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Post by Thundersnow on Mar 2, 2024 14:11:22 GMT -5
I like that Mike actually mentioned possibly doubling the salespeople. That’ll cause an inflection in scripts. Mike is anticipating the approval for PEDS which means they will need to increase the salesforce and get them trained before the ROLL OUT. The only question is will MNKD sign a PARTNER for Afrezza??? Can MNKD handle this rollout??? They will only get ONE SHOT......This time around their guns will be loaded with SUPERIOR DATA so they will have to hit the ground the RIGHT WAY. I don't think they will get a 3rd chance. Should MNKD Partner with a larger Pharma with GLOBAL Muscle and CLOUT? |
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Post by Thundersnow on Mar 2, 2024 14:14:23 GMT -5
I like that Mike actually mentioned possibly doubling the salespeople. That’ll cause an inflection in scripts. Hate to inject a dose of reality into our new found optimizm, but here goes. If we don't solve the insurance and cost issues, a doubling of the salesforce will do nothing but increase our burn rate. IMO......if you BUILD IT....They WILL COME. Once insurance cos. see the Superior Data and realize this will LOWER THEIR COSTS...they will come ONBOARD. Then it will snowball down to the doctors and make their lives easier. IT'S ALL ABOUT THE DATA. |
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Post by Thundersnow on Mar 2, 2024 14:18:39 GMT -5
Agree with mango. Also, both Mike and Steve described that the results from the INHALE-1 (pump/switch) and INHALE-3 (Pediatrics) trials are what they're counting on to inform their marketing decision making. Mike specifically said, "we could double the quantity of salespeople..." and went on to say they needed to have data to help them to know what the next steps should be in terms of additional trials, etc. I really liked hearing that because, well, I like informed decision making, but also because it showed a willingness to continue to buttress current information available with additional information to continue to develop a current portfolio influential to prescription writers at least, if not also ADA SoC and insurance providers.
The bottom-line is they're not shooting in the dark, and they're not afraid of increasing the sales force when they can be confident the time is right for that move.
I sure hope Mike does not double the sales force again until we know what we are doing. We have been through this 4X now. We can't keep doing the same thing over and over. Nothing is going to change as long as the PBMs are in control. For the kids there are set number of pediatric centers that they need to target - I think the number is 40. At most we need 4 sales reps for those forty sites. Mike has to be laser focused right now and figure out the cost/insurance issue. Its time to put the big boy pants on. Few T2s will get insurance. Some T1s will but as Ginger V. found out it won't be easy. Lets assume Mike figures out the cost issue and now anyone can buy for $35 with no pre auths. Then the answer is really easy. Its the afrezza GLP study Mike mentioned with an arm of afrezza head to head against the GLPs. If he does not figure out the cost issue then the best he has is a portion of the T1 market who get through the insurance denial process. Afrezza remains a niche drug. Doing a T2 study would make ZERO sense. At that point the money is better spent on lobbying the ADA for SoC T1 changes and then hope for better T1 insurance coverage. I believe the CIPLA Trial targets the T2 market. I'm not saying the FDA will consider their trial data but I seem to remember CIPLA's trial is focused on T2. |
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Post by agedhippie on Mar 2, 2024 16:09:00 GMT -5
IMO......if you BUILD IT....They WILL COME. Once insurance cos. see the Superior Data and realize this will LOWER THEIR COSTS...they will come ONBOARD. Then it will snowball down to the doctors and make their lives easier. IT'S ALL ABOUT THE DATA. How will it lower their costs? There is no data to quantify that and that is the problem - outcomes are what matter. Right now Afrezza is a lot more expensive to insurers than RAA, and there is nothing to say that over the long term there will be less complications. Doctors may well like it, but if the insurers are not covering it the doctors will not be writing prescriptions. |
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Post by prcgorman2 on Mar 2, 2024 16:31:16 GMT -5
I think its fair to say Afrezza has been here for “the long term” based on years of pre-approval clinical trials and 10 years post approval. FDKP (hope I got the acronym right) that is the carrier for Afrezza and Tyvaso DPI was proved to the satisfaction of the FDA twice: once for Afrezza and again for Tyvaso DPI in the face of a direct attack from a “concerned citizen” (what complete BS). Beyond that, Afrezza is human insulin. That has a pretty good track record too. You ( agedhippie) convinced me before that full-scale multi-arm studies are the path for convincing prescribers and ADA board members, and you convinced me that insurers don’t care about long-term compliance near as much as you might hope from data, but there I always remained a bit skeptical. Insured might change insurers a few times in their life, but at this point I’ve had the same insurance provider for most of two decades even though it wasn’t continuous. There’s an opportunity to explore the discussion for underwriting is my unprofessional opinion. |
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Post by Thundersnow on Mar 2, 2024 23:19:44 GMT -5
IMO......if you BUILD IT....They WILL COME. Once insurance cos. see the Superior Data and realize this will LOWER THEIR COSTS...they will come ONBOARD. Then it will snowball down to the doctors and make their lives easier. IT'S ALL ABOUT THE DATA. How will it lower their costs? There is no data to quantify that and that is the problem - outcomes are what matter. Right now Afrezza is a lot more expensive to insurers than RAA, and there is nothing to say that over the long term there will be less complications. Doctors may well like it, but if the insurers are not covering it the doctors will not be writing prescriptions. How does it lower their costs??? A diabetic can spend upwards of $35,000 in costs every time they go to the Emergency Room for a Hypoglycemic Event. As you know Afrezza has a very LOW HYPO history and insurance companies will notice. I have an ER doctor friend and he says he sees about 2 patients a week with Hypoglycemic problems. Add in LESS EFFECTS of High BG....they will save money on comorbidity problems. |
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Post by longliner on Mar 2, 2024 23:41:04 GMT -5
How will it lower their costs? There is no data to quantify that and that is the problem - outcomes are what matter. Right now Afrezza is a lot more expensive to insurers than RAA, and there is nothing to say that over the long term there will be less complications. Doctors may well like it, but if the insurers are not covering it the doctors will not be writing prescriptions. How does it lower their costs??? A diabetic can spend upwards of $35,000 in costs every time they go to the Emergency Room for a Hypoglycemic Event. As you know Afrezza has a very LOW HYPO history and insurance companies will notice. I have an ER doctor friend and he says he sees about 2 patients a week with Hypoglycemic problems. Add in LESS EFFECTS of High BG....they will save money on comorbidity problems. Not to mention they may die from it.................................. |
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Post by agedhippie on Mar 3, 2024 4:30:35 GMT -5
How will it lower their costs? There is no data to quantify that and that is the problem - outcomes are what matter. Right now Afrezza is a lot more expensive to insurers than RAA, and there is nothing to say that over the long term there will be less complications. Doctors may well like it, but if the insurers are not covering it the doctors will not be writing prescriptions. How does it lower their costs??? A diabetic can spend upwards of $35,000 in costs every time they go to the Emergency Room for a Hypoglycemic Event. As you know Afrezza has a very LOW HYPO history and insurance companies will notice. I have an ER doctor friend and he says he sees about 2 patients a week with Hypoglycemic problems. Add in LESS EFFECTS of High BG....they will save money on comorbidity problems. I honestly don't know how you can spend upwards of $35,000 on ER costs for treating hypoglycemia. Hypoglycemia in the ER is treated by a glucagon shot which provokes a liver glucose dump and fixes the problem. Worst case it is an IV drip with glucose and possibly potassium. Maybe there are other treatments but nobody I know has ever had anything else - maybe they were just lucky. My suspicion is that to run up a large bill the primary issue is going to be something other than hypoglycemia although hypoglycemia could be in the mix.
Looking at the numbers though, 2 people per shift per week is a tiny number given the size of the insulin using population. It would be very easy to comfortably exceed any saving by the higher insulin cost of using Afrezza. It would probably be more cost effective to look at what caused that hypo and how to manage it next time (misjudging a dose size is the most common one I have heard of and Afrezza will not help there.)
Right now the only outcomes data is from the phase 3 trial and Afrezza has the same results as RAA so the comorbidity benefit is not something insurers are going to accept. Long term trial data would fix that.
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Post by agedhippie on Mar 3, 2024 4:32:45 GMT -5
How does it lower their costs??? A diabetic can spend upwards of $35,000 in costs every time they go to the Emergency Room for a Hypoglycemic Event. As you know Afrezza has a very LOW HYPO history and insurance companies will notice. I have an ER doctor friend and he says he sees about 2 patients a week with Hypoglycemic problems. Add in LESS EFFECTS of High BG....they will save money on comorbidity problems. Not to mention they may die from it.................................. They are unlikely to die from it, they are far more likely to die from DKA which is high (and no insulin) |
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Post by peppy on Mar 3, 2024 4:47:21 GMT -5
Not to mention they may die from it.................................. They are unlikely to die from it, they are far more likely to die from DKA which is high (and no insulin)anaerobic metabolism. 1 glucose molecule in the presence of oxygen is 33 ATP and the electron transport. Lub Dub. 0 glucose molecules in the presence of oxygen = 0 ATP 1 glucose molecule in absence of oxygen = 2 ADP molecule. It is difficult to transport any electrons and the electron chain..... Lub....da. Anaerobic metabolism is considerably less efficient than oxidative metabolism. A single glucose molecule generates only 2 ATP molecules while being metabolized to 2 pyruvate molecules via anaerobic glycolysis, whereas subsequent oxidative metabolism of the pyruvates via the tricarboxylic acid cycle yields 34 ATP. |
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Post by peppy on Mar 3, 2024 4:53:55 GMT -5
How does it lower their costs??? A diabetic can spend upwards of $35,000 in costs every time they go to the Emergency Room for a Hypoglycemic Event. As you know Afrezza has a very LOW HYPO history and insurance companies will notice. I have an ER doctor friend and he says he sees about 2 patients a week with Hypoglycemic problems. Add in LESS EFFECTS of High BG....they will save money on comorbidity problems. I honestly don't know how you can spend upwards of $35,000 on ER costs for treating hypoglycemia. Hypoglycemia in the ER is treated by a glucagon shot which provokes a liver glucose dump and fixes the problem. Worst case it is an IV drip with glucose and possibly potassium. Maybe there are other treatments but nobody I know has ever had anything else - maybe they were just lucky. My suspicion is that to run up a large bill the primary issue is going to be something other than hypoglycemia although hypoglycemia could be in the mix. Looking at the numbers though, 2 people per shift per week is a tiny number given the size of the insulin using population. It would be very easy to comfortably exceed any saving by the higher insulin cost of using Afrezza. It would probably be more cost effective to look at what caused that hypo and how to manage it next time (misjudging a dose size is the most common one I have heard of and Afrezza will not help there.) Right now the only outcomes data is from the phase 3 trial and Afrezza has the same results as RAA so the comorbidity benefit is not something insurers are going to accept. Long term trial data would fix that.
" I honestly don't know how you can spend upwards of $35,000 on ER costs for treating hypoglycemia." First time visiting this country? hahahaha. Thank you for the coarse. Have you ever given yourself glucagon at home? It is IM correct..... How does that go Aged? DKA ...And really, why not start an IV drip at home, D 5, or 2.5%? stick a butter fly in a foot vein, two hands, and some tape, get the insulin taper correct. |
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Post by longliner on Mar 3, 2024 5:32:42 GMT -5
I honestly don't know how you can spend upwards of $35,000 on ER costs for treating hypoglycemia. Hypoglycemia in the ER is treated by a glucagon shot which provokes a liver glucose dump and fixes the problem. Worst case it is an IV drip with glucose and possibly potassium. Maybe there are other treatments but nobody I know has ever had anything else - maybe they were just lucky. My suspicion is that to run up a large bill the primary issue is going to be something other than hypoglycemia although hypoglycemia could be in the mix. Looking at the numbers though, 2 people per shift per week is a tiny number given the size of the insulin using population. It would be very easy to comfortably exceed any saving by the higher insulin cost of using Afrezza. It would probably be more cost effective to look at what caused that hypo and how to manage it next time (misjudging a dose size is the most common one I have heard of and Afrezza will not help there.) Right now the only outcomes data is from the phase 3 trial and Afrezza has the same results as RAA so the comorbidity benefit is not something insurers are going to accept. Long term trial data would fix that.
" I honestly don't know how you can spend upwards of $35,000 on ER costs for treating hypoglycemia." First time visiting this country? hahahaha. Thank you for the coarse. Have you ever given yourself glucagon at home? It is IM correct..... How does that go Aged? ...And really, why not start an IV drip at home, D 5, or 2.5%? stick a butter fly in a foot vein, two hands, and some tape, get the insulin taper correct. I'm sorry, but did you just tell Aged to GFH peppy? If so, timely. |
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Post by peppy on Mar 3, 2024 5:45:07 GMT -5
" I honestly don't know how you can spend upwards of $35,000 on ER costs for treating hypoglycemia." First time visiting this country? hahahaha. Thank you for the coarse. Have you ever given yourself glucagon at home? It is IM correct..... How does that go Aged? ...And really, why not start an IV drip at home, D 5, or 2.5%? stick a butter fly in a foot vein, two hands, and some tape, get the insulin taper correct. I'm sorry, but did you just tell Aged to GFH peppy? If so, timely. No. I need agedhippie . A veritable fountain of knowledge. BTW have you ALL been to the MNKD trading and technical analysis thread? Let's see 108 members yesterday....were able to read that thread. |
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Post by agedhippie on Mar 3, 2024 8:08:38 GMT -5
" I honestly don't know how you can spend upwards of $35,000 on ER costs for treating hypoglycemia." First time visiting this country? hahahaha. Thank you for the coarse. Have you ever given yourself glucagon at home? It is IM correct..... How does that go Aged? DKA ...And really, why not start an IV drip at home, D 5, or 2.5%? stick a butter fly in a foot vein, two hands, and some tape, get the insulin taper correct. I have been here a while now, but the biggest shock was finding that you had to pay for an ambulance! I have never given myself glucagon. It's awkward to do because the most common version (and the only one I have seen) as a powder that has to be mixed with saline and then it's an IM shot. The success rate by people other than EMS crews is pretty awful because of the steps involved. There are newer versions now, including from Zealand, that don't require all that are premixed as well as a nasal version. I have never seen them myself. The bi-hormone pumps like iLet are designed to use these alongside insulin to maintain levels. Glucagon shots are unpleasant (look at the side effects!) but in small doses it's fine. Off-label you can split the shot to give a small boost. If you are in DKA you go to hospital immediately. DKA can kill you in hours, and when you hear a diabetic has died it is usually DKA (in burnout when they are not taking insulin properly this kills overnight.) I am trying to think of cases that have ended up in hospital. Usually it's a drip and then they will keep you in until you are holding at around 120. Typically that is quite quick, but sometimes they will hold you for a day. I don't know how that costs out but surely it is less that $35,000. |
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Post by liane on Mar 3, 2024 8:33:56 GMT -5
agedhippie - You'd be appalled if you knew all the ins and outs of our healthcare system. I will share one tidbit. In the 90's, I worked for a volunteer ambulance. We were funded by allocations from the towns we served (taxpayer money) and donations. We never charged a bill for transporting residents of our towns - only for non-residents and transients. That almost got us in major hot water with the federal government and Medicare - it could involve fines and jail time as it was discriminatory. We had to start billing everyone the same, though we didn't aggressively try to collect from our residents.
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