At this time, Civica plans 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. It believes it can have these versions of insulin available by 2024.
In January 2018, Civica Rx launched as a not-for-profit generic drug company. It initially included five healthcare systems: the U.S. Department of Veterans Affairs (VA), Intermountain Healthcare, Ascension, SSM Health and Trinity Health.
Currently, the nonprofit provides about 60 generic sterile injectable drugs to more than 55 hospital systems, which represents more than 1,500 hospitals and a third of all licensed hospital beds in the U.S. It is even in the process of building a 140,000 square-foot sterile injectable manufacturing plant in Petersburg, Virginia.
And now it has set its sights on insulin. The organization announced its intentions to manufacture and distribute insulins that will be available to individuals with diabetes at lower prices than those presently on the market. Civica is working with partners CivicaScript and The Civica Foundation, as well as Arnold Ventures, Beyond Type 1, Blue Cross Blue Shield Association and 12 independent BCBS companies, the 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.
It plans to manufacture three insulins – glargine, lispro and aspart – which are interchangeable with Sanofi’s Lantus, Eli Lilly’s Humalog and Novo Nordisk’s Novolog, respectively. It will co-develop and produce the drugs, run clinical trials and file the necessary paperwork with the U.S. Food and Drug Administration. At this time, Civica plans 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. It believes it can have these versions of insulin available by 2024.
In his State of the Union address earlier this week, President Joe Biden specifically targeted drug companies that manufacture insulin and called for a cap of $35 per month for diabetic patients. In his speech, President Biden said, “Imagine what it’s like to look at your child who needs insulin and have no idea how you’re going to pay for it. Let’s cap the cost of insulin at $35 a month so everyone can afford it. Drug companies will still do very well. And while we’re at it, let Medicare negotiate lower prices for prescription drugs, like the VA (Veterans Administration) already does.”
Current prices for insulin products run $100 to more than $500.
“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. “Through mission-driven partnerships, we are choosing to create a new market reality where no one is forced to ration essential diabetes medications.”
Civica plans to have the three insulins formulated for both vials and prefilled pens. It has entered into a co-development and commercial agreement with GeneSys Biologics for the manufacturing of the insulin biosimilars. Civica will then use drug substance manufactured in partnership with GeneSys and will have exclusive rights in the U.S. to market and sell them at lower costs. Civica’s facility, which is being built in Petersburg, Virginia, is expected to be operational in early 2024.
“Both 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,” stated 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 profitability.”
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