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Post by sayhey24 on Aug 16, 2016 20:15:54 GMT -5
If they all had CGMs which were connected to the cloud and they were remotely monitored, this would be a huge help. I had a long talk with Mike about this. For those not using a CGM if they tested 90 minutes after meals in addition to morning and night and entered it into a web app for remote monitoring this would do it too. I think the Vdex model is what they need to get up and going to solve the question you raise. Both Verily and IBM are working towards this remote monitoring service in addition to what Vdex announced. Maybe a more lightweight solution like the San Meditech approach is all MNKD needs to jump afrezza and get the remote monitoring to improve retention. I suspect a CGM loaner program for T2s for about 2 months is all the T2s would need with the CGM. After that manual testing would probably do it. Then again if San Meditech could get US approval and the CGM price into the $50-100 range a lot more T1 and T2s would own them. agreed. I hadn't heard about "if San Meditech could get US approval ". do you have more information?
I am still watching glucowise for distribution. nothing yet. What is the current status? When will it be available to order?GlucoWise™ is currently in development and will be available to purchase once clinical trials are completed. We expect to start taking pre-orders in late 2016.
www.gluco-wise.com/
The last I checked glucowise was still "in development". I would not hold my breath. If you are looking for a real non-invasive product today cnogacare.co/products/ As far as San Meditech they are the largest CGM product in China. They have sold about 50k units and have a cloud monitoring application. Their manufacturing cost is pennies on the dollar compared to Dexcom and if introduced into the US could make CGMs a commodity product. Their needle is also very small and their reported results are better than Dexcom. They gave US marketing to Glutalor who was at ADA 76. I suspect they are trying to OEM to a big BP like J&J or Bayer for US approval although Bayer may be busy trying to buy Monsanto. Rumor has it they also have a non-invasive CGM which really works but I have not seen it. I am still holding my breath for the Verily and IBM cloud services. I am not sure what approach they will take with their CGM. We know the Verily/Dexcom and the Medtronic/IBM relationships and Medtronic had the "CGM under glass" at ADA 76 after rumor has it not landing the San Meditech deal. I am not sure where Verily is with their non-invasive contract with Dexcom.
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Post by rayskum on Aug 16, 2016 20:51:39 GMT -5
My understanding of the current patient on-boarding process is that they first need to get the titration pack, which is Rx, before they get free samples to try. Please correct me if wrong. To get the first Rx, they need to go through insurance hurdles. Instead, why don't they get titration pack first as a free sample so they are relieved of the pain to deal with insurance. If they are convinced after trying the sample, hopefully they are more determined to get Afrezza and fight harder to get insurance coverage. I think this will lead to higher retention rate.
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Post by LosingMyBullishness on Aug 16, 2016 21:11:29 GMT -5
trying to think it through, I am wondering if giving a beginners blood glucose check guide may help. those that do not have a continuous glucose monitor may find it most helpful the first week to check your blood glucose levels: AND Then suggest times most helpful to assess whether they took enough units and/or may need a follow up dose. something like for the first week check your blood glucose before eating. calculate if you need a 4u small meal, 8u medium meal or 12 large meal dose. check your blood sugar again in 45 mins? an hour?
One more thing compound, did matt in one of his video's suggest a 45 min time on a follow up dose? at a long meal because he calculated the window well?
Pep
People with out continuous glucose monitors, efficacy will probably be judged through Hga1c? The tighter the control post meal the better? How to use Afrezza without a CGM is critical as less than 10% of Type 1 diabetics have a CGM and almost nobody on Medicare has one. That's without discounting the number who have one but never use it. Telling people to retest after 45 minutes is not going to be popular, the likely outcome is that they will not retest (you are meant to test 2 hours after eating today but I don't know anyone who does) so plan for that to fail. I would not bother about retention numbers after 12 weeks. People will get a 180 cartridge pack initially which will probably last 6 weeks then they will need a new prescription for their normal dose, then 3 months later they will renew. The key times will be the transition from titration to regular use, and the first renewal of the regular prescription. I am not sure if those show as NRx or TRx though. The key thing to remember is that the early adopters were prepared to put in a lot more work and work through more issues than typical diabetics will be. You are asking people to forget everything they know about something that they understand which keeps them alive day to day - that's a big ask. Handling that jump sensitively will be critical to success - the first thing that a diabetic learns is that what works for one person often will not work for another. Aged: and your suggestion is?
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Post by Deleted on Aug 16, 2016 21:20:34 GMT -5
My understanding of the current patient on-boarding process is that they first need to get the titration pack, which is Rx, before they get free samples to try. Please correct me if wrong. To get the first Rx, they need to go through insurance hurdles. Instead, why don't they get titration pack first as a free sample so they are relieved of the pain to deal with insurance. If they are convinced after trying the sample, hopefully they are more determined to get Afrezza and fight harder to get insurance coverage. I think this will lead to higher retention rate. your understanding is true ? or you are assuming? patients start of samples first and with something like insulin all the more. Mike mentioned in some call , Doc's wanted samples and copay's in the office before they start rxing. The first rx if the patient wants to continue is titration pack, so the usage pattern is known and another rx based on usage known.
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Post by rayskum on Aug 16, 2016 23:28:02 GMT -5
If patients start with samples, assuming they got the the right amount of units, why would they need a titration pack as the first Rx. They should already know by then the right size, shouldn't they? That is why I thought they start with an Rx first. As I stated earlier, I am not clear on the process details. So, it might be just confusion on my part. Thanks in advance for the clarification.
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Post by prvs on Aug 17, 2016 5:49:02 GMT -5
If patients start with samples, assuming they got the the right amount of units, why would they need a titration pack as the first Rx. They should already know by then the right size, shouldn't they? That is why I thought they start with an Rx first. As I stated earlier, I am not clear on the process details. So, it might be just confusion on my part. Thanks in advance for the clarification. I don't understand either. To my mind the samples shouldn't be given out at all. The titration packs have enough product to reach the right dosage, but the sample packs have less product. Right? Won't the patient who gets a sample have the same problem-running out of product after a few days-as before? If the sample runs out do they go back to the endo for another appointment to get the titration pack?
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Post by sportsrancho on Aug 17, 2016 6:35:16 GMT -5
If patients start with samples, assuming they got the the right amount of units, why would they need a titration pack as the first Rx. They should already know by then the right size, shouldn't they? That is why I thought they start with an Rx first. As I stated earlier, I am not clear on the process details. So, it might be just confusion on my part. Thanks in advance for the clarification. I don't understand either. To my mind the samples shouldn't be given out at all. The titration packs have enough product to reach the right dosage, but the sample packs have less product. Right? Won't the patient who gets a sample have the same problem-running out of product after a few days-as before? If the sample runs out do they go back to the endo for another appointment to get the titration pack? I got the impression we were not giving out samples. But everyone keeps talking about them, so I'm not sure what to think either.
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Post by peppy on Aug 17, 2016 6:57:48 GMT -5
I don't understand either. To my mind the samples shouldn't be given out at all. The titration packs have enough product to reach the right dosage, but the sample packs have less product. Right? Won't the patient who gets a sample have the same problem-running out of product after a few days-as before? If the sample runs out do they go back to the endo for another appointment to get the titration pack? I got the impression we were not giving out samples. But everyone keeps talking about them, so I'm not sure what to think either. Agreed, Listening to the conference call, I am paraphrasing, the titration packs are ready. They were going to make some sample packs. Perhaps, if you are going to get a titration pack, you could leave the doctors office with a sample pack?
It turns out, this is human insulin and their is a learning curve. For most new users 18 years and up, their insulin regimen completely changes. The titration pack should provide information for the learning curve.
The sample pack is almost use less except as a gift of extra doses if and when you need them?
Let's see how the endos use them. Nice guys hand out a sample pack? Afrezza is true regular human insulin (RHI). It is identical to the insulin native to the human body. Read more: mnkd.proboards.com/thread/6028/afrezza-monomeric-human-insulin#ixzz4HadgxPw4
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Post by agedhippie on Aug 17, 2016 7:02:08 GMT -5
If patients start with samples, assuming they got the the right amount of units, why would they need a titration pack as the first Rx. They should already know by then the right size, shouldn't they? That is why I thought they start with an Rx first. As I stated earlier, I am not clear on the process details. So, it might be just confusion on my part. Thanks in advance for the clarification. I don't understand either. To my mind the samples shouldn't be given out at all. The titration packs have enough product to reach the right dosage, but the sample packs have less product. Right? Won't the patient who gets a sample have the same problem-running out of product after a few days-as before? If the sample runs out do they go back to the endo for another appointment to get the titration pack? Is the sample pack just intended as a bridge between the office visit ("here, have this") where no prescription is required for samples, and getting the titration pack on prescription? If insurance and pre-authorization remains an issue this would allow the patient to start while the care center fought with the insurers. This avoids losing momentum from the visit. I have no idea if this is the reason but it would make sense although you could use titration packs as samples but I guess they want to sell those.
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Post by agedhippie on Aug 17, 2016 7:11:04 GMT -5
The key thing to remember is that the early adopters were prepared to put in a lot more work and work through more issues than typical diabetics will be. You are asking people to forget everything they know about something that they understand which keeps them alive day to day - that's a big ask. Handling that jump sensitively will be critical to success - the first thing that a diabetic learns is that what works for one person often will not work for another. Aged: and your suggestion is? Is there a fix for this (I think that is what you are asking)? No, it's a data point. Don't don't expect the level of engagement in the general population that you have in the early adopters. This is true of pretty much everything and not just Afrezza.
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Post by uvula on Aug 17, 2016 7:57:14 GMT -5
We can not get their names because of privacy issues but I agree to try to reach out to them and help them to understand how to properly use it, and its benifits. HIPAA prevents this. However I believe Sanofi had stats on why people stopped and under the terms of the partnership that should now be passed to Mannkind. Mnkd does not have access to patient names but certainly their doctors know who they are. Get the doctors on board with afrezza and they can reach out to their patients who tried afrezza and stopped using it.
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Post by prvs on Aug 17, 2016 8:19:48 GMT -5
The titration and insurance issues are kind of a chicken and egg problem. Did patients stop using Afrezza because they couldn't titrate with limited packs and then discover insurance wouldn't cover Afrezza anyway? Or did they try Afrezza knowing they would have to fight for coverage and then find out they couldn't titrate and just gave up? I'll bet both scenarios played out multiple times. Maybe what Mike and the team are trying to overcome is just plain frustration.
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Post by peppy on Aug 17, 2016 8:34:53 GMT -5
agreed. I hadn't heard about "if San Meditech could get US approval ". do you have more information?
I am still watching glucowise for distribution. nothing yet. What is the current status? When will it be available to order?GlucoWise™ is currently in development and will be available to purchase once clinical trials are completed. We expect to start taking pre-orders in late 2016.
www.gluco-wise.com/
The last I checked glucowise was still "in development". I would not hold my breath. If you are looking for a real non-invasive product today cnogacare.co/products/ As far as San Meditech they are the largest CGM product in China. They have sold about 50k units and have a cloud monitoring application. Their manufacturing cost is pennies on the dollar compared to Dexcom and if introduced into the US could make CGMs a commodity product. Their needle is also very small and their reported results are better than Dexcom. They gave US marketing to Glutalor who was at ADA 76. I suspect they are trying to OEM to a big BP like J&J or Bayer for US approval although Bayer may be busy trying to buy Monsanto. Rumor has it they also have a non-invasive CGM which really works but I have not seen it. I am still holding my breath for the Verily and IBM cloud services. I am not sure what approach they will take with their CGM. We know the Verily/Dexcom and the Medtronic/IBM relationships and Medtronic had the "CGM under glass" at ADA 76 after rumor has it not landing the San Meditech deal. I am not sure where Verily is with their non-invasive contract with Dexcom. Thank you say hey. I think this is good to know about. Regarding, cnogacare.co/portfolio-item/combo-glucometer/ interesting. I do not see a buy button. Are they for sale? same boat as www.gluco-wise.com/ coming soon? we have to be so close.
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Post by agedhippie on Aug 17, 2016 11:21:56 GMT -5
The Cnogacare link has a really interesting FAQ on the issues around optical glucose measurement.
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Post by surplusvalue on Aug 17, 2016 12:02:10 GMT -5
The titration and insurance issues are kind of a chicken and egg problem. Did patients stop using Afrezza because they couldn't titrate with limited packs and then discover insurance wouldn't cover Afrezza anyway? Or did they try Afrezza knowing they would have to fight for coverage and then find out they couldn't titrate and just gave up? I'll bet both scenarios played out multiple times. Maybe what Mike and the team are trying to overcome is just plain frustration. Regarding agedhippie's post (earlier in this thread) about Sanofi probably having stats as to why people stopped using and your post, MNKD at the CC's made it clear that it was a combination of factors including those who used sample packs and didnt go any farther. As I recall factors involved were titration/initial dosing problems (including but not limited to running out), coverage(insurance), preauthorization hurdles, and pricing and a combination thereof. Spirometry turned out not to be as big an issue as initially thought.
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