|
|
Post by vdexdiabetes on Jan 8, 2019 12:39:19 GMT -5
I had to reply
"But this certainly isn't best for the patients." So true. If there's one overriding theme to the surprises we've learned at Vdex, it's how often patient care is sacrificed to some other consideration. Sad but true.
|
|
|
|
Post by InvesterSam on Jan 8, 2019 12:58:55 GMT -5
Uvula, we treat both Type 1 and 2 patients, obviously many more twos than one. Getting insurance coverage is difficult, and we certainly don't so much get coverage in place of metaformin, but in addition to it. Virtually all patients who come to us are uncontrolled (HbA1c well above 7) and on medication. Most patients are on metaformin and many of those are taking the maximum daily dose, 2000mg. In that case, because the patient is still uncontrolled, the physician needs another tool. We then have to work through the prior authorization process to get the Afrezza approved. Sometimes we succeed. Sometimes the insurance plan wants us to try some interim step like maybe a GLP. The physician has to fight for Afrezza. VDEX white paper showed an amazing result in diabetes control. However, I think the white paper may not have a good appeal to medical doctors because of the limited number of data which can potentially be cherry-picked. However, if you can present all 200+ data including not-so-dramatic results and even failures if exist, doctors may become more interested even though the VDEX patient population is biased, actively seeking treatment. Knowing the negative bottom-line is as much or even more important as knowing the positives. I am not in the medical field. And I do not know if there is required regulatory clearances to do it or not or your business related obstacles. My wishful thinking. Thanks. |
|
|
|
Post by uvula on Jan 8, 2019 13:14:55 GMT -5
With the vdex patient population, they can only show that Afrezza works great for patients that fail to respond to metfornin. The data say nothing about patients that do respond to metfornin.
We know what would happen if that clinical study was conducted, but we have no proof now.
|
|
|
|
Post by traderdennis on Jan 8, 2019 16:09:31 GMT -5
Thank you sayhey! When asking about HMOs, I was thinking Kaiser Permanente and other key payers. If Mankind could get them onboard would the dominoes likely start to fall?  Mike C said in the last call: “The third topic here I want address is payers/patient access. We are continuing to see positive payer coverage as we start out 2019 as evidenced by our recent signing of the contract with Kaiser [ph] and ongoing discussions with other key payers.” From the Kaiser website: Founded in 1945, Kaiser Permanente is one of the nation’s largest not-for-profit health plans, serving 12.2 million members, with headquarters in Oakland, California. It comprises: • Kaiser Foundation Hospitals and its subsidiaries • Kaiser Foundation Health Plan, Inc. • The Permanente Medical Groups Health Plan Membership, by Region Northern California: 4,288,153 Southern California: 4,530,385 Colorado: 655,437 Georgia: 356,744 Hawaii: 252,977 Mid-Atlantic States (Va., Md., D.C.): 772,340 Northwest (Ore./Wash.): 606,159 Washington: 705,267 Medical Facilities and Physicians Hospitals: 39 Medical Offices: 690 Physicians: Approximate as of June 30, 2018, representing all specialties 22,013 Nurses: Approximate as of December 31, 2017, representing all specialties 58,345 Employees: Approximate, representing technical, administrative and clerical employees and caregivers 217,173 Data as of September 2018, unless otherwise noted. KP is not likely to ever be a very large customer of Afrezza. Their protocols always emphasize generic medication over newer meds. Only specialist can prescribe non first line medications. KP prefers to use humalin and novalin (generic insulins) wherever possible. |
|
|
|
Post by ltta on Jan 8, 2019 17:17:46 GMT -5
Then I have to wonder what Mike C meant on the last call when he said:
“The third topic here I want address is payers/patient access. We are continuing to see positive payer coverage as we start out 2019 as evidenced by our recent signing of the contract with Kaiser [ph] and ongoing discussions with other key payers.”
Are Endos not considered specialists?
|
|
|
|
Post by traderdennis on Jan 8, 2019 19:19:13 GMT -5
Then I have to wonder what Mike C meant on the last call when he said:
“The third topic here I want address is payers/patient access. We are continuing to see positive payer coverage as we start out 2019 as evidenced by our recent signing of the contract with Kaiser [ph] and ongoing discussions with other key payers.”
Are Endos not considered specialists?
And the endos typically basic humilin -n . The number of hoops I saw some go to just to get pens instead of syringes are massive at KP. As a philosophy they are the most cost conscious HMO out there. KP is the closest model to European socialized medicines and not not likely to every prescribe designer drugs if there is a similar and even if it is not equal version out there. |
|
|
|
Post by sayhey24 on Jan 8, 2019 19:46:09 GMT -5
Positive payer coverage does not get you scripts. Doctors write the scripts. What I think I am hearing from VDex is with a little effort they are getting insurance coverage. The difference between VDex and the rest of the doctors is VDex is writing afrezza scripts. Until confronted with the option of writing the afrezza script or lose the patient they will continue to follow the current SOC. The problem is we need more VDex like clinics writing scripts. This clinic in the Bronx is designed for 600 PWDs per week and has 32 chairs. If we had 10 clinics doing 100 new scripts each week that would be a lot more scripts than we currently have with our 100 sales guys. amsterdamnews.com/news/2017/nov/16/diabetes-center-opens-south-bronx/ |
|
|
|
Post by vdexdiabetes on Jan 8, 2019 20:46:31 GMT -5
With the vdex patient population, they can only show that Afrezza works great for patients that fail to respond to metfornin. The data say nothing about patients that do respond to metfornin. We know what would happen if that clinical study was conducted, but we have no proof now. Uvula and investorsam, just to clarify a couple points: I do think doctors will tend to be dismissive of our White Paper results, but not because of the sample size. Rather, the results are subject to the criticism of not being the result of rigorous study design with double-blinded providers and the presence of a control group. We knew that when we wrote the paper. If you go back to the introductory part of the paper, you'll read a section where we say that Vdex is not a research organization but a diabetes-treatment practice. To reiterate the point, and I think it bears repeating, there are lots of studies with lots of medications that show significant clinical efficacy (some 40 new FDA approved meds for diabetes since 2005) in the controlled, artificial world of an FDA-type study. The drugs are all put through formalized study as was Afrezza. The real problem comes with everyday use in real patients. There is where you see many (perhaps most) diabetes drugs fail, or least underwhelm. Afrezza is just the opposite. The data gathered in the formal FDA trails was underwhelming, but in practice the drug does phenomenally well. In our White Paper we're simply documenting what happens in real-world use of Afrezza. And, isn't this where it matters? As an aside, MNKD has a treasure trove of data gathered with the Medtone inhaler device showing outstanding results, data that the FDA will not let them publicize in support of the Dreamboat device. There are lots of ways are White Paper might be criticized as a study, but it cannot be criticized as merely a report of our observations in the use of Afrezza in real-world patients. That's what it is. I guess one might say its just lies. I find it interesting how often our outstanding results are criticized, as if there are better results anywhere else. As if PWD are doing so well with existing meds and protocols. We know they're not! The diabetes industry acknowledges that few patients, something like 30%, get to goal of an HbA1c of 7. And 7 is nothing to be proud of. This is well above the point where microvascular damage occurs. So, even if you get a patient to 7, s/he will still have complications. And, by the way, often patients get to 7 for a while but over time as their disease worsens, they go higher. Our goal in founding Vdex was to get them to normal levels or at worst, below the point of microvascular damage which is an HbA1c of about 6.2. We can do this because of Afrezza. We really feel the situation ought to be flipped on its head. The diabetes industry ought to be asked to defend what they're doing. |
|
|
|
Post by mango on Jan 8, 2019 21:21:29 GMT -5
With the vdex patient population, they can only show that Afrezza works great for patients that fail to respond to metfornin. The data say nothing about patients that do respond to metfornin. We know what would happen if that clinical study was conducted, but we have no proof now. Uvula and investorsam, just to clarify a couple points: I do think doctors will tend to be dismissive of our White Paper results, but not because of the sample size. Rather, the results are subject to the criticism of not being the result of rigorous study design with double-blinded providers and the presence of a control group. We knew that when we wrote the paper. If you go back to the introductory part of the paper, you'll read a section where we say that Vdex is not a research organization but a diabetes-treatment practice. To reiterate the point, and I think it bears repeating, there are lots of studies with lots of medications that show significant clinical efficacy (some 40 new FDA approved meds for diabetes since 2005) in the controlled, artificial world of an FDA-type study. The drugs are all put through formalized study as was Afrezza. The real problem comes with everyday use in real patients. There is where you see many (perhaps most) diabetes drugs fail, or least underwhelm. Afrezza is just the opposite. The data gathered in the formal FDA trails was underwhelming, but in practice the drug does phenomenally well. In our White Paper we're simply documenting what happens in real-world use of Afrezza. And, isn't this where it matters? As an aside, MNKD has a treasure trove of data gathered with the Medtone inhaler device showing outstanding results, data that the FDA will not let them publicize in support of the Dreamboat device. There are lots of ways are White Paper might be criticized as a study, but it cannot be criticized as merely a report of our observations in the use of Afrezza in real-world patients. That's what it is. I guess one might say its just lies. I find it interesting how often our outstanding results are criticized, as if there are better results anywhere else. As if PWD are doing so well with existing meds and protocols. We know they're not! The diabetes industry acknowledges that few patients, something like 30%, get to goal of an HbA1c of 7. And 7 is nothing to be proud of. This is well above the point where microvascular damage occurs. So, even if you get a patient to 7, s/he will still have complications. And, by the way, often patients get to 7 for a while but over time as their disease worsens, they go higher. Our goal in founding Vdex was to get them to normal levels or at worst, below the point of microvascular damage which is an HbA1c of about 6.2. We can do this because of Afrezza. We really feel the situation ought to be flipped on its head. The diabetes industry ought to be asked to defend what they're doing.Time to go nuclear. |
|
|
|
Post by uvula on Jan 8, 2019 23:09:40 GMT -5
Just so my intentions are clear. I am not criticizing vdex or the white paper. Both are excellent. Others were suggesting that the vdex paper proved stuff that vdex never claimed it proved.
|
|
|
|
Post by vdexdiabetes on Jan 9, 2019 0:20:33 GMT -5
Uvula, I didn't take offense to any of your points or question your intentions. The value of this board and posters such as you is that you elicit information and clarify issues. All good. I failed to clarify a point you made in an earlier post regarding how we handle metformin. We've treated patients who've failed on metformin and who've succeeded. One patient referenced in the White Paper had an HbA1c of 6.5 when we began treating. I believe he was on metformin only. Most docs wouldn't have changed anything. We did, we put him on Afrezza, brought him down to 5.5 (non-diabetic), and took him off metformin. Here's the point: we believe that the status quo treatment paradigm for diabetes is deficient. Whether metformin or GLPs or SGLT2 inhibitors or anything else, it doesn't matter. We believe the best and first treatment, and for many the only treatment, is Afrezza. Our experience validates that whether or not any formal study does. I should tell you that our physician advisors did not start at this philosophical point. They were appropriately skeptical. They needed to study Afrezza and understand it. In time, they felt the case was clear; the evidence was overwhelming. The fact that Al Mann said similar things years ago wasn't what convinced them. Experience with real people did.
Now, clearly we understand our treatment protocol is radical and revolutionary. The mainstream of diabetes thought won't get to where we are anytime soon. But, we've only gotten here because we studied the issue honestly, open-mindedly and without any bias. We were driven to our position by the data. We know we will be criticized and to that criticism we say: bring us 20 diabetics managed according to the existing ADA protocols and let us take over their care. You'll see.
|
|
|
|
Post by sayhey24 on Jan 9, 2019 6:39:49 GMT -5
VDex - and let me add, you got to where you are because you prescribed afrezza. Other doctors are not and will not until forced to because they are losing patients or are required to because of standard changes.
Changes to the standard are going to take time, lots of time. Opening dedicated, well advertised clinics will take much less time and will directly impact these doctors who will not other budge.
"Focusing" as Mike said last Friday and sending sales guys out to talk to these well entrenched doctors is pretty much a waste of time. Better to open the clinic next to them and take their patients. This can be done in short order and should be a profit center instead of a sales expense.
|
|
|
|
Post by vdexdiabetes on Jan 9, 2019 10:48:49 GMT -5
You're absolutely correct sayhey
|
|
|
|
Post by cretin11 on Jan 9, 2019 12:47:07 GMT -5
Great conversation here, thanks vdexdiabetes for all you are doing!
|
|
|
|
Post by ltta on Jan 18, 2019 19:48:13 GMT -5
Thank you sayhey! When asking about HMOs, I was thinking Kaiser Permanente and other key payers. If Mankind could get them onboard would the dominoes likely start to fall? Mike C said in the last call: “The third topic here I want address is payers/patient access. We are continuing to see positive payer coverage as we start out 2019 as evidenced by our recent signing of the contract with Kaiser [ph] and ongoing discussions with other key payers.” From the Kaiser website: Founded in 1945, Kaiser Permanente is one of the nation’s largest not-for-profit health plans, serving 12.2 million members, with headquarters in Oakland, California. It comprises: • Kaiser Foundation Hospitals and its subsidiaries • Kaiser Foundation Health Plan, Inc. • The Permanente Medical Groups Health Plan Membership, by Region Northern California: 4,288,153 Southern California: 4,530,385 Colorado: 655,437 Georgia: 356,744 Hawaii: 252,977 Mid-Atlantic States (Va., Md., D.C.): 772,340 Northwest (Ore./Wash.): 606,159 Washington: 705,267 Medical Facilities and Physicians Hospitals: 39 Medical Offices: 690 Physicians: Approximate as of June 30, 2018, representing all specialties 22,013 Nurses: Approximate as of December 31, 2017, representing all specialties 58,345 Employees: Approximate, representing technical, administrative and clerical employees and caregivers 217,173 Data as of September 2018, unless otherwise noted. KP is not likely to ever be a very large customer of Afrezza. Their protocols always emphasize generic medication over newer meds. Only specialist can prescribe non first line medications. KP prefers to use humalin and novalin (generic insulins) wherever possible. TD, Kaiser not a very large customer? Then why this new position at Mannkind?
|
|
