Experimenting with Baqsimi Nasal Glucagon

 

Puffing a brand new form of rescue glucagon up my nose to treat a low blood sugar is everything I thought it could be.

No kidding. With just a two-click press of a plunger and surprisingly forceful blast of powdery mist up into a nostril, Lilly's new Baqsimi nasal glucagon began circulating into my bloodstream. Within 10 minutes I could tell it was working, boosting my blood sugars that had plummeted into the 40s and were still dropping. Not long after, my CGM (continuous glucose monitor) graph started showing the rise.

After monitoring the Baqsimi effect for two hours post-low, my wife and I were convinced that this first-ever intranasal glucagon, approved by FDA in July 2019, is indeed a game-changer. It is worlds apart from the traditional mix-and-inject glucagon kits we PWDs (people with diabetes) have been forced to endure as the only emergency glucagon option since 1961.

Unfortunately, most patients will struggle to access this great new product, as Lilly failed to ensure affordability with its July launch. This new nasal glucagon is priced on par with existing injectable glucagon kits at ~$300. But unlike those existing kits, many insurers are blocking coverage for this new-to-market product, so patients face that high list price unless they’re lucky enough to qualify for a special one-time savings card. 

Whether enough people can or will fork out the out-of-pocket cost to allow Baqsimi to succeed commercially remains to be seen.

In any case, here’s my personal experience trying it out — from access and affordability aspects, to my BG (blood glucose) results, to what my wife thought of using it on me.

Trying Baqsimi at home

I was fortunate to get a chance to try this new nasal glucagon in an early clinical trial in 2014, prior to Lilly Diabetes buying it from Canada-based Locemia Solutions. Clearly, that was just an early prototype, but it worked well and I liked the form factor. So I've been anticipating this product for years now, eager to try it out once it got approved and launched.

After some wrangling, I was able to obtain Baqsimi using a savings card (as described below).

To test it out, I decided I could stage a self-induced Low at home, with careful self-monitoring and supervision from my wife. Using #Afrezza inhaled insulin was a key here, because it's so fast-acting compared to traditional injected insulin and only stays in the system for about 90 minutes total. So dosing it without food lowered my blood sugars quickly to cause hypoglycemia.

In doing this experiment, I had a few important criteria:

• go Low (my threshold is 70 mg/dL, but honestly I didn't care as long as I didn't dip low enough to lose my mind or slip into unconsciousness)

• make sure there's no active insulin on board (IOB) counteracting the Baqsimi; I let my blood sugars go up into the 200s in order for the Afrezza to have enough time to work and fade away

• no hypo-treating with food, juice or carbs that would give me false data on how much Baqsimi is raising my glucose

• turn off my Tandem Diabetes t:slim X2 Basal-IQ feature, which predicts Lows and auto-suspends your basal rate in order to prevent or soften hypos

With these rules in mind, I was ready to begin my experiment in order to mimic what a real, unwanted Low and how Baqsimi would rescue me by raising my BG.

After dosing the Afrezza, my CGM showed me dropping down to 45 mg/dL. This was actually lower than I'd planned, and I could feel the classic unpleasant symptoms -- shivering and sweating simultaneously, blurry vision, loss of focus, trembling. And my BGs were still dropping, evidenced by the half-down arrow on my CGM trend line. I knew where this was going, based on my 35 years with T1D and the many bad hypos I've survived.

It was time to dose Baqsimi.

Getting a loved one involved

Since our loved ones are usually those forced to administer emergency glucagon in case of bad lows, I really wanted my wife to have the experience using this for the first time. We were both impressed with the simple, easy-to-read instructions on the product container and label. It describes the easy three-step process with clear illustrations of how you dose Baqsimi up the nose.

The only thing missing, per my wife Suzi: Actual guidance on how far up the nose to stuff the Baqsimi dispenser. She also notes that when pushing (or squeezing) the plunger, she didn't expect two different clicks signaling that the full dose had been administered. She'd only expected one, and had started pulling the Baqsimi away from my nose before the second click occurred.

For that reason, we weren't sure if the full dose had been administered as it's supposed to be. So it came down to monitoring my CGM results to know for sure. As we later learned, it worked wonderfully.

• Works within minutes: Baqsimi started boosting my BGs within 5-10 minutes, as I could feel my levels rising even before it became apparent on the CGM screen within 15 minutes.

• Big emergency boost: In 50-55 minutes, saw a total 156 mg/dL rise (from 45 with slight dip arrow, to 208) on my Dexcom G6 CGM. That's also a 3.3-point rise per minute observed over that timeframe.

• An hour afterward: Following that first BG-boost, I leveled off and gradually dropped about 90 points over the next hour before adding food into the mix to keep myself steady beyond the glucagon.

• No other influencing factors: And to be clear, I had my regular basal rate running except for a 20-minute basal suspend when URGENT LOW appeared on my CGM, and I had no other active carbs or IOB (insulin on board) because the Afrezza was 100% out of my system by the time I got my Baqsimi dose.

In short, my wife and I like it and think it's a great new option compared to traditional injected glucagon kits. I've also been pleased to read positive reviews from others around the D-Community who've tried Baqsimi, notably Kelly Close at diaTribe.

Baqsimi access and affordability

Lilly is using the catchy product tagline "Got Your Baq." Unfortunately, as noted, the list price of Baqsimi so far will make it inaccessible to too many people. Here's how the struggle to obtain it went for me:

When Baqsimi first made it into pharmacies, I immediately contacted my endo to have him write me a prescription for a single dispenser. He did that and called it in to my local Walgreens pharmacy. I also knew about Lilly's first-fill offer they were promoting, a discount card that can lower the initial Rx order to as little as $0. Sounds great, right?

Well, it didn't work for me. My state-based HMO plan in Michigan quickly denied coverage for Baqsimi, and I later learned they'd done what many other insurers were doing -- putting a "new to market" block on Baqsimi coverage. As a result, the Lilly discount offer wouldn't work, because it's designed for those who have insurance that is already covering Baqsimi at some level. Without coverage, the discount offer isn't possible. I was told my cash price would be $336 for a single Baqsimi dispenser, so at first, I nearly gave up.

But it turns out that Lilly later started a second savings offer that bypasses insurance completely. This required me to call the Lilly Solutions Center (established in 2018, as a result of increasing blow-back over insulin pricing) at 833-808-1234. During a brief 15-minute call, I provided some personal information to ensure eligibility: my full name, product at issue, my household income, the name of my prescribing doctor, whether I have private insurance and nothing government-run like Medicare/Medicaid, and ensuring that I wouldn't be asking for any insurance reimbursement for this order.

Good news, the woman on the phone told me after running some numbers. They could help me!

She explained that this second, no-insurance option was a savings card. But they wouldn't send an actual card, rather she provided the info by phone. My instructions were to give the code numbers provided to my local pharmacist when filling my prescription for Baqsimi.

At the pharmacy, once they ran all the info -- and specifically confirmed that this was a primary insurance rather than a secondary claim -- they quoted me a cash price of $1.75 (yes, less than $2) for my Baqsimi!

Being a one-time offer, I'm not able to use it again; my only regret is that I didn't have my endo originally write a prescription for a dual-pack, which would've given me a second Baqsimi dispenser to have on hand in case of actual emergency. The savings offer may allow me to get another Rx for $95, but that's still quite an investment.

While I appreciate the initial savings card offer, it's frustrating of course that these discount offers are even necessary in the first place.

Unlike insulin -- which falls into an overly-complicated category of a broken system with inflated list prices and payer rebates -- Baqsimi is a first-of-its-kind product unlike anything else. It seems Lilly could've stepped outside the box here to offer a affordable base price.

Instead, people are again forced to make a decision on whether to pay a crazy-high price or do without the most advanced diabetes treatment that could literally save their life in certain situations.

Hypoglycemia awareness and rescue glucagon

Thankfully, Baqsimi isn't the only new emergency glucagon product making a debut to replace the arcane mix kits. Xeris Pharmaceuticals recently got FDA approval for its equally remarkable new emergency glucagon called Gvoke. They've launched a ready-to-use pre-filled syringe product in pharmacies already, and sometime in early 2020 they plan to launch their EpiPen-style version called HypoPen.

Much like Lilly, though, Xeris has priced their Gvoke PreFilled Syringe comparible price to existing glucagon, roughly $280 -- just as expensive and out of reach for many patients. Also, the new Xeris glucagon is of course still injected, so Lilly's non-invasive nasal version will likely be preferable for many people. Down the road at least a couple years, Xeris is also planning a mini-dosing version that will change the "break the glass for emergency" way we think about glucagon today.

Meanwhile, we expect to see movement on Zealand Pharma's new Dasiglucagon soon too. That will another stable and ready to use injectable device, and the glucagon will also be administered in a pump-version under development.

I attended a recent event hosted at Lilly's Cambridge Innovation Center, in which the Pharma giant brought in a number of diabetes advocates to discuss the issue of severe hypoglycemia. This was a global forum with folk from outside the USA, and Lilly made a point of illustrating that this wasn't product-focused; we weren't supposed to talk specific products or companies, but more generally about the topic of severe hypos and ways PWDs address them.

There was a lot of chat about Fear of Hypos (FoH) but many noted that they're not afraid of severe low blood sugars. Personally, I fear of hypos, probably because I've experienced some doozies throughout my life and especially when I was a child. For me, I think it's more a matter of "losing control" and that scares me. Not everyone thinks the same, though.

Interestingly, one presentation at that forum from a UK-based doctor delved into the recent CRASH (Conversations and Reactions to Severe Hypos) study that looked at global glucagon use within our D-Community. It showed how few PWDs actually have or use emergency glucagon for various reasons, and how people respond to these emergencies and the follow-up (or lack thereof) with their healthcare professionals. The data wasn't surprising, but again it highlighted how important new severe hypo treatments are... and how important user access is.

We're happy to see products like Baqsimi being introduced, and truly believe they have the potential to change everything abut emergency glucagon and responding to dangerous low blood sugar reactions. But again, the best innovations mean nothing if people can't -- or choose not to -- access them. And that, Friends, is why Baqsimi may very well be far less effective and revolutionary for the Diabetes Community as it could be.

Originally published at DiabetesMine