|
|
Post by agedhippie on Mar 6, 2024 8:00:08 GMT -5
yes, so back to my question.... Is it a G6 or G7 under a different name for over the counter sale? It is a G7 with a software mod to disable alarms and with restricted bluetooth pairing. Basically the same idea as the Dexcom One which is a G6 also with some of the functionality disabled. They are building products with standard hardware that then has different features enabled. |
|
|
|
Post by sayhey24 on Mar 6, 2024 9:41:31 GMT -5
... According to the FDA approved afrezza label during the 175 study afrezza provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed with those that did not add afrezza to their current treatment. OK - afrezza wins. You would think if you were a T2 taking metformin and you were not controlled and your doctor prescribed to add afrezza your insurance would cover it. Nope - it will not. The PBM will deny coverage. You are not getting afrezza. ... Aged has explained the situation. BP is controlling the PBMs by "bundling" their products. If the PBM offers afrezza, the BPs will jack up their prices on other "bundled" drugs. PBMs will not cover afrezza. ... Wouldn't it make sense to run a trial with the Stelo in one group, the G7 in another and have a placebo group and afrezza as a mono therapy and see if you can get the Stelo approved for afrezza? ... Taking these in order... The 175 trial showed nothing unexpected. You took a group of people where oral meds were no-longer sufficient, split them in two and added Afrezza to one group. All that trial showed is that Afrezza is better than nothing (in fairness that was what had to be achieved for approval) and literally any insulin would have achieved that bar. However, the SoC says there are other things you should use before insulin, Afrezza or other RAA, and there was no trial against those and hence no coverage. PBMs can be forced to cover Afrezza provided you can clearly show a superior outcome. The poster child for this is the CGM. Insurers really didn't want to cover CGMs and I remember a time when you had to be hypo-unaware to get a CGM which is a very small group. But the CGM manufacturers put in the work with trials to prove that first all T1 had better outcomes if they used a CGM, and then the same for insulin using T2. It took over a decade but they got there in the end because they had indisputable data from multiple trials which changed the SoC forcing coverage. I would expect Afrezza with kids to follow the same pattern as with adults unless the trial can pull a rabbit out of the hat. AID pumps get really good results with kids, and are something the endos are familiar with. Pumps also absorb a lot of the workload from the kids and parents. All of that said, if the trial can turn iin significantly better results than the comparator arm I can see endos moving towards Afrezza. The benefit of large centers is that they have people whose sole job is handling pre-auths. You will not get Stelio approved for Afrezza because Stelio is explicitly not approved as a medical device. If you were taking Afrezza you can get a G6 or G7 today without any arguments, you don't need a Stelio. I thought you told us that big pharma are bundling drugs and for the PBMs to get the discounts they need to buy the bundle and thats why they won't cover both Novalog and Humalog. With CGMs I am assuming this is a very different model and bundling was not involved. I would think afrezza would need to be in a whole new class of insulin to break out of your bundling theory as it was in the original Inflation Reduction Act when "form inhaled" was required. I guess this is doable but is not happening anytime soon especially for the T2s. As far as the Stelo. I like it. I think its a big step forward for wide spread glucose monitoring and people starting to ask questions on the post prandial spike. We are also going to see a lot more levels and Ro type companies. When they go to their doctor, a libre 3 or G7 can be prescribed along with the afrezza but until MNKD can get past the PBMs afrezza is doomed in the T2 market. |
|
|
|
Post by prcgorman2 on Mar 6, 2024 9:42:57 GMT -5
Same business model as Intel and others. Easier to build full functionality and disable parts then to produce purpose-built variations.
Not trying to discourage further discussion, but we may have run the course on 4Q2023 and Full Year Results.
|
|
|
|
Post by agedhippie on Mar 6, 2024 13:11:50 GMT -5
I thought you told us that big pharma are bundling drugs and for the PBMs to get the discounts they need to buy the bundle and thats why they won't cover both Novalog and Humalog. With CGMs I am assuming this is a very different model and bundling was not involved. I would think afrezza would need to be in a whole new class of insulin to break out of your bundling theory as it was in the original Inflation Reduction Act when "form inhaled" was required. I guess this is doable but is not happening anytime soon especially for the T2s. As far as the Stelo. I like it. I think its a big step forward for wide spread glucose monitoring and people starting to ask questions on the post prandial spike. ... If the SoC requires it then bundling rules do not apply as the pharma cannot shut out the SoC pathway. The PBM can try and push you down an alternate pathway if one exists, but the cannot close it hence step therapy. This is one of the big pluses for orphan drugs - no competition. Oddly I think you are right about CGMs. I seem to be able to pick Dexcom or Libre, not sure about Senseonics as I didn't look. There is a trick where you can bypass the CGM as durable medical equipment (DME) if you get it with a pump. DME is a medical benefit, not a pharmacy benefit and so the co-pay is a lot lower. You are correct, Afrezza would need to be a new class. This has happened before; animal insulin -> human insulin -> RAA. But each of those steps had lots of data showing better outcomes for the class and Afrezza lacks that so it's grouped with RAA as it's rapid acting. I seriously doubt seeing a post prandial spike is going to move anyone. The way it will go is the person will ask the doctor about the spike and the doctor will say that the spike is far less important than the overall time in range so focus on that. For T2 this comes down to the old adage of "eat to your meter" - find what does and doesn't work for you (for some weird reason certain cupcakes don't spike me and I have no idea why.) Most people would rather avoid certain foods than take insulin, and that's not necessarily bad as a lot of those foods are highly processed. |
|
|
|
Post by agedhippie on Mar 6, 2024 13:15:29 GMT -5
Same business model as Intel and others. Easier to build full functionality and disable parts then to produce purpose-built variations. Not trying to discourage further discussion, but we may have run the course on 4Q2023 and Full Year Results. Wait, we are discussing the 4Q2023 results? |
|
|
|
Post by cretin11 on Mar 6, 2024 13:25:20 GMT -5
Let’s not end this without mentioning SAFETY.
|
|
