Civica Inc. announces plans to manufacture and distribute affordable insulin

Lehi-based Civica Inc. has announced 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.

“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,” a Civica press release said.

Civica is a nonprofit generic pharmaceutical company created by hospital systems and philanthropies in 2018 to reduce and prevent chronic drug shortages in hospitals and the unpredictable price spikes that often accompany them. Its stated mission is to make quality generic medicines accessible and affordable to everyone. It was created and governed by a number of leading hospital systems nationwide.

“Diabetes is arguably America’s most expensive chronic condition, and it is heartbreaking that millions of people are rationing their care and putting their lives at risk because they can no longer afford insulin,” said Dan Liljenquist, board chair of Civica, senior vice president of Salt Lake City’s Intermountain Healthcare and the innovator behind Civica’s nonprofit business model. “Through mission-driven partnerships, we are choosing to create a new market reality where no one is forced to ration essential diabetes medications.”

Martin VanTrieste, president and CEO of Civica Rx, added, “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. 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 that spirit, we will ensure patients know where Civica’s low-cost insulin is available.”

Civica will produce three insulins — glargine, lispro and aspart (biologics corresponding to, and 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 drug product, 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, a significant discount to prices charged to uninsured individuals today.

Civica plans to sell its insulins at one low, transparent price for all, basing the price on the cost of development, production and distribution. CivicaScript’s 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. A maximum recommended consumer price for outpatient prescription medications is a concept CivicaScript is pioneering in the generic market, the company said.

Contingent on FDA approval, Civica anticipates that the first insulin (glargine) will be available for purchase as soon as early 2024.

As many as one-quarter of insulin users skip doses or take less than prescribed amounts due to high costs, according to a recent study published in JAMA Internal Medicine. The drug has become inaccessible for many, causing debilitating and preventable illness. This disproportionately impacts people with diabetes who are Native American, Hispanic or black, since they are more likely to be uninsured and underinsured.

“Bold philanthropic partners have made it possible, with committed funds to date of over two-thirds of our $125 million goal, for us to undertake this affordable insulin initiative,” said Ken Boyden, executive director of The Civica Foundation. “We are incredibly grateful for their leadership. They each have a passion for and commitment to building pathways to reliable drug access and affordability.”

Civica has entered into a co-development and commercial agreement with GeneSys Biologics for these three insulin biosimilars. Civica will use drug substances produced in partnership with GeneSys and will have exclusive rights in the U.S. to market and sell these insulins at costs that are substantially lower than what is currently available in the U.S.

Civica, along with CivicaScript and The Civica Foundation, is collaborating on this effort with partners that represent nearly every corner of the diabetes ecosystem, including Arnold Ventures, Beyond Type 1, Blue Cross Blue Shield Association, and 12 independent BCBS companies (Arkansas Blue Cross and Blue Shield, Blue Cross and Blue Shield of Alabama, Blue Cross and Blue Shield of Hawaii, Blue Cross and Blue Shield of Vermont, Blue Cross of Idaho, Blue Shield of California, CareFirst BlueCross BlueShield, Excellus BlueCross BlueShield, Florida Blue, Highmark Blue Cross Blue Shield, Horizon Blue Cross Blue Shield of New Jersey, Independence Blue Cross), 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.

The insulins will be manufactured at Civica’s state-of-the-art 140,000-square-foot manufacturing plant, being built in Petersburg, Virginia. The facility, expected to be operational in early 2024, will ultimately have the capacity to produce a substantial amount of the insulin needed in the United States, with additional space to increase production if necessary.