|
|
Post by rrtzmd on Oct 11, 2015 11:46:11 GMT -5
Thanks for the link, but even there the longest study I saw was only 2 years. Although an extreme example, mesothelioma sometimes won't appear until 10-20 years after exposure to asbestos. Regardless, the point I was trying to get to is that although the adverse effect on FEV1 is small with afrezza, there seems to be no explanation as to why it exists at all, or, for that matter, why it resolves after discontinuing afrezza. The same question arises as to why does afrezza cause more anti-insulin antibodies versus subcutaneous insulin. Is the FEV1 effect related in some fashion to the appearance of anti-insulin antibodies? Not knowing the causes of an adverse effect while knowing that there is an adverse effect is bound to inhibit prescribing practice to some extent. Rule #1: primum non nocere. Rule #2: always remember rule #1.
|
|
|
|
Post by liane on Oct 11, 2015 13:20:06 GMT -5
All medications have the potential for side effects and adverse events. The wise physician weighs the risks vs benefits. The alternatives to Afrezza - we all know the risk / benefit profiles. Oral anti-glycemics have a variety of side effects and risks - some quite serious. Injected insulin - hypos, scar tissue, loss of good injection sites, and erratic absorption. All of Afrezza's alternatives have shown to have sub-par blood glucose control as evidenced by A1c. So tell me - which route does the least harm?
|
|
|
|
Post by harryx1 on Oct 11, 2015 13:57:34 GMT -5
Thanks for the link, but even there the longest study I saw was only 2 years. Although an extreme example, mesothelioma sometimes won't appear until 10-20 years after exposure to asbestos. Regardless, the point I was trying to get to is that although the adverse effect on FEV1 is small with afrezza, there seems to be no explanation as to why it exists at all, or, for that matter, why it resolves after discontinuing afrezza. The same question arises as to why does afrezza cause more anti-insulin antibodies versus subcutaneous insulin. Is the FEV1 effect related in some fashion to the appearance of anti-insulin antibodies? Not knowing the causes of an adverse effect while knowing that there is an adverse effect is bound to inhibit prescribing practice to some extent. Rule #1: primum non nocere. Rule #2: always remember rule #1. Your welcome. You originally stated "preservatives in Afrezza" - if you have done some research then you should be aware that there are only 2 ingredients in Technoshpere Insulin 1.) FDKP 2.) Human Insulin (NO preservatives) What preservatives are used in insulin? Phenol and m-cresol (meta-cresol) www.sciencedirect.com/science/article/pii/S2214750014001541www3.epa.gov/airtoxics/hlthef/cresols.html |
|
|
|
Post by suebeeee1 on Oct 11, 2015 15:59:59 GMT -5
I have been reflecting recently on how I should feel about the weekly game show we all play called name that Afrezza script count. I must admit that I had an overly rosy outlook on how fast the script counts were going to grow once marketing started. This expectation has lead me to watch each week with a morbid fascination that this is the week where its going to break big. ........ Snipped for brevity....... Some final thoughts. As evidenced in the social media arena, Afrezza works and works very well. In fact, many have described Afrezza as a paradigm shift in diabetic treatment. It appears that once a patient changes to Afrezza they will not be changing back. Therefore, that steady script number will not change for any reason. Because people need to control their diabetes in all seasons, in a good economy or bad economy until there is a cure. That kind of consistency in a drug will make Mannkind stock very valuable indeed. Yeah, I remember back, not long ago when there was a poll each week measuring how much were all thought the script counts were going to go up each Friday. 100%. 200% Then they stopped because they were too depressing...... Then very few insurance companies added Afrezza to their formularies. Why?. Most probably because Sanofi is charging them too much to compete with the generic alternatives. But then again, most insurance formularies already carry some high priced, non-generic alternatives, but Sanofi won't even meet those prices, why? Clearly, Afrezza is vastly superior and easy for an insulin novice to learn and understand. It will undoubtedly become the first drug used for type 2 in the future, a HUGE market. We will find out what my husband's A1c is after his first few months on Afrezza soon... And I am more than hopeful. Crazy digestive issues have totally ceased since he initiated Afrezza. I with you, have no doubt this will be a blockbuster, SOMEDAY. Sigh, it's that someday that has me grieving. It'd like it to be there today and I think Sanofi has handled this badly (not alone here). All promised a drug that would cost no more than the prandial pens. Again, why does Sanofi charge so darn much? Suebeeee1 Holding onto her Afrezza stock until someone pries it out of her cold, dead hands, as well |
|
|
|
Post by kball on Oct 11, 2015 18:51:15 GMT -5
I have been reflecting recently on how I should feel about the weekly game show we all play called name that Afrezza script count. I must admit that I had an overly rosy outlook on how fast the script counts were going to grow once marketing started. This expectation has lead me to watch each week with a morbid fascination that this is the week where its going to break big. ........ Snipped for brevity....... Some final thoughts. As evidenced in the social media arena, Afrezza works and works very well. In fact, many have described Afrezza as a paradigm shift in diabetic treatment. It appears that once a patient changes to Afrezza they will not be changing back. Therefore, that steady script number will not change for any reason. Because people need to control their diabetes in all seasons, in a good economy or bad economy until there is a cure. That kind of consistency in a drug will make Mannkind stock very valuable indeed. Yeah, I remember back, not long ago when there was a poll each week measuring how much were all thought the script counts were going to go up each Friday. 100%. 200% Then they stopped because they were too depressing...... Then very few insurance companies added Afrezza to their formularies. Why?. Most probably because Sanofi is charging them too much to compete with the generic alternatives. But then again, most insurance formularies already carry some high priced, non-generic alternatives, but Sanofi won't even meet those prices, why? Clearly, Afrezza is vastly superior and easy for an insulin novice to learn and understand. It will undoubtedly become the first drug used for type 2 in the future, a HUGE market. We will find out what my husband's A1c is after his first few months on Afrezza soon... And I am more than hopeful. Crazy digestive issues have totally ceased since he initiated Afrezza. I with you, have no doubt this will be a blockbuster, SOMEDAY.
Sigh, it's that someday that has me grieving. It'd like it to be there today and I think Sanofi has handled this badly (not alone here). All promised a drug that would cost no more than the prandial pens. Again, why does Sanofi charge so darn much? Suebeeee1 Holding onto her Afrezza stock until someone pries it out of her cold, dead hands, as well Issues? This is the first i think i'm aware of hearing this. Gas? Cramps? Constipation? Abdominal pain? Any of these?...if not too personal |
|
|
|
Post by mnholdem on Oct 11, 2015 19:39:54 GMT -5
|
|
|
|
Post by od on Oct 11, 2015 20:04:54 GMT -5
Yeah, I remember back, not long ago when there was a poll each week measuring how much were all thought the script counts were going to go up each Friday. 100%. 200% Then they stopped because they were too depressing...... Then very few insurance companies added Afrezza to their formularies. Why?. Most probably because Sanofi is charging them too much to compete with the generic alternatives. But then again, most insurance formularies already carry some high priced, non-generic alternatives, but Sanofi won't even meet those prices, why? Clearly, Afrezza is vastly superior and easy for an insulin novice to learn and understand. It will undoubtedly become the first drug used for type 2 in the future, a HUGE market. We will find out what my husband's A1c is after his first few months on Afrezza soon... And I am more than hopeful. Crazy digestive issues have totally ceased since he initiated Afrezza. I with you, have no doubt this will be a blockbuster, SOMEDAY.
Sigh, it's that someday that has me grieving. It'd like it to be there today and I think Sanofi has handled this badly (not alone here). All promised a drug that would cost no more than the prandial pens. Again, why does Sanofi charge so darn much? Suebeeee1 Holding onto her Afrezza stock until someone pries it out of her cold, dead hands, as well Issues? This is the first i think i'm aware of hearing this. Gas? Cramps? Constipation? Abdominal pain? Any of these?...if not too personal |
|
|
|
Post by rrtzmd on Oct 11, 2015 21:08:04 GMT -5
Thanks for the link, but even there the longest study I saw was only 2 years. Although an extreme example, mesothelioma sometimes won't appear until 10-20 years after exposure to asbestos. Regardless, the point I was trying to get to is that although the adverse effect on FEV1 is small with afrezza, there seems to be no explanation as to why it exists at all, or, for that matter, why it resolves after discontinuing afrezza. The same question arises as to why does afrezza cause more anti-insulin antibodies versus subcutaneous insulin. Is the FEV1 effect related in some fashion to the appearance of anti-insulin antibodies? Not knowing the causes of an adverse effect while knowing that there is an adverse effect is bound to inhibit prescribing practice to some extent. Rule #1: primum non nocere. Rule #2: always remember rule #1. Your welcome. You originally stated "preservatives in Afrezza" - if you have done some research then you should be aware that there are only 2 ingredients in Technoshpere Insulin 1.) FDKP 2.) Human Insulin (NO preservatives) What preservatives are used in insulin? Phenol and m-cresol (meta-cresol) www.sciencedirect.com/science/article/pii/S2214750014001541www3.epa.gov/airtoxics/hlthef/cresols.htmlRegarding "preservatives," I think I corrected my error elsewhere. However, afrezza does have a third ingredient -- polysorbate 80. |
|
|
|
Post by mbseeking on Oct 11, 2015 21:29:07 GMT -5
Can someone articulate simply what will change the insurance situation? I've seen many times the 6-12 months review period (post launch) mentioned (which we are now in), but then what happens at the healthcare companies?
It seems the smoking gun we are missing is the authoritative proof that Afrezza lowers A1Cs better than anything else. But other than blogs, such as Finta's, I cant see that proof anywhere else. If I was an insurance company I'm not sure how else I could justify it. There was some reference to a clamp study as providing this , but I believe this has largely been dismissed now. Is that correct? Is there another study underway that might provide this proof?
The only other thing that might lead to more coverage I've seen on this board is a case (or two) where the individual has harassed their healthcare provider and then succeeded in coverage.
Insurance coverage is clearly the problem (search on the new drug Teojeo and it already has far far better coverage), but I'm lacking the knowledge of how Afrezza's improves. Is it simply time, a long time?
|
|
|
|
Post by suebeeee1 on Oct 11, 2015 22:33:10 GMT -5
Sigh, it's that someday that has me grieving. It'd like it to be there today and I think Sanofi has handled this badly (not alone here). All promised a drug that would cost no more than the prandial pens. Again, why does Sanofi charge so darn much? Suebeeee1 Holding onto her Afrezza stock until someone pries it out of her cold, dead hands, as well Issues? This is the first i think i'm aware of hearing this. Gas? Cramps? Constipation? Abdominal pain? Any of these?...if not too personal It's all OK.....Metformin and Onglyza side effects! Gone now with Afrezza! |
|
|
|
Post by jpg on Oct 11, 2015 22:50:49 GMT -5
For a significant number of patients metformin has terrible digestive side effects. That is one of the reasons companies try reformatting it (with hit and miss improvements of 'digestive issues').
|
|
|
|
Post by mnholdem on Oct 12, 2015 8:21:19 GMT -5
Some final thoughts. As evidenced in the social media arena, Afrezza works and works very well. In fact, many have described Afrezza as a paradigm shift in diabetic treatment. It appears that once a patient changes to Afrezza they will not be changing back. Therefore, that steady script number will not change for any reason. Because people need to control their diabetes in all seasons, in a good economy or bad economy until there is a cure. That kind of consistency in a drug will make Mannkind stock very valuable indeed. ... Then very few insurance companies added Afrezza to their formularies... In the past month ( 7th month after launch ):
Formulary Status (Afrezza) | Sept 12, 2015 | Oct 12, 2015 | +/- Change | | Total Plans | 6,950 | 6,963 | +13 | | Preferred | 90 | 95 | + 5 | | Covered | 2,242 | 2,261 | +19 | | Restricted | 1,412 | 1,446 | +34 | | Not Covered | 3,206 | 3,161 | - 45 |
Of the 45 plans that picked up coverage of Afrezza in September, Restricted coverage outnumbered Preferred+Covered placement in formularies.
It seems like a trickle right now but, according to Hakan, we should started seeing increasing coverage throughout months 7-12 post launch.
Source: FormularyLookup.com
|
|
|
|
Post by rrtzmd on Oct 12, 2015 9:52:37 GMT -5
Can someone articulate simply what will change the insurance situation? I've seen many times the 6-12 months review period (post launch) mentioned (which we are now in), but then what happens at the healthcare companies? It seems the smoking gun we are missing is the authoritative proof that Afrezza lowers A1Cs better than anything else. But other than blogs, such as Finta's, I cant see that proof anywhere else. If I was an insurance company I'm not sure how else I could justify it. There was some reference to a clamp study as providing this , but I believe this has largely been dismissed now. Is that correct? Is there another study underway that might provide this proof? The only other thing that might lead to more coverage I've seen on this board is a case (or two) where the individual has harassed their healthcare provider and then succeeded in coverage. Insurance coverage is clearly the problem (search on the new drug Teojeo and it already has far far better coverage), but I'm lacking the knowledge of how Afrezza's improves. Is it simply time, a long time? The only thing that can change the insurance situation is high quality data demonstrating that afrezza is superior to lispro for treating diabetes. Currently, to move toujeo up the tier ladder, Sanofi is conducting a 3,000 subject "real life" study. Unless Sanofi comes up with something similar that results in demonstrating that afrezza is worth its added expense, it will remain a reimbursed only when "medically necessary" item. |
|
|
|
Post by mnholdem on Oct 13, 2015 7:02:49 GMT -5
... Then very few insurance companies added Afrezza to their formularies... In the past month ( 7th month after launch ):
Formulary Status (Afrezza) | Sept 12, 2015 | Oct 12, 2015 | +/- Change | | Total Plans | 6,950 | 6,963 | +13 | | Preferred | 90 | 95 | + 5 | | Covered | 2,242 | 2,261 | +19 | | Restricted | 1,412 | 1,446 | +34 | | Not Covered | 3,206 | 3,161 | - 45 |
Of the 45 plans that picked up coverage of Afrezza in September, Restricted coverage outnumbered Preferred+Covered placement in formularies.
It seems like a trickle right now but, according to Hakan, we should started seeing increasing coverage throughout months 7-12 post launch.
Source: FormularyLookup.com
Overnight, two plans moved Afrezza from Restricted (now @ 1,444 plans) to Preferred (now @ 97 plans). I thought this site was updated weekly, but apparently there are daily updates. I'm considering starting a table, similar to what Liane does with script counts, only this one would track Formulary Status from the free site FormularyLookup.
What does everyone think of that idea? Board members would able to track changes in formulary coverage for Afrezza (I'm thinking of updating by week).
|
|
|
|
Post by engineer4life on Oct 13, 2015 7:40:29 GMT -5
I am for it. Thank you for taking the initiative.
|
|
