How Civica Rx Aims to Change the U.S. Insulin Market
Editor’s Note: People who take insulin require consistently affordable and predictable sources of insulin at all times. If you or a loved one are struggling to afford or access insulin, visit GetInsulin.org.
Beyond Type 1 is a proud partner of the Civica Rx Insulin Development Project. Read our news coverage of the initiative.
In March 2022, Civica Rx—a non-profit drug manufacturing company—announced its upcoming entrance into the insulin market. Launching in 2024, Civica Rx aims to manufacture and distribute biosimilar rapid-acting and long-acting insulin for no more than $30 per vial and $55 per box of five pens, regardless of insurance status.
To learn more about the organization’s plans, we sat down with Civica Rx board chair Dan Liljenquist.
The transcript below has been edited for length and clarity.
Beyond Type 1: Hello, everyone. My name is Lala Jackson. I’m on the content team here at Beyond Type 1. Today I am joined by Dan Liljenquist. He is the board chair of Civica. Dan, thank you so much for being here. Can you tell us about the news that was announced today?
Dan Liljenquist: Great to be with you, Lala. I’m so excited. We’ve just announced today that Civica Rx, which is a nonprofit generic drug company, will be manufacturing insulin.
We are developing three molecules of insulin—a Civica version of Humalog, Novolog and Lantus—that we hope to bring to the market in 2024 and hopefully fix the outrageous insulin pricing that’s happened in this country. I’m excited about it.
It is so exciting. I have lived with type 1 since I was 10 years old. I have gone through many bouts of not being able to afford insulin, the life-sustaining drug that we need to survive, so the idea that a nonprofit manufacturer is entering this space and trying to make sure it can be offered at such a low, accessible price is going to be life-changing to a lot of folks. It’s going to change how we navigate the world and are able to access these things.
I’d love to dive in a little bit into what Civica Rx is and why they are choosing to make this step.
Civica is a nonprofit drug company that came out of an idea I had in August of 2016. I grew up with three brothers who had type 1 diabetes and I saw up close and personal their struggles with insulin affordability over the years. It really bothered me.
These are drugs that have been on the market for decades, and somehow people were able to corner these products and essentially hold patients hostage. I thought, “Gosh, government has tried to solve this and they really struggled to solve it. What if we did something differently? What if we organized a new type of business?”
That’s where the idea of Civica came—let’s create a nonprofit company that operates efficiently and effectively like a for-profit would, but with the shareholders being society and particularly those who struggle with the disease, rather than a subset of people who want to make money at somebody else’s expense.
I don’t own a penny of stock in this organization, I’ll never make a dime. I don’t want to. But hopefully, we can bless a lot of lives with what we’re doing.
Civica has already treated 28 million people with products that Civica’s made. This is an organization that’s already functioning and operating. Insulin will just be our next effort to bring affordability to patients.
Before we dive into the logistics of some of that and how it will come to market, I’d like to learn a little bit more about your background and why this is so important to you.
You’ve been in this space a long time. You have brothers who have type 1. You’ve been working in healthcare for a long time. You’ve been named as a Modern Healthcare top innovator, top influential leader. You’ve written in the New England Journal of Medicine about why there’s a case for a nonprofit drug manufacturer.
Why is this work so deeply important to you?
My dad was a professor of medicine at Vanderbilt and an endocrinologist. Where my mom grew up in Idaho, there were no doctors who could care for her two nephews and a niece who had type 1 diabetes.
When I was 10 years old, my parents adopted a set of twins from Colorado foster care. These twins had fetal alcohol syndrome, but also developed type 1 diabetes at 18 months and two years old. Frankly, nobody would take them; their cases were complex. My parents adopted them and they moved into my room with me.
I grew up waking up in the middle of the night dozens of times with my brothers in hypoglycemic shock with my parents trying to get glucose into their system. I watched them in and out of the hospital with diabetic ketoacidosis (DKA). They had a hard time managing their own disease given their other cognitive difficulties. Then, when I was 14, my younger brother, a biological brother, developed type 1 diabetes himself.
I grew up with this and I’ve seen the burden of disease—not only the crushing, constant effort to stay healthy, but then watching how insulin prices have grown by double digits every year for the last 20 years. It’s become an unaffordable disaster for people who are already managing a really complex disease.
If there’s a modern-day version of involuntary servitude, it’s having type 1 diabetes because you literally owe your soul to a company that tells you how much you’re going to pay to live.
So many companies have gotten in on the diabetes drugs market. Companies are making money off of the rebate model that drives the pharmacy benefit manager (PBM) structure.
That’s what we’re determined to fix with Civica. These drugs are clearly past their patented life. They belong in the public domain. Civica’s mission is to make sure that now that they’re in the public domain, they are available and affordable to everybody.
For my brothers, this is a personal thing for me. This is extremely emotional for me too. I’ve seen it up close—the suffering that people have experienced by not affording their medication. We can fix it.
I think that’s one of the really key points. Often, the word that’s used to describe insulin is life-saving, but that almost implies that it’s an intervention when something has gone wrong, rather than it being life-sustaining. We need it to survive. The idea that there are so many companies and systems that block us from getting the thing that we need to survive is shameful. It’s a mess.
I want to dive in a little bit into how Civica plans to navigate the current mess. You talked a bit about PBMs (pharmacy benefit managers) and rebates. For our audience who doesn’t know how that all works together, it’s just a system of—the insulin is made, but then it has to go through all of these hurdles and dollars are added on top of it until it gets to the person who needs it to survive.
How does Civica plan to navigate this existing messed-up system?
It starts really at the core, which is that nobody owns Civica. We’re governed by health systems and philanthropies. We’ve got large payers who are also involved and they don’t own us either.
There are no shareholders to pay, so we’re only going to charge enough for us to be a self-sustaining organization.
When we make [the insulin] available to retailers, pharmacies, etc., printed on the vials will be what we think is a fair price at retail—essentially a maximum [suggested] retail price so people know whether or not they’re getting ripped off.
We’ve also agreed we’re not going to pay rebates. I think that’s one of the challenges here is that the existing supply chain—the PBMs, the wholesalers, all of that supply chain—they’ve created the highway between the manufacturer and the patient.
They take tolls along that entire road… when a patient shows up and pays (if you’re on a high deductible plan, or you have no insurance at all) $200 or $300 for a vial of insulin, that money gets spread around on the back end among these different players. It all comes down to the patient paying the cost.
What Civica is doing is saying, “We’re not going to play that game.” We’re going to work with any retailer that wants to carry us, any pharmacy that wants to carry us, but we’re going to work with them on our terms. We’re going to publish a fair price for insulin and we’re going to hold to that price.
The great thing is that we do have large retailers who are interested in doing this because they know that [the current system] is wrong, they’re just stuck in a system that’s really dominated by the existing players.
We’re trying to create a new market. It’s going to be so much less expensive; this will move the entire market.
It is really exciting but also, fully admitting, I’m almost scared to believe in the possibility of this. It’s been so long, it’s been so burdensome. Letting myself get excited about it almost feels dangerous.
You’ve talked about how Civica is approaching this differently, but I want to dive into the example of biosimilar drugs, essentially the generic version of biologic drugs. We’ve seen a couple of manufacturers try to come to market with a biosimilar, saying that it’s going to be far more accessible, but it still ends up being $150 for a vial. That’s not accessible to most people.
Can you explain a little bit about the biosimilars market and how Civica is getting into that?
Absolutely. These drugs are biosimilars to Humalog, Novolog and Lantus—aspart, lispro and glargine. These are not complex drugs. When they were developed it was really complex, but now this type of science, it’s not that hard to do. We’re well into that process with a partner called GeneSys [Biologics], who’s bringing those three molecules forward for us.
The beautiful thing is that the FDA recently created a pathway for interchangeability for biosimilars. That’s what we’re going for with these drugs.
We will be the lowest price in the market. So when somebody writes a prescription for Humalog or Novolog, with interchangeability [the prescription could get filled with Civica insulin] automatically at the pharmacy counter.
If we don’t get interchangeability [at pharmacies], we still have This references the number of people covered by health insurance that works with Civica Script, not the number of people who require insulin. Currently, there are roughly 8.3 million people in the U.S. who require insulin to regulate blood glucose levels. Source: American Action Forum140 million people covered by large payers [i.e. insurance companies] involved in Civica Script, and what we’re talking about with them is to have Civica insulin be a tier-one covered drug [on their prescription drug formulary].
We’ll make sure that there’s access to these insulins.
This is all coming aimed for 2024?
Aimed for as low as possibly $25 a vial?
We are going to make it as low as possible. We think it’ll be no more than $30 a vial; that’s the retail price. Then for a five-pack of pens, no more than $55.
We actually think we can do better, but we don’t want to over promise and under deliver.
It’s such a massive change from the current market. I want to talk a little bit about barriers. The current system is complex. There’s a lot of money changing hands, there’s a lot of people who are fighting for the status quo.
What are some things that could become barriers, and how can the community help raise our voices to make sure that those barriers, if they come up, everybody knows about them?
I think the biggest risk we have is that there’s so much money that trades hands here already at the expense of people with type 1 diabetes that the market will try to lock us out. That’s where we need the community to be really aware.
When Civica brings insulin to the marketplace, we need to have the community understand where to get it. We need to make sure that they’re raising awareness with their pharmacies. We’re going to need this community to be aware of where they can get the product and also put pressure on retail pharmacies who don’t carry Civica insulin to carry it.
We’ll get the ball rolling on our side too. We have a couple of large retailers that’ll carry our insulin, and frankly, I think everybody will end up carrying it because it’s a life-sustaining medication that you need every day.
We also have a lot of very interested parties from across the aisle, Republicans and Democrats, who are very supportive of what we’re doing. It’s a free-market approach. We don’t have our hand out to the government. Both sides of the aisle seem to like it.
We’re also going to be watching very closely to see how the market responds. We expect oligopolies and monopolies to try to preserve their market share, but on this one, I think we’ve got the right methodology to pierce that and democratize insulin.
We’ll engage with [the Beyond Type 1 community]. We’ll let you know how to help. This will be an ongoing conversation. We’ll have regular updates so we can let you know when we’re hitting milestones.
Civica is a transparent company. We only exist to make sure that patients receive the medications they need and that they’re affordable.
I’m so excited to watch this happen. I’m excited to fight for it if need be.
I know there have been years in my life where I couldn’t afford insulin. It was always that feeling of where is the next vial going to come from, how am I going to keep myself alive? That level of tension; we hold it in our bodies, everyone who’s gone through it. It’s something that can’t be explained to anyone else who hasn’t gone through it. It’s like being in a permanent about-to-be-in-a-car-crash state.
The idea that there’s a possibility for this to change, that the entire market can change—I think it’s something that I and everyone in this community who has dealt with this are willing to follow along, to do whatever needs to happen to make sure it does happen.
As we close out this conversation, what would you like people who rely on insulin to know about you and about Civica?
I just want you to know that I understand the struggle you go through. I see it with my brothers. One of my brothers has since died by suicide, partly because of the stress that he was under. My other brothers are dealing with this disease every day. My dad’s an endocrinologist, as is another brother who is an endocrinologist. Diabetes is in our blood.
What I love about what we’re trying to do here—I grew up on the stories of Banting and Best, Frederick Banting and Charles Best, how they discovered insulin and this miracle drug and how they donated the patent for $1 to the University of Toronto, because they wanted to make sure that nobody was excluded from being treated.
We lost our way as a society on that one. I don’t think it’s society at large. I think people understand that this is broken, but I think there are certain choke points in this process that have allowed abuse to happen and it has cost lives. It has certainly cost peace of mind and economic stability.
What I want you to know about me is I’m playing for a societal return here. It’ll matter for my brothers, but it’ll matter equally for everybody else to the same level. That excites me.
What I love about this is that we can do these things. We can tackle some of these societal issues with market forces themselves and it’s just about organizing a new market.
Who I’m talking to right now is the demand side of that market. All of you take insulin every day. If you vote with your feet, we can make this happen. We will bring the insulin to the market, and then we just have to make sure we can find you. When we find you, we’ll create a new market and a new day for people with diabetes.
I’m so excited to keep tabs on everything that you’re doing. I’m excited to keep talking to you over these next few years as we see Civica come into the market, and I am so excited for that day in 2024 where we get to have little dance parties and celebrate the day it’s available to folks.
Thank you so much for your time today and for updating us on this news. I hope you have a great rest of your day. Thank you for all that you’re doing.
Thanks, Lala. Good to be with you.