Nonprofit drug manufacturer Civica announced this morning that it plans to manufacture and distribute insulins that, once approved, will be available to people with diabetes at no more than $30 per vial and no more than $55 for a box of five pen cartridges—significantly less than insulins now on the market, it says.
“The availability of affordable insulins will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications,” Civica said in a March 3 news release.
Civica was founded in 2018 by three philanthropies and seven health systems, six of the latter nonprofit systems with multiple hospitals enrolled in 340B (CommonSpirit Health, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health). It now serves 55 health systems and more than 1,500 hospitals and it highlights its reach to “340B hospitals caring for vulnerable patients in some of the country’s most underserved areas.”
Civica said it will produce three insulins: glargine, lispro and aspart (biologics corresponding to and interchangeable with Sanofi’s Lantus, Lilly’s Humalog, and Novo Nordisk’s Novolog respectively). Each of which will be available both in vials and prefilled pens. Civica said it will co-develop and manufacture the drug product, complete the clinical trials, and file the necessary applications for U.S. Food and Drug Administration (FDA) approval.
“Contingent on FDA approval, Civica anticipates that the first insulin (glargine) will be available for purchase as soon as early 2024,” the company said.
“Civica plans to set a recommended price to the consumer of no more than $30 per vial and no more than $55 for a box of five pen cartridges, a significant discount to prices charged to uninsured individuals today,” the company said. Prices will be based on development, production, and distribution costs, it said.
Civica said its “policy for pharmacies and others who choose to distribute Civica insulins reflects its philosophy that prices to consumers should be fair, reasonable and transparent, and be no more than the public, recommended price.”
Civica’s announcement comes two days after President Biden urged Congress in his State of the Union message to cap monthly cost sharing for insulin at $35. Bills to do so have been introduced in the U.S. House and Senate, and Senate Majority Leader Chuck Schumer (D-N.Y.) has said he will call for a vote before the full Senate this month.
Insulin and diabetes drug manufacturers AstraZeneca, Lilly, Novartis, Novo Nordisk, and Sanofi were the first pharmaceutical companies to impose conditions on 340B pricing when covered entities use contract pharmacies.