Take a deep breath, Friends: the world’s first (seemingly) commercially viable inhalable insulin product is here. Today, Sanofi has officially launched MannKind’s long-awaited Afrezza, and we hear the product is already appearing in some pharmacies nationwide. Housed in a tiny, handy inhaler device, Afrezza is said to bring not only convenience, but also some new medical benefits to the world of rapid-acting insulin.
“I don’t know if it’s gonna be a blockbuster, but I do think it’s gonna have a niche,” says Dr. Steve Edelman of UC San Diego and TCOYD (a type 1 himself), who was one of the lead investigators on Afrezza clinical trials.
“I can say it has been shown in clinical trials to reduce hypoglycemia, but FDA won’t let (Sanofi) put that in the labeling. I was at the FDA public hearing in Washington, DC, and they spent all the time trying to refute the data instead of trying to understand it… It’s just a total shame FDA didn’t allow them to put that benefit in the label.”
“Afrezza really does work extremely well. I can see myself taking it for incidental hypers where subcutaneous insulin is way too slow and stays around in your system way too long,” he adds.
Whoa… aside from the obviously enormously superior design of the inhaler device itself over the previous Exubera fiasco, we’ve been skeptical about the practicality of Afrezza. After all, it’s just for prandial dosing, so even most type 2s would need a shot a day of long-acting insulin to complete their therapy, right? And how precise can inhaled dosing possibly be? Plus, it’s hard to get your head around how this stuff reduces hypoglycemia. Last not least, there are the issues of pricing and insurance reimbursement.
Read on… and please don’t miss the product Q&A at the end of this post.
Edelman was kind enough to share with us a bunch of research data directly from his published review showing evidence of Afrezza’s edge over fast-acting Humalog insulin on core measures including pharmacokinetic (PK) and pharmacodynamic (PD), and GIR, or glucose infusion rate (the amount of glucose needed to counteract the insulin).
The bottom line is that Afrezza appears in the bloodstream faster and gets out quicker, so it’s much more likely to be peaking when your carbs are forcing a glucose spike, and to be out of your system rapidly enough to avoid lingering lows.
That’s why Edelman thinks Afrezza will be great for correction doses, even just a few hours after meals – you can bring down highs quickly without the risk of stacking insulin.
btw, for type 2 users who may not need it, it’s not requirement to be using a basal insulin alongside Afrezza, he says.
And the kicker: you also don’t gain as much weight as you may with subQ insulin, Edelman adds. Now those are some real-world advantages!
Check out this video of Dr. Edelman discussing – and using! – Afrezza:
Stefan Schwarz, Sanofi’s US Afrezza Lead, tells us that the whole system of dosing is much improved too.
“A dose of Exubera was not expressed in equivalent measure to subcutaneous units. Afrezza is equivalent, and has linear dosing, so an 8-unit cartridge is the same as two cartridges of 4 units.”
But given those set dose sizes of 4 or 8 units, it’s still murky to us how physicians will know to set dosing, i.e. for a large versus a small meal (assuming precise carb-counting doesn’t come into play here)? The company’s official response:
“Physicians should adjust dosing based on a person's metabolic needs, blood glucose monitoring results and goals for glycemic control. Physicians may also need to adjust the dosing based on changes such as a person's level of activity or meal patterns, such as nutrient content or timing.”
OK, can’t wait to see that in action.
Contrary to what’s been stated in some media coverage, FDA approval is for all adults with both type 1 and type 2 diabetes. Of course patients can’t have any “contraindications” that would compromise their lungs, like COPD or asthma, or if you’re a smoker, you’re out. (See Prescribing Info, PDF)
It is not yet approved for pediatric patients, but Sanofi says it’s actively working with FDA to define the protocol for a study in children.
Interestingly, every patient who wants to get approved for an Afrezza prescription will first have to take a lung test called FEV1 (Forced Expiratory Volume test), Edelman tells us. Despite the scary name, it’s a simple breath test doctors can do right in the office, if they have the machinery.
Edelman says most primary care physicians do have an FEV1 device right in their office, but he doesn’t know any endos who have one.
“It’s not expensive, and it’s a big improvement over the Pulmonary Function test you had to get before prescribing Exubera – which was expensive and required patients to go to a special lab… Who knows? Maybe Sanofi will start providing (FEV1 tests) to doctors?” he adds.
Who Will Want Afrezza / “An Unmet Need”
While it may be hard for most of us type 1s to imagine patients flocking to Afrezza as they run screaming from needles, apparently there is quite a large segment of PWDs who could really benefit -- type 2s on oral drugs who still qualify as “uncontrolled” and those on basal insulin who need it, but are just not yet willing to add mealtime insulin shots, according to Sanofi’s Schwarz.
Leading endo Dr. Edelman agrees. “Resistance to taking insulin is PERSISTENT. I see so many patients who just won’t take it – even one military vet who’s been shot at, says to me, ‘you could shoot me through the head before I take that injection,” he says.
Well, there’s some great anecdotal evidence that this easy-to-use no-needles product indeed fills an “unmet need.”
Availability and Cost
This is where the big controversy lies, it seems: will enough people be willing to pay for it? Of course, as a new drug Afrezza won’t be covered by many insurance plans at launch, and at a “tier” with higher copays for those that do.
Sanofi’s Schwarz wouldn’t offer pricing details in advance of shipping, but says Sanofi will have tools in place to help patients in need access the drug, including copay cards.
We did some of our own informal research by calling our local Walgreens, CVS and Kroger pharmacies and were told that they don’t yet stock Afrezza on their shelves, but if you can obtain a doctor’s prescription, those pharmacies can order it for you now from a nearby distribution center, which usually fill orders in just 24 hours.
CVS wasn't hip to sharing prices without an Rx, but Walgreens and Kroger both quoted a cost of $334 out-of-pocket cash price for a box of 30 4-unit cartridges + 60 of the 8-unit cartridges.
We also checked with insurer Anthem BCBS that currently pays 50% of our insulin costs; they would do the same for Afrezza, they say, so our price would be $130.80 for a box of 60 of the 4-units that should last a month. So yes, it’s comparable to our current insulin prices – and even potentially a bit less than what many pay for a month's worth of Humalog or Novolog currently.
A well-known investor-blogger over at Seeking Alpha notes that “cost conscious insurers often wait for a year after a product is launched to cover it.”
Some of you may have already discovered the blog and twitter feed of Sam Finta (@afrezzauser), a type 1 who took part in Afrezza’s clinical trials and participated in the FDA Advisory Committee hearing for the product.
“My experience says it’s definitely a ‘life changer’ and my observation is you’ll never go back to your old regimen,” he writes.
As Seeking Alpha noted, bloggers are going to be key for this product, as “word of mouth will do what no amount of paid pharmacy reps can do!” Amen to that.
On that note, we had some very specific questions from a day-to-day user perspective, submitted to Sanofi’s Schwarz. Here’s what we learned:
DM) Can the inhaler/device be recycled?
SS) No, the inhaler should be discarded after 15 days of use and replaced with a new one to maintain drug delivery.
Can the insulin cartridge be recycled?
No, used cartridges should be discarded in the regular household trash. You can tell when a cartridge is used, the white cup has moved to the center of the cartridge.
How much insulin in one puff on the inhaler? Is one unit one puff?
Cartridges come in two dosing strengths, 4 units (.35 mg of insulin) and 8 units (.7 mg of insulin). One cartridge is one dose administered with one inhalation. For patients who require doses exceeding 8 units, patients may use a combination of 4 unit and 8 unit cartridges.
How will a patient know that they've inhaled the whole puff?
Patients are able to deliver their full dose with a normal inhalation.
What sort of container or carrying case will be provided? i.e. how will patients carry Afrezza around?
Afrezza is available as 4 unit and 8 unit single-use cartridges. Three cartridges are contained in a single cavity of a blister strip. Each card contains 5 blister strips separated by perforations for a total of 15 cartridges. Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package). The perforation allows users to remove a single strip containing 3 cartridges, which can be carried in a pocket or a purse.
At this time, there is no manufacturer carrying case for the inhaler. Third-party companies often design and offer those. And we continue to evaluate patient needs to determine if any additional support here should be considered.