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Post by agedhippie on Jan 29, 2023 0:41:05 GMT -5
I take it the A1c was influenced by the nighttime hypos and so it could be argued that, in addition to QoL, the A1c was higher in reality? Did Humana cover Afrezza in the formulary with PA, or not cover it at all? stevil Perhaps the A1c does reflect " the probability of complications." What is the probability of complication from frequent nighttime hypos that you only know about with a continuous glucose monitor? If you have frequent nightime hypos you will not need a CGM to know about them! (Unless you are hypo unaware which is relatively rare and a whole order of magnitude more difficult)
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Post by agedhippie on Jan 29, 2023 0:37:26 GMT -5
If Aged were to divulge his employer, I might join your sentiments PRC. As Aged is aware I assume he works for a competing Pharma Company or a Financial firm that has ill intentions regarding Afrezza in particular and Mannkind in general. He is also one of my favorite posters.... Lol. I have no intention of disclosing my employer; they don't deserve that, and I don't have a burning desire to be fired. More practically it's a pointless since people who think I am a fifth columnist will just say I lied. Are we going to ask everyone who posts on this board about their employers?
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Post by agedhippie on Jan 28, 2023 9:58:19 GMT -5
Already have 1 denial from one Humana MAP, nonformulary. This new Afrezza Assist group is way better than the previous. I’ve learned how to document better to get Afrezza approved but they must be doing something different because this one got approved. I was expecting it to because the guy is struggling to get control with novolog and is hypoglycemic often overnight but his A1c was 6.7 so I thought might deny it simply because his diabetes is technically “well controlled”. Maybe there is hope for humanity after all. I take it the A1c was influenced by the nighttime hypos and so it could be argued that, in addition to QoL, the A1c was higher in reality? Did Humana cover Afrezza in the formulary with PA, or not cover it at all? stevil
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Post by agedhippie on Jan 28, 2023 9:51:58 GMT -5
The real answer is ASAP but the magic number is 2hrs. to start to incur measurable damage but as you say they all say the same thing. What they all say is over 140 is bad and they can see the damage. You want to get the BG under 140 asap is what the research says but 2hours or more is really bad. The TV commercials for the SGLT2s so excited about reaching an A1c of 7 are nothing to get excited about in fact in doing so I could argue as dangerous. The two hours number comes from the time it takes a non-diabetic to return to baseline after a typical meal so it's assumed that longer is bad. I am not sure that there is research showing that outside that association it's actually dangerous - but I really don't know.
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Post by agedhippie on Jan 28, 2023 9:47:58 GMT -5
There is nothing relevant there. They all say the same thing, high levels cause nerve damage. What they don't say is over how long, how regularly, and how high. You need to quantify the impact and that means answering those questions. Wow... tobacco much? Nothing to see here.. high levels cause lung damage, but, but , but, how long, how regularly, and how high. Please Marlboro quantify the impact.... Here ace, let me help, it's f-----n bad! In case you haven't been paying attention (which I know you have) the diabetes rates are skyrocketing! Actually the damage is well quantified for tobacco and there is a ton of research on it. You can even get the damage from smoking a single cigarettes a day, and the probability of a one a day pattern leading to 20 a day. That's nit picking on my part though. The issue here is that in order for Afrezza to be seen as superior it must have data showing the benefit accrued. Fast return to baseline is a feature, the question is does it matter. Diabetes is like lead in the water, one glass isn't going to cause any damage worth bothering about, but high doses over several years... Diabetes is a disease where area under the graph matters, and the easiest way to measure that is an A1c. The medical world has well established and researched charts giving the probability of complications against A1c - it's why they pick 7 as a target for A1c (and why I pick 6.5!) You don't want to wait 20 years to see how a treatment plays out so you look at the A1c that the treatment achieves and say from the data that you expect complications to change by X%.
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Post by agedhippie on Jan 28, 2023 0:55:27 GMT -5
... It is interesting, before the $35 Plan D Medicare coverage for insulin T1s were getting insulin 80% off through Plan B. Now they can get that same insulin which may have been costing them $135 on Plan B for $35 on Plan D and they don't need the pump to get it. I don't know what impact this is going to have but I think I remember about 50% of pump users are on Medicare. I think we will see many dropping the pump as they don't need the pump to get cheap insulin. From July Part B insulin is also capped. Nobody uses a pump to get cheap insulin, that's not serious.
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Post by agedhippie on Jan 28, 2023 0:50:20 GMT -5
I completely agree that you will cannot get a better time to baseline than Afrezza short of IV delivery and that will never catch on! The issue for me, and probably the medical community given Stevil's comments, is how much does the speed of return to baseline matter. That falls back to A1c and maybe TIR as the current proxies for complications. Actual complications data can take literally a decade to acquire because diabetes moves so slowly (thankfully). It's why there is still a focus on A1c in diabetes trials despite it not being a perfect measure - it's well understood and in a large population it predicts those complications. I thought we have been through this many times - here are a few examples per Jenny Ruhl... There is nothing relevant there. They all say the same thing, high levels cause nerve damage. What they don't say is over how long, how regularly, and how high. You need to quantify the impact and that means answering those questions.
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Post by agedhippie on Jan 27, 2023 18:04:17 GMT -5
I have watched how stubborn highs stick, a quick return to safe range will cause less damage. This is the entire race, less damage. That it also comes with less needle sticks is an added bonus (another damage). As the current studies continue forward Afrezza time in range (TIR) & rapid return to safe range (RRTSR) advantages will become clearer. I also believe word is spreading due to the Pediatric trial, parents are starting to push for access. I unfortunately have fought the nicotine battle on both fronts (smoke and chew). A friend who quit tobacco 20 years ago said he misses it every morning with his first cup of coffee. I still after 25 years occasionally dream I'm chewing (more of a nightmare). Not that I'm advocating for it, but, if technosphere could utilize a drug with 1/10th the addictive power of what big tobacco uses, we would never again have a refill problem. I completely agree that you will cannot get a better time to baseline than Afrezza short of IV delivery and that will never catch on! The issue for me, and probably the medical community given Stevil's comments, is how much does the speed of return to baseline matter. That falls back to A1c and maybe TIR as the current proxies for complications. Actual complications data can take literally a decade to acquire because diabetes moves so slowly (thankfully). It's why there is still a focus on A1c in diabetes trials despite it not being a perfect measure - it's well understood and in a large population it predicts those complications.
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Post by agedhippie on Jan 27, 2023 17:30:00 GMT -5
c I would like to add catching your CGM sensor on a door or desk... Not if you have the eversence from senseonics .. implantable under the skin . You know if it wasn't for the insertion/extraction process I would be all over that. It just seems a so much better way.
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Post by agedhippie on Jan 27, 2023 17:28:18 GMT -5
Indeed, but what does that translate to in the real world? With STAT Afrezza returned a 5% improvement over RAA, but still nearly 20% less than a modern pump. Doctors look at the whole picture, not just one feature. (Thanks for the offer but I will decline the Marlboro, the data doesn't look good ) If you look at the time which afrezza was active - basically 8am to 10pm, who won? There has to be a reason Lane Desborough is now working with MNKD. BTW - does anyone really want to wear a pump if they don't have to? I think Mike's experience at the kids camp says it all. If you want to slap one on before bed, maybe thats the way to go. A shot or two during the day and afrezza at meal time seems a lot easier and provides better control. Why does anyone wear a pump rather than take Afrezza? Maybe because they see the trade of 76% TIR with minimal work vs. the 62% TIR the best group in STAT got with Afrezza as worth doing.
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Post by agedhippie on Jan 27, 2023 17:10:29 GMT -5
I have never worn an insulin pump. I try to imagine an active kid wearing a pump and not getting it banged up and ripped off. Would someone who knows pumps and closed-loop systems please tell me how this works with kids' swimming, wrestling, tree climbing, sweaty baseball playing, football ... you know, normal stuff. This is one of those things that used to really suck. Plus those unanswered questions like to I use a long tube and catch it on door handles, or a short tube which is, umm, a little painful if you drop the pump and it rips out the site when the weight of the pump hits the end of the tubing six inches above the floor. While we on this topic I would like to add catching your CGM sensor on a door or desk... Ok - rant over. More seriously activities is why Omnipod is so popular for kids. You can do whatever you want including swimming and its stuck to you so no more drops. I have extravagated the drop problem since it's pretty rare, but it hurts when it happens! The advantage of the new pumps like the Omnipod 5 is that it will look after your child's levels with minimal dependency on the child or parent. This is why pumps are heavily pushed with pediatrics - you want automation.
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Post by agedhippie on Jan 27, 2023 11:22:27 GMT -5
Indeed, but what does that translate to in the real world? With STAT Afrezza returned a 5% improvement over RAA, but still nearly 20% less than a modern pump. Doctors look at the whole picture, not just one feature. (Thanks for the offer but I will decline the Marlboro, the data doesn't look good ) In the real world, the longer time spent out of range the more damage that occurs, nothing works as fast as Afrezza. The Marlboro was tongue in cheek. I would never give you a cancer stick.. I have had many vices over the years, but tobacco has never been one of them The longer time out of range the more damage occurs, but how much more? We are talking about 5% TIR difference in STAT which is interesting, but the real question is how material is that 5%? My suspicion is that if your TIR is in the 50s it's significant, if it's in the 70s it's not.
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Post by agedhippie on Jan 27, 2023 11:07:59 GMT -5
... agedhippie, did you see stevil’s remarks on what he’d like to see in a study? Any comments? sayhey24 and sports, et al, does Mannkind research what doctors want to see for study results? i.e., what should be studied, and what would be persuasive results? I assume the answer is yes and that this and the work Dr. Kendall did informed the pediatric and other trial designs, but kind of curious how study designs are formulated. I think he is spot on, but that's unsurprising since he is exactly the target audience. What would I think the trial should look like? Not unlike the ABC trial, but more controlled (be specifically with the pumps) and far larger. Run it for a year, but have an extension on the end of the trail where you continue to track the participants. This lets you quantify the benefits (is TIR longer, hBA1c lower, weight gain less, etc.) and by how much. That "how much" is the important part.
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Post by agedhippie on Jan 26, 2023 20:11:43 GMT -5
... Aged then started to point out some things which did not add up. I contacted MNKD who then went to work on their side contacting CMS. I did the same with my team. In the end we both ended up with the same answer from CMS. For 2023 a pre auth would be required. Aged was right. It was not in the "covered" formularies. Once it gets approved through the pre auth process the PWD will not pay more than $35.... To be clear though. If the drug isn't in the formulary a pre-auth will not help since there is nothing to pre-authorize - the drug is not covered, period. However, where it is covered but requires a pre-authorization then it will be capped at $35 if authorized.
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Post by agedhippie on Jan 26, 2023 19:59:46 GMT -5
... 3) Yes, Afrezza absolutely will get you back into range faster than any other insulin. That's the feature, but what is the benefit? To quantify the benefit you need data and that means large trials. No trials = no data = no SoC change. Until you have evidence it's just a theory - that's true of all science. We drove by a brick building in NC called "The Tobacco Institute". My daughter asked "what do they study in there?", I said "that's where they study how to prove that tobacco is good for you." The longer out of range the more damage. Have another Marlboro, friend, they're FDA approved. Indeed, but what does that translate to in the real world? With STAT Afrezza returned a 5% improvement over RAA, but still nearly 20% less than a modern pump. Doctors look at the whole picture, not just one feature. (Thanks for the offer but I will decline the Marlboro, the data doesn't look good )
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