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" 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 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 boasts to investors that the company's "affordability options" in the U.S. supposedly helped over 1 million 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. In just 2 years, nearly a third of Humalog sales are the un-branded, un-rebated version of the product. Apparently, it's cheaper for Lilly to sell an unrebated version of the product than it is to bribe PBM's with 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 glargine biosimilar, nor on its 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.

The Civica Rx move stands to fundamentally disrupt what could arguably be called a price-fixing racket 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 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.

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's still making the insulin in bulk offshore in India), but the fill & finish is 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. 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 where 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 GoodRx coupons). 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 versions 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'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 co-pay is now $35 (pre-deductible!); but if Civica Rx's price is $30/vial, it would still 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 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. 











The biosimilar insulin varieties that Civica Rx plans to market will 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.    

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). 

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 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 pharmceuticals and the PBM rebate mess that now exists. Other biosimilar joint partnerships, such as Lannett Company, Inc. and China's HEC are 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 slower than Novolog or Fiasp 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/.

Sunday, February 06, 2022

Welldyne's WellCardRx Discount Card/App: Another PBM-Powered Discount Card

In several recent posts during the past few years, I've addressed the emergence of prescription drug discount cards and apps. Perhaps the most notable post on that can be seen HERE.









Much of that began with the company known as GoodRx Holdings, Inc., but a downside to GoodRx is because it only has access to a single formulary (most PBM's typically merchandise a high-price/high-rebate formulary which benefits the PBM, as well as other formularies demanded by big clients which tend to favor lower cost generic drugs) offered by each PBM it does business with, that also means it may not have access to the other formularies which mainly preference generic drugs, hence GoodRx's prices on many generics, quite frankly, stink. That's when I discovered a work-around of sorts.

Using the PBM known as Express Scripts (now a wholly-owned business unit of the commercial healthcare insurance company Cigna, which the company refers to as its "Evernorth" business unit, perhaps because the PBM name had become kind of toxic and a different name helps investors realize that different management is now running the business) as an example, the Express Scripts formulary GoodRx has access to is quite evidently the largest formulary offered by Express Scripts which is called the Express Scripts' National Preferred Formulary (NPF). That is it's largest commercial formulary, with more than 28 million covered lives and that formulary tends to favor high-price/high-rebate drugs. Meanwhile, it offers a completely different formulary called the Express Scripts' National Preferred Flex Formulary, tends to favor drugs with lower list prices (generics) over the high-list/high-rebate versions of drugs, and the Flex formulary is notably excluded from GoodRx.

That said, patients can still access the Express Scripts' National Preferred Flex Formulary via the company's own coupon-generating website/app known as InsideRx. I have found that its Express Scripts Mail Order Pharmacy by InsideRx (which is a cash-pay pharmacy) is sometimes the low-price leader on some generic drugs. Rivals OptumRx (owned by United Healthcare) called OptumPerks https://perks.optum.com/ and MedImpact (which is de facto controlled by Kaiser Permanente) which owns/operates ScriptSave WellRx https://www.wellrx.com/ and Americas Pharmacy https://www.americaspharmacy.com/ each offer their own coupon-generating websites/apps.

One PBM I failed to acknowledge the PBM known as Welldyne Rx, Inc. (and its subsidiary WellDyneRx LLC), which is one of the few PBM's which still publishes an annual drug trend report which isn't pure fiction or PR fluff. Its 2021 Drug Trend Report can be viewed at https://welldyne.com/wordpress/uploads/2021/06/WellDyne-2021-Drug-Trend-Report.pdf. Welldyne has a coupon-generating website/app of its own, and it may be worth including among those you search. The reason I omitted it is because it is not currently even in the top 7 of PBM's by volume of prescriptions processed. Still, Welldyne is a PBM and it, like several of its bigger rivals, also offers a discount card/app. In fact, the only big PBM's which I don't believe offers discount card programs of their own are CVS Health, and Humana. Maybe they do, or maybe they have ones in development, I simply don't know about them.

Drug Channels lists the top PBM's by market share HERE. For the ease of simplicity, the following slide is courtesy of the Drug Channels institute (I am acknowledging them as the source and including a link to it above).









As noted, much like its bigger PBM rivals Express Scripts, OptumRx and MedImpact, a smaller PBM named WellDyneRx also has a discount card program, although it was moderately more difficult for me to find and use. For example, Welldyne's corporate website barely even acknowledges the existence of a discount card. That may be by design (maybe?). Not every PBM (including MedImpact) acknowledges coupon card programs because they effectively help cannibalize access to the PBM's discounted drugs by anyone with a card, including an individual whose employer hires Welldyne as its PBM, but has a high-deductible insurance plan which requires the covered individual to satisfy a substantial deductible before they are eligible to use pharmacy benefits. 

Think of it this way: 

Suppose Employer A has insurance thru Anthem, but hires Welldyne as its PBM. That happens. But if Employer A says that a covered individual must first satisfy a deductible of $2,000 before pharmacy benefits kick in, it means the patient is effectively on his/her own to buy prescription drugs until they've satisfied that $2,000 deductible. Instead, the PBM rebates are being given to employers as "premium offsets" rather than going towards patient relief in terms of pharmacy benefits. That happens routinely today.

It happens all the time with companies like Cigna/Evernorth-Express Scripts, United Healthcare-OptumRx, and Aetna (a subsidiary of CVS Health) and its Caremark PBM business. Yet all of these companies' PBM's (except CVS Health's Caremark) are willing to sell access to their drug discount services to anyone with a coupon-card/app, effectively cannibalizing Employer A's pharmacy benefits. Right now, nothing stops that from happening. And, I don't think they could stop it even if they wanted to because the PBM has no knowledge of HR records to know when an individual starts at a company or leaves, even if the corporate parent is exactly the same. So,  the PBM discount cards are marketed kind of quietly, on the down-low in order to avoid potential litigation from entities like Employer A.

I tell people with employer-sponsored, high-deductible insurance plans with (for example) United Healthcare which cover virtually no prescriptions until they satisfy substantial deductibles two things:

First, buying drugs at artificially-inflated pharmacy cash prices does not meaningfully satisfy their deductibles. Yes, it contributes SOMETHING, but not nearly as much as they've been led to believe. For example, they might be paying $23.40 to buy 90 tablets of the generic statin rosuvastin calcium (generic Crestor), but they are only being credited about $4.50 for that purchase. The problem is insurance doesn't have to disclose how much pharmacy purchases contribute towards satisfying your deductible. That's a big disconnect. But we know with certainty that's happening all the time. And, they can even use OptumPerks to buy that drug at a deeply-discounted price from Optum! The same is true with Cigna's Express Scripts/InsideRx arrangement.

Second, the solution to their Rx affordability problem is for patients to buy the prescriptions using coupons (many coupons are from the PBM's themselves). The other reality is medical services (doctor's visits, hospitalizations, lab-work (if not covered), etc. will help them satisfy the deductible much sooner than drug purchases will under almost any circumstances because money is being taken away from patient relief by the insurance company to sell more policies. That's pretty sleazy.

Anyway, back to one coupon-generating website/app I forgot to include was one by the PBM Welldyne, The Welldyne coupon card/app is called WellCardRx. Its website is located at https://wellcardrx.com/


To access it, the company also requires you to complete a form requesting some basic personal information including your name, address and email address. Visit https://wellcardrx.com/get-a-card/ to enroll. One slight oddity is the presence of a field which must be answered called "Referring Group ID", and individuals are required to enter a valid value in that field for the company to send you an active card. However, the tiny text at the bottom of the footnote to that information says:

In order for your card to be active, you will have to write-in (or type-in on the online form) a "Referring Group ID" on the card. If you don't have a "Referring Group ID" (and most people won't unless their employer insurance plan-sponsor has hired Welldyne as its PBM) but the "default" value for this field for individuals whose healthcare plans do NOT use Welldyne Rx as their PBM is: WDRXDEF.

Also, the company says that for the "Member ID" field, individuals may use their 10-digit phone #, followed by a 2-digit person code. Those codes include: 01=Member, 02=Spouse, 03=Dependent, etc.

In summary, the key pieces of info (aside from your name) on your WellCardRx are the following:

Name 
Member ID Enter member's 10-digit phone #, add 2-digit person code.  01=Member, 02=Spouse, 03=Dependent, etc. 
BIN 008878
PCN WDN
Group ID WDRXDEF
Processor NetCard Systems 

To the best of my knowledge, Welldyne does not really "encourage" people to use of its own mail order pharmacy as say Express Scripts does, although I suppose one could try to use that if they are truly interested (and on small-molecule drugs like pills, it may be the easy option). 

Still, I did not notice significant discounts by going that route as I did with Cigna/Evernorth/Express Scripts' InsideRx. Many still find it easier to go to pharmacy near them. The site says "To have your prescriptions delivered to your home, enroll in Mail Order". The instructions will require you to enter both a "Referring Group ID" and a "Member ID" in accordance with the info. in the preceding paragraph. I believe because you are using a discount card, and not an insurance plan which uses Welldyne as its PBM, you likely will need this basic info. Welldyne Rx also does say your card must be activated but if you complete the info with the relevant Group ID noted about, and to enroll, they can call the PBM call center at 888-479-2000, its call center representatives are available 24/7 to assist.

That said, I encourage my readers to include WellDyne's WellCardRx https://wellcardrx.com/ to its list of rival coupon-generating websites/apps (among them: SingleCare https://www.singlecare.com/, GoodRx https://www.goodrx.com/, InsideRx https://www.insiderx.com/, OptumPerks https://perks.optum.com/, ScriptSave WellRx https://www.wellrx.com/, America's Pharmacy https://www.americaspharmacy.com/, BlinkHealth https://www.blinkhealth.com/ and ScriptHero https://www.scripthero.com/) to shop for discounted prescription drug prices. 

WellCardRx isn't quite as easy-to-use as some of its PBM-powered rivals, but it does appear to offer discounts on authorized-generic insulin (in particular, Lilly Insulin Lispro, not Novo Nordisk Insulin Aspart) but its true generic drug and eventually biosimilar prices are also worthy of searching. 

To search prices on WellCardRx, visit https://wellcardrx.com/start-saving-now/pharmacy-savings/ and go to the paragraph marked "Discount Pricing Tool" and select the link to see discount price estimates for prescription drugs in your area. It notes: "Discounted prices are estimates. Savings will be calculated at time of drug purchase."

Beware: you will be asked to enter the drug's name (also beware that some names cannot be found; if they cannot, try searching under the brand-name or drug class such as "insulin" until the name comes up automatically on the website or app) and you'll also need to enter the drug dosage/strength, frequency of dosage, how many units of the drug you're buying (such as tablets, vials of insulin or boxes of insulin pens), how frequently you refill the script, and your zip code. WellCardRx will then provide a list of about 5 pharmacies in your geographic area (based on zip code) plus its own mail-order pharmacy. The search functionality, if I'm being frank, is not great.

It's hard to believe, but Welldyne's site is slightly more cumbersome to use compared to Express Scripts InsideRx is (because that one's actually pretty buggy, although it has far better discounts than rival OptumRx's does). But it may be worth the effort. For example, Welldyne's WellCardRx appears to offer discounts on Lilly Insulin Lispro (the "authorized" generic). Of course, the site says that prices are estimates; you must check with your pharmacist to determine the actual price you'll be charged at the checkout counter. But there are enough prescription drug coupons to include WellCardRx among those you compare prices on.

Sunday, January 16, 2022

Discerning Hope from Hype Related to Novo Nordisk Glucose-Responsive Insulin

Below are excerpts from an investor report on Novo Nordisk from the Wall Street investment bank known as Credit Suisse (the New York-based research business of the Swiss banking giant which mainly serves billionaire clients was formerly known as First Boston). I will discern my take-aways as it pertains to the few notes about Novo Nordisk's much-hyped (by the company itself) glucose-responsive insulin. There is some progress, but it is by no means a done deal.  

On November 4, 2021, Credit Suisse attended a London sell-side meeting with Novo Nordisk A/S's Karsten Knudsen (CFO), Camilla Sylvest (EVP Commercial Strategy) and Martin Lange (EVP Development). Most of the dialogue was about the company's GLP business (Ozempic, Saxenda, Xultophy [iself a combo drug consisting of Novo's GLP-1 agonist and its basal insulin analogue degludec sold under the brand name Tresiba] and Wegovy -- all of which are New & Improved versions of the company's "original" GLP-1 agonist which was branded as Victoza, and that product was little more than an improved version of the biologic drug branded as Byetta which the old Amylin Pharmaceuticals commercialized before that company's ultimate demise; most of its intellectual property assets were acquired by AstraZeneca, although Lilly kept some developed during its joint venture with Amylin. Today, Lilly sells a new and improved version of its own GLP-1 agonist which is branded as Trulicity) and GLP-1 agonists and derivatives thereof now drive the vast majority of Novo Nordisk's current revenues in the U.S. and outside the U.S.

Insulin has largely become an afterthought to Novo Nordisk when it comes to to the company's bottom line. Still, Novo Nordisk began with insulin and still likes to boast that it's the world's largest insulin manufacturer (mostly because of relentless acquisitions made around the world, largely bankrolled by profits derived in the United States). Indeed, Novo Nordisk told investors that global insulin growth of 2% was still solid and that Novo Nordisk is taking global volume share, although the bottom-line impact of that has been offset by U.S. price declines. Novo Nordisk expects no changes to its insulin business as a result of the continued U.S. pricing pressures it faces. 75% of its U.S. insulin revenues are paid to PBM's to secure commercial healthcare insurance company formulary placement. 

Side-note: currently, there are a growing number of biosimilars of Novo Nordisk's current bestselling prandial insulin analogue, with approximately 4 now in development for Novo Nordisk's insulin aspart alone (including from Viatris/Biocon, Lannett/HEC, and Sandoz/Gan & Lee) which means Novo Nordisk really needs a hit with glucose-responsive insulin, because none of its basal insulin varieties have done very much to improve the company's bottom line.

In spite of the fact that GLP-1's now account for most of Novo Nordisk's revenues, Novo Nordisk is still investing in new insulin varieties. 

Aside from a once-weekly basal insulin Novo Nordisk calls Icodec (which seems to be targeting the massive Type 2 patient audience), another insulin variety the company is finally more seriously investing in glucose-responsive insulin. Novo Nordisk's glucose-responsive insulin is based mainly on technology the company acquired in 2018 when it bought at UK-based university startup called Ziylo. Ziylo's glucose binding molecules are synthetic molecules that were designed by University of Bristol (UK) Professor Anthony Davis. However, it was actually the University of Bristol acquisition which brought Novo Nordisk closer to making it happen, and so far, that seems to be working well, although it is still VERY early in development. So much for the myth that Novo Nordisk is a company which develops everything in-house!

The stable, synthetic molecules developed by the University of Bristol exhibit an unprecedented selectivity to glucose in complex environments such as blood. Still, Novo Nordisk was historically something of a patent troll when it came to glucose-responsive insulin. Over the years, Novo Nordisk has filed dozens of pre-emptive patients which were never really based on science, all in an effort to scare rivals from even pursuing the concept. 

Recall that in July 2021, rival Lilly made headlines of its own when that company acquired a Los Angeles-based startup called Protomer Technologies (see https://medcitynews.com/2021/07/eli-lilly-gets-glucose-sensing-smart-insulin-via-buyout-of-preclinical-protomer/ for the news). In November 2020, Lilly had led an equity investment in Protomer alongside the JDRF T1D Fund (Protomer received seed capital from JDRF, but T1D nonprofit is legally independent of JDRF T1D Fund and there is no management overlap; also the JDRF T1D Fund is largely bankrolled by a billionaire father named Sean Doherty and his desire to advance treatments for his T1D son named Finn). All told, Protomer raised $6.6 million seed financing. In July 2021, Lilly subsequently acquired the rest of Protomer that it did not already own. It is unclear how far Lilly's Protomer investment really is, although it is likely not very far behind the Novo Nordisk/Ziylo effort, which has only completed Phase I clinical trials and now must do some work before it goes to Phase II.

Back to Credit Suisse's November 2021 meeting with Novo Nordisk top execs. Novo Nordisk told Credit Suisse that its early Phase I clinical trials of glucose-responsive insulin had demonstrated good proof-of-principle, although the company admitted that the company still needs to refine it further before it can progress. More specifically, the company revealed that its Phase I trial results indicate the company needs to look at PK (Pharmacokinetic) properties before progressing. PK is the study of how the body interacts with administered substances for the entire duration of exposure. But Novo Nordisk reminded investors that PK analysis is not likely to be a major barrier because that's something Novo Nordisk is very good at.

The company also revealed that it would offer more details on its broadening technology platforms at its March 3, 2022 Capital Markets Day ("CMD") to be held in Copenhagen, Denmark. Perhaps more details will be revealed in that event.

There are no guarantees of course, but presuming everything works out as anticipated and there are no unpleasant Phase II or Phase III clinical trial results, this suggests serious development efforts are finally underway. If that happens, we could potentially see glucose-responsive insulin by 2035 because Novo Nordisk needs a hit in insulin (its basal insulin varieties were technologically successful, but none have achieved blockbuster status because they do not serve an unmet need, and now that rival Sanofi Lantus has seen patents expire, the new competitive dynamic is ever-lower prices which Novo Nordisk doesn't want to do). Still, I wouldn't hold my breath waiting for glucose-responsive insulin to happen just yet.