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Post by kfchen1988 on Aug 14, 2015 9:22:14 GMT -5
I need help understand the Insurance Coverage for Afrezza. Why does it take 6 months to 12 months before those insurance company start thinking about MNKD's Afrezza as stated in the CC? How come Sinofi's other products get better insurance coverage when they launched?
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Post by mnholdem on Aug 14, 2015 10:01:12 GMT -5
By "other" I assume you mean Toujeo. The reason Toujeo is getting insurance coverage right out of the gate is because Toujeo is the exact same drug molecule used in the popular Lantus. Insurers consider Toujeo as being the same as Lantus, only stronger.
Afrezza, on the other hand, is totally new and there is nothing like it. Insurers typically want more information than is provided by the drug company before assigning a new drug a Tier level, so it's commonplace for them to wait 6-12 months to learn more before reviewing it.
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Post by joeypotsandpans on Aug 14, 2015 10:03:50 GMT -5
I need help understand the Insurance Coverage for Afrezza. Why does it take 6 months to 12 months before those insurance company start thinking about MNKD's Afrezza as stated in the CC? How come Sinofi's other products get better insurance coverage when they launched? Toujeo is based off the same molecule as Lantus, it doesn't get the "new drug block", plain and simple. Afrezza is totally new and the bitch left her footprint with the "non inferiority" as opposed to proving "superiority" designed trials. They were admonished by the panel member that questioned why they set up the trials that way...of course they couldn't answer the question but later in the lunch line overheard saying "orders from above". The HF shorting and the minions working for them knew they had plan B which was if/when it got approved with a "non inferior" label not to mention the black box warning and spirometry requirement it would buy a decent amount of time as it coincided with the competition lowering pricing to monopolize the formulary status. The coordinated marketing blitz you see with ads now on TV touting "approved by most insurance plans" is too obvious... They knew all along they had the inside rigged, it exuded from their brash smug confidence (how many times have you heard a long say they're too confident like they know something)...however, they didn't realize what they were up against regarding the Sam's and Eric's which reinforced the longs confidence...thus you have the battleground that has become the continuing MNKD saga. c'est la vie until someone or something takes on the establishment...hopefully it is SNY in this case  mn just saw you beat me to it...but figured I would add some background |
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Post by kfchen1988 on Aug 14, 2015 10:06:00 GMT -5
Understood! Thank you Guys!
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Post by mnholdem on Aug 14, 2015 10:22:06 GMT -5
Thanks, joey.
I posted that exchange from ADCOM (reprinted below) where a physician seemed incredulous when he asked the FDA trial lead who was responsible for not designing the protocols to show superiority. "Me personally" came the reply from the FDA doctor, who explained that he considered placebo injections to be unethical. That may have lit off a firestorm, but the physician had the grace to explain that many, many, MANY trials use placebo injections, to which the FDA doc changed the tune to, "we wanted to be fair."
It seemed hypocritical, to me, that somebody at the FDA made certain that Afrezza would NOT be treated fairly. Just my opinion.
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[reprint - link below]
As long as I'm complaining, in another part of the ADCOM transcripts, a physician challenges the FDA, stating that the trial protocols could have easily been used to prove superiority. Who was responsible for this? Read on...
Clarifying Questions Page 196 – Page 210
Page 202
1 DR. CALHOUN: Thanks. Bill Calhoun. I
2 have two questions for Dr. Yanoff and one for Dr.
3 Paterniti. First question for Dr. Yanoff. You
4 also commented on your Slide 22 that this was an
5 unblended study. It's a non-inferiority, and so
6 errors in -- or limitations in the execution of
7 this study will bias toward no difference, which,
8 in fact, as we heard this morning, then favors
9 finding a non- inferiority finding as opposed to a
10 superiority study, in which the bias toward the
11 null is a conservative approach.
12 The question is the FDA's been working
13 with the company for five years, by my count, in
14 pulling this product to market. And so the
15 question is was the agency responsible for
16 recommending a non- inferiority, unblended design
17 for the primary efficacy study?
18 DR. YANOFF: Yes, FDA was involved, me
19 personally, after the first submission, in
20 recommending the trial designs for the two studies
21 that they -- we wanted them to come in with the --
22 with the two new devices. And since we wanted to
Page 203
1 try to limit it to two studies, one in type 1 and
2 type 2, because we already had some data with the
3 MedTone device, we really had to go for what would
4 be the best trial for each type of diabetes. And
5 in type 1, a placebo-controlled trial would be
6 non-ethical, so
7 DR. CALHOUN: And explain to me why that
8 is? Because that would be an injection -- the only
9 thing it would add would be an injection of
10 placebo in those people who are randomized to
11 active inhaled drug, and the addition --
12 DR. YANOFF: Right.
13 DR. CALHOUN: -- of a dummy inhaler to
14 those who were getting injected -- and that's
15 certainly not -- in my view, that's certainly not
16 unethical. We have trials that are far more
17 invasive than that --
18 DR. YANOFF: Uh-huh.
19 DR. CALHOUN: -- in other therapeutic
20 areas, so I don't think that's unethical at all.
21 DR. YANOFF: I appreciate your view. In
22 general, in the Division of -- in DMEP, we've
Page 204
1 approached all -- tried to be fair to all the
2 programs, and in general, our approach has been to
3 not require blinded studies for type 1 --
4 DR. CALHOUN: Okay.
5 DR. YANOFF: -- to require dummy
6 injections.
Pretty lame answer by the FDA's Dr. Yanoff. The FDA does not require blinded studies (which could indicate superiority) for type 1 because they want to be fair?
Read more: mnkd.proboards.com/user/407/recent?page=6#ixzz3insC9880
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Post by abcabcacba1 on Aug 14, 2015 10:33:57 GMT -5
WHY Sanofi did not target Afrezza to type 2, majority of diabetic patient? Or insurance accept family medicine doctor to write a prescription?
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Post by jay1ajay1a on Aug 14, 2015 10:37:44 GMT -5
You have to love the way this all works.
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Post by joeypotsandpans on Aug 14, 2015 11:12:38 GMT -5
You have to love the way this all works. Would love to see class action lawsuit against the insurance companies to expose everything that is criminal behind this...I have UHC just like NCcapitalist...same issue, I'm sure we could find a diabetic attorney that might prefer this treatment...it wreaks of anti trust as well, just flat out wrong on so many fronts! |
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Post by traderdennis on Aug 17, 2015 13:11:15 GMT -5
WHY Sanofi did not target Afrezza to type 2, majority of diabetic patient? Or insurance accept family medicine doctor to write a prescription? It is going to take some time. There are very cheap drugs for type 2's so there is a cost justification hurdle to get through. |
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