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Post by Deleted on Oct 4, 2016 10:26:34 GMT -5
At the 2015 ASM in Danbury, Al had brought with him an FEV 1 meter he purchased at Ralph's (which is part of Kroger). The product was / is made by microlife and his point of bringing it I believe was to show how readily such products were and as a consumer purchased item, simple to use. Here is the Microlife product: www.amazon.com/Microlife-Peak-Meter-Spirometry-White/dp/B000BH8TUAWhile the above link shows it at $43.95 in bulk, obviously it would be much less. At one point I had thought that there was discussion about including one of these with every sample. Not inexpensive but a way to ease things along. Unfortunately, MNKD cannot give these to docs for legal reasons / anti-kickback but I believe the device can be used across multiple patients. Doc would just have to record data and test takes all of 30 seconds start to finish with actual airway evacuation of a second. Now potentially, here is a solution that could be attached to every sample box - feel free someone to send to Mike C. www.walgreens.com/store/c/omron-peak-flow-meter-adult-or-pediatric-model-pf-9940/ID=prod6145605-productScotta, This is a peak flow meter - it does not provide necessary FEV values. The Microlife product on Amazon does FEV1. Not sure about the Omron product but it probably would not be hard to get an FEV1 reading out of it if it does not already do it. Measuring airflow is not difficult to do. |
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Post by dreamboatcruise on Oct 4, 2016 11:43:33 GMT -5
Unless you are a Dr I don't think either of us know if we are right or wrong. Just ask yourself who you would sue if you suffered some lung ailment in consequence of an incorrect or misinterpreted lung test -- the guy at the health fair who did the test or your doctor who took the test at face value and went ahead and prescribed the drug. I think these tests are fairly foolproof. I've had this test before and it seems that instructing a patient incorrectly or using the device incorrectly would result in incorrectly low readings not incorrectly high readings... e.g. if a person stops exhaling too soon when they could have gone longer. If readings seem lower than expected I think often the patient will be instructed again and the test given again to confirm. I really find it hard to believe that false high readings would be a legitimate problem. This is a lung capacity test and the patient is trying to blow as much air as possible. Where is the extra air going to come from to give a false high reading? The result is a number generated by the machine... how is this misinterpreted? It's not a lung x-ray. |
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Post by od on Oct 5, 2016 8:00:41 GMT -5
gonetotown , You are way out of line and spreading FUD. You are not a doctor, and know not of what you speak. Spirometry is a very simple test and can be administered by almost anyone with very minimal training. The devices now are inexpensive and reliable. Health fairs are common, and the variety of tests performed at them are acceptable to physicians. There is absolutely no reason for an expensive pulmonologist visit. Consider this fair warning. Liane, I post this with the following considerations: - I have the utmost respect for you and your thinking;
- I don’t disagree re: gonetotown’s motives;
- I am professionally familiar with spirometry, having consulted in the space to the leading device manufacturer/marketer, medical groups, and pharmaceutical companies;
- I believe lung function tests are, at most, a minimal barrier to Afrezza prescriptions (big change in my thinking from February 2015); and
- I am long MNKD (not one sell order).
I am not suggesting that results of a lung function test performed at a health fair are any less accurate than one performed in a providers office; as you wrote – “Spirometry is a very simple test and can be administered by almost anyone with very minimal training.... There is absolutely no reason for an expensive pulmonologist visit.” But, if a patient presented with a lipid, blood sugar, or PSA result from a health fair, would you intervene clinically (if necessary) without confirming the results? I believe providing Spirometry at health fairs is an excellent way to engage with patients to introduce Afrezza and direct them to an ‘open-minded’ provider. Of course, patient awareness will result in greater provider awareness, but, I fear/expect that health fair results will not, on their own, impact the prescribing behavior of Afrezza-resisting providers. |
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Post by liane on Oct 5, 2016 8:50:49 GMT -5
In the case of spirometry for the purpose of prescribing Afrezza, we're looking for a negative result, and I would consider the test from a health fair sufficient. In the case of an elevated lab result for which you are going to want to treat with medication and follow periodically, you might repeat the test. Keep in mind that you often don't introduce medication on the first elevated lab result, depending on the condition. Even done in the office, an initial elevated lab result is often confirmed before beginning medication.
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Post by od on Oct 5, 2016 8:58:06 GMT -5
In the case of spirometry for the purpose of prescribing Afrezza, we're looking for a negative result, and I would consider the test from a health fair sufficient. In the case of an elevated lab result for which you are going to want to treat with medication and follow periodically, you might repeat the test. Keep in mind that you often don't introduce medication on the first elevated lab result, depending on the condition. Even done in the office, an initial elevated lab result is often confirmed before beginning medication. Got it, thank you. |
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Post by gonetotown on Oct 5, 2016 9:18:41 GMT -5
gonetotown , You are way out of line and spreading FUD. You are not a doctor, and know not of what you speak. Spirometry is a very simple test and can be administered by almost anyone with very minimal training. The devices now are inexpensive and reliable. Health fairs are common, and the variety of tests performed at them are acceptable to physicians. There is absolutely no reason for an expensive pulmonologist visit. Consider this fair warning. Liane, I post this with the following considerations: - I have the utmost respect for you and your thinking;
- I don’t disagree re: gonetotown’s motives;
- I am professionally familiar with spirometry, having consulted in the space to the leading device manufacturer/marketer, medical groups, and pharmaceutical companies;
- I believe lung function tests are, at most, a minimal barrier to Afrezza prescriptions (big change in my thinking from February 2015); and
- I am long MNKD (not one sell order).
I am not suggesting that results of a lung function test performed at a health fair are any less accurate than one performed in a providers office; as you wrote – “Spirometry is a very simple test and can be administered by almost anyone with very minimal training.... There is absolutely no reason for an expensive pulmonologist visit.” But, if a patient presented with a lipid, blood sugar, or PSA result from a health fair, would you intervene clinically (if necessary) without confirming the results? I believe providing Spirometry at health fairs is an excellent way to engage with patients to introduce Afrezza and direct them to an ‘open-minded’ provider. Of course, patient awareness will result in greater provider awareness, but, I fear/expect that health fair results will not, on their own, impact the prescribing behavior of Afrezza-resisting providers. The ultimate test of whether spirometry is a "minimal barrier" is the number of endos doing them to prescribe afrezza. However, posted here when talking about the shareholder lawsuit was some testimony by a former afrezza rep saying that spirometry was a major barrier to getting endos to write scripts. Has anything changed? If it was a "major" barrier a year ago, why would it not be a major barrier now? And if it's so "simple," then why exactly is it a major barrier? |
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Post by gonetotown on Oct 5, 2016 9:29:52 GMT -5
Just ask yourself who you would sue if you suffered some lung ailment in consequence of an incorrect or misinterpreted lung test -- the guy at the health fair who did the test or your doctor who took the test at face value and went ahead and prescribed the drug. I think these tests are fairly foolproof. I've had this test before and it seems that instructing a patient incorrectly or using the device incorrectly would result in incorrectly low readings not incorrectly high readings... e.g. if a person stops exhaling too soon when they could have gone longer. If readings seem lower than expected I think often the patient will be instructed again and the test given again to confirm. I really find it hard to believe that false high readings would be a legitimate problem. This is a lung capacity test and the patient is trying to blow as much air as possible. Where is the extra air going to come from to give a false high reading? The result is a number generated by the machine... how is this misinterpreted? It's not a lung x-ray. How does the saying go -- "sh_t happens"? And who's there to take advantage when it does? The malpractice lawyer. Doctors are not allowed to blame machines for faulty interpretations. EKG machines offer interpretations, but see what happens if the doctor takes the machine's word, it's wrong, and the patient suffers iinjury. |
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Post by mechstan on Oct 5, 2016 9:48:40 GMT -5
The ultimate test of whether spirometry is a "minimal barrier" is the number of endos doing them to prescribe afrezza. However, posted here when talking about the shareholder lawsuit was some testimony by a former afrezza rep saying that spirometry was a major barrier to getting endos to write scripts. Has anything changed? If it was a "major" barrier a year ago, why would it not be a major barrier now? And if it's so "simple," then why exactly is it a major barrier? The reason it was a major barrier when Sanofi was marketing Afrezza was because of the following reasons:
1. Sanofi made no effort to promote a Spirometry device so the endos can obtain them and perform spirometry in their office. This resulted in the patient having to go somewhere else to get the test done. Then the patient has to schedule another appointment with the endo to get an Afrezza Rx. Lots of time and effort have to be expended to get a Afrezza Rx.
2. Patients/doctors have to fight insurance for Spirometry reimbursement.
Has anything changed? Yes.
MNKD has addressed #1 above by promoting spirometry devices to endos that cost in the range of $450-$750. Patient doesn't have to go anywhere else for spirometry test.
There is MNKD Cares that can take care of spirometry reimbursement if there's any such issue.
Spirometry testing should no longer be a barrier with the plan MNKD has implemented.
If you had spent as much time researching MNKD's 2.0 Marketing Plan as you are spewing out these ignorant statements of yours, you wouldn't be asking these stupid questions.
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Post by mnholdem on Oct 5, 2016 9:50:46 GMT -5
The ultimate test of whether spirometry is a "minimal barrier" is the number of endos doing them to prescribe afrezza. However, posted here when talking about the shareholder lawsuit was some testimony by a former afrezza rep saying that spirometry was a major barrier to getting endos to write scripts. Has anything changed? If it was a "major" barrier a year ago, why would it not be a major barrier now? And if it's so "simple," then why exactly is it a major barrier? Most endocrinologists don't have equipment to perform a simple FEV1 test at their own clinic. When this became apparent shortly after Sanofi launched Afrezza, Al Mann responded quickly and decisively to eliminate this "barrier" by publicly advocating that Sanofi provide a low-cost spirometer. He even provide them with the name of a reliable model. Unfortunately, the Agreement gave Sanofi the final say in marketing Afrezza and what they chose was to promote one of their subsidiary company's elaborate full lung-function testing system, which happened to be expensive as hell.
The "barrier" was not about the test. It was the endocronologists not having the equipment to perform the simple test. Whether Sanofi made it into a "major barrier" no longer matters since MannKind has provided a low cost solution that enables the endo to purchase their own spirometer to quickly perform an FEV1 test and to generate additional revenue for the clinic at the same time. 
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Post by Deleted on Oct 5, 2016 9:58:06 GMT -5
mnholdem mechstan you are just feeding the troll gonetotown . You do have great patience. For some one with basic common sense , its easy to see the difference between Sanofi days and now. Not sure if gonetotown is lacking such common sense.
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Post by gonetotown on Oct 5, 2016 10:07:19 GMT -5
The ultimate test of whether spirometry is a "minimal barrier" is the number of endos doing them to prescribe afrezza. However, posted here when talking about the shareholder lawsuit was some testimony by a former afrezza rep saying that spirometry was a major barrier to getting endos to write scripts. Has anything changed? If it was a "major" barrier a year ago, why would it not be a major barrier now? And if it's so "simple," then why exactly is it a major barrier? The reason it was a major barrier when Sanofi was marketing Afrezza was because of the following reasons:
1. Sanofi made no effort to promote a Spirometry device so the endos can obtain them and perform spirometry in their office. This resulted in the patient having to go somewhere else to get the test done. Then the patient has to schedule another appointment with the endo to get an Afrezza Rx. Lots of time and effort have to be expended to get a Afrezza Rx.
2. Patients/doctors have to fight insurance for Spirometry reimbursement.
Has anything changed? Yes.
MNKD has addressed #1 above by promoting spirometry devices to endos that cost in the range of $450-$750. Patient doesn't have to go anywhere else for spirometry test.
There is MNKD Cares that can take care of spirometry reimbursement if there's any such issue.
Spirometry testing should no longer be a barrier with the plan MNKD has implemented.
If you had spent as much time researching MNKD's 2.0 Marketing Plan as you are spewing out these ignorant statements of yours, you wouldn't be asking these stupid questions.
As I recall, SNY offered spirometry equipment through their own distributor, but at what price I don't know. I do know that Jones Medical has been offering this for over 15 months: www.jonesmedical.com/pdf/Spirometry-for-Inhaled-Insulin-Easy-As-123.pdfHas Jones Medical been making a success of it? |
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Post by od on Oct 5, 2016 10:19:53 GMT -5
The ultimate test of whether spirometry is a "minimal barrier" is the number of endos doing them to prescribe afrezza. However, posted here when talking about the shareholder lawsuit was some testimony by a former afrezza rep saying that spirometry was a major barrier to getting endos to write scripts. Has anything changed? If it was a "major" barrier a year ago, why would it not be a major barrier now? And if it's so "simple," then why exactly is it a major barrier? The reason it was a major barrier when Sanofi was marketing Afrezza was because of the following reasons:
1. Sanofi made no effort to promote a Spirometry device so the endos can obtain them and perform spirometry in their office. This resulted in the patient having to go somewhere else to get the test done. Then the patient has to schedule another appointment with the endo to get an Afrezza Rx. Lots of time and effort have to be expended to get a Afrezza Rx.
2. Patients/doctors have to fight insurance for Spirometry reimbursement.
Has anything changed? Yes.
MNKD has addressed #1 above by promoting spirometry devices to endos that cost in the range of $450-$750. Patient doesn't have to go anywhere else for spirometry test.
There is MNKD Cares that can take care of spirometry reimbursement if there's any such issue.
Spirometry testing should no longer be a barrier with the plan MNKD has implemented.
If you had spent as much time researching MNKD's 2.0 Marketing Plan as you are spewing out these ignorant statements of yours, you wouldn't be asking these stupid questions.
Excellent post mechstan. Two comments - My understanding is that when properly coded spirometry reimbursement was never an issue of significance. I believe SNY distributed spirometry reimbursement guidelines. |
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Post by od on Oct 5, 2016 10:48:15 GMT -5
The ultimate test of whether spirometry is a "minimal barrier" is the number of endos doing them to prescribe afrezza. However, posted here when talking about the shareholder lawsuit was some testimony by a former afrezza rep saying that spirometry was a major barrier to getting endos to write scripts. Has anything changed? If it was a "major" barrier a year ago, why would it not be a major barrier now? And if it's so "simple," then why exactly is it a major barrier? Most endocrinologists don't have equipment to perform a simple FEV1 test at their own clinic. When this became apparent shortly after Sanofi launched Afrezza, Al Mann responded quickly and decisively to eliminate this "barrier" by publicly advocating that Sanofi provide a low-cost spirometer. He even provide them with the name of a reliable model. Unfortunately, the Agreement gave Sanofi the final say in marketing Afrezza and what they chose was to promote one of their subsidiary company's elaborate full lung-function testing system, which happened to be expensive as hell.
The "barrier" was not about the test. It was the endocronologists not having the equipment to perform the simple test. Whether Sanofi made it into a "major barrier" no longer matters since MannKind has provided a low cost solution that enables the endo to purchase their own spirometer to quickly perform an FEV1 test and to generate additional revenue for the clinic at the same time.
The lack of spirometer penetration in practices was known by industry prior to launch. Not to take away from Al Mann's advocacy for getting devices to practices (giving away is violative) it was not a breakthrough marketing idea. One of the benefits to practices of performing spirometry is reimbursement. Very low cost devices, such as the one Al Mann suggested, do not include FEV1 percent of predicted values, which is necessary for reimbursement. They are satisfactory to attend to the boxed warning. The device MNKD is introducing does provide data necessary for reimbursement. |
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Post by sportsrancho on Oct 5, 2016 10:57:42 GMT -5
...some testimony by a former afrezza rep saying that spirometry was a major barrier to getting endos to write scripts. Has anything changed? If it was a "major" barrier a year ago, why would it not be a major barrier now?
That was a SNY rep being told to sell another drug. IMO
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Post by dreamboatcruise on Oct 5, 2016 11:17:30 GMT -5
I think these tests are fairly foolproof. I've had this test before and it seems that instructing a patient incorrectly or using the device incorrectly would result in incorrectly low readings not incorrectly high readings... e.g. if a person stops exhaling too soon when they could have gone longer. If readings seem lower than expected I think often the patient will be instructed again and the test given again to confirm. I really find it hard to believe that false high readings would be a legitimate problem. This is a lung capacity test and the patient is trying to blow as much air as possible. Where is the extra air going to come from to give a false high reading? The result is a number generated by the machine... how is this misinterpreted? It's not a lung x-ray. How does the saying go -- "sh_t happens"? And who's there to take advantage when it does? The malpractice lawyer. Doctors are not allowed to blame machines for faulty interpretations. EKG machines offer interpretations, but see what happens if the doctor takes the machine's word, it's wrong, and the patient suffers iinjury. Lung function test is far simpler than EKG, both in knowing how to perform the test and interpreting results. Details matter. Doctors do typically understand details. A reasonable doctor is not going to have a patient try to do an EKG at home, but they will have them take BG readings at home... and use those home generated results in clinical decisions. This is because the BG test is simple and results in a simple number that can be conveyed easily without any need for patient "interpretation" built into what is conveyed. A false good reading on a lung function test is probably even less likely than erroneous BG readings. I believe lung function is something that some patients are instructed to do at home. This is a simple, reliable test. |
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