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Post by suebeeee1 on May 18, 2015 10:55:01 GMT -5
While I'm doing the happy dance that we are above my breakeven point on my options, I seriously doubt we will stay up here long. Again, I am a long and intend to stay that way but I think the shorts will need to drive this down at least one more time.
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Post by babaoriley on May 18, 2015 11:02:36 GMT -5
This seems to be a popular thread, so I'll post this here. The below is from an MD whom I know through another message board, where we throw out various ideas from time to time. Many of the ideas have had to be thrown back... Nevertheless, he's a very sharp guy and he became interested in MNKD a couple of years ago when I brought it to his attention. Here, he comments on Medscape and a couple of our stumbling blocks, insurance coverage and spirometry, and some more topics as well:
"FWIW insurance preauthorization is NEVER worked out in advance of launch of a product that does not show clear, clinically relevant superiority in approval trials or substantial cost advantage. It is always a matter of debate by the committee in charge of the insurance plan drug formulary, and committees generally meet every 3-6 months and often want to see what other 3rd party payers are doing prior to making a decision, so the process can drag out. Sanofi can assist practices in obtaining preauthorization or lower tier status for individual patients by setting up a unit that essentially runs interference between the doc and the ins. co.
Second, spirometers that measure just FEV1 (what the FDA requires) are cheap and, at least til the product gains sufficient momentum, Sanofi may nearly give them to doctors in the manner that kodak in its better days gave away cameras to sell film. There are ~5K endocrinologists in the US per a 2011 quote but if Sanofi focused on group practices I bet they would get a lot of patient screening potential with less than 1000 spirometers. And they might not have to give them away if doctors can charge for the test, even fully functional equipment (measuring the range of what spirometry can measure, not just FEV1) will pay for itself very quickly. So they would likely arrange with a spirometer manufacturer or two to subsidize a 25% discount for selected endocrine practices. As for primary care, many already have spirometry and those that don't should because they take care of asthma and COPD, so the subsidy might be much less.
Third, without actually saying it the Medscape pieces essentially spelled out Sanofi's strategy for diabetes treatment like a rosetta stone. Eligible type I will receive Toujeo and prandial Afrezza. I imagine they will sell the combo to 3rd party payers at a good discount to achieve low-tier formulary status but, over time, superior A1C / FBS control with far fewer hypos and enhanced patient satisfaction will establish it as the #1 modality and then special discounting will end until something just as good goes generic. Eligible type II will receive prandial Afrezza, if needed, on top of metformin and other agents, but Afrezza marketing will target it to move up the ladder to first or second position over time.
Long term pulmonary toxicity / cancer remains the big unknown, but it was never a high probability and is seeming less likely over time with greater patient experience. However, it does not take very many untoward coincidences - cancer or whatever - to spook patients and docs so they need to stay out in front on this with a credible study or meta-analysis. I think that would show commitment to the highest safety standard and be a feather in Sanofi's cap."
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Post by thekindaguyiyam on May 18, 2015 11:29:22 GMT -5
the rosetta stone. excellent contribution. thanks!
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Post by od on May 18, 2015 12:53:23 GMT -5
This seems to be a popular thread, so I'll post this here. The below is from an MD whom I know through another message board, where we throw out various ideas from time to time. Many of the ideas have had to be thrown back... Nevertheless, he's a very sharp guy and he became interested in MNKD a couple of years ago when I brought it to his attention. Here, he comments on Medscape and a couple of our stumbling blocks, insurance coverage and spirometry, and some more topics as well: "FWIW insurance preauthorization is NEVER worked out in advance of launch of a product that does not show clear, clinically relevant superiority in approval trials or substantial cost advantage. It is always a matter of debate by the committee in charge of the insurance plan drug formulary, and committees generally meet every 3-6 months and often want to see what other 3rd party payers are doing prior to making a decision, so the process can drag out. Sanofi can assist practices in obtaining preauthorization or lower tier status for individual patients by setting up a unit that essentially runs interference between the doc and the ins. co. Second, spirometers that measure just FEV1 (what the FDA requires) are cheap and, at least til the product gains sufficient momentum, Sanofi may nearly give them to doctors in the manner that kodak in its better days gave away cameras to sell film. There are ~5K endocrinologists in the US per a 2011 quote but if Sanofi focused on group practices I bet they would get a lot of patient screening potential with less than 1000 spirometers. And they might not have to give them away if doctors can charge for the test, even fully functional equipment (measuring the range of what spirometry can measure, not just FEV1) will pay for itself very quickly. So they would likely arrange with a spirometer manufacturer or two to subsidize a 25% discount for selected endocrine practices. As for primary care, many already have spirometry and those that don't should because they take care of asthma and COPD, so the subsidy might be much less. Third, without actually saying it the Medscape pieces essentially spelled out Sanofi's strategy for diabetes treatment like a rosetta stone. Eligible type I will receive Toujeo and prandial Afrezza. I imagine they will sell the combo to 3rd party payers at a good discount to achieve low-tier formulary status but, over time, superior A1C / FBS control with far fewer hypos and enhanced patient satisfaction will establish it as the #1 modality and then special discounting will end until something just as good goes generic. Eligible type II will receive prandial Afrezza, if needed, on top of metformin and other agents, but Afrezza marketing will target it to move up the ladder to first or second position over time. Long term pulmonary toxicity / cancer remains the big unknown, but it was never a high probability and is seeming less likely over time with greater patient experience. However, it does not take very many untoward coincidences - cancer or whatever - to spook patients and docs so they need to stay out in front on this with a credible study or meta-analysis. I think that would show commitment to the highest safety standard and be a feather in Sanofi's cap." Spirometers that measure only FEV1 allow providers to clear the black-box hurdle, however, tests administered with those devices are not reimbursable. You are correct that fully-functional spirometers are a good investment and dependent on practice volume pay for themselves quickly. Despite commonly posted comments that almost all primary care providers have spirometers, the real number is closer to 40%. (The major manufacturers will confirm.)
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Deleted
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Post by Deleted on May 18, 2015 13:15:59 GMT -5
This seems to be a popular thread, so I'll post this here. The below is from an MD whom I know through another message board, where we throw out various ideas from time to time. Many of the ideas have had to be thrown back... Nevertheless, he's a very sharp guy and he became interested in MNKD a couple of years ago when I brought it to his attention. Here, he comments on Medscape and a couple of our stumbling blocks, insurance coverage and spirometry, and some more topics as well: "FWIW insurance preauthorization is NEVER worked out in advance of launch of a product that does not show clear, clinically relevant superiority in approval trials or substantial cost advantage. It is always a matter of debate by the committee in charge of the insurance plan drug formulary, and committees generally meet every 3-6 months and often want to see what other 3rd party payers are doing prior to making a decision, so the process can drag out. Sanofi can assist practices in obtaining preauthorization or lower tier status for individual patients by setting up a unit that essentially runs interference between the doc and the ins. co. Second, spirometers that measure just FEV1 (what the FDA requires) are cheap and, at least til the product gains sufficient momentum, Sanofi may nearly give them to doctors in the manner that kodak in its better days gave away cameras to sell film. There are ~5K endocrinologists in the US per a 2011 quote but if Sanofi focused on group practices I bet they would get a lot of patient screening potential with less than 1000 spirometers. And they might not have to give them away if doctors can charge for the test, even fully functional equipment (measuring the range of what spirometry can measure, not just FEV1) will pay for itself very quickly. So they would likely arrange with a spirometer manufacturer or two to subsidize a 25% discount for selected endocrine practices. As for primary care, many already have spirometry and those that don't should because they take care of asthma and COPD, so the subsidy might be much less. Third, without actually saying it the Medscape pieces essentially spelled out Sanofi's strategy for diabetes treatment like a rosetta stone. Eligible type I will receive Toujeo and prandial Afrezza. I imagine they will sell the combo to 3rd party payers at a good discount to achieve low-tier formulary status but, over time, superior A1C / FBS control with far fewer hypos and enhanced patient satisfaction will establish it as the #1 modality and then special discounting will end until something just as good goes generic. Eligible type II will receive prandial Afrezza, if needed, on top of metformin and other agents, but Afrezza marketing will target it to move up the ladder to first or second position over time. Long term pulmonary toxicity / cancer remains the big unknown, but it was never a high probability and is seeming less likely over time with greater patient experience. However, it does not take very many untoward coincidences - cancer or whatever - to spook patients and docs so they need to stay out in front on this with a credible study or meta-analysis. I think that would show commitment to the highest safety standard and be a feather in Sanofi's cap." Spirometers that measure only FEV1 allow providers to clear the black-box hurdle, however, tests administered with those devices are not reimbursable. You are correct that fully-functional spirometers are a good investment and dependent on practice volume pay for themselves quickly. Despite commonly posted comments that almost all primary care providers have spirometers, the real number is closer to 40%. (The major manufacturers will confirm.) link to the comment that 40% is the real number?
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Post by gomnkd on May 18, 2015 15:09:31 GMT -5
I'll be shocked if only 40% of PCP's had spirometeres. Many use it for annual physicals. Also PCP's use it before referring to a pulmonologist.
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Post by dwcarter654 on May 18, 2015 15:29:34 GMT -5
I believe that the slides Harry posted from the BOA meeting also indicated that MNKD had access to SNY generic insulin.
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Post by od on May 18, 2015 16:19:15 GMT -5
Spirometers that measure only FEV1 allow providers to clear the black-box hurdle, however, tests administered with those devices are not reimbursable. You are correct that fully-functional spirometers are a good investment and dependent on practice volume pay for themselves quickly. Despite commonly posted comments that almost all primary care providers have spirometers, the real number is closer to 40%. (The major manufacturers will confirm.) link to the comment that 40% is the real number? NIH - www.nhlbi.nih.gov/files/docs/resources/lung/copd_wksp.pdf - The report is old; my homework suggests little progress in penetration since publication. It would be great to learn I am wrong at 40%.
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Post by od on May 18, 2015 16:22:06 GMT -5
I'll be shocked if only 40% of PCP's had spirometeres. Many use it for annual physicals. Also PCP's use it before referring to a pulmonologist. Shocking more PCP's don't invest in spirometers - a necessary clinical tool and practice revenue generator.
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Post by babaoriley on May 18, 2015 16:55:36 GMT -5
I think the reason most docs don't have them is maintenance - I believe they have to be cleaned after every other use.
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Post by chyaboi on May 18, 2015 19:45:16 GMT -5
OD,
What page is that fact listed? I have read through it, maybe I missed it, but can't seem to find that fact in the posted article. Thanks in advance
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Post by Deleted on May 18, 2015 20:05:25 GMT -5
OD, What page is that fact listed? I have read through it, maybe I missed it, but can't seem to find that fact in the posted article. Thanks in advance Couldn't find it either . Not to mention the document is 11 yrs old. Last three or four docs I've been to all had them, so in my survey it's 100%
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Post by od on May 18, 2015 20:27:47 GMT -5
OD, What page is that fact listed? I have read through it, maybe I missed it, but can't seem to find that fact in the posted article. Thanks in advance Couldn't find it either . Not to mention the document is 11 yrs old. Last three or four docs I've been to all had them, so in my survey it's 100% Page 9 - "When diagnosing COPD, only 32 percent of primary care physicians and 79 percent of pulmonologists state they use spirometry for diagnosis all the time. That figure should be 100 percent." I am sure you will question my logic that there is a correlation between PCP's having a spirometer and using a spirometer. In 2010 COPD was the third leading cause of death in America - a good reason to use a spirometer if you have one. Re: age of NIH report, it was acknowledged in the original post. Suggestion - call one or more spirometer manufacturers; ask the question.
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Post by Deleted on May 18, 2015 21:08:57 GMT -5
You made the statement, I just asked for the data. Turns out there was no data, just an assumption.
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Post by od on May 18, 2015 21:43:10 GMT -5
You made the statement, I just asked for the data. Turns out there was no data, just an assumption. Agreed, an assumption, but I believe a logical assumption (not sure how else to interpret the information.) Call a spirometer manufacturer, have the conversaion - you may rethink your assumption. In the end, I don't think it matters and we will look back on spirometer access as a distracting rabbit hole. I have not seen documentation that appropriate patients are lost if they are sent out for lung function testing; as long as they receive an Afrezza prescription, all is good. If SNY executes well, provider prescribing behavior/inertia will come around. To me, the black box issue was all about how it would impact initial sales and the affect on PPS - market timing. Family is long and patient.
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