More than 1.3 million Americans ration insulin, an essential hormone that can be life-saving for those with diabetes. It’s because they cannot afford the hundreds of dollars each month it costs some patients. Cost-cutting measures — including delaying buying the drug, taking less than needed, and skipping doses, according to a recent study at Harvard Medical School — can put a patient’s health at risk.
The century-old drug costs nearly $100 per unit in the United States. The next most expensive average cost in the developed world? Insulin in Japan costs $14.40 per unit.
The lack of affordability around insulin inspired Eric Moyal to leave his job in 2022 and launch Project Insulin, a Providence-based nonprofit whose mission is to ensure Americans have access to affordable insulin.
Q. Why is insulin so expensive in the United States?
Moyal: Three large pharmaceutical companies make 90 percent of the insulin that’s distributed around the country. They have a monopoly around it. So this isn’t a science problem, it’s a monopoly and money problem. The patents have expired, we can make a generic insulin, but it takes a lot of capital to do so.
Also, different countries have different health care systems. We have a very convoluted set of middle organizations. Insurance companies aside, just the process of getting insulin from the manufacturer to the patient includes pharmacy benefit managers, wholesalers, distributors, the list goes on. These different middle organizations add to the cost, while the manufacturers continue to make a pretty hefty profit.
Q. How would Project Insulin make insulin more affordable?
A. We plan on making an affordable, generic insulin, but we’re an access company. Our mission is to make it affordable by cutting out a lot of the middlemen. Then we would be partnering with health clinics directly, especially those that serve populations that are underinsured or uninsured. When we cut out all the different pieces, we would have a flat rate whether you have insurance or not.
Q. What would that flat rate be?
A. Hopefully between $10 to $20 per vial. There is no copay, and no list price.
Q. How will you be manufacturing insulin?
A. We’ll be outsourcing the manufacturing. I can’t say if we’ve identified one yet [due to legal reasons], but we have proposals in from a variety of drug developers. Most of these plants are worldwide, but they have facilities in the United States, which is important to us. Having it done here makes the Food and Drug Administration scrutiny higher, which shows our product is airtight. We’re not just a generic drug maker, but we’re a high-quality generic to patients. Also, from a distribution standpoint, it is cheaper to make and ship from different parts of the US compared to having shipping containers travel [from abroad] and be distributed around the country.
Q. What are the regulatory hurdles you’ll have to overcome?
A. The manufacturers have to have the equipment to make the insulin, which is not as common today as it was 10 to 15 years ago. A lot of drug manufacturers have moved on to mRNA drugs [such as the COVID vaccines]. Insulin is sort of viewed as a not-so-sexy, old-time kind of drug in the industry.
In 2010, President Barack Obama signed into law a biosimilars act that didn’t come into play until 2020. It included insulin, and what it did was allow you to create a biosimilar, or a generic drug, through an expedited FDA approval process. Your focus of the drug development isn’t on showing that this drug can work since this isn’t a novel drug. We already know insulin works, but we would have to do a comparative analysis that shows it works similarly to what’s on the market. We’ll have to go through a Phase 1 trial, but won’t have to worry about Phase II or Phase III.
Q. From a budget perspective, what will this take?
A. If you’re developing a novel drug, you’re going to need up to $1 billion, or more. For this, with an expedited FDA approval pathway, we’re projecting about $15 million to $20 million. That process will likely take about five years.
Obviously, $20 million is a lot of money, but it’s not an insane amount of money. One in three people know someone who has been prescribed insulin, the nation spends $15 billion on insulin alone, and 15 percent of people who have insulin-dependent diabetes can’t afford their insulin. There is a clear path forward, and it is possible to tackle this problem head on.
Q. How are you raising money?
A. I have a background in fund-raising. After graduating college, I worked at Brandeis University where I helped coordinate the 2020 and 2021 Giving Tuesday Campaigns that raised more than $2 million. We did receive a $50,000 grant recently from a private foundation, and mostly have been receiving donations from individuals on a smaller scale — from $10 to several hundred each. Those might seem small, but it helps keep the lights on, right?
Q. What’s your plan for 2024?
A. We need $400,000 to begin drug development. I am optimistic we’ll raise that and succeed in starting and completing that phase of development in 2024.