paul
Researcher
Posts: 134
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Post by paul on Aug 17, 2019 15:52:56 GMT -5
Cgm’s /data app’s don’t mitigate some of the cost ? lessen the length of time to complete a trial.. might not be as bad as everyone thinks ... Providing CGMs would add to the cost. I don't think a trial would necessarily take years. It would take quite a few subjects -- likely in the hundreds -- but if it focused on improving A1c it could be done in six months. From what I have read, however, there may be a problem is establishing a standard dosing regimen. I studied the afrezza facebook page and see quite a few complaints about variable responses to afrezza, timing their doses, problems with slow digesting carbs, etc. And while other users make various suggestions, there doesn't seem to be a consensus on the best approach. Coming up with a study where treatment of each subject has to be tailored individually could be complicated. Ultimately, it simply may not be worth the efort.
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Post by agedhippie on Aug 17, 2019 22:14:21 GMT -5
Cgm’s /data app’s don’t mitigate some of the cost ? lessen the length of time to complete a trial.. might not be as bad as everyone thinks ... Actually CGMs would increase the cost because they are expensive to run. I would love them to go down that path because of purely selfish reasons - we used to sometimes get left over supplies donated to us (we ran a non-profit that distributed supplies to diabetics who were in need). The reason for the time element is because that's how long it takes for things to change rather than because of the operational side.
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Post by agedhippie on Aug 17, 2019 22:19:04 GMT -5
The Future Of Clinical Trials: How AI & Big Tech Could Make Drug Development Cheaper, Faster, & More Effective August 7, 2018 Share The Future Of Clinical Trials: How AI & Big Tech Could Make Drug Development Cheaper, Faster, & More Effective on Facebook Share The Future Of Clinical Trials: How AI & Big Tech Could Make Drug Development Cheaper, Faster, & More Effective on Twitter Share The Future Of Clinical Trials: How AI & Big Tech Could Make Drug Development Cheaper, Faster, & More Effective on LinkedIn Share The Future Of Clinical Trials: How AI & Big Tech Could Make Drug Development Cheaper, Faster, & More Effective via Email Artificial Intelligence Digital Health Testing new drugs is a slow, expensive, and manual process. Artificial intelligence has the potential to disrupt every stage of the clinical trials process — from matching eligible patients to studies to monitoring adherence and data collection. AI isn't much help for trials since the difficulty is in the logistics. IoT on the other hand is a big help because it automates the collection and loading into the data lakes. That's a tedious and error prone part at the moment. I think every major pharma out there is looking at doing this right now because the cloud services make it achievable.
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Post by helmut8056 on Aug 18, 2019 5:48:35 GMT -5
Another excellent reason why VDEX should be front & center.
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paul
Researcher
Posts: 134
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Post by paul on Aug 18, 2019 6:44:34 GMT -5
How do I high lite Paul's last sentence in his message 17 hrs. ago so I can reference the significance of VEDEX? Go to my post, hit the quote button next to the thumbs up sign. That quotes the entire post. Then use the underline button -- an underlined "u" -- in the bar at the top of the page to highlight whatever you want.
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Post by hellodolly on Aug 18, 2019 7:46:50 GMT -5
Cgm’s /data app’s don’t mitigate some of the cost ? lessen the length of time to complete a trial.. might not be as bad as everyone thinks ... Providing CGMs would add to the cost. I don't think a trial would necessarily take years. It would take quite a few subjects -- likely in the hundreds -- but if it focused on improving A1c it could be done in six months. From what I have read, however, there may be a problem is establishing a standard dosing regimen. I studied the afrezza facebook page and see quite a few complaints about variable responses to afrezza, timing their doses, problems with slow digesting carbs, etc. And while other users make various suggestions, there doesn't seem to be a consensus on the best approach. Coming up with a study where treatment of each subject has to be tailored individually could be complicated. Ultimately, it simply may not be worth the efort. I spend quite a bit of time there, too. I read "questions about dosing"...you read complaints. I read "real life individual approaches" based on personal experience from users, you read lack of consensus. Your summation is correct, no matter how you read it, initiating a study to tailor individualized treatment would be complicated. Thus, the solutions offered by users with their personal experiences has helped so many, that...too, is also found on the same FB page.
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Post by prcgorman2 on Aug 18, 2019 18:37:22 GMT -5
I'm seeing "VDEX is our savior" for the SoC.
I don't get it, so I need someone (believable) to explain what a diabetes clinic operator is going to do to overcome the lack of "Class A or B" evidence required to persuade the ADA, most endos, and however many of the 225,000 PCPs that Afrezza should be a preferred prandial insulin solution to achieve A1C and TIR goals?
Videos of happy PWDs is heart-warming but it's not going to do bupkis for the issue of acquiring evidence of superiority from a large-scale clinical trial.
You can argue VDEX improves retention, but draw the picture (in dollars and time) between improved retention and acknowledged SOC for A1C and TIR.
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Deleted
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Post by Deleted on Aug 18, 2019 22:40:56 GMT -5
I'm seeing "VDEX is our savior" for the SoC. I don't get it, so I need someone (believable) to explain what a diabetes clinic operator is going to do to overcome the lack of "Class A or B" evidence required to persuade the ADA, most endos, and however many of the 225,000 PCPs that Afrezza should be a preferred prandial insulin solution to achieve A1C and TIR goals? Videos of happy PWDs is heart-warming but it's not going to do bupkis for the issue of acquiring evidence of superiority from a large-scale clinical trial. You can argue VDEX improves retention, but draw the picture (in dollars and time) between improved retention and acknowledged SOC for A1C and TIR. We don't need SOC change right now. We need the Gov't to approve Afrezza for Medicare & Medicaid. Once that happens the insurance companies will get onboard and remove all restrictions. Then sales will make the HOCKEY STICK move. VDEX nor anyone else will get the ADA to change the SOC.
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paul
Researcher
Posts: 134
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Post by paul on Aug 18, 2019 22:45:45 GMT -5
I'm seeing "VDEX is our savior" for the SoC. I don't get it, so I need someone (believable) to explain what a diabetes clinic operator is going to do to overcome the lack of "Class A or B" evidence required to persuade the ADA, most endos, and however many of the 225,000 PCPs that Afrezza should be a preferred prandial insulin solution to achieve A1C and TIR goals? Videos of happy PWDs is heart-warming but it's not going to do bupkis for the issue of acquiring evidence of superiority from a large-scale clinical trial. You can argue VDEX improves retention, but draw the picture (in dollars and time) between improved retention and acknowledged SOC for A1C and TIR. We don't need SOC change right now. We need the Gov't to approve Afrezza for Medicare & Medicaid. Once that happens the insurance companies will get onboard and remove all restrictions. Then sales will make the HOCKEY STICK move. VDEX nor anyone else will get the ADA to change the SOC. Ultimately, tier placement depends on contracts negotiated by the PBMs and insurers with the pharmas. With the current status of afrezza as just equal to humalog and novolog, until Mannkind gets the financial muscle to nudge aside the likes of Lilly and Novo, afrezza tier placement likely will remain low and its use subject to restrictions.
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Post by nylefty on Aug 19, 2019 0:46:33 GMT -5
I'm seeing "VDEX is our savior" for the SoC. I don't get it, so I need someone (believable) to explain what a diabetes clinic operator is going to do to overcome the lack of "Class A or B" evidence required to persuade the ADA, most endos, and however many of the 225,000 PCPs that Afrezza should be a preferred prandial insulin solution to achieve A1C and TIR goals? Videos of happy PWDs is heart-warming but it's not going to do bupkis for the issue of acquiring evidence of superiority from a large-scale clinical trial. You can argue VDEX improves retention, but draw the picture (in dollars and time) between improved retention and acknowledged SOC for A1C and TIR. We don't need SOC change right now. We need the Gov't to approve Afrezza for Medicare & Medicaid. Once that happens the insurance companies will get onboard and remove all restrictions. Then sales will make the HOCKEY STICK move. VDEX nor anyone else will get the ADA to change the SOC. I'm on Medicare and it's not up to the government to "approve" Afrezza. It's up to the commercial insurance companies who offer supplemental drug coverage to Medicare recipients. My supplemental plan does offer Afrezza to Medicare recipients, with a Prior Authorization requirement. Here's what Medicare.gov says: Most Medicare drug plans have their own list of covered drugs, called a formulary. Plans cover both generic and brand-name prescription drugs. The formulary includes at least 2 drugs in the most commonly prescribed categories and classes. This helps make sure that people with different medical conditions can get the prescription drugs they need. All Medicare drug plans generally must cover at least 2 drugs per drug category, but plans can choose which specific drugs they cover.
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Post by ktim on Aug 19, 2019 0:50:25 GMT -5
I'm seeing "VDEX is our savior" for the SoC. I don't get it, so I need someone (believable) to explain what a diabetes clinic operator is going to do to overcome the lack of "Class A or B" evidence required to persuade the ADA, most endos, and however many of the 225,000 PCPs that Afrezza should be a preferred prandial insulin solution to achieve A1C and TIR goals? Videos of happy PWDs is heart-warming but it's not going to do bupkis for the issue of acquiring evidence of superiority from a large-scale clinical trial. You can argue VDEX improves retention, but draw the picture (in dollars and time) between improved retention and acknowledged SOC for A1C and TIR. We don't need SOC change right now. We need the Gov't to approve Afrezza for Medicare & Medicaid. Once that happens the insurance companies will get onboard and remove all restrictions. Then sales will make the HOCKEY STICK move. VDEX nor anyone else will get the ADA to change the SOC. Medicaid coverage for Afrezza is pretty good. The "government" doesn't make decisions about Medicare coverage. All drugs under Medicare are covered by Part D or Advantage plans, which are private insurance companies making the decisions.
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Post by boca1girl on Aug 19, 2019 8:16:39 GMT -5
We don't need SOC change right now. We need the Gov't to approve Afrezza for Medicare & Medicaid. Once that happens the insurance companies will get onboard and remove all restrictions. Then sales will make the HOCKEY STICK move. VDEX nor anyone else will get the ADA to change the SOC. I'm on Medicare and it's not up to the government to "approve" Afrezza. It's up to the commercial insurance companies who offer supplemental drug coverage to Medicare recipients. My supplemental plan does offer Afrezza to Medicare recipients, with a Prior Authorization requirement. Here's what Medicare.gov says: Most Medicare drug plans have their own list of covered drugs, called a formulary. Plans cover both generic and brand-name prescription drugs. The formulary includes at least 2 drugs in the most commonly prescribed categories and classes. This helps make sure that people with different medical conditions can get the prescription drugs they need. All Medicare drug plans generally must cover at least 2 drugs per drug category, but plans can choose which specific drugs they cover.
If we can get a new classification (category) of “ultra rapid”, then maybe we can finally get decent coverage.
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Post by prcgorman2 on Aug 19, 2019 9:22:03 GMT -5
I'm on Medicare and it's not up to the government to "approve" Afrezza. It's up to the commercial insurance companies who offer supplemental drug coverage to Medicare recipients. My supplemental plan does offer Afrezza to Medicare recipients, with a Prior Authorization requirement. Here's what Medicare.gov says: Most Medicare drug plans have their own list of covered drugs, called a formulary. Plans cover both generic and brand-name prescription drugs. The formulary includes at least 2 drugs in the most commonly prescribed categories and classes. This helps make sure that people with different medical conditions can get the prescription drugs they need. All Medicare drug plans generally must cover at least 2 drugs per drug category, but plans can choose which specific drugs they cover.
If we can get a new classification (category) of “ultra rapid”, then maybe we can finally get decent coverage. I'm a fan bocagirl but can't resist a joke at your expense. (My sincerest apology in advance if I manage to genuinely offend.)
Your "If" statement reminded me of the joke, "If we had some ham we could have ham and eggs for breakfast if we had some eggs."
I 100% agree with your supposition and your conclusion, but it's the unsaid that made me want to tease.
My post last night was intended to challenge more extreme VDEX sycophants to explain clearly how VDEX can solve the Afrezza sales challenges created by the lack of "Class A or B" data to prove superiority of Afrezza as compared to the competitor RAA prandial insulins. To me, THAT lack of a first class clinical trial is Rome and all roads lead there.
Afrezza will not get the new "ultra rapid" classification and be able to put that on the label or tell it to Endos and PCPs without it.
For years I have refused to believe that there couldn't be quicker, cheaper, alternatives to achieving the sales goals such as TV DTC and on-line media campaigns, but those have and are being tried and the weekly NRx is stubbornly not making material progress. And, I continue to refuse to believe that Mannkind management or their salesforce are stupid, greedy, and lazy, and will not accept those complaints as valid reasons for the lack of new Afrezza sales success. Like nearly all of us, these people are making good faith efforts and we should respect them for it.
We have the facts and we've been told over and over what is lacking and what is required. It's time to recognize it (for me at least) and then demand a plan that acknowledges the challenge and builds in a roadmap to achieving first class clinical results that provide the A or B quality of data on the scale that is required, even if that is 5 years away.
Because of the Sanofi perfidy, like a baby Mannkind must crawl before it can walk before it can run. I believe the current roadmap being executed is sensible given where Mannkind is in it's journey, but I want to see more acknowledgement for how/when we get to being able to lay legitimate claim to superiority which is probably a longer term goal unless something happens sooner to accelerate it.
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Post by mnholdem on Aug 19, 2019 10:09:05 GMT -5
Good points. While I am far from being a “sycophant” about VDex, their business plan seems to rely heavily on results. As you point out, without empirical evidence, MannKind’s sales strategy cannot include results that are not supported by the label.
This is one reason why I believe the former CEO wanted to collaborate with VDex to gather real-world clinical evidence which the FDA now accepts for label upgrades, provided scientific rigors are met in gathering and presenting the clinical data.
It seems by now that much of the required lung safety data could have been gathered by ALL clinics that are prescribing Afrezza. It all comes down to management to devise a viable approach to gathering a data pool.
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paul
Researcher
Posts: 134
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Post by paul on Aug 19, 2019 12:16:24 GMT -5
Good points. While I am far from being a “sycophant” about VDex, their business plan seems to rely heavily on results. As you point out, without empirical evidence, MannKind’s sales strategy cannot include results that are not supported by the label. This is one reason why I believe the former CEO wanted to collaborate with VDex to gather real-world clinical evidence which the FDA now accepts for label upgrades, provided scientific rigors are met in gathering and presenting the clinical data. It seems by now that much of the required lung safety data could have been gathered by ALL clinics that are prescribing Afrezza. It all comes down to management to devise a viable approach to gathering a data pool. You refer to "required lung safety data." What kind of data is required?
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