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Post by stevil on Mar 17, 2022 13:26:35 GMT -5
I liked the flying hamburgers. Afrezza needs health insurance is all. Even Stevil told us part of his physicians training is don't fight insurance coverage.If he orders something that isn't covered by insurance, the pharmacy calls him to change the order. Cretin you seem to be a troll. Not exactly. I do fill out PAs from time to time if I think the patient really needs the medication and I'm sure I can convince the insurance company that they do. Sometimes insurance companies just put a PA barrier on medications because they know it will be enough to deter us from prescribing. Other times, they make the barrier a mountain and require a ton of extra documentation and sometimes testing to justify our decisions as well as "step-therapy" where you have to try and fail x, y, and z before they'll cover A. It's just a game they play and we're subject to it. It doesn't improve healthcare at all. I'd actually contend the opposite. There are some docs that need leashes because they'll prescribe the latest and greatest to keep the drug reps bringing them great lunches and dinners but most of the time it just increases workload and burden which leads to burnout- all for the sake of saving a few dollars. These PAs can sometimes take 15 min each to complete and we do not get reimbursed for them. This is on top of all of the other work we're already doing. As you can see, the time adds up quickly and it is completely unrealistic to do this for even 2 patients a day as this would cause an extra half hour of unpaid work every day. And that's only for the chance insurance will approve. I believe Mike said only 70% of the PAs get approved, so for every 3 PAs you submit for Afrezza, you're wasting your time on 1 of them. That's going to put you off from trying unless it's really a "must have" situation. Fewer true videos than these. Tragic, really. Hopefully doctors will be the ones making decisions for their patients in the future once this system collapses. One can only hope. www.youtube.com/shorts/ayyafnuQ5m4www.youtube.com/shorts/FVAFfd3oCgA
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Post by stevil on Mar 16, 2022 14:39:26 GMT -5
Why? I would think you would do this in three steps; get the non-asthma kids approved; get the black box removed; do a follow-up small study for kids with asthma - Because it implies the manufacturer is concerned enough about its validity to make it seem as though it is probably a real risk. - Doctors look at this stuff when they look at trials. They're going to assume that the risk is real. - Why do extra work if you don't have to? Time and money are not free. - The more times you force doctors to review data, the less likely you are that they'll get the message. Meaning, if they look at the trial once and see the exclusion criteria, they'd then have to be informed again later on that the risk was proven illegitimate. What usually happens is they review data, make conclusions, and move on. We've seen this issue play out with Exubera already.
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Post by stevil on Mar 16, 2022 11:54:52 GMT -5
If I remember correctly, MNKD isn't doing themselves any favors by having asthma be part of the exclusion criteria for the peds trial.
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Post by stevil on Mar 16, 2022 9:43:53 GMT -5
I'm excited about the prospect of clofazimine. I don't know the prevalence of the disease but I've run into a couple patients already and they're on 3 different antibiotics and have to take them daily for a year. It's a very difficult disease to treat and cure. Hopefully clofazimine is the answer. I don't think the market for it would be all that large, but it could solve a difficult problem. The antibiotic cocktail is all generic and isn't too expensive, so I'm curious to see the business benefits of developing it.
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Post by stevil on Dec 15, 2021 11:14:30 GMT -5
I've tried to give perspective on this in the past but I'll try again. The great majority of doctors are far from lazy, careless, lack compassion, etc. They're human beings with families and other obligations outside of medicine who already work long hours and are taxed with excessive documentation and paperwork.
There are plenty of other factors to derail and distract them from "the practice of medicine". That is not an excuse, it's a fact.
Add to this the ever increasing drug formulations and I would say it is impossible (no hyperbole) to stay on top of all new medications. When drug companies simply change the formulation of a compound from tablet to liquid to inhaled or add a longer-acting molecule to the same basic active ingredient, it's not hard to get a new formulation of an already existing drug.
I'm still in residency and I've already stopped paying attention to "the latest and greatest" simply because the pharmaceutical industry is out of control. They will do whatever they can to make more money. Changing an already existing compound is the cheapest way to do so as the bulk of the research and development has already been done. There is very little innovation these days to justify the cost of new medications.
It is up to the manufacturer to differentiate their product, not the physician's. Without evidence to prove why their product is superior to the existing standard of care, do not expect physicians to do clinical trials of their own unless personally motivated for some other reason. So when a physician sees "human insulin" - which has existed in other formulations since the 70s- do not be surprised if there is slow uptake in the context of poor clinical trials proving superiority. The standard of care is such for a reason. It has been tried and true and has yielded the greatest and most beneficial results over a patient population.
I'll add that it will be even harder for Afrezza to become the sole standard of care for diabetes once SGLT-2s and GLP-1s go off patent as their benefits extend beyond diabetes into the cardiac and renal spaces. The only way I see Afrezza being used exclusively is if the diabetes is caught early and effectively treated to prevent further comorbid conditions. Once those other comorbidities arise, depending on glucose control, Afrezza may be the odd man out if additional glucose control is not needed with other therapies. SGLT-2s are now or soon becoming the standard of care for heart failure and chronic kidney disease patients, regardless of diabetes status as the use has shown great benefit for these other conditions. GLP-1s are soon to follow.
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Post by stevil on Nov 5, 2021 16:17:33 GMT -5
Do you think that a 20-patient study is enough to compel the FDA? If so, that would be sweet. This was a feasibility study. It looks like they'll probably do a larger study later on. I wouldn't expect any changes to be made based off of this info. This small study was done to help determine if and how a larger study should be done to get the desired results. The results of the larger trial will be the ones that should make waves.
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Post by stevil on Sept 7, 2021 12:01:09 GMT -5
The more weeks the patients are on tyvaso DPI the more they improve. To see gradual continuous improvement in the 6 MWD is amazing. Which is the biggest reason this will get FDA approval. It’s an improvement over current therapy.
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Post by stevil on May 12, 2021 19:16:03 GMT -5
I wonder if it has to do with inspiratory pressure. One would think you'd have to inhale pretty deeply/have good air movement to get proper deep lung penetration with DPI. Maybe nebulizing is for those who are unable to breathe forcefully enough for the medication to get where it needs to go with a single breath.
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Post by stevil on May 2, 2021 14:29:27 GMT -5
While not privy to "the process" the FDA employs, I'd imagine the length of time and the ability to cut in line has more to do with a backlog due to limited resources.
There are only so many people at the FDA who can spend X amount of hours in a day reviewing information to approve or deny therapies. The way this process was hastened was by removing certain regulations that were viewed as unnecessary, thus decreasing the number of boxes that needed to be checked in order to get approved. Then, if someone wants to jump the line for priority review, they can pay another company to swap places with them in line. I don't believe the FDA was paid the money for priority review. I believe whichever company traded places with UTHR received the cash.
The MVD analogy was actually quite good if you need to see how this plays out.
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Post by stevil on Jan 12, 2021 8:38:31 GMT -5
I'm curious to see the trial results of the inhaled cannabinoid for panic attacks. There actually would be a huge market for that class. Right now there are only a few decent options- mostly Atarax and Buspar that are not benzodiazepines. Currently, SSRI's and psychotherapy are first line for panic attacks, but SSRIs are medications you need to take for weeks before their effect kicks in and good luck finding people who will do therapy when they can pop a pill instead, never mind the added time and expense that comes with it since insurance doesn't always cover those sessions. So I'm excited to see that one for sure- could be huge potential if it works well without side effects.
As far as migraine goes, I've been on here in the past to share my lack of excitement over an inhaled -triptan. Not that it wouldn't be a great idea to throw our hat in the ring and see what happens. It's just that there are already so many other options- oral, liquid, nasal spray, IM injection- that I really don't see much of a market for it, at least a market that will make MNKD a lot of money. Generics are cheap and it's highly unlikely insurance will pay a premium when there are already so many other options. I can see reimbursement being a huge issue. I've also stated that if they really want to get into the migraine space that they should get into the cGRP meds like Aimovig that are currently IM. I think there's an oral tablet coming in the future that could negate an inhaled option, but at least for now, this seems to be the future of migraine medicine. They're insanely expensive and they have no side effects and patients love them.
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Post by stevil on Mar 22, 2020 12:20:57 GMT -5
It is highly unlikely that Trep-T would do anything of benefit for coronavirus patients. Trep-T is a vasodilator, which means it improves blood flow to the lungs. The issue with coronavirus is not that the lungs are starved for blood. It's a pneumonia which causes consolidation of fluid in the parenchyma of the lung. Essentially, this causes dead space in the lung that blocks air from participating in blood/gas exchange. Hopefully more simply stated, if the lung is like a balloon, if you fill part of the balloon with water, that part of the balloon will no longer be able to be filled with air as there is already something taking its place. The lung is already being properly supplied with blood- that's not the issue. The issue is that the blood that is reaching the lungs cannot participate in blood/gas exchange because the surface area of the lungs is reduced. stevil , where are you? Have you walked into a room yet where the patient is wet and short of breath, labored? What are you doing for personal protection? Fortunately for me, I don't have to see these patients since PPE is so limited. It would be a waste for me to gown, glove, and mask up just to have my attending come in behind me and have to do the same, regardless.
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Post by stevil on Mar 22, 2020 9:06:27 GMT -5
It is highly unlikely that Trep-T would do anything of benefit for coronavirus patients.
Trep-T is a vasodilator, which means it improves blood flow to the lungs. The issue with coronavirus is not that the lungs are starved for blood. It's a pneumonia which causes consolidation of fluid in the parenchyma of the lung. Essentially, this causes dead space in the lung that blocks air from participating in blood/gas exchange.
Hopefully more simply stated, if the lung is like a balloon, if you fill part of the balloon with water, that part of the balloon will no longer be able to be filled with air as there is already something taking its place. The lung is already being properly supplied with blood- that's not the issue. The issue is that the blood that is reaching the lungs cannot participate in blood/gas exchange because the surface area of the lungs is reduced.
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Post by stevil on Nov 2, 2019 5:30:54 GMT -5
IDK if you can call that an angle at all. Do people really worry about this? Do ppl inhaling their asthma inhalers really give other people anxiety about the planet? fake news A long time ago generic Albuterol inhalers were taken off the market because their excipients contained CFCs. This was a common problem amongst all sorts of pressurized containers. The idea was that they caused harmful radicals in the ozone layer and were hastening its depletion. So stuff like this actually does happen. Cost went from about $6 per inhaler up to $45+. As you can imagine, people were upset when it happened
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Post by stevil on Aug 31, 2019 18:16:27 GMT -5
Aimovig's insert says it is administered subcutaneously once a month. I don't see that inhalation would offer much advantage. Also, it's a monoclonal antibody and best I can tell from google those are not well absorbed via lung inhalation. As far as insurance coverage, it would run into the same problem as afrezza in that the trials would need to show superiority, otherwise Amgen's financial muscle would keep it on the lower tiers. You are correct about sub-q, I was mistaken about IM... the mental picture of the auto-injector had a much longer needle than reality. I was unaware that mab's could not be loaded onto TS. That kind of sucks for future potential. Are you sure that it wasn't aerosol, because I know that is true. Aimovig isn't even well covered right now because it is so expensive. But the manufacturer doesn't care- they give prescription cards out for an entire year's worth of free medication knowing that insurance will eventually catch up once they see how much money it saves them in yearly ED visits. So they're giving people the free nose candy to get them addicted so that if their insurance decides to deny coverage, they'll hear hell from potentially millions of customers. It will not take much convincing once the data proves how valuable these preventative medications are. Unlike with Afrezza, the cost savings is immediately realized by insurance companies as migraines happen monthly vs ailments caused by decades of poor glucose control. I would contend superiority isn't even necessary right now as there is no true dominant player. This is an emerging and evolving field currently and all it would take is something to set one apart from the other. This is assuming of course that one does not prove to be vastly superior eventually. If given the option of injecting vs inhaling, there is a psychological barrier that many have to injecting. Once they get over it, it's not a big deal, but if a doctor gives them the option of inhaling or injecting and the results are even similar or mildly inferior, I'd be surprised if the inhaled version doesn't win out. This is all a moot point, of course, if MNKD can't figure out a way to load CGRPs onto TS. It would be the responsibility of the partner to do the marketing, coverage, and trials, too. This class is on its way and is going to be huge in the not too distant future. Hopefully MNKD can secure their slice of the pie. edit: Sorry for the detour from the OP. Didn't mean to steer this so far off topic.
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Post by stevil on Aug 31, 2019 18:08:10 GMT -5
I totally disagree. The CGRP antagonists are very new and lack robust safety data, especially long-term safety data. There also has not been any carcinogenesis and mutagenesis studies conducted with Aimovig. I'll assume the same is true for the others like it. It would be extremely high risk for MannKind to go this route. There simply has not been enough research and studies done with these etc... I don't see them taking this route this early on, and while there is more questions and unknowns that still remains with this new class. By the way, constipation is a common side effect, as well as pain from the injection. Cramps and muscle spasms was also experienced in participants during trials. Every novel drug that comes to market runs the risk of serious adverse effects. That's a given. However, doctors look at the whole picture when deciding whether to prescribe or not. How serious are the adverse reactions vs the benefits of therapy. You are correct about constipation. I forgot about that because, if memory serves, it was very insignificant- something like low single digits vs placebo. Doctors will consider it for people with GI illnesses like gastroparesis or other diseases and opioid dependence, but for the other millions of people, they won't bat an eyelash at constipation (or cramps and muscle spasms- btw, these will disappear if it is inhaled). There are calcitonin receptors in the GI system that cause the constipation, so this would likely remain even if inhaled. I'm not sure I'd take my patient seriously about their migraines if they told me they didn't want to prevent a migraine due to constipation. You're comparing what you know about Afrezza with other drugs. That is not how perception of other drugs work. Sure, there will be slow adopters with all things new, but this is different than Afrezza because there have already been multiple thousands of people on CGRPs without any serious events, and there hasn't been another drug in its class that already has red flags. You might see slow adoption with GP's, but if you're a neurologist, there is added pressure to make your patient's better. It is not unethical to reach for the biggest gun in your arsenal if it has proven to be safe over many patient years. There is a very large therapeutic index and it does not interact with other drugs. There are many other prophylactic regimens, but outside of botox, GPs generally know how to prescribe them. By the time referrals go to a neurologist, they have tried and failed all of those other medications and are seeking relief from their conditions. For many migraine sufferers, the risk is well worth it. Their quality of life is greatly diminished because their headaches are completely debilitating.
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