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‘It's changed my life’ | Inhaled form of insulin a ‘game-changer’ for diabetics

A newer form of insulin delivery is bettering the lives of some diabetics - but after seven years on the market, patients say it needs more name recognition.

SACRAMENTO, Calif. — There’s a form of insulin that’s changing the lives of diabetics who use it, but doctors and patients alike say it doesn’t have widespread name recognition.

It’s called Afrezza. It’s FDA-approved, and it is the only drug of its kind, in terms of being an inhaled, non-liquid form of insulin. It has also been on the market for more than seven years.

Why should you care? The CDC says 11% of the U.S. population has diabetes—or about one in every 10 people. It disproportionately affects communities of color—especially among Indigenous, Black and Hispanic Americans.

Many people know someone with diabetes, and if Afrezza could make a positive difference in how they manage their disease, then this is an option they can consider but they have to know about it first.

Anthony Hightower was diagnosed with Type 1 diabetes at age 13 in 1983, “so that puts me at 38 years living with Type 1 diabetes,” he said.

Hightower, his partner Letty Santana – who was diagnosed in 1999 – and their friend Matt Macedo – diagnosed at age 25, all have Type 1 diabetes.

“It can be a very lonely disease if you don't have that support,” Santana said.

They’re part of a Sacramento-based group called Duck Fiabetes, which Hightower started years ago as a team name for a cycling event.

“And now, you know, we have this community of diabetics here locally in Sacramento,” Hightower said. “We've hosted roller-skating parties, baseball games.”

They tell other diabetics about an insulin delivery method that has changed their lives, but to understand how it works, it’s important to know the basics of diabetes.

For that, ABC10 turned to Dr. Adeela Ansari of Mercy Medical Group in Elk Grove.

“Diabetes is a condition where your pancreas doesn't produce enough insulin,” Dr. Ansari said, adding that everybody needs insulin to turn blood sugar – or glucose – into energy that fuels our bodies.

“It is important for your blood sugar to be at a certain range,” Dr. Ansari said. “If patients have diabetes, it results in much higher level of blood sugar, which leads to, in the long-run, more complications - affecting your eyes, your kidneys, nerves and high risk of strokes and heart disease.”

There are several types of diabetes, but generally, Type 1 patients have to put insulin into their body every day and some Type 2 patients do as well.

The most common way – by far – is through liquid insulin that can be taken by injection or by using a pump, which involves an insulin dispenser connected to a small tube placed just under the skin.

People who use insulin to control their blood sugar levels take extra around a meal or snack – commonly referred to as mealtime – or bolus – insulin. That’s because the food will raise their blood sugar level and they need the insulin to help lower it back to a safe range.

But as Hightower explains, figuring out the right timing and dosage of insulin is complicated. 

“An injection, for me, takes about 45 minutes to an hour to start working, which is very difficult,” he said. “If you're going out to eat, you don't know what you're going to pick…but yet you still have to guess and count your carbs and figure out what you're going to have, take your insulin based on those calculations. And then 45 minutes-to-an hour later, if your food’s not ready, you could be in trouble.”

That’s because the insulin starts kicking in but the food hasn’t arrived, so someone’s blood sugar level can drop below safe levels.

Alternatively, he said, a lot of people are now “just taking their injections once their food is there or right when they order it, but…now you're dealing with these high blood sugars because you've already eaten but you've only taken your insulin just before you've eaten.”

That means those people face blood sugars that “are sky high for 45 minutes to an hour or so before your insulin starts to kick in,” Hightower said. “And then the traditional insulins continue to work for three to five hours, so now your food is out of your body, your insulin is still working, and you're dropping below that low level, so now you're feeling these post-meal hypoglycemic reactions.”

Both approaches, he said, can lead to a low blood sugar level.

“Hypoglycemic reactions are when your blood sugar drops below a certain level and gives you this feeling of like you're about to die,” Hightower said.

He, Santana and Macedo, however—all of whom used liquid insulin for years—say that the guessing game is not a problem for them anymore.

They now use an insulin delivery method that’s inhaled. It’s the only one on the market—and it’s been available for about seven years. It’s called Afrezza.

“Having the liquid insulin was always a struggle,” Santana said. “Going from that to Afrezza has just been absolutely life-changing. It's been so freeing.”

“I would say it’s absolutely life-changing,” Macedo agreed, as did Hightower.

“It's changed my life, as far as my diabetes is concerned,” he said.

Instead of having to calculate the exact amount of liquid insulin to take based on a guess of the amount of grams of carbohydrates in a meal, Afrezza comes in just three different doses.

“I don't count carbs anymore,” Hightower said. “I just see a meal and see small, medium, large and dose accordingly.” 

“That kind of just gives you a range,” Santana said. “As long as you're within this range, you're fine.”

Macedo said Afrezza is a whole new way of thinking about insulin.  

The biggest benefit is how quickly Afrezza gets to work and then gets out of their systems, they all said.

“You have a noticeable effect between 10 and 12 minutes,” Hightower said. “We can see it because we all wear a thing called a continuous glucose monitor (CGM), and that goes in every five-minute increments.”

To demonstrate, Santana held up her phone, which displayed an app that’s connected wirelessly to her CGM.

“15 minutes after you've inhaled, you'll see a noticeable effect,” Hightower said, pointing to Santana’s screen. “If you're starting to trend up, it starts to level out and then starts to go back down to the level that you want it to be.”

Afrezza acts rapidly – and then gets out quickly, they explained.

“Liquid insulin is four hours out of your system,” Santana said, whereas “Afrezza is out in 90 minutes.”

“The beauty of Afrezza is the speed in and speed out. It's not necessarily that it’s inhaled; to me, that's a bonus,” Hightower said. “Now, I actually take it when my meal is delivered to me…so while my food is now digesting and out of my system, my blood sugar is starting to level out because Afrezza is leveling out.”

Dr. Ansari agrees.

“I definitely can tell you, it's a game changer for patients,” she said.

There’s another kind of insulin that many diabetics use to control their disease, and it’s called their background - or basal – insulin. That a baseline insulin that helps regulate their blood sugar level over the course of many hours, whereas mealtime – or bolus – insulin like Afrezza is specifically for when someone with diabetes is putting food in their body.

Afrezza is faster-acting than other mealtime insulins, Dr. Ansari said, because of how the inhaled insulin is absorbed into the bloodstream through the lungs.

“The majority of the injectable insulin are delivered through capillary system, which takes longer time to really peak and stay longer in your system. But when you look at Afrezza, it really delivers the insulin directly into the arterial blood system, so it goes quickly into taking effect very fast as opposed to the injectable,” Dr. Ansari said.

Michael Castagna is CEO of MannKind, the company that makes Afrezza. He likened the technology of Afrezza to Dippin’ Dots ice cream.

“So like those freeze little pellets –  we freeze-dry Afrezza in nitrogen in a monomeric form, so as soon as you inhale it into your lungs, it releases the technology into your blood,” Castagna said. “There's no waste. There's no time waiting for it to travel through your tissue.”

There are about 3,000 doctors throughout the U.S. who prescribe Afrezza, Castagna said, and about 10,000 patients taking it. That’s a fraction of 1% of the people who could potentially benefit.

“There are about 4 million, 5 million people who live with diabetes on insulin every day for their mealtime control,” Castagna said.

However, Afrezza has been in the market for some seven years. People who use it call it life-changing. ABC10 asked him why it isn't more widely used and known about?

“I would say to two main things,” Castagna began, explaining that he has worked on this for about five years now. “First was the company didn't have a lot of money…so therefore, we couldn't raise awareness….The majority of people do not know it exists.”

This is no large company. Although MannKind has several drugs in the pipeline, Afrezza was its first on the market, in 2015, with a second one set to launch this summer, a company spokesperson told ABC10.

“And then the second one is doctors,” Castagna said. “Because they were trained on injectable insulin, they know injectable insulin. We didn't train the U.S. doctors on inhaled insulin…Doctors just don't believe it sometimes. It's very frustrating. But I tell them to get your own clinical experience. Why wait?”

Because it’s not widely known, Dr. Ansari said Afrezza can be something both doctors and insurance companies unfamiliar with it are hesitant to sign off on.

“It's not preferred on most of the plans, so when you're prescribing this, you really have these challenges to do tons of paperwork to get approval,” she said. “Once you really overcome that, and I think that patients really see the difference, you really change their life.”

She said the drug is expensive, too, so ABC10 asked Castagna about that.

“Our goal is not to hinder patient access through money but really let people experience the product, get great results, and then, you know, appeal to an insurance company if they’re having a problem,” he said. “We have a cash pay program as well, so anyone who has commercial insurance they pay no more than $15 (per month). If you have no insurance, we try to cap it around $100 a month.”

He said MannKind offers a free four-month trial to patients whose insurance doesn’t cover Afrezza and who also can’t otherwise afford it. He encourages anyone with questions about affordability to reach out.

“You have to jump through a lot of hoops, so it is important to find a doctor that can fight for you,” Macedo sad.

“I think at this point, more and more insurance companies are more accepting of it,” Hightower added. “The one that I’m on, I don’t even need a prior authorization. It’s on their tier one.”

“As a provider,” Dr. Ansari said, “I would really listen to what their concerns are. If I see that they have been burned out with their current method of managing their diabetes and this might really help them, I would definitely offer this as a choice for them.”

That’s why Santana, Hightower and Macedo say they try to share about Afrezza with their fellow diabetics – in Sacramento and beyond.

“We want to stand up on these mountainsides and just yell, “Guys, just give it a try. Just try it once and then see if it works for you,’” Santana said. “I know friends of mine that have successful use of insulin pumps, really successful – injectable, they want to inject, that's how they want to manage their diabetes…and that's perfectly great and fine. So I'm like, ‘This is just another option, just in case you want to try it.’”

One challenge with liquid insulin, she said, is that it has to be refrigerated. She, Hightower and Macedo all say that they don’t refrigerate their Afrezza cartridges and it works well for them. Afrezza’s website says an unopened cartridge stored at room temperature must be used within 10 days. A refrigerated cartridge has a longer life. See that guide here.

A version of Afrezza for kids is still in clinical trials. Castagna said he’d also eventually like to see a version of Afrezza approved for gestational diabetes – for women who get the disease while pregnant.

Possible side effects of Afrezza include decreased lung function. Macedo and Santana said they had a small cough for several weeks when they first started Afrezza, but then it went away. See other possible side effects here.

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