Could the non-profit organization Civica Rx solve the insulin price crisis in the United States?

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Doctors have been treating diabetes with insulin since 1922. A century later, about 1 in 5 of the 37 million Americans with diabetes take this drug, a hormone that helps cells absorb sugar from the blood.

This drug helps stave off a host of medical problems, including heart disease, kidney disease, and stroke. Some 1.6 million Americans with type 1 diabetes, a condition in which people don’t produce insulin, depend on it for survival. The same is true for millions of people with type 2 diabetes, a condition in which the body does not produce enough insulin.

But it’s estimated that one in four Americans who need it are having such a hard time affording the life-saving drug that they’re skimping on doses because insulin prices have been skyrocketing for years. For example, the total cost—not including insurance coverage—of about a month of a commonly used type of insulin called glargine has nearly tripled, from $99 in 2010 to $284 in 2022.

The exact amount Americans pay for insulin varies widely, depending on their insurance coverage and the version of the drug they are prescribed.

Civica Rx, a non-profit organization that makes generic drugs, is trying to help solve this problem. It plans to produce generic insulin for up to $30 for a month’s worth of medication at a plant under construction in Petersburg, Virginia. Eventually, the drugmaker intends to sell the three most popular types of insulin, starting in 2024 along with glargine.

Based on my research on the pharmaceutical industry and my work as a physician who treats patients with diabetes, I believe this effort, announced in March 2022, could significantly increase access to insulin for hundreds of thousands of people who need it but cannot currently afford it. this.

Protesters gathered at the New York Stock Exchange to commemorate World Diabetes Day 2019, drawing attention to the growing insulin rationing crisis caused by steep price hikes.

Erik McGregor/Getty

Americans rely on strong competition from low-cost generic drugs to make pharmaceuticals more affordable. This system has always had more success with blockbuster drugs like atorvastatin – a cholesterol-lowering drug better known under the brand name Lipitor – and azithromycin – an antibiotic sold under the brand name Zithromax.

Unfortunately, this system has failed to contain increases in insulin prices, which are much higher in the United States than in other countries.

One of the reasons this has been the case has to do with the fact that insulin is a biological drug, which means that it is produced using DNA technology by living organisms. Biologic drugs are more difficult to manufacture and are regulated by the Food and Drug Administration in a different way than more conventional drugs.

I am excited about this initiative because it promises to increase access for everyone who needs insulin in the United States, regardless of their insurance status or where they purchase medication.

One reason is that Civica Rx is a not-for-profit organization that will be better able than private sector drugmakers to push the interests of those who pay for insulin – patients and health insurers – before those of investors.

Another is its pricing strategy. Civica Rx expects to charge only about 20% of list prices for branded insulin products. Walmart and some other big-box retailers already sell insulin at a discount, but their prices are still higher than what the nonprofit plans to charge.

And the results of my own research suggest that intellectual property protections are unlikely to be a significant impediment to Civica’s efforts.

I am also optimistic with the support of major insurers like Anthem and Blue Cross Blue Shield Association for this effort. It is reassuring to see that the leadership of Civica Rx includes many people with decades of experience in the pharmaceutical industry and in health policy.

But I see some reasons to be less optimistic.

First, there have been previous attempts to manufacture generic insulin in the United States. None succeeded.

Another possibility is that brand-name insulin makers are trying to pressure doctors into prescribing new, patent-protected versions of insulin, which would be harder for Civica Rx to market as a generic, at least initially.

Success is far from guaranteed, as established players all have a strong financial stake in seeing Civica’s efforts fail.

Several state legislatures have also attempted to address this issue. Some have enacted laws requiring drug price transparency and provided funds to ensure emergency access to insulin.

But to date, these varied responses have failed to drive down the prices of branded insulin products, although I think it’s possible prices would have risen faster without them.

Congress is also reacting.

Four weeks after Civica Rx announced plans to produce insulin at prices well below current prices, the U.S. House of Representatives passed a bill that would limit insulin copayments to 35 $ for insured patients. This measure was also included in President Joe Biden’s Build Back Better spending plan.

The House bill would leave out many patients, including the uninsured. But the move would also mark a positive step if the Senate follows suit.

People living with insulin-dependent diabetes have long been waiting for someone to do something to make it more affordable. It seems like that moment is finally coming.

Jing Luo is an assistant professor of medicine at the University of Health Sciences in Pittsburgh

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