Civica Rx, a non-profit generic drug maker backed by hospitals, insurance companies and philanthropists, announced Thursday that it plans to manufacture and sell insulin for no more than $30 per vial. It is expected to be available in early 2024, pending federal approval.
Insulin, on which more than 8 million Americans with diabetes depend, has been a poster child for the rising cost of prescription drugs.
Although insulin was invented more than a century ago and costs little to make, the brand-name products Civica Rx is targeting have a list price of about $300 per vial, according to the Gary & Mary West Foundation. Ltd., which co-founded the Civica RX. The cost has nearly tripled since 2010.
According to a study published in 2019 in the medical journal JAMA Internal Medicine, the high cost has led 1 in 4 people with diabetes to skip rations or supplements. Black, Latino or Native American patients are disproportionately affected because they are more likely to be uninsured or under-insured.
Several efforts have been made to help diabetics pay for their medication, the latest being a $35 cap on insulin prices that President Joe Biden called for in his State of the Union address on Tuesday. However, Congress has yet to pass any such measure. It was included in the Democrats' $1.75 trillion Build Back Better package, which is on hold in the Senate.
Civica Rx, which was established in 2018 to manufacture generic drugs that are in short supply or subject to price hikes, aims to produce three insulin products that will be available in vials and prefilled pens. They will be interchangeable with Lantus, Humalog and NovoLog and will be co-developed by GeneSys Biologics, a biopharmaceutical company based in India.
A box of five pen cartridges will cost no more than $55.
However, before it can roll out the drugs, Civica Rx needs to complete clinical trials and receive approval from the US Food and Drug Administration. In addition, it must complete construction of a 140,000-square-foot manufacturing plant in Petersburg, Virginia.
The nonprofit is raising $125 million to fund the insulin effort and has secured a commitment for more than two-thirds of the funding, Ken Boyden, executive director of The Civica Foundation, said in a statement.
The venture will eventually be self-sustaining, said Shelley Lifford, Vice-Chairman of the Board of Civica RX. It will initially produce enough insulin to cover about 30% of the market.
"The people who are going to benefit greatly from this opportunity that we're providing at Civica are those who are underinsured or uninsured who can't pay for their drugs," Lifford said.
Unlike other efforts, which primarily focus on reducing what patients pay for insulin, Civica Rx aims to drive down the price of the drug.
"Civica's goal of producing and selling insulin at very low prices could be a significant disruption to the current system," said Stacy Dusetzina, associate professor of health policy at Vanderbilt University School of Medicine. "There are some big potential wins for consumers."