insurance 2024

[hopingandwilling]

The U.S. and New Zealand are the only countries that allow direct-to-consumer prescription drug advertisements. In the U.S., television viewers are subjected to an especially increasing volume of drug commercials. If one watches the national news programs daily at 5:30 p.m., the thirty-minute time slot is broken into two categories: 20 minutes of news and usually 10 minutes of drug company ads for their drug. But what about all the other countries of the world---what happens there as it relates to a given drug? For starters, the price they pay for their drugs at a drugstore (just as we do in the US), in many cases, U.S. payors and patients are shelling out for more than their international counterparts. The Rand Corporation's analysis found that prices for brand-name drugs were an average of 344% of those in comparison countries. (Nov 29, 2023) Let me clarify what the respected Rand Corporation is telling us---with the exception of two countries, the USA, and New Zealand, in the United States of America, the price we pay for a given drug on a $3.44 ratio, and on average in all the other nations of the world they pay on a ratio $1.00 for the same drug. Now, this is where it gets interesting when it comes to an insulin drug being marketed on a worldwide basis. Novo Nordisk, a Danish company, ranks in the top 10 most profitable drug companies in the world based on its leadership role in the diabetes market. My point is simply that a drug being successful isn’t just based on TV advertising or even print advertising. Doctors are the ones who write the prescriptions, and what a doctor should seek is the resolution of their patient’s medical situation. So why is it that the same drug coming out of one manufacturing plant cost $3.44 in the United States, but only cost $1.00 in the rest of the world? And if you want to use Afrezza as the comparator drug, keep in mind that clinical trial data only shows their efficacy is comparable to injectable insulin. Does one not understand why MannKind has never submitted Afrezza for approval in Europe or Asia? The only other nation where Afrezza has been marketed is Brazil, and they have failed miserably there. Why would one think India’s government health system is going to pay 300% more for an insulin product that is inhaled? In Washington DC, there are currently 1,834 registered lobbyists working for pharmaceutical and health products, meaning the industry has more than three lobbyists for each member of Congress. (Feb 2, 2023) Socialism is simply an organization/group that joins together by combining their resources(money), time and efforts where the members reap the benefit of their combined efforts. And yet, there are those who think socialism does not exist in the United States and thus forget that the very first healthcare system in the United States was begun with legislation by President John Adams. Then, in 1929, the first health insurance program was begun in Dallas, Texas, where a select group of individual workers agreed to join and obtain guaranteed health care from a given hospital. The name for this socialized health insurance program was Blue Cross; later, when the loggers in the Northwestern area of the US were found working with axes and tall trees, they were having and suffering from accidents with said axes and trees. They asked to join the Blue Cross group, and that is why today we know this original socialized program as Blue Cross-Blue Shield.

The point of this history lesson is that for MannKind to spend money on TV advertising is a waste of money because at the end of the day they must show on their prescribing label, that only 39% of each dosage goes into the patient's lungs and that Afrezza is only comparable to injected insulin  for lowering A1c levels---and most of all it is the most expensive insulin drug on the market for use by diabetics. Solve these three issues and Afrezza would have a chance to generate and keep initial patients using the drug--with a current 75% dropout rate of users, things look bleak for the future.

[prcgorman2]

Nice try. I’ve read many of the FDA guidelines for advertising and they don’t require anything like saying “only 39% of each dosage goes into the patient’s lungs”.

[agedhippie]

Feb 4, 2024 10:32:18 GMT -5 prcgorman2 said:

Nice try. I’ve read many of the FDA guidelines for advertising and they don’t require anything like saying “only 39% of each dosage goes into the patient’s lungs”.

That is also the same fundamental error that gets made about Yutrepia. The efficiency is irrelevant if you can still achieve a therapeutic dose. There is no prize for minimizing the API used, only for getting desired outcome. Afrezza is a lot less efficient than sub-q if you just look at quantity of insulin used, but that's irrelevant because you can still achieve the desired outcome. This is why you never see professionals using the efficiency argument.

[cppoly]

Aged, UTHR likes to use in their presentation slides that Yutrepia's delivery is inferior because the majority of the dose does not go where it needs to with deep penetration into the lungs and instead it gets stuck in the back of the throat.

How did LQDA get this passed with the FDA and do you think this is a legitimate talking point for UTHR?

Comparatively speaking, Yutrepia is documented with higher % cough compared to Tyvaso DPI. Thoughts?

[agedhippie]

Feb 4, 2024 11:25:48 GMT -5 cppoly said:

Aged, UTHR likes to use in their presentation slides that Yutrepia's delivery is inferior because the majority of the dose does not go where it needs to with deep penetration into the lungs and instead it gets stuck in the back of the throat.

How did LQDA get this passed with the FDA and do you think this is a legitimate talking point for UTHR?

Comparatively speaking, Yutrepia is documented with higher % cough compared to Tyvaso DPI. Thoughts?

That's an easy question. It got past the FDA because it delivers the required outcome, that's all the FDA cares about. How much is stuck in the throat is irrelevant if the drug works. It's legitimate, but weak argument as the efficiency is never going to be a factor with doctors but you may as well throw it out there anyway. If I was UTHR I would probably use it, but with no real expectation of success.

How much higher will the cough discontinuation rate be for Yutrepia than Tyvaso DPI in the real world as opposed to trial? Nobody will know until it launches.

[cppoly]

Thanks Aged. But, there's no threshold for an acceptable percentage of patients coughing with Yutrepia from an FDA perspective? If it was 50%, would the FDA be ok with that?

[agedhippie]

Feb 4, 2024 14:45:50 GMT -5 cppoly said:

Thanks Aged. But, there's no threshold for an acceptable percentage of patients coughing with Yutrepia from an FDA perspective? If it was 50%, would the FDA be ok with that?

The FDA will not care about the cough (other than requiring it on the label as a side effect) unless it impacts the outcome. You could have a 100% and it would still be approved if it provided the outcome. The FDA is concerned with safety and efficacy, it will leave the acceptability of the side effects to the patient (see GLP-1 for weight loss as an example!)

[sayhey24]

Feb 4, 2024 10:20:59 GMT -5 lennymnkd said:

someone suggested mark cuban / cost plus drugs . Com are they any better?

I understand costplusdrugs.com  Does that make them better?  This entire insurance/PBM/Saving Card/etc.  seems like a scam which I still need to understand better but in the end MNKD is only selling 800 scripts a week which seems to me to be a failure for MNKD.  I guess we can just keep doing the same thing over and over.  Its been 6 years.

Costplusdrugs typical model is the manufacturer adds 15% and Mark adds 15%.  If afrezza total cost is $30, MNKD would get $4.50 profit which is not much but what is the goal over the next 2 years?  While getting $750 a box sounds great, if you are only selling 800 boxes and not expanding the user base is this really working?  Right now we need to get to the 25-50k base which Bill from VDex suggested.  I do think that Mark Cuban running around on a bunch of business and TV talk shows with his hair on fire pumping afrezza would sure not hurt.  How many boxes of afrezza could be sold at $39?  I would think a lot more than 800, especially if you have Cuban as the pitch boy explaining he has a near cure for T2 diabetes.

[lennymnkd]

If Marks concept hold us accountable to just 15% that’s a tough one / but if he take 15% on what we determine is a fair price for us
I would think that would be great .

[agedhippie]

Feb 4, 2024 17:57:28 GMT -5 sayhey24 said:

...
Costplusdrugs typical model is the manufacturer adds 15% and Mark adds 15%.  If afrezza total cost is $30, MNKD would get $4.50 profit which is not much but what is the goal over the next 2 years?  While getting $750 a box sounds great, if you are only selling 800 boxes and not expanding the user base is this really working?  Right now we need to get to the 25-50k base which Bill from VDex suggested.  I do think that Mark Cuban running around on a bunch of business and TV talk shows with his hair on fire pumping afrezza would sure not hurt.  How many boxes of afrezza could be sold at $39?  I would think a lot more than 800, especially if you have Cuban as the pitch boy explaining he has a near cure for T2 diabetes.

While this is a nice idea it is not commercially viable and Mike would be finally be fired by even this BoD if he tried it. The BoD want the endocrine division to breakeven, not make an epic loss. My feeling is that the BoD have moved on from Afrezza and have it in care and maintenance mode.

[agedhippie]

Feb 4, 2024 18:24:09 GMT -5 lennymnkd said:

If Marks concept hold us accountable to just 15% that’s a tough one / but if he take 15% on what we determine is a fair price for us
I would think that would be great .

I am pretty sure he would want the price to the patient to match LillyDirect or why would he not just leave it to Lilly? (Lilly cash price is $35 per prescription, not per box.)

[hopingandwilling]

Aged,

What you point out so well, the FDA doesn't care about whether a patient coughs when taking a drug, they are concerned mainly about whether the drug does not kill you and if it offers efficacy benefits for the patient. The fact it takes four times as much of Afrezza to achieve efficacy requirements is not the issue.  The issue is that the four times the drug to obtain the efficacy desired, the issue is the four times the amount cost more money for what Afrezza is competing against an injectable insulin. We are talking about insulin---the FDA doesn't care if the drug is injected, nebulized, given as a pill dosage,(you can't dose insulin orally) or snorted up your nose with a straw, or given via an inhaler. The FDA is concerned with safety and efficacy of a drug. The FDA isn't concerned with the price of what a company will charges for a drug.  When injected the dosage is guaranteed to be nearly 100% delivered to the patient's blood stream where it will then be distributed throughout the body where it is needed. Every organ in the human body has blood distributed to it, with the only exception being the cornea of your eye. And sadly, for some men at the most inopportune time for their penis--I've heard! Again, this is only a rumor I've heard about!

The gate keepers for our drugs being for paid for, is the insurance company and ultimately the patient. Thus, the issue is that an insurance company doesn't want to pay for four times the dosage of INSULIN to obtain their goal--and this is why Afrezza cost too much!  The idea that insulin can be obtained for a limit of $35.00 is not the reality because either the insurance company or the patients is going to eat the difference.  For a good example--go to Goodrx, and where no insurance can be applied in the transaction, the cheapest that Goodrx will charge for Afrezza is $400+.  This simply means that MannKind is charging more much more than $400.00 for supplying Afrezza.The $35.00 limit to an insulin user hinges on whether an insurance company or the patient will pay the difference being actually charged for a given drug by the manufacturer of the drug.

Let me give you a true analogy. Many,many years ago my grandfather lived in Lakeland, Florida and my mother would take me and my younger brother to visit him. Lakeland is between Orlando and Tampa.  In those days, Orlando and where Disneyland is located was filled with orange groves and growers would have roadside stands where they offered travelers orange juice. They road sign stated--"All the orange juice you can drink for 10 cents." After passing several of these enticing stands and their fantastic offering for their orange juice, my mother stopped at one of the stands. My brother and I were elated--all the orange juice we could drink and we could get it for a dime. My mother order orange juice for both of us and put two dimes on the counter. The cups where hardly larger than a thimble. My brother and I down the orange juice in one swallow. We put the cups back on the counter and our mother told the owner she wanted a refill for each of us. He poured the orange juice into our cups and then told my mother it would be another twenty cents. My mother protested and told the owner that his sign said all the orange juice you can drink for a dime. The owner replied, Yes! But, that one cup is all you can drink for a dime! 
Those thinking like my mother and those thinking that MannKind is going to compete on prices that an insurance company is going to pay for Afrezza -- The insurance companies are telling Afrezza users, they ain't paying four dimes more than what they can get for a dime!

PS: My mother never again stopped at a roadside orange stand when we visited our grandfather.

[lennymnkd]

At 35.00 .. sure would take a long time to get a couple of billion back 🤔

[prcgorman2]

After this many years and all of the painful moments, MannKind is finally on a good footing for growing in terms of reducing interest expense, increasing revenue streams, and becoming increasingly profitable. I don’t obsess about Afrezza being a blockbuster anymore, and I will be perfectly happy if MannKind can acheive the revenue goals they recently shared in a slide on the topic. I do want to see Afrezza be more profitable and it has been steadily growing since 2017, but the growth is slow. I’m hopeful the Pediatric trial needed to change the label and permit prescribing to children, especially children with Type 1 diabetes, helps provide some moderate acceleration and perhaps over time even more can be done. e.g., full-scale multi-arm clinical trials. In the meantime, I like the strategy of orphan lung diseases with accelerated FDA approval processes, and limited competition. Hopefully, MannKind will also work out the insurance coverage challenges, eventually.

[sayhey24]

Feb 4, 2024 20:57:24 GMT -5 prcgorman2 said:

After this many years and all of the painful moments, MannKind is finally on a good footing for growing in terms of reducing interest expense, increasing revenue streams, and becoming increasingly profitable. I don’t obsess about Afrezza being a blockbuster anymore, and I will be perfectly happy if MannKind can acheive the revenue goals they recently shared in a slide on the topic. I do want to see Afrezza be more profitable and it has been steadily growing since 2017, but the growth is slow. I’m hopeful the Pediatric trial needed to change the label and permit prescribing to children, especially children with Type 1 diabetes, helps provide some moderate acceleration and perhaps over time even more can be done. e.g., full-scale multi-arm clinical trials. In the meantime, I like the strategy of orphan lung diseases with accelerated FDA approval processes, and limited competition. Hopefully, MannKind will also work out the insurance coverage challenges, eventually.

The kids trial is going to help a lot but this several years away and is only for a portion of the T1 market.  If it stays at $1200 a box few kids mom's will be able to afford it.

Between this and the India study there should be label changes in 2 years.  In the mean time what can be done to increase the base?  I have not really seen the steady growth in afrezza.  I see Mike's slides but how much is a 20% increase year over year of only 800 boxes?  It sounds great but its really nothing.

Without the user base Big Pharma will continue to beat down afrezza.  Its the last thing they want disrupting their $100B diabetes market.  I think the goal right now should be expanding the user base with afrezza making a small profit and closing down V-Go which is losing money while Tyvaso DPI continues to pay the bills.

In 2 years if the user base has not grown to a noticeable size Big Pharma will throw another knuckle ball or two at MNKD.  Did you watch the video I posted in the other thread with Calley Means?  If not he says a lot of the things about BP which I am warning about.  tuckercarlson.com/the-case-against-ozempic/