Eli Lilly & Co.'s announcement that 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, or PBMs — at a time when Congress has shifted its focus to them.
Insulin has come to embody the perversity of the U.S. health care 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 United States — 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 March 1 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 health care analyst Sean Dickson. 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.
But while Lilly is cutting the "wholesale acquisition price," or list price, of its big-selling insulin drugs, "will other 'parties at play' cause this price to increase before it hits my pharmacy counter?" asked Rebecca Kelly of Richmond, Kentucky, who has Type 1 diabetes and is an activist for lower drug prices.
Those parties include gigantic pharmacy benefit managers — 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 pharmacy benefit managers 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 incomes 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."
In 2018, Novo Nordisk, amid public rancor over rising insulin prices, considered a 50% cut, according to the report. But the company's board decided against it, noting that "many in the supply chain will be negatively affected ($) and may retaliate." The company also feared that irate insurers might retaliate against Novo's blockbuster diabetes and weight-loss drugs like Ozempic, which compete against Lilly's Mounjaro.
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.
For example, Sanofi paid rebates worth 2% to 4% of its insulin list price in 2013, but 56% in 2018, according to the Senate report. Over that period, Sanofi tripled the price of its Lantus insulin to about $275 per vial. A 2018 study estimated it costs roughly $2 to $4 to produce a vial of analog insulin, the type used by most patients.
Most of the insulin list price increases have gone to PBMs, the go-between companies. For example, Lilly earned about $25 for each Humalog injection pen from 2013 to 2018, while the list price increased from $57 to $106. Net prices have remained stable the past few years and insulin revenues actually declined last year, according to recent Sanofi and Lilly financial reports.
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Trade secrecy makes it hard to see which portions of the kickbacks end up as profit or savings for pharmacy benefit managers, insurers, pharmacies, or patients. But patients who are uninsured, are underinsured, or pay high deductibles can end up with whopping insulin bills, because their copayments are tied to the drug's list price.
"The system transfers financial resources from sick patients to healthy, premium-paying beneficiaries, the opposite of what insurance is supposed to do," Erin Trish, co-director of the University of Southern California Schaeffer Center for Health Policy & Economics, told a Senate Commerce Committee hearing Feb. 16.
Medicare beneficiaries, for example, paid a collective $1 billion out-of-pocket for their insulin in 2020, more than four times what they paid in 2007, according to a KFF study. So did many others.
Kelly, a 48-year-old personal trainer, got insulin through her husband's insurance but had to pay out-of-pocket until she met a $5,000 deductible each year. So in 2019, the Kellys dropped the policy and decided to risk the open market. They ended up driving to Canada, where Kelly told KHN she spent $256 on eight vials of insulin that would have cost $2,616 at her local pharmacy. During the pandemic, she used Lilly coupons that enabled her to buy Humalog for $35 per vial, enough for about two weeks.
Despite coupon programs, surveys conducted since 2017 showed that up to a quarter of U.S. patients reported skimping on insulin because of its cost. Some patients have died while trying to ration the drug.
The contrast with other developed countries is stark. Germans with diabetes pay around $5 for a month's worth of insulin. In the United Kingdom, patients pay nothing.
Federal legislation signed into law last year capped out-of-pocket insulin costs at $35 per month for Medicare recipients. At least 22 states and the District of Columbia have set caps on private plans as well.
The three big insulin makers have fought off competition that could lower prices across the board. They've done this, for example, by introducing their own, slightly less expensive "authorized generics," which discourage other companies from entering the insulin market. It wasn't until 2021 that a competitor brought a long-acting "biosimilar" insulin — essentially a generic version of Lantus — to the market, and it has barely made a dent. The company, Viatris, which since sold its product to Biocon Biologics, did win entry to one formulary by creating an essentially identical product, tripling its list price and offering PBMs a big rebate.
These kinds of behaviors have increasingly drawn congressional attention, and drug manufacturing attack ad campaigns.
"Imagine a world where a cheaper product, yet equally effective, has a harder time selling," Sen. Chuck Grassley (R-Iowa) said at the Feb. 16 Commerce Committee hearing. "That's the prescription drug industry."
Still, Lilly's announcement may be a harbinger of better news for the most economically vulnerable people with diabetes.
California has funded a plan to make and distribute its own insulin. Separately, Civica, a nonprofit drug manufacturer, hopes by the end of 2024 to sell insulin produced in India. Civica will bypass benefit managers and provide the drug to any pharmacy that promises to sell it for no more than $30 per vial, said Allan Coukell, its senior vice president for public policy.
Civica plans to produce enough insulin for a third of all U.S. patients, he said.
This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.
Posted in: Healthcare News | Pharmaceutical News
Tags: Diabetes, Drugs, Health Care, Hearing, Insulin, Lantus, Manufacturing, Medicaid, Medicare, Pandemic, Pharmacy, Prescription Drug, Type 1 Diabetes
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