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Post by lakers on Jan 16, 2016 2:23:41 GMT -5
What are the specific challenges for Afrezza on the market? There are several factors that have potentially contributed to its low success thus far, including: Reimbursement for Afrezza has been lacking, which may have made it more costly or inaccessible for patients and harder for doctors to prescribe. Afrezza’s label does not include some of the factors that made it a compelling choice compared to other rapid-acting insulins in clinical trials, including reduced hypoglycemia and “ultra rapid-acting” action. This was really a shame for many, and it also limited what the communication with consumers could look like. Afrezza was launched at the same time as Sanofi’s new basal insulin Toujeo, and it’s possible Toujeo’s launch overshadowed that of Afrezza to a certain extent. We’ve heard that awareness for Afrezza is not high among patients and providers, though it’s not clear if (or to what extent) this directly impacted its sales. We did know a number of doctors, nurses, and patients that had an excellent experience with Afrezza, and we liked the degree to which this was available as an alternative given that so many people are not doing as well as they (or their healthcare teams) would like on traditional “multiple daily injections." New insulins often take time to reach a large audience (even for now-blockbuster insulins like Lantus), and it’s expected that this would be particularly true for a new form of insulin that is inhaled insulin. According to a conversation we had with Sanofi management, nearly two-thirds of Afrezza users who have tried it to date haven’t continued using it after the first-prescription. If that’s true, it’s unclear what exactly is driving the drop-off in use: reimbursement issues? coughing side effects? not enough advantage vs. injectable insulin? The fact that there hasn’t been optimal follow-up is unfortunate, since some of these are addressable. The previous failure of the first inhaled insulin, Exubera, may have negatively influenced perceptions of inhaled insulin in general, especially to healthcare providers. Even Sanofi’s marketing slogan for Afrezza – “Surprise – It’s Inhaled Insulin” – perhaps focused too much on its inhaled design, rather than focusing on what inhaled insulin means for people with diabetes: “No needles!” However, the FDA also regulates direct-to-consumer marketing, so there may have been restrictions in place here. We spoke to diaTribe advisor Dr. Irl Hirsch in December about Afrezza, and he echoed some of these hassles: “In my clinic since Afrezza was launched, out of ten prescribing clinicians … we’ve had three patients try to get the drug, one flunked their pulmonary function test (the mandatory lung-screening test to get Afrezza), two were denied by insurance, and here we are at the end of 2015 and not a single patient of over 3,000 are inhaling their insulin.” In a different world, if endocrinologists had more time and if reimbursement were better, anyone with an A1c over 7% might have been invited to try it. We also point out that in the US, the world has changed – it used to be that doctors and nurses could recommend changes to their patients – or that patients could request certain products. Now, particularly in reimbursement-constrained environments like the Pacific Northwest, the payers are the ones who make the decisions and it’s barely possible for healthcare providers to recommend anything, given the time required and overall difficulty. Still, MannKind is no stranger to challenges. Afrezza was initially rejected by the FDA twice, in 2010 and 2011, before finally receiving approval in 2014. While the road ahead will be challenging, we continue to hear from our readers how for many people, Afrezza has made an incredible impact in their diabetes management. As one patient we spoke to last year told us, “I’ve been impressed at how quickly it works. If I take it at the right time then I can keep my blood sugars at a pretty normal range. My goal with Afrezza is to maintain an A1c that is a normal person’s A1c and it looks like I may be able to do that.” We hope MannKind will find a way to bring this insulin to more people with diabetes – the faster action, lower rate of hypoglycemia, and absence of needles are advantages that could benefit many people. –AB/AJW/KC - See more at: diatribe.org/sanofi-terminates-partnership-mannkinds-inhaled-insulin-afrezza?platform=hootsuite#sthash.8WdYLzSj.dpuf |
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Post by dudley on Jan 16, 2016 14:53:00 GMT -5
" We spoke to diaTribe advisor Dr. Irl Hirsch in December about Afrezza, and he echoed some of these hassles: “In my clinic since Afrezza was launched, out of ten prescribing clinicians … we’ve had three patients try to get the drug, one flunked their pulmonary function test (the mandatory lung-screening test to get Afrezza), two were denied by insurance, and here we are at the end of 2015 and not a single patient of over 3,000 are inhaling their insulin.” In a different world, if endocrinologists had more time and if reimbursement were better, anyone with an A1c over 7% might have been invited to try it. We also point out that in the US, the world has changed – it used to be that doctors and nurses could recommend changes to their patients – or that patients could request certain products. Now, particularly in reimbursement-constrained environments like the Pacific Northwest, the payers are the ones who make the decisions and it’s barely possible for healthcare providers to recommend anything, given the time required and overall difficulty."
It is mind-boggling that not one single doctor in his clinic would try to prescribe on his own. This Dr. Hirsch holds the Diabetes Treatment and Teaching Chair at the University of Washington School of Medicine. Good grief, does he even follow the developments in diabetes? How can someone who should be in the forefront of following treatments not want to prescribe something that is demonstrating never-before-seen improvements in patient results to even one single patient in his clinic? Stuff like this is just pure X-files and defies all rational thought. The final sentence about payers making the decisions also clearly illustrates the need for pricing Afrezza the same as RAA's. The odds of coverage should go up dramatically if it is just a matter of covering Afrezza at the same cost to the payer - not sure why they would fight against that. Matt has already talked about that so most likely pricing adjustments are underway right now. Hopefully underway right now as well is an updated website clearly laying out the science (monomer insulin and how it mimics the insulin produced in a normal pancreas vs. the hexamer engineered insulins every competing product uses) as well as dosing tips showing the timing divergence from injectable. Also a video showing the stark contrast in injecting vs inhaling should be prominent. This video to me is one of the most compelling stories I have ever seen and influenced my investing decision a lot - it is just one of those things that when you see it you cannot believe it is not going to be incredibly successful. They could dispense with the music obviously but a well-done video showing the dramatic difference in inhaling your dose vs injecting your dose should be paramount in the marketing. They HAVE to start making very clear and obvious separation from themselves and the rest of the insulin pack. They can't make claims to the superiority of the product due to FDA restrictions but they can certainly point out the science of the product, the fact of all the thousands and thousands of patient hours and lab tests with no lung issues, and of course the compelling video story just mentioned. Anyone going to the website should see all this first and foremost - "21st century" marketing HAS to grab the attention and make an impact. I'd personally much rather see a razor sharp website than TV commercials. I have cut the cord and never even watch TV - I can't get reception and cable is just way too overpriced. Cord cutting is increasingly common and even if a TV ad does get your attention one thing most people are going to do anymore is go to the website. The website HAS to create the "patient pull" where they are so convinced they pester their doctor for the script or switch doctors. Furthermore one website can reach the entire world 24/7 whereas a TV commercial has limited reach and only to those who happen to be viewing their TV at the precise moment the commercial is airing. I used to walk away and do something else during commercial breaks because they drove me crazy. TV advertising is crazy expensive and of limited effectiveness. Sanofi miserably failed to do ANY of this - all they did was pay their reps for negligible results. I'd be willing to wager Sam Finta on his own has gotten more patients on Afrezza than the entire field of Sanofi reps. |
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Post by agedhippie on Jan 20, 2016 18:06:45 GMT -5
It is mind-boggling that not one single doctor in his clinic would try to prescribe on his own. This Dr. Hirsch holds the Diabetes Treatment and Teaching Chair at the University of Washington School of Medicine. Good grief, does he even follow the developments in diabetes? How can someone who should be in the forefront of following treatments not want to prescribe something that is demonstrating never-before-seen improvements in patient results to even one single patient in his clinic? Stuff like this is just pure X-files and defies all rational thought. The final sentence about payers making the decisions also clearly illustrates the need for pricing Afrezza the same as RAA's. The odds of coverage should go up dramatically if it is just a matter of covering Afrezza at the same cost to the payer - not sure why they would fight against that. Matt has already talked about that so most likely pricing adjustments are underway right now. Dr Hirsh is a Type 1 diabetic, one of the top diabetes researchers in the country, and well connected in the diabetes online community so it's safe to assume he is well aware of Afrezza. The clinic he is talking about is the University of Washington Medical Center Endocrine and Diabetes Care Center, he is the director of diabetes care. |
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Post by peppy on Jan 20, 2016 18:45:12 GMT -5
It is mind-boggling that not one single doctor in his clinic would try to prescribe on his own. This Dr. Hirsch holds the Diabetes Treatment and Teaching Chair at the University of Washington School of Medicine. Good grief, does he even follow the developments in diabetes? How can someone who should be in the forefront of following treatments not want to prescribe something that is demonstrating never-before-seen improvements in patient results to even one single patient in his clinic? Stuff like this is just pure X-files and defies all rational thought. The final sentence about payers making the decisions also clearly illustrates the need for pricing Afrezza the same as RAA's. The odds of coverage should go up dramatically if it is just a matter of covering Afrezza at the same cost to the payer - not sure why they would fight against that. Matt has already talked about that so most likely pricing adjustments are underway right now. Dr Hirsh is a Type 1 diabetic, one of the top diabetes researchers in the country, and well connected in the diabetes online community so it's safe to assume he is well aware of Afrezza. The clinic he is talking about is the University of Washington Medical Center Endocrine and Diabetes Care Center, he is the director of diabetes care. I can not figure out why these highly thought of, knowledgeable endocrinologists have taken the position not to prescribe Afrezza . Hirsh isn't much older than I am. He can read and he can see. screencast.com/t/CCPlxUEONQf screencast.com/t/J0YuvokN screencast.com/t/vYtJCrf1HX
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Post by agedhippie on Jan 20, 2016 23:22:29 GMT -5
Dr Hirsh is a Type 1 diabetic, one of the top diabetes researchers in the country, and well connected in the diabetes online community so it's safe to assume he is well aware of Afrezza. The clinic he is talking about is the University of Washington Medical Center Endocrine and Diabetes Care Center, he is the director of diabetes care. I can not figure out why these highly thought of, knowledgeable endocrinologists have taken the position not to prescribe Afrezza . Hirsh isn't much older than I am. He can read and he can see. screencast.com/t/CCPlxUEONQf screencast.com/t/J0YuvokN screencast.com/t/vYtJCrf1HX Easy, it's anecdotal. What you have is a small self-selecting (and motivated) group so you would expect good results. The question is how it plays in a larger and more average group which is why you have trials. At least he tried but if the insurers will not pay why does he want to waste time prescribing a drug the patient cannot get (which seemed to be what happened)? |
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Post by dudley on Jan 22, 2016 20:03:14 GMT -5
Easy, it's anecdotal. What you have is a small self-selecting (and motivated) group so you would expect good results. The question is how it plays in a larger and more average group which is why you have trials. At least he tried but if the insurers will not pay why does he want to waste time prescribing a drug the patient cannot get (which seemed to be what happened)?HE (Dr. Hirsh) did NOT try. There were 3 PATIENTS who tried - my guess is they had heard about Afrezza and wanted to try it so asked for a prescription and were subsequently denied the insurance coverage. Only 3 patients in a year out of a practice of 10 prescribing clinicians is a pretty clear indication NOBODY in that clinic has any interest in stepping outside of the status quo. There ARE doctors like Bode and Edelman who manage to get their patients on Afrezza with seemingly no difficulty. Per Sanofi there are at least a couple of thousand of patients using it regularly. I wonder if a doctor like Hirsh, supposedly in the forefront of diabetes, could be bothered to prescribe Afrezza for a patient above target A1c if it is priced at parity and insurance covers it with no problem? It goes back to the original argument(s) where the marketing has to be compelling and the pricing has to come down to parity. Patient pull from marketing has to overcome inertia on the part of complacent endos and insurance has to kick in. This is another reason to get international quickly and get the patient count growing. The more patients using Afrezza the more success stories emerge, word of mouth etc. - all required to get the paradigm shifting. Getting into China would be huge - and the Chinese interest has been mentioned before. |
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Post by dreamboatcruise on Jan 22, 2016 22:21:04 GMT -5
Easy, it's anecdotal. What you have is a small self-selecting (and motivated) group so you would expect good results. The question is how it plays in a larger and more average group which is why you have trials. At least he tried but if the insurers will not pay why does he want to waste time prescribing a drug the patient cannot get (which seemed to be what happened)? HE (Dr. Hirsh) did NOT try. There were 3 PATIENTS who tried - my guess is they had heard about Afrezza and wanted to try it so asked for a prescription and were subsequently denied the insurance coverage. Only 3 patients in a year out of a practice of 10 prescribing clinicians is a pretty clear indication NOBODY in that clinic has any interest in stepping outside of the status quo. There ARE doctors like Bode and Edelman who manage to get their patients on Afrezza with seemingly no difficulty. Per Sanofi there are at least a couple of thousand of patients using it regularly. I wonder if a doctor like Hirsh, supposedly in the forefront of diabetes, could be bothered to prescribe Afrezza for a patient above target A1c if it is priced at parity and insurance covers it with no problem? It goes back to the original argument(s) where the marketing has to be compelling and the pricing has to come down to parity. Patient pull from marketing has to overcome inertia on the part of complacent endos and insurance has to kick in. This is another reason to get international quickly and get the patient count growing. The more patients using Afrezza the more success stories emerge, word of mouth etc. - all required to get the paradigm shifting. Getting into China would be huge - and the Chinese interest has been mentioned before. That probably is a minimum. But the sobering thing is, parity doesn't necessarily insure great coverage. I assume Apidra is roughly the same price as Novolog and Humalog, and yet only 15% preferred and 22% covered... with 35% restricted and 28% no coverage at all. There are games that come into play in negotiating placement. Getting up to 37% would be helpful, but that still probably leaves many overworked doctors with the impression that it isn't worth the hassle getting on the Afrezza bandwagon. |
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Post by Deleted on Jan 22, 2016 23:03:31 GMT -5
HE (Dr. Hirsh) did NOT try. There were 3 PATIENTS who tried - my guess is they had heard about Afrezza and wanted to try it so asked for a prescription and were subsequently denied the insurance coverage. Only 3 patients in a year out of a practice of 10 prescribing clinicians is a pretty clear indication NOBODY in that clinic has any interest in stepping outside of the status quo. There ARE doctors like Bode and Edelman who manage to get their patients on Afrezza with seemingly no difficulty. Per Sanofi there are at least a couple of thousand of patients using it regularly. I wonder if a doctor like Hirsh, supposedly in the forefront of diabetes, could be bothered to prescribe Afrezza for a patient above target A1c if it is priced at parity and insurance covers it with no problem? It goes back to the original argument(s) where the marketing has to be compelling and the pricing has to come down to parity. Patient pull from marketing has to overcome inertia on the part of complacent endos and insurance has to kick in. This is another reason to get international quickly and get the patient count growing. The more patients using Afrezza the more success stories emerge, word of mouth etc. - all required to get the paradigm shifting. Getting into China would be huge - and the Chinese interest has been mentioned before. That probably is a minimum. But the sobering thing is, parity doesn't necessarily insure great coverage. I assume Apidra is roughly the same price as Novolog and Humalog, and yet only 15% preferred and 22% covered... with 35% restricted and 28% no coverage at all. There are games that come into play in negotiating placement. Getting up to 37% would be helpful, but that still probably leaves many overworked doctors with the impression that it isn't worth the hassle getting on the Afrezza bandwagon. hence superiority trial which will force everyone to get on Afrezza bandwagon.. I am not sure why Mannkind is just sitting silent. Its been 18 months since approval and 12 months since in market. The only users / doctors right now are the educated ones .. we need the superiority trial for the sheep who just follow the numbers ( excuse my language ) and there are lots of them |
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Post by dreamboatcruise on Jan 22, 2016 23:20:13 GMT -5
That probably is a minimum. But the sobering thing is, parity doesn't necessarily insure great coverage. I assume Apidra is roughly the same price as Novolog and Humalog, and yet only 15% preferred and 22% covered... with 35% restricted and 28% no coverage at all. There are games that come into play in negotiating placement. Getting up to 37% would be helpful, but that still probably leaves many overworked doctors with the impression that it isn't worth the hassle getting on the Afrezza bandwagon. hence superiority trial which will force everyone to get on Afrezza bandwagon.. I am not sure why Mannkind is just sitting silent. Its been 18 months since approval and 12 months since in market. The only users / doctors right now are the educated ones .. we need the superiority trial for the sheep who just follow the numbers ( excuse my language ) and there are lots of them SNY was the one that dragged their feet on planning the trial. There was meeting of users at end of year in SD that was to get feedback to design trial. I wouldn't characterize it as "just sitting silent" on the mere fact they yet to announce anything about the trial. Sooner is better than later, but right now they've got so many things on their plate it would be hard to pull the trigger on everything at the same time. Wouldn't want to be trying to run MNKD myself... little sleep I suspect. |
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Post by kball on Jan 23, 2016 9:54:20 GMT -5
hence superiority trial which will force everyone to get on Afrezza bandwagon.. I am not sure why Mannkind is just sitting silent. Its been 18 months since approval and 12 months since in market. The only users / doctors right now are the educated ones .. we need the superiority trial for the sheep who just follow the numbers ( excuse my language ) and there are lots of them SNY was the one that dragged their feet on planning the trial. There was meeting of users at end of year in SD that was to get feedback to design trial. I wouldn't characterize it as "just sitting silent" on the mere fact they yet to announce anything about the trial. Sooner is better than later, but right now they've got so many things on their plate it would be hard to pull the trigger on everything at the same time. Wouldn't want to be trying to run MNKD myself... little sleep I suspect.And continuing nightmares while wide awake throughout the day |
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Post by agedhippie on Jan 23, 2016 11:23:45 GMT -5
There were 3 PATIENTS who tried - my guess is they had heard about Afrezza and wanted to try it so asked for a prescription and were subsequently denied the insurance coverage. Only 3 patients in a year out of a practice of 10 prescribing clinicians is a pretty clear indication NOBODY in that clinic has any interest in stepping outside of the status quo. That's how endos work in diabetes. Every time someone says they have a better mousetrap you don't immediately switch everyone and then find out in fact it wasn't what was claimed, that's a recipe for disaster. Instead they find some willing volunteers from their patients, verify the claims with them, and then act on the results. The outcome from this particular group was that one failed the lung test, and the other two could not get insurance cover. Now they know there is a problem, bad insurance coverage, so they wait for that to be fixed and then try again. Right now however patients cannot get their prescriptions filled so the doctors cannot get comfort that Afrezza is a better mousetrap. Without that assurance doctors are not about to waste time trying to get patients to move. |
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Post by dreamboatcruise on Jan 23, 2016 16:07:24 GMT -5
There were 3 PATIENTS who tried - my guess is they had heard about Afrezza and wanted to try it so asked for a prescription and were subsequently denied the insurance coverage. Only 3 patients in a year out of a practice of 10 prescribing clinicians is a pretty clear indication NOBODY in that clinic has any interest in stepping outside of the status quo. That's how endos work in diabetes. Every time someone says they have a better mousetrap you don't immediately switch everyone and then find out in fact it wasn't what was claimed, that's a recipe for disaster. Instead they find some willing volunteers from their patients, verify the claims with them, and then act on the results. The outcome from this particular group was that one failed the lung test, and the other two could not get insurance cover. Now they know there is a problem, bad insurance coverage, so they wait for that to be fixed and then try again. Right now however patients cannot get their prescriptions filled so the doctors cannot get comfort that Afrezza is a better mousetrap. Without that assurance doctors are not about to waste time trying to get patients to move. I suspect you're spot on for a vast majority of Endos. The trick will be getting funding to see us through solving this problem. I don't think there is a short solution to it. |
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