Doctors have been treating diabetes with insulin since 1922. A century later, about a fifth of the 37 million Americans living with diabetes take the drug — a hormone that helps cells absorb sugar from blood.
This medicine helps prevent a variety of medical problems including heart disease, kidney disease, and stroke. About 1.6 million Americans are living with Type 1 diabetes, a condition where people don’t produce any insulin, depending on it for survival. So do millions of people with Type 2 diabetes – a condition in which the body doesn’t make enough insulin.
But an estimated 1 in 4 Americans have had such a hard time taking the life-saving drug that they skip doses because the price of insulin has skyrocketed over the years. For example, the full cost — without insurance — of about a month’s worth of a commonly used 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 nonprofit that makes generic drugs, is trying to help solve this problem. They are planning to make regular insulin for no more than $30 for a month’s worth of the drug at a plant under construction in Petersburg, Virginia. Ultimately, the drugmaker plans to sell all three of the most popular insulins, starting in 2024 with glargine.
Based on my research into the pharmaceutical industry and my work as a physician treating diabetes patients, I believe this effort, published in March 2022, could significantly increase insulin access for hundreds of thousands of people who need it but cannot currently afford it.
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 such as atorvastatin – a cholesterol control drug better known by the brand name Lipitor – and azithromycin – an antibiotic sold under the brand name. Zithromax.
Unfortunately, this system has been unable to contain the rise in the price of insulin, which is much higher in the United States than in other countries.
One reason this happens is because insulin is a biologic drug, meaning it is produced using DNA technology by living organisms. Biologic drugs are more difficult to manufacture and are regulated differently by the Food and Drug Administration than conventional drugs.
I’m excited about this initiative because it promises to increase access to all people who need insulin in the United States, regardless of insurance status or where they get the medication.
One reason is that Civica Rx as a nonprofit will be more able than private sector drugmakers to put the interests of those who pay for insulin – the patient and the health insurer. – get ahead of investors.
Another is its pricing strategy. Civica Rx plans to only charge about 20 percent of the list price for branded insulin products. Walmart and several other big-box retailers already sell insulin at a discounted price, but their prices are still higher than what the nonprofit estimates.
And the findings from my own research suggest that intellectual property protection probably won’t be a significant barrier to Civica’s efforts.
I am also optimistic that there is support from major insurers such as Anthem and the Blue Cross Blue Shield Association for this effort. It is reassuring that Civica Rx’s leadership includes many people with decades of experience in the pharmaceutical and health policy industries.
But I see some reasons to be less optimistic.
First, there have been previous attempts to produce original insulin in the US. None of the attempts were successful.
Another possibility is that brand-name insulin manufacturers could try to push doctors to prescribe newer versions of the insulin that are protected by patents, which would be more difficult for Civica Rx to market. as a generic drug — at least initially.
Success is far from guaranteed, as established players all have a strong financial interest in seeing Civica’s efforts fail.
Several state legislatures have also attempted to address the issue. Some have enacted legislation mandating drug price transparency and providing funds to ensure emergency access to insulin.
But so far, these mixed responses have failed to bring down the price of branded insulin products, although I think it’s possible that prices would go up faster without them.
Congress is also responding.
Four weeks after Civica Rx announced its plan to make insulin far below current prices, the U.S. House of Representatives passed a bill that limits insulin copays to $35 for insured patients. dangerous. The measure is also part of President Joe Biden’s stalled Build Back Better spending plan.
The House bill would eliminate many patients – most especially the uninsured. But the measure would also mark a positive step if the Senate follows suit.
People living with insulin dependent diabetes have been waiting a long time for someone to do something to make it more affordable. Looks like the time may have finally come.
Jing Luo is an assistant professor of medicine at the University of Pittsburgh Health Sciences
https://www.thedailybeast.com/could-non-profit-civica-rx-solve-the-us-insulin-price-crisis?source=articles&via=rss Can Nonprofits Solve America’s Insulin Price Crisis?