Thoughts on Afrezza Scripts and Other Things
Apr 14, 2017 18:06:48 GMT -5
sportsrancho, ezloop, and 13 more like this
Post by compound26 on Apr 14, 2017 18:06:48 GMT -5
1. Afrezza works and works wonderfully
We know that Afrezza works based on: (a) growing body of positive user reviews; (b) growing body of medical journal and magazine reports and coverage; (c) the various tests conducted by users like Matt B. demonstrating how Afrezza works and how great it is working; and (d) comments and experiences of Afrezza prescribing physicians. Also see posts by docfrezza on this.
Per my personal count, as of today, I can identify about 70 people (instead of the often quoted a dozen or so active Afrezza users that various people often claiming) who have shared in social media their (or their family member’s) experience on afrezza. In addition to Sam Finta, Eric, etc. that we are familiar with, they also included people like Damon Dash, Aaron Kowalski, Dr. Steven Adelman, Laura (LJ), Jeremy Fultz, Amy Tenderich, Mike Hoskins, Daniele Hargenrader, Kevin Michelizzi and Robin Jarrell, etc.
As to why the trial results of Afrezza have not been as good as the real word experience of some of the active users we have seen, Sam Finta (AfrezzaUser) explained it pretty well in his blogs:
"There has been so much discussion about the FDA Afrezza Drug trials and why I feel as a participant in the Affinity 1 trial, there were significant “hold backs” as to why we were not able to materially outperform Injectable Insulin because of the protocols on the trials. This is no longer the case!
To Summarize here are just a few of the hold backs why Afrezza didn’t get to show how great it works:
a. Afrezza Dosing was only changed approx. every 6 weeks, and not flexible dosing depending on meal
b. No CGM’s allowed
c. Time in Zone not measured
d. Patient Quality of Life not measured
e. Brand new Afrezza users vs. Very experienced Injectable users (what if it was brand new injectable users vs. experienced Afrezza users—would that be fair? No-they would stop the trial right away because it would be a TKO/referee stops contest victory for Afrezza which we are already proving by “real-world” experience.)"
In my view, the last point (point e. above) is the most important factor. Afrezza, being a paradiam-shifting product to a new user, at this stage, needs sometime to titrate (dial-in). I think poor titration and under-dosing probably are the main causes for user drop-out in Afrezza commercial launch so far.
2. Why Afrezza ramp up has been slow
It appears to me right now two biggest obstacles are doctor’s reservation to prescribe and patient’s low awareness.
2.1 doctor’s reservation to prescribe
About doctor’s reservation to prescribe, I would say the most important comment I heard from the last conference call is the following statement that Mike made.
“First, our big prescribers that really loved Afrezza did not come back on Board. And in fact, one of them passed away unfortunately, and that did hurt the Q4 performance. When we expected a certain amount of prescribers to come on Board and we did our forecast, we went back to them and said, what’s going on? What happened? We know you like the drug, you had a good history of prescribing.
And one of the number one things we heard consistently was, I just need to see a rep for more often and just not top of mind. This is a very competitive category and that fit into our realization in order to grow faster, we really had to scale up. So we’ve done that.”
To me, the fact that these big prescribers did not come back means that Mannkind has lost the best low-hanging fruits to quickly ramp the scripts.
And as for their explanation for not coming back: “I just need to see a rep for more often and just not top of mind. This is a very competitive category”, my thinking is that who knows what is the true reason. This could just be an excuse. And Mannkind being a small biotech with precarious cash position and plummeting share prices certainly also be a factor for the doctors to be hesitate to come back (i.e., worried about the staying power of Mannkind).
To change this, Mannkind will need improved label, clinical studies and high profile medical papers to persuade the doctors to change their attitude. Before any of this occurs, I am not expecting to see any huge jump in scripts.
All of the planned studies that Mannkind have discussed so far (doses and range studies and pediatric studies) are good and the label change will also be welcome. I sure hope that the studies can be carried out as soon as possible!
I would also want Mannkind to run a Afrezza correction study, basically using Afrezza as a supplemental tool to RAAs and orals for T1s and T2s when BG levels are high (say 180 or above).
Dr. Steven V. Edelman pointed out in this video that use Afrezza as a supplement to oral pills and/or basal for Type 2s just for corrections is worth consideration. Daniele Hargenrader also described such usage in this youtube video. This study should be relatively easy and quick to run. And the improvement in A1Cs should be easy to prove. With such a study, Mannkind can produce a Afrezza-Correction kit, with 10-20 cartridges per pack to be used for by PWDs as necessary. This product will have the following advantage:
a. Cheaper, more acceptable to PWDs and insurance companies, therefore better access;
b. Less frequent usage means less restriction/concern from FDA/doctors on impact on lung capacity, which means less restrictive label and broader prescription.
2.2 low awareness of PWDs
So far, in terms of digital promotion, we have only seen a few twitter messages from Mannkind on Afrezza and a few pop-up afreza ads. Personally, I think twitter is not the idea tool for marketing Afrezza. Will someone unaware of Aferzza to to the Afrezza twitter accounts and click on the promoting messages there? Unlikely to me.
For digital marketing, I think the best places are the various diabetes forums. Tudiabetes.org. Diabetesdaily, etc. Those are the places where PWDs pose questions and seek advices on treatment day in and day out.
The last discussions of Afrezza on Tudiabetes.org is now 13 days ago. www.tudiabetes.org/forum/search?q=afrezza%20order%3Alatest
And there appears to be some discussion of Tresiba on a daily basis. www.tudiabetes.org/forum/search?q=tresiba%20order%3Alatest
You would think there would be more to discuss about Afrezza than Tresiba as Afrezza is much more different than the current products on the market.
I think Mannkind should have some of their patient advocates monitor the major diabetes forums on a daily basis. If someone is asking a question about afrezza on a forum, I am sure one of the afrezza bashers will appear and jump in and based on what I have seen so far, I am less certain whether I can expect an actual Afrezza user to participate in any such discussion.
There probably is someway where Mannkind can encourage actual Aferzza uers to share their experiences more on these forums. In other words, get the word out about Afrezza. It is to the benefit of the Afrezza users. If they do not spread the words and Afrezza is not success, they will lose access to the product as well.
In my view, these forums are like the JDRF and TCOYD events. The differences are that these forums are open 24/7 and you do not have to fight people across the countries to get the word out.
3. An idea to gather crowd on JDRF and TCOYD events
I have not been to any JDRF and TCOYD events that Mannkind participated. So have no idea on how such event actually goes.
How about Mannkind doing something different to attract more attention and participation? I recall someone on this board has mentioned the idea of flying Matt B. (who, by the way is in Australia) out to do the coke challenge live.
Is it possible that on such an event, Mannkind doing a live coke challenge, whereby, one or more Afrezza users will drink a cup of coke and shows his/her CGM lines every 5/10 minutes. Mannkind can invite others, whether diabetic or not, to participate in the challenge and drink a cup of coke at the same time with the afrezza users and monitor and show his/her BG levels every 5/10 minutes.
Whoever has the best BG level at 30/60 minutes will receive a nominal prize, say a $100 gift card or a similar amount donation in his/her name to JDRF/TCOYD and a small afrezza coke challenge trophy (and a cute aferzza dreamboat as a souvenir, with an outsulin mascot toy for the kids if applicable)!
Kids will love to see that!
Mannkind can repeat such challenge in every two/three hours in each such event. I would image this will be crowd gathering.
Also, in such a challenge, it will not be important whether the afrezza user(s) in such a case actually have the lowest BG levels or win the challenge. As long as this help PWDs to see aferzza's impressive ability to stop BG from rising after a cup of afrezza, this will serve the purpose of getting the word out. So it is not important who the winner is.
4. Titration and Retention
Also to help titration, not sure how Mannkind Care has been doing on this. One thing probably will help is that to make sure any new patient also has access to to an Afrezza patient advocate like Anthony and knows that he can also get to places like the Afrezza facebook group for help. www.facebook.com/groups/1491153011166114
5. Afrezza User Survey
Another thing that I think one of the Afrezza users can do is to do an Afrezza user survey. Per my personal count, as of today, I can identify about 70 people (instead of the often quoted a dozen or so active Afrezza users that various people often claiming) who have shared in social media their (or their family member’s) experience on afrezza. If I dig a little bit deeper, it is likely that I may be able to identify around 100 of those users who have shared in social media their (or their family member’s) experience on afrezza.
In view of this, can we do a survey of these users, asking them to provide the following information:
a. Is he/she still on afrezza;
b. If not, what is the main reason for he/she to drop afrezza (e.g., titration issues, dosage issues, insurance coverage issues, doctors’ noncooperation, side effects, etc., this could help Mannkind’s marketing decisions and efforts);
c. If yes, how long he/she has stayed on afrezza;
d. His/her A1Cs before he/she started using afrezza;
e. His/her A1Cs after he/she started using afrezza;
f. How much units of Afrezza he/she uses per day/week/month;
g. Typical dosage for a breakfast/lunch/dinner;
h. Typical dosing time for a breakfast/lunch/dinner;
i. How he/she dose for fatty food like a pizza;
j. What he/she likes afrezza the best;
k. What is the main challenge in using afrezza;
l. Has he/she felt life quality improved since suing afrezza and if so, in what aspects;
m. Has he/she experienced any discomfort or side effects;
n. What is he/her cost per month on Afrezza (and on RAA if he/she used RAA before adopting afrezza);
o. What suggestion of improvement he/she has towards Mannkind regarding afrezza.
In effect, this will be a survey like what AfrezzaUser (Sam Finta) has done with respect to the pioneer group of afrezza users, but with a relatively larger sample size, probably with a sample group of around 50-100 people. This definitely will not count as serious medical report or journal work, however, it will definitely provide some insight to Mannkind and prospective afrezza users and garner some attention among the PWDs.
This will be a good project for someone like Dr. Steven Adelman, Amy Tenderich, Mike Hoskins, Daniele Hargenrader, Sam Finta and Robin Jarrell, if any of them will be interested in taking up such a project. Alternatively, I would imagine someone like liane, who I recall is a registered nurse, will also be a good candidate to take up such a project?
To make the survey easier to complete, perhaps we can devise a web form and send the survey target a link to the web form, where they can just type their answers and click submit.
We know that Afrezza works based on: (a) growing body of positive user reviews; (b) growing body of medical journal and magazine reports and coverage; (c) the various tests conducted by users like Matt B. demonstrating how Afrezza works and how great it is working; and (d) comments and experiences of Afrezza prescribing physicians. Also see posts by docfrezza on this.
Per my personal count, as of today, I can identify about 70 people (instead of the often quoted a dozen or so active Afrezza users that various people often claiming) who have shared in social media their (or their family member’s) experience on afrezza. In addition to Sam Finta, Eric, etc. that we are familiar with, they also included people like Damon Dash, Aaron Kowalski, Dr. Steven Adelman, Laura (LJ), Jeremy Fultz, Amy Tenderich, Mike Hoskins, Daniele Hargenrader, Kevin Michelizzi and Robin Jarrell, etc.
As to why the trial results of Afrezza have not been as good as the real word experience of some of the active users we have seen, Sam Finta (AfrezzaUser) explained it pretty well in his blogs:
"There has been so much discussion about the FDA Afrezza Drug trials and why I feel as a participant in the Affinity 1 trial, there were significant “hold backs” as to why we were not able to materially outperform Injectable Insulin because of the protocols on the trials. This is no longer the case!
To Summarize here are just a few of the hold backs why Afrezza didn’t get to show how great it works:
a. Afrezza Dosing was only changed approx. every 6 weeks, and not flexible dosing depending on meal
b. No CGM’s allowed
c. Time in Zone not measured
d. Patient Quality of Life not measured
e. Brand new Afrezza users vs. Very experienced Injectable users (what if it was brand new injectable users vs. experienced Afrezza users—would that be fair? No-they would stop the trial right away because it would be a TKO/referee stops contest victory for Afrezza which we are already proving by “real-world” experience.)"
In my view, the last point (point e. above) is the most important factor. Afrezza, being a paradiam-shifting product to a new user, at this stage, needs sometime to titrate (dial-in). I think poor titration and under-dosing probably are the main causes for user drop-out in Afrezza commercial launch so far.
2. Why Afrezza ramp up has been slow
It appears to me right now two biggest obstacles are doctor’s reservation to prescribe and patient’s low awareness.
2.1 doctor’s reservation to prescribe
About doctor’s reservation to prescribe, I would say the most important comment I heard from the last conference call is the following statement that Mike made.
“First, our big prescribers that really loved Afrezza did not come back on Board. And in fact, one of them passed away unfortunately, and that did hurt the Q4 performance. When we expected a certain amount of prescribers to come on Board and we did our forecast, we went back to them and said, what’s going on? What happened? We know you like the drug, you had a good history of prescribing.
And one of the number one things we heard consistently was, I just need to see a rep for more often and just not top of mind. This is a very competitive category and that fit into our realization in order to grow faster, we really had to scale up. So we’ve done that.”
To me, the fact that these big prescribers did not come back means that Mannkind has lost the best low-hanging fruits to quickly ramp the scripts.
And as for their explanation for not coming back: “I just need to see a rep for more often and just not top of mind. This is a very competitive category”, my thinking is that who knows what is the true reason. This could just be an excuse. And Mannkind being a small biotech with precarious cash position and plummeting share prices certainly also be a factor for the doctors to be hesitate to come back (i.e., worried about the staying power of Mannkind).
To change this, Mannkind will need improved label, clinical studies and high profile medical papers to persuade the doctors to change their attitude. Before any of this occurs, I am not expecting to see any huge jump in scripts.
All of the planned studies that Mannkind have discussed so far (doses and range studies and pediatric studies) are good and the label change will also be welcome. I sure hope that the studies can be carried out as soon as possible!
I would also want Mannkind to run a Afrezza correction study, basically using Afrezza as a supplemental tool to RAAs and orals for T1s and T2s when BG levels are high (say 180 or above).
Dr. Steven V. Edelman pointed out in this video that use Afrezza as a supplement to oral pills and/or basal for Type 2s just for corrections is worth consideration. Daniele Hargenrader also described such usage in this youtube video. This study should be relatively easy and quick to run. And the improvement in A1Cs should be easy to prove. With such a study, Mannkind can produce a Afrezza-Correction kit, with 10-20 cartridges per pack to be used for by PWDs as necessary. This product will have the following advantage:
a. Cheaper, more acceptable to PWDs and insurance companies, therefore better access;
b. Less frequent usage means less restriction/concern from FDA/doctors on impact on lung capacity, which means less restrictive label and broader prescription.
2.2 low awareness of PWDs
So far, in terms of digital promotion, we have only seen a few twitter messages from Mannkind on Afrezza and a few pop-up afreza ads. Personally, I think twitter is not the idea tool for marketing Afrezza. Will someone unaware of Aferzza to to the Afrezza twitter accounts and click on the promoting messages there? Unlikely to me.
For digital marketing, I think the best places are the various diabetes forums. Tudiabetes.org. Diabetesdaily, etc. Those are the places where PWDs pose questions and seek advices on treatment day in and day out.
The last discussions of Afrezza on Tudiabetes.org is now 13 days ago. www.tudiabetes.org/forum/search?q=afrezza%20order%3Alatest
And there appears to be some discussion of Tresiba on a daily basis. www.tudiabetes.org/forum/search?q=tresiba%20order%3Alatest
You would think there would be more to discuss about Afrezza than Tresiba as Afrezza is much more different than the current products on the market.
I think Mannkind should have some of their patient advocates monitor the major diabetes forums on a daily basis. If someone is asking a question about afrezza on a forum, I am sure one of the afrezza bashers will appear and jump in and based on what I have seen so far, I am less certain whether I can expect an actual Afrezza user to participate in any such discussion.
There probably is someway where Mannkind can encourage actual Aferzza uers to share their experiences more on these forums. In other words, get the word out about Afrezza. It is to the benefit of the Afrezza users. If they do not spread the words and Afrezza is not success, they will lose access to the product as well.
In my view, these forums are like the JDRF and TCOYD events. The differences are that these forums are open 24/7 and you do not have to fight people across the countries to get the word out.
3. An idea to gather crowd on JDRF and TCOYD events
I have not been to any JDRF and TCOYD events that Mannkind participated. So have no idea on how such event actually goes.
How about Mannkind doing something different to attract more attention and participation? I recall someone on this board has mentioned the idea of flying Matt B. (who, by the way is in Australia) out to do the coke challenge live.
Is it possible that on such an event, Mannkind doing a live coke challenge, whereby, one or more Afrezza users will drink a cup of coke and shows his/her CGM lines every 5/10 minutes. Mannkind can invite others, whether diabetic or not, to participate in the challenge and drink a cup of coke at the same time with the afrezza users and monitor and show his/her BG levels every 5/10 minutes.
Whoever has the best BG level at 30/60 minutes will receive a nominal prize, say a $100 gift card or a similar amount donation in his/her name to JDRF/TCOYD and a small afrezza coke challenge trophy (and a cute aferzza dreamboat as a souvenir, with an outsulin mascot toy for the kids if applicable)!
Kids will love to see that!
Mannkind can repeat such challenge in every two/three hours in each such event. I would image this will be crowd gathering.
Also, in such a challenge, it will not be important whether the afrezza user(s) in such a case actually have the lowest BG levels or win the challenge. As long as this help PWDs to see aferzza's impressive ability to stop BG from rising after a cup of afrezza, this will serve the purpose of getting the word out. So it is not important who the winner is.
4. Titration and Retention
Also to help titration, not sure how Mannkind Care has been doing on this. One thing probably will help is that to make sure any new patient also has access to to an Afrezza patient advocate like Anthony and knows that he can also get to places like the Afrezza facebook group for help. www.facebook.com/groups/1491153011166114
5. Afrezza User Survey
Another thing that I think one of the Afrezza users can do is to do an Afrezza user survey. Per my personal count, as of today, I can identify about 70 people (instead of the often quoted a dozen or so active Afrezza users that various people often claiming) who have shared in social media their (or their family member’s) experience on afrezza. If I dig a little bit deeper, it is likely that I may be able to identify around 100 of those users who have shared in social media their (or their family member’s) experience on afrezza.
In view of this, can we do a survey of these users, asking them to provide the following information:
a. Is he/she still on afrezza;
b. If not, what is the main reason for he/she to drop afrezza (e.g., titration issues, dosage issues, insurance coverage issues, doctors’ noncooperation, side effects, etc., this could help Mannkind’s marketing decisions and efforts);
c. If yes, how long he/she has stayed on afrezza;
d. His/her A1Cs before he/she started using afrezza;
e. His/her A1Cs after he/she started using afrezza;
f. How much units of Afrezza he/she uses per day/week/month;
g. Typical dosage for a breakfast/lunch/dinner;
h. Typical dosing time for a breakfast/lunch/dinner;
i. How he/she dose for fatty food like a pizza;
j. What he/she likes afrezza the best;
k. What is the main challenge in using afrezza;
l. Has he/she felt life quality improved since suing afrezza and if so, in what aspects;
m. Has he/she experienced any discomfort or side effects;
n. What is he/her cost per month on Afrezza (and on RAA if he/she used RAA before adopting afrezza);
o. What suggestion of improvement he/she has towards Mannkind regarding afrezza.
In effect, this will be a survey like what AfrezzaUser (Sam Finta) has done with respect to the pioneer group of afrezza users, but with a relatively larger sample size, probably with a sample group of around 50-100 people. This definitely will not count as serious medical report or journal work, however, it will definitely provide some insight to Mannkind and prospective afrezza users and garner some attention among the PWDs.
This will be a good project for someone like Dr. Steven Adelman, Amy Tenderich, Mike Hoskins, Daniele Hargenrader, Sam Finta and Robin Jarrell, if any of them will be interested in taking up such a project. Alternatively, I would imagine someone like liane, who I recall is a registered nurse, will also be a good candidate to take up such a project?
To make the survey easier to complete, perhaps we can devise a web form and send the survey target a link to the web form, where they can just type their answers and click submit.
