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Post by beardawg on Sept 18, 2017 7:16:52 GMT -5
Ultra on label is KEY but Less Hypo opens the door! I think it's the other way around. Ultra is a feature and what will happens is doctors will ask what the impact of that speed is - the trial data says it has no impact. Reduced hypos on the other hand is a benefit, it's obvious why you want that and the data supports it. Doctors want drugs to have benefits, not features. The biggest benefit with ultra label is that formularies can now let it be prescribed since it's in a different category than all other rapid acting insulins. They can bypass the current exclusions in place. |
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Post by akemp3000 on Sept 18, 2017 7:49:39 GMT -5
Medicare requires insurance companies to approve two drugs within each classification. Some classifications only have one drug. If so, that drug is approved for insurance coverage. Mannkind has basically requested three levels of label change for Afrezza the latter of which is its own classification. If Afrezza gets a new classification relating to ultra-fast acting or inhaled insulin, this will be big...no, very big.
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Post by nadathing on Sept 18, 2017 11:25:34 GMT -5
That would be great to get a label designation that no other Insulin has. But you can expect that the Big Pharma boys will lobby the FDA to try and prevent that from happening. This is a war and they are in it to destroy the little company MannKind. All the talk about BP wants to destroy MNKD..... If they really are afraid of our success then why they just don't buy the company and own the product ? They can get it right now at a super discount price. Truth is they don't believe in the product and are not interested at all until our scripts reach levels worth talking about. Spot on. No one is afraid of MNKD impacting their diabetes franchise. There is no significant interest in TS. I truly thought TS would have BP knocking on MNKD's door. Hard to believe how wrong I was. The truth is, most people who have tried Afrezza did not experience good results and did not refill their scripts. Very well could be a titration issue, but it is what it is. I refuse to believe that most don't refill due to insurance issues. I would not fill a script knowing I could not afford to refill it. |
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Post by liane on Sept 18, 2017 11:27:31 GMT -5
The truth is, most people who have tried Afrezza did not experience good results and did not refill their scripts. And your proof is what? |
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Post by dreamboatcruise on Sept 18, 2017 12:00:09 GMT -5
The truth is, most people who have tried Afrezza did not experience good results and did not refill their scripts. And your proof is what? Management has basically admitted that retention was a significant problem... though, true, that doesn't have to mean "most people". I was also rather shocked when I had a discussion with a random doctor I met about 6 months ago that said Afrezza works for "some" but doesn't work for "many". While I didn't ask for clarification of terms and it was off the cuff choice of words, that is an anecdotal example of perception that Afrezza has efficacy problems. Hopefully we've made progress, as management has indicated, and hopefully our label change will further improve odds of good experiences for patients. Undoubtedly, experienced Afrezza prescribing docs know how to educate patients, but we likely still have many doctors that agree to prescribe Afrezza when a patient asks but then lack knowledge to properly educate patients about timing and dose quantity for best results. |
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Post by dreamboatcruise on Sept 18, 2017 12:21:09 GMT -5
Medicare requires insurance companies to approve two drugs within each classification. Some classifications only have one drug. If so, that drug is approved for insurance coverage. Mannkind has basically requested three levels of label change for Afrezza the latter of which is its own classification. If Afrezza gets a new classification relating to ultra-fast acting or inhaled insulin, this will be big...no, very big. There could still be step requirements and prior authorizations, couldn't there? Hopefully that label change would mean the coverage for Afrezza in Medicare would be as good as the best RAA... but I'm waiting to see it in writing before getting too excited. |
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Post by Deleted on Sept 18, 2017 12:28:36 GMT -5
dreamboatcruise "Management has basically admitted that retention was a significant problem" Link please
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Post by dreamboatcruise on Sept 18, 2017 12:40:02 GMT -5
dreamboatcruise "Management has basically admitted that retention was a significant problem" Link please Conference calls. There has been more than one where they've talked about this. Definition I'm using for significant is that they raised the issue and selling the idea that improving on retention is a meaningful accomplishment. Perhaps they were simply searching for positives to talk about and there never was a problem with retention. I tend to give benefit of doubt to management, especially when it would seem logical from other evidence, such as the fact that we know from sources (Edelman and others) that following the prescribing guidelines would probably result in both non-ideal timing of dose but also under dosing (i.e. 1 unit of RAA doesn't really translate to 1 unit of AFrezza). Are you saying you don't believe retention was ever a problem? That would seem strange to me given how long you've followed MNKD and Afrezza, but if it is you're true belief, so be it. To me that would imply bad things for Afrezza. I much prefer the idea that our poor results to date have come from problems that management has identified and has viable plans to solve. |
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Post by Deleted on Sept 18, 2017 12:42:58 GMT -5
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Post by dreamboatcruise on Sept 18, 2017 12:49:35 GMT -5
Well, before I go hunting for it, please answer as to whether you are claiming that management has NOT talked about improving retention by improving education and/or support for new patients with regard to dosing. If you haven't listened to the calls or don't remember them well enough to state an opinion on what management has or hasn't said on this, I think you should be the one to take the time to educate yourself by listening to the past calls. If you're merely wanting to discredit a fact you don't like by disingenuously asking me to go through a lot of effort to find some info for you, I'm not too keen on that. If you're stating you've listened to calls and you think I am wrong about management stating they've made these improvements... I'll hunt it down and expect an apology from you when it is provided. I'd encourage others to chime in if they believe what I'm saying is not true. I'm not infallible in my memory, but pretty darn certain on this point. |
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Post by Deleted on Sept 18, 2017 12:52:17 GMT -5
dreamboatcruise I have listened to numerous calls and cannot recall hearing management saying "retention is a significant problem."
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Post by sportsrancho on Sept 18, 2017 12:57:18 GMT -5
I talked to a ( part time MNKD Rep) Not the ones we have now. This was way over a year ago. The stuff that the area SNY rep told her was pure BS. They had no idea how to help patients dose. ( meaning the SNY reps )
That was then...now talking to people out in the field its insurance. People do get their scripts and THEN find out they have to write a letter:-( And if they don't say what the insurance company wants to hear they get rejected. Just ask Hillard. Or the many people that we all know that have been or are still going through it.
It didn't work for some because a unit is not a unit. And there were no directions! Kids can figure it out, they don't have as much fear, and are used to technology.
We need the dosing to be right on the label. Then we need the different class for better insurance IMO.
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Post by akemp3000 on Sept 18, 2017 13:01:32 GMT -5
Medicare requires insurance companies to approve two drugs within each classification. Some classifications only have one drug. If so, that drug is approved for insurance coverage. Mannkind has basically requested three levels of label change for Afrezza the latter of which is its own classification. If Afrezza gets a new classification relating to ultra-fast acting or inhaled insulin, this will be big...no, very big. There could still be step requirements and prior authorizations, couldn't there? Hopefully that label change would mean the coverage for Afrezza in Medicare would be as good as the best RAA... but I'm waiting to see it in writing before getting too excited. Agreed and those of us who have followed the MNKD/FDA relationship for years know we have to wait until we see it in writing. If we could get coverage as good as the best RAA, that would be a big step forward. |
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Post by saxcmann on Sept 18, 2017 13:02:54 GMT -5
I talked to a ( part time MNKD Rep) Not the ones we have now. This was way over a year ago. The stuff that the area SNY rep told her was pure BS. They had no idea how to help patients dose. ( meaning the SNY reps ) That was then...now talking to people out in the field its insurance. People do get their scripts and THEN find out they have to write a letter:-( And if they don't say what the insurance company wants to hear they get rejected. Just ask Hillard. Or the many people that we all know that have been or are still going through it. It didn't work for some because a unit is not a unit. And there were no directions! Kids can figure it out, they don't have as much fear, and are used to technology. We need the dosing to be right on the label. Then we need the different class for better insurance IMO. Exactly Sports! |
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Post by dreamboatcruise on Sept 18, 2017 13:04:15 GMT -5
dreamboatcruise I have listened to numerous calls and cannot recall hearing management saying "retention is a significant problem." I did not put that in quotes. Have you heard management talking about improving retention? Yes, or no? I clearly stated above that my use of the word significant meant that management chose to highlight retention improvement in a call. If the improvement is deemed significant enough to talk about, I would then categorize the problem being addressed as having been significant. If you want to quibble with words then state you are quibbling with words. I'm guessing by you ignoring my last post and putting things in quotes that were not, that you are playing disingenuous games. So sorry... not interested in that sort of game playing. I stand by what I've said and further explained... management has indicated that retention has been a problem, improvements have been made through doc education and patient support, and they are awaiting label change they view as important in further improving this. [none of this is in quotes... my summary of things I've seen stated by management] |
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