Frankly, I'm not sure what to think about script numbers from the various data services. The market is tracking these carefully, but nobody can tell me exactly who is represented by these numbers. Even worse, people are comparing Afrezza script numbers to Exubera script numbers without knowing if there have been any changes to the way data was collected then vs now. I wish I had industry expertise, but sadly I do not.
Seems like the next solid data point won't come until the end of April when Sanofi reports its quarter. I doubt we get actual sales data, but management should at least comment about the launch. When do they plan to start the post marketing safety study required by the FDA? When do they plan to move forward with a NDA for Afrezza in Europe? What kind of direct to consumer advertising will the FDA let them do?
From the industry? No? Hedge fund smart#$%$? Posting under multiple names? Anybody here actually know the answer to this question?
Afrezza is great for poor seniors. Med management is a nightmare for elderly. Same goes for some of the poor who don't speak English. I think its where the drug gets traction first.
Do you work in healthcare? Your past posts don't suggest that. Nobody likes an NYC hedge fund smart@ss
Poor diabetics are generally treated by PCPs. In addition, most rxs are handled by a pharmacy benefit management company, which is usually separate from the insurer. How do you know that an insurance company won't pay?
Medicaid is an important early player.
I read that Afrezza is getting on the state medicaid formularies in places like TX. Primary care docs treat diabetics on medicaid, not Endos. I think we could see traction here first.
This is awesome news! My wife interviewed with a UT clinic in El Paso. She didn't end up taking the job, but seeing what primary care docs in under served areas have to face was eye opening. The typical pt is hispanic, has advanced type II diabetes and probably high blood pressure. Might already be seeing the first signs of peripheral neuropathy. The doc has a 15 - 30 min window to treat this person. No way pt is getting insulin on the first visit. There isn't enough time for the education required. The pt gets a "sugar is killing you" lecture along with metformin and instructions to see an endo. Of course, pt can't afford an endo, so insulin might be started on the next visit to the clinic if there ever is one. In any case, the doc has to under prescribe insulin because if the pt has a hypo, they won't inject again, and it could end up killing them. The clinic's typical pt has less than a high school education, and its easy to make a mistake with dosing. Plus, Hispanics hate to inject. Probably not big $$$$ here but a heck of a lot of goodwill.
It is really, really tough for me to get a clear read on insurance coverage for Afrezza. For example, from what I understand, there is no uniform Medicare Part D formulary. It depends on which private pharmacy benefit management plan you go with. In addition, for private pharmacy benefit management companies, there is more than one formulary depending on which insurance company administers the policy and which sub plan you have. My Mother and myself both have Express Scripts as our pharmacy benefit management company. My mother is retired, and her insurance company is BCBS of NJ. I priced Afrezza at $15 per 90 day supply mail order with her plan. I am working, and my insurance company is Aetna. I priced Afrezza at $100 per 90 day supply mail order with my plan. So, what is Express Scripts coverage of Afrezza? Well, it depends. Does anybody know if there is some kind of central clearing house where all this data from all these plans is kept?
A second, but equally important issue is the relationship between the insurance company (eg. Aetna) and the pharmacy benefit management company (eg Express Scripts). Clearly, the insurance company pays the PBM for its services, but the details are a mystery to me. Everybody keeps talking about how Afrezza will save insurance companies money in the long run because of reduced hypos, but I'm not sure that matters to the PBM. They just want to provide treatment at the cheapest cost and make a profit. For the PBM to want to give preferred status to Afrezza, the insurance companies are going to have to somehow pay them more. Does anybody know how often contracts are renewed between insurance companies and PBMs? Seems like the process could take quite a while to work.
FWIW, the social media posts are not 100% positive, but most people clearly like the drug. Afrezza User goes into some reasons why he thinks current user experience will be better than trials, so you might want to check his twitter. With all of that said, I still think your concern is legit. There is clearly a group of people for which Afrezza has been life changing. They are mostly Type 1s, and they are very vocal.
The thing about any kind of social media is that it tends to over weight extreme opinions, either good or bad. A person who has an average experience seldom takes the time to post. What the current buzz tells me is that almost nobody is having a bad experience with Afrezza, and at least some people are having a great experience with it, but we have no idea about the proportion of average versus great. We need to be careful not to make too much of this too soon.
As far as being a D-bag is concerned, I think the people who voted thumbs down on your post are the real d-bags. The fools who go around screaming buyout and huge scripts on Friday are doing much more harm than good. Let's keep our expectations realistic. Geeez
The median time to maximum effect of AFREZZA (measured by the peak rate of glucose infusion). See rxlist. The sample size is 12. Way too small.
I wouldn't call Russ a dim wit. His post sounded pretty intelligent to me. In any case, the blumb about inhaling the powder directly was an anon comment, not from Russ. My point about there not being enough PD data remains.
Somebody else posted about this before, but I wanted to bring it up again. If you go to Afrezza rxlist, you will see both listed. The punchline is that, according to data there, Afrezza gets to the patient faster but actually brings blood sugar down at the same rate as rapid acting insulin. We know this isn't true for guys like Afrezza User and Peakabull, but I did find one blog by Russfit where he claims that it worked slower than his RAI. So looked at the details on rxlist and found out that this Pharmacodynamics was only measured for 12 type one diabetics. And the standard deviation of that 12 person sample was HUGE. Its hard for me to understand why MNKD would get so little data on something so important. For those who have looked at the clinical trial data in detail ... is there any place where a more extensive study of Pharmacodynamics has been done? This is really, really important.
Google has given me prices between $75 and $5,000. I think a doc on here posted that he bought one for $40, but another person said they cost around $500. Most small practices are cheap. How sophisticated does the machine really need to be?
BTW, I know docs can charge for this test and make money if Afrezza takes off, but its a chicken and egg sort of thing, and initial cost does matter.
Afrezza will start at tier 3 on everybodys formulary. That's SOP. You are right that it won't be a first line treatment for type 2s, Metformin comes first. Plenty of pts need more. I can't understand why anybody would need preapproval from insurance if Afrezza were priced like a pen. Having imaginary friends is a sign of schizophrenia, not diabetes. You sre on the wrong board.
Any Endo response you get from this board would automatically be biased.
FWIW, my wife is a doc, and she does occasionally change meds pts who are doing well if they ask. The average pt is too complacent to do that, but a small minority will, and most docs will say yes as long as there are no lung issues. Medicine is a business, and you need to keep the customer happy unless there is a good reason not to. I don't expect this kind of thing to generate much in the way of sales, but it might actually bring a few docs on board. A knowledgable pt asking about a new drug makes an impression on a good doc.
First Endos, then GPs, then the consumer. The only consumer outreach near term is likely to be social media and PR. This is going to be a garden variety launch, and Afrezza is going to have to be vetted by the medical community just like every other new drug. Its not a bad thing, its just that some of you have unrealistic expectations.
Before Toujeo is launched (if it is approved), SNY's diabetes sales force has no other new products to talk about. So, from a sales call standpoint to Endos, Afrezza should get plenty of bandwidth. I don't expect any mass media direct to consumer ads, but I don't recall that happening with any new product launch. Other than that, Afrezza should have all the usual tchotchkies, brouchures and coupons.
SI bothers me too. This isn't retail, and the big boys have access to info we do not. If I had to guess about the short thesis, they think
1. Its Exubra.
2. Even if it isn't, it uses too much insulin and margins will be bad.
I don't think its Exhubra, but I do worry about margins. Not sure what bulk insulin costs. Not sure what other material costs there are. We can estimate overhead based on current depreciation, but its not enough to make me comfortable. Would really love to hear from others on this one.