Thursday, June 30, 2022

Sanofi Joins The Ranks of $35/vial Insulin, Adds New Unbranded Insulin to Product Lineup

Yesterday, Sanofi U.S. made an announcement: Effective on July 1, 2022, the company will lower out-of-pocket cost of insulin for uninsured patients and expand access in underserved communities (in reality, the lower prices are available to anyone including those who have insurance deductibles to satisfy or if they're covered by Medicare as long as the insulin purchases are not submitted as insurance or Medicare claims; users must pay cash). The press release can be viewed at https://www.news.sanofi.us/2022-06-29-Sanofi-to-lower-out-of-pocket-cost-of-insulin-for-uninsured-patients-and-expand-access-in-underserved-communities.

Sanofi has been a laggard relative to its rivals Lilly and Novo Nordisk. For example, in 2019, both Lilly and Novo Nordisk each announced plans to introduce lower-priced "unbranded" prandial insulin analogue products which are not impacted by PBM rebating. Those efforts have been generally successful in ensuring more widespread affordability (prices are artificially-inflated due to the manner in which pharma commercializes drugs; relying on Pharmacy Benefit Managers ["PBM's"] to secure an exclusive therapeutic class position on drug formularies). 

The U.S. FTC recently announced a new policy whereby PBM's and the drug companies which pay legally-exempted kickbacks in the form of "rebates" for exclusive formulary placement may be in violation of several laws, including Section 5 of the FTC Act, Section 3 of the Clayton Act, Section 2 of the Robinson-Patman Act, and the Sherman Act to name several (see the new policy statement at https://www.ftc.gov/system/files/ftc_gov/pdf/Policy%20Statement%20of%20the%20Federal%20Trade%20Commission%20on%20Rebates%20and%20Fees%20in%20Exchange%20for%20Excluding%20Lower-Cost%20Drug%20Products.near%20final.pdf for details).

Regardless of what the FTC may or may not do, since launching in 2020, unbranded insulin now accounts for nearly 1/3 of Lilly's U.S. Humalog sales. Lilly continues to commercialize its newer, still patent-protected, slightly faster prandial analogue branded Lyumjev (as does rival Novo Nordisk with Fiasp). However, Lilly no longer sees paying PBM's legally-exempted kickbacks in the form of multi-billion dollar rebates as a competitive necessity to maintain sales of an insulin which has now lost patent exclusivity. 

Lilly found that it was cheaper for the company to simply cut prices on the unbranded insulin to a price of $35/vial with a manufacturer coupon from https://www.insulinaffordability.com/ than it was to increase multi-billion dollar bribes paid to PBM's needed to secure formulary placement. Rival Novo Nordisk is addicted to PBM rebates which is eating into the company's insulin margins forcing it to pursue the GLP-1 market for T2D for most of its profits. It has made no price reductions for Novo Nordisk Insulin Aspart (yet). But, I'm betting the company will simply "retire" Novolog instead. Still, none of the big insulin-makers have reduced insulin prices to $30/vial (which they could; the patents on these insulin analogues have all expired) which is why the March 3, 2022 Civica biosimilar announcement will undoubtedly add competitive pressures to reduce prices by another $5/vial.
 

U.S. sales of Sanofi insulins have been declining. In late 2021, Sanofi's bestselling basal insulin analogue branded Lantus was dropped from several big PBM formularies, including both Express Scripts and Prime Therapeutics who both dropped Lantus in favor of Biocon's interchangeable glargine product branded as Semglee which is commercialized by Viatris (for the time-being anyway; Biocon recently acquired that company's share of their joint venture, with access to key staff for a period of 2 years following the closure of that acquisition). The company also sells a separate unbranded glargine biosimilar known (for the time being, at least) as simply Viatris U-100 Insulin Glargine also exists with a lower list price but the price is still quite high, although price comparison sites do not typically include the unbranded product in their searches. Still, the list price is 65% LOWER than the identical, branded product sold as Semglee.

Anyway, Sanofi's Lantus being dropped from two key formularies has cut very deeply into Sanofi's U.S. insulin sales. A complicated spinoff for insulin and other active pharmaceutical ingredients to a new stand-alone company known as Euro API recently occurred; although for the time being, the nuts-and-bolts distribution of its insulin still remains with Sanofi. Still, Sanofi's ValYOU coupons aimed mainly at the uninsured market (but available to ANYONE) have been caught in a time-warp with prices fixed at $99/vial while its biggest rivals now have products selling for as little as $35/vial. This is especially notable for Sanofi's prandial insulins (including its proprietary but now out-of-patent Apidra and its biosimilar of Lilly Humalog branded as Admelog). Sanofi has been mainly focused on Lantus, letting those other products fall by the wayside in terms of sales.

As part of this initiative, Sanofi will also introduce an "unbranded" basal insulin analogue which will be called simply Sanofi U-100 Insulin Glargine Injection. The FDA-mandated disclosure insert in the unbranded insulin glargine product discloses the new product is from Winthrop US, which is a separate business unit dedicated to commercializing "authorized generic" products (the FDA defines an "authorized generic" as exactly the same product as an approved branded drug, but is marketed without the brand-name on the label), not too dissimilar to rival's Novo Nordisk Pharma Inc. which commercializes that company's unbranded insulins.

Since Lilly introduced its unbranded insulin lispro in late 2019, it has revealed to company investors that its unbranded insulin called simply Lilly U-100 Insulin Lispro Injection now accounts for nearly 1/3 of the company's U.S. Humalog sales (and that shift has occurred in less than 3 years on the market). In fact, that shift required virtually no marketing, no army of salesmen/saleswomen calling on doctors offices and no costly TV ads. I also estimate that Novo Nordisk's Insulin Aspart Injection likely accounts for about 20% of that company's U.S. Novolog sales because it is 20% more expensive than Lilly's unbranded insulin sells for.

Critics say the big insulin companies' commitment to unbranded insulins are only half-hearted and questionable at best, and appear to be more of a PR move aimed at deflecting criticism away from their role, rather than a core underlying business strategy. For example, none of their newest prandial insulin analogues have unbranded versions, nor do any of their basal insulin analogues (until now, anyway). Therefore, it is perhaps unsurprising that Sanofi's first (and so far, only) unbranded insulin product will only be for insulin glargine.

Regardless, with the new announcement, Sanofi's under-utilized proprietary prandial analogue branded as Apidra (U-100 insulin glulisine rDNA origin) which very recently lost patent exclusivity) will NOT have an unbranded version, although I believe the ValYOU coupons will still work on it. 


 


 

Starting July 1, 2022, the Sanofi ValYOU https://www.teamingupfordiabetes.com/sanofidiabetes-savings-program manufacturer coupons will enable patients to purchase Sanofi insulin products at a cost of just $35/vial.

As a point of comparison, the lowest price for a branded biosimilar version of glargine known as Semglee can be purchased today from Express Scripts Cash-Pay Mail Order Pharmacy by InsideRx for $86.79/vial, which considerably more expensive than Lilly Insulin Lispro sells for with a manufacturer coupon at just $35/vial. But the Sanofi announcement will now put more much-needed downward pressure on rival glargine prices whose prices have remained stubbornly-inflated when compared to prandial insulin varieties.

Not ironically, as I have covered in several recent posts this year, on March 3, 2022, nonprofit drug-maker Civica, Inc. announced its intention to commercialize three insulin biosimilars, including one of U-100 glargine for a price of just $30/vial possibly as early as 2024 (assuming it encounters no regulatory delays) promises competitive pressure on big insulin to reduce their prices even further.

The Sanofi move is certainly a step in the right direction after years of doing next to nothing, although it still leaves many unanswered questions about big insulin-makers' long-term commitments to unbranded insulin strategies, and also why their price reductions are only to $35/vial rather than $30/vial?

Still, the price reductions are welcome news for U.S. patients. It will put immediate downward pressure on the prices for Lantus and biosimilars of that product.

Thursday, June 23, 2022

PBM Trade Group "A Summary of Insulin Coverage in Medicare Part D" Study from Milliman, Inc. Health

The PBM trade group known as the Pharmaceutical Care Management Association (PCMA) recently commissioned Milliman Health to conduct a study of Medicare beneficiaries enrolled in a Part D Plan to determine if they "prefer" brand-name basal insulins over the biosimilar Semglee which is made by Biocon (currently commercialized by Viatris, although Biocon recently announced it was acquiring Viatris half of their joint venture). 

In reality, it is little more than smoke and mirrors from a PBM trade group.

The reason PCMA commissioned the study was to try and generate "evidence" that patients somehow prefer costly, heavily-rebated branded insulins over biosimilars. The study can be seen at https://www.pcmanet.org/wp-content/uploads/2022/06/6-7-22-Insulin-Landscape-Summary-report.pdf

If you visit slide #7 (the one which addresses "Long-Acting Insulin"), that addresses the reality that many Medicare Part D plan members are covered by a plan which now "prefers" Biocon's Semglee over Sanofi's Lantus. Cigna's Express Scripts last year dropped Sanofi Lantus in favor of Semglee (likewise, the PBM known as Prime Therapeutics also preferred Semglee, although Prime relies upon Express Scripts for price negotiations and retail pharmacy coverage). So far, there are a handful of basal glargine biosimilars including Semglee, another unbranded version called Viatris U-100 Insulin Glargine, as well as two made by Lilly including Basaglar and another which will be branded as Rezvoglar which was approved under a new FDA procedure specifically for biosimimilars (Basaglar was approved under the old FDA approval method as a "follow-on" biologic).

But this study was more an exercise in trying to prove the value PBM's say they deliver, rather than compelling, methodologically-sound market research.

I would dare say that the reality is that what Medicare Part D beneficiaries want most is for their Part D plans to share the financial benefit of any savings the plan generates by choosing lower-cost biosimilars, rather than making them pay costs which are comparable to the brand-name innovator product for a biosimilar drug (in this case, Sanofi [soon to be known as Euro API] Lantus).

In the end, the research does not actually prove much of anything. If Part D beneficiaries received Semglee at a price of $60/vial, they might find that "preferable" to Lantus. Instead, Express Scripts is charging patients anywhere from $162.11/vial to $194.82/vial for branded Lantus (although with a ValYOU coupon from Sanofi they can buy it for a price of $99/vial), while Semglee can be purchased for a price ranging from $67.94/vial to $85.75/vial.

The basal insulin market is even more distorted price-wise than the prandial insulin market is if you can believe it. Its therefore unsurprising that Civica (which plans to introduce a biosimilar of glargine first) at a price of just $30/vial or $55 for a box of 5 insulin pens will aim to disrupt the basal insulin market first.

Friday, June 10, 2022

How the Civica Insulin Announcement Could Be Disruptive to the PBM Kickback Scheme

Yours truly has written an article. I have given some more serious thought to the Civica insulin announcement made on March 3, 2022 (my article has a link to the original press release) and I think it could be very disruptive to what I have dubbed the "PBM Kickback Scheme". You can read my assessment below, or at https://www.slideshare.net/ScottStrumello/civica-insulin-assessment.


Ironically, this month's New England Journal of Medicine also has a very interesting (and similar) analysis of the exact same topic (the Civica insulin announcement) in its "Perspective" section in an article entitled "A Radical Treatment for Insulin Pricing" (the link to the article can be found at https://www.nejm.org/doi/full/10.1056/NEJMp2203001, although I'm not sure you can buy per-article access to NEJM as unless you subscribe to NEJM, which is different from other journals).

I opted to to self-publish my own article in Scribd because there were points which others have chosen to gloss over which I believe the diabetes world should understand. Those elements happen to be core business strategies. 

Still, my underlying assessment is essentially the same as the NEJM article, and I'm generally in agreement with Harvard's Leemore Dafny: the Civica insulin effort stands to be disruptive. She generalizes it as being disruptive to pharmacy supply chain entities, whereas I believe it will be most disruptive to the PBM kickback scheme (hence my own article title).

In her article, Harvard's Leemore Dafny did identify what she saw as potential risks for Civica which she felt were worthy of acknowledging. For example, she speculated on what types of specific barriers Civica might encounter in executing its insulin plan.

I was especially bothered about the first element she wrote about, because it would be very easy to envision PBMs' doing such a thing using their creepy retail pharmacy contracts (if those don't already contain provisions which they could threaten pharmacies with if they carry Civica insulins), in which she writes:

"Civica will face important barriers to executing this plan, though. In addition to usual implementation and regulatory challenges, intermediaries threatened by this approach may introduce new obstacles; for example, they might pressure pharmacies not to carry Civica's insulin products."

It's easy to envsision PBM's attempting to pressure pharmacies within their retail networks from carrying Civica insulins. After all, the PBM kickback scheme is dependent on patients buying heavily-rebated, branded insulins. If they carry a less costly insulin, that scheme is disrupted. Hence we can imagine PBM's threating pharmacies within their networks that they'll consider it a violation of the PBM contract if they were to carry Civica insulins. The pharmacy contracts PBM's use are now subject to recently-announced FTC scrutiny, which will conduct a study of the impact which PBM contracts have on prescription drug prices for patients and other entities in the prescription drug supply chain.

That said, I believe the other risk she identified isn't a threat at all. She opined: "intermediaries won't try to block Civica's end run and will instead promote new diabetes agents that would be subject to the existing system".

That idea is far-fetched because a vast majority (by some estimates, around 77%) of U.S. insulin users have the autoimmune form (Type 1) of diabetes, and while they use significantly less insulin volume than patients with Type 2 use, the reality is that not one new agent has been ever been developed which has FDA approval for Type 1 diabetes. As a result, no alternative therapies to insulin exist for treating T1D; there are NO new "diabetes agents" for them to promote to that patient population, hence that will not happen.

For the record, NEJM did a very short (7:35) interview with Leemore Dafny about her NEJM article. The NEJM interview link can be found at https://www.nejm.org/doi/full/10.1056/NEJMp2203001 or you can catch that short interview below.
 

I also managed to locate the URL for the MP3 of NEJM interview (NEJM didn't make finding it easy):
https://www.nejm.org/doi/do_file/10.1056/NEJMdo006587/NEJMdo006587.mp3

 

In the article I authored (above), I documented some of the underlying biosimilar insulin business strategies which I thought was particularly relevant to the conversation.

Most notably, my analysis is that biosimilar manufacturers of insulin are essentially FORCED to use offshore manufacturing to ensure their margins are fat enough so they can pay massive rebates to PBM's in hopes of landing one. When that happens, the profits for the biosimilar-maker will roll-in remarkably quickly. In fact, we know that Viatris/Biocon makes its insulin offshore in a massive Biocon factory located in Johor, Malaysia (not far from the Singapore border), and it finally managed to land itself on several formularies in 2021, when its insulin rebates persuaded Express Scripts to drop the innovator Sanofi Lantus from its formularies and instead switch to its FDA-designated "interchangable" U-100 glargine biosimilar Semglee instead. Ditto for the PBM Prime Therapeutics.

Note that Prime Therapeutics as a PBM is basically joined at the hip with Express Scripts anyway. In late 2019, Prime Therapeutics announced a partnership with Express Scripts to provide its retail pharmacy network and pharmaceutical manufacturer contracting, hence it pretty much does whatever Express Scripts does, although unlike Express Scripts, Prime Therapeutics does include both the branded (Semglee) and unbranded (Viatris U-100 Insulin Glargine) versions of the insulin glargine on its formularies, with comparable placement for both on its formularies (Sanofi's Lantus is still excluded), ultimately leaving the decision up to employer plan sponsors if they opt to include the less costly, unbranded product. Many plan sponsors choose not to do so, as it potentially reduces the amount of rebate dollars they can collect as "premium offsets" because patients aren't helping to bankroll it with their own pharmacy expenditures.

For its part, the March 3, 2022 Civica insulin press release contained a curiously little-acknowledged, yet critically important paragraph (see the release at https://www.businesswire.com/news/home/20220303005321/en/Civica-to-Manufacture-and-Distribute-Affordable-Insulin/ for details), which reads:

"Civica has entered into co-development and commercial agreement with GeneSys Biologics for these three insulin biosimilars. Civica will use drug substance produced in partnership with GeneSys and will have exclusive rights in the U.S. to market and sell these insulins at costs that are substantially lower than what is currently available in the U.S."

That means is the Active Pharmaceutical Ingredient ("API") for its insulins will be cultured in biorwactors at Hyderabad, India-based GeneSys Biologics and the API will then be shipped in bulk to Civica's own factory in Petersburg, Virginia which for insulin will essentially become a "fill & finish" facility rather than an actual manufacturing facility where the insulin is actually made. I'm not sure what they mean when they say the insulin will be manufactured in Virginia, because it will actually be manufactured in India. For the record, by some estimates, Hyderabad, India produces some 40% of API's used by U.S. drug companies. Some is due to pharma's greed to line their own shareholder's pockets, and occasionally its because the sources for those API's are mainly from Indian or Chinese companies.

JDRF's CEO Aaron Kowalski acknowledged this reality in an interview he did for the "Diabetes Connections With Stacey Simms - Type 1 Diabetes" podcast. If you listen carefully to that conversation (the link to that podcast can be accessed at https://diabetes-connections.com/i-think-we-have-an-answer-jdrfs-ceo-explains-the-plan-for-non-profit-insulin/) (to hear it; you can skip ahead to 5:46) in which he says:

"So, there's kind of two components to this: one is we're working with a partner in India who will be manufacturing the active part of the insulin, so that would be the insulin molecule itself. And then, that will be shipped to a plant in Virginia where they will package and bottle the insulin or put it in pens. They, the Civica team has been building that plant, and this manufacturer has the capability of making insulin already."

Only Civica will be packaging insulin which has already been cultured in GeneSys Biologics bioreactors located in Hyderadad, India. Why do they insist in saying that Civica is actually "making" or "manufacturing" that insulin when they are essentially packaging and labeling it with a reputable partner located offshore?

Oddly, that's the not-so-little part which I believe really turns the PBM rebate game on its head. The Civica insulin plan will instead use the margins which are derived from offshore manufacturing to instead reduce patient prices, rather than pay legally-exempted kickbacks to PBM's as rebates. By comparison, Viatris/Biocon is using the margins it derives from making their glargine insulin in Johor, Malaysia to pay massive rebates to Express Scripts and Prime Therapeutics so they carry the medicine on their formularies.

That's a very big deal if Civica actually pulls it off.

The NEJM interview with Leemore Dafny said "I've been told that they've hired a number of experts who have a lot of experience in this part of the value chain...they also have partnership from a lot of payers" as a result, she sees room for optimism in the business model Civica will be taking.

Those are certainly positive signs.

But in MY article, I also acknowledge another unappreciated side-effect of the Civica insulin deal which has so far yet to be acknowledged by anyone:

Civica will transfer the ability for patients and their doctors to freely select a particular insulin. That was previously a dynamic which PBM contracting and rebate aggregation effectively ended. That means that now, once Civica's insulins are introduced, biosimilar versions of insulin at an affordable price could effectively become a reclaimed dynamic which PBM's seized from patients and their doctors.

That's how diabetes is managed in most other affluent markets; yet the U.S. is a rare outlier in that our choice of insulin is based on whichever company pays the PBM the biggest rebates, not the one which is therapeutically most beneficial to the patient. Remember: Novolog and Humalog are NOT designated by the FDA as being "interchangeable" with one another, but the PBM's treat them as interchangeable anyway (in effect, PBM bean-counters are practicing medicine without an actual medical license).

In any event, its worth acknowledging that both myself and NEJM concur that the Civica insulin arrangement promises to disrupt an industry which has proven itself resistant to fundamental change. It will be a great day in the U.S. when that happens!

Tuesday, May 31, 2022

Abbott's Freestyle Libre 3 Finally Receives FDA Approval; Expected to Launch Later in 2022

Today, Abbott received FDA approval for the Freestyle Libre 3 model. When reporters asked, Abbott said it will become available later in 2022, but did not elaborate further. Abbott's press release on the topic (see footnote #5) said "At this time, FreeStyle Libre 3 is not currently eligible for Medicare reimbursement, and Medicaid eligibility may vary by state." Abbott explains its Medicare situation at https://www.freestyle.abbott/us-en/medicare.html. That said, Abbott could attain CMS/Medicare coverage at a later date. Also unclear is whether Libre 3 received the iCGM designation as the Libre 2 did. It was expected, but unclear in the press release that came out today.

The pricing for Libre 3 will reportedly match that of the previous model the Libre 2 (meaning it will be 30% cheaper than Dexcom), but will match most of the key points of differentiation which Dexcom currently enjoys, including continuous real-time glucose readings automatically delivered to a person's smartphone each minute, although I'm unsure if that uses up your mobile phone's battery life faster (by comparison, the Dexcom G6 provides readings every 5 minutes), and the FreeStyle Libre 3 system was cleared for use with the FreeStyle Libre 3 iOS and Android mobile apps, which enable users to view their glucose levels in real time, track their glucose history and trends, and set up optional alarms plus notifications to help them be alerted of serious medical events like hypoglycemia. Recall that last June (2021), I opined I might be willing to switch to Libre 3 when it comes out given frustrations I've experienced with Dexcom and the fact that I feel the company presumes it will always enjoy my business (see my post at https://blog.sstrumello.com/2021/06/should-i-say-adios-to-dexcom-g7-hello.html for details).







Libre 3 calls itself the world's smallest, thinnest glucose sensor (the size of two pennies stacked on top of one another) that can be worn up to 14 days to deliver continuous, real-time glucose readings. I'm not sure how well the adhesive holds for 14 days, but the tiny size certainly helps it remain attached. The Libre 3 does require a 60-minute warm-up. By comparison, the new Dexcom G7 model will only require a 30-minute warm-up (so half the time). But the Dexcom G7 sensors will still only last 10 days, compared to 14 days for the Libre 3 model, so that trade-off is one cost-conscious patients may consider worthwhile. After all, that means they'll spend less money with the Libre 3 system than they will with Dexcom G7. Patients with healthcare plans with deductibles might notice the lower costs, although both companies have been working to secure more widespread coverage of their products pre-deductible.


The sensor and transmitter is combined in both the Freestyle Libre 3 and Dexcom G7 models in an all-in-one sensor/transmitter insertion.

By comparison, the size of the rival Dexcom G7 is considerably bigger than Libre 3, being about the size of three quarters stacked on top of one another (compared to 2 pennies stacked atop one another for Abbott Freestyle Libre 3). Still, because of the smaller size and different shape, the new Dexcom G7 can be inserted on the back of the upper arm, the abdomen, or, for children ages 2-17, on the upper buttocks.

The accuracy of glucose monitors (particularly continuous glucose monitoring systems) is typically described with a metric called "MARD", or mean absolute relative difference. MARD is listed as a percentage, describing how far off you can expect your sensor reading to be from your actual plasma blood glucose level. Generally, this means that the lower the percentage, the more accurate the sensor. If MARD was zero, there would be NO difference between plasma blood glucose and sensor values, hence the lower the MARD percentage (closer to zero), the more accurate it is.

As for accuracy, the FreeStyle Libre 3 has a MARD of 7.9% at 14 days of use and is the first device to have a MARD of less than 8%. By comparison, the Dexcom G7 has a MARD of 8.2% for those wearing the device on their upper arm. In reality, the differences in accuracy between Abbott Freestyle Libre 3 and Dexcom’s new G7 models are marginal and one cannot really say either CGM is significantly more or less accurate. In fact, the difference could well be attributed to the math and statistical calculations from the trial sample sizes for each company, and not because one is any more or less accurate than the other.

Libre 3 Will Be Priced 30% Less Than Dexcom G7

Abbott Freestyle Libre 3 will also continue to be 30% less costly than rival products (e.g. Dexcom). That strategy began with the Libre 2 model, although that model lacked all the features the new Libre 3 model has. Still, according to Abbott, patients with commercial insurance can expect to generally pay between $0 and $60 per month for sensors. Abbott is pricing the product aggressively in the U.S. hoping to lure Dexcom users away, although its lack of Medicare coverage remains a key limitation for Libre 3. But if Libre 3 is successful in the commercial insurance market, we can expect it to pursue the Medicare market. Time will tell on that.

Below are some relevant articles worthy of reading.

https://www.medtechdive.com/news/abbott-libre-3-CGM-fda-clearance/624591/

https://www.prnewswire.com/news-releases/abbotts-freestyle-libre-3-receives-us-fda-clearance--features-worlds-smallest-thinnest-and-most-accurate-14-day-glucose-sensor-301557561.html

https://www.abbott.com/corpnewsroom/strategy-and-strength/freeStyle-libre-3-worlds-smallest-sensor-is-here.html

https://www.abbott.com/corpnewsroom/strategy-and-strength/freestyle-libre3-welcome-to-the-us.html

https://beyondtype1.org/freestylelibre3-fda-approval/ 

Wednesday, May 04, 2022

The Business of Diabetes: How The PBM Insulin Scheme Is Poised to Be Disrupted by Civica Rx

So, with this week's news focused on other areas (like the Supreme Court), I thought it might be appropriate to focus on something which is still very broken, yet seems poised to be resolved by good old fashioned market forces: insulin prices.

The U.S. "market" for insulin is bedeviled by the same problem that causes all U.S. prescription drug prices to be so high: Pharmacy Benefit Managers ("PBM's") are manipulating prescription drug discounting behind-the-scenes in order to enrich themselves at everyone else's expense. Most discounts PBM's collect come in the form of cash rebates, which are paid by pharmaceutical companies to secure a place on PBMs' (and, by extension, insurance companies') preferred drug formularies. 

Today, the top three PBM's are vertically-integrated with large healthcare insurance companies — Cigna's Evernorth unit/Express Scripts, United Healthcare Group's Optum and CVS Health's Caremark (the company also owns the health insurance company Aetna) — collectively process more than 77% of all prescriptions delivered to Americans according to the Drug Channels Institute. These PBM's are classic oligopolies, where just a handful of companies dominate a market, arrogate disproportionate profits for themselves, deliver marginal value to justify enormous fees, and exercise undue leverage over other businesses dependent on the market they dominate.

As might be expected, PBM's prefer to operate without attention; yet, when confronted, they forcefully argue that they are invaluable to payers and consumers (even while the data they use to justify their savings is often questioned by lawmakers). Yet the PBM's are notorious for price gouging, which not only impacts patients' wallets and access to prescription drugs, especially on brand-name medications, plus PBM's are also adversely impacting prices on the emerging U.S. biosimilars market. Generic drugs tend to be the one segment of the market where the PBM influence is not completely dominated by PBM's because generics happen to be the segment of prescription drugs not technically subject to PBM rebating ordinarily used to secure formulary placement. Generics generally receive no rebates, which is partially why they are less costly (in addition to having no almost no R&D costs).

The U.S. Federal Trade Commission ("FTC") needs to investigate PBM's and their corporate affiliates (commercial health insurance companies), and should partner with the U.S. Department of Health and Human Services ("HHS") to eliminate extortionate fees and abusive business practices which are so detrimental to consumers and competition. The FTC recently deadlocked on formally studying PBM contracting practices, but such a study still needs to happen. And, once the FTC studies it, the FTC and ultimately, the U.S. Department of Justice will likely need to sue to dismantle the PBM-insurance company oligopoly in an effort to dismantle their monopoly on drug discounts. 

I am old enough to remember when they did that to the old "Ma Bell" telephone company monopoly called the Bell System known as AT&T back in 1982/1984. the breakup of the old Bell System was mandated on January 8, 1982, by an agreed consent decree providing that AT&T Corporation would, as had been initially proposed by AT&T, relinquish control of the regional Bell Operating Companies that had provided local telephone service in the country. For the record, the company known as AT&T today is the result of the Baby Bell known as SBC acquiring most of the pieces (excluding the company today known as Verizon; it was previously the regional bell operating companies for the Middle-Atlantic [PA, NJ, NY] and New England states) after the historic break-up. That will take a number of years.

That said, more recently, there are some signs the market has responded with some positive directions. 

In 2019, for example, in response to widespread patient complaints over runaway insulin prices, two of the three biggest insulin manufacturers (Eli Lilly and Novo Nordisk) both introduced so-called "authorized generic" versions of their blockbuster prandial insulin varieties. See the Lilly press release "Lilly to Introduce Lower-Priced Insulin", PR Newswire, March 4, 2019, https://www.prnewswire.com/news-releases/lilly-to-introduce-lower-priced-insulin-300805560.html and the Novo Nordisk press release "Novo Nordisk launching additional US insulin affordability offerings in January 2020", PR Newswire, September 6, 2019, https://www.prnewswire.com/news-releases/novo-nordisk-launching-additional-us-insulin-affordability-offerings-in-january-2020-300913167.html for more.

At the time of those press releases in 2019, the two insulin manufacturers told the press they would sell lower-priced versions of some of their blockbuster rapid-acting analogues for half price. At the time Lilly Insulin Lispro https://www.lillyinsulinlispro.com/ and Novo Nordisk Insulin Aspart https://www.nnpi.com/ hit the market in 2020, savvy patients very quickly discovered they could actually buy those insulins for considerably less than half-price, and instead buy them for about 70-75% off the artificially-inflated cash retail price by simply using a readily-available GoodRx coupon.

A year later, Lilly announced (see https://www.prnewswire.com/news-releases/lilly-again-reduces-list-price-of-insulin-lispro-injection-as-latest-change-to-affordability-options-301386117.html) that the company would further reduce the price of Lilly Insulin Lispro by an additional 40%. Today, patients can buy that particular insulin variety for $35/vial even without insurance, although patients do require a Lilly manufacturer coupon from https://www.insulinaffordability.com/ in order to get that lower price. Incidentally, that price is STILL about $5 MORE than what patients in Canada pay for Humalog. I paid $37.79 in Canadian dollars for a vial of Humalog when I visited Montreal in November 2021 -- based on the currency exchange rate at the time, that worked out to $30 U.S. dollars. So, insulin was still cheaper in Canada.

So far, the two companies only offer "authorized generic" (the FDA defines an "authorized generic" as an approved brand-name drug that is marketed as a generic product without the brand-name, or trade name, on the label), "unbranded biologic" (as Novo Nordisk refers to its Novo Nordisk Insulin Aspart) or "non-branded insulin" (as Lilly calls Lilly Insulin Lispro) for just a few of their bestselling prandial insulin products. Most of their other insulin varieties (including basal insulins) currently do not have authorized generics. If the manufacturers are truly committed to the branded/unbranded strategy, every single insulin variety they now sell should also have authorized generic versions. This is a request for Lilly and Novo Nordisk to step up on that; it's been several years. Novo Nordisk boasted to investors in its 2021 annual report that the company's "affordability options" in the U.S. supposedly helped over 1 million "vulnerable" Americans in 2021; just imagine how many could be helped if the company had unbranded versions of every insulin they now sell? For the record, Lilly seems to have concluded that it can achieve sales growth mainly via the unbranded (and un-rebated to PBM's) product, and recently told investors that since being introduced less than 2 years ago, Lilly Insulin Lispro now accounts for 30% of U.S. Humalog sales. Think about that: in just 2 years, nearly a third of U.S. Humalog sales are the un-branded, un-rebated version of the product. Apparently, it's cheaper for Lilly to sell an un-rebated version of the product to patients than it is to bribe PBM's with billions in cash rebates. Especially since Humalog has now lost patent-protection in the U.S.

One biosimilar-maker has so far also introduced both a branded and unbranded version of a biosimilar insulin. That branded/unbranded strategy was necessitated by the PBM demand for cash rebates needed to place the biosimilar on drug formularies. Viatris which sells biosimilar insulins manufactured by Biocon (Biocon recently announced the company was acquiring all of Viatris' share of their U.S. joint venture) of Sanofi U-100 Lantus which is branded as Semglee. Recognizing that it is a biosimilar, an unbranded version called simply Viatris Insulin Glargine also sells -- reportedly at 65% less than Semglee sells for -- in U.S. pharmacies. The two (Viatris/Biocon) now have a biosimilar version of Novolog/U-100 insulin aspart currently pending FDA approval, as well a biosimilar version of Sanofi's U-300 insulin glargine which Sanofi calls Toujeo (also still pending FDA approval). To my knowledge, they do NOT currently have a biosimilar of Humalog pending approval at this time. The reason for the branded/unbranded strategy is so the biosimilar-maker can also compete in PBM rebates which mainly benefit PBM's and the insurance companies which own them. A heavily-rebated product could achieve substantial sales overnight by landing the biosimilar on a PBM formulary. That happed last year, when Cigna's Express Scripts announced it was dropping Sanofi Lantus from its formulary and adding Semglee instead. The unbranded version of their products also enables the company to sell a less costly product as well. But, as might be imagined, it has caused widespread confusion among patients and pharmacists alike.

In September 2019, JDRF CEO Aaron Kowalski was interviewed by the American Journal of Managed Care ("AJMC") about the organization's position related to insulin pricing legislation (see https://www.ajmc.com/view/jdrfs-kowalski-sees-hope-in-bipartisan-support-for-insulin-pricing-reform for the article), and he told AJMC that JDRF's official position was that action was needed not only by Congress, but also by insulin makers, health plans, and the executive branch. The most important goal: ending a crosspayment scheme that many blame for potentially deadly insulin price increases. Behind the scenes, JDRF helped persuade Civica Rx to enter the biosimilar insulin space (more in a forthcoming paragraph).

Several (not ALL) insulin manufacturers have made moves to lower the list price of insulin by simply bypassing the PBM rebate mess completely. Still, in the current system, drug companies give discounts to pharmacy benefit managers and health plans, while increasing prices at the pharmacy counter. Lilly offers a manufacturer coupon for patients does enable them to buy Lilly Insulin Lispro at a cost of $35/vial. But Novo Nordisk, Sanofi and Viatris/Biocon have all failed to do the same. And, Lilly only offers the lower prices on Lispro and some old-school biosynthetic insulin varieties, but not on its Basaglar or a second glargine biosimilar to be branded as Rezvoglar, nor on its newer Lyumjev faster prandial insulin.

So with that said, the March 3, 2022 announcement from Civica Rx https://www.civicainsulin.org/ that the nonprofit drug company plans to (in collaboration with the JDRF and the Helmsley Charitable Trust to name a few) sell biosimilar versions of insulin glargine, aspart and lispro (possibly as early as 2024 assuming it receives regulatory approvals in a timely fashion) at one low, transparent price for all, basing the prices on the cost of development, production and distribution. When those biosimilars hit the market (planned for 2024), the Civica Rx insulin varieties will sell for no more than $30 per vial and no more than $55 for a box of five prefilled pens. The Civica Rx press release can be read at https://www.businesswire.com/news/home/20220303005321/en/Civica-to-Manufacture-and-Distribute-Affordable-Insulin/. The insulin will actually be cultured offshore in bioreactors at partner GeneSys Biologics Pvt. Ltd. facilities in Hyderabad, India. The insulin then will be shipped (in bulk) to Civica Rx's new 140,000 square-foot "fill & finish" facility, now being built in the vicinity of 2820 North Normandy Drive in Petersburg, VA 23805 (just south of the state capital Richmond) where the insulin will be put into vials and pens, with mandatory FDA labeling and placed into boxes, and then shipped to pharmacies nationwide.

Both JDRF and Civica Rx published information documents about the arrangement. I combined them into a single document which can be seen below, or by visiting HERE.

The Civica Rx move stands to fundamentally disrupt what could arguably be called a price-fixing racket (or ponzi scheme) to fix insulin prices at artificially-inflated prices. I suspect we may see Lilly and Novo Nordisk respond by correspondingly reducing their own insulin prices, or to simply stop making the now out-of-patent prandial insulin analogue products and simply retire them. I've experienced the manufacturers "retire" many insulin varieties I once used. Right now, they already have newer, marginally-faster products (NN Fiasp and Lilly Lyumjev) which are patent-protected, and they could theoretically just sell authorized generic versions of those products instead. We could also see biosimilar-makers respond with price reductions of their own when they receive FDA approval on their biosimilar versions of aspart and U-300 glargine now pending approval (right now, Biocon and Lannett have ones pending approval which will be made in Malaysia and China, respectively). 

In that scenario, the losers will be PBM's which have been manipulating prices behind-the-scenes to enrich themselves. The PBM's really deserve that. No one should worry about the PBM's. They'll just make up for it on other drug categories.

Thursday, April 07, 2022

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

Last February (2021), I wrote a blog post called "How to Navigate Life with a Chronic Disease Like T1D and High-Deductible Insurance Plans" (read my post at https://blog.sstrumello.com/2021/02/how-to-navigate-life-with-chronic.html for details).

I still stand by all of the recommendations I made in that blog post because I actually used (and still use some) the methods described effectively and saved a lot of money by doing so. But times change, and sometimes strategies need to evolve with changes that happen in the world around us.

Intro of "Authorized Generic" Insulins, plus Branded/Unbranded Biosimilars

For example, in 2019 when both Lilly and Novo Nordisk each announced they would introduce less costly versions of their blockbuster rapid-acting insulin analogues to be sold at half-price in the U.S., savvy patients very quickly discovered that they could actually purchase Lilly Insulin Lispro or Novo Nordisk Insulin Aspart for about 75% off the bogus cash retail prices simply by presenting the pharmacist a GoodRx coupon, and voila: instant 75% savings. In fact, using the GoodRx method is actually cheaper than Walmart's Relion Novolog offering if patients buy the insulin at the lowest cost pharmacy in their area (which I blogged about HERE).

For example, by patronizing Walgreens, a patient can today buy a vial of Novo Nordisk Insulin Aspart for $58.83/vial compared to the company's co-branded Walmart Relion Novolog which retails currently for $72.88/vial. The GoodRx method is actually 19% less costly than buying a vial of Relion Novolog at Walmart. But that is still more costly than buying Lilly Insulin Lispro is. That said, there are a number of insulin aspart biosimilars (not so many of insulin lispro to my knowledge) in development which may ultimately lead to Novo Nordisk to eventually "retire" the product and market Fiasp instead. That could lead to only biosimilar-makers selling the product once branded as Novolog.

Lilly Reduced Price of Insulin Lispro by Another 40%



 

 

 

 


Anyway, since the 2019 move to introduce a less costly version known as Lilly Insulin Lispro, Lilly subsequently announced it would further reduce its price on Lilly Insulin Lispro by an additional 40% (see the Lilly press release at https://www.prnewswire.com/news-releases/lilly-again-reduces-list-price-of-insulin-lispro-injection-as-latest-change-to-affordability-options-301386117.html for full details) effective on January 1, 2022. Lilly's press release said that its Lilly Insulin Lispro would now sell for approximately 70% less than Lilly's branded U-100 Humalog insulin (the insulin is exactly the same, though it has a different NDC number, a different box and label, yet it is made on the exact same assembly line). Lilly execs have told investors that Lilly Insulin Lispro now accounts for at least 30% of Humalog sales in the U.S. Also, investor presentations show that Lilly Insulin Lispro accounts for most of the recent U.S. Humalog sales growth.

U.S. prescription drug prices have always been fuzzy because in the pharmaceutical industry, ALL of the price numbers are bogus. The list prices are bogus (unless you actually pay them), the discounts are undisclosed, hence no one really knows what the true prices really are or how big the discounts are, and the retail pharmacy has almost no control over the prices it charges due to their contracts with Pharmacy Benefits Managers ("PBM's"). The PBM makes all the decisions on prices, not the retail pharmacy. And, a pharmacy could not be in business without a contract with a PBM.

Finding Less Costly Lilly Insulin Lispro Isn't Easy

That said, obtaining the 40% less costly Lilly Insulin Lispro isn't as easy as just going to the pharmacy and asking the pharmacist for it. GoodRx won't get you the new 40% lower price, either (GoodRx are PBM coupons, and you need a drug manufacturer coupon for that). When Lilly Insulin Lispro hit the market in 2020, patients discovered they could buy that insulin for about 75% off the cash price by using a GoodRx coupon. Hence, the 2021 Lilly announcement of another price reduction initially looked to patients like more pharma smoke and mirrors. But, it actually IS possible to do better than that. The key is patients need a manufacturer coupon to be able to buy it for just $35/vial, which is a pretty decent price.




 

 

 


Earlier this year, Lilly very quietly launched something it calls the Lilly Insulin Value Program found at the website https://www.insulinaffordability.com/ which to my knowledge is the only site offering these manufacturer discount coupons. Whether a patient has commercial insurance or no insurance at all, the manufacturer coupons are the method to get that lower price. These coupons are direct from the manufacturer. With the Lilly Insulin Value Program, virtually anyone can freely download coupons to buy Lilly Insulin Lispro for a price of just $35/vial — virtually no screening for eligibility is required, and the manufacturer coupons can be downloaded instantly. 

My Canada Insulin-Buying Experience

For the record, I went to Montreal Canada in November 2021, and visited a pharmacy to buy a vial of Humalog (the pharmacy I patronized was Jean Coutu). The price I was charged to buy a vial of Humalog was $37.79 Canadian Dollars, so given the exchange rate, that equaled $30.02 in U.S. Dollars. The U.S. is getting closer to Canadian insulin prices, although we still aren't there yet.




 

 

 

 

 

 

 


Unlike Lilly's previous (and other) Patient Affordability Programs which required patients to provide lots and lots of personal financial info to the company so it could decide if a patient is even eligible (plus the decision was not made instantly, and there was no guarantee patients would even be eligible), the Lilly Insulin Value Program works differently. Virtually anyone can download a coupon instantly.

Lilly offers two coupons: one is for patients with commercial healthcare insurance, and it offers a different coupon for those cash-paying patients with no insurance at all. The price with both coupons is exactly the same, except that the two coupons helps Lilly to understand which insurance companies its insulin users are coming from. Many have insurance plans which "prefer" Novo Nordisk insulins, but the ones who "prefer" Lilly insulins are those which Lilly hopes to persuade to actually cover its insulin as a "preventative treatment" eligible for pre-deductible coverage in accordance with new IRS rules. Hence, that particular coupon requires the patient to present a valid insurance card in order to get the $35/vial price. 

Don't Shoot the Messenger!

Look, I understand some advocates decry the need for coupons from big insulin manufacturers. But the reality is that the U.S. prescription drug market is fundamentally broken, and in order to operate in that dysfunctional market, rebates are how drug companies market prescription drugs in the U.S. For the time being, we are stuck working within the broken system we live in. And, the most effective solution to the affordability problem right now is coupons. Please don't shoot the messenger!

For virtually ALL new, still patent-protected prescription drugs, I suggest patients should make themselves aware of what I call the "New Drug Rule" which is basically the only discounts patients are likely to get are directly from the drug manufacturers themselves, rather than the PBM coupons. 

My friend's mother uses a drug prescribed for irritable bowel syndrome (my mother lives with an autoimmune inflammatory bowel disease called Ulcerative Colitis, so I never really understood how IBS is different from IBD, but IBS is more mild than IBD) called Linzess (linaclotide) made by AbbVie, and it still enjoys patent exclusivity, so we found a manufacturer coupon enabling her to get that drug for as little as $30 with the Linzess Savings Program, a similar manufacturer coupon to Lilly's Insulin Value Program.Insured patients can, however, use the Lilly Insulin Value Program $35/vial for Lilly Insulin Lispro coupon intended for those who pay cash if the other does not work for some reason (but those cost Lilly more money, plus it does not help the company focus its marketing on insurance company plans which fail to cover its insulin pre-deductible).

Ignore the Big Health Insurance Myth: "Rx Purchases at an artificially-inflated cash price will reduce your deductible"

As for the other methods I described, the coupon route is a growing part of U.S. prescription affordability. Without a lengthy dialogue about coupons, as you might realize, there are manufacturer coupons, and then there are PBM coupons. Both manufacturer and PBM coupons offer deep Rx discounts, but it is important that patients ignore the myth (and it is a MYTH) that covered patients should not use coupons because they don't contribute towards satisfying a deductible. That is, at best, only a half-truth. The reality is patients only receive credit applied towards their deductibles for the deeply-discounted, PBM-negotiated prices, not the a artificially-inflated cash retail prices charged at the pharmacy checkout counter. That's a rip-off. Beware that not all manufacturers offer coupons on all drugs they sell, but when they do, the manufacturer discounts can be pretty good.

As for PBM coupons (all but the first are powered by one or more PBM's), they're hit or miss. I encourage my readers to search EACH of the following coupon-generating websites/apps:

SingleCare (which is the only website/app NOT powered by a PBM) https://www.singlecare.com/ 

GoodRx (powered by a combo of PBM's including: Cigna's Evernorth/Express Scripts, United Healthcare Group's OptumRx, Navitus which is a PBM owned by the nonprofit hospital chain SSM Health & Costco, and MedImpact Health Systems, Inc. which is de facto controlled by its single largest client Kaiser Permanente. Note that GoodRx only offers access to one formulary offered by each PBM, and each PBM offers different drug formularies including both high price/high rebate formularies, and low price/low rebate drug formularies which tends to favor generics; the single formulary access limits GoodRx's ability to always offer the lowest Rx drug prices) https://www.goodrx.com/ 

InsideRx (run by Cigna's Evernorth/Express Scripts PBM) https://www.insiderx.com/

OptumPerks (run by United Healthcare's OptumRx PBM) https://perks.optum.com/

ScriptSave WellRx (run by Kaiser Permanente's* PBM MedImpact) https://www.wellrx.com/ 

America's Pharmacy (run by Kaiser Permanente's* PBM MedImpact) https://www.americaspharmacy.com/ 

BlinkHealth (powered by Kaiser Permanente's* PBM MedImpact) https://www.blinkhealth.com/

ScriptHero (run by drug wholesaler McKesson, and powered by the company's own CoverMyMeds, plus SingleCare and WellRx) https://www.scripthero.com/ 

WellCardRx (run by the PBM WellDyne) https://wellcardrx.com/

*On April 20, 2022, there was news (see HERE for details) that Kaiser Permanente had signed a contract with Cigna's Evernorth/Express Script to provide various services, which will eventually include PBM services which are now provided by the PBM known as MedImpact. MedImpact's full PBM contract with Kaiser Permanente is officially up for renewal in 2023.

I recommend searching online using ALL of these coupon-generating websites/apps to find the lowest out-of-pocket cost for each prescription drug. I recommend investing an afternoon searching each prescription drug your household uses on a chronic basis and making the choice where to buy the drugs based on lowest prices and personal convenience.

Patients who use this shop-for-the-best-price method will not only save anywhere from 55% to 90% on Rx drug prices, plus because insurers give them only pennies on the dollar of what they pay at the pharmacy checkout, they should satisfy their deductible fairly close to the date they did when they paid outrageous cash retail prices for the same prescription drugs because of how little credit their insurance company applies towards their deductibles for drug purchases.

For example, my previous insurer Cigna paid for generic Crestor (rosuvastatin calcium) 10 mg tablets as a "preventative treatment" which it could do under IRS rules, hence I paid nothing for the drug. But when I was switched to Aetna (which is owned by CVS Health, who also owns the PBM known as Caremark), I was charged $33.84 for a 90-day supply of that same drug. The drug, incidentally, is made in India and costs CVS Health pennies on the dollar. I believed I was being taken advantage of by Caremark, so I asked the PBM to no longer auto-refill that mail order prescription. I then shopped for a better price and found I could buy it and initially found it by using the OptumPerks coupon-generating website/app (I bought it from rival United Healthcare's Optum Store, which is run by its PBM OptumRx for just $15.00 for a 90-day supply). Optum now mails it to my home just as Caremark once did, only I save 56%. By the way, a conversation with Caremark revealed that Aetna was only crediting me just $4.50 applied toward my deductible, even while Caremark charged me $33.84 for that drug. I would have to refill the drug for like 2 years to save what I did simply by bypassing my own insurance once.

As noted, it also works for insulin. But the lowest price for that seems to be with Lilly's Lilly Insulin Value Program which is a manufacturer coupon enabling patients to buy Lilly Insulin Lispro for a cost of $35/vial. I actually PREFER lispro over aspart (my insurance company's "preferred" insulin brand is from Novo Nordisk), but at just $35/vial, I could actually just skip whatever brand Caremark says I should use, but my co-pays have been pretty low (my last refill was $17.42 for 3 vials, which is an average cost of $5.81/vial) so I do use Fiasp instead. I simply avoid Novolog (aspart) completely. I still prefer lispro over any Novo Nordisk insulin variety, but prefer Fiasp's time-activity profile slightly over Novolog's which I derisively call "slow-mo log" because it was only marginally faster than Regular for me.

I still like the true generic test strips which work in the old OneTouch Ultra meters I blogged about HERE. I have found those to be a very cost-effective alternative to overpriced test strips. 

But OneTouch has since stopped making the old Ultra meters, so it may not be a viable alternative if you don't have a trunk full of old meters. In that case, you CAN use a meter from Roche's Accu-Chek. There are coupons enabling you to buy those at a price of about $12.25 for 50 test strips with a SingleCare coupon.

That works out to a cost of $0.24/strip. By comparison, the generic OneTouch Ultra test strips from Unistrip Technologies, Inc. http://www.unistrip-tech.com/ and GenUltimate! http://pharmatechsolutions.co/ work out to a cost of about $0.16/strip which is a lower price. For the record, Pharmatech Solutions appears to have shifted focus to sell its strips abroad for the time being, so its unclear if they're currently being sold in the U.S. anymore. But I lucked out: fortunately, my insurance now covers my test strips pre-deductible in accordance with the 2019 IRS re-classification as a "preventative treatment" eligible for pre-deductible coverage.

But my current insurance company Aetna/CVS Caremark was a complete pain-in-the-ass about covering the quantity of test strips I use (I use between 12-14 test strips per day). It took nearly a year before they approved my endo's appeals. Then, the clerks at CVS Pharmacy couldn't figure it out. First, they kept submitting the order and being denied. Eventually, they figured out that the quantity I was approved for was not evenly divisible by 100, which meant they had to use an NDC for packages of 50 test strips in order to fill my script. That was a hassle I eventually resolved. But it proved to me what a pain-in-the-ass Caremark actually is as a PBM. The company's sole concern is about how to keep the cash flowing into CVS Health's corporate coffers. Patient care is merely the fraudulent "front" they use to get there.

BTW, CVS Health (in spite of not operating a Caremark-powered coupon-generating website/app as its big rivals do) does operate a less generous coupon-generating website for some insulin, specifically Novo Nordisk rDNA biosynthetic "human" insulin. It calls the coupon-generating website ReducedRx https://www.reducedrx.com/ and offers some discounts for cash-payers on certain older Novo Nordisk rDNA biosynthetic "human" insulin varieties. If you use one of those insulin varieties, this site could save you some money. I haven't compared their prices to Lilly Humulin insulin varieties.

It doesn't matter too much now. By this summer, I could end up being covered by a completely different healthcare plan. Every few years, the contract goes up for bid and usually it means a switch to a new carrier. A previous employer finally worked around that by using a Professional Employer Organization (or "PEO") which meant a reliable contract with premiums which did not double when the contract expired. But not every organization has figured out how to do that, hence they put their insurance benefits up for bid and use a broker to solicit bids from insurance companies. Usually it means switching to a different insurance company. 

Over the past decade, I've been covered by virtually all of them: Anthem, United Healthcare, EmblemHealth of New York, Cigna, and Aetna. I could go on an on about what each company does differently, and how I navigated that, but the point is that patients must look out for their own costs. Insurance and PBM's are NOT looking out for you; they are more concerned with lining their own pockets so patients must navigate this dysfunctional system on their own.

These methods may help.

On the bright side, I am optimistic that the Civica Rx biosimilar insulin deal on insulin glargine, lispro and aspart. They have a website at https://www.civicainsulin.org/ (I blogged about the Civica Rx announcement HERE) which has potential to truly disrupt the dysfunctional status quo. In fact, the New England Journal of Medicine covered that in this month's issue. See their coverage at https://www.nejm.org/doi/full/10.1056/NEJMp2203001 (note: if you're not a NEJM subscriber, as your doctor for a copy of the article; they likely subscribe or can get the article text for you if you asked them nicely).

Wednesday, March 23, 2022

My Recent Podcast on "The Diabetes Way"

A frequent complaint about U.S. prescription drug prices is it is difficult to explain WHY the prices here are so high. A frequent pharma answer to the question WHY is this happening is "it's complicated". They aren't kidding. It IS complicated. But today, there are tools on the internet which can help many people navigate the dysfunctional U.S. system without being taken to the cleaners. I recently did a podcast about that which might be worth listening to. But it's helpful to understand how I became the guy the podcasters wanted to interview about the subject.

Back in September 2021, I was invited as a guest to speak with Diabetic Investor David Kliff on his Wacky World of Diabetes podcast where we talked-shop about diabetes stuff and what I was doing. David admitted that he follows me on Twitter and occasionally enjoys some of my short commentary associated with news on the diabetes front. He is also making an effort to interview more diabetes patients in his podcast. I was featured in an episode entitled "A No-Nonsense Perspective on the Business of Insulin with Scott Strumello" (catch the podcast at https://diabeticinvestor.com/its-podcast-day/). Among the topics we talked about was the insulin pricing crisis and how the dual branded/unbranded strategy deployed by Lilly (and to a slightly lesser extent Novo Nordisk) for rapid-acting analogues seemed to be a solution which worked effectively for some people (if the patients actually KNEW the option existed; the companies have invested no resources in marketing those). In recent years, my focus was on runaway out-of-pocket insulin costs because I was directly impacted by the issue. I was covered under an employer-sponsored healthcare insurance plan which had an individual deductible of more than $2,000 which I had to satisfy before I received any pharmacy benefit.

Pharmacy retail prices for cash-payers are artificially-inflated (on all drugs, not just insulin) due to PBM contracts with drugstores (drugstores are forced to contract with PBM's or they would have zero business). I mentioned how in 2019, Lilly and Novo Nordisk each announced plans to introduce unbranded (so-called "authorized generic") versions of Humalog and Novolog (respectively) starting in 2020 (Sanofi did not). 

The initial hype around these was the products would retail for half-price, but savvy patients quickly discovered they could buy Lilly Insulin Lispro and Novo Nordisk Insulin Aspart for 75% off the bogus cash retail price using readily-available GoodRx coupons. Lilly subsequently reduced prices on Lilly Insulin Lispro even further (see the company press release HERE) and today, patients can get Lilly Insulin Lispro for about $35/vial with a readily-available Lilly manufacturer coupon (visit https://www.insulinaffordability.com/ and click the relevant button to download one of the discount cards (the manufacturer coupons work on all Lilly insulin varieties, including the company's insulin glargine biosimilar branded as Basaglar). No personal information was required to get the manufacturer coupon. Alternatively, you can simply use a GoodRx coupon and buy Lilly Insulin Lispro for $43.43/vial.

Since being introduced, Lilly's CEO Dave Ricks has told Lilly investors that at least 30% of all Humalog sales in the U.S. are the "unbranded" version called Lilly Insulin Lispro. Also, Lilly investor presentations show that Lilly Insulin Lispro is now generating most of the product's growth in the U.S. market.

Novo Nordisk did not follow Lilly's decision to further reduce prices of Novo Nordisk Insulin Aspart. But that did not stop Novo Nordisk A/S from bragging to investors in its Q4 2021 investor presentation (see the archived presentation at https://seekingalpha.com/article/4483536-novo-nordisk-s-2021-q4-results-earnings-call-presentation and visit slide #135) about how "In 2021, more than 1 million people were reached by Novo Nordisk insulin affordability offerings in the US".

That's a rather curious point of pride for Novo Nordisk to brag about to investors. Instead of interpreting that to mean that the company has a helpless addiction to PBM rebates needed to secure commercial healthcare insurance company drug formulary placement, it should be a point worthy of reflecting about how badly the company's U.S. business is broken and the reason its insulin margins are so low and continue declining. But instead, the Danish company boasted to investors about how comprehensive its U.S. affordability options are.

Anyway, David Kliff manages his Wacky World of Diabetes podcast in a way I rather like: he EDITS his podcasts for organization and clarity (even though they are recorded in a way that flows naturally like a real conversation) so the podcast follows a flow for listeners to follow the discussion, and hopefully walks away more informed about whatever topic was discussed.

Shortly after my visit to David's Wacky World of Diabetes podcast, he informed me of a new website he and a woman named Amber Clour (who's a diabetes podcaster in her own right) were starting called The Diabetes Way https://thediabetesway.com/ which they describe as:


 

 

 

 

 

 

 

 


 



"A unique approach in how we think about diabetes, including answers to questions, a candid podcast and blog, resources and tools, surveys, trivia, rewards ... all delivered with a lighthearted approach".

 


 

 

 

 

 

 

As noted, David also introduced me to his partner in the venture Amber Clour (a fellow T1D), and we all did a podcast called The Dave and Amber Show for The Diabetes Way on March 14, 2022. You can listen to that podcast below, or by visiting https://thediabetesway.com/podcast/fighting-rising-drug-prices.html. But my topic this time around was about how PBM's are now cannibalizing their own plan-sponsor clients with coupon-generating websites and apps and how patients can take advantage of that cannibalistic behavior for their own financial benefit.





I also helped to co-write a relevant blog post which provides a number of useful links which we discussed in that podcast. To read it and catch the links, visit https://thediabetesway.com/blog/whats-behind-the-diabetes-drug-cost-curtain-1.html for the details.

Monday, March 07, 2022

Generic Glucagon for $200, Where's the Savings? Get it for $5...WITH a coupon

In December 2020, the U.S. FDA approved several long-delayed generic versions of traditional mix-and-inject form of glucagon emergency kits. Among them were from Amphastar Pharmaceuticals, Inc. of Rancho Cucamonga, CA https://www.globenewswire.com/news-release/2020/12/29/2151177/0/en/Amphastar-Announces-Approval-for-Glucagon-for-Injection-Kit-1mg.html which was the very first, followed by another from Fresenius Kabi USA based in Lake Zurich, IL (in suburban Chicago, the parent company is based outside of Frankfurt Germany) https://www.businesswire.com/news/home/20200205005106/en/Fresenius-Kabi-Introduces-Glucagon-Emergency-Medicine-Kit.



 


 

 

 

 

 

 

 


Sally Choe, Ph.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, noted the approval was a major step forward for people with diabetes. 

"Glucagon for injection has been approved for use in the U.S. for more than 20 years [blogger note: it's actually been on the market nearly 50 years; the same old-school kits were the ones my parents had when I was a child, although they weren't biosynthetic versions back then], but until today, there has been no approved generic of this important drug that can save the lives of people who may experience the serious condition of very low blood sugar," she said in a statement.

The FDA statement suggests that FDA approvals for other generics would be a straightforward matter, but without visit to the FDA orange book, I'm not sure there are any others right now.

The FDA decisions on generic glucagon were a very long-overdue move to lower prices, rather than innovating on glucagon, which has traditionally been a very cumbersome and inconvenient treatment. Given a choice, most patients or caregivers would prefer the newer glucagon autoinjector hypopens from Xeris or Zealand Pharma which are far more convenient for caregivers to use because neither requires reconstitution which the old-school kits require (and let's face it, by the time patients need glucagon, they usually can't give it to themselves).

FDA's own research proves that greater competition among generic drug makers is associated with lower overall generic drug prices. For products with a single generic producer, the generic Average Manufacturer Prices (AMP) reported to the Centers for Medicare and Medicaid Services (CMS) comes in 39% lower than the brand AMP before generic competition, compared to a 31% reduction using invoice prices. With two competitors, generic prices are 54% lower. With four competitors, generic prices are 79% less. With six or more competitors, generic prices using show price reductions of more than 95% compared to brand prices. 

Accordingly, old-school glucagon emergency kits should be priced about 54% less than Lilly's or Novo Nordisk's glucagon emergency kits. That doesn't appear to be true on glucagon emergency kits, which is victimized by the PBM rebate scheme which also impacts insulin. So far, prices on the newer generic glucagon kits are only marginally lower (IF they are even lower; sometimes they are not) than the brand-name old-school products from Lilly and Novo Nordisk. 

For example, the prices for the Fresenius Kabi glucagon kits sell for about $200.00 a kit (or even more) compared to the average prices for the branded products from Lilly and Novo Nordisk, which are now priced about $209.25 assuming one uses a GoodRx coupon to get the lower price from a local pharmacy. McKesson's ScriptHero (which is powered internally by CoverMyMeds, SingleCare and the PBM MedImpact's own ScriptSave WellRx) won the lowest price, coming in at $127.37 at Walgreens. Currently, manufacturer coupons on Zegalogue pens brings the cost of that down to about $25.00 for a 2-pack. Based on my review of the coupon fine-print, I also believe that Zealand Pharma's Zegalogue coupon also works for non-insured cash-paying customers; many coupon offers exclude cash-payers, so this one is different.

Still, one must ask why FDA had done absolutely nothing until December 2020? Something was badly broken about that.

Patients with commercial healthcare insurance CAN now get the Fresenius Kabi glucagon kit for a mere $5.00 with a coupon https://kabicare.us/wp-content/themes/kabicare/documents/Glucagon-Emergency-Kit-CoPay-Saving-Card.pdf so the cost is very reasonable with that. I'm not certain why there's a Medicare/Medicaid/VA exclusion, but most coupons seem to try excluding those (that said, the coupon does appear to work for cash-payers up to a maximum dollar amount), but one part I don't understand is why it even requires a coupon to get that price? 

It's a GENERIC! 

Aren't generics SUPPOSED to be much cheaper in the first place?

We know that ongoing FDA inaction on generics, combined with FDA prioritization of newer, branded products, is a reason prices still remain sky-high on old-school glucagon rescue kits. Especially now that multiple generic versions are available. Let's face it: there's no reason for an old-school generic glucagon product first developed in the 1930's should cost patients nearly $200.00, and yet that's the case in the badly-broken U.S. prescription drug market. Why?!

In the end, its yet another example of how completely dysfunctional the U.S. prescription drug market really is.

Author P.S., March 18, 2022: Since this post, I reached out to a several people who might be in a position to influence Civica Rx to also include old-school, mix-and-inject glucagon rescue kits along with insulin when it anticipates a launch in early 2024. I heard back from virtually all of them, specifically people at Civica Rx and JDRF's CEO Aaron Kowalski. The consensus was the same for all of them: "Good idea. Glucagon rescue kits are not new, nor are they innovative like new  Xeris Gvoke or Zealand Pharma's Zegalogue products (and maybe Lilly's Baqsimi) are, yet they are all victimized by the same rebate-driven market dysfunction, and in spite of several generics, prices on these are all stubbornly high, therefore it makes sense to also consider mix-and-inject glucagon rescue kits." Watch this space!

Thursday, March 03, 2022

Civica Rx: We're Entering the U.S. Insulin Biosimilar Business!

This morning, I woke up and unplugged my phone from its charger, and went to close Twitter (which I forgot to close last night before I went to bed) and at the top was a press release from Civica Rx. The press release is here: Civica to Manufacture and Distribute Affordable Insulin http://dlvr.it/SL0QZV 

The news was greeted as a welcome development by JDRF, Beyond Type 1 and the Helmsley Charitable Trust to name a few. The ADA said nothing formally about it as of 10:00 AM. In essence, Civica Rx says it plans to sell biosimilar versions of Lantus, Humalog and Novolog. 

As usual, there's a lot of details unpack here. 

Here are some details you aren't likely to get elsewhere. 















One highlight is that Civica Rx isn't selling anything...yet. The company expects to do so starting in 2024 assuming it encounters no unexpected approval delays. The company announced a while back that it was creating an operating unit called CivicaScript dedicated to lowering the cost of select high-cost generic medicines at the pharmacy counter. 

It is following a "cost-plus" (which is the actual cost plus a limited margin) model similar to others such as Mark Cuban's CostPlus Drug Company startup (which could also offer insulin biosimilars, but hasn't committed to doing so), but Civica says it will require that retailers sell its insulin biosimilars for "no more than" $30/vial, or $55 for a pack of 5 pens". Civica already has a website for the insulin products at https://civicainsulin.org/. Civica Rx also published a detailed fact sheet at https://www.civicainsulin.org/wp-content/uploads/2022/03/Civica-Insulin-Announcement-Fact-Sheet.pdf which I encourage you to read. 

Civica has some advantages over other biosimilar makers. For one thing, it will be packaging the insulin in the U.S. state of Virginia (it appears to be still making the insulin in bulk offshore in India, at least initially), but the fill & finish is definitely being handled domestically. The overwhelming strategy of biosimilar-makers (so far) has been to work within the rebate-driven mess that defines the U.S. insulin market. The reason they need to do it offshore is so the margins are high enough, and then using those margins to pay rebates in order to bribe (I mean pay "rebates") to PBM's to "prefer" the biosimilar insulin brands over the innovator brand-name products. They're forced to make the drugs offshore in places like China or Malaysia. But by avoiding the rebate-driven mess, Civica can use the savings to pass them along to patients instead.

Rival biosimilar manufacturer Viatris/Biocon are already doing just that with the Lantus biosimilar branded as Semglee, which Drug Channels says Viatris proudly announced that Semglee would become the "first-ever interchangeable insulin biosimilar preferred on Express Scripts' largest formulary. Currently, that gives Semglee an exclusive, 12-month period to be the only "interchangeable" biosimilar of Lantus. For 2022, the branded Semglee product will be on Express Scripts’ National Preferred Formulary (NPF). The NPF is Express Scripts' largest commercial formulary, with more than 28 million lives. Express Scripts also highlighted the exclusion of the Lantus reference product from its NPF. Put another way: Viatris had to nearly triple the list price of Semglee before Express Scripts would add the product to its formulary." 

Drug Channels adds: "Rival PBM Prime Therapeutics also added Semglee over Lantus to its drug formularies". But Drug Channels notes: "For Prime Therapeutics' 33 million members, both the branded and unbranded versions will have comparable formulary placement. (Lantus will be excluded.) Prime's press release states: "we are not beholden to rebates, as we're able to also prefer the lowest net cost therapy." Adam Fein who is the principal author of the Drug Channels blog says: "I interpret that statement to mean that the net costs are comparable for the two versions." 

A few companies now deploying semi-successful work-arounds using the dual branded/unbranded strategy whereby a high-price/high-rebate branded version sells to PBM's, and another identical "unbranded" version of the same product with a different NDC number are already on the market now. Both Lilly and Novo Nordisk are already doing this for their Humalog and Novolog innovator products, and their unbranded products can be purchased for cash at prices which are about 75% less than the rebated products (to get them for 75% off, patients must use coupons, such as from the manufacturer or a firm like GoodRx). But the companies are NOT doing the dual strategy for a host of other insulin varieties they sell, including their newest (and still patent-protected) prandial insulin varieties known as Novo Nordisk Fiasp (the name means "Faster Insulin Aspart") and Lilly Lyumjev. 

Similarly,  Novo Nordisk's is not selling any unbranded versions of its basal insulin varieties, including Levemir and Tresiba, nor does Lilly's own Lantus biosimilar branded as Basaglar sell an unbranded version. Novo Nordisk also questionably sells a more costly version of Novolog merchandised as Walmart Relion Novolog which sells for MORE money than Novo Nordisk Insulin Aspart sells for at WalGREENS with a GoodRx coupon, raising questions about exactly how "affordable" the Walmart co-branded variety of that insulin actually is. More likely, that is simply padding Novo Nordisk's bottom line. Biosimilar makers including Biocon are now also planning to deploy the same branded/unbranded strategy for a biosimilar of Novo Nordisk's now out-of-patent Novolog (Biocon has a version of aspart now working its way through the FDA approval process). 





Civica doesn't appear to want to play the PBM rebate game at all, which is to its (and patients') benefit. It seems that it will sell insulin varieties sold through pharmacies and then directly to consumers. 

Based on Civica Rx's actions and statements, it appears to want to bypass the PBM's completely. For patients this means lower, more-predictable out-of-pocket costs for medicines needed for survival. Patients can ask their doctors to prescribe insulin under the generic drug name, enabling the patient to switch from the unbranded and/or biosimilar branded to the innovator branded versions once any deductible has been satisfied. 

With any luck, more insurance plans will eventually adopt the 2019 IRS guidelines which classifies insulin as a "preventative" treatment eligible for pre-deductible coverage, although I'm still forced to use the insulin brand my insurance company "prefers" due to rebates. My (pre-deductible!) insulin cost is actually quite reasonable; but if Civica Rx's price is $30/vial, it could still potentially be cheaper for me to buy that product than the formulary brand my insurance says I should be using. I would likely choose to use insulin lispro over insulin aspart (which is Aetna's preferred brand right now). Unclear is if Lilly might respond by further reducing prices on its own "authorized generic" Lilly Insulin Lispro. The company has already reduced prices by an additional 40%, and its theoretically possible it would (and COULD) reduce its prices to be comparable. Right now, they are collecting as much as the company thinks it can.

You may recall that Civica Rx is a startup drug company based in the Salt Lake City, UT area which was launched by seven health systems/nonprofit hospital chains along with philanthropic funding. It was formed four years ago with philanthropic backing from the Arnold Foundation (a Texas-based nonprofit bankrolled by multibillionaire John D. Arnold, whose Arnold Ventures LLC also helps to fund a number of other nonprofits in the healthcare space, including T1International and David Mitchell's Patients for Affordable Drugs) and a few others. Civica Rx was started in response to repeated shortages for drugs hospitals rely on but were oddly in very short supply. Among them: IV bags of saline (which is basically sterile salt water) which curiously experienced acute shortages a few years ago.

Civica Rx's press release today was a validation of something which the startup had been hinting it was thinking about doing for the past few years: Civica Rx has officially announced it intends to sell its own biosimilar versions of three widely-prescribed insulin analogue brands at no more than $30 a vial, or $55 for a box of five pen cartridges which it says is for people with or without insurance. However, based on the company's statements, the insulin will not become available until early 2024, while a manufacturing facility is completed and regulatory approvals are obtained. It also says it will start with insulin glargine, which already has several biosimilars, but those are curiously expensive. But a number of others are now pending FDA approval, so perhaps the Civica price will be a differentiator. 

The Civica Rx insulin biosimilars will reportedly be produced in partnership with GeneSys Biologics (a privately-held Indian biotech firm which is based in Hyderabad, India) at Civica's 140,000 square-foot "fill & finish" facility, now being built in the vicinity of 2820 N Normandy Dr Petersburg, VA 23805 (just south of the state capital Richmond). The facility is expected to be operational in early 2024. Civica also says that as a result of its partnership with GeneSys Biologics, it will have exclusive rights in the U.S. to market and sell these three insulin biosimilars at costs that will be substantially lower than what's currently available in the U.S. 











Based on the information in the press release, it appears the biosimilar insulin varieties that Civica Rx plans to market might actually be manufactured (cultured in bioreactors) in bulk offshore at GeneSys Biologics Pvt. Ltd. facilities in Hyderabad, India (located about 450 miles away from Mumbai). Hyderabad reportedly manufactures about one-third of India's bulk drugs. The actual GenSys Biologics manufacturing facility is located separately (the address can be found HERE) from the privately-held company's executive offices, but are still quite nearby.  Its unclear whether Civica Rx's Petersburg, Virginia factory will simply be a "fill & finish" facility whereby bulk drugs are packaged and labeled for sale to consumers, or whether there are longer-term plans to actually manufacture the insulin someday in Virginia with GenSys Biologics' assistance. That's what most biosimilars do so the margins are large enough to pay bribes to PBM's in the form of cash rebates to secure formulary placement. That not-so-little problem badly needs disruption.  

This much seems abundantly clear: U.S. insulin prices are badly distorted because of the PBM rebates needed to secure formulary placement. But if costs can bypass that mess, there is room for Civica's model to be successful. 

India-based Biocon recently announced plans to acquire its partner's half of its partnership with Viatris for $3.335 billion. Viatris has been under pressure from investors to shore-up the company's balance sheet and to start repaying some of its substantial debts. 

Kiran Mazumdar-Shaw, Biocon's executive chair said in an interview that Biocon Biologics' acquisition "Fills the gap in our missing capabilities in developed markets, especially around supply chain and commercialization". 

News outlets also reported that for the next two years, Viatris will continue providing commercial and other transition services before turning things over fully to Biocon. Rajiv Malik, president and CEO of Viatris, will also join Biocon Biologics' board. 

As noted, the two companies are already commercializing an FDA-designated "interchangeable" insulin biosimilar to Sanofi's Lantus (U-100 insulin glargine) branded as Semglee (the FDA designation as "interchangeable" is a meaningless distinction because PBM's routinely force patients to switch between non-interchangeable insulins regardless of whether they are designated as interchangeable or not). 

The "interchangeable" designation is relevant mainly to drug companies which want the ability for pharmacists to switch their products without the doctors' permission, but "therapeutically equivalent" non-interchangeable product switches by PBM's happen all the time (switching patients from Humalog to Novolog, for example because the PBM is paid a bigger rebate; the products are NOT the same), combined with a second, unbranded version called simply Viatris Insulin Glargine which avoids the costly rebate problem is the work-around. It does work and enables less-costly products to be sold in pharmacies with lower out-of-pocket costs. 

The Semglee/Glargine biosimilar products are manufactured in a massive factory Biocon set up that's located in Johor, Malaysia not far from the Singapore border. The dual branded/unbranded biosimilar strategy was developed largely thanks to Viatris ability to successfully navigate the peculiarities of the U.S. market for pharmaceuticals and the PBM rebate mess that now exists. Other biosimilar joint partnerships, such as Lannett Company, Inc. and China's HEC seem to be pursuing the same strategy as Biocon and Viatris followed using what they did as a guide for commercialization success. They use cheaper, offshore manufacturing to enable lower manufacturing costs to accommodate massive rebates needed to bribe PBM's to "prefer" their products over the innovators'. 

The two companies (Biocon and Viatris) already have a version of insulin aspart (innovator brand-name: Novolog) now proceeding through the FDA-approval process. In January 2022, the application received a complete response letter (CRL) from the FDA for the biologics license application (BLA) for Insulin Aspart which was filed by Viatris. 

The CRL on insulin aspart did not identify any outstanding scientific issues with the product, but Biocon did not provide any other specifics in its statement. The company said it intends to respond to the FDA’s requests but did not elaborate further. But in a follow-up to the announcement, CNBC reported that the CRL had to do with process data provided by the companies. In an interview with the news outlet, Kiran Mazumdar-Shaw of Biocon, said that the FDA informed the companies that its BLA was "incomplete". Exactly what made it incomplete was not disclosed. The insulin aspart product already sells in Europe under the brand-name Kirsty (it was previously branded as Kixelle). 

Beyond Kirsty, Biocon and Viatris also have a U-300 version of insulin glargine in development. Innovator Sanofi calls that insulin variety Toujeo which contains 3x as much insulin in each unit and that is also now working its way through FDA approval. That's slightly behind in development relative to insulin aspart (the Novolog biosimilar), but is expected to follow. Toujeo mainly targets the insulin-resistant Type 2 population, but is really little more than a much higher-concentration version of U-100 insulin glargine branded as Lantus. 

Meanwhile, the Biocon-manufactured insulin biosimilars now selling in the U.S. at different price-points in the U.S. thanks to the PBM-rebate mess. For example, while the list price for insulin glargine-yfgn (which is the generic drug name used for Biocon's Lantus copy) ranges from $62.19/vial at Rite-Aid pharmacies to $104.49/vial at Walgreens. But Walgreens is now promoting its own Walgreens Prescription Savings Club which it charges $20/year for individuals or $35 family each year, and under that program, is currently selling Viatris Insulin Glargine as a vial for $71.99 and a box of five pens for $84.99. The price for pens is good but its a rip-off for a vial of glargine insulin.

Walgreens Savings Club's prices on insulin pens, in particular, are quite competitive (but patients have to pay an annual fee to get the price). Patients can buy vials of glargine (or maybe Semglee?) for even less by using an InsideRx coupon and buying from Express Scripts Cash-Pay Mail Order Pharmacy by InsideRx for $67.94/vial. Note that Express Scripts only accepts e-scripts from cash-paying customers. 

For whatever reason, the prevailing insulin manufacturer mindset seems to be that glargine should mainly be sold in more costly insulin pens. For example, I think Lilly's Basaglar only comes in pens, not vials. Some may be as a way to avoid patient and doctor resistance among insulin-na├»ve Type 2 patients as pens are possibly viewed by manufacturers as being less threatening than vials and syringes, But the cost differential to patients is significant: insulin pens cost about one-third more money even though patients only use them once per day and do not need portability as they do with prandial insulin varieties. As a long-term T1D, I'm not really bothered by injections (I've been doing them for 46 years), and have found cheaper vials are an effective way to slash prices on insulin because you receive more insulin on a per-unit basis than you do with costly pens. 

But the Civica Rx announcement is the first of what will hopefully be several startups which aim to cut out the expensive PBM middlemen and slash patient out-of-pocket. It's possible that others, including the Mark Cuban CostPlus Drug Company could also pursue the same strategy of bypassing PBM's on insulin (maybe?) which increase (not decrease) costs for all involved. 

But the success of the Civica Rx insulin venture may determine if they decide copy other insulin varieties. 

While some are still patent protected, others like Sanofi's rapid-acting Apidra (U-100 insulin glulisine rDNA origin) could also be added if enough consumers buy Civica Glargine, Lispro and Aspart and whose patents have already expired.

Sanofi's Apidra is the last of the first three FDA-approved prandial insulin analogue varieties from the 1990's. I used it myself a number of years ago. In terms of speed, I found Apidra fell in between Humalog which is still fastest (even faster than Novo Nordisk Fiasp) but not quite as slow as Novolog or Fiasp are, which have much slower peaks of activity. But it was a competent rapid-acting analogue and some may find its time-activity profile works better for them than Humalog or Novolog (not certain how it compares to Lyumjev).

Today, hardly anyone in the U.S. uses Aprida these days because Sanofi was focused solely on selling Lantus and Sanofi salespeople never really talked to doctors about Apidra and many patients are unaware of its existence. 

I applaud Civica Rx's announcement. If its prices are what they promise, it will be less than my own co-pay now is, meaning it will still be a less costly option than the "preferred" formulary brand of my insurance company. That's a great disruption IMHO!

Author P.S., March 15, 2022: Since I originally published this post, on March 15, 2022, Scott Benner's Juicebox Podcast: Type 1 Diabetes interviewed JDRF CEO Aaron Kowalski about how the Civica Rx announcement came about, and some more details about that partnership. I particularly enjoyed the discussion Aaron Kowalski had about how he believed it was necessary for JDRF to actually manufacture insulin given that the market had proven impervious to efforts to market reforms to the Rx rebate-driven market dysfunction and the conversation he had about that with the JDRF Board. Listen to his podcast by visiting https://podcasts.apple.com/us/podcast/juicebox-podcast-type-1-diabetes/id962416631?i=1000554077747.

Author P.S., March 29, 2022:  On March 29, 2022, D-Mom and Podcaster Stacey Simms' podcast called Diabetes Connections also interviewed JDRF CEO Aaron Kowalski. Her questions were slightly different from those of Scott Benner, hence I recommend listening to her interview as well since it provides greater understanding of the Civica Rx insulin announcement and how that will actually work. Listen to that particular podcast by visiting https://diabetes-connections.com/i-think-we-have-an-answer-jdrfs-ceo-explains-the-plan-for-non-profit-insulin/.