Transcript 0:00 Regardless of diabetes tech, therapies, and management styles, we all need insulin. Without it, we simply can't survive. 0:08 I feel so lucky to live in a world where I not only have access to the insulin and medical supplies I need, but I have the choice in the tools that I use to manage my diabetes. 0:18 But what if a company decided to discontinue its product that works best for you? Well, today's guest is sharing her experience of facing this reality, an insulin that's being taken away without a viable replacement. 0:32 Welcome to the show. I'm Justin. I have Type 1 diabetes, and on here, I talk all things diabetes tech, news, and research with industry leaders and those living with diabetes and using the tech. 0:42 And this is our second installment of our new series, Diabetes Advocates, where we highlight community stories from people with diabetes just like you and me. 0:52 And today, we are speaking with a founding member of the Alliance to Protect Insulin Choice, Allison Smart. Allison is leading the initiative to raise awareness and hopefully bring back Levemir to the US market. 1:05 Now, Levemir is a long-acting insulin used by people with Type 1 and Type 2, and it has been discontinued by its manufacturer, Novo Nordisk, without a viable biosimilar replacement. 1:17 Allison's daughter is just one of tens of thousands of people that rely on Levemir to manage their diabetes. 1:24 This conversation highlights the threat to Levemir, but also the larger theme of choice and accessibility in diabetes management. 1:32 We wanna use these videos to raise awareness about experience, tips, hardships, and wins in the diabetes community, and we're doing all of this in about under 20 minutes. 1:41 If you or someone you know has a story to share, feel free to DM me on Instagram or just comment on YouTube, and we'll find you. 1:49 Also, this series will be becoming a podcast soon, so you can also listen to it on audio platforms instead of just YouTube. But for now, let's get into it. Allison, welcome to the show. It's great to have you here. 2:02 Thanks for coming on. Justin, thank you. That intro was great. [laughs] Thank you. Loved it. [laughs] Thank you so much. So for people who aren't familiar with Levemir, I mean, I wasn't. I've never used it. 2:14 I hadn't really heard of it. Can you explain to us what it is and what makes it different from other long-acting insulins? I would love to do that. 2:23 And I'm gonna call it, I'll call it Levemir, but I'll also call it Detemir, so that can be kinda confusing. That's the generic name, though there's no generic. Okay. Levemir is the brand name. 2:33 I've just gotten used to calling it Detemir because when it comes back, it likely will be known as Detemir, if we can get- Mm-hmm... this figured out. This is the insulin that you're able to... 2:42 Most people dose it twice daily and differentiate... O- often, they like to be able to differentiate day and night dosing, kind of like a lot of people do with a pump. 2:50 Uh, there are some people, though, that only use it once a day, and there are some that use it three times a day. So it's the insulin that you can kind of play around with a little bit. 2:59 And just, let's compare that to other insulins. So there's glargine, most commonly known as Lantus. Mm-hmm. But there are other names for it. Um, there's Toujeo is extra strength, but it's still glargine. 3:11 There's Basaglar. So glargine lasts roughly 20 to 24 hours, although the, the Toujeo lasts longer. Um, and it has different pharmacokinetic profile. 3:22 And then the other option is Tresiba or degludec, and that has a roughly 42-hour profile. It's a little confusing because you take all three of them every day, sometimes twice a day. 3:32 Um, you know, sometimes there's some variability, but Detemir's unique. You see that change quite quickly. And a lot of people, like you said, like to differentiate that day and night dosing. 3:42 Or in pregnancy, insulin need, needs change quickly, and they like to be able to quickly change that over time. And there are other, there are a few other differences. Glargine has an acidic profile. 3:52 Some people say that it hurts upon injection. The others don't. The others have a neutral profile. Detemir is well proven to cause less weight gain than both glargine and degludec. 4:02 Also, Detemir is the only one that can be diluted for very small children. 4:06 So it's, it's unique, and there are some people that tolerate one definitely better than the others, and that's, that's our big argument, that we should be able to choose. Okay. 4:15 And so why did Levemir or Detemir work so well for your daughter? Yeah, I'd love to talk about that. So she's been diagnosed for four and a half years. She's 17 years old. 4:25 She initially used Lantus or glargine, and her blood sugar was more erratic using that insulin. When we got onto Levemir, we were able to titrate it easier. She, she moves it with her menstrual cycle. 4:39 She takes more at a certain time of her cycle than another. Also, she's an athlete. 4:43 She plays tennis nearly every day, and she also adjusts it for, especially for really high, when she has a tournament weekend, she might want to use less, either while she's playing or that night. 4:54 She has quite a system that she uses. We did go back onto glargine after a few years of using Levemir to say, "Let, let's give it a try again." And again, it's harder for her to move it. 5:04 Her blood con- her blood glucose control is worse when she doesn't have it. She's also used an insulin pump. 5:11 It worked fine for her during the week, but when she would do those tennis tournament competitions, it was very difficult, and several times, she ended up removing it and going back to shots. It was just easier for her. 5:23 She just played a match the other day that was over 100-degree heat, several hours long, and it just, having that baseline of Detemir for her works really well, and we can't lose the option of multiple options of multiple daily injections. 5:38 Oh, so what exactly happened here? Why is Levemir in jeopardy of not being produced anymore? So the company that made Levemir made over half the global supply of insulin. They're now- Wow... shifting... Yeah. 5:53 They're now shifting many of their manufacturing facilities to GLP-1s. All three of the major insulin manufacturers are shifting focus to GLP-1s. 6:03 So as that's happening, new manufacturers are coming into the space, and they're making biosimilars, which is basically like a generic. 6:11 Um, but all, but these, uh, biosimilar manufacturers are focusing on one long-acting insulin, glargine, and two fast-acting insulins, aspart and lispro, more commonly known as Novolog and Humalog. 6:23 We're gonna have, in a few years, more than 10 copies of glargine, but no company is making detemir, and there are quite a few reasons behind that. 6:31 There isn't a clear regulatory path to approval now that the original product has been removed. 6:36 So it takes several years to develop a copy, and the term biosimilar, you have to prove biosimilarity to the original product. 6:45 If the original product isn't on the market, we're in this weird middle ground where there isn't a clear regulatory pathway. Interesting. 6:52 And so how can a company get away with discontinuing what seems to be an essential drug for so many people? The argument is that people are fine with glargine or degludec, and that's kind of the general belief. 7:07 But to take a 12-hour-hour insulin away and leave people with a 24 and a 42, and with pharmacokinetics that some just don't tolerate, that's our argument, and that's, that's why I keep flying back to Washington, DC, and having meetings and saying, "Let's, we need to figure out a pathway." 7:24 Wow. When did you realize that this wasn't a fight that you were going on on your own? 7:32 So I, like many others, started reaching out to advocacy organizations and pharmaceutical companies and legislators and said, "Okay, there's gotta be a path here, right?" 7:43 And, and the answer pretty clearly was, "It just is what it is." 7:48 But as I was researching that, at the same time, on social media and through other contacts, I was reaching out to others, and we formed a coalition, and now we've got a clear group that, that meets. 7:59 Uh, uh, this has been a two-and-a-half year journey. 8:01 The first year, there was a Senate HELP hearing in, uh, September of 2024, and we were able to reach constituents of any senator's district to, who were affected by this. 8:12 So there's quite a network of people who are working on this. Do you know how many people are being impacted by this that, like, I guess, want to stay on it? Here's the statistics. 8:21 The latest statistics we have, from 2022, there were 9 million in the United States using insulin. One million of those were Levemir users. Obviously, some Levemi- Levemir users were okay switching. Some were not. 8:34 We don't have that exact number. I still run into people all the time who didn't know what we were working on. For example, I was at a conference just a week or so ago, and I met a man who said, "Oh, I used Levemir. 8:46 I had great blood sugar control. Four years ago, it was removed from my formulary plan." Mm. "My insurance wouldn't pay for it anymore." This was four years ago, before the discontinuation. He said, "I was put onto J-O. 8:58 I, I immediately gained 40 pounds, and it's stayed on ever since." But he's never talked to anyone about it or, you know, he just thought, "I didn't have a choice." 9:06 But we don't have exactly what number, what percentage of that million. Okay. What was the moment when you decided someone needs to do something about this? It was very early. It was very early. 9:19 I, I was having a conversation with my husband, and I said, "We can't let this go. 9:24 [laughs] Like, I don't feel like, I, I just, I just feel like, I feel like there's been something brewing for a while, and this is it, and we need to go all in." And he immediately said, "You know, if not us, who?" 9:37 So, but of course, we need a ton of help. This is not, [laughs] this is not anything I can do. Uh, this is a huge, huge project, and we've got a lot of help, but boy, we need a lot more help. 9:49 Take us into where you are now with the advocacy. Yeah. Uh, so we have a team. 9:55 We meet frequently with con- congressional offices and Senate offices, the FDA, and Health and Human Services, and our team, um, often it's me or sometimes it's virtual, sometimes it's in person, but our team is consistently one of a group of physicians who specialize in diabetes and pregnancy, typically. 10:13 Um, and there is a pharmaceutical distributor who would like to distribute this. It's an outsourcing facility based in the United States, and a representative of that company comes on. 10:23 There's a lawyer who is helping pro bono who understands the regulatory pathway, and then we'll typically have constituents from, you know, or others from Alliance to Protect Insulin Choice on the call. 10:35 So that's the group that meets, and then just the recent developments. 10:39 So we actually had a meeting recently with Novo Nordisk executives, and they said they are looking into providing part of the, um, part of the ingredients, so we're thrilled about that, and we're hopeful. 10:50 They're still, nothing is set in stone. They're still working on that, but that's exciting. We were thinking we would have to do it without their help at all, but now that that help might be coming, that's a big deal. 11:00 Health and Human Services and the FDA is also researching this, and, um, so good things are happening. What you just said about Novo getting involved in even trying to help, that, that shocked me just now. I mean, 11:14 take me into that experience, hearing that from them. That was huge because, uh, the first several years it was, "No, you guys are just a small group. We're not gonna help." There were some things that led to that. 11:26 I was at the American Diabetes Association conference in June in New Orleans, and I actually was able to talk to the CEO of Novo Nordisk. 11:33 We had a great conversation, and he said, "I'd like to have my executives talk to you further." And so our team has been meeting with their team, and we're thrilled about that. Now, what are the next steps? 11:43 I assume the FDA needs to get involved now, too. Yeah. There's not a clear regulatory pathway, as I mentioned. There are a couple pathways that can happen. There's the, uh... I'm just gonna quickly touch on three. 11:54 There's the traditional biologics license application pathway. That pathway is not very likely. It, it requires the original product. 12:01 It takes several years, several hundred million dollars, and the original product to compare it against. So that one, we don't really think will happen. There's another pathway that could happen. 12:11 Insulin was designated a biologic in 2020, so not very long ago. So for 15 years of Detemir's lifetime, Detemir's been around since 2005, it was designated a drug. 12:21 And if a drug is in shortage, there's a compounding pathway. 12:24 It still goes through the same rigorous FDA standards, but it d- is, doesn't require the expense and the length of time, and that could happen quickly if, if the FDA would allow this to be designated as a drug and to, if they would put this on the drug shortage pathway. 12:39 And then the third pathway is if Novo Nordisk would assist with some of the ingredients, that will still require FDA clarity. So why is the drug shortage designation the cr- one of the critical next steps here? 12:52 Because that pathway we talked about, that compounding pathway, that's how that works. 12:57 So this company I mentioned that, that joins us, and for a lot of these meetings, they're called a 503B outsourcing facility, and what they do is they resolve shortages. So we really need organizations like this. 13:09 It's called Stack Pharma. They also make other, um, like some oncology drugs that, that some companies don't see as lucrative anymore, and they make these kind of drugs available. 13:20 So that's why putting this drug on the drug shortage list by the FDA would directly give an avenue forward for us to have access. How quickly do you think a manufacturer could begin producing a generic version? 13:34 Through this compounding pathway, it could happen within 90 days. It could happen, like, now. And if Novo Nordisk does help, it would totally depend on how quickly they could help us. 13:44 If they could send some of the ingredients, actually called the active pharmaceutical ingredient, which is the backbone of an insulin, if they could send that right away, they have some left over, this could get done immediately. 13:55 Uh, like, with well within 90 days. Mm-hmm. But short of that, and, and the argument would be, well, it takes longer to figure out the regulatory process, it would take longer, but remember, people are really struggling. 14:07 I, I met a physician, a pediatric endocrinologist, and we were talking, she said, "I have a patient who's two years old. He was diagnosed..." It's a little boy, a toddler. "He was diagnosed several months ago. 14:17 He was put on Lantus. His blood sugar was erratic, very high, very low. Um, he was switched to Levemir twice a day. He has excellent blood sugar control. It's very stable." So this patient has been a real advocate. 14:32 Both the patient's mother and that physician have come on with us with calls with their congressional representative. 14:38 They even recently flew to an appointment with some key, um, political members in California who are working on this. 14:45 So that's just one story of how important this is and how it, it makes a big difference when people reach out and join this effort. 14:52 Yeah, I mean, I couldn't imagine if someone came and told me that the, the drug or the tool that I use to manage my diabetes is gonna be taken away tomorrow, and there's no substitute. 15:02 Like, diabetes impacts every moment of our lives, and when you find something that works, it's so, so important. Everyone listening understands that. 15:10 What can our listeners or people in this community, what can they do to help? How can they get involved? The main thing we need is more voices, and funding would certainly help. 15:21 So we have a website, alliancetoprotectinsulinchoice.org. We are a nonprofit. We could use funding. 15:27 We could use people reaching out, sharing your stories, or even just people understanding the importance of this, reaching out to your legislators, or reaching out to us and saying, "How can you help?" Great. 15:36 Allison, thank you so much for coming on. Thank you so much for sharing your story. We're definitely gonna be following it, and we've got resources to everything we discussed down in the show notes. 15:46 Thank you, everyone, for listening. Uh, we will tech you later.
