Wednesday, July 14, 2021

Making Sense of the Novo Nordisk-Walmart Partnership to Sell Some Discounted Insulin Analogues

On June 29, 2021, Walmart Inc. and the American business unit of Novo Nordisk A/S (which is based just outside of Princeton, New Jersey known as Novo Nordisk Inc.) dropped what was intended to be a news bombshell coming just as the ADA Scientific Sessions was coming to a close. 

In fact, the insulin makers had hardly any big news coming from the ADA Scientific Sessions themselves this year or for the past several years (about the biggest news was from 2018 when, Novo Nordisk acquired a UK-based company known as Ziylo to use its technology to try and develop glucose-responsive insulin, but that still has a long while before it is ready for commercialization ... if ever), because most have shifted R&D towards GLP-1 inhibitors for T2D, and regularly get assaulted over runaway prices, so why not make some headlines by doing something intended to capture press attention of a captive audience?!





In essence, the pharmacies in Walmart's retail stores will start selling a version of Novo Nordisk's slightly older (and now out-of-patent, more on that in a minute) rapid-acting insulin analogue branded as Novolog which they will call Relion Novolog in the U.S. for $72.88 per vial and the company's 5-pack of insulin pens branded as FlexPens for $85.88. See the press release from Walmart HERE https://www.businesswire.com/news/home/20210629005683/en/Walmart-Revolutionizes-Insulin-Access-Affordability-for-Patients-With-Diabetes-With-the-Launch-of-the-First-and-Only-Private-Brand-Analog-Insulin for details). 


In Walmart's press release, the company boasted that this would be the "first-ever private branded analogue insulin", which it also claimed would "revolutionize the access and affordability to diabetes care" by offering customers a significant price savings without compromising quality. The product will be called ReliOn Novolog vials and FlexPens.

Dr. Cheryl Pegus, Walmart's EVP of health and wellness said that at least 3 million Walmart customers have diabetes. "This price point we hope will improve, and hopefully revolutionize the accessibility and affordability of insulin," Pegus said in a press call.

"We know many people with diabetes struggle to manage the financial burden of this condition, and we are focused on helping by providing affordable solutions. We also know this is a condition that disproportionately impacts underserved populations. With ReliOn Novolog insulin, we're adding a high-quality medication for diabetes to the already affordable ReliOn line of products and continuing our commitment to improve access and lowering cost of care," Dr. Pegus said in the announcement.



Behind the scenes, however, U.S. patients quickly started questioning the so-called Walmart "Always Low Prices" assertion on insulin. In fact, Walmart abandoned that old but well-known slogan after 19 years for a far less-memorable one with simply "Save money. Live better," back in 2007.

Walmart insulin has long been a go-to response from people who are clueless just how much U.S. insulin list prices have increased over the past decade and don't really care but they want to sound semi-informed and empathetic. 

Depending upon the insulin variety and the time period examined, we can safely say that the retail list prices for rapid-acting insulin analogues have increased by more than 1000% (that's over one thousand percent) since being introduced. The following charts were courtesy of articles published in Business Insider.










Faced with an upcoming election year imperative which it had basically done nothing about for several years when former Lilly exec Alex Azar ran the U.S. Department of Health and Human Services, the Trump Administration did try several things (some of which sounded positive) to live up to his promise to bring the cost of insulin way down. Most efforts resulted in lawsuits from PhRMA, but one was achieved: on July 17, 2019, the IRS expanded its list of preventive care benefits that may be provided by high-deductible health plans (HDHP) paid for without having satisfied a deductible, and that list now includes diabetes treatments (which were previously omitted). The IRS rules also apply to healthcare savings accounts. Unfortunately for the Trump administration, the impact did not happen quickly enough to save his presidency. 

Because each company has a different healthcare insurance plan year "start dates", hardly anyone enjoyed the benefit of a change which I argued insulin makers should have taken years earlier but had failed to do so. However, now that the rule has been in place for a few years, more and more patients are starting to realize the benefit of pre-deductible insulin coverage, and more will continue to do so when their employer healthcare plans are renewed or sign up with a new insurer.

Anyway, the Walmart ReliOn Novolog intro sounded oddly suspicious because Walmart has been known to switch its "house-brand" to Lilly-made insulins in the past. Most recently, in June 2010, it switched house-brands of insulin from Novo Nordisk to Lilly (see https://www.biospace.com/article/releases/wal-mart-changes-insulin-partner-to-eli-lilly-and-company-/ for a memory refresh if you don't remember that temporary switch to Lilly insulin), plus the markdowns weren't nearly as deep as Novo Nordisk admits it now pays in rebates to U.S. pharmacy benefits managers ("PBM's") to secure commercial healthcare insurance company formulary placement, so the Walmart move may help some, but certainly not all.

Insulin Prices 75% Off












In Novo Nordisk's recent investor presentations over the past year or so, the company has finally started to reveal to investors exactly how much money (as a percentage of gross sales) it spends on prescription drug rebates paid to PBM's, perhaps because investors seem to ask the company about it every single time the company releases its quarterly earnings. It is a LOT of money!

Previously, rebates were considered a fiercely-guarded "trade secret", but following Novo Nordisk's financial meltdown in 2016, when former CEO Lars Rebien Sørensen uncharacteristically announced he was "retiring early" (something which almost never happens in Denmark), followed by a stream of investor lawsuits because investors felt the company had misled them on the magnitude of the company's U.S. rebate problems, the company has started to reveal its exposure to Rx rebates in the U.S.

In Novo Nordisk's third quarterly investor presentation of 2020, the company revealed that 71% of the company's gross U.S. sales were going out the window to PBM's in the form of rebates paid to PBM's. By the time the company had released its Q4 2020 earnings, in its presentation, Novo Nordisk disclosed that Rx rebates had increased to 74% of gross U.S. sales - a quarter-over-quarter increase of 3%. The following image is from slide #103 of the Novo Nordisk A/S Q4 2020 investor presentation. Note the figure in the last quarter in the graph on the right side in which the 2020 data point was revealed to be 74%):

That's absolutely bonkers. 

Novo Nordisk tends to remove its quarterly investor presentations from the company website over time, but archived copies are still accessible via SeekingAlpha.com, visit Novo Nordisk A/S Earnings Presentation Slides (specifically, see slide #103) archived at https://seekingalpha.com/article/4403040-novo-nordisk-s-2020-q4-results-earnings-call-presentation for the reveal.

So the Rx rebate monster is alive and well, and Novo Nordisk decided to copy rival Lilly's move to sell what it refers to as an "Unbranded Biologic". As it turned out, half-price wasn't really the price, its actually a fair amount less. 



Savvy consumers quickly discovered they could get readily-available GoodRx coupons online (or on their smartphone app) which actually made the out-of-pocket expense for a vial of the unbranded biologic of Novo Nordisk U100 Insulin Aspart to be about 75% off the suggested retail price of brand-name Novolog when purchased at Walgreens. For that reason, the pharmaceutical industry's baseless claim that slashing prices by 90% would kill their businesses and R&D is revealed to be just a falsehood. In fact, they are already marking prices down by at least 75% on insulin with zero impact to their own bottom lines. 

Voila! 75% off -- instantly. No strings attached. No enrollment required. No providing the company with personal information.

The good news for patients is that the "authorized generics" (or as Novo Nordisk calls them "unbranded biologics") versions have brought much-needed affordability to insulin that now looks comparable to what the rest of the world pays for rapid-acting insulin analogues. With discount coupons, the price is about $55/vial, which is about the same amount they pay for a vial of Novolog in Germany (or Novorapid as its called in that country). Still, basal insulin analogues are not quite as affordable ... yet ... but we know with certainty that there are at least 3 copies of insulin glargine working their way through the FDA approval process. 

Add to that a Lilly copy branded as Basaglar and another called Semglee from Viatris, and there are several. But Sanofi's (now EuroAPI's) aggressive discounting of brand-name Lantus with coupons and back-door discounts, means that Lantus remains the undisputed king of basal insulin varieties in spite of repeated efforts from Novo Nordisk to develop newer basal analogues. So far, commercial healthcare insurance company payers are balking at paying Novo Nordisk any kind of premium price for the company's newest "Lantus killer" known as Tresiba (insulin degludec rDNA origin). Insurance is happy to take Lantus rebates at the expense of Tresiba.

For its part, Novo Nordisk's current CEO Lars Fruergaard Jørgensen and the company he leads has basically said that while Novo Nordisk expects to maintain its global leadership in the insulin market, most of the company's revenue growth has been derived from GLP-1 agonist products used in the treatment of some patients with Type 2 diabetes while the company continues to make minor improvements to those to extend the company's patent exclusivity. The company also acquired an FDA-label extension for its Victoza to be used as a weight-loss drug. But the company's big profit driver is now clearly Type 2 diabetes meds, not insulin which is the only FDA-approved treatment for autoimmune Type 1 diabetes (T1D) whose lives depend upon exogenous insulin. In fact, the company made a rare acquisition when it acquired Ziylo to help it with glucose-responsive insulin, if that makes it thru clinical trials successfully which remains a big IF.

Longtime Business Strategy: "Retire" Old Insulin Varieties and FORCE Patients to Use Newer Patent-Protected Insulins

For their part, both Novo Nordisk and Lilly have resurrected a very old playbook by planning to "retire" their now out-of-patent rapid-acting insulin analogues with new & improved versions which remain patent protected. 

Over my 46 years living with T1D, they've done it to me 3 times where they simply stopped making the insulin I prefer using. First I used the Lilly Iletin Lente series (there were three of them: Semilente, Lente, and Ultralente). That worked reasonably well for my needs. But then Lilly partnered with startup Genentech to introduce synthetic insulins no one really wanted or needed because they did not offer superior glycemic control and had a higher price tag to boot. So Lilly simply stopped making the older products and forced patients to use the new Humulin products which no one was asking for. At that point, I switched from Iletin Lente (L) to Humulin L. That worked no better, and I stopped having signs of impending hypoglycemia which the company worked to discredit in spite of cases being documented globally. But then, a few years later, Lilly stopped making the entire Lente series of Humulin insulins.

Generally speaking, that's been a recurring pattern. 

First, they retired U-40 versions and forced patients to adopt U-100 versions instead. That also meant getting new syringes. Then they dropped insulin varieties sourced from abbatoir animal sources. With that retirement, at least the same insulin varieties were offered. But the Lente series required them to make Semilente and Ultralente and mix them to create Lente. That was the first old-school product to get the axe. But it had a newer, patent-protected version it called Humalog (U100 insulin lispro rDNA origin) to replace it. That was the first truly lab-invented insulin which supposedly delivered superior glycemic control ... for a higher price, naturally.

In 2017, Novo Nordisk got FDA approval for a marginally-faster version of its insulin workhorse Novolog. It is a slightly faster version of insulin aspart, so it gave the new product the name "Fiasp" which means Faster insulin aspart. Rival Lilly followed suit when a faster version of its bestselling Humalog was FDA-approved on June 15, 2020. Lilly branded that as Lyumjev (insulin lispro-aabc rDNA origin), but it acts much like Novo Nordisk's Fiasp does, and Lilly's patent expires 3 years after Novo Nordisk's patents on Fiasp expire. 

Back to the Walmart Relion Novolog analog intro. 

One reason the Walmart announcement wasn't quite the ray of hope some expected was because a subsidiary of the U.S. business unit for Novo Nordisk called Novo Nordisk Pharma Inc. https://www.nnpi.com/ copied its rival Eli Lilly & Company, Inc. also introduced "authorized generic" insulins called U100 Novo Nordisk Insulin Aspart back in 2020. After rival Lilly did so, we discovered that CVS Health, owner of the large Caremark PBM business and also owner of commercial healthcare insurance company Aetna, refused to carry the less costly product in its pharmacies because it wanted jumbo insulin rebates from Lilly and Novo Nordisk on brand-name insulin varieties rather than carrying the less heavily rebated (and cheaper) insulin varieties which would deliver important, more affordable access for patients. But rival Walgreens DID carry the less heavily-rebated product. They may need to order it, but a pharmacist can handle that for patients.

Recall that Eli Lilly announced on March 4, 2019 its plan to sell what the press called a "half-priced" version of its own Humalog merchandised by its ImClone Systems Inc. subsidiary which the company had acquired in 2008. The press release for the Lilly announcement can be read HERE. Lilly dubbed its "authrorized generic" U100 Lilly Insulin Lispro. The effort was a means to try and bypass the pharmacy benefits manager (PBM) mess which demand ever-higher "rebates" from pharmaceutical companies, and artificially bloat the list price cost of prescription drugs for many consumers at the pharmacy checkout counter.

After Lilly's move, Novo Nordisk determined that Lilly's idea was an effective one on the affordability front, so on September 6, 2019 (see the company's press release HERE), it too promised to (just as Lilly was already doing as part of the company's affordability options) to launch its own "authorized generic" version of Novolog. Just as U100 Lilly Insulin Lispro faced some struggles persuading some big drugstore chains like CVS to even carry it because they are financially addicted to Rx rebate dollars, Novo Nordisk U100 Insulin Aspart can't be purchased at all pharmacies (but as noted, big pharmacy rival Walgreens carries it).

As I've revealed in several recent posts over the past year (look to the archives), the presence of coupon-generating websites/apps like GoodRx have started to change the rules. Insurance plans haven't quite figured that out yet. 

But many patients find it is still cheaper to use GoodRx coupons while they're satisfying a deductible because they can take advantage of discounted, PBM-negotiated prices on prescriptions by paying cash. Even though it contributes nothing to their deductibles, the reality is that insurance companies only credit patients 25% of the bloated price they pay for insulin, which means it makes more sense financially to simply bypass insurance until their deductibles are satisfied. People with diabetes usually satisfy deductibles about halfway through the year given the costly insulin, glucose meters, CGM sensors, as well as quarterly appointments with their endocrinologists or family doctor which means they satisfy deductibles more quickly than many others.

New & Improved Means Patent Exclusivity for Pharma. Superior Glycemic Control? Yeah, That Too.

Consider these images which come from a presentation I gave in autumn 2020 (see my post about and and the entire presentation HERE) which I believe says more than 1000 words can: 

As noted, Novo Nordisk and Lilly each now have "new & improved" rapid-acting insulin analogues which they will focus on trying to switch patients over to because those products still enjoy years of patent exclusivity on the market. If you think about the recent Walmart announcement with Novo Nordisk, it makes perfect sense. 

Novo Nordisk already has a pretty large inventory of Novolog and we know there are several biosimilars in the works, including from both Viatris/Biocon, and Lannett/HEC. A third may be in the works from Novartis-Sandoz/Gan & Lee, although the latter seems spooked by the rebate problem in the U.S., so we haven't seen or heard much from that partnership. Of note: all of those involve a U.S. business handling FDA applications and approvals, while the products are manufactured in Asia and shipped across the Pacific Ocean via the Port of Los Angeles. Viatris/Biocon has a massive insulin factory in Malaysia, while Lannett is partnering with China-based HEC which already makes Lantus and Novolog biosimilars being sold in China. 

Perhaps you can imagine Novo Nordisk's dilemma. 

It has a massive inventory of a now-old product (Novolog) which is likely to face a number of biosimilar copies in the the next few years. It already has several copies from rivals sold in Europe, although the U.S. is traditionally the company's cash-cow. Cutting a deal with Walmart might offer it a solution to sell its existing Novolog inventory. The price isn't marked-down quite as much as rebates require, so it looks like its a benevolent company partnering with Walmart which is known for lower prices, and it has national distribution. And, if the price is still too high, Walmart can always sell it for even less.

Sounds like a win for Novo Nordisk. But Walmart appears to benefit less. Unless Novo Nordisk happens to pay Walmart some kind of rebate. Instead of reducing prices for consumers, Walmart might keep the rebate dollars. But if sales aren't great, Walmart can always reduce prices on the product even further.

Biosimilars have not materially reduced prices for insulin in the U.S., but the data suggest that once there are several of each biosimilar on the market, prices do tend to fall. Currently, only Lantus (U100 insulin glargine rDNA origin) has more than one biosimilar on the market. There's a Lilly copy called Basaglar and another one from Viatris/Biocon called Semglee. Sanofi also makes a version of Novolog sold in Europe, but has said it won't bother selling one in the U.S. because sales for its Admelog biosim have been falling. In response, Sanofi (to be called Euro API soon) has aggressively slashed prices of original Lantus to keep market share, so both biosimilars have struggled thanks to the "rebate wall" which harms biosimilars.

Fiasp will replace Novolog (Fiasp stands for Faster insulin aspart), while Lyumjev will replace Humalog. Its only a matter of when, likely not IF that happens. Over my 46 years of living with T1D, I've had countless insulin varieties "retired" and removed from the market on me. First, it was Lilly's Iletin. I hated the biosynthetic varieties, which delivered no meaningful clinical benefit in terms of glycemic control, but it caused me hypoglycemia unawareness, plus it raised the prices, too. Some benefit! But retiring the old product was the way the companies forced people to switch from Iletin to Humulin, which hardly anyone wanted to do. 

Of rapid-acting analogue insulins, so far only Humalog has a rival on the U.S. market which is made by Sanofi (soon to be known as Euro API) branded as Admelog. I've tried it and it works as well as Humalog and it is somewhat cheaper with a coupon from Sanofi (catch my post HERE). However, sales of Admelog have been steadily falling. Part of the reason is because parent company Sanofi was more concerned about spinning the company off as a stand-alone company to even worry about it, so insulin product managers lacked resources to effectively address it, but once the spin-off happens, maybe things will change. 

Side note: At the recent ADA Scientific Sessions, another French biotech company called Adocia released news that it will soon trial an improvement to rapid-acting insulin analogues by including an analogue of amylin to those insulins (see the press release HERE for detail). That's a conversation for another day, but its worth noting because a stand-alone (its approved only as an adjunctive treatment to insulin) amylin analog treatment called Symlin already exists, this is the first to add it back into insulin since manufacturers started removing it from insulin years ago. That company (Adocia) said: "In Type 1 diabetes, ultimately, neither insulin nor amylin are secreted (and GLP-1 secretion is deficient). It is therefore possible that the use of insulin alone cannot address all the metabolic deficiencies related to [Type 1] diabetes." If I had to guess, I'd say that Sanofi/EuroAPI could offer "new & improved" biosimilars of lispro and aspart by adding things like amylin to the boiosimilars thanks to research done by a different France-based biotech firm (they'd have to sign a partnership first, so we can look for something like that). That would yield not only improved glycemic control, but would also offer the benefit of longer patent windows for a company whose insulin business has been struggling.

Perhaps that can be something Euro API will investigate to turn its struggling commodity insulin business around? 

Who knows, but its certainly the type of thing which might help the company which has arguably become a one-trick pony in the insulin biz, relying on Lantus for virtually all of its insulin revenues in the U.S.

But Walmart's Novo Nordisk Novolog deal is yet another crack in the rebate wall fortress (and one which is long overdue). Whether its enough to knock the proverbial rebate wall down completely remains to be seen. 

Adam Fein, CEO of the Drug Channels Institute eloquently summarized the utter stupidity of U.S. prescription drug pricing (see his post at https://www.drugchannels.net/2021/03/how-goodrxs-rapid-growth-creates.html for details) this way:

"Pharmacy pricing and benefit design are fundamentally broken. Three out of four consumers who used GoodRx already had commercial, Medicare, or Medicaid insurance. 

This means that someone — the consumer, their employer, and/or the government — paid insurance premiums for a pharmacy benefit managed by a PBM. Yet it was still worthwhile for people to bypass their [own healthcare insurance] plan's out-of-pocket costs and PBM network rates in favor of a different PBM's rates [offered thru GoodRx].

Discount cards such as GoodRx save consumers money by leveraging the craziness baked into the U.S. pharmacy pricing, reimbursement, and dispensing system. It's hard not to dislike a system that enables these games."

"Craziness" is describing the situation kindly from a man whose very business is as a consultant is to help paying clients (pharma, drug wholesalers, pharmacy benefits managers, insurance company formulary managers, and pharmacy retailers) to navigate a dysfunctional U.S. "drug channels" system and maximize their own benefits from it. 

I'm more blunt about it: it is completely stupid, and no other country in the world does it the American way because it costs SOOOOO much more money. So yeah, it is incredibly stupid. It is a way to piss away nearly $200 billion/year kind of stupid.

Patients should still shop around for the best deal on insulin aspart (especially if they still have a deductible to satisfy or they are uninsured). Also, there are several U100 insulin aspart biosimilars in development right now (which explains Novo Nordisk's imperative to "retire" it) from Viatris (formerly known as Mylan)/Biocon and Lannett Company/HEC. Others could be in the works from Novartis' Sandoz unit/Gan & Lee (which was announced with some fanfare back in 2018). 

Just remember: GoodRx coupons may likely enable you to buy insulin aspart (made by Novo Nordisk) for even less than Walmart is currently selling it. I have yet to determine if GoodRx coupons can be used at Walmart to buy Relion Novolog insulin, which might mean the prices are even lower. For me personally, I refuse to pay for Novo Nordisk insulins if I don't have to because they just aren't as effective for me, but currently, GoodRx coupons redeemable at Walgreens pharmacies nationwide are selling vials of Novo Nordisk U100 Insulin Aspart for $52.78. GoodRx offers coupons for vials of Lilly U100 Insulin Lispro purchased at Walgreens for $48.07/vial.







Pharma created this stupid situation, and pharma has an obligation to fix it without the help of government. 

For once, we can honestly say that government did nothing to create the situation we now find ourselves in because the prevailing decades-long U.S. policy has been laissez-faire when it came to drug prices. Pharma lobbied for that, and pharma got exactly what it wanted. Now, insurance companies are bigger than drug companies are, and they are more powerful than drug companies, and suddenly, pharma is crying for Washington politicians to help save them from the rebate system they created and continue to perpetuate. 

Ignore them. 

They lie when they say a 90% price slashing will hurt R&D (we know with certainty they are already slashing insulin prices by 75%); what it will do is force pharma to buy back less of their own stock and pay senior executives less in bonuses.

It's just another day in the insane U.S. insulin market. 

Remember: I called it stupid for a genuine reason. 

But patients/consumers shouldn't have to pay for stupid. If price controls are what fixes it, pharma deserves to have price controls imposed upon them. 

Patients already have enough scars from a completely stupid and dysfunctional Rx market.

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 Type 1 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 intellectual property 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 (and the Libre 14-Day system which works with smartphones) 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. Abbott claims the Freestyle Libre system is priced at 70% below the list price of other CGM systems. 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 this one appears to enable the batteries to reportedly be changed by the patient, so I think its 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!