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Post by Deleted on Aug 21, 2013 14:00:08 GMT -5
douge, Afrezza and Exubera may both be inhaled, but totally different pharmacokinetics. I agree, Afrezza is the superior product of the two entering and taking effect in 12-14 mins. It's a new class of insulin, ultra rapid acting. But my point is to validate the fact that many will still compare it to it's predecessor and since Exubera failed doctors may be hesitant in prescribing a new form of insulin (technosphere technology) that's inhalable. Also note managed-care companies scrutinize every new drug through the lens of cost vs. benefit, Afrezza is going to be 10-15% more costing between 1200-2000 US dollars therefore it will take some time (1 year at least) before healthcare covers Afrezza and it will be more than likely classified in tier 2. |
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Post by StevieRay on Aug 21, 2013 14:01:46 GMT -5
en.wikipedia.org/wiki/Inhalable_insulinThank you for proving my point. They're both classified and categorized as inhalable insulin. For insulin-treated patients with diabetes, the needle required for a subcutaneous (sc) injection of insulin is the symbol for their disease. The pain associated with this route of insulin administration was reduced substantially in the last decades by the development of modern needles with their extremely sharp tips, a polished surface, and a coating that allows easy penetration into the skin. Therefore, once patients experience that a sc injection is more or less free of pain in most cases (when you do not hit a nerve ending directly), this is no longer a hurdle for most patients. I'm sorry Douge but you'll have to do a better job of convincing me. I think we both agreed already on the classification and yes both are inhaled. What about the actual drug and the PK Profile? Would love to paste a slide here but I can't. It's not about how the drug gets into the body it's about how well the drug works. Lets discuss this in more detail. I really want to hear what you have to say about the two drugs. Please continue. |
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Post by Deleted on Aug 21, 2013 14:04:02 GMT -5
If MNKD does not partner before this FDA approval decision they will be dead in the water. They NEED a marketing partner. They are therefore not in an advantaged position as I have kept saying and thus a "fair" deal is less likely to be struck. I therefore see MNKD marketing alone and being bought out in the future as have Al Mann's other companies previously such as MiniMed. Picture this, not even a multimillion-dollar ad campaign could save Exubera. Pfizer has been pitching the product (BusinessWeek.com, 7/24/07) on TV and the Web since July. The company reported that Exubera only brought in sales of $12 million in the first nine months of this year.
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Post by Deleted on Aug 21, 2013 14:04:48 GMT -5
en.wikipedia.org/wiki/Inhalable_insulinThank you for proving my point. They're both classified and categorized as inhalable insulin. For insulin-treated patients with diabetes, the needle required for a subcutaneous (sc) injection of insulin is the symbol for their disease. The pain associated with this route of insulin administration was reduced substantially in the last decades by the development of modern needles with their extremely sharp tips, a polished surface, and a coating that allows easy penetration into the skin. Therefore, once patients experience that a sc injection is more or less free of pain in most cases (when you do not hit a nerve ending directly), this is no longer a hurdle for most patients. I'm sorry Douge but you'll have to do a better job of convincing me. I think we both agreed already on the classification and yes both are inhaled. What about the actual drug and the PK Profile? Would love to paste a slide here but I can't. It's not about how the drug gets into the body it's about how well the drug works. Lets discuss this in more detail. I really want to hear what you have to say about the two drugs. Please continue. The PK profile is different but both are inhaled into the lungs. Both need a device to use. Both are more expensive in price. Afrezza's insulin is broken into its monomeric components, resulting in significantly shorter time to peak insulin levels (14 minutes for Afrezza and 49 minutes for Exubera). This monomeric formulation is reputed to more closely mimic the natural insulin response of healthy individuals as well as decrease the risk of hypoglycemia and is weight neutral. Stevie, please also respond to my comment about Afrezza's pricing and how that will be a barrier to inhalable insulin becoming adapted (as I believe MNKD approval is likely). Also, although Pfizer stopped producing/manufacturing Exubera, they still have the rights to make it. If inhalable market catches on Exubera can theoretically once again be produced and compete with Afrezza for market share. |
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Post by brentie on Aug 21, 2013 14:16:25 GMT -5
Here's what Al said... The bottom line is always costs. Will patients get insurance coverage for Afresa? We’re working with the reimbursement advisory panels to make sure we’re within 5% of the current costs of Humalog and Novolog — so people will get essentially the same reimbursement they get now. We believe that we’ll be covered by most mainstream health plans within six months of launch. Don’t forget this also saves a lot of money because you don’t need nearly as many expensive test strips for fingersticks, by an order of magnitude. For Type 2s, maybe they’ll just need a fasting test once a week. If you’re Type 1, you will want to do a few more. www.diabetesmine.com/2009/11/the-truth-about-afresa-inhalable-insulin-a-chat-with-al-mann.html |
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Post by StevieRay on Aug 21, 2013 14:17:00 GMT -5
I'm sorry Douge but you'll have to do a better job of convincing me. I think we both agreed already on the classification and yes both are inhaled. What about the actual drug and the PK Profile? Would love to paste a slide here but I can't. It's not about how the drug gets into the body it's about how well the drug works. Lets discuss this in more detail. I really want to hear what you have to say about the two drugs. Please continue. The PK profile is different but both are inhaled into the lungs. Both need a device to use. Both are more expensive in price. Afrezza's insulin is broken into its monomeric components, resulting in significantly shorter time to peak insulin levels (14 minutes for Afrezza and 49 minutes for Exubera). This monomeric formulation is reputed to more closely mimic the natural insulin response of healthy individuals as well as decrease the risk of hypoglycemia and is weight neutral. Stevie, please also respond to my comment about Afrezza's pricing and how that will be a barrier to inhalable insulin becoming adapted (as I believe MNKD approval is likely). Also, although Pfizer stopped producing/manufacturing Exubera, they still have the rights to make it. If inhalable market catches on Exubera can theoretically once again be produced and compete with Afrezza for market share. The pricing of Afrezza as I understand is about $2000 per year and I believe Matt has been in contact with health care providers to discuss benefits & coverage. But you appear to be changing the subject. Lets compare the two drugs. |
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Post by Deleted on Aug 21, 2013 14:20:56 GMT -5
Here's what Al said... The bottom line is always costs. Will patients get insurance coverage for Afresa? We’re working with the reimbursement advisory panels to make sure we’re within 5% of the current costs of Humalog and Novolog — so people will get essentially the same reimbursement they get now. We believe that we’ll be covered by most mainstream health plans within six months of launch. Don’t forget this also saves a lot of money because you don’t need nearly as many expensive test strips for fingersticks, by an order of magnitude. For Type 2s, maybe they’ll just need a fasting test once a week. If you’re Type 1, you will want to do a few more. www.diabetesmine.com/2009/11/the-truth-about-afresa-inhalable-insulin-a-chat-with-al-mann.htmlThanks Brent, www.youtube.com/watch?v=Vlg7J0Y1RfU2:45 6 months for coverage. Fda approval is expected to take place this April so we wont be covered till October. As I've stated and I was correct, we'll be in tier 2. yikes. We'll be competitive but we'll be priced higher. |
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Post by Deleted on Aug 21, 2013 14:23:25 GMT -5
The PK profile is different but both are inhaled into the lungs. Both need a device to use. Both are more expensive in price. Afrezza's insulin is broken into its monomeric components, resulting in significantly shorter time to peak insulin levels (14 minutes for Afrezza and 49 minutes for Exubera). This monomeric formulation is reputed to more closely mimic the natural insulin response of healthy individuals as well as decrease the risk of hypoglycemia and is weight neutral. Stevie, please also respond to my comment about Afrezza's pricing and how that will be a barrier to inhalable insulin becoming adapted (as I believe MNKD approval is likely). Also, although Pfizer stopped producing/manufacturing Exubera, they still have the rights to make it. If inhalable market catches on Exubera can theoretically once again be produced and compete with Afrezza for market share. The pricing of Afrezza as I understand is about $2000 per year and I believe Matt has been in contact with health care providers to discuss benefits & coverage. But you appear to be changing the subject. Lets compare the two drugs. I've already compared them and made the point we both agreed on. I said they were similar in that they are both inhaled. Afrezza works in 14 mins. Exubera in 49. Both work under an hour. Both need devices to be used. Both cost more than existing insulin. Once again, If MNKD does not partner before this FDA approval decision they will be dead in the water. They NEED a marketing partner. They are therefore not in an advantaged position as I have kept saying and thus a "fair" deal is less likely to be struck. I therefore see MNKD marketing alone and being bought out in the future as have Al Mann's other companies previously such as MiniMed. Picture this, not even a multimillion-dollar ad campaign could save Exubera. Pfizer has been pitching the product (BusinessWeek.com, 7/24/07) on TV and the Web since July. The company reported that Exubera only brought in sales of $12 million in the first nine months of this year. |
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Post by StevieRay on Aug 21, 2013 14:24:05 GMT -5
Here's what Al said... The bottom line is always costs. Will patients get insurance coverage for Afresa? We’re working with the reimbursement advisory panels to make sure we’re within 5% of the current costs of Humalog and Novolog — so people will get essentially the same reimbursement they get now. We believe that we’ll be covered by most mainstream health plans within six months of launch. Don’t forget this also saves a lot of money because you don’t need nearly as many expensive test strips for fingersticks, by an order of magnitude. For Type 2s, maybe they’ll just need a fasting test once a week. If you’re Type 1, you will want to do a few more. www.diabetesmine.com/2009/11/the-truth-about-afresa-inhalable-insulin-a-chat-with-al-mann.htmlWhen patients are in compliance and are actually controlling their blood sugar levels their organs last a lot longer than those folks who are out of control and live with wild daily swings in their blood sugar. Afrezza provides patience with much more control and are more likely to be in compliance thus reducing the long term cost of side effects like blindness, liver & pancreas failure and loss of limbs just to name a few. |
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Post by Deleted on Aug 21, 2013 14:25:36 GMT -5
Here's what Al said... The bottom line is always costs. Will patients get insurance coverage for Afresa? We’re working with the reimbursement advisory panels to make sure we’re within 5% of the current costs of Humalog and Novolog — so people will get essentially the same reimbursement they get now. We believe that we’ll be covered by most mainstream health plans within six months of launch. Don’t forget this also saves a lot of money because you don’t need nearly as many expensive test strips for fingersticks, by an order of magnitude. For Type 2s, maybe they’ll just need a fasting test once a week. If you’re Type 1, you will want to do a few more. www.diabetesmine.com/2009/11/the-truth-about-afresa-inhalable-insulin-a-chat-with-al-mann.htmlWhen patients are in compliance and are actually controlling their blood sugar levels their organs last a lot longer than those folks who are out of control and live with wild daily swings in their blood sugar. Afrezza provides patience with much more control and are more likely to be in compliance thus reducing the long term cost of side effects like blindness, liver & pancreas failure and loss of limbs just to name a few. Yes, that's the purpose of insulin. |
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Post by Deleted on Aug 21, 2013 14:29:17 GMT -5
* Afrezza is expensive – almost 10-15% more expensive than traditional insulin
* insulin needles today are so small, they are pretty much painless
* the diabetic smokers would rather continue smoking than use Afrezza (inhaled through the lungs)
* regular PFTs are a pain.
* PCPs are already inundated enough during their 5-minute patient visits.
* Strange dosing system with 3 and 10 units (which most patients who actually were on clinical trial complained about and wanted additional smaller doses) I believe AU also talked about wanting various dosing system options.
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Post by StevieRay on Aug 21, 2013 14:33:58 GMT -5
* Afrezza is expensive – almost 10-15% more expensive than traditional insulin * insulin needles today are so small, they are pretty much painless * the diabetic smokers would rather continue smoking than use Afrezza (inhaled through the lungs) * regular PFTs are a pain. * PCPs are already inundated enough during their 5-minute patient visits. * Strange dosing system with 3 and 10 units (which most patients who actually were on clinical trial complained about and wanted additional smaller doses) I believe AU also talked about wanting various dosing system options. Maybe you missed this point. "We’re working with the reimbursement advisory panels to make sure we’re within 5% of the current costs of Humalog and Novolog — so people will get essentially the same reimbursement they get now. We believe that we’ll be covered by most mainstream health plans within six months of launch." |
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Post by Deleted on Aug 21, 2013 14:37:31 GMT -5
Also note the withdrawal of Pfizer and Lilly (and of Novo in part) put a high hurdle in front of MannKind. Currently, it is also not clear if Nektar (the inventor of Exubera) can and will continue the story of Exubera. They received certain payments by Pfizer and are actively searching for a partner. Nektar has been actively searching for a partner with a product that has already recieved FDA approval for the past 5 years to no avail!
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Post by Deleted on Aug 21, 2013 14:40:15 GMT -5
* Afrezza is expensive – almost 10-15% more expensive than traditional insulin * insulin needles today are so small, they are pretty much painless * the diabetic smokers would rather continue smoking than use Afrezza (inhaled through the lungs) * regular PFTs are a pain. * PCPs are already inundated enough during their 5-minute patient visits. * Strange dosing system with 3 and 10 units (which most patients who actually were on clinical trial complained about and wanted additional smaller doses) I believe AU also talked about wanting various dosing system options. Maybe you missed this point. "We’re working with the reimbursement advisory panels to make sure we’re within 5% of the current costs of Humalog and Novolog — so people will get essentially the same reimbursement they get now. We believe that we’ll be covered by most mainstream health plans within six months of launch." I didn't miss the point... "" We’re working with the reimbursement advisory panels to make sure we’re within 5% of the current costs of Humalog and Novolog — so people will get essentially the same reimbursement they get now. We believe that we’ll be covered by most mainstream health plans within six months of launch." This does not necessarily equate to Afrezza being within 5%. Much like how management was working with FDA last approval "closely to ensure all bases are covered" only to be rejected and given a CRL. There's a difference between forward looking and optimistic statements versus fact as disclosed in every CC. |
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Post by Deleted on Aug 21, 2013 14:45:04 GMT -5
Dosage: Even if you tell the patients that x milligrams are comparable to the metabolic effect induced by x international units of sc injected regular human insulin, this is a source of confusion and error for the nonexpert (= many general practitioners). If the companies were forced by the regulatory agencies to use such numbers for the insulin dose, the practical usage of inhaled insulin is thereby hampered.
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