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Afrezza
Mar 4, 2017 12:52:26 GMT -5
Post by sweedee79 on Mar 4, 2017 12:52:26 GMT -5
Another question... how can we say the pricing is similar to Novolog and Humolog when you need 3 to 4xs as much??? How likely is it that insurance companies will want to pay for this when it is 3 to 4xs higher in price ?? .. I just get more confused by the day ... and more and more discouraged about how we can market Afrezza under these circumstances ... Management had to have been aware of these problems all along... did they think it would all just resolve itself?? I just don't understand it... With the price increases the fast acting insulin analog makers have had, the price of the afrezza titration pack is comparable to subq fast acting these days. Afrezza uses regular insulin, not an analog. (is my understanding.)
aged. or all, correct me if I am wrong. I do not want to look it up.
I think I misunderstood .... they basically changed the Afrezza "unit" size so that it would be equal to that of analog... in order to prevent confusion.. ? Thanks Peppy
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Post by peppy on Mar 4, 2017 13:03:28 GMT -5
With the price increases the fast acting insulin analog makers have had, the price of the afrezza titration pack is comparable to subq fast acting these days. Afrezza uses regular insulin, not an analog. (is my understanding.)
aged. or all, correct me if I am wrong. I do not want to look it up.
I think I misunderstood .... they basically changed the Afrezza "unit" size so that it would be equal to that of analog... in order to prevent confusion.. ? Thanks Peppy I did the same sweedee. It took me a while to think it all through. The diabetes had to be soooooo careful with insulin subq. Now they can take insulin. Technosphere Insulin. interesting gig.
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Afrezza
Mar 4, 2017 13:24:13 GMT -5
Post by agedhippie on Mar 4, 2017 13:24:13 GMT -5
I don't think the second dose approach it tenable. You are meant to do that today with RAA but I don't know anyone on pens who does (pumps are different because the pump can do it automatically with a square wave bolus). The problem is that while it is easy to bolus with the meal it's disruptive to have to do the follow on so people just don't. The real world results are going to reflect that which is why trial data matters and early adopters are given far less weight. You very well could be right. Second dosing may not happen. I really have no idea how this is going to play out. I have mentioned before about "that one doctor" who did have his patients in the trials do follow-up dosing and their results were outstanding and along the lines of what the early adopters report. He also said when questioned by the FDA why he did not do this with Novolog , he said " I would have killed my patients". Where Onduo lands with what they are doing is anyone's guess - except guys like Steve Edelman. But they keep talking about T2s, Primary Care Physicians, early insulin use, time in range leveraging CGMs and the cloud. Will they succeed, I have no idea. Will text alerts to remind the PWDs be enough, maybe. Will a text to their spouse help, probably. Can they really change how diabetes is currently treated, maybe. Who is going to pay for this service? Google clearly has the money to disrupt the healthcare market and I really think they would like a win for Verily. Do they need afrezza to do this? I think the time in range study says they do. Do they need MNKD, probably not but they do need the afrezza PK and its easy to use. The RAAs are not good enough. Thats the lesson learned with the Artificial Pancreas and why Al developed afrezza. Additionally, if they really do plan on early insulin intervention and changing the step program, inhaling for 3-6 months is a much better option for most new T2s aside from the PK. Is anything happening between Onduo and MNKD, I have no idea. What we do know is Mike is targeting the Endos, not PCPs and current scripts are all but nothing. He also said when questioned by the FDA why he did not do this with Novolog , he said " I would have killed my patients".I guess all his pump users are dead then? That is exactly what a square wave bolus on a pump does. You use it for high fat meals - it's ideal for pizza. I don't think prodding people to retest will work. Meters can do that today but nobody ever uses it. It's trivial to automate the delivery, the problem who wants alerts all the time saying test! Consumer resistance will kill that one, it's high friction. I will make a prediction - closed loop APs will use ordinary RAA and get perfectly satisfactory results. Yes a faster acting and clearing insulin would be nice, but a pumpable glucagon is far, far, more important. Anyway trials are due this year for the first closed loop system so we will see how they do - I admit I am curious. I agree with you on the early use of insulin in T2. I think an initial round of insulin therapy would be good. The problem is the cost. By deferring insulin (and the US defers the use of insulin longer than anywhere else in the west) health systems can manage costs. A lot of T2 will never need insulin at all so why incur that cost is the theory. Metformin is to effective and to cheap to ignore.
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Afrezza
Mar 4, 2017 13:53:54 GMT -5
Post by sayhey24 on Mar 4, 2017 13:53:54 GMT -5
You very well could be right. Second dosing may not happen. I really have no idea how this is going to play out. I have mentioned before about "that one doctor" who did have his patients in the trials do follow-up dosing and their results were outstanding and along the lines of what the early adopters report. He also said when questioned by the FDA why he did not do this with Novolog , he said " I would have killed my patients". Where Onduo lands with what they are doing is anyone's guess - except guys like Steve Edelman. But they keep talking about T2s, Primary Care Physicians, early insulin use, time in range leveraging CGMs and the cloud. Will they succeed, I have no idea. Will text alerts to remind the PWDs be enough, maybe. Will a text to their spouse help, probably. Can they really change how diabetes is currently treated, maybe. Who is going to pay for this service? Google clearly has the money to disrupt the healthcare market and I really think they would like a win for Verily. Do they need afrezza to do this? I think the time in range study says they do. Do they need MNKD, probably not but they do need the afrezza PK and its easy to use. The RAAs are not good enough. Thats the lesson learned with the Artificial Pancreas and why Al developed afrezza. Additionally, if they really do plan on early insulin intervention and changing the step program, inhaling for 3-6 months is a much better option for most new T2s aside from the PK. Is anything happening between Onduo and MNKD, I have no idea. What we do know is Mike is targeting the Endos, not PCPs and current scripts are all but nothing. He also said when questioned by the FDA why he did not do this with Novolog , he said " I would have killed my patients".I guess all his pump users are dead then? That is exactly what a square wave bolus on a pump does. You use it for high fat meals - it's ideal for pizza. I don't think prodding people to retest will work. Meters can do that today but nobody ever uses it. It's trivial to automate the delivery, the problem who wants alerts all the time saying test! Consumer resistance will kill that one, it's high friction. I will make a prediction - closed loop APs will use ordinary RAA and get perfectly satisfactory results. Yes a faster acting and clearing insulin would be nice, but a pumpable glucagon is far, far, more important. Anyway trials are due this year for the first closed loop system so we will see how they do - I admit I am curious. I agree with you on the early use of insulin in T2. I think an initial round of insulin therapy would be good. The problem is the cost. By deferring insulin (and the US defers the use of insulin longer than anywhere else in the west) health systems can manage costs. A lot of T2 will never need insulin at all so why incur that cost is the theory. Metformin is to effective and to cheap to ignore. I don't know if what Onduo is doing is going to work or not but the technology now exists to support it. And, as I said above Google/Verily need a win so the money will be there. We do know the current ADA step program is not working well. If Onduo's step 1 is early insulin intervention and 50%+ can be taken off all medication for years and long term the insurance company saves a ton of money, Onduo may just have a winner. I believe that is their bet and interestingly Josh Riff is more on the insurance side of things. If they make this a winner and I see no reason they won't this will be devastating to the BPs and will impact the endo business. I think Bernie Sanders may just like this.
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Post by sweedee79 on Mar 4, 2017 14:03:49 GMT -5
we have figured out the dosing for the most part. The diabetes figured it out for us. Not the physicians. As a general rule, I dose about 10 minutes after I start eating, which is before my glucose levels start to rise from the meal. As I mention in the video, the best time to dose seems to depend on the fat content of the meal. And for some high fat meals, a follow up dose of Afrezza is neccesary.
I have found the same rule also applies if a follow-up dose is required. It is important to have the follow-up dose before the levels begin to rise out of range. If I had a CGM with alerts, I would use this to notify me as soon as it levels began to increase. That way I wouldn’t miss the optimum time for the follow-up.
It is worth remembering that much, much more Afrezza is needed to correct high glucose levels than to cover meals.
The follow up dose at 45 mins after initial dose if glucose is going up and between 120 and 130.
The titration pack. They know. They have to get the physicians and diabetes the knowledge and comfort.
Additionally corrections: one 4 u will bring glucose down 30mg/dl in 90 mins from the pharmacist and diabetic that wrote the article. Easy as pie really. Once you know.
afrezzadownunder.com/2015/10/afrezza-timing-is-everything/
Its not surprising that it was the patients who figured this out for us.... Diabetes is a very mysterious disease sometimes and different for every person.. therefore PWD, even those using an analog are problem solving every single day with their insulin, food and exercise etc .. I sure have learned a lot thru my experiences with my dad.... (and he is learning from me .. )
There are times when he has no control over his diabetes and has no idea what is causing the problems... it could be a small infection somewhere in his body that he is unaware of ... or it could be something else... A glass of wine will lower blood sugar... .fat slows down metabolism of carbs.. etc.. there are so many factors when you are talking about diabetes and blood sugar levels .. and so much to know .. and a hypo could very easily kill someone my dads age.. its no wonder docs are scared... especially when people like to jump on the lawsuit wagon asap ...
The one thing I do know is what I saw when my dad was on Afrezza... He had more energy .... he was way more active... happier person... lost weight.... blood pressure decreased .. lost weight ... A1C was better ... yes we had our problems too... and we didn't have the support we needed ..... but the positives far outweighed the problems...
I also want to say that I don't want my dad on an analog... even if it is delivered by an "artificial pancreas" ... It isn't a superior insulin... it isn't Afrezza ... and it will never do for my dad what Afrezza did...
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Afrezza
Mar 4, 2017 14:13:49 GMT -5
Post by sayhey24 on Mar 4, 2017 14:13:49 GMT -5
we have figured out the dosing for the most part. The diabetes figured it out for us. Not the physicians. As a general rule, I dose about 10 minutes after I start eating, which is before my glucose levels start to rise from the meal. As I mention in the video, the best time to dose seems to depend on the fat content of the meal. And for some high fat meals, a follow up dose of Afrezza is neccesary.
I have found the same rule also applies if a follow-up dose is required. It is important to have the follow-up dose before the levels begin to rise out of range. If I had a CGM with alerts, I would use this to notify me as soon as it levels began to increase. That way I wouldn’t miss the optimum time for the follow-up.
It is worth remembering that much, much more Afrezza is needed to correct high glucose levels than to cover meals.
The follow up dose at 45 mins after initial dose if glucose is going up and between 120 and 130.
The titration pack. They know. They have to get the physicians and diabetes the knowledge and comfort.
Additionally corrections: one 4 u will bring glucose down 30mg/dl in 90 mins from the pharmacist and diabetic that wrote the article. Easy as pie really. Once you know.
afrezzadownunder.com/2015/10/afrezza-timing-is-everything/
Its not surprising that it was the patients who figured this out for us.... Diabetes is a very mysterious disease sometimes and different for every person.. therefore PWD, even those using an analog are problem solving every single day with their insulin, food and exercise etc .. I sure have learned a lot thru my experiences with my dad.... (and he is learning from me .. )
There are times when he has no control over his diabetes and has no idea what is causing the problems... it could be a small infection somewhere in his body that he is unaware of ... or it could be something else... A glass of wine will lower blood sugar... .fat slows down metabolism of carbs.. etc.. there are so many factors when you are talking about diabetes and blood sugar levels .. and so much to know .. and a hypo could very easily kill someone my dads age.. its no wonder docs are scared... especially when people like to jump on the lawsuit wagon asap ...
The one thing I do know is what I saw when my dad was on Afrezza... He had more energy .... he was way more active... happier person... lost weight.... blood pressure decreased .. lost weight ... A1C was better ... yes we had our problems too... and we didn't have the support we needed ..... but the positives far outweighed the problems...
You have probably already mentioned this before but what happened that your Dad is no longer using afrezza?
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Post by sweedee79 on Mar 4, 2017 14:16:49 GMT -5
Its not surprising that it was the patients who figured this out for us.... Diabetes is a very mysterious disease sometimes and different for every person.. therefore PWD, even those using an analog are problem solving every single day with their insulin, food and exercise etc .. I sure have learned a lot thru my experiences with my dad.... (and he is learning from me .. )
There are times when he has no control over his diabetes and has no idea what is causing the problems... it could be a small infection somewhere in his body that he is unaware of ... or it could be something else... A glass of wine will lower blood sugar... .fat slows down metabolism of carbs.. etc.. there are so many factors when you are talking about diabetes and blood sugar levels .. and so much to know .. and a hypo could very easily kill someone my dads age.. its no wonder docs are scared... especially when people like to jump on the lawsuit wagon asap ...
The one thing I do know is what I saw when my dad was on Afrezza... He had more energy .... he was way more active... happier person... lost weight.... blood pressure decreased .. lost weight ... A1C was better ... yes we had our problems too... and we didn't have the support we needed ..... but the positives far outweighed the problems...
You have probably already mentioned this before but what happened that your Dad is no longer using afrezza? He had insurance problems and simply got fed up with it all.... there is only one part d insurance that covers Afrezza... it is Express Scripts... and they only cover at tier 3 or 4
He also has had a lot of problems with docs.....
And he is pissed off at MNKD ... LOL ... says they need to start advertising .... He doesn't think that patients should have to go thru all of this...
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Afrezza
Mar 4, 2017 14:20:51 GMT -5
Post by peppy on Mar 4, 2017 14:20:51 GMT -5
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Post by sayhey24 on Mar 4, 2017 14:26:07 GMT -5
You have probably already mentioned this before but what happened that your Dad is no longer using afrezza? He had insurance problems and simply got fed up with it all.... there is only one part d insurance that covers Afrezza... it is Express Scripts... and they only cover at tier 3 or 4
He also has had a lot of problems with docs.....
And he is pissed off at MNKD ... LOL ... says they need to start advertising .... He doesn't think that patients should have to go thru all of this...
Tell your Dad he has lots of company in being pissed off at MNKD. Its all very sad but hope springs eternal. Why MNKD didn't start selling direct at $30 a box last year, I have no idea. With some radio advertising and a deal with a Teledoc firm getting both the script and product would be a breeze.
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Post by dreamboatcruise on Mar 4, 2017 14:41:26 GMT -5
With the price increases the fast acting insulin analog makers have had, the price of the afrezza titration pack is comparable to subq fast acting these days. Afrezza uses regular insulin, not an analog. (is my understanding.)
aged. or all, correct me if I am wrong. I do not want to look it up.
I think I misunderstood .... they basically changed the Afrezza "unit" size so that it would be equal to that of analog... in order to prevent confusion.. ? Thanks Peppy Basically yes. Because not all insulin reaches the bloodstream when inhaled, Exubera didn't state insulin amount in "units". They instead used mg. Patients transitioning from injected insulin found this confusing. Based on that MNKD decided they needed to have a one to one mapping from injected "unit" to an equivalent inhaled "unit" (which does represent a different amount of insulin in the inhaler). Potentially this was a mistake, as it seems there isn't a direct equivalency due to different pd/pk action and it may be more confusing rather than less to imply that there is. IMO
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Post by sayhey24 on Mar 4, 2017 16:00:43 GMT -5
I think I misunderstood .... they basically changed the Afrezza "unit" size so that it would be equal to that of analog... in order to prevent confusion.. ? Thanks Peppy Basically yes. Because not all insulin reaches the bloodstream when inhaled, Exubera didn't state insulin amount in "units". They instead used mg. Patients transitioning from injected insulin found this confusing. Based on that MNKD decided they needed to have a one to one mapping from injected "unit" to an equivalent inhaled "unit" (which does represent a different amount of insulin in the inhaler). Potentially this was a mistake, as it seems there isn't a direct equivalency due to different pd/pk action and it may be more confusing rather than less to imply that there is. IMO Small, Medium and Large is what I have been saying for a long time. Units means nothing to a new T2 and for existing insulin users its very confusing. The 2u for the kiddies should be XSmall. I guess the plan was to run the trials head to head with Exubera not expecting them to pull the product. Maybe they should have initially submitted for the occasional user - correction use and the medtone would have been OK for that. I still think they should put some 4s in a 20count box, call it afrezza-Rx and request a label with no restrictions for copd and smoking and market it as a must have - just in case. Maybe it would save some ER visits. Maybe all EMTs would carry it.
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Post by agedhippie on Mar 4, 2017 16:58:04 GMT -5
Basically yes. Because not all insulin reaches the bloodstream when inhaled, Exubera didn't state insulin amount in "units". They instead used mg. Patients transitioning from injected insulin found this confusing. Based on that MNKD decided they needed to have a one to one mapping from injected "unit" to an equivalent inhaled "unit" (which does represent a different amount of insulin in the inhaler). Potentially this was a mistake, as it seems there isn't a direct equivalency due to different pd/pk action and it may be more confusing rather than less to imply that there is. IMO Small, Medium and Large is what I have been saying for a long time. Units means nothing to a new T2 and for existing insulin users its very confusing. The 2u for the kiddies should be XSmall. I guess the plan was to run the trials head to head with Exubera not expecting them to pull the product. Maybe they should have initially submitted for the occasional user - correction use and the medtone would have been OK for that. I still think they should put some 4s in a 20count box, call it afrezza-Rx and request a label with no restrictions for copd and smoking and market it as a must have - just in case. Maybe it would save some ER visits. Maybe all EMTs would carry it. For a hypo the last thing you need is more insulin If you meant for DKA then the priority is fluids and electrolytes, they deal with glucose a surprisingly long way down the line. DKA causes hypokalemia and if you take insulin early it makes this worse which can easily kill the patient with a heart attack (arrhythmia strictly speaking). They are all over your potassium levels until your discharge. The other thing people don't realize is that you get breathless (and incredibly ill-tempered) when your sugars are high so inhaled solutions are less than ideal.
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Afrezza
Mar 4, 2017 16:59:33 GMT -5
Post by peppy on Mar 4, 2017 16:59:33 GMT -5
Basically yes. Because not all insulin reaches the bloodstream when inhaled, Exubera didn't state insulin amount in "units". They instead used mg. Patients transitioning from injected insulin found this confusing. Based on that MNKD decided they needed to have a one to one mapping from injected "unit" to an equivalent inhaled "unit" (which does represent a different amount of insulin in the inhaler). Potentially this was a mistake, as it seems there isn't a direct equivalency due to different pd/pk action and it may be more confusing rather than less to imply that there is. IMO Small, Medium and Large is what I have been saying for a long time. Units means nothing to a new T2 and for existing insulin users its very confusing. The 2u for the kiddies should be XSmall. I guess the plan was to run the trials head to head with Exubera not expecting them to pull the product. Maybe they should have initially submitted for the occasional user - correction use and the medtone would have been OK for that. I still think they should put some 4s in a 20count box, call it afrezza-Rx and request a label with no restrictions for copd and smoking and market it as a must have - just in case. Maybe it would save some ER visits. Maybe all EMTs would carry it. sayhey, I like you so do not take me wrong. It was Matt from down under that came up with small, medium and large dose, and it is on video tape.
secondly, the medtone failed and did not meet non inferior. www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm390865.pdf
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Post by agedhippie on Mar 4, 2017 17:14:02 GMT -5
If Onduo's step 1 is early insulin intervention and 50%+ can be taken off all medication for years and long term the insurance company saves a ton of money, Onduo may just have a winner. I believe that is their bet and interestingly Josh Riff is more on the insurance side of things. If they make this a winner and I see no reason they won't this will be devastating to the BPs and will impact the endo business. I think Bernie Sanders may just like this. This requires a complete change to the [broken] way the US health system works. Today the incentive is for the insurers to have at most a three year horizon. If a treatment doesn't pay for itself in that time it doesn't get their interest. This is because the majority of insurance is through the workplace and when you change jobs the odds are you are off their books and on average people change jobs every three years. This introduces moral hazard. The insurer does not bear the cost of their actions, another insurer, or more likely, the government does. Most Type 2 diabetics get it later in life and the probability is that by the time the expensive complications turn up you will be on Medicare and the insurer gets away free and clear. Effectively the government subsidizes the insurance industry. The fix is portable insurance (Obamacare?) or a national heath system like Medicare.
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Post by peppy on Mar 4, 2017 19:49:50 GMT -5
If Onduo's step 1 is early insulin intervention and 50%+ can be taken off all medication for years and long term the insurance company saves a ton of money, Onduo may just have a winner. I believe that is their bet and interestingly Josh Riff is more on the insurance side of things. If they make this a winner and I see no reason they won't this will be devastating to the BPs and will impact the endo business. I think Bernie Sanders may just like this. This requires a complete change to the [broken] way the US health system works. Today the incentive is for the insurers to have at most a three year horizon. If a treatment doesn't pay for itself in that time it doesn't get their interest. This is because the majority of insurance is through the workplace and when you change jobs the odds are you are off their books and on average people change jobs every three years. This introduces moral hazard. The insurer does not bear the cost of their actions, another insurer, or more likely, the government does. Most Type 2 diabetics get it later in life and the probability is that by the time the expensive complications turn up you will be on Medicare and the insurer gets away free and clear. Effectively the government subsidizes the insurance industry. The fix is portable insurance (Obamacare?) or a national heath system like Medicare. So the health insurance people pay $6000 a year for doesn't want to pay to, " 50%+ can be taken off all medication for years ." Interesting gig.
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