In case you missed this

[joeypotsandpans]

in the scripts thread which non members don't get access to, I thought I would put here. Just to give you the proper context, this was a response to Matt regarding his response to boca on her anti-trust statement regarding the rebates that Novo is giving UHC to blackball Afrezza:


8 minutes ago

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Post by joeypotsandpans on 8 minutes ago

matt Avatar

3 hours ago matt said:

boca1girl Avatar

Nov 21, 2017 at 6:14am boca1girl said:

MNKD needs to file a complaint with the Federal Trade Commision (FTC) on the anti-competitive pricing practices in the drug industry. I hope Bernie Sanders sees this article and makes a public stink about it. I don’t agree with many of Bernie’s positions, but he is “right on” with regards to dirty drug pricing practices.


Matt's response to Boca:

This has been to federal court, including the court of appeals, on previous occasions. The ruling was that if the rebate is a unilateral offer by the manufacturer to the purchaser (essentially the PBM) then the price discount in exchange for greater market share is entirely legal. A rebate does not require the purchaser to do to anything; it is simply an extra price discount if they do the desired act. For those interested, the seminal case in this area is White and White Inc v. American Hospital Supply Corp (723 F. 2d 495). You can bet all the PBMs and drug company lawyers have read the case many times.



You can think of it in terms of automobiles; if a consumer makes a qualifying purchase then Ford will give an extra $1,500 cash back on the purchase of a new mini-van but they will give nothing if the consumer buys a Chevy instead. The consumer is free to buy the Chevy but can save a bit of cash on the Ford, or the consumer can buy no new car at all. This is a unilateral offer by Ford that requires no action by any consumer and thus it is legal.



The issue is not one of pricing or bundling product as that ship sailed long ago. The issue is whether a PBM should be legally obligated to offer every drug approved by FDA on similar terms, or whether they should be free to substitute equivalent products or charge extra, perhaps a lot extra, for a non-preferred brand. Afrezza has not been recognized by the FDA as anything fundamentally different from a rapid acting insulin, and until that changes it will be difficult to enforce a requirement that a PBM supply it at all as the FDA and all the states permit free substitution of generic drugs as equivalent medications. That distinction was a stake with the recent label change request for an "ultrarapid" designation, but that didn't happen.


My response to Matt's response:

That doesn't preclude patients from going after UHC for denied benefits, apparently they have a history of doing so, www.modernhealthcare.com/article/20160920/NEWS/160929989 bad faith insurance is a whole different story than taking bribes or so called rebates as they term it from manufacturers topclassactions.com/lawsuit-settlements/lawsuit-news/279158-279158/ when a physician goes out of their way and issues prior authorizations for a drug due to various reasons and it still gets denied, it needs to be looked into and addressed....just stating that there are similar drugs available doesn't work in the long term, for example, if someone is allergic to the metal from the injectors and ends up with severe medical issues due to being denied an alternative way to take the medication if it is available that is a huge problem imo for the insurer to dismiss just because an alternative generic or other less costly insulin was available.



I went to my endo appointment yesterday as my primary wanted to refer me to one after my last visit three weeks ago. I was at the counter giving the desk clerk my info, I noticed the OPTUM sign above on the wall, and said "oh you guys are OPTUM so you are owned by UHC?" the answer was yes...I knew at that point my appointment was going to get interesting. I didn't know what to expect regarding the endo that I was about to see. When I was called in, the medical asst. went through their routine, weight, height, take off your shoes (they check your feet for any signs of neuropathy) and the general questions, allergies, current meds, etc. I told her I have been taking the inhaled insulin to which she was pretty clueless. She said the endo had one more patient in front of me and would be in shortly....when she entered, I thought to myself ok here we go but to my surprise she said "I am so excited to see you after reading your chart, I have been reading up on this and you're my first patient to be using this, (I felt like saying no shit you're part of UHC and that is likely the reason why) but I continued to listen and answer her questions. By the time we were done, she had taken the reps name that handles this region and ironically knew the prior rep from SNY that is now with DEXCOM so she texted her that she was seeing me at that moment. I suggested to the endo that she contact the endo office in town that has been working with it since it came out as their practice is extremely backed up and they could probably use a good open minded young endo, she'd probably end up much better in the long run Also, as chance would have it, Spiro was calling me while I was at the appt. I said to her "oh this guy has been on it for a couple of years now, do you mind if I answer it and he can tell you what he thinks"...she said ok, and Spiro went on about how wonderful it has been and indirectly how his other lab numbers have come in line, needless to say when I was leaving the appt. to my pleasant surprise she seemed pretty sold on it. I just texted the rep a copy of her card and told her I swapped her info to her as well. I also suggested she go to afrezzauser.com so she can get Sam's perspective and other info as well. Just wanted to share with you all as the wall will weaken with each brick that gets displaced







Read more: mnkd.proboards.com/thread/9029/scripts-stock-price?page=2#ixzz51Gq4ipUQ

[hans]

Joey,
That's fantastic news. Nothing works best like word of mouth (well, DTC comes in as a close second.  ).  Thanks Joey...

[joeypotsandpans]

Also, regarding using the auto rebate analogy to one for drugs and health insurers is ludicrous IMO, buying a car and saving money is one thing, getting denied a drug that could save your life and limbs is quite another.

Speaking of analogies, this reminds me of SO's answer where he said that ARNA's current trials and coming out with a treatment for PAH compared to MNKD coming out with one is like Budweiser compared to starting a micro brewery start-up....if he understood that ARNA is going through trials for a new drug, compared to MNKD which already has had favorable talks with the FDA on an inhalable version of a drug already on the market he may not have said it the way he did. In SO's article yesterday regarding the vote, I asked him if he was still long ARNA to which he replied he was. I asked his opinion if there were parallels with ARNA and MNKD as in his July article he wrote about his feelings of ARNA's decision to dilute through a secondary offering. His response was interesting to the points I made in the query. When you realize that ARNA went and let their only drug go to the partner they were with for some royalties, it makes me feel like MNKD having a second drug with a growing sales force would not quite be a micro brewery to a Budweiser type situation. For those that want you can read the question and response in SO's article seekingalpha.com/article/4131508-mannkind-shareholder-vote-shares-center-stage but it also goes into the question of his owning ARNA as a potential conflict of interest in not being biased on writing about MNKD as a potential competitor with respect to treating PAH.

[sportsrancho]

Great job you two!! Team work! All very interesting... awareness, word-of-mouth, results and more results.

[gamblerjag]

Dec 14, 2017 15:53:25 GMT -5 joeypotsandpans said:

in the scripts thread which non members don't get access to, I thought I would put here. Just to give you the proper context, this was a response to Matt regarding his response to boca on her anti-trust statement regarding the rebates that Novo is giving UHC to blackball Afrezza:


8 minutes ago

ReplyQuote Edit Post Options

Post by joeypotsandpans on 8 minutes ago

matt Avatar

3 hours ago matt said:

boca1girl Avatar

Nov 21, 2017 at 6:14am boca1girl said:

MNKD needs to file a complaint with the Federal Trade Commision (FTC) on the anti-competitive pricing practices in the drug industry. I hope Bernie Sanders sees this article and makes a public stink about it. I don’t agree with many of Bernie’s positions, but he is “right on” with regards to dirty drug pricing practices.


Matt's response to Boca:

This has been to federal court, including the court of appeals, on previous occasions. The ruling was that if the rebate is a unilateral offer by the manufacturer to the purchaser (essentially the PBM) then the price discount in exchange for greater market share is entirely legal. A rebate does not require the purchaser to do to anything; it is simply an extra price discount if they do the desired act. For those interested, the seminal case in this area is White and White Inc v. American Hospital Supply Corp (723 F. 2d 495). You can bet all the PBMs and drug company lawyers have read the case many times.



You can think of it in terms of automobiles; if a consumer makes a qualifying purchase then Ford will give an extra $1,500 cash back on the purchase of a new mini-van but they will give nothing if the consumer buys a Chevy instead. The consumer is free to buy the Chevy but can save a bit of cash on the Ford, or the consumer can buy no new car at all. This is a unilateral offer by Ford that requires no action by any consumer and thus it is legal.



The issue is not one of pricing or bundling product as that ship sailed long ago. The issue is whether a PBM should be legally obligated to offer every drug approved by FDA on similar terms, or whether they should be free to substitute equivalent products or charge extra, perhaps a lot extra, for a non-preferred brand. Afrezza has not been recognized by the FDA as anything fundamentally different from a rapid acting insulin, and until that changes it will be difficult to enforce a requirement that a PBM supply it at all as the FDA and all the states permit free substitution of generic drugs as equivalent medications. That distinction was a stake with the recent label change request for an "ultrarapid" designation, but that didn't happen.


My response to Matt's response:

That doesn't preclude patients from going after UHC for denied benefits, apparently they have a history of doing so, www.modernhealthcare.com/article/20160920/NEWS/160929989 bad faith insurance is a whole different story than taking bribes or so called rebates as they term it from manufacturers topclassactions.com/lawsuit-settlements/lawsuit-news/279158-279158/ when a physician goes out of their way and issues prior authorizations for a drug due to various reasons and it still gets denied, it needs to be looked into and addressed....just stating that there are similar drugs available doesn't work in the long term, for example, if someone is allergic to the metal from the injectors and ends up with severe medical issues due to being denied an alternative way to take the medication if it is available that is a huge problem imo for the insurer to dismiss just because an alternative generic or other less costly insulin was available.



I went to my endo appointment yesterday as my primary wanted to refer me to one after my last visit three weeks ago. I was at the counter giving the desk clerk my info, I noticed the OPTUM sign above on the wall, and said "oh you guys are OPTUM so you are owned by UHC?" the answer was yes...I knew at that point my appointment was going to get interesting. I didn't know what to expect regarding the endo that I was about to see. When I was called in, the medical asst. went through their routine, weight, height, take off your shoes (they check your feet for any signs of neuropathy) and the general questions, allergies, current meds, etc. I told her I have been taking the inhaled insulin to which she was pretty clueless. She said the endo had one more patient in front of me and would be in shortly....when she entered, I thought to myself ok here we go but to my surprise she said "I am so excited to see you after reading your chart, I have been reading up on this and you're my first patient to be using this, (I felt like saying no shit you're part of UHC and that is likely the reason why) but I continued to listen and answer her questions. By the time we were done, she had taken the reps name that handles this region and ironically knew the prior rep from SNY that is now with DEXCOM so she texted her that she was seeing me at that moment. I suggested to the endo that she contact the endo office in town that has been working with it since it came out as their practice is extremely backed up and they could probably use a good open minded young endo, she'd probably end up much better in the long run Also, as chance would have it, Spiro was calling me while I was at the appt. I said to her "oh this guy has been on it for a couple of years now, do you mind if I answer it and he can tell you what he thinks"...she said ok, and Spiro went on about how wonderful it has been and indirectly how his other lab numbers have come in line, needless to say when I was leaving the appt. to my pleasant surprise she seemed pretty sold on it. I just texted the rep a copy of her card and told her I swapped her info to her as well. I also suggested she go to afrezzauser.com so she can get Sam's perspective and other info as well. Just wanted to share with you all as the wall will weaken with each brick that gets displaced







Read more: mnkd.proboards.com/thread/9029/scripts-stock-price?page=2#ixzz51Gq4ipUQ

well this post is going to be pretty boring compared to for Joey just said LOL but when I was working today I spoke with an LVN or soon to be LVN and she was talking about diabetes and I talked about afrezza. And she said she hadn't heard of it but when I mentioned the new drug inhaled insulin and showed her a picture of the delivery device she said oh yeah I just went to a diabetes seminar for classes that she needed to take and they were talking about the new drug she said the people were very shocked that there was another way To receive insulin other than injections.so it is getting out there in all mediums

[matt]

Dec 14, 2017 16:13:33 GMT -5 joeypotsandpans said:

Also, regarding using the auto rebate analogy to one for drugs and health insurers is ludicrous IMO, buying a car and saving money is one thing, getting denied a drug that could save your life and limbs is quite another. 

No, that is exactly the point.  When you are unhappy with a situation you have the right to take it to court, but the first step in that process is to file a pleading.  The pleading must state, with particularity, what statute or common law the other party violated or else the case gets dismissed.  Auto rebates are an example of a permitted unilateral contract, and it is the unilateral nature of the agreement that makes it so.  The fact that the subject matter is a drug or some other life saving treatment instead of a car matters not at all; unilateral rebates are legal whatever the product category, while bilateral contracts are a restraint of trade.  PBM rebates are unilateral and that makes them legal.  That was my entire point in the original post; please don't read more into it than what I put there.

The original poster said that the company should complain to the FTC.  Fair enough, but denying a patient access to a particular drug is not something the FTC is empowered to regulate.  Don't like your new mini-van?  You can't complain to the FDA about that.  You might get the attention of the US Traffic Highway Administration or some other agency under the Department of Transportation, but not FDA.  Similarly, FTC regulates fair trade which, at the federal level, essentially means anti-trust law, and what drug manufacturers and PBMs do with negotiating rebates passes muster in the courts under anti-trust so FTC has nothing more to say about it.

Similarly, you can complain in court that UHC does not cover the drug but they make no secret of that since they publish their formulary.  However, if you want to sue for a coverage decision you have to assert the right cause of action in the right court.  Getting around an insurance plan is even more difficult that winning an anti-trust case because insurance companies are regulated by each individual state and there is no federal law that dictates what is, and is not, covered beyond the specific mandates in the Affordable Care Act, most of which are about to be repealed as part of tax reform.  Which leave you the option of your state regulator or, even better, switching your insurer away from UHC (which I highly recommend anyway; United Health is one of the worse companies out there).  If your insurance is through your employer that may not be an available choice, but you do have alternatives.  State or federal courts probably aren't on the list of options likely to work.

[joeypotsandpans]

For those that refuse to read SO's articles there is the most recent weekly one today that talks about scripts, the following is my comment posted so thought I would share and also memorialize if for some reason they come up with a reason for deleting

Readers:

Fact: This author is currently long ARNA which is in clinical trials to develop a drug to treat pulmonary arterial hypertension (PAH) of which MNKD has stated is the next product it plans on developing and has had favorable discussions with the FDA about an inhalable form of an existing approved treatment. This in and of itself brings into question the distinct possibility that there is an inherent potential of a conflict of interest. As much as the author may feel that potential issue doesn't exist, the fact remains that it absolutely does due to the direct competitive nature in the pharmaceutical business. The author should not take it personally but rather accept that as long as he has a potentially competing position it can lead to some questioning if nothing else at a minimum the potential for sub-conscious bias to exist.

Also a fact in full disclosure I am long MNKD and also have a direct conflict of interest as a current user of Afrezza. However, although gains financially from any appreciation of the equity would of course be welcomed, more importantly is my interest in seeing the drug's success from a selfish health aspect as well as for others that are afflicted with the disease. It has taken me close to two years to get my prescription filled primarily due to being on United Healthcare's plan and prescription arm via OPTUM. Thankfully that has changed due to having the option during my most recent open enrollment to switch to Express Scripts which covers Afrezza with no issues.

MNKD's corporate mgmt. and sales team were instrumental in helping me both with referring me to an existing endo practice that has worked with and is an advocate of the product since the SNY rep was calling on them. If appointment times are any indication their practice must be thriving due to length of time to schedule a visit. Having since started on Afrezza, my blood glucose levels have dropped to much more manageable levels and I fully expect that at my next scheduled visit my labs will show a significant drop in my Hba1c reading.

I recently met with as some may know as Spiro who has been on Afrezza for almost two years and his reading (which have been posted publicly) continue to come in at non-diabetic numbers with no reported side effects.

I do not disagree with the author's current numbers regarding scripts, however, I do believe that the ad campaign and continued progress with patient and provider awareness and demand, the pressure and long battle with insurance will absolutely eventually get resolved. The ultimate question is how long will that take but the company continues to make progress every day/week/month as time goes by.

Overall, considering this was essentially originally a research and manufacturing entity it has made RELATIVELY considerable strides in becoming a stand alone innovative pharmaceutical company.

Regarding the s/p one has to also realize that there was all time record short interest (as of close of business 11/30) so the battle between those hardened in their investing beliefs continue to make this a battleground stock, although with the competitive nature of the industry and what's potentially at stake it should not come as any surprise to those that have been following it for years.