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Post by peppy on Jun 2, 2017 19:36:43 GMT -5
Hippie, I see it a bit differently. In Brasil as in the UK and many other countries with single payer HI, governments will want to reduce cost as you said. But you need to look at TCO (a parallel if you will). Treating diabetes cost is like an iceberg. You see the cost of Afrezza which is the tip of the iceberg, but most of the costs lie with treatments of problems caused by not having diabetes under control. Those costs are far greater that the cost of Afrezza which is not much more expensive than regular injectables anyway. Certainly the UK system takes that approach and NICE evaluates several parameters including quality of life. The problem is going to be that NICE is purely evidence based so they are going to take the trial data and base their decision off that. I think if the cost in use is equivalent to RAA then they will pass it. If the cost is higher than RAA then they will follow the same path as with Exubera and make it registered needle-phobics only. If Afrezza is EMA approved then people could buy it in the UK outside the NHS regardless of any NICE finding as NICE has no remit outside the NHS. It would obviously limit the market (insulin is free in the UK) but there will still be some people prepared to pay out of pocket. Quote; insulin is free in the UK Aged the analogs? Humalog, Novolog, Apidra or "ReliOn Brand " type?
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Post by sayhey24 on Jun 2, 2017 20:11:46 GMT -5
Hippie, I see it a bit differently. In Brasil as in the UK and many other countries with single payer HI, governments will want to reduce cost as you said. But you need to look at TCO (a parallel if you will). Treating diabetes cost is like an iceberg. You see the cost of Afrezza which is the tip of the iceberg, but most of the costs lie with treatments of problems caused by not having diabetes under control. Those costs are far greater that the cost of Afrezza which is not much more expensive than regular injectables anyway. Certainly the UK system takes that approach and NICE evaluates several parameters including quality of life. The problem is going to be that NICE is purely evidence based so they are going to take the trial data and base their decision off that. I think if the cost in use is equivalent to RAA then they will pass it. If the cost is higher than RAA then they will follow the same path as with Exubera and make it registered needle-phobics only. If Afrezza is EMA approved then people could buy it in the UK outside the NHS regardless of any NICE finding as NICE has no remit outside the NHS. It would obviously limit the market (insulin is free in the UK) but there will still be some people prepared to pay out of pocket. I am not sure I am following the thinking here. You said the reason that BIOMM is building a regular insulin plant rather than an RAA plant is because of pricing. I suspect the reason is the RAAs are patented and BIOMM would have to cut a deal with the RAA patent owner. I don't think there is much of a cost difference in brewing up one molecule versus a similar one. The pricing would then be up to BIOMM and the RAA owner. It would seem to me the human insulin they are going to make could be raw material for afrezza production. It would also seem to me the "pricing" is what BIOMM and Mannkind decide as the insulin is the biggest material cost in afrezza. If BIOMM can make and supply to MNKD cheap, I would think they could come up with some pretty good pricing. It would also seem to me that given a choice between BIOMM making Novalog, Aprida or Humalog versus making afrezza in this day and age its a no brainer if what I am trying to do is control meal time BG spikes. Over the next several years time in range will start to replace A1c as the standard for care. With CGMs there is no place to hide. When the T2s start understanding they are 200+ after a meal and its taking all night to get them back to a somewhat reasonable number and they can finally get this real time feedback there is a pretty good chance some will start doing more to take care of themselves and demand better care. Today, about the only feedback is they are told to come back to the doctor in 6 months so they can be told their A1c sucks. Today's standard of care they get is a real beauty. For the T2s with no money who can only afford NPH most don't use it today on a regular basis. No one likes taking the shots, its a hassle and since their 300+ BG is not going to kill them tomorrow, they put it off unless a loved one is nagging them all the time. If BIOMM and MNKD can price it very aggressively, again afrezza wins. Its better and cheaper. If MNKD figures out a way to manufacture the powder in Danbury and bulk ship and fill in China, Amphastar would have their hands full just supplying the insulin for the Chinese market. That lets BIOMM take South America.
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Post by peppy on Jun 2, 2017 20:58:09 GMT -5
Certainly the UK system takes that approach and NICE evaluates several parameters including quality of life. The problem is going to be that NICE is purely evidence based so they are going to take the trial data and base their decision off that. I think if the cost in use is equivalent to RAA then they will pass it. If the cost is higher than RAA then they will follow the same path as with Exubera and make it registered needle-phobics only. If Afrezza is EMA approved then people could buy it in the UK outside the NHS regardless of any NICE finding as NICE has no remit outside the NHS. It would obviously limit the market (insulin is free in the UK) but there will still be some people prepared to pay out of pocket. I am not sure I am following the thinking here. You said the reason that BIOMM is building a regular insulin plant rather than an RAA plant is because of pricing. I suspect the reason is the RAAs are patented and BIOMM would have to cut a deal with the RAA patent owner. I don't think there is much of a cost difference in brewing up one molecule versus a similar one. The pricing would then be up to BIOMM and the RAA owner. It would seem to me the human insulin they are going to make could be raw material for afrezza production. It would also seem to me the "pricing" is what BIOMM and Mannkind decide as the insulin is the biggest material cost in afrezza. If BIOMM can make and supply to MNKD cheap, I would think they could come up with some pretty good pricing. It would also seem to me that given a choice between BIOMM making Novalog, Aprida or Humalog versus making afrezza in this day and age its a no brainer if what I am trying to do is control meal time BG spikes. Over the next several years time in range will start to replace A1c as the standard for care. With CGMs there is no place to hide. When the T2s start understanding they are 200+ after a meal and its taking all night to get them back to a somewhat reasonable number and they can finally get this real time feedback there is a pretty good chance some will start doing more to take care of themselves and demand better care. Today, about the only feedback is they are told to come back to the doctor in 6 months so they can be told their A1c sucks. Today's standard of care they get is a real beauty. For the T2s with no money who can only afford NPH most don't use it today on a regular basis. No one likes taking the shots, its a hassle and since their 300+ BG is not going to kill them tomorrow, they put it off unless a loved one is nagging them all the time. If BIOMM and MNKD can price it very aggressively, again afrezza wins. Its better and cheaper. If MNKD figures out a way to manufacture the powder in Danbury and bulk ship and fill in China, Amphastar would have their hands full just supplying the insulin for the Chinese market. That lets BIOMM take South America. alrighty then. MNKD has contracts with Amphstar for insulin. 18 million worth our next round after the renegotiated contract?
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Post by brotherm1 on Jun 2, 2017 21:10:31 GMT -5
Dang it Peppy. I'm sitting here chillin and enjoying #24's beautiful dissertation and you go ahead and axe a question and strain my brain. What's the answer Peppy? ⚾️
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Post by agedhippie on Jun 2, 2017 21:25:38 GMT -5
Certainly the UK system takes that approach and NICE evaluates several parameters including quality of life. The problem is going to be that NICE is purely evidence based so they are going to take the trial data and base their decision off that. I think if the cost in use is equivalent to RAA then they will pass it. If the cost is higher than RAA then they will follow the same path as with Exubera and make it registered needle-phobics only. If Afrezza is EMA approved then people could buy it in the UK outside the NHS regardless of any NICE finding as NICE has no remit outside the NHS. It would obviously limit the market (insulin is free in the UK) but there will still be some people prepared to pay out of pocket. Quote; insulin is free in the UK Aged the analogs? Humalog, Novolog, Apidra or "ReliOn Brand " type? All insulin (as well as strips). For certain medical conditions, including diabetes not managed by diet alone, you are entitle to a medical exemption certificate which makes all prescriptions free. Without the certificate prescriptions have a fixed cost of £8.60 ($11.10) per item although you can buy a £29.10 3 month pass as well.
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Post by brotherm1 on Jun 2, 2017 21:59:01 GMT -5
I am not sure I am following the thinking here. You said the reason that BIOMM is building a regular insulin plant rather than an RAA plant is because of pricing. I suspect the reason is the RAAs are patented and BIOMM would have to cut a deal with the RAA patent owner. I don't think there is much of a cost difference in brewing up one molecule versus a similar one. The pricing would then be up to BIOMM and the RAA owner. It would seem to me the human insulin they are going to make could be raw material for afrezza production. It would also seem to me the "pricing" is what BIOMM and Mannkind decide as the insulin is the biggest material cost in afrezza. If BIOMM can make and supply to MNKD cheap, I would think they could come up with some pretty good pricing. It would also seem to me that given a choice between BIOMM making Novalog, Aprida or Humalog versus making afrezza in this day and age its a no brainer if what I am trying to do is control meal time BG spikes. Over the next several years time in range will start to replace A1c as the standard for care. With CGMs there is no place to hide. When the T2s start understanding they are 200+ after a meal and its taking all night to get them back to a somewhat reasonable number and they can finally get this real time feedback there is a pretty good chance some will start doing more to take care of themselves and demand better care. Today, about the only feedback is they are told to come back to the doctor in 6 months so they can be told their A1c sucks. Today's standard of care they get is a real beauty. For the T2s with no money who can only afford NPH most don't use it today on a regular basis. No one likes taking the shots, its a hassle and since their 300+ BG is not going to kill them tomorrow, they put it off unless a loved one is nagging them all the time. If BIOMM and MNKD can price it very aggressively, again afrezza wins. Its better and cheaper. If MNKD figures out a way to manufacture the powder in Danbury and bulk ship and fill in China, Amphastar would have their hands full just supplying the insulin for the Chinese market. That lets BIOMM take South America. alrighty then. MNKD has contracts with Amphstar for insulin. 18 million worth our next round after the renegotiated contract? "The minimum annual purchase commitments in calendar years 2017 through 2023 have been modified to be €2.7 million ($3,019,100) of insulin in the fourth quarter of 2017, €8.9 million ($9,951,847) in 2018, €11.6 million ($12,970,946) in 2019, €15.5 million ($17,331,868) in 2020 and in 2021, and €19.4 ($21,692,789) million in 2022 and in 2023. MannKind may request to purchase additional quantities of RHI API in excess of its annual minimum purchase commitments...."
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Post by agedhippie on Jun 2, 2017 22:20:06 GMT -5
Certainly the UK system takes that approach and NICE evaluates several parameters including quality of life. The problem is going to be that NICE is purely evidence based so they are going to take the trial data and base their decision off that. I think if the cost in use is equivalent to RAA then they will pass it. If the cost is higher than RAA then they will follow the same path as with Exubera and make it registered needle-phobics only. If Afrezza is EMA approved then people could buy it in the UK outside the NHS regardless of any NICE finding as NICE has no remit outside the NHS. It would obviously limit the market (insulin is free in the UK) but there will still be some people prepared to pay out of pocket. I am not sure I am following the thinking here. You said the reason that BIOMM is building a regular insulin plant rather than an RAA plant is because of pricing. I suspect the reason is the RAAs are patented and BIOMM would have to cut a deal with the RAA patent owner. I don't think there is much of a cost difference in brewing up one molecule versus a similar one. The pricing would then be up to BIOMM and the RAA owner. It would seem to me the human insulin they are going to make could be raw material for afrezza production. It would also seem to me the "pricing" is what BIOMM and Mannkind decide as the insulin is the biggest material cost in afrezza. If BIOMM can make and supply to MNKD cheap, I would think they could come up with some pretty good pricing. ... If BIOMM and MNKD can price it very aggressively, again afrezza wins. Its better and cheaper. If MNKD figures out a way to manufacture the powder in Danbury and bulk ship and fill in China, Amphastar would have their hands full just supplying the insulin for the Chinese market. That lets BIOMM take South America. It's cost because Regular insulin is much cheaper to produce than RAA and is far lower tech (Indian producers sell 10mL vials for around $3). BIOMM want Regular insulin to sell into the bulk market because it has a far lower price point which is important for the Brazilan health services budget. The RAA patents have largely expired so BIOMM is free to copy them however it lacks the ability. There are now biosimilars for Humalog (Sanofi and Bicon) and for Novolog (Biocon). There are at least four companies who have produced or are producing Lantus biosimilars as well. Sanofi's Humalog biosimilar passed the EMA last month so it's now approved for sale in Europe. I am not sure how aggressively Afrezza can be marketed in Brazil. If they want to match Humalog's price in Brazil that would be $18 for a box of 8u Afrezza before BIOMM gets their cut. I am pretty certain Mannkind cannot make it for that sort of price (and if they can they should cut their US price right now and bypass the PBMs). My feeling is that they will not try and compete, but rather market Afrezza as a premium product.
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Post by brotherm1 on Jun 2, 2017 23:11:08 GMT -5
25% do very well and have their own private health insurance; and the lack of doctors and clinics together with the need for more health services to the majority should make Brazil a good place for Jeff Dachis and One Drop to work some deals. Good article from 2014: www.google.com/amp/s/www.theatlantic.com/amp/article/361854/
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Post by sayhey24 on Jun 3, 2017 7:08:18 GMT -5
I am not sure I am following the thinking here. You said the reason that BIOMM is building a regular insulin plant rather than an RAA plant is because of pricing. I suspect the reason is the RAAs are patented and BIOMM would have to cut a deal with the RAA patent owner. I don't think there is much of a cost difference in brewing up one molecule versus a similar one. The pricing would then be up to BIOMM and the RAA owner. It would seem to me the human insulin they are going to make could be raw material for afrezza production. It would also seem to me the "pricing" is what BIOMM and Mannkind decide as the insulin is the biggest material cost in afrezza. If BIOMM can make and supply to MNKD cheap, I would think they could come up with some pretty good pricing. ... If BIOMM and MNKD can price it very aggressively, again afrezza wins. Its better and cheaper. If MNKD figures out a way to manufacture the powder in Danbury and bulk ship and fill in China, Amphastar would have their hands full just supplying the insulin for the Chinese market. That lets BIOMM take South America. It's cost because Regular insulin is much cheaper to produce than RAA and is far lower tech (Indian producers sell 10mL vials for around $3). BIOMM want Regular insulin to sell into the bulk market because it has a far lower price point which is important for the Brazilan health services budget. The RAA patents have largely expired so BIOMM is free to copy them however it lacks the ability. There are now biosimilars for Humalog (Sanofi and Bicon) and for Novolog (Biocon). There are at least four companies who have produced or are producing Lantus biosimilars as well. Sanofi's Humalog biosimilar passed the EMA last month so it's now approved for sale in Europe. I am not sure how aggressively Afrezza can be marketed in Brazil. If they want to match Humalog's price in Brazil that would be $18 for a box of 8u Afrezza before BIOMM gets their cut. I am pretty certain Mannkind cannot make it for that sort of price (and if they can they should cut their US price right now and bypass the PBMs). My feeling is that they will not try and compete, but rather market Afrezza as a premium product. This list may be a bit dated but Biocon may not be as far along as you are saying. blog.diabeteslab.org/2016/01/the-future-of-insulin-new-insulin-formulations-under-development/For the RAAs why Sanofi wants to make generic Humalog I can't explain. Regardless, you are trying to make the argument NPH, the RAAs and afrezza are all the same and one can substitute for the other based on "price". I am not following this. If the goal is controlling meal time sugar spikes, NPH is not going to do it. Neither is Novalog, Humalog, Fiasp or any other current or in-works RAA. Only afrezza and a healthy pancreas do this. If Sanofi is now trying to make Lilly products and each is trying to eat each other's lunch yet the only product which will get the job done is afrezza, it just seems a matter of time before one has to back up the money truck and pay MNKD what they want for the buy-out. We are about 2 years away from people walking around with Tim Cook's CGM. Between what Verily is doing and what Cook is doing in 2 years its all about meal time control. T2's don't need a basal, don't need metformin, any SGLT or any other non-sense if they can address meal time spikes. The only way T2s can do this today is with ultra-low carb diets because no one wants the needles and hypo risk with current RAAs and insurance is not paying for it because no one is seeing the after meal sugar numbers today. The question is was Stefan Schwarz right? He knew early on the PCPs were going to continue to give the T2s ultra-poor care unless he could change the paradigm.
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Post by mnkdfann on Jun 3, 2017 7:28:43 GMT -5
They appear to have had only 10 million American dollars in cash at the end of the first quarter. They have a strange website -- www.biomm.com -- which doesn't seem to say much of anything specific about what they do. Reading the annual report says they have been building some sort of large factory in Minas Gerais since 2014 for the production of various insulins, and that it's supposed to go into operation sometime next year. I think it also says that Brazil currently imports all of its insulin. I guess this is the plant. Note, Nova Lima is in Minas Gerais. www.bio.org/sites/default/files/11h00%20BIOMM%20Heraldo.pdf
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Post by peppy on Jun 3, 2017 7:48:34 GMT -5
It's cost because Regular insulin is much cheaper to produce than RAA and is far lower tech (Indian producers sell 10mL vials for around $3). BIOMM want Regular insulin to sell into the bulk market because it has a far lower price point which is important for the Brazilan health services budget. The RAA patents have largely expired so BIOMM is free to copy them however it lacks the ability. There are now biosimilars for Humalog (Sanofi and Bicon) and for Novolog (Biocon). There are at least four companies who have produced or are producing Lantus biosimilars as well. Sanofi's Humalog biosimilar passed the EMA last month so it's now approved for sale in Europe. I am not sure how aggressively Afrezza can be marketed in Brazil. If they want to match Humalog's price in Brazil that would be $18 for a box of 8u Afrezza before BIOMM gets their cut. I am pretty certain Mannkind cannot make it for that sort of price (and if they can they should cut their US price right now and bypass the PBMs). My feeling is that they will not try and compete, but rather market Afrezza as a premium product. This list may be a bit dated but Biocon may not be as far along as you are saying. blog.diabeteslab.org/2016/01/the-future-of-insulin-new-insulin-formulations-under-development/For the RAAs why Sanofi wants to make generic Humalog I can't explain. Regardless, you are trying to make the argument NPH, the RAAs and afrezza are all the same and one can substitute for the other based on "price". I am not following this. If the goal is controlling meal time sugar spikes, NPH is not going to do it. Neither is Novalog, Humalog, Fiasp or any other current or in-works RAA. Only afrezza and a healthy pancreas do this. If Sanofi is now trying to make Lilly products and each is trying to eat each other's lunch yet the only product which will get the job done is afrezza, it just seems a matter of time before one has to back up the money truck and pay MNKD what they want for the buy-out. We are about 2 years away from people walking around with Tim Cook's CGM. Between what Verily is doing and what Cook is doing in 2 years its all about meal time control. T2's don't need a basal, don't need metformin, any SGLT or any other non-sense if they can address meal time spikes. The only way T2s can do this today is with ultra-low carb diets because no one wants the needles and hypo risk with current RAAs and insurance is not paying for it because no one is seeing the after meal sugar numbers today.The question is was Stefan Schwarz right? He knew early on the PCPs were going to continue to give the T2s ultra-poor care unless he could change the paradigm. quote: The only way T2s can do this today is with ultra-low carb diets because no one wants the needles and hypo risk with current RAAs and insurance is not paying for it because no one is seeing the after meal sugar numbers today. reply: I know a T2. Their plan seems to be ignore it. Will not take a blood glucose. Out of site out of mind. This T2 is overweight.
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Post by agedhippie on Jun 3, 2017 9:17:07 GMT -5
It's cost because Regular insulin is much cheaper to produce than RAA and is far lower tech (Indian producers sell 10mL vials for around $3). BIOMM want Regular insulin to sell into the bulk market because it has a far lower price point which is important for the Brazilan health services budget. The RAA patents have largely expired so BIOMM is free to copy them however it lacks the ability. There are now biosimilars for Humalog (Sanofi and Bicon) and for Novolog (Biocon). There are at least four companies who have produced or are producing Lantus biosimilars as well. Sanofi's Humalog biosimilar passed the EMA last month so it's now approved for sale in Europe. I am not sure how aggressively Afrezza can be marketed in Brazil. If they want to match Humalog's price in Brazil that would be $18 for a box of 8u Afrezza before BIOMM gets their cut. I am pretty certain Mannkind cannot make it for that sort of price (and if they can they should cut their US price right now and bypass the PBMs). My feeling is that they will not try and compete, but rather market Afrezza as a premium product. This list may be a bit dated but Biocon may not be as far along as you are saying. blog.diabeteslab.org/2016/01/the-future-of-insulin-new-insulin-formulations-under-development/For the RAAs why Sanofi wants to make generic Humalog I can't explain. Regardless, you are trying to make the argument NPH, the RAAs and afrezza are all the same and one can substitute for the other based on "price". I am not following this. If the goal is controlling meal time sugar spikes, NPH is not going to do it. Neither is Novalog, Humalog, Fiasp or any other current or in-works RAA. Only afrezza and a healthy pancreas do this. If Sanofi is now trying to make Lilly products and each is trying to eat each other's lunch yet the only product which will get the job done is afrezza, it just seems a matter of time before one has to back up the money truck and pay MNKD what they want for the buy-out. We are about 2 years away from people walking around with Tim Cook's CGM. Between what Verily is doing and what Cook is doing in 2 years its all about meal time control. T2's don't need a basal, don't need metformin, any SGLT or any other non-sense if they can address meal time spikes. The only way T2s can do this today is with ultra-low carb diets because no one wants the needles and hypo risk with current RAAs and insurance is not paying for it because no one is seeing the after meal sugar numbers today. The question is was Stefan Schwarz right? He knew early on the PCPs were going to continue to give the T2s ultra-poor care unless he could change the paradigm. Biocon is working on producing analogs because they are off patent, your argument was that BIOMM couldn't work on RAA because of patents. Sanofi has produced and got EMA approval to sell a Humalog biosimilar in Europe. So there is no question that BIOMM could produce an analog unobstructed by patent if they had the ability which they do not. Why has Sanofi produced a Humalog biosimilar? Because there is a huge established market for Humalog and it is easier to compete on price (as the Lantus biosimilars have proven) than it is to educate the market as Afrezza is trying to do. Take Brazil as an example - Humalog is costs the $18 for the equivalent of a box of Afrezza and Sanofi can undercut that. For most of the world that is what matters. "If the goal is controlling meal time sugar spikes..." is all very well but it's not the goal the medical profession care about. Rightly or wrongly (and I tend to your view here) their goal is HbA1c, and for that the trial data says they are all the same. Well not NPH because that's a basal insulin more like Levemir (in that it is twice daily) which is where the EU countries are looking at it.
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Post by lennymnkd on Jun 3, 2017 9:22:35 GMT -5
HERALDO MARCHEZINI CEO 25 years of experience in the industry, former Sanofi ́s CEO From their exsecutive website !
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Post by myocat on Jun 3, 2017 9:31:16 GMT -5
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Post by mnkdfann on Jun 3, 2017 9:41:54 GMT -5
HERALDO MARCHEZINI CEO 25 years of experience in the industry, former Sanofi ́s CEO From their exsecutive website ! Thanks for sharing, but you are just repeating what others posted days ago in this same thread. See page 5.
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