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 medicine helps prevent many medical problems including heart disease, kidney disease and stroke. About 1.6 million Americans living with type 1 diabetes, a condition in which people do not produce any insulin, depend on it for their survival. So do the millions more people with type 2 diabetes — a condition in which the body doesn’t make enough insulin.
But an estimated 1 in 4 Americans who need it have so much trouble enrolling this life-saving drug that they skimp on dosage because insulin prices have skyrocketed for years. For example, the full cost of about a month’s worth of a commonly used insulin called glargine — not counting insurance coverage — has nearly tripled from US$99 in 2010 to $284 in 2022.
The exact amount Americans pay for insulin varies quite widely depending on their insurance coverage and which version of the drug they are prescribed.
Civica Rx, a non-profit that manufactures generic drugs, is trying to help solve this problem. It plans to produce generic insulin at a factory in Petersburg, Virginia, for more than $30 a month for the drug. The drugmaker eventually intends to sell all three of the most popular types of insulin starting with glargine in 2024.
Based on my research about the pharmaceutical industry and my work as a doctor who treats patients with diabetes, I believe this effort, announced in March 2022, will increase access to insulin for the hundreds of thousands of people who care about it. Those who need it but currently cannot afford it.
Generic insulin competition is limited
Americans rely on strong competition from low-cost generic drugs to make pharmaceutical products more affordable. This system has historically been more successful with blockbuster drugs like atorvastatin — a cholesterol-controlling drug better known by the brand name Lipitor — and azithromycin — an antibiotic sold under the brand name Zithromax.
Unfortunately, this system has failed to stop the rise in insulin prices, which are far higher in the United States than in other countries.
One reason this happens is that insulin is a biological drug, which means it is produced by living organisms using DNA technology. Biologic drugs are harder to manufacture and are regulated by the Food and Drug Administration in a different way than more traditional drugs.
see reasons for optimism
I’m excited about this initiative because it promises to increase access to all people who need insulin in the US, regardless of insurance status or where they buy the drugs.
One reason is that Civica Rx is a nonprofit that will be able to put the interests of those who pay for insulin — patients and health insurers — ahead of investors, compared to those of private-sector drugmakers.
Another is its pricing strategy. Civica Rx plans to charge only 20% of list prices for brand-name insulin products. Walmart and some other big box retailers already sell insulin at a discount, but their prices are still higher than those of the nonprofit plan.
And the findings of my own research suggest that intellectual property protection will not be a major deterrent to Civica’s efforts.
I am also optimistic about this effort due to the support of large insurers such as Anthem and the Blue Cross Blue Shield Association. It is reassuring that the Civica Rx is led by many people with decades of experience in the pharmaceutical industry and health policy.
But I see some reason to be less optimistic.
First, there have been prior attempts to manufacture generic insulin in the US, none to success.
Another possibility is that brand-name insulin makers may try to persuade doctors to prescribe new patent-protected versions of insulin, which would be harder to market as generics for Civica Rx — at least. starting.
Success is not guaranteed, given that all established players have a strong financial interest in seeing Civic’s efforts fail.
Legislators are taking action
Several state legislatures have also tried to tackle this problem. Some have enacted laws mandating drug price transparency and providing funding to guarantee emergency access to insulin.
But to date these mixed reactions have failed to drive down prices for brand-name insulin products, although I think it’s possible that prices would have risen sharply without them.
Congress is also responding.
Four weeks after Civica Rx announced its plans to produce insulin at significantly lower than current prices, the US House of Representatives passed a bill that would limit insulin copies to $35 for insured patients. The measure was also part of President Joe Biden’s stalled Build Back Better spending plan.
The House bill would leave many patients – especially uninsured. But the measure would also mark a positive step forward if the Senate should follow suit.
People with insulin-dependent diabetes have been waiting for a long time to do something to make it more affordable. It looks like that time may finally come.