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Post by Deleted on Jul 7, 2015 11:15:39 GMT -5
If this has been hashed over already pls point me to the thread as I could not find one here. My question is this - why not a flood of early adopters instead of a trickle? My thought process is this - there were thousands of diabetics introduced to afrezza during the many trials over the years and in my mind it was a given that they would have provided the initial sales push and yield thousands of scripts out of the gate. I'm still waiting. I take the positive experiences at face value as well as the life changing claims but I am completely baffled why there arent more scripts from these mnay thousands of trial participants?! Those that participated in the trials surely saw the benefits even if they were under strict control on how to use it. In fact, since it works so well I would think those trial users would have been chomping at the bit to have free reign of usage?! Any insight is appreciated.
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Post by yossarian on Jul 7, 2015 11:23:10 GMT -5
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Post by jfl on Jul 7, 2015 11:28:36 GMT -5
Weren't the trial participants spread throughout the globe? Afrezza is only available in the USA.
Within the USA, marketing this product has been extremely weak. Some products, like Sovaldi that actually cures a disease, may not require much marketing to hit $9 billion in 9 months. However, Afrezza is not one of those.
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Post by esstan2001 on Jul 7, 2015 11:36:13 GMT -5
The participants in the studies numbered in the 100s not 1000s. ... Davinci is referring to all the Mannkind run studies thru the FDA since the mid 2000's- more like 5k-6k (although not all were on Techo-Insulin; a fair part were in comparator arms)
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Post by lakefox333 on Jul 7, 2015 11:39:07 GMT -5
Very simple! Very limited insurance coverage! I am a perfect example. I am a Type 2 who has been on Afrezza for 3+ months, only taking metformin prior. After the discount card I'm paying $160 per month. Because I have not been on "other insulin" treatments my insurance refuses to cover it. I just checked the July CVS/Caremark Formulary and it is not there, but neither is Toujeo. I'm willing to pay for it hoping it's gets coverage later this year. But how many other Type 2 diabetics can afford $160 or more per month? No surprise to me the scripts have been slow to grow!
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Post by joeypotsandpans on Jul 7, 2015 12:01:21 GMT -5
Very simple! Very limited insurance coverage! I am a perfect example. I am a Type 2 who has been on Afrezza for 3+ months, only taking metformin prior. After the discount card I'm paying $160 per month. Because I have not been on "other insulin" treatments my insurance refuses to cover it. I just checked the July CVS/Caremark Formulary and it is not there, but neither is Toujeo. I'm willing to pay for it hoping it's gets coverage later this year. But how many other Type 2 diabetics can afford $160 or more per month? No surprise to me the scripts have been slow to grow! How much is one's life worth, let alone quality of life ? I'm not being facetious here, rather $160/mo could come from lots of places in a monthly budget, also having spoken to a rep, they are working diligently with the practitioners regarding the prior authorizations...you can also contact Sanofi directly and they will send you some paperwork to fill out to get the process expedited. More importantly, one of the issues for the insurance companies as it was explained to me is that for Afrezza to gain "a spot" one of the competing RAA's would have to be displaced from the tier...so they are approaching it from a different angle. Filter out the noise, MNKD will continue to "climb the proverbial wall of worry" as it has for quite some time....24 mos. ago there were many that bet it wouldn't be in existence today let alone about to thrive. Currently adding to position, and adding Sanofi calls as well.
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Post by eddiemoy on Jul 7, 2015 12:39:03 GMT -5
Very simple! Very limited insurance coverage! I am a perfect example. I am a Type 2 who has been on Afrezza for 3+ months, only taking metformin prior. After the discount card I'm paying $160 per month. Because I have not been on "other insulin" treatments my insurance refuses to cover it. I just checked the July CVS/Caremark Formulary and it is not there, but neither is Toujeo. I'm willing to pay for it hoping it's gets coverage later this year. But how many other Type 2 diabetics can afford $160 or more per month? No surprise to me the scripts have been slow to grow! How much is one's life worth, let alone quality of life ? I'm not being facetious here, rather $160/mo could come from lots of places in a monthly budget, also having spoken to a rep, they are working diligently with the practitioners regarding the prior authorizations...you can also contact Sanofi directly and they will send you some paperwork to fill out to get the process expedited. More importantly, one of the issues for the insurance companies as it was explained to me is that for Afrezza to gain "a spot" one of the competing RAA's would have to be displaced from the tier...so they are approaching it from a different angle. Filter out the noise, MNKD will continue to "climb the proverbial wall of worry" as it has for quite some time....24 mos. ago there were many that bet it wouldn't be in existence today let alone about to thrive. Currently adding to position, and adding Sanofi calls as well. I would say most people don't care until their health is really bad. I know I'm one of those who keeps on procrastinating.
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Post by babaoriley on Jul 7, 2015 13:35:03 GMT -5
How much is one's life worth, let alone quality of life ? I'm not being facetious here, rather $160/mo could come from lots of places in a monthly budget, also having spoken to a rep, they are working diligently with the practitioners regarding the prior authorizations...you can also contact Sanofi directly and they will send you some paperwork to fill out to get the process expedited. More importantly, one of the issues for the insurance companies as it was explained to me is that for Afrezza to gain "a spot" one of the competing RAA's would have to be displaced from the tier...so they are approaching it from a different angle. Filter out the noise, MNKD will continue to "climb the proverbial wall of worry" as it has for quite some time....24 mos. ago there were many that bet it wouldn't be in existence today let alone about to thrive. Currently adding to position, and adding Sanofi calls as well. I would say most people don't care until their health is really bad. I know I'm one of those who keeps on procrastinating. I would say you are correct with that assessment, eddie.
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Post by monetpenet on Jul 7, 2015 14:34:34 GMT -5
Very simple! Very limited insurance coverage! I am a perfect example. I am a Type 2 who has been on Afrezza for 3+ months, only taking metformin prior. After the discount card I'm paying $160 per month. Because I have not been on "other insulin" treatments my insurance refuses to cover it. I just checked the July CVS/Caremark Formulary and it is not there, but neither is Toujeo. I'm willing to pay for it hoping it's gets coverage later this year. But how many other Type 2 diabetics can afford $160 or more per month? No surprise to me the scripts have been slow to grow!
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Post by dreamboatcruise on Jul 7, 2015 15:42:58 GMT -5
Very simple! Very limited insurance coverage! I am a perfect example. I am a Type 2 who has been on Afrezza for 3+ months, only taking metformin prior. After the discount card I'm paying $160 per month. Because I have not been on "other insulin" treatments my insurance refuses to cover it. I just checked the July CVS/Caremark Formulary and it is not there, but neither is Toujeo. I'm willing to pay for it hoping it's gets coverage later this year. But how many other Type 2 diabetics can afford $160 or more per month? No surprise to me the scripts have been slow to grow! How much is one's life worth, let alone quality of life ? I'm not being facetious here, rather $160/mo could come from lots of places in a monthly budget, also having spoken to a rep, they are working diligently with the practitioners regarding the prior authorizations...you can also contact Sanofi directly and they will send you some paperwork to fill out to get the process expedited. More importantly, one of the issues for the insurance companies as it was explained to me is that for Afrezza to gain "a spot" one of the competing RAA's would have to be displaced from the tier...so they are approaching it from a different angle. Filter out the noise, MNKD will continue to "climb the proverbial wall of worry" as it has for quite some time....24 mos. ago there were many that bet it wouldn't be in existence today let alone about to thrive. Currently adding to position, and adding Sanofi calls as well. I've never heard of this notion that there are only a certain number of "spots" for particular drug categories. Can you, or anyone else, shed some light on how that works? Who drives the requirement that there are only X number of RAAs on the formulary. Does formulary management make agreements that preclude bringing new drugs in... e.g. Caremark says "Novo, if you agree to X $ per script we'll promise that you are the only Tier 2 RAA"? Do agreements like that exist and would they have to expire before Afrezza could gain Tier 2 access? Surely going from restricted pre-authorization to simple tier 3 wouldn't be precluded? Some formularies only have one RAA at tier 2. I can't imagine Afrezza being the only tier 2, so this notion that it must displace seems odd. Maybe this is a topic that deserves its' own thread if there is anyone that has insight into this.
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Post by mnholdem on Jul 8, 2015 8:55:42 GMT -5
I ran across a formulary the other day the has Levemir at Tier 2 and Lantus at Tier 3 requiring pre-approval. It got me to thinking that insurance company coverage may also be based upon pricing negotiations with various pharmaceuticals. Unless proven superior, the nod in a crowded field may go to whoever has the lowest price. It will take some time for Sanofi to convince insurers of the impact Afrezza with have on hypoglycemia. How many months (or years) of evidence with be needed before payers become convinced that Afrezza results in lower overall costs just from reduced trips to emergency rooms. Factor in other complications from the ravages of "out of control" blood glucose and Afrezza seems to be a no-brainer to those who have researched it.
Hopefully some of the European trial data - as well as post-approval FDA trials - will yield some empirical evidence. Until then, I suspect that Sanofi will have to negotiate coverage. They may reduce pricing, if it means getting Afrezza to Tier 2, but something tells me they know Afrezza is good enough to justify the higher price and they'll be reluctant to trim profits. If they are convinced that this will become a blockbuster, Sanofi will take the slow and steady approach.
In other words, endure some short-term pain for long-term gains. For example, Sanofi may realize that it's better to wait to convince some of the more demanding insurers until after the data has been compiled from the clamp study scheduled to begin shortly, to be completed in December 2015.
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Post by esstan2001 on Jul 8, 2015 9:15:47 GMT -5
...It will take some time for Sanofi to convince insurers of the impact Afrezza with have on hypoglycemia. How many months (or years) of evidence with be needed before payers become convinced that Afrezza results in lower overall costs just from reduced trips to emergency rooms. Factor in other complications from the ravages of "out of control" blood glucose and Afrezza seems to be a no-brainer to those who have researched it. ... I also wonder if insurance companies monitor outcomes themselves and make some of these decisions independent of FDA / manufacturer data- I somewhat thought this to be the case, would explain why more heavily resourced Ins. Co's make formulary moves while bumpkin Ins. is slow on the draw... anyone knowledgeable care to comment?
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Post by Deleted on Jul 8, 2015 13:16:34 GMT -5
I ran across a formulary the other day the has Levemir at Tier 2 and Lantus at Tier 3 requiring pre-approval. It got me to thinking that insurance company coverage may also be based upon pricing negotiations with various pharmaceuticals. Unless proven superior, the nod in a crowded field may go to whoever has the lowest price. It will take some time for Sanofi to convince insurers of the impact Afrezza with have on hypoglycemia. How many months (or years) of evidence with be needed before payers become convinced that Afrezza results in lower overall costs just from reduced trips to emergency rooms. Factor in other complications from the ravages of "out of control" blood glucose and Afrezza seems to be a no-brainer to those who have researched it. Hopefully some of the European trial data - as well as post-approval FDA trials - will yield some empirical evidence. Until then, I suspect that Sanofi will have to negotiate coverage. They may reduce pricing, if it means getting Afrezza to Tier 2, but something tells me they know Afrezza is good enough to justify the higher price and they'll be reluctant to trim profits. If they are convinced that this will become a blockbuster, Sanofi will take the slow and steady approach. In other words, endure some short-term pain for long-term gains. For example, Sanofi may realize that it's better to wait to convince some of the more demanding insurers until after the data has been compiled from the clamp study scheduled to begin shortly, to be completed in December 2015. I wrote quite a bit here on proboards recently (last 6 months) about other drugs where insurance companies refuse to cover costs until damage is confirmed. This came up from Gilead and one of their new hep C drugs that work extremely well at curing the disease but costs around 90k. Insurance companies have refused to pay not because it works so well but strictly over costs. I included links as well. Bottom line that I took away is that in today's day in America, our insurance industry does not cover what works best, only what works well enough at the cheapest price. Hopefully the lawsuit filed against the insurance company over this issue will make it to the supreme court. So, it's not about proving superiority as demonstrated by gileads drug and the lack of coverage there. It's all about costs and with the availability of plenty of cheaper options for diabetes management that sort of work kinda maybe, insurance companies appear to defer to those options first regardless of whether they are the best option or not for patients. I wrote more detail in other posts, but, here's the link to the article: blogs.wsj.com/pharmalot/2015/05/26/consumer-sue-anthem-for-denying-coverage-for-a-hepatitis-c-drug/Bottom line for the next year or two for afrezza is less about afrezza and how well it works and more about the cost of afrezza in my very humble opinion. I'm starting to believe that SNY, or, frankly ANYONE had no idea just how quickly and dramatically the insurance landscape is changing in the US in terms of what get covered and by how much and, more importantly - the "WHY". If SNY understood the importance of cost as much as it's appearing to be nowadays, I do believe they might have priced it lower than all other treatments to simply beat on price and get on Tier 2 formularies across the board. Profits would have to be made ala wall mart - pure volume!
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Post by dreamboatcruise on Jul 8, 2015 13:41:30 GMT -5
I ran across a formulary the other day the has Levemir at Tier 2 and Lantus at Tier 3 requiring pre-approval. It got me to thinking that insurance company coverage may also be based upon pricing negotiations with various pharmaceuticals. Unless proven superior, the nod in a crowded field may go to whoever has the lowest price. It will take some time for Sanofi to convince insurers of the impact Afrezza with have on hypoglycemia. How many months (or years) of evidence with be needed before payers become convinced that Afrezza results in lower overall costs just from reduced trips to emergency rooms. Factor in other complications from the ravages of "out of control" blood glucose and Afrezza seems to be a no-brainer to those who have researched it. Hopefully some of the European trial data - as well as post-approval FDA trials - will yield some empirical evidence. Until then, I suspect that Sanofi will have to negotiate coverage. They may reduce pricing, if it means getting Afrezza to Tier 2, but something tells me they know Afrezza is good enough to justify the higher price and they'll be reluctant to trim profits. If they are convinced that this will become a blockbuster, Sanofi will take the slow and steady approach. In other words, endure some short-term pain for long-term gains. For example, Sanofi may realize that it's better to wait to convince some of the more demanding insurers until after the data has been compiled from the clamp study scheduled to begin shortly, to be completed in December 2015. I've said the same thing in the past with regard to a likely trade-off with pricing and speed of formulary placement improvement. The higher than expected price would seem to mean one of two things... A) they know the clinical benefits will allow them to be preferred even with a higher price than traditional RAA's or B) the apparent higher price simply allows negotiating room to get on formulary. It may well be a combination. Maybe they offer steeper discounting to early adopter formularies and then will let things play out for a while as the news builds of patient success and doctors start telling insurers that they must cover it. However, I don't think the clamp studies would be the magic bullet to get insurers to move. I really don't know what it will show that we don't already know. @davinci... I would agree with you on insurers not necessarily putting a lot of weight on long term cost issues. I think it is two issues... Companies as a whole have very short term views with regard to profit and health insurers in particular know that something that they do now will cost them and yet the patient may well be off to some other insurer or on Medicare by the time the savings kick in. Of course if there is strong evidence of less severe hypos requiring hospital visits... that could be a saving right now and get their attention.
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Post by esstan2001 on Jul 8, 2015 13:45:17 GMT -5
... I'm starting to believe that SNY, or, frankly ANYONE had no idea just how quickly and dramatically the insurance landscape is changing in the US in terms of what get covered and by how much and, more importantly - the "WHY". If SNY understood the importance of cost as much as it's appearing to be nowadays, I do believe they might have priced it lower than all other treatments to simply beat on price and get on Tier 2 formularies across the board. Profits would have to be made ala wall mart - pure volume! I'd bet that they had a clue on the insurance landscape. They also announced a soft launch. It is more likely than not IMO that they intentionally priced a bit higher to both give them some negotiation room, and fully knowing that there will be limited initial patient demand corresponding to limited patient / Dr. awareness, keep the demand more closely matched to the limited nascent ability to supply. More preferential pricing at the getgo is NOT going to markedly impact demand before physician training or consumer DTC- does not make sense; I would think that they would not want demand to outstrip supply even if they could generate the patient demand through a lower price and more ins coverage.
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