Afrezza Status Report

[compound26]

I am taking CCI's suggestion and created a separate thread on this.

While cash and runway remains the top concern for Mannkind, I do feel that progress is being made in a few fronts. So here is the plus and minus of Mannkind's state of union right now based on my observation:

Minus:

1. low cash reserve;

2. slow ramp of TRs in relaunch of Afrezza

plus:

1. seems like insurance coverage is improving.

Below is what Brian in Tudiabetes.org observed. Brian is a moderator in Tudiabetes.org and I think his comments are generally well-thought, objective and to the point.

www.tudiabetes.org/forum/t/whos-tried-tresiba/55665/209?u=charles5

"One needs to be careful about "insurance coverage." Afrezza for the most part has moved from being considered investigation and experimental and being excluded from formularies. But it doesn't mean that it has good insurance coverage. It usually takes a year or two for a new "me too" drug to move from branded non-preferred status to preferred status. And this is a big change drug. My insurance (Aetna) still considers Afrezza branded non-preferred and may still do so for some time. This means that I pay 50%. The going rate for a kit of 30 4 unit cartridges and 60 8 unit cartridges is $300. I would probably need two kits a month based on my initial experience, so Afrezza would cost me about $300/month or about $3,600/year. I currently pay $160/year for my Humalog. I (and probably most people) likely don't have good insurance coverage for Afrezza."

2. awareness of Afrezza is growing

Based on Brian's post above, Brian recently started to try out Afrezza. And I check Tudiabetes.org often and in my view, there have been growing number of members expressed their interest in trying out Afrezza in the last two-three months (i.e., since Afrezza re-launch). There also has been a growing number of posts discussing Afrezza in the last two to three months. Whereas, after Sanofi dropped Afrezza and before the relaunch, there hardly wasn't any discussion of Afrezza on Tudiabetes.

3. Mannkind appears to be able grow awareness of Afrezza better than Sanofi did

In addition to what I observed on Tudiabetes, we also noticed that Mannkind have been active on JDRF and TCOYD walks recently. I do not have the impression of seeing Sanofi did anything like that while they were marketing Afrezza. These activities got to improve awareness of Afrezza to some degree. One small example of the effect is what Hillard said in his tweet:

Clearly Mike and his team are doing something that Sanofi has failed to do.

4. Afrezza's effectiveness is continued to be proved by the PWDs

I noticed that a lot of the opinion-leaders have tried out Afrezza and they stick to it. While Afrezza's sales is still minimal, such proof is still encouraging. The list of people include (in addition to the earliest adopters like Sam Finta, Eric Fenar, Mike P, Spiro, Laureen, Adam Lasher, Afrezzaguy, Gus, Matt B, and Laura (LJ), etc.): Aaron Kowalski (JDRF Chief Mission Officer and Scientist), Duck Fiabetes NorCal (diabetes blogger), Kevin Michelizzi (diabetes blogger), Mike Hoskins (Diabetes Mine), Amy Tenderich (Diabetes Mine), Daniele Hargenrader (Diabetes Dominator) and cynthia rogers-celt (active member in Tudiabetes.org). And now we have Brian (moderator in Tudiabetes.org) trying out Afrezza.

I am especially encouraged by Brian's comment below:

"This means that I pay 50%. The going rate for a kit of 30 4 unit cartridges and 60 8 unit cartridges is $300. I would probably need two kits a month based on my initial experience, so Afrezza would cost me about $300/month or about $3,600/year. I currently pay $160/year for my Humalog. I (and probably most people) likely don't have good insurance coverage for Afrezza."

So Brian is trying out Afrezza, knowing that he would probably have to pay (out of pocket) $3,600/year a year (versus $160/year for Humalog). He clearly sees the great benefits and value of having Afrezza in his tool box in his fight against diabetes.

[madog365]

Agree on most points. In the minus column - #1 is the what majority of the negativity is focused on by company bashers on this board.

I believe this point will be resolved within the next 2-3 weeks.

[compound26]

Some other observations I have (purely my personal opinion) are that:

1. Afrezza is mainly patient driven

In almost all cases where an afrezza prescription is written, it appears a PWD has asked for Afrezza. So while education the doctors is still a key and very important, it appears the decisive factor of increasing prescriptions is to raise awareness of Afrezza among PWDs.  

So direct to patient campaign is the key to increase prescription for Afrezza.

It appears Mannkind is getting this and doing their part. Hope they can keep working and improving in this respect.

2.   who are the ideal potential Afrezza users

Based on what have observed, the people who are interested in Afrezza tend to have the following characteristics:

a.  They care about managing diabetes and want to have a good A1C number. 

As some posters have observed, if someone does not care about this, it is difficult to get them interested in trying out Afrezza.

b.   They have pretty good knowledge about the disease and the state of art of the tools managing the disease

This is related to item (a).  Otherwise, they probably will never find out about Afrezza.

c.   They have the patience to take the time to dial it in 

It appears it takes some time and effort to dial in Afrezza (which may include tinkering with basal as well).

So it appears any dexcom CGM user probably satisfies the above conditions. Plus, getting a CGM will definitely help a PWD dial in Afrezza and getting better A1C number. They as a group are much more likely (compared with the PWDs as a general group) to be interested and become successful in trying out and dialing in Afrezza.

From this perspective, a Dexcom/Afrezza co-promotion makes perfect sense. However, not sure if Matt and Mike (michaelcastagna ) can make this happen.  One thing could be helpful is that Al Mann used to be mentor to Kevin Sayer (CEO of Dexcom). 

[bwills]

Oct 26, 2016 10:45:09 GMT -5 madog365 said:

Agree on most points. In the minus column - #1 is the what majority of the negativity is focused on by company bashers on this board.

I believe this point will be resolved within the next 2-3 weeks.

It seems like it pretty much must be resolved in the next several weeks; the question is how.

[zuegirdor]

Oct 26, 2016 10:59:44 GMT -5 bwills said:

Oct 26, 2016 10:45:09 GMT -5 madog365 said:

Agree on most points. In the minus column - #1 is the what majority of the negativity is focused on by company bashers on this board.

I believe this point will be resolved within the next 2-3 weeks.

It seems like it pretty much must be resolved in the next several weeks; the question is how.

There have to be a few brilliant people out there with big money and hearts. Otherwise you can have the whole of human enterprise and I am checking out!

[saxcmann]

"From this perspective, a Dexcom/Afrezza co-promotion makes perfect sense. However, not sure if Matt and Mike (michaelcastagna ) can make this happen. One thing could be helpful is that Al Mann used to be mentor to Kevin Sayer (CEO of Dexcom)".

I also think dexcom/afrezza co-promotion makes perfect sense for both parties. This news could happen before end of year. Not sure what this does to pps or cash situation. Are we waiting for fda approval on dexcoms new device?

[compound26]

Oct 26, 2016 10:51:09 GMT -5 compound26 said:

Some other observations I have (purely my personal opinion) are that:

1. Afrezza is mainly patient driven

In almost all cases where an afrezza prescription is written, it appears a PWD has asked for Afrezza. So while education the doctors is still a key and very important, it appears the decisive factor of increasing prescriptions is to raise awareness of Afrezza among PWDs.  

So direct to patient campaign is the key to increase prescription for Afrezza.

It appears Mannkind is getting this and doing their part. Hope they can keep working and improving in this respect.

2.   who are the ideal potential Afrezza users

Based on what have observed, the people who are interested in Afrezza tend to have the following characteristics:

a.  They care about managing diabetes and want to have a good A1C number. 

As some posters have observed, if someone does not care about this, it is difficult to get them interested in trying out Afrezza.

b.   They have pretty good knowledge about the disease and the state of art of the tools managing the disease

This is related to item (a).  Otherwise, they probably will never find out about Afrezza.

c.   They have the patience to take the time to dial it in 

It appears it takes some time and effort to dial in Afrezza (which may include tinkering with basal as well).

So it appears any dexcom CGM user probably satisfies the above conditions. Plus, getting a CGM will definitely help a PWD dial in Afrezza and getting better A1C number. They as a group are much more likely (compared with the PWDs as a general group) to be interested and become successful in trying out and dialing in Afrezza.

From this perspective, a Dexcom/Afrezza co-promotion makes perfect sense. As Sam Finta has pointed out long time ago, this will be real time monitoring +real time treatment, which probably signifies the new age of diabetes management. However, not sure if Matt and Mike (michaelcastagna ) can make this happen.  One thing could be helpful is that Al Mann used to be mentor to Kevin Sayer (CEO of Dexcom). 

I would also add that, IMHO, any active member of an online diabetes forum (such as Tudiabetes.org) probably also satisfies the above conditions (as ideal target consumer for Afrezza).

These people care about their disease and are eager to learn on new treatment developments.  And if they have problems in dialing in, they will more likely engage other members' help.

Let's look at Tudiabetes.org for example. Look at some of the topics that are being discussed as of this moment:

    a.    Tresiba Basal insulin
    b.    Anyone take the wrong dose of insulin?
    c.    Painful diabetic neuropathy and my 1st Endocrinologist visit what should i ask and/or tell?
    d.    What to do before eating with high blood sugar
    e.    Complications: has anyone ever reversed them?
    f.    Losing Weight for Type 1
    g.   NON-Flatliners (Problem Solving) Thread

Aren't those subjects regarding which some of our Afrezza users have a lot of positive things to say (about their experience with Afrezza)?  For example, it will be very powerful if IM_TypeOne tell the story (see the tweet message below) herself to the Tudiabetes.org members in connection with the question: Complications: has anyone ever reversed them?

And how about any of those Afrezza users (in the following post) share their own stories to other PWDs while directly responding to such PWDs' questions?

www.afrezzajustbreathe.com/afrezza-less-complications/

Sam, Terry, Mike P and a few others have been doing a phenomenal job educating the members of Tudiabetes.org on Afrezza. However, there are not enough of them to offer such help. So right now, there are no Afrezza users' input in most of those topics.  We need many more Afrezza users to chime in to offer their experiences on Afrezza. 

Think about it, the members posting an issue there often is somewhat frustrated with some aspects of their existing treatment and they are asking for help. Are that the idea opportunities to share with them the many benefits of Afrezza (that in many cases will be able to solves their issues (like IOB, wide swings of BG levels, etc.) And when an Afrezza user chime in, he/she can potentially reach many members at the same time. 

Can Matt and Mike (michaelcastagna ) think of someway to really encourage our loyal Afrezza users to step up and chime in on those diabetes forums?  Tudiabetes.org is just one of them. But I am sure there are other such forums. IMHO, as long as such users sincerely and honestly share their experience on Afrezzam with a view to help others, their participation will be more than welcome by other members.   Plus, (a) there won't be any financial cost to Mannkind (so it's free!) and (b) the Afrezza users themselves are not bound by the FDA labels in telling their stories. 

[peppy]

Nice thread compound.
I went to the tudiabetes site once, the discussion thread was afrezza.
There was a diabetic woman on the site who said in paraphrase,
"I have a cgm and a pump. I am not going to change." She made the point she had to work at getting that equipment support, and has it.
Being that I am not a diabetic, I left the area.
She told me/us how she felt.
It is a difficult disease.

[compound26]

peppy I know it is not easy. As mannmade has put it in another thread, the education process is a slow process, whether you are educating the doctors or the PWDs themselves. In this case, this is especially the case as we are dealing with a paradigm-shifting product and the incumbent won't give up their interests without a tough fight.

For forums like tudiabetes.org, since it is online forum devoted to PWDs, the job falls on the actual Afrezza users to spread the words there. We non-diabetics should generally refrain from messing with their discussions.  However, IMHO, with Sam, Terry, Mike and a few other pioneer Afrezza users there, I feel that the Tudiabetes.org members (to the extent they know something about Afrezza) now generally have a better and more positive view of Afrezza than, say, a year ago.

I would also encourage each of you to do what you can to encourage any Afrezza user you personally know to step up their efforts to educate other PWDs about Afrezza. We are starting from such a low level (in terms of TRx) right now, each additional converted Afrezza user will be a small yet significant progress towards our ultimate success.  

[sayhey24]

Oct 26, 2016 16:09:36 GMT -5 saxcmann said:

"From this perspective, a Dexcom/Afrezza co-promotion makes perfect sense. However, not sure if Matt and Mike (michaelcastagna ) can make this happen. One thing could be helpful is that Al Mann used to be mentor to Kevin Sayer (CEO of Dexcom)".

I also think dexcom/afrezza co-promotion makes perfect sense for both parties. This news could happen before end of year. Not sure what this does to pps or cash situation. Are we waiting for fda approval on dexcoms new device?

I have had this discussion many times with MNKD since the 2015 launch including with Al at the 2015 ASM.  Stefan Schwarz said last year "sometimes you start out in one direction and then adjust".  Sanofi's original direction was selling to Endo's and primary care for the T2's not under control.  I think they quickly realized there was more inertia in getting doctor's to prescribe than anyone thought.  A year later we know a few things; Verily and Sanofi formed Onduo; Stefan thinks afrezza is an amazing drug; Dexcom gave Verily a $100M contract to develop a non-invasive CGM; Steve Edelman/TCOYD has been involved in the Onduo protocol development; and Josh Riff wants to remove the "friction" in diabetes care.  What we don't know is if either Dexcom or MNKD will be part of the Onduo "product" offering.  If what Verily is developing is any good I would think at least Dexcom will be.  I think Kevin Sayers once said "I have never seen anything like it" when asked about afrezza and the results the early adopters were getting.  It sure seems Stefan and Steve and Kevin all like afrezza but it just needs to overcome "Endo Inertia".  Maybe Vdex and Onduo can help.

[compound26]

Another good example of someone with CGM and active on diabetic forum being an ideal consumer of Afrezza:

"from 8.1 to 5.9 A1C in 3 months time?"

Wondering when we will have enough exposure of great results of Afrezza to cause a tipping point for much wider adoption of Afrezza.

Allen3    1h

Thanks Sam. Sometimes you just have to try it to believe it. I want people to understand it's not always a problem with them, it's their insulin. I have learned SO much from tudiabetes.org since I got active again. Thanks to all who share information on here to help others.

I mean, from 8.1 to 5.9 A1C in 3 months time? Seriously? After years and years of having a high A1C. All thanks to a CGM and Afrezza. I had all but given up.

www.tudiabetes.org/forum/t/tresiba-basal-insulin/50202/556?u=charles5

[centralcoastinvestor]

Nov 8, 2016 17:05:13 GMT -5 compound26 said:

Another good example of someone with CGM and active on diabetic forum being an ideal consumer of Afrezza:

"from 8.1 to 5.9 A1C in 3 months time?"

Wondering when we will have enough exposure of great results of Afrezza to cause a tipping point for much wider adoption of Afrezza.

Allen3    1h

Thanks Sam. Sometimes you just have to try it to believe it. I want people to understand it's not always a problem with them, it's their insulin. I have learned SO much from tudiabetes.org since I got active again. Thanks to all who share information on here to help others.

I mean, from 8.1 to 5.9 A1C in 3 months time? Seriously? After years and years of having a high A1C. All thanks to a CGM and Afrezza. I had all but given up.

www.tudiabetes.org/forum/t/tresiba-basal-insulin/50202/556?u=charles5

We just need time.  Time to change the status quo.  The change will happen.  Matt and Mike know this.

[compound26]

Nov 8, 2016 17:05:13 GMT -5 compound26 said:

Another good example of someone with CGM and active on diabetic forum being an ideal consumer of Afrezza:

"from 8.1 to 5.9 A1C in 3 months time?"

Wondering when we will have enough exposure of great results of Afrezza to cause a tipping point for much wider adoption of Afrezza.

Allen3    1h

Thanks Sam. Sometimes you just have to try it to believe it. I want people to understand it's not always a problem with them, it's their insulin. I have learned SO much from tudiabetes.org since I got active again. Thanks to all who share information on here to help others.

I mean, from 8.1 to 5.9 A1C in 3 months time? Seriously? After years and years of having a high A1C. All thanks to a CGM and Afrezza. I had all but given up.

www.tudiabetes.org/forum/t/tresiba-basal-insulin/50202/556?u=charles5

mannmade  Allen (www.tudiabetes.org/forum/t/my-try-of-afrezza/55853/93) is good example of someone who has tried out Afrezza, initially had some issues/doubts with Afrezza and then after dialed in, absolutely loves Afrezza.  Below you can see a few of his posts regarding his journey on Afrezza so far:

3 months ago:

Very disappointed. Will retest and try to take it before eating and wo coffee. I have stomach distress when drinking coffee due to the acid so I'm wondering if that plays into. I am going to cut out coffee for a week (if i can) and try it again.

6 weeks ago:

Yep Afrezza works great for that. I will be starting my 2nd try of it soon, and one thing it does do is minimize lows. It isnt a carb to insulin match so its very flexible unlike the normal novolog type insulin. I would say you'd be the perfect candidate for it. You dont have anything to lose by try…

3 weeks ago:

Hi Sam, Not sure where you got that I was frustrated from my last post... It is indeed working out great for me for the purposes I mentioned. And this is based on a rather routine schedule, it will be even more amazingly helpful when I travel or my routine gets hectic. I am definitely sticking wit…

Yeah I dont use the 4's at all really. Im using 8's almost exclusively for meals and corrections. The main use for me seems to be fast corrections and to minimize the post meal spike. I still use novolog for rest of the meal as Afrezza just doesn't work as a total replacement for me.

3 days ago:

I mean, from 8.1 to 5.9 A1C in 3 months time? Seriously? After years and years of having a high A1C. All thanks to a CGM and Afrezza.

One day ago:

"Lately yes cause I've been too lazy to put my pump back on. If it gets too resistant I take a shot. You get really spoiled on Afrezza, the idea of taking slow novolog is just like... ugh."

So his experience show that it needs time, efforts and devotion to dial in Afrezza. However, once you dial in, it is such a powerful tool that you wonder, why isn't everyone using this?

[mannmade]

Thanks Compound. Useful info. Appreciate it...

[boomboom]

Nov 11, 2016 17:04:43 GMT -5 compound26 said:

Nov 8, 2016 17:05:13 GMT -5 compound26 said:

Another good example of someone with CGM and active on diabetic forum being an ideal consumer of Afrezza: ....

That was a great post. It makes me wonder how long it takes a user of current prandials (or even basals) to get dialed in. is it 3 months? I just cannot imagine it being better due to the delayed and residual characteristics of current prandials. As an engineer I try to come up with engineering analogies for all situations and current prandials are similar to what is called an over-damped response in a feedback loop. If you overshoot, you overshoot big. If you undershoot, you undershoot big. With Afrezza, the parameters of the control loop are tuned. Every industry that deals with these types of control systems make extreme efforts to optimize these loops. Its in our nature as human beings and will prove the same for a product that gets you closer to the response you want.

I would love to see a transfer function comparison for different prandials against Afrezza over a large sample size of different people. It would allow mathematical proof that Afrezza is just a better solution to compensate for a currently poorly designed control loop. If the cgm charts are not enough to convince someone, logic may be able to assist