Abbott CGMs cleared to integrate with automated insulin delivery systems by Elise Reuter for MedTechDive.com, 6 March 2023.
Automated insulin delivery (AID) systems include an insulin pump that communicates with a continuous glucose monitor, which can adjust the amount of insulin administered to a user based on real-time glucose data. With the new clearance, Abbott plans to offer the updated FreeStyle Libre 2 and Libre 3 sensors in the U.S. later this year, replacing its current systems.
The company is currently working with insulin-pump makers Insulet and Tandem for future integrations. In Germany, the Libre 3 sensor is authorized to work with the mylife Loop solution made by Ypsomed and CamDiab, with future launches planned in the UK, Switzerland and the Netherlands. The clearance further supports Abbott’s 15% growth target this year for the Libre, and its longer-term goal of $10 billion in sales by 2028.
Bigfoot Biomedical takes next steps for its holistic diabetes management platform by Sean Whooley for DrugDeliveryBusiness.com, 6 March 2023.
Less than two years ago, Bigfoot Biomedical launched its Bigfoot Unity platform in some U.S. states. CEO Jeffrey Brewer last year called it a “transformational attempt” to simplify CGMs and the data they produce. It features a smart insulin pen cap, which takes data from a CGM and informs the patient exactly how much insulin they need.
Just last month, the company made a major play to further bolster this platform. It sold pump-based automated insulin delivery technology patents to pump maker Insulet for $25 million. This asset sale generated significant funds to expand the Bigfoot Unity diabetes management system.
Bigfoot soon after received FDA clearance for the Android mobile app for Bigfoot Unity. The mobile app allows users to input and review therapy recommendations from healthcare professionals. Users can also access a glanceable display of their current glucose range and receive real-time alerts. Bigfoot said 41% of U.S. smartphone users choose Android devices, further expanding the platform’s reach.
Why Does Insulin Cost So Much? Big Pharma Isn’t the Only Player Driving Prices by Arthur Allen for MedPageToday.com, 12 March 2023.
Eli Lilly & Co.’s announcement that opens in a new tab or window it is slashing prices for its major insulin products could make life easier for some diabetes patients while easing pressure on Big Pharma. It also casts light on the profiteering methods of the drug industry’s price mediators — the pharmacy benefit managers (PBMs) — at a time when Congress has shifted its focus to them.
Insulin has come to embody the perversity of the U.S. healthcare system as list prices for the century-old drug, which 8.4 million Americans depend on for survival, quintupled over two decades to more than $300 for a single vial. Just because Lilly — which sells about a third of the insulin in the U.S. — lowers its price doesn’t mean all patients will pay less, even in the long run.
Lilly capped the out-of-pocket costs of its most popular insulins at $35 effective immediately and said that later this year the list price of its “authorized generic” Lispro — which is identical to Humalog, its bestselling brand-name insulin — would fall to $25 a vial. This followed President Joe Biden’s State of the Union address, and speeches since, in which he has blamed “Big Pharma” and its “record profits” for the incredible expense of insulin.
David Ricks, Lilly CEO, in interviews on 1 March 2023, called for other manufacturers to join his company in “taking away the affordability challenges” of diabetes.
Even as Lilly promotes its altruism, this move may actually save it money, said healthcare analyst Sean Dickson, JD, MPH. A federal rule taking effect next year penalizes companies that charge Medicaid high prices, especially for older, branded drugs. Lowering the list price of Humalog would allow Lilly to pay significantly less in rebates to government Medicaid programs that buy the drug.
Drugmakers have long ceased to be the only, or even primary, villain of the insulin price scandal. The three companies that produce nearly all the insulin in this country — Lilly, Sanofi, and Novo Nordisk — posted stagnant or declining revenue from their versions of the drug in recent years despite the steadily climbing list prices they charged. They’ve even advised investors that they don’t see insulin sales as a high-profit area anymore.
Those parties include gigantic PBMs — owned by CVS Health and insurance giants UnitedHealthcare and Cigna — that have aggressively played the insulin makers off one another in a way that mainly fattened their own accounts, as was revealed in a scathing 2021 Senate Finance Committee report.
In theory, when PBMs negotiate contracts with drug manufacturers on behalf of insurers, they pass along savings to patients. In practice, while the hard-nosed bargaining may benefit the well-insured, it can hurt patients on fixed income and others less able to afford their insulin.
To compete for access to insured patients, according to the report, the three insulin makers in the 2010s steadily increased rebates and fees paid to the powerful PBMs, which are owned by or allied with major insurers. This spurred drugmakers to keep raising their list prices, because the more they paid in rebates — calculated as a percentage of list price — the better their placement on insurance formularies, the complex lists of drugs insurers cover for patients.
In other words, the more the insulin makers compete, the more consumers — the unlucky ones, anyway — may pay.
“Insulin is a commodity, so formulary position is everything,” said David Kliff, who edits the website Diabetic Investor. “It’s like location in real estate.”
Sanofi and Novo Nordisk did not directly respond to Lilly’s price-dropping move but noted, in statements, that their discount programs already provide cheap insulin for those who need them. Millions of Americans have used these coupons, but patients like Kelly say they come with red tape and can be unreliable.
Lilly declined to respond to a question about how its cut in list price might affect negotiations with insurers, which have come to expect big rebates on drugs with competitively high list prices.