|
Post by ilovekauai on Jun 20, 2016 13:57:09 GMT -5
Or from Piso, Italy! Arrivederci...
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Jun 20, 2016 14:22:34 GMT -5
Looks like Mike H pretty much confirmed they are reducing the price come July. "Part of the re-launch includes a new NDC (National Drug Code) number that standardizes the Afrezza copay as a single price-point instead of the patient having to pay different copays for varying cartridge concentrations. MannKind won't be releasing that cost until July, but it will be less than the approximate $19 per day it costs the average patient using an injectable mealtime insulin."www.healthline.com/diabetesmine/afrezza-news-updatesmadog, in the kindest way, in the past I have done the math. $125 dollar vial apidra/ 30 days = $4.16 250 dollar 4u/8u 30 day afrezza = 8.33
as I recall I found an article that put fast acting at $3.19/day. afrezza was running 10 to 11 dollars a day.
I have never seen $19 dollars a day for injectable meal time insulin.
Data from some studies showed: •Onset of action within 16 to 21 minutes for Afrezza compared to 45 to 52 minutes for subcutaneous insulin across trials •Afrezza's duration of action at clinically relevant doses was consistently shorter by 2 to 3 hours •Afrezza's labeled dose overestimates its effect, meaning patients need better titration to get the appropriate dose •A 4-unit Afrezza cartridge provides approximately the same insulin exposure as 3.1 units of Humalog. •Lung tests showed PWDs didn't experience any negative lung effects after three months going up to 24 months
This is interesting and so relevant to where mnkd is today. I recall this pricing from last year - afrezza was running about 8/day and injectables were running about 3-4/day. I made the assumption at the time that the cost was pegged to cover sny and mnkd's costs plus some profits. Cutting sny out of the loop sort of helps - at least mnkd doens't have to factor in sny's profit margin. The cost to produce afrezza is still an unknown - unless it's been made public and I missed it (anyone?). Assuming those numbers aren't out there yet, that's the big question - what is the cost to produce afrezza?! While I don't expect matt to provide that level of detail, we will know the costs of producing afrezza when they announce their new pricing or when we simply discover it over time. MNKD can't afford to sell afrezza at a loss, they don't have resources to play that game and a lot of expenses beyond just admin and manufacturing. But I do expect mnkd to reduce the cost down to the bare bones and still turn a profit on each script written. Otherwise, what's the point?! So, the questions I am waiting to have answered, or, at least enough info that I can extrapolate a reasonable assumption are these: 1. what is the cost of production? 2. what is the break even price point per script? 3. how many scripts need to be written to meet expenses? Answers to 1-3 above will tell us whether they can reduce the cost to match or beat injectables. Simply reducing the price doesn't tell investors what they need to know. lol...well, at least until it's too late, like the next quarterly call but as an investor that's too late. I'm pretty sure matt wont' tell us any of this but either they have a complete handle on this or someone isn't doing their job. It's one or the other. But one thing they can't hold close to the vest is sales price and from there we can make educated guesses on the rest with confirmation during quarterly's between rev's, earnings, and script counts.
|
|
|
Post by seanismorris on Jun 20, 2016 15:20:26 GMT -5
IMO the benefits of Afrezza far outweigh any perceived negs, so often and repeatedly brought up here by some. Time will tell if I'm correct, I stand by the future success of this company which is coming in the years ahead, and look forward to that time with great happiness; not only for the sake of MNKD and my investment, but for all diabetics worldwide who will benefit from this fantastic endeavor. Aloha. Almost everyone here was once a bull. We all thought Afrezza would sell itself because it was a superior product, but MannKind has made one misstep at another (granted many by Sanofi). Why hasn't MannKind done another clinical trial to show superiority? What efforts have they made to improve the label? If they did these things I'd be a lot more bullish. All I see them doing is burning cash. A sales force is going to help, pricing is going to help, insurance coverage is going to help... But are they addressing the fundamental problem? They need Docs to believe in superiority. What you and I think doesn't matter. I see them addressing 50% of the problem and that's not going to get us a win. There are many things I like about MannKind. Bringing Mike on board was fantastic. Their pipeline is promising (but a year away from data). Their fundamental research is excellent and their patent protection is top notch. But their clinical trials and their trial design has been atrocious. As things stand, I don't think they can sell (the idea of) Afrezza to Docs. I think Docs feel like beta testers, rather than something they can prescribe with confidence.
|
|
|
Post by prvs on Jun 20, 2016 15:44:15 GMT -5
If you google the Italian Dr's name and SNY you can find they have paid him multiple times in the past for "research support" I googled and didn't find this. Do you have a link? Not that I don't believe there are paid bashers out there, it was just hard to find that info via google. Thanks
|
|
|
Post by ilovekauai on Jun 20, 2016 15:50:43 GMT -5
Mahalo for your opinion. Time will tell as stated by me how it shakes out. IMO you're not willing to give the 2.0 Launch a shot to succeed for whatever, in lieu of all the progress accomplished since January, which is very noteworthy IMO. I'm willing to give the new launch a chance. You mention: "almost everyone here once was a bull." Actually, I suspect almost everyone here, still is. Cheers.
|
|
|
Post by kc on Jun 20, 2016 15:56:48 GMT -5
If you google the Italian Dr's name and SNY you can find they have paid him multiple times in the past for "research support" Sanofi and many other Pharma's paid him.
Faculty and Disclosures www.medscape.org/viewarticle/806373 WebMD Global requires each individual who is in a position to control the content of one of its educational activities to disclose any relevant financial relationships occurring within the past 12 months that could create a conflict of interest.
Stefano Del Prato, MD
Professor, Department of Endocrinology and Metabolism, University of Pisa School of Medicine; Director, Section of Metabolic Diseases and Diabetes, Azienda Ospadaliero-Universitaria Pisana, Pisa, Italy
Disclosure: Stefano Del Prato, MD, has disclosed the following relevant financial relationships: Served as an advisor or consultant for: AstraZeneca Pharmaceuticals LP; Boehringer Ingelheim Pharmaceuticals, Inc.; Bristol-Myers Squibb Company; Eli Lilly and Company; GlaxoSmithKline; Intarcia Therapeutics, Inc.; Janssen Pharmaceuticals Products, L.P.; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Novo Nordisk; Roche; Takeda Pharmaceuticals North America, Inc. Served as a speaker or a member of a speakers bureau for: GlaxoSmithKline; Novartis Pharmaceuticals Corporation; Sanofi Received grants for clinical research from: Merck & Co., Inc.; Novo Nordisk; Sanofi; Takeda Pharmaceuticals North America, Inc.
Dr Del Prato does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the European Medicines Agency.
Dr Del Prato does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the European Medicines Agency.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Jun 20, 2016 16:31:41 GMT -5
Ba Fungul Stefano
|
|
|
Post by LosingMyBullishness on Jun 20, 2016 16:54:32 GMT -5
In order for Afrezza to be a success, the price needs to be competitive or discounted with rapid acting insulins. Given its non-inferiority, I don't see how payers, insurance companies and doctors can ignore Afrezza once the price is reduced. The question is, when will MannKind reduce the price? Mike Castagna feel free to chime in. I would argue that the primary underlying problem is that the label says: "AFREZZA provided less HbA1c reduction than insulin aspart, and the difference was statistically significant. More subjects in the insulin aspart group achieved the HbA1c target of ≤7% (Table 4)" Even lowering the price can't overcome that comment. An insurer looking at reimbursing type 1s is bound to ask why should it pay anything at all for something that is less effective; the argument being that long term costs of complications could outweigh short term savings from a cheaper insulin. What is really needed is a study to conclusively demonstrate that afrezza is superior to lispro. That would pretty much solve most of the product's problems. I understand that this is what the label says. Do you also see the main argument of all the Afrezza users are that they could achieve lower A1c values and could keep it in a much smaller = healthier range than with all the other more sluggish mealtime insulin?
|
|
|
Post by capnbob on Jun 20, 2016 17:37:48 GMT -5
I would argue that the primary underlying problem is that the label says: "AFREZZA provided less HbA1c reduction than insulin aspart, and the difference was statistically significant. More subjects in the insulin aspart group achieved the HbA1c target of ≤7% (Table 4)" Even lowering the price can't overcome that comment. An insurer looking at reimbursing type 1s is bound to ask why should it pay anything at all for something that is less effective; the argument being that long term costs of complications could outweigh short term savings from a cheaper insulin. What is really needed is a study to conclusively demonstrate that afrezza is superior to lispro. That would pretty much solve most of the product's problems. I understand that this is what the label says. Do you also see the main argument of all the Afrezza users are that they could achieve lower A1c values and could keep it in a much smaller = healthier range than with all the other more sluggish mealtime insulin? The problem is that "the main argument of all the Afrezza users " will not be used to assign tier or to decide reimbursement. Insurance companies work strictly from well-designed clinical trials.
|
|
|
Post by kc on Jun 20, 2016 17:45:41 GMT -5
I understand that this is what the label says. Do you also see the main argument of all the Afrezza users are that they could achieve lower A1c values and could keep it in a much smaller = healthier range than with all the other more sluggish mealtime insulin? The problem is that "the main argument of all the Afrezza users " will not be used to assign tier or to decide reimbursement. Insurance companies work strictly from well-designed clinical trials.
That is very problematic for us that Insurance companies work that way. Mike C. retweeted this link today from Abbvie and It perfectly outlines this issue. go to the site and read about it.
|
|
|
Post by peppy on Jun 20, 2016 17:52:19 GMT -5
I understand that this is what the label says. Do you also see the main argument of all the Afrezza users are that they could achieve lower A1c values and could keep it in a much smaller = healthier range than with all the other more sluggish mealtime insulin? The problem is that "the main argument of all the Afrezza users " will not be used to assign tier or to decide reimbursement. Insurance companies work strictly from well-designed clinical trials.
You know not of what you speak. www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM191895.pdf look at enough clinical trials, and you realize, some very poor drugs approved quickly on very poor clinical trials. Rats and 6 week clinical trials.
|
|
|
Post by LosingMyBullishness on Jun 20, 2016 17:54:04 GMT -5
I understand that this is what the label says. Do you also see the main argument of all the Afrezza users are that they could achieve lower A1c values and could keep it in a much smaller = healthier range than with all the other more sluggish mealtime insulin? The problem is that "the main argument of all the Afrezza users " will not be used to assign tier or to decide reimbursement. Insurance companies work strictly from well-designed clinical trials. Cap, I understand your comment. I also understand that insurers care most about spending less for more. I reckon that such statement that they require extensive studies is more to fence off new expensive medication or new obscure treatments. Insurers also know how the FDA work. It is not very difficult to see that the trials were carried out in such a way that Afrezza could not play out its capabilities. People from the trials were very clear and consistent about it. And you believe that insurers willfully ignore this even when they have a chance to spend less money? I do not see this dogmatic approach. FDA yes, insurers no. Insurers will see a potential and will ask for a high discount because of the label.But they will not reject it because of the label. My assumption with all due respect is that you exaggerated this issue.
|
|
|
Post by capnbob on Jun 20, 2016 23:42:05 GMT -5
The problem is that "the main argument of all the Afrezza users " will not be used to assign tier or to decide reimbursement. Insurance companies work strictly from well-designed clinical trials. Cap, I understand your comment. I also understand that insurers care most about spending less for more. I reckon that such statement that they require extensive studies is more to fence off new expensive medication or new obscure treatments. Insurers also know how the FDA work. It is not very difficult to see that the trials were carried out in such a way that Afrezza could not play out its capabilities. People from the trials were very clear and consistent about it. And you believe that insurers willfully ignore this even when they have a chance to spend less money? I do not see this dogmatic approach. FDA yes, insurers no. Insurers will see a potential and will ask for a high discount because of the label.But they will not reject it because of the label. My assumption with all due respect is that you exaggerated this issue. People deciding on formularies don't research opinions on whether a trial was carried out "correctly." They read the results, assess the quality of the statistics, and go from there. That's the reason afrezza isn't covered at present. Take Cigna, for example: www.cigna.com/pdf/jan-2016-prescription-drug-list-changes.pdfNote in the "advantage drug list" and the "value prescription list," Humalog is covered but Afrezza, Apidra, Novolin, Novolo are not. In the "Cigna National (Standard) and Performance Prescription Drug List," Humalog, Novolin, and Novolo are covered but Afrezza and Apidra are not. Cigna most likely brokered some "deal" with Lilly and couldn't care less how apidra or novolin or afrezza compared. To them they are all just "non-inferior" to humalog.
|
|
|
Post by capnbob on Jun 20, 2016 23:56:51 GMT -5
|
|
|
Post by mnkdfann on Jun 24, 2016 20:04:09 GMT -5
While I don't expect matt to provide that level of detail, we will know the costs of producing afrezza when they announce their new pricing or when we simply discover it over time. MNKD can't afford to sell afrezza at a loss, they don't have resources to play that game and a lot of expenses beyond just admin and manufacturing. But I do expect mnkd to reduce the cost down to the bare bones and still turn a profit on each script written. Otherwise, what's the point?! So, the questions I am waiting to have answered, or, at least enough info that I can extrapolate a reasonable assumption are these: 1. what is the cost of production? 2. what is the break even price point per script? 3. how many scripts need to be written to meet expenses? Answers to 1-3 above will tell us whether they can reduce the cost to match or beat injectables. Simply reducing the price doesn't tell investors what they need to know. lol...well, at least until it's too late, like the next quarterly call but as an investor that's too late. I'm pretty sure matt wont' tell us any of this but either they have a complete handle on this or someone isn't doing their job. It's one or the other. But one thing they can't hold close to the vest is sales price and from there we can make educated guesses on the rest with confirmation during quarterly's between rev's, earnings, and script counts. If you look at the article "MannKind will market AFREZZA Better" mentioned in the Articles forum on this board, I think the answer is plain that the price will not be matching or beating that of injectibles. At least that is my takeaway from these statements by Castagna: "The next big objection is around cost because people perceive Afrezza to be more expensive than currently marketed injected mealtime insulin, but we just completed an analysis and the average cost to society for a rapid acting analogue is around $19/day, but the out of pocket costs vary by insurance design/coverage. In spite of a 35% price increase in injected meal-time insulin in the last 24 months since Afrezza was reviewed by the FDA, Afrezza has had zero price increases during that time, yet we still get accused of being too expensive." "We will strive to be more innovative around how payors will evaluate our brand value proposition because you can’t compare a Tesla and a Prius and claim that because they are both electric they should cost the same on a retail or discounted basis." He seems to be prepping people for a "why Afrezza is worth paying more for" type of campaign. Not sure insurers will buy in. We'll see.
|
|