|
Post by agedhippie on Mar 6, 2024 7:25:58 GMT -5
Maybe it's time for the PBMs to go the way of the dinosaur? Something I pray for every day.
|
|
|
Post by agedhippie on Mar 6, 2024 6:04:09 GMT -5
always enjoy longliner’s active imagination 🤣 So, you've followed NRXP with their imaginary naked shorts, imaginary spinoff and imaginary dividend? Having taken a quick look at them I can see why they have problems. And yes, while the spin off is real the dividend is imaginary. Basically they are asset stripping the part with the best prospects into a spin off and the dividend is shares in the spin off (something the shareholders already own). I wouldn't want to be holding NRXP at the end of that process. I particularly like the founder and beneficial owner selling 400k shares Christmas 2022 and the company giving him 300k for free a week later. Typical SPAC really. This doesn't belong here. It should be in other biotech stocks.
|
|
|
Post by agedhippie on Mar 6, 2024 4:16:21 GMT -5
For the longest time since Dave Kendall left we had been complaining Mike needed to get some serious "thought leaders" telling the afrezza story. Mike listened and put Irl on the payroll awhile back and he is "study chair" for the Inhale-3 study. The bottom line is afrezza is the real deal and everyone knows it. The only thing stopping afrezza is the PWDs ability to get access to it and as long as the PBMs have the blockade in place, not even Al Mann himself would be able to sell it. Then again Al would figure out a way around or through the blockade. Everyone does not know it or you wouldn't still get endos confusing Exubera and Afrezza, or having forgotten about Afrezza entirely. Last year this same presentation was given by Kevin Kaiserman, an MNKD VP, and consequently sank without trace. This year pretty much the same topic is being given by Irl Hirsch who is a well known endo and as a result will get a lot more attention. Lack of adoption is not a "blockade", it is a consequence of expecting insurers to pick up the tab for a more expensive insulin with no trial data to show a clear outcome improvement.
|
|
|
Post by agedhippie on Mar 5, 2024 18:15:32 GMT -5
... Speaking of Dexcom they had an interesting PR today about ATTD finance.yahoo.com/news/dexcom-showcases-leadership-aid-power-080000213.htmlI seems they are finally starting to look at the T2 market so they did a GLP1 study. Mike needs to pick up the phone and give Kevin a call to do the study Mike mentioned on the last call adding afrezza to GLP1s. DXCM would be able to tell a hell of a lot better story adding afrezza and the value of CGMs with afrezza and GLPs than just the GLPs alone. ... Dexcom are already covered for insulin using T2, they want to get it for non-insulin users as well now. Adding insulin to GLP-1 would defeat that aim.
|
|
|
Post by agedhippie on Mar 5, 2024 15:52:04 GMT -5
Found it! That was hard work and mildly disappointing. This the same as last year, a 10 minute presentation on a standardized meal test covering the two hours post-prandial which Afrezza should hit out of the park. Basically nothing new and just a larger data set. However, since it's Irl Hirsch rather than the Vice President - Medical Affairs and Safety at Mannkind delivering the results I expect more people will pay attention this time (it avoids the appearance of being biased.)
The Results section says just for the first two hours (main outcomes include peak glucose during the first 2 hours), but the Methods section says 2-6 hours following ingestion of the meal, and hopefully the talk will include details on beyond the two hour mark as that is important.
-----
POSTPRANDIAL GLUCOSE FOLLOWING A BOLUS WITH INHALED INSULIN VERSUS USUAL CARE (ID 442) Presenter Irl B. Hirsch (United States of America) Lecture Time 17:15 - 17:25 Abstract Background and Aims Technosphere Insulin is an ultra-rapid-acting inhaled insulin. This study evaluates the efficacy and safety during the postprandial period following a bolus with inhaled insulin compared to usual care. This study builds on the oral presentation delivered at ATTD 2023 in Berlin with a larger sample size and longer analysis window following the meal.
Methods 120-140 adults with type 1 diabetes and using continuous glucose monitoring (CGM) at 19 investigational sites were randomized 1:1 to continue their current insulin therapy (MDI or CSII with or without automation) or to the study group using inhaled insulin. All subjects ingested a standardized meal and glucose was monitored with blinded CGM for 2-6 hours following ingestion of the meal. The inhaled insulin group took their inhaled insulin dose immediately prior the meal while the usual care group took their rapid-acting insulin analogue 10 +/- 5 minutes before the meal.
Results The main outcomes include peak glucose during the first 2 hours, time to peak glucose, AUC 180 mg/dL, and safety events. As of September 12, 2023, 30 participants have completed the standardized meal. The remaining participants will complete the randomized meal challenge by December 2023. Complete results will be presented.
Conclusions Expected conclusion to include summary of results highlighting the efficacy and safety outcomes.
|
|
|
Post by agedhippie on Mar 5, 2024 11:58:26 GMT -5
... Having Hirsch present the data seems a bit of an anomaly in my opinion. I suspect these data that Hirsch is presenting will be ground breaking. You are absolutely right. Having Irl Hirsch presenting this gives it serious credibility.
|
|
|
Post by agedhippie on Mar 5, 2024 8:44:46 GMT -5
The only metric you need is the AGP from the CGM with the food profile/diary.... The GMI is on the AGP report, as are the TIR bands. Nobody I know does a food diary - life is short!
|
|
|
Post by agedhippie on Mar 4, 2024 19:14:30 GMT -5
Favorable overall outcome is … superior a1c? There seems to be affection for superior a1c AND improved Time In Range (TIR). The affection for TIR is being able to better know impact from excursions although I think there ought to be a further qualification, and it may exist and I'm just ignorant, the ratio of excursions high versus low. FWIW, I assume excursions on the high-side (e.g., above 170) are the dominant pattern, but for treating any given person with diabetes, the ratio (and specifics) would be even better. Kind of rambling, but my experience has me obsess about performance metrics. The HbA1c result is still taken as the primary result because there is a few decades of data mapping HbA1c levels to complications. This means you can say with a reasonable degree of certainty what will happen on what timescale for a given HbA1c. The issue with HbA1c results is that there things that can lead to inaccuracy, but for the majority it works. This is why HbA1c is primary. The better approach is HbA1c and GMI. This is where the CGM result is averaged to calculate what the HbA1c result should be the HbA1c is a proxy for the average of the last three months. The benefit is that if eliminates the variables that can cause problems with an HbA1c, plus you only need two weeks of numbers. The problem is that it's not clear how accurately it mirrors your HbA1c (my GMI is a lot lower) and as such it may not map to the outcomes properly. The jury is still out but it's gaining traction. TIR is really just a breakdown of the GMI showing the percentage of time in various bands. And in answer to the earlier question I break high far more often than you break low, but with a low carb diet that may not be true (I do not eat low carb). The catch with all of this, and why outcomes are important, is that you do not need a non-diabetic HbA1c. At around 6.5% the rate of complications more or less goes flat. It means that there is little real value in getting below that (not saying that people shouldn't try if they want to.) The absolute difference in the rate of complications between 6.5 and non-diabetic is negligible. This is why doctors settle for sub 7.0 and don't push non-diabetic numbers- you are well into diminishing returns (personally I think 6.5 is a better target as 7.0 is still has a small but noticeably elevated risk) ... more than you ever wanted to know about metrics and T1 diabetes
|
|
|
Post by agedhippie on Mar 4, 2024 11:45:37 GMT -5
This is a brilliant statement "you cannot compete on price because if the PBM takes your insulin the pharma will jack up the price for all the other drugs the PBM needs to get from them". As far as the trial data we already have it. Afrezza will cause less hypos but thats not going to do anything as long as the PBM is jacking the price of afrezza out of the market and blockading PWDs from getting it. As you said they need to keep doing this no matter what or they screw up their "bundles". Its sounds to me Mike is between a rock and hard place if he wants to keep dealing through the PBMs and afrezza is doomed to the land of misfit niche drugs. The post-hoc analysis of the 171 trial showed that Afrezza produced less hypos, the PK/PD trial for approval showed a fast return response, what more can you ask for? Simple - does the trial data show a demonstrably better outcome. That has been the failure to date and why you need a large scale trial. Without that data nothing will change because that's what the endos care about - they are concerned with the overall outcome and not with single symptoms. Mike has no option but to continue with PBMs because they control the market. Of course he doesn't need to sell through that market, but then he is in the minor leagues with all that implies.
|
|
|
Post by agedhippie on Mar 3, 2024 16:01:30 GMT -5
... Why is afrezza a lot more expensive to insurers than the RAAs? Its what the PBMs are negotiating for the insurers. Are we saying the PBMs can't negotiate a better deal with Mike or are we saying the PBMs don't want to negotiate a better deal with Mike? ... Absolutely don't want to. Why do you think your insurer covers Humalog or Novolog, but not both? It's because the pharmas offer bundles. If you are a single drug company like MNKD then you cannot compete on price because if the PBM takes your insulin the pharma will jack up the price for all the other drugs the PBM needs to get from them. The only way you can beat that is to get trial data showing superior long term outcomes.
|
|
|
Post by agedhippie on Mar 3, 2024 15:54:43 GMT -5
I remember when Mike discussed this during a presentation. Most Hypo events can land a person in the ER for up to 15 hours. You know how they operate and every minute the bill goes up. I can quite imagine that is possible. However, the number of times you end up in ER for a hypo is vanishingly small. Your body is really good at telling you that you are low in time for you to fix it. There is a group where that is not true though. If you are hypo-unaware you don't know you are low until you collapse. That used to be the only way you got a CGM in the old days. The thing with treating a hypo in hospital is that there is no expensive procedures involved, it's really just a glucagon shot and, maybe, an IV. If they keep you in it is for observation. It's why I think $35k is rather high.
|
|
|
Post by agedhippie on Mar 3, 2024 15:01:55 GMT -5
I like the idea of a long-term trial but will argue Afrezza human insulin helps prevent hypos. If I remember correctly, less hypos was one of the most important benefits to Sam Finta. Less hypos is always good. From day one I have said that the best way to sell this though is to talk about predictable absorption. Look at Ginger, she won her appeal for Afrezza on exactly those grounds. That is the fastest path to grow although it is still not mass market.
|
|
|
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.
|
|
|
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)
|
|
|
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.
|
|