ROCHESTER, Minn. — Subject to Food and Drug Administration approval, inexpensive insulin will hit pharmacies in 2024.
The affordable insulin will be produced by Civica, a Utah-based nonprofit generic drug maker.
The society is an initiative launched in 2018 by a list of supporting philanthropies and 55 leading health systems, including the Mayo Clinic.
Insulin products will carry a suggested price cap of $30 for one vial, $55 for a box of five pen cartridges, or approximately $55 to $75 per month, based on an average usage estimate provided by Civica.
The product acquisition system will link the manufacturer directly to retail pharmacies, without price reduction by payers or intercession by pharmacy benefit managers.
Civica CEO Martin VanTrieste said patented insulin can easily cost upwards of $400 a month, suggesting the company’s upcoming product launch will significantly reduce out-of-pocket costs for patented products currently borne by unpaid patients. insured or underinsured.
“From what we see in the market, our insulin will be 90% cheaper than what’s out there today,” VanTrieste said. “…We will provide quality, low-cost insulin to any consumer in the United States…Anyone who needs insulin can get it from us.”
The manufacturer announced the news in a statement that identified the three so-called insulin analogues as new or upcoming generic drugs glargine (brand name Lantus), lispro (brand name Humalog) and aspart (brand name Novolog).
Insulin prices have risen at high rates in recent years, forcing patients to take less than necessary or go without.
An October 2020 study by the Rand Corporation reported that insulin prices in the United States are more than 8 times higher than in 32 comparator countries. A 2018 report from the American Diabetes Association reported that high prices are causing patients to ration their insulin.
“I call it the insulin crisis,” Van Trieste said. “…We have seen that the market is not going to repair itself.”
The announcement marks the first Civica product directly available to consumers and the first organic product made by the nonprofit, which otherwise operates through a membership model specifically created by a coalition of interests to address shortages. of common generic drugs sold for use in hospitals.
Since 2018, Civica says it has sold its 1,500 member hospitals low-cost versions of 60 generic injectable drugs that were previously in short supply, including 11 drugs used by hospitals to treat patients with COVID-19.
“Mayo received its first shipment of Civica in 2020, when the pandemic began,” said Eric M. Tichy, vice president of Pharmacy Formulary, Mayo Clinic Health System and member of the Civica Drug Selection Advisory Committee. “I would like to think that the drug shortages during the pandemic would have been much worse if we hadn’t had Civica.”
Participating Civica member hospitals pay a one-time fee to purchase from its range of low-cost generic hospital drugs. The goal, Tichy said, is to turn insulin and generic drugs “into utility — where the price is very stable and you don’t have to think about it.”
Van Trieste calls the market for older generic drugs before Civica “a broken business model, caused by a race to the bottom on prices.”
By contrast, he says, the insulin market had no incentive to control prices.
“There is an insulin production oligopoly between three manufacturers, three primary wholesalers and three pharmacy benefit managers who distribute insulin through the supply chain,” he said.
“There is no real competition to keep prices low and prices keep going up. There is a debate about who the culprit is… In the end, the patient doesn’t care why the prices are so high. The patient needs to pay for their insulin.”
“Insulin is a complex molecule,” explains Tichy. “It really shows that Civica is going in a different direction than the small molecules” of previous products. “It’s a great expansion of their capabilities.”
Tichy also qualifies the news as a victory for access to healthcare.
“Diabetes is one of those diseases that really affects a lot of economically disadvantaged people. There’s a disproportionate amount of diabetes in African American and Hispanic people, so there’s also a health equity aspect that’s very important. For me, this is something where Civica goes beyond helping hospitals to help the community at large.”
Tichy says he doesn’t foresee any negative market repercussions from the introduction of a cost-cutting nonprofit.
“My observation is that it improves market behavior, because other people in the industry have adopted some of the things that Civica does, like holding six months of safety stock in the supply channel… The industry had moved to a just-in-time process where the entire channel had a three-month supply.”