupons for a vial of that sold for $105.71 at several different pharmacies (not quite as discounted as the authorized generic version of Lilly Insulin Lispro, but most patients don't use as much basal insulin as they do insulin for bolus coverage of meals and corrections. By comparison, Lantus and Basaglar did not seem to offer as generous discount coupons at GoodRx (although the websites of those insulin brands may offer coupons). But that insulin is the one that will have the most biosimilar versions. There are currently two, but we know of at least two more in development from Sandoz and Lannett in the works. Typically, the more versions of the same product which exist, discounts and coupons are the way that competition manifests itself in the market.

Note that GoodRx has different coupons for use at different pharmacies in your geographic area and on different prescription drugs. I say lowest price wins, but I'll leave that decision up to you. It has a mobile app you can use in-store.