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Right Care Alliance Presentation
1.
Assessing Blame for
U.S. Insulin Prices Today Presented by: Scott Strumello November 15, 2020
2.
© 2020 Scott
Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020 › Some know me from my Twitter handle at https://twitter.com/sstrumello or the place I began my work in diabetes, a blog I call "Scott's Web Log" at https://blog.sstrumello.com which I started in Sept. 2005 at the encouragement of my friend (RIP), Deb Butterfield who authored the book "Showdown With Diabetes". My blog is still active, its just not updated as often as it once was. › I was diagnosed with autoimmune Type 1 diabetes (T1D) at age 7 in 1976 (you do the math). That also means I'll become eligible for a 50-year Joslin Medal in about 4 years, in 2026. › At the time of my diagnosis, the country was celebrating the American Bicentennial which was a big deal that year (hence the logo on the upper right side). My recollection of Independence Day that year was an unquenchable thirst and going to the bathroom every 15 minutes. – When I was diagnosed, we did not (yet) even have self-testing of blood glucose. We used Clinitest urine testing which was close to useless. But the standard treatment at the time was regular insulin injections (up to 4x/day) and following an exchange diet, but that was about it. The DCCT wouldn't be published until 1993, after I'd lived with T1D for >16 yrs. › I'm not a pharma defender or apologist, I currently have NO conflicts-of-interest, nor have I had any previously. Who Is Scott Strumello?
3.
© 2020 Scott
Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020 Patient Insulin Prices in the U.S. are Out-of-Control › Over the past decade alone, insulin prices have tripled in the U.S., while patient out-of- pocket costs per prescription more than doubled. › Peer-reviewed evidence from Yale University shows one-in-four U.S. patients with T1D are rationing their use of insulin because they cannot afford it. This is no surprise to patients.1 – The most dramatic statement we hear from patient advocacy organizations is: "We need to do better". Really?! › To better understand the situation, I investigated. I discovered that solving the question of where blame lies is like peeling an onion; whereby each layer is peeled away to reveal yet another layer that shares some responsibility for today's insulin prices. › There is PLENTY of blame to go around, but I believe the entity which deserves the most blame are the nation's commercial healthcare insurance companies, who are seldom (if ever) blamed for the problem. Insurance happens to be doing several things which significantly increases patient costs for insulin. In this presentation, I'll make the case why I think insurance rightfully deserves blame for runaway insulin prices. – Most notably, changes in benefit designs (specifically the advent of high-deductibles) means many patients have been regularly subjected to the bogus "wholesale acquisition costs" (a.k.a. list prices) for insulin which are higher here than in any other country on earth
4.
© 2020 Scott
Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020 Why does insulin cost more in the U.S. compared to everywhere else on earth? › First, I learned how pharma competes on price for insulin. Its not due to a lack of competition, but because of the manner in which pharma actually competes on price for formulary placement. Volume-based discounts are given in the form of secretive rebates paid to intermediaries in the drug distribution system. But it also enables Rx rebate money to be misused for other purposes, and that's exactly what's happened. › The most effective solution is legislative action. To date, 8 states (from red Utah to purple New Hampshire to blue Washington) have passed price caps into law, and a dozen more have introduced bills to cap insulin prices. While price caps leave underlying market dysfunction intact (and leave things like glucose testing supplies untouched), they force insurance plans to share the benefit of Rx rebates with patients whose purchases actually generated the rebates — which is the reason they work. – Public pressure is forcing states to fill a void left by the federal government › We'll discuss this more a bit later, but know that patient activism is working. After public shaming before Congress and a stream of bad press in late 2019 and early 2020, both Lilly and Novo Nordisk in 2020 launched "half-priced" authorized generic versions branded as U-100 Lilly Insulin Lispro and U-100 Novo Nordisk Insulin Aspart.2, 3 – Half-price was an arbitrary percentage; but we know from seeing the companies' quarterly earnings reports filed with the SEC throughout 2020 that neither company saw any adverse profit impact from the introductions of lower-cost products. So what took them so long?
5.
© 2020 Scott
Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020 "It's the Rx Rebates, Stupid!" › Realized "net" prices paid to drug companies for insulin have been flat or declining for at least 5 years (although companies in the space contend it has been going on since around 2003)5, yet patient prices are rising rapidly. The Drug Channels Institute estimated that in 2018, total pharma rebates were $166 billion, which increased to $185 billion in 2019. Certain classes of drugs including insulin are much more heavily-discounted thru rebates. We also know that rebates amount to about 70% of the list price for insulin4, 5. So where is all that money going? › As noted, pharma discounts on insulin happen thru undisclosed rebates paid to intermediaries in the drug distribution system, a practice the industry defends and protects as "trade secrets". They artificially raise the list price of insulin so they can give ever-bigger rebates to insurance co's who pay for most prescriptions. But insurance companies fail to share the prescription drug rebates with people with diabetes who generate those rebates. Instead, insurance is giving the insulin rebates to employers as "premium offsets" in order to sell more new policies. – Surveys reveal that more and more employers admit that they're increasingly 'hoarding' Rx rebates rather than sharing the savings with the covered employees whose very prescriptions generated the rebates › This is why former FDA commissioner Dr. Scott Gottlieb made headlines on March 7, 2018 at a conference organized by the health insurance industry known as the National Health Policy Conference of AHIP when he told the attendees (see https://cnb.cx/2y51uEb for details): “You're doing it wrong! Sick people aren't supposed to be subsidizing the healthy. That's exactly the opposite of what most people thought they were buying when they bought into the notion of having insurance." And yet, that is exactly what is happening today. › In September 2019, Aaron Kowalski, PhD and the CEO of the JDRF, wrote in a journal submission to the American Journal of Managed Care (see https://www.ajmc.com/journals/evidence-based-diabetes-management/2019/september-2019/jdrfs- kowalski-sees-hope-in-bipartisan-support-for-insulin-pricing-reform): "We see the issues related to the rebate system as being the biggest challenge for us right now. In a normal capital market where you have at least 3 similar products, as we do for most types of insulin, you'd see competition driving retail prices down. The rebate system lets the 3 insulin makers chase the prices up rather than chase them down. It hurts everyone, but it is extremely painful to people who are uninsured, who are underinsured, and who have high deductibles or copays."
6.
© 2020 Scott
Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020 What to know about PBM's › In early 2017, the pharma trade group Pharmaceutical Research and Manufacturers of America (PhRMA) announced plans to spend in the "high" tens of millions of dollars each yr. for 4-5 years (including print, TV and online ads). PhRMA identified Pharmacy Benefits Managers (PBM's) as the entity responsible for pushing up drug spending by their demanding higher rebates from drug makers. The aim was to shift blame away from pharma, but was mostly self-serving. – In fact, PBM's play a role, but the PhRMA narrative omits the party perhaps most responsible for runaway pharmaceutical prices: healthcare insurance companies. PhRMA concluded it would not bite the hands that feed it. – Vertical integration means PBM's are now wholly-owned subsidiaries of big healthcare insurance companies (drugstore chain and PBM CVS Health acquired an insurer of its own when it bought Aetna for $69 billion in 2018). These entities pay for more than 75% of all U.S. Rx drug spending. › PBM's contribute to high drug prices, but they work for (or are owned by) insurance companies
7.
© 2020 Scott
Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020 Insurance Companies: Enormously Profitable, But Ethically Bankrupt (Patients with diabetes are one of their ATM's) › Health insurance is enormously profitable. In October 2020, when the country's largest commercial health insurer, UnitedHealth Group, reported a better-than-expected $3.2 billion in quarterly profit, the Associated Press observed that even after offering policyholders' cuts in premiums and co-pays, UHC still raked in over $1 billion/MONTH. › As noted, insurance collects billions in insulin rebates each year, but (1) they're giving the rebates to employers (not to patients) in order to sell more policies. (2) They also force patients to pay the bogus list price (calling that "plan cost") for insulin. Finally, (3) insurance only gives patients credit (applied towards deductibles) for their own deeply- discounted insulin prices — totaling about 30% of what patients actually pay. › Healthcare insurance companies also successfully lobbied the Financial Accounting Standards Board (FASB) for an exemption to ordinary net cost accounting standards for prescription drug rebate dollars, and misclassify that money (which amounted to $185 billion in 2019, up from $166 billion in 2018) as "general revenue," making it difficult for even forensic accountants to follow the money. – BTW: I know RCA is based in Boston, although I don't know how many of this audience are based there. I earned my B.S. from Bentley University in Waltham, which is a school known for teaching accountancy. I mention it because I think the FASB exemption request was highly unusual.
8.
© 2020 Scott
Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020 Any Guess on How Long Before Humalog and Novolog Disappear Into History? (Over my 46 yrs. with T1D, Insulin Varieties I Once Relied On Have Been Routinely "Retired" by Pharma)
9.
Next-Gen Insulins are
Designed to Keep Prices Sky-High and Patent-Protected (Glycemic control? Yeah, that too.) Novolog (insulin aspart rDNA origin) has been usurped by Fiasp Humalog (insulin lispro rDNA origin) has been usurped by Lyumjev © 2020 Scott Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020
10.
© 2020 Scott
Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020 Planned Insulin Obsolescence is a Pharma Strategy › Novo Nordisk A/S announced on September 29, 2017 that it had received FDA approval for a marginally-faster version of Novolog (insulin aspart injection rDNA origin) branded as Fiasp – The company discovered, rather unpleasantly, that insurance company payers refused to pay a cent more for Fiasp than they did for Novolog, but it was still worth launching in order to secure ongoing patent-protection › Likewise, on June 15, 2020, rival Eli Lilly & Company, Inc. received FDA approval for a marginally-faster version of Humalog (insulin lispro injection rDNA origin) branded as Lyumjev › We have yet to see evidence that Humalog and Novolog will be imminently retired (payers will decide that), but biosimilar versions are either already on the market (including Sanofi Admelog) or are pending FDA review which could accelerate their retirements, and history has proven what pharma will likely do
11.
© 2020 Scott
Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020 New Tools Everyone Now Has Access To › The great news is that new tools now enable patients to access to the same deeply-discounted PBM-negotiated prices for prescription drugs (including insulin) even without insurance or if you're still trying to satisfy a deductible. – Not every app/website offers the same discounts, and some don't even offer discounts on insulin, so your job is to search them all › When you use these tools, you become a cash-paying customer. But going thru insurance means you pay an unacceptably high price for insulin and receive next-to-nothing applied towards your deductible. Patients are better-off paying cash and getting insulin with readily-available coupons. › Not all pharmacies cooperate, but some do. Most notable in my experience is Walgreens.
12.
© 2020 Scott
Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020 How Rx Coupon-Generating Tools Work › Coupon-generating tools/apps work in the following way: 1. Start with the pharmacy's bogus cash prescription price 2. Save money for consumers by providing easy access to a PBM's discounted network rates on Rx drugs (GoodRx partners with multiple PBM's, including Cigna's Express Scripts, United Healthcare's OptumRx, MedImpact, and Navitus) 3. Collect a portion of the fee that pharmacies ordinarily pay to a PBM > One tool which I'll talk about is called GoodRx. It raised $1.14 billion in an IPO on Sep. 23, 2020. GoodRx is already very profitable. Its adjusted net income — meaning earnings before interest, taxes, depreciation and amortization (EBITDA) — is currently 40%!
13.
Check out the
75% savings on insulin with these coupons! (Coupons redeemable at Walgreens; Lilly says the list price for Humalog is $275.00/vial. To use these, have your Dr. write your script for either "Insulin Lispro" or "Insulin Aspart") © 2020 Scott Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020
14.
https://www.goodrx.com/ Rx Coupon-Generating Tools
Are Offering Big Discounts on Authorized Generic Insulins › Already noted is the first tool which is GoodRx. GoodRx offers coupons on Lilly Insulin Lispro (Humalog) for $68.38/vial at Walgreens. GoodRx also offers coupons on Novo Nordisk Insulin Aspart for about $4 more/vial. Insulin pens are slightly more costly. › A rival is RxSaver by RetailMeNot which offers coupons on Novo Nordisk Insulin Aspart (Novolog) for $67.00/vial at Walgreens. It also offers a slightly-less generous coupon than its rival for Lilly Insulin Lispro, plus insulin pens for both are slightly more costly. › Both apps/websites offer these discounts on the authorized generic versions of Humalog and Novolog sold at Walgreens and some smaller pharmacies – CVS refuses to carry the less-costly versions, so patronize Walgreens instead (at least until you satisfy a deductible) › Patients can download these apps right now! https://www.rxsaver.com/ © 2020 Scott Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020
15.
© 2020 Scott
Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020 How I learned to slash my insulin expenses Step 2: $99.00/vial with mfg coupon Step 1: $275.00/vial Pharmacy Cash List Price Step 3: $68.38/vial with GoodRx Coupon
16.
© 2020 Scott
Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020 Endnotes/References 1. One in four patients say they've skimped on insulin because of high cost, Yale Daily News, December 3 2018, https://news.yale.edu/2018/12/03/one-four-patients-say-theyve-skimped-insulin-because-high-cost 2. 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 3. 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 4. Sanofi, Fighting Back in Insulin Price Debate, Says Its Net Prices Fell 11%, Wall Street Journal, March 4 2020, https://www.wsj.com/articles/sanofi-fighting-back-in-insulin-price-debate-says-its-net-prices-fell-11-11583340721 5. Novo Nordisk A/S Q3 2020 Earnings Slideshow Presentation, November 30, 2020, Slides #99 and #101 https://investor.novonordisk.com/q3-2020-presentation/ or archived at https://seekingalpha.com/article/4383283-novo- nordisk-s-2020-q3-results-earnings-call-presentation
17.
© 2020 Scott
Strumello for presentation on behalf of the Right Care Alliance. Content may be shared in its entirety only. November 15, 2020 'Big Pharma never Sleeps' Artwork by NYC artist Appleton (Artworks) https://appletonartwork.com/
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