What is the path to improved insurance coverage and tiering?

[goyocafe]

“Dr. Kendall jawboning his friends and medical contacts is not going to get it done. Rehashing the same studies that are already out there is not going to get it done either. Either MNKD steps up and funds a large and extremely compelling study that proves the economic benefits of Afrezza to the healthcare system, or else to quote the great Yogi Bera, it will be deja vu all over again.”

Read more: mnkd.proboards.com/thread/10681/path-improved-insurance-coverage-tiering#ixzz5YQBxI8Re

I have to say Matt, that has to be one of the most negative and depricating statements I've read from you in all the years of you posting on this message board. I have to wonder why someone like yourself, who is clearly very intelligent and knowledgeable in this field, would continue to spend time on this message board, and possibly invested in the company, with such a disposition regarding Afrezza and Mannkind's chances of success. What's your motive? Just curious. I know if I felt the way you've described in the your post, I would have been long gone from this investment and this board years ago. And I seriously doubt I would spend time posting such negative opinions on the subject if I no longer had a vested interest in the company.

I also have to wonder, if what you're saying is true, why Dr. Kendall would abandon a top job at Lilly to take on the task of "jawboning" his way to failure, surely recognizing with all of his experience that his chances of success were virtually zero as you have indicated. When I first read your post, I was actually in disbelief to think he'd be that naive. Is it really possible that even having spent time as the CMO for the ADA that he'd suddenly take on the role of Don Quixote and start chasing windmills? I personally have to believe he is smarter than that. Didn't he indicate when he took the job that there was a myriad of studies that have not been presented to the medical community and that there was sufficient information already to help justify Afrezza becoming a part of the SOC for diabetes? And this was without the need for additional studies. Did that suddenly stop being true? I haven't heard Mannkind state anything differently than what Dr. Kendall has indicated when he first started working for the company. 

I appreciate your posts if for no other reason than they challenge me to continue to find my own veins of gold in the information that Mannkind has shared with us over the years about the future of the company and Afrezza. I continue to believe. Maybe I'll slay a windmill or two of my own before this is all done. 

Time will tell.

 

[pat]

I don't know what Matts motivations are either.

But I must admit it's incredible to watch the conversations between Nate Pile and assorted users on Stocktwits. I don't know if it's the same person or multiple people, but "they" positions themselves as shareholders. Then they relentlessly question everything about the companies efforts. It's obvious to me "they" are short the stock and trying to undermine our (investors) confidence in the company so we'll sell to them (and they can cover their short). My question is whether anyone in our little community of retail stock owners actually buys into the BS?

Nates made it pretty plain that he thinks there are a lot of people who own the stock and aren't going to sell and there are some people who shorted the stock and have made a lot of money on paper. If the company massively dilutes or goes out of business the short sellers realize those gains. However, that's largely off the table. So it's a stale mate. The short sellers are trying to get the investors they sold short shares to to sell them back at a lower price.

I suspect Matt may be part of this effort.

The thing that really blows me away is that the short sellers attacking the company are obviously intelligent and well-educated. The LFD pieces are well written and creative - if you can look past the fact they are complete nonsense. Likewise the attacks on Nate are also well orchestrated and clever. Just think if these people took that training and talent and put it to productive use for society. I wonder how they are able to reconcile what they do for a living internally. I put a lot of stock in the rudyrd Kipling poem the man in the glass. Are thes folks so devoid of any character or internal moral compass that they just don't care?

[mnholdem]

There is a difference between becoming THE Standard of Care and being equally represented in the current edition that doctors refer to.

Inhaled insulin is not equally represented in the current ADA publication, especially the selection charts which still list only subcutaneous injection for mealtime insulin, even though Afrezza has been an FDA-approved non-inferior alternative since 2014. 

Dr. Kendall's efforts today can be directed at the lethargic ADA board to get the SoC updated.

Superiority studies are a different matter and an important step in becoming the "Gold" standard and a worthwhile future endeavor but, in my opinion, simply getting inhaled insulin adequately communicated in the ADA Standard of Care for Diabetes would lead to a significant increase in prescriptions and coverage. 

[golfeveryday]

Dec 1, 2018 8:42:40 GMT -5 mnholdem said:

There is a difference between becoming THE Standard of Care and being equally represented in the current edition that doctors refer to.

Inhaled insulin is not equally represented in the current ADA publication, especially the selection charts which still list only subcutaneous injection for mealtime insulin, even though Afrezza has been an FDA-approved non-inferior alternative since 2014. 

Dr. Kendall's efforts today can be directed at the lethargic ADA board to get the SoC updated.

Superiority studies are a different matter and an important step in becoming the "Gold" standard and a worthwhile future endeavor but, in my opinion, simply getting inhaled insulin adequately communicated in the ADA Standard of Care for Diabetes would lead to a significant increase in prescriptions and coverage. 

great point. Absolutely agree.

[peppy]

[falconquest]

Dec 1, 2018 8:27:40 GMT -5 pat said:

I don't know what Matts motivations are either.

But I must admit it's incredible to watch the conversations between Nate Pile and assorted users on Stocktwits. I don't know if it's the same person or multiple people, but "they" positions themselves as shareholders. Then they relentlessly question everything about the companies efforts. It's obvious to me "they" are short the stock and trying to undermine our (investors) confidence in the company so we'll sell to them (and they can cover their short). My question is whether anyone in our little community of retail stock owners actually buys into the BS?

Nates made it pretty plain that he thinks there are a lot of people who own the stock and aren't going to sell and there are some people who shorted the stock and have made a lot of money on paper. If the company massively dilutes or goes out of business the short sellers realize those gains. However, that's largely off the table. So it's a stale mate. The short sellers are trying to get the investors they sold short shares to to sell them back at a lower price.

I suspect Matt may be part of this effort.

The thing that really blows me away is that the short sellers attacking the company are obviously intelligent and well-educated. The LFD pieces are well written and creative - if you can look past the fact they are complete nonsense. Likewise the attacks on Nate are also well orchestrated and clever. Just think if these people took that training and talent and put it to productive use for society. I wonder how they are able to reconcile what they do for a living internally. I put a lot of stock in the rudyrd Kipling poem the man in the glass. Are thes folks so devoid of any character or internal moral compass that they just don't care?

I have stated it before but I don't find any issues with Matt's realistic view of the situation. Now, you may argue with my choice of the word "realistic" but before you do go check the share price. I believe, inasmuch as people don't want to hear it, that Matt is right. I have always found his posts to be a pragmatic and useful perspective. And is it not the right of shareholders who hand over their money to hold management's feet to the fire to achieve a return? This has been a dismal investment for most longs despite the superior nature of Afrezza. Also, please don't challenge anyone's right to post on this board. So long as they follow the rules then the reason they post should not be in question. A diversity of views is beneficial. It's your job to weed through them and develop your own perspective.

[pat]

I think management is doing OUTSTANDING and worth every penny they are getting - which includes part of the money I’ve sunk into the equity of this company.

I’m not challenging anyone’s right to post anything anywhere. I’m explaining what I perceive to be a concerted effort to undermine the ability of the company to finance itself through the use of disinformation.

If you’re a fan of Matt remain so.

If I question it’s motives it’s my right to do so.

Is the falcon in your screcar n name related to USAF academy by chance? If that’s too personal feel free not to answer.

[peppy]

Dec 1, 2018 8:27:40 GMT -5 pat said:

I don't know what Matts motivations are either.

But I must admit it's incredible to watch the conversations between Nate Pile and assorted users on Stocktwits. I don't know if it's the same person or multiple people, but "they" positions themselves as shareholders. Then they relentlessly question everything about the companies efforts. It's obvious to me "they" are short the stock and trying to undermine our (investors) confidence in the company so we'll sell to them (and they can cover their short). My question is whether anyone in our little community of retail stock owners actually buys into the BS?

Nates made it pretty plain that he thinks there are a lot of people who own the stock and aren't going to sell and there are some people who shorted the stock and have made a lot of money on paper. If the company massively dilutes or goes out of business the short sellers realize those gains. However, that's largely off the table. So it's a stale mate. The short sellers are trying to get the investors they sold short shares to to sell them back at a lower price.

I suspect Matt may be part of this effort.

The thing that really blows me away is that the short sellers attacking the company are obviously intelligent and well-educated. The LFD pieces are well written and creative - if you can look past the fact they are complete nonsense. Likewise the attacks on Nate are also well orchestrated and clever. Just think if these people took that training and talent and put it to productive use for society. I wonder how they are able to reconcile what they do for a living internally. I put a lot of stock in the rudyrd Kipling poem the man in the glass. Are thes folks so devoid of any character or internal moral compass that they just don't care?

Matt knows, matt he has posted that MNKD would be bankrupt/gone a few times over the years.
Back in whatever year it was that Matt P got the sanofi settlement was once. 
Then also prior to the United Therapeutics deal.

In my world, Matt comes in handy for some of the technical stuff like, Explaining channel incentives. (rebates, kickbacks, The Standards and Poors, SPX.)  
"There are a bunch of incentives you can give to a distributor or PBM to increase the sales of your product. The rebate is just one of them and is designed to compensate the PBM for getting doctors to use the preferred drugs on the formulary.

Others include:
- Discount from selling price provided to the distributor. Since the distributors hold product for resale to pharmacies (and sometimes PBMs) they need to make some profit. The larger the discount, the more incentive they have to carry your product in their warehouse.
- Paying for warehouse space, so many dollars per pallet of storage.
- Offering more liberal return and allowance policies, such as for expired or damaged product.
- Extended payment terms. If a distributor can buy Afrezza with, say 45 days to pay Mannkind, and the distributor sells the product on-ward with 20 day terms, they get an effective 25 days of free credit. The three national wholesalers turn inventory about 45 times a year, or roughly once every 9 days.
- The company can run pricing specials, just like Coca-Cola runs price specials around major holidays.
- Patient rebate cards are a form of channel incentive since it encourages usage of the product, but Mannkind eats the cost.

I can go on, but anything that makes it more profitable for the intermediaries to carry and encourage use of Afrezza, or anything that makes it cheaper for the patient to use Afrezza, can be considered a channel incentive. Anything that is paid to an affiliated person of Mannkind, like a bonus to the territory salesperson, is a sales incentive rather than a channel incentive. Regardless, all such incentives hit the Mannkind P&L, with channel incentives showing up in the "gross to net" adjustment and sales incentives showing up under selling expenses.

As to prcgorman2's comment that the practices of PBMs should be outlawed, that is a plausible idea but nothing they do at the moment is illegal. A PBM has no fiduciary obligation to get a medication for the lowest possible price since their customer is not the patient but rather the insurance company that pays the bill. If the PBMs are not serving the needs of the insurance companies, the insurer can switch to other PBMs that provide the same service for less. Some prescription plans are such that the patient pay more in co-pays that what the drugs actually cost. I take one medication that I obtain through a mail order pharmacy for $11 for a 90-day supply which is less than the $20 co-pay from my insurer. If I ordered it through my PBM, they would be making $9 (likely more) in profit which is entirely legal. My point is that if you want to control PBM business practices, then the Affordable Care Act has to be changed. If the government wants to legislate which services must be covered at what out-of-pocket cost, then they can't complain when insurers competing for patients attempt to cut costs so that their plan is more competitive in the marketplace. That was the whole idea of the law."
========================================================================================

[brotherm1]

Some good info sometimes. I could apprectiate the posts much more without the hyperbole and slants though

[stevil]

Dec 1, 2018 9:41:18 GMT -5 falconquest said:

Dec 1, 2018 8:27:40 GMT -5 pat said:

I don't know what Matts motivations are either.

But I must admit it's incredible to watch the conversations between Nate Pile and assorted users on Stocktwits. I don't know if it's the same person or multiple people, but "they" positions themselves as shareholders. Then they relentlessly question everything about the companies efforts. It's obvious to me "they" are short the stock and trying to undermine our (investors) confidence in the company so we'll sell to them (and they can cover their short). My question is whether anyone in our little community of retail stock owners actually buys into the BS?

Nates made it pretty plain that he thinks there are a lot of people who own the stock and aren't going to sell and there are some people who shorted the stock and have made a lot of money on paper. If the company massively dilutes or goes out of business the short sellers realize those gains. However, that's largely off the table. So it's a stale mate. The short sellers are trying to get the investors they sold short shares to to sell them back at a lower price.

I suspect Matt may be part of this effort.

The thing that really blows me away is that the short sellers attacking the company are obviously intelligent and well-educated. The LFD pieces are well written and creative - if you can look past the fact they are complete nonsense. Likewise the attacks on Nate are also well orchestrated and clever. Just think if these people took that training and talent and put it to productive use for society. I wonder how they are able to reconcile what they do for a living internally. I put a lot of stock in the rudyrd Kipling poem the man in the glass. Are thes folks so devoid of any character or internal moral compass that they just don't care?

I have stated it before but I don't find any issues with Matt's realistic view of the situation. Now, you may argue with my choice of the word "realistic" but before you do go check the share price. I believe, inasmuch as people don't want to hear it, that Matt is right. I have always found his posts to be a pragmatic and useful perspective. And is it not the right of shareholders who hand over their money to hold management's feet to the fire to achieve a return? This has been a dismal investment for most longs despite the superior nature of Afrezza. Also, please don't challenge anyone's right to post on this board. So long as they follow the rules then the reason they post should not be in question. A diversity of views is beneficial. It's your job to weed through them and develop your own perspective.

I agree. I remember getting flamed to death on here a few years ago for my negative views that ended up becoming reality. 

No matter the motivation, one should always keep an open mind. Know what you know and allow yourself to be challenged by what you don’t.

My endorsement is also for matt, although I’ll probably also get lumped into the short brigade. Mike himself said way back when that shareholders would thank him someday for saving the company. I don’t think it was unreasonable for matt to predict bankruptcy. Those words sound pretty dire to me. 

[peppy]

Dec 1, 2018 11:36:36 GMT -5 stevil said:

Dec 1, 2018 9:41:18 GMT -5 falconquest said:

I have stated it before but I don't find any issues with Matt's realistic view of the situation. Now, you may argue with my choice of the word "realistic" but before you do go check the share price. I believe, inasmuch as people don't want to hear it, that Matt is right. I have always found his posts to be a pragmatic and useful perspective. And is it not the right of shareholders who hand over their money to hold management's feet to the fire to achieve a return? This has been a dismal investment for most longs despite the superior nature of Afrezza. Also, please don't challenge anyone's right to post on this board. So long as they follow the rules then the reason they post should not be in question. A diversity of views is beneficial. It's your job to weed through them and develop your own perspective.

I agree. I remember getting flamed to death on here a few years ago for my negative views that ended up becoming reality. 

No matter the motivation, one should always keep an open mind. Know what you know and allow yourself to be challenged by what you don’t.

My endorsement is also for matt, although I’ll probably also get lumped into the short brigade. Mike himself said way back when that shareholders would thank him someday for saving the company. I don’t think it was unreasonable for matt to predict bankruptcy. Those words sound pretty dire to me. 

stevil
The time has come. You now get to prescribe. The standards of Care in what ever speciality/disease you end up in written.
The revolving door of patients coming in.
Now you get to see. These patients, the ones that will become yours, over time;  you will get the visual, the lab results, the x-rays.
Come back and let us know. - These pills/medications worked the patient got better. -These pills worked for this, caused that, new pills for that....
Come back and let us know, did the health of these people improve? 
I know you have read every word on the package insert of every prescription you give out, you know the organs that will be affected. 
That is part of the job description.

I was at Mayo a few years ago, I watched the people come in the door. These people did not look well.

[falconquest]

Dec 1, 2018 10:05:57 GMT -5 pat said:

I think management is doing OUTSTANDING and worth every penny they are getting - which includes part of the money I’ve sunk into the equity of this company.

I’m not challenging anyone’s right to post anything anywhere. I’m explaining what I perceive to be a concerted effort to undermine the ability of the company to finance itself through the use of disinformation.

If you’re a fan of Matt remain so.

If I question it’s motives it’s my right to do so.

Is the falcon in your screcar n name related to USAF academy by chance? If that’s too personal feel free not to answer.

There is a long history here of accusing those who post a realistic (and potentially negative sounding) view that they are undermining the company. That was the basis for my post. It's always communicated as some kind of "short seller conspiracy" which I find rather silly. Does anyone really believe they can undermine the share price by posting on a message board? Conversely, all the positive posts in the world will not cause the share price to rise.  As for my screen name, I don't mind the question. It is a reference to the name of my sailboat.

[mnholdem]

Thanks for posting the step charts peppy. Everyone can clearly see that before meal bolus excludes inhaled insulin and refers only to injectables.

[goyocafe]

Dec 1, 2018 15:05:31 GMT -5 mnholdem said:

Thanks for posting the step charts peppy. Everyone can clearly see that before meal bolus excludes inhaled insulin and refers only to injectables.

And after the STAT results, it’s an obvious omission considering the reduced hypos and other pluses identified in the study. 

[stevil]

Dec 1, 2018 12:21:37 GMT -5 peppy said:

Dec 1, 2018 11:36:36 GMT -5 stevil said:

I agree. I remember getting flamed to death on here a few years ago for my negative views that ended up becoming reality. 

No matter the motivation, one should always keep an open mind. Know what you know and allow yourself to be challenged by what you don’t.

My endorsement is also for matt, although I’ll probably also get lumped into the short brigade. Mike himself said way back when that shareholders would thank him someday for saving the company. I don’t think it was unreasonable for matt to predict bankruptcy. Those words sound pretty dire to me. 

stevil
The time has come. You now get to prescribe. The standards of Care in what ever speciality/disease you end up in written.
The revolving door of patients coming in.
Now you get to see. These patients, the ones that will become yours, over time;  you will get the visual, the lab results, the x-rays.
Come back and let us know. - These pills/medications worked the patient got better. -These pills worked for this, caused that, new pills for that....
Come back and let us know, did the health of these people improve? 
I know you have read every word on the package insert of every prescription you give out, you know the organs that will be affected. 
That is part of the job description.

I was at Mayo a few years ago, I watched the people come in the door. These people did not look well.

Peppy,

Not yet. I can't prescribe anything until June, but even then, I will need my supervising physician to sign off on it. I don't yet know where I'm going for residency, although I have been given a few winks from my top choice, but it's not a given that I will be able to prescribe Afrezza.

I have already seen a lot of people have success with metformin and the GLP-1's. The nice thing about the latter (Trulicity) is that they only require a once/week injection schedule. Compliance is a huge hurdle with the diabetic population. Many don't care about their disease, others just are either uninterested or incapable of understanding the severity of their disease. I kid you not, I once spent 30 minutes counseling one of my patients in the hospital and at the end of it, she still didn't understand what glucose was or how/why her levels were so high. And I did my best to simplify it. Level of education is a hurdle. As awful as you and everyone else think it is (and I agree it is unfortunate), there is only a limited amount of time you get to spend with each patient as a physician. In my observation throughout the past year and a half, there seems to be a correlation between education level and glucose control. The more educated typically earn more money, buy healthier food, have better access to healthcare, and understand the importance of seeing their physician regularly and are able to interpret what their doctor tells them and make better choices because they understand the consequences of their decisions. I haven't looked it up to see if anyone has studied this, but what this means (again from my experience) is that diabetes is more of a disease of the poorly insured and less compliant, at least for the type 2 population. 

The issue that the majority of people on here don't seem to understand is that even though Afrezza may be the best solution for diabetes, it isn't the best solution for every person with diabetes. You can have the best drug in the world, but if people won't take it as they're supposed to, it isn't going to work all that well. Therefore, I've actually become a bigger fan of bariatric surgery (gastric sleeve) and GLP-1 use. Insurance coverage is still an issue with those, but they are so wonderful because they require less compliance from the patience to be effective. 

On top of this, I did a presentation in front of residents and supervising physicians last week, and had incredible difficulty compiling compelling trial data for the use of Afrezza for better glucose control. I found that I was forced to explain the science and why Afrezza "should" work better because the available trial data just does not support the use of Afrezza over other insulins. At best, Afrezza spent 9 fewer minutes every day in hypoglycemic ranges and less weight gain than RAAs with 1-2 hours more "in range" so an argument could be made for the use of Afrezza in those experiencing difficult control with multiple severe hypoglycemic events. At that point, safety takes precedence to overall magnitude of reduction, since Afrezza lowered A1c less than RAAs in nearly every arm that has been studied. At the end of the day, doctors are currently taught to treat to a number, not for control.

I will do my best to convince my supervising physician to allow me to prescribe Afrezza, but the residency I'll hopefully be practicing at is in a very large hospital in a metropolitan area with the homeless and impoverished making up the majority of the patient population. Insurance will be an enormous hurdle. Going back to my previous example, counseling will be an enormous hurdle. I will get dinged in my residency if I spend too much time with my patients. Part of my education is learning how to be efficient. Then, once I start practicing independently, I'll have a tremendous debt burden that has been accruing interest since the day I stepped foot onto my medical school campus. As much as I want to help my patients, I first have an obligation to my family. Insurance doesn't pay you for spending longer than they deem necessary for an office visit. I can sometimes justify a higher level of billing if I document properly, but that takes even more time since thorough documentation takes considerably longer than normal documentation. For those who want to throw stones because of this, I would highly encourage you to tell your employer you don't want 20% of your paycheck every week. 

I will do my best for every one of my patients that I see. But my best will be different for each of them because you need to tailor care to what is attainable for each of them. Not every patient wants the best care. Not every patient is willing/able to do what is necessary to get the best results. The trick is to figure out what will be best for them and to work as hard as I can to help ensure they get what they want and need to achieve their goals.