Afrezza Update: Giving Inhaled Insulin a Second Try, As MannKind Re-Launches

http://type2diabetestreatment.net/diabetes-mellitus/afrezza-update-giving-inhaled-insulin-a-second-try-as-mannkind-re-launches/

I"m not afraid to say that I like to inhale.

My Afrezza inhaled insulin, that is.

I"ve gotten past my initial reservations about this novel type of powdered insulin and have been giving it another try over the past month, after taking a much-needed break from my insulin pump.

My blood sugars have been outstanding, and my A1C has dropped significantly in the first month of my #PumpHiatus.

That"s of course exciting for me, and with all the interesting news about Afrezza and its manufacturer MannKind Corp, recently, this is an exciting time for the product overall.

So before getting to my own personal experiences with Afrezza, let"s first take a look at the related news coming out of the American Diabetes Association"s 76th Scientific Sessions in the Big Easy earlier this month. MannKind had a strong showing at ADA, complete with science data on needed label changes, new product marketing, new research and sales partnerships, and a glimpse at a next-gen, Bluetooth-enabled Dreamboat inhaler.

What"s New for Afrezza and MannKind?

MannKind 2.0: For those questioning the California-based company"s viability in this insulin marketplace, there"s a lot to be excited about.Remember that early this year Sanofi dropped Afrezza, turning the manufacturing and marketing responsibilities back over to MannKind. That left many wondering how long the company could survive, especially after this Spring"s sad news that longtime biotech pioneer and Afrezza founder Al Mann passed away and wouldn"t be infusing money into the company. MannKind"s been very adamant that it is financially secure despite rumors to the contrary, and it has ramped up efforts to relaunch Afrezza commercially -- picking up the pieces of what it says Sanofi mismanaged in the initial launch.

MannKind has said it won"t be seeking other partners for Afrezza anytime soon, but it hasn"t closed that door for good.

Chief Commercial Officer Michael Castagna tells us, "If we feel a need to partner we can look later this year as there are a lot of companies with capacity, but it’s important to me that MannKind relaunches and does it right with specialists to ensure adoption before we go out to primary care doctors. Once we get patients taking this and generating more demand, the Payer situation will improve as well."

Re-Launching Afrezza: This week, MannKind is beginning the product sales force relaunch, in a way that"s more comprehensive and common-sense than how Sanofi handled the initial launch a year ago.The full re-launch is planning for July.

MannKind"s efforts to make this product more viable and visible to doctors, Payers, and people with diabetes include:

• Titration Packs: These are being rolled out to doctors offices, to allow patients to get a better feel for how Afrezza works and how to adjust their doses accordingly. The packs will include a 90-count of 4-unit cartridges and 90-count of 8 unit cartridges -- offering more options for experimenting with different dosing amounts. This should help both patients and doctors, many of whom have been unsure of how to prescribe Afrezza since the dosing isn"t an exact unit-to-unit translation. This also makes it better for patients so they don"t need refills too quickly or have to pay extra co-pays for more cartridge packs.

• Better Pricing:Part of the re-launch includes a new NDC (National Drug Code) number that standardizes the Afrezza copay as a single price-point instead of the patient having to pay different copays for varying cartridge concentrations. MannKind won"t be releasing that cost until July, but for the average patient using 50 units per day it will be less than the approximate $19 a day it costs an insurer compared to an injectable mealtime insulin.

• Lung Test: The FDA requires a lung capacity test before a patient can start on Afrezza, and up to now that"s typically meant doctors have had to write a separate prescription for that test to be performed. Doctors almost always had to send patients out somewhere else to get this test, often requiring more insurance fuss and an additional lab fee before a PWD could even start the drug. Now, MannKind is working with a third-distributor to sell the affordable handheld lung testers (known as spirometers) to doctors offices so they can perform the lung test on-site. The cost to physicians will be roughly $400. MannKind tells us the hope is that many doctors will buy this tester over the next month and "streamline that into the patient experience."

• Savings Card: This is a carry-over from the Sanofi partnership, but the savings card program is still available for people needing financial assistance to pay for this product. The first Afrezza prescription fill is $0 (!) and after that refills are no more than a $30 co-pay (up to $150 per Rx). Anyone on federal insurance such as Medicare and Medicaid is not eligible, unfortunately.

• New Local Diabetes Care Centers:MannKind"s is working with new healthcare company VDEX (which stands for "Victory Over Dextros") that is setting up clinical care and teaching centers across the U.S. These centers will be devoted to providing affordable local diabetes education, testing and supplies. They"ll offer a number of treatment options, but definitely plan to highlight Afrezza as a treatment of choice. They plan to launch this summer with two locations on the West Coast -- including Sherman Oaks, CA, where MannKind is headquartered. Thecenters will be primarily located next to existing urgent care facilities but eventually also in retail centers offer after-hours availability, staffed by nurse practitioners and consulting endos and medical assistants. VDEX execs tells us the new centers will have a "different aura" than standard doctors" offices, with a hospitality focus where PWDs are referred to as "guests" rather than "patients."

Afrezza for Kids? News broke on the first day of the big ADA conference that MannKind is collaborating with the JDRF to study Afrezza in pediatric populations. There isn"t much more detail available on that yet, but MannKind"s Castagna tells us kid-style Afrezza is likely a few years out.

Even if it"s a longer-term goal, we"re encouraged by this news as it shows that JDRF has some faith that MannKind can survive in this marketplace.

Smart Afrezza Inhaler: One of the cool things we saw in MannKind"s booth at ADA was a demo of its BluHale technology, a small electro-acoustic device that affixes to the dry powder inhaler. It measures the sound generated during use, which indicates the amount pressure of inhalation. I was able to do a trial inhale to test the strength of my own inhalation technique, displayed on a nearby laptop screen. (I was actually able to see that I"m inhaling too hard, and can tone it down a bit).

According to MannKind folk, the company"s toying with the idea of creating a next-gen Bluetooth-enabled Dreamboat inhaler that will enable patients to track dosing, lung capacity, types of cartridges, etc. Plans for this smart Afrezza inhaler are not firmed up yet, but what a great idea! We hope that"s something the company ultimately decides it can and should do!

Real Science vs. Real-World Experiences?

MannKind presented data from a number of studies at the Scientific Sessions, huge boons in getting product labeling changes for better doctor prescribing and patient use.

One of the big challenges Afrezza faced in its first year was that the FDA wouldn"t allow "less hypoglycemia" to be included on the product label, something that many have observed hindered its appeal. Also, the dosing information wasn"t clearly mapped out in the early months; it"s now become more common knowledge just how quickly it works compared to injectable insulin, and that a 4-unit cartridge is more equal to 3 units while an 8-unit is more like 6 units for many PWDs.

Data from some studies showed:

• Onset of action within 16 to 21 minutes for Afrezza compared to 45 to 52 minutes for subcutaneous insulin across trials
• Afrezza"s duration of action at clinically relevant doses was consistently shorter by 2 to 3 hours
• Afrezza"s labeled dose overestimates its effect, meaning patients need better titration to get the appropriate dose
• A 4-unit Afrezza cartridge provides approximately the same insulin exposure as 3.1 units of Humalog.
• Lung tests showed PWDs didn"t experience any negative lung effects after three months going up to 24 months

Despite this late-breaking data presented in New Orleans, it"s a somewhat uphill battle as some in the medical community are relying on outdated, incomplete data to base their prescribing decisions, MannKind execs tell us.

In a session on inhaled insulin by Dr. Stefano del Prato from Italy, he presented data indicating that there is "no clinical significance" in reducing A1C. This doctor was actually saying to a lecture-hall room of medical professionals that Afrezza isn"t clinically effective, thereby basically implying that it"s not worth prescribing or fighting for patient access to this medicine.

I was stunned.

Sitting in Dr. del Prato"s session, I was blown away by the evident disconnect here between the science community and PWDs and doctors who"ve been seeing so much real-world success with Afrezza.

Later, this doctor backpedaled a bit after an endo stood up during the comment period and voiced her frustration that Dr. del Prato"s findings were not optimized, mostly because the research was performed in the very early months following launch, when real-life dosing practices and even A1C data from longer use were not yet clear.

del Prato said that may very well be the case, and maybe clinical studies need to be "reworked." But he still countered that as of now, his data doesn"t prove Afrezza is any better than regular insulin.

While many users may disagree, I overheard a few doctors talking after the session making comments like, "Why bother prescribing?" and "what a waste of a product, especially with potential long-term lung effects."

Disconcerting, IMHO.

But I also heard a comment at ADA from Aaron Kowalski, Chief Mission Officer of JDRF and a longtime type 1 himself who"s been using Afrezza for a while now. In response to questions about potential long-term complications from this inhaled medication that "isn"t natural," he basically said that we aren"t meant to inject insulin subcutaneously either. Puts things into perspective, no?

My Personal Experience Using Afrezza

After deciding to disconnect from my pump in early May for a much-needed break, I found myself on twice-a-day injections of Lantus along with Novolog. That"s when I thought about trying Afrezza again, pursuaded by what I"ve heard from others using the product -- including both my mom who uses Afrezza, and Dr. Jeremy Pettus who"s a trusted D-peep and tried Afrezza again himself.

That all convinced me to give Afrezza another go, despite my lackluster experience the first time around. And now I"m pretty geeked out to be part of this whole Inhaled Insulin Story that"s been in the works since just FIVE YEARS after insulin was first available back in 1922!

Thanks to some sample packs, I"ve been using Afrezza since May 11. It"s not 100% all the time for me, and I"ve had to learn to maneuver follow-up dosing for larger carb or higher protein meals. But in just a month, I"ve seen magical results that have turned me into an Afrezza fan.

The data speaks for itself:

Granted, this is just the very first month or so of my #PumpHiatus. Right now, my diabetes management is a big focus and Afrezza"s still the "bright and shiny" new toy that I"m having fun with. Before long, I"ll get more set in my routine and my data will be less glamarous, I"m sure.

I"ve also heard others say that over the course of time they saw a need for more Afrezza than they"d started out with. That"s something our own AmyT here at the "Mine has experienced, as she"s been using Afrezza for more than a year now and has talked about needing to bump up her doses.

So be it, I"m fine with that -- especially now that I"ve seen the new titration packs coming soon.

I"m now going about getting my first official prescription filled, and I"m eager to continue using Afrezza as long as I"m able to get my hands on it. I"m still nervous about MannKind"s business prospects, but I"m remaining optimistic. With the recent scientific data now official and all of MannKind"s proactive planning, I"m excited for what Afrezza"s future holds.

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn"t adhere to Healthline"s editorial guidelines. For more information about Healthline"s partnership with Diabetes Mine, please click here.

Type 2 Diabetes Treatment
Type 2 Diabetes Diet
Diabetes Destroyer Reviews
Original Article
#DiabetesMellitus