Nonprofit generic pharmaceutical company Civica Rx is gearing up to manufacture and sell lower-cost insulin, a move that follows President Biden’s State of the Union comments singling out insulin’s rising cost and calling out for a price cap of $35 per vial.
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Civica plans to sell its insulin at no more than $30 per vial. By comparison, the branded versions of insulin can cost four times that amount—and even more for those who are uninsured. Those high prices lead as many as 25% of insulin users to skip doses or reduce their doses, Lehi, Utah-based Civica said in its Thursday announcement, citing a study published in JAMA Internal Medicine.
The Civica insulin won’t be ready for another two years. The insulin manufacturing facility is still being built, and the products will need to secure FDA approval. Civica said it will make three types of insulin, follow-on versions of the marketed products Sanofi’s Lantus, Eli Lilly’s Humalog, and Novolog from Novo Nordisk. The Civica biosimilars will be produced in a 140,000 square-foot plant in Petersburg, Virginia. When finished, Civica said that the site is expected to start producing insulin in early 2024 with capacity to produce “a substantial amount of the insulin needed in the United States, with additional space to increase production if necessary.” If approved by the FDA, Civica said its first insulin product, a version of Lantus, could reach the market in early 2024.
During the State of the Union address, President Biden pointed out a 13-year-old Virginia boy and his father who both have type 1 diabetes and rely on daily injections of insulin. Biden said a $35 price cap would make the biologic drug affordable, while still allowing drug companies to earn a profit. In a statement released after the address, the pharmaceutical industry trade group PhRMA called for a holistic legislative solution, adding that allowing “the government to set prices isn’t the answer.”
Civica said it is basing its pricing on the cost of developing, producing, and distributing insulin. In addition to the $30 vials, insulin will be made available in pen cartridges. A box of five cartridges will cost no more than $55. Those prices will be the same for those who have insurance as well as those who do not. Civica notes that current legislation proposing price caps on insulin would not apply to the uninsured, who pay more out of pocket for their medication.
Civica, which is led by President and CEO Martin VanTrieste, a former Amgen executive, was formed in 2018 by a coalition of health organizations that represent hospitals. It received its initial $30 million in funding from three philanthropic organizations: the Laura and John Arnold Foundation, the Peterson Center on Healthcare, and the Gary and Mary West Foundation. At its launch, Civica focused on making 14 hospital-administered generic drugs that face chronic shortages. In 2020, the nonprofit received a $55 million financial commitment from the Blue Cross Blue Shield Association and 18 of its state insurance companies.
“We know that to really solve for the insulin cost and access challenges so many Americans face, we need a process—from manufacturing to setting a transparent price—that ultimately lowers the cost of the drug for those living with diabetes,” VanTrieste said in Thursday’s announcement. “In that spirit, we will ensure patients know where Civica’s low-cost insulin is available.”
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