Tuesday, August 22, 2023

Why Amazon Pharmacy's Recent Insulin Move is Helpful, But Not Groundbreaking

On August 15, 2023, Amazon Pharmacy (fka PillPack) announced (see https://www.aboutamazon.com/news/retail/amazon-pharmacy-insulin-coupons/ for the announcement) that it would begin automatically applying various manufacturer coupons to more than 15 common insulins and diabetes devices (including Dexcom, which offers a coupon for up to $200 per month at https://www.dexcom.com/en-us/savings-center-cgm-without-insurance/ even without insurance). So far, no coupons from Abbott on Freestyle Libre 3 sensors, but the longer wear-time of 14-days means Libre 3 sensors still cost about one-third less than Dexcom's 10-day wear-time. Some products, such as blood glucose test strips, may not be as cheap with Amazon Pharmacy as by patronizing Mark Cuban Cost Plus Drug Company and buying Roche Accu-Chek test strips for just $16.79 for a vial of 50 test strips (compared to Amazon Pharmacy's cash price of $24.00 per vial of 50 Accu-Chek test strips). diaTribe News had a pretty good summary of the Amazon Pharmacy move at https://diatribe.org/amazon-pharmacy-unveils-35-monthly-insulin which is worth reading.

Several years ago, I would have applauded the Amazon Pharmacy move. Today, while I think it is helpful and I hope it prompts other pharmacies to do the same thing, but it's not really groundbreaking. The reason is because of all of the underlying work that patient advocates such as I have done to enable this over the past six years, and now Amazon Pharmacy marches in and is trying to take credit for all of the real work people like me helped to make a reality.

As the diaTribe News' summary explained, despite the recent insulin list price cuts announced by Lilly, Novo Nordisk and Sanofi, a relatively new report from Democratic Senators Elizabeth Warren, Richard Blumenthal, and Raphael Warnock (see https://www.warren.senate.gov/imo/media/doc/Report%20on%20Insulin%20for%20Uninsured%20Patients%20-%2007.12.2023%20(updated)1.pdf for access to the report) revealed that accessing discounted insulins from pharmacies is still a lot harder than it seems. 

In the Senators' report, in a survey of over 300 pharmacies, less than half did not even sell Lilly Insulin Lispro Injection (U-100), which is Lilly's less costly unbranded "authorized generic" prandial insulin. Meanwhile, the vast majority of pharmacies still sold branded Humalog, the more expensive brand-name version which tends to be heavily-rebated to PBMs. Many people were charged more than what the drug companies had promised, according to the report. On average, people without insurance paid $97.51 for Lilly Insulin Lispro. This is nearly four times the $25 rate that Lilly has set in the U.S. for its unbranded insulin. Beyond these findings, the report explained that patients must navigate confusing resources regarding insulin pricing. As a result, many people end up paying significantly more than the discounted price. 

Such is the dilemma pharma companies have created with their odd, co-dependent relationship with predatory Pharmacy Benefit Managers (PBMs). While I think the March 2023 announcements by Lilly, Novo Nordisk and Sanofi that they would further reduce insulin list prices and to pay for that, they would stop paying PBMs rebates for formulary placement was a much-needed development, we are not likely to realize the full benefit of that until 2024.

In fact, Lilly was the very first big insulin manufacturer to introduce a less-costly version of Humalog called by it's generic drug name back in March 2019 (see https://www.prnewswire.com/news-releases/lilly-to-introduce-lower-priced-insulin-300805560.html for the press release). At the time, Lilly told everyone the product would be sold for half-price of what branded Humalog cost. In essence, Lilly introduced an unbranded version of its bestselling prandial insulin in order to bypass the list price increases needed to pay ever-higher legally-exempted rebate kickbacks paid to PBMs in order to secure formulary placement. But savvy patients with diabetes very quickly discovered they could buy unbranded Lilly Insulin Lispro for even less than half-price, and simply could use a GoodRx (or rival) coupon to buy it for 75% off the price of branded Humalog. Eventually, Lilly introduced its coupons attainable from https://www.insulinaffordability.com/.

In September 2019, rival Novo Nordisk realized that Lilly was onto something, and essentially copied Lilly's strategy by introducing an unbranded version of Novolog (see the press release at https://www.prnewswire.com/news-releases/novo-nordisk-launching-additional-us-insulin-affordability-offerings-in-january-2020-300913167.html for details). The PBM rebate contracting model for insulin had been under pressure for years. In 2020, Novo Nordisk disclosed to investors that the company was paying-out 74% of its gross U.S. sales as rebates paid to PBMs required to secure formulary placement. The company offered its own coupons at https://www.novocare.com/diabetes/help-with-costs/savings-offers.html. In Novo Nordisk's 2021 Annual Report, the company revealed to investors that between 2017 and 2021, the company's realized "net" prices for insulin had fallen by an average of 16.75% per year during that period. The company also acknowledged that "more than 1 million" Americans had been reached by the company's "affordability offerings" during that year, and the single biggest component of that was its unbranded (sold under the generic drug name), un-rebated "authorized generic" version of Novolog called insulin aspart which launched in September 2019 (its unbranded basal insulin degludec was only introduced in September 2022). In other words, the company realized the PBMs were not providing any added value; the insulin sold itself.

The PBM rebate contracting model for insulin had been under pressure for years. Indeed, research undertaken by University of Southern California published in the November 2020 issue of JAMA Health Forum https://jamanetwork.com/journals/jama-health-forum/fullarticle/2785932, researchers there offered one of the most comprehensive looks at the insulin distribution chain and showed exactly which players were profiting, by how much, all from selling insulin.

The USC conclusion was that insulin's list price had indeed been going up, not down, with trade secrets and other protections preventing many researchers from pinpointing exactly who was receiving profits from its sale. Meanwhile, the realized "net" price — what manufacturers receive after accounting for all the discounts and payments to distribution system entities — had been falling. USC researchers analyzed the flow of money across all distribution system participants — manufacturers, wholesalers, pharmacies, PBMs, and health plans — and found that middlemen in the distribution process were then taking home approximately 53% of the "net" proceeds from the sale of insulin, up from 30% in 2014. Meanwhile the share going to insulin manufacturers had fallen by 33% over the same period of time.

However, big pharma wasn't completely ready to abandon the PBM commercialization model just yet. Nevertheless, effective January 1, 2022, Lilly announced it would further reduce the price of its unbranded Humalog by an additional 40% (see the 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 detail). Presumably, Lilly realized it could sell unbranded Humalog without paying PBMs multimillion dollar kickbacks which the PBMs should have realized was a bad omen for their not-so-little kickback scheme. Novo Nordisk did not cut its unbranded insulin prices any further, but in September of that year, the company did introduce an unbranded version of its basal insulin Tresiba called Insulin Degludec Injection U-100 (and U-200) which I covered in my post HERE (catch Novo Nordisk's coverage at https://www.novonordisk-us.com/media/news-archive/news-details.html?id=133808).

Still, at the time the less costly unbranded insulins were introduced in 2019, some major pharmacy chains like CVS refused to carry the unbranded products because the company's Caremark PBM division made so much money on branded insulin rebates, and then by forcing patients to pay artificially-inflated prices for branded insulins. But rival Walgreens (which does not own a PBM) sold the unbranded products and ultimately, CVS Pharmacy was ultimately forced to carry them, too (if begrudgingly).

Rival Sanofi was a bit of a laggard on the unbranded insulin front, until two of its biggest PBM clients Express Scripts (see https://www.prnewswire.com/news-releases/express-scripts-will-unlock-20-million-in-savings-for-clients-in-2022-by-preferring-the-first-interchangeable-insulin-biosimilar-301404121.html for more) and Prime Therapeutics both dropped the Lantus reference product from their preferred drug formularies and replaced it with Viatris/Biocon Semglee instead. That essentially forced Sanofi to introduce an unbranded version of Lantus in July 2022 (catch my coverage HERE) as its rivals did (catch the press release at https://www.news.sanofi.us/2022-06-29-Sanofi-to-lower-out-of-pocket-cost-of-insulin-for-uninsured-patients-and-expand-access-in-underserved-communities/). Sanofi also offered its own coupons at https://www.teamingupfordiabetes.com/sanofidiabetes-savings-program.

Nevertheless, navigating through this highly dysfunctional mess is no small undertaking as the Senators' report correctly concluded. It is especially difficult on those who lack commercial healthcare insurance (the uninsured) who tend to be most vulnerable. Amazon Pharmacy will make it a bit easier for patients to navigate if they can get over having to buy everything via mail order. It would be really nice if a big pharmacy player like Costco or Walgreens copied the idea.

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