Although insulin was discovered more than a century ago and cost little to produce, the catalog price of Civica Rx-branded products is approximately $ 300 per vial, according to the Gary and Mary West Foundation, co-founder of Civica Rx . Expenditure has almost tripled since 2010.
The high price has caused approximately 1 in 4 people with diabetes to give or miss doses, according to a study published in 2019 in the medical journal JAMA Internal Medicine. Patients who are black, Hispanic, or Native American are disproportionately affected because they are more likely to be uninsured or underinsured.
Founded in 2018 for the production of generic drugs that are in short supply or subject to price spikes, Civica Rx aims to produce three insulin products that will be available in vials and pre-filled pens. They will be interchangeable with Lantus, Humalog and Novolog and will be jointly developed by GeneSys Biologics, a biopharmaceutical company based in India.
A box of five pen cartridges will cost no more than $ 55.
However, before a drug can be released, Civica Rx must complete clinical trials and obtain approval from the US Food and Drug Administration. It also needs to complete the construction of a 140,000-square-foot manufacturing plant in St. Petersburg, Virginia.
The nonprofit is raising $ 125 million to undertake the insulin effort and has committed more than two-thirds of the funding, said Ken Boyden, executive director of The Civica Foundation, in a statement.
The company will eventually be self-sustaining, said Shelley Lifford, vice chairman of the Civica Rx. It will initially produce enough insulin to cover about 30% of the market.
“Those who will benefit greatly from this opportunity that we provide at Civica are those who are underinsured or uninsured, who cannot afford to pay for their medicines,” Lifford said.
Unlike other efforts that focus primarily on reducing what patients pay for insulin, Civica Rx aims to reduce the cost of the drug itself.
“Civica’s goal of producing and selling insulin at very low prices could be an important disruption to the current system,” said Stacy Dusecina, an associate professor of health policy at Vanderbilt University School of Medicine. “There are some big potential benefits for consumers.”