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Post by dreamboatcruise on Jan 4, 2016 9:46:13 GMT -5
As I had worried it looks like the formulary numbers worsened slightly with the new year. According to formularylookup.com 3% went from "covered" to "restricted" (assuming this isn't another glitch, but we had anecdotal reports this was happening). At least that isn't a big number.
On that news I may actually be buying a bit more. Seems like there is a confluence of negative news now, with possibility we start turning positive from here.
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Post by Deleted on Jan 4, 2016 9:56:57 GMT -5
total plans reduced to 6933 from 6952. restricted went down from 1470 to 1449 . not covered from 3143 to 3175 . covered from 2248 to 2227 . preferred from 91 to 82
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Post by silentknight on Jan 4, 2016 10:22:45 GMT -5
We all knew that would be the case. Posters here informed us a few months ago that their plans had removed or reduced coverage for Afrezza. As we see insurance coverage getting worse for 2016, again, I ask the question "What has SNY been doing for the last year?"
Script numbers are not improving, insurance coverage is not improving, and there have been no updates on studies or efforts to improve the label nor any strategy to increase sales. Last year, Sanofi partnered with Regeneron to launch their cholesterol fighting drug, Praluent. In only four months, FOUR MONTHS, the drug had been listed as preferred under insurance plans. I understand that not every drug launch is the same, and there there are special circumstances with each, but if you can make a drug preferred under health plans that costs in excess of $14,000 per year, then you can't tell me that you can't do the same with Afrezza.
They might blame the label and the box warning for everything, but there doesn't appear to be any effort on the part of SNY to improve that either, at least not through superiority studies or announced efforts. At a very minimum. they could be educating more GPs and Endo's on Afrezza to increase script numbers out of the 300/400 range per week for NRx. You can't tell me that a global drug company like SNY can't manage more than a rough average of 7 scripts per week out of each state in America with a diabetic population as big as it is.
Everything thus far screams of an intentional dedicated effort on the part of SNY to limit Afrezza's sales and market saturation. Why? They express disappointment with sales and do nothing to improve them. It doesn't pass the smell test, especially given the recent lawsuit by Genzyme for their violation of their partnership with them.
I've said it before, but given what we've seen over the last year, if there was a strategy to bleed MNKD until they capitulate into a cheap sale or better yet bankruptcy to allow SNY to scoop up Afrezza for cheap, they couldn't be doing a better job than they are now.
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Post by lorcan458 on Jan 4, 2016 10:51:32 GMT -5
The new CEO starts tomorrow. He's speaking at an event in a couple of weeks. We'll have a pretty good idea if we will finally get a change in direction towards a more active, assertive and communicative approach. I've also never seen anything like this behavior from all involved (Mannkind, Sanofi, and Wallstreet) for any stock I've owned. The absolute disconnect between the quality of the product and the stock price is surreal, absurd in a way, with this absurdity reinforced by the behavior of both Sanofi and Mannkind. We should be at $18 - $25 with script counts 10x - 50x what we have.
The real world results are well established. The time to speak loudly (medical conferences, medical journals) about the proper dosing of Afrezza and the entirely different methodology of diabetes management is overdue. I realize there are legal constraints on advertising to the public, what I am talking about is persistent, ubiquitous publishing of real world results being in front of doctors and pharmacists.
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Post by Deleted on Jan 4, 2016 10:55:06 GMT -5
The new CEO starts tomorrow. He's speaking at an event in a couple of weeks. We'll have a pretty good idea if we will finally get a change in direction towards a more active, assertive and communicative approach. I've also never seen anything like this behavior from all involved (Mannkind, Sanofi, and Wallstreet) for any stock I've owned. The absolute disconnect between the quality of the product and the stock price is surreal, absurd in a way, with this absurdity reinforced by the behavior of both Sanofi and Mannkind. We should be at $18 - $25 with script counts 10x - 50x what we have. The real world results are well established. The time to speak loudly (medical conferences, medical journals) about the proper dosing of Afrezza and the entirely different methodology of diabetes management is overdue. I realize there are legal constraints on advertising to the public, what I am talking about is persistent, ubiquitous publishing of real world results being in front of doctors and pharmacists. The only connection to the stock price are script counts. The quality has nothing to do with the stock price. If quality had anything to do with it there would not be a 120 million shares short. Scripts increase so will the share price. |
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Post by compound26 on Jan 4, 2016 11:48:23 GMT -5
As I had worried it looks like the formulary numbers worsened slightly with the new year. According to formularylookup.com 3% went from "covered" to "restricted" (assuming this isn't another glitch, but we had anecdotal reports this was happening). At least that isn't a big number. On that news I may actually be buying a bit more. Seems like there is a confluence of negative news now, with possibility we start turning positive from here. DBC, there is also evidence that in certain instances, even though the formulary placement did not change, the prior authorization requirement for Afrezza has been removed. In other words, the formulary tracker does not reveal all the improvements in insurance coverage. Perhaps it is easier for Sanofi to persuade the insurance company to remove the PA requirement than to persuade the latter to move Afrezza to tier 2? If that is the case, hope more and more plans will follow suit and remove the PA requirement for Afrezza. mnkd.proboards.com/post/54332mnkd.proboards.com/post/54327mnkd.proboards.com/post/54306 |
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Post by mnholdem on Jan 4, 2016 11:50:30 GMT -5
My apologies for not posting the Monday numbers earlier this morning, but I had to play some catch up at the office after returning from a 2-week holiday hiatus.
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I really was hoping to see a significant jump, similar to glitch that FormularyLookup posted, then rescinded, several weeks ago when a full 10% of plans moved from Not Covered to Covered. I suppose that FL could still be waiting for some delayed submittals, but today's results are a disappointment to me.
It seems that most of those who have discussed this issue agree that 3rd Party payers are not going to move Afrezza to a better Tier level until either the label is improved or the price is reduced.
Sanofi isn't lowering the price. Does that indicate that they expect a label change? If so, when? Sanofi explained in 2014 that they would be planning to take actions to get label improvement. I honestly do not understand the strategic significance of them being so tight-lipped about their progress in this regard.
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Post by dreamboatcruise on Jan 4, 2016 11:52:51 GMT -5
We all knew that would be the case. Posters here informed us a few months ago that their plans had removed or reduced coverage for Afrezza. As we see insurance coverage getting worse for 2016, again, I ask the question "What has SNY been doing for the last year?" Script numbers are not improving, insurance coverage is not improving, and there have been no updates on studies or efforts to improve the label nor any strategy to increase sales. Last year, Sanofi partnered with Regeneron to launch their cholesterol fighting drug, Praluent. In only four months, FOUR MONTHS, the drug had been listed as preferred under insurance plans. I understand that not every drug launch is the same, and there there are special circumstances with each, but if you can make a drug preferred under health plans that costs in excess of $14,000 per year, then you can't tell me that you can't do the same with Afrezza. They might blame the label and the box warning for everything, but there doesn't appear to be any effort on the part of SNY to improve that either, at least not through superiority studies or announced efforts. At a very minimum. they could be educating more GPs and Endo's on Afrezza to increase script numbers out of the 300/400 range per week for NRx. You can't tell me that a global drug company like SNY can't manage more than a rough average of 7 scripts per week out of each state in America with a diabetic population as big as it is. Everything thus far screams of an intentional dedicated effort on the part of SNY to limit Afrezza's sales and market saturation. Why? They express disappointment with sales and do nothing to improve them. It doesn't pass the smell test, especially given the recent lawsuit by Genzyme for their violation of their partnership with them. I've said it before, but given what we've seen over the last year, if there was a strategy to bleed MNKD until they capitulate into a cheap sale or better yet bankruptcy to allow SNY to scoop up Afrezza for cheap, they couldn't be doing a better job than they are now. I assume when you say ask, you intend that to be rhetorical... as you know as do the rest of us that we really have little info on what SNY has or has not been doing, because of their policy of not allowing MNKD to disclose any info. And your statement about no "updates" on efforts and strategy oddly implies that we were ever told details. It is a bit of a leap to go from saying we've had no updates on the efforts and strategy to saying "They express disappointment with sales and do nothing to improve them." Just because we are being told next to nothing does not mean nothing is being done. |
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Post by dreamboatcruise on Jan 4, 2016 12:33:00 GMT -5
As I had worried it looks like the formulary numbers worsened slightly with the new year. According to formularylookup.com 3% went from "covered" to "restricted" (assuming this isn't another glitch, but we had anecdotal reports this was happening). At least that isn't a big number. On that news I may actually be buying a bit more. Seems like there is a confluence of negative news now, with possibility we start turning positive from here. DBC, there is also evidence that in certain instances, even though the formulary placement did not change, the prior authorization requirement for Afrezza has been removed. In other words, the formulary tracker does not reveal all the improvements in insurance coverage. Perhaps it is easier for Sanofi to persuade the insurance company to remove the PA requirement than to persuade the latter to move Afrezza to tier 2? If that is the case, hope more and more plans will follow suit and remove the PA requirement for Afrezza. mnkd.proboards.com/post/54332mnkd.proboards.com/post/54327mnkd.proboards.com/post/54306If it is going from PA to any tier without step therapy requirement or PA then it should be reflected in formularylookup.com as switching from "restricted" to "covered". Hopefully if there are ones that have improved that will be reflected quickly. In some of those threads you cite I did see some comments that I think might have been comparing to 2015 plan documents posted before Afrezza was on the market... i.e. I'm skeptical of Afrezza going from not being mentioned on 2015 plan to being covered on 2016 as something that wasn't already reflected in the formularylookup.com numbers prior to years end. I would think most all formularies would have placed Afrezza somewhere, even if "not covered", prior to releasing 2016 formulary. |
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Post by silentknight on Jan 4, 2016 13:03:20 GMT -5
We all knew that would be the case. Posters here informed us a few months ago that their plans had removed or reduced coverage for Afrezza. As we see insurance coverage getting worse for 2016, again, I ask the question "What has SNY been doing for the last year?" Script numbers are not improving, insurance coverage is not improving, and there have been no updates on studies or efforts to improve the label nor any strategy to increase sales. Last year, Sanofi partnered with Regeneron to launch their cholesterol fighting drug, Praluent. In only four months, FOUR MONTHS, the drug had been listed as preferred under insurance plans. I understand that not every drug launch is the same, and there there are special circumstances with each, but if you can make a drug preferred under health plans that costs in excess of $14,000 per year, then you can't tell me that you can't do the same with Afrezza. They might blame the label and the box warning for everything, but there doesn't appear to be any effort on the part of SNY to improve that either, at least not through superiority studies or announced efforts. At a very minimum. they could be educating more GPs and Endo's on Afrezza to increase script numbers out of the 300/400 range per week for NRx. You can't tell me that a global drug company like SNY can't manage more than a rough average of 7 scripts per week out of each state in America with a diabetic population as big as it is. Everything thus far screams of an intentional dedicated effort on the part of SNY to limit Afrezza's sales and market saturation. Why? They express disappointment with sales and do nothing to improve them. It doesn't pass the smell test, especially given the recent lawsuit by Genzyme for their violation of their partnership with them. I've said it before, but given what we've seen over the last year, if there was a strategy to bleed MNKD until they capitulate into a cheap sale or better yet bankruptcy to allow SNY to scoop up Afrezza for cheap, they couldn't be doing a better job than they are now. I assume when you say ask, you intend that to be rhetorical... as you know as do the rest of us that we really have little info on what SNY has or has not been doing, because of their policy of not allowing MNKD to disclose any info. And your statement about no "updates" on efforts and strategy oddly implies that we were ever told details. It is a bit of a leap to go from saying we've had no updates on the efforts and strategy to saying "They express disappointment with sales and do nothing to improve them." Just because we are being told next to nothing does not mean nothing is being done. Of course my questions are rhetorical and you are correct. It is possible that they are doing something, but perception is reality and it certainly appears as if they aren't doing anything. You've seen short authors come out in droves to attack the stock, citing poor sales, lack of commitment by SNY, and silence from MNKD as major sources of evidence to support their positions. Can anyone offer any evidence to the contrary to refute them besides our hopes and beliefs that SNY is in fact working to improve it? I certainly can't and conjecture about what a few mysterious meetings might mean for the marketing strategy or improving sales lacks any concrete factual basis to do much either. The stock has been punished because of poor sales stemming from lack of insurance coverage and a price point that is ridiculously too high. It's a double whammy and certainly not a strategy I would employ if I wanted to make a product successful. On face value, it looks like SNY has gone out of its way to make Afrezza UNAVAILABLE to the public instead of the opposite. No doctor education, overpricing, and reducing insurance coverage is not a strategy that I would boast of if I was in their marketing department, that is, unless it's all intentional. Afrezza is unparalleled in the treatment of diabetes and more effective than anything on the market. That's a fact. We don't have the label to back it up, and perhaps they're working on it. Would it really expend that much effort and resources to make a statement along the lines of "Afrezza remains an important piece of our diabetes treatment strategy and we are committed to its success. We are currently undertaking efforts for label improvement via superiority studies and are exploring other options to ensure diabetics worldwide achieve better blood glucose control using this revolutionary new product." It would do nothing to harm their business plan and would do everything to shut up the naysayers, yet there is nothing. Why? There has been nothing but deafening silence from them. That is not what I would expect from a committed partner. |
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Post by silentknight on Jan 4, 2016 15:14:43 GMT -5
Case in point, a poster from YMB (stanleyttu) gave his account of having to convince his endo to prescribe Afrezza and claimed that the endo was awaiting his results before she prescribed it to additional patients. The endo's nurse said she had been educated about Afrezza only after the patient had expressed interest in the drug. That is not a story that is unprecedented and has become increasingly common among users.
If patients are having to do all the marketing for the drug by word of mouth, then why pray tell, has SNY has spent the last year wasting MNKDs time. There has been absolutely nothing to show for the last year from Sanofi besides flat script growth and no mention of the product save expressing their disapproval with sales. Afrezza's lack of market saturation is a direct result of Sanofi in my opinion either by incompetence or intention. Take your pick. They have been an obstacle to its success thus far and not an advocate for it as they should be.
I encourage both SNY and MNKD to refute my claim. But, if after a year doctors around the country still haven't heard of Afrezza and all the marketing we have that has proven successful is patient word of mouth, MNKD already had all the marketing efforts they needed without SNY. Throw in the lack of EU/Asia/Australia approval and I'm at a loss at what SNY brings to the equation at all.
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Post by mnholdem on Jan 4, 2016 15:32:21 GMT -5
It's quite likely that while Sanofi has been targeting a select group of diabetics, they've been missing the opportunity to bring Afrezza to other groups.
At his Presentation at IR Thematic Seminar of New Medicines, Andrew Purcell, Vice President, Commercial Business Unit Head U.S. Diabetes, gave the initial presentation of Sanofi's plan for commercializing Afrezza and indicated that Sanofi's initial target was going to be early diabetics who are resistant to starting insulin therapy. The targets were comprised of two groups:
- Insulin Initiation: Patients on 2+ OADs or GLP1 +/-OADS
- Insulin Intensification: Patients on Basal Insulin or Basal +/-GLP1+/-OAD
Sanofi's initial commercial strategy targeted 3.1 million early diabetes patients, but did not target patients on basal + prandial insulin, like Sam and/or Eric.
Instead, Sanofi targeted the diabetics who are on metformin, basal+metformin or another similar combination. Oral medications cost a few dollars per month compared to hundreds of dollars for Afrezza. While Afrezza was demonstrated to be superior to metformin, Sanofi has been attempting to convince 3rd party payers that Afrezza's health advantages outweigh the much lower costs of metformin and other oral meds.
Based on coverage, Sanofi doesn't appear to be winning them over.
Regardless, Purcell's Afrezza presentation stated "The launch will occur in two phases":
Phase One: 2015 U.S. Launch - Novel product delivery
- Early adopters
- Current label
Phase Two: Expansion Drivers - Potential ex-U.S. launches
- Supply of Sanofi insulin
- Label enhancement studies
- Safety study completion
There is no indication that Sanofi has begun Phase Two other than a few meager references by management at recent earnings calls that the JAC team is working on planning ex-U.S. launches. If Sanofi is sticking to the commercial plan that it presented, they should now be working on the expansion drivers. Also, based on results from early adopters, investors may think Sanofi would be wise to adjust their commercial strategy to expand their targets to include diabetics that are using basal + prandial insulin, thinking that market-based adjustment could cause script numbers to rise rapidly.
It appears that Sanofi sales reps are finally reaching the PCPs, so perhaps there will soon be an uptick in the number of weekly scripts being written. However, I think that the label enhancement studies are what have the potential to end the debate AND the struggle to negotiate for better coverage. That is the one announcement I am waiting patiently to hear.
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Post by shake34 on Jan 4, 2016 20:16:51 GMT -5
What does SNY have to do to get label improved? What kind of study needs to be done? How long would it take? Could they actually be working on this without us knowing about it? |
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Post by dreamboatcruise on Jan 4, 2016 20:35:04 GMT -5
What does SNY have to do to get label improved? What kind of study needs to be done? How long would it take? Could they actually be working on this without us knowing about it? A lot depends on what they are trying to get on the label. FDA trials are public, so no, nothing in secret. The already finished clamp studies might be used to change the label with regard to ketoacidosis, though that seems minor improvement. To get A1c improvement claim would require new trials not yet announced... the type would be a trial with proper protocols for Afrezza with a comparator group on traditional SQ RAA to show Afrezza can lead to lower A1c. Some have speculated that it would take minimum of 2 years for trial and label change. In my opinion trials could be done quicker but I don't have much insight into how long FDA review for a label change might take. |
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Post by peppy on Jan 4, 2016 20:40:43 GMT -5
What does SNY have to do to get label improved? What kind of study needs to be done? How long would it take? Could they actually be working on this without us knowing about it? I looked at this one time and found the answer in the guidelines. An increased improvement in HgA1c is the standard. So improved hgA1c on afrezza vs the hgA1c achieved by fast acting SubQ insulin. The studies done with afrezza; Afrezza was non inferior reduction in HgA1c but not superior reduction.
-------------------------------------------------------------------------------------------------------------------------------------- On another note and yet superiority is proven every day. screencast.com/t/TDdCuhKJ
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