Once approved, the insulins will be available to patients for no more than $30 per vial.
Civica plans to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. Civica will produce three insulins — glargine, lispro, and aspart (biologics that could be interchangeable with Lantus, Humalog, and Novolog respectively) — each of which will be available both in vials and prefilled pens.
Civica will co-develop and manufacture the insulins, complete the clinical trials, and file the necessary applications for FDA approval. 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.
Civica, along with CivicaScript and The Civica Foundation, is collaborating on this effort with partners including Blue Cross Blue Shield Association and 12 independent BCBS companies, as well as Gary and Mary West Foundation, Glen Tullman Family Foundation, Intermountain Healthcare, JDRF, Kaiser Permanente, Peterson Center on Healthcare, Providence, The Leona M. and Harry B. Helmsley Charitable Trust, Transcarent, and Trinity Health.
“More than 8 million Americans rely on insulin to live, but many can’t afford to take the amount they need because of the historically high and prohibitive cost of insulin,” Martin VanTrieste, president and CEO of Civica Rx, said in a press release. “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.”
In one study, about a quarter of patients with diabetes who took insulin skipped doses or took less than prescribed amounts because of high costs. This resulted in poor glycemic control, according to this study, which was published in 2019 in JAMA Internal Medicine. Additionally, about a third of patients didn’t discuss this with their doctors.
The insulins will be manufactured at Civica’s manufacturing plant, being built in Petersburg, Va. The facility is expected to be operational in early 2024, and Civica anticipates that the first insulin (glargine) will be available as soon as early 2024.
Civica has entered into co-development and commercial agreement with GeneSys Biologics for the three insulin biosimilars. Civica will have exclusive rights in the United States to market and sell these insulins.
Civica is a nonprofit, generic pharmaceutical company that was created by hospital systems and philanthropies in 2018 to reduce and prevent chronic drug shortages in hospitals. CivicaScript is an operating unit that aims lower the cost of select high-cost generic medicines at the pharmacy counter.