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Post by peppy on Jan 29, 2019 8:44:44 GMT -5
I screwed up the post. From the last page, the last post, Matt said, There are three factors working here: 1. If we use the numbers put forth above, Afrezza is roughly four times as expensive as Novolog at full retail. Time is range becomes relevant to managed care if, and only if, the improved time in range translates to reduced costs for the managed care provider. Realistically, managed care will have to pay the premium price for Afrezza on many patients to save the additional costs for a few patients that do not stay in range. Can Afrezza be economically justified on this basis? Perhaps, but it certainly isn't an obvious conclusion or there wouldn't be an issue. The cost and difficulty of doing a large study that tracks all costs of diabetic care and differences in outcomes is what is needed, and MNKD simply doesn't have the money or the organization to generate that data. 2. Never forget the impact of competition. Novo and Lilly both boosted their insulin prices over the last ten years and enjoy very sizeable profit margins on these legacy products. If MNKD were able to do a detailed pharmacoeconomic study that proves that time in range is economically relevant for the providers, what keeps Novo or Lilly from simply dropping prices back to 2010 levels? The legacy products are probably still marginally profitable at less than $100 / month, and that is a tough price point for MNKD to compete against. Novo, especially, would rather sell their legacy product at $100 than to lose market share to MNKD, and Lilly is not much different. 3. Managed care looks at incremental prices after all rebates and discounts. The large PBMs don't pay retail and a lot of the rebates they enjoy get passed back to the managed care group that contracted them. They are going to compare the cost of Novo or Lilly product,, net of rebates, against the negotiated prices for extra medical services for those patients that do not stay in range. Only if the net costs make sense will managed care make a change, and the net costs are hard to know from the outside looking inward. ============================================================================================= MNKD has unit pricing. 1.27 units afrezza/dollar .79 a unit. (There are type one and type two diabetics. For instance Laura K uses 4 unit cartridges. I think Eric F type one uses 4 unit also. and add on doses per CGM.)   |
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Post by agedhippie on Jan 29, 2019 10:17:37 GMT -5
... MNKD has unit pricing. 1.27 units afrezza/dollar .79 a unit. FIASP or Humalog unit pricing in the UK: .03 a unit This is just me being bitchy about US insulin prices...  |
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Post by goyocafe on Jan 29, 2019 10:22:12 GMT -5
... MNKD has unit pricing. 1.27 units afrezza/dollar .79 a unit. FIASP or Humalog unit pricing in the UK: .03 a unit This is just me being bitchy about US insulin prices... You're not alone. I wonder how many on this board thought that FDA approval was the ultimate barrier to entry, and success, for Afrezza. Who would have thought it was a broken health system. Makes perfect sense in hindsight, however. |
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Post by seanismorris on Jan 29, 2019 11:40:37 GMT -5
FIASP or Humalog unit pricing in the UK: .03 a unit This is just me being bitchy about US insulin prices... You're not alone. I wonder how many on this board thought that FDA approval was the ultimate barrier to entry, and success, for Afrezza. Who would have thought it was a broken health system. Makes perfect sense in hindsight, however. Maybe we need Afrezza approved in Mexico, so Americans can go there and get it for a reasonable price. |
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Post by sweedee79 on Jan 29, 2019 12:17:15 GMT -5
I think we need large trial data proving Afrezza superior.. and in a class of it's own..
Cuz insurance doesn't want to pay for something unless they are forced to.
At this point injectable controls market.. it's cheaper and in line with SOC...
UGH!!!!! The truth hurts..
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Post by jred on Jan 29, 2019 14:59:18 GMT -5
No way to look behind the curtain and see the effect on price of the negotiated deals, but came across this chart in an article on GoodRx reflecting cash prices. Don't quite understand how the price increases per insulin unit would be helping to drive scripts. Looks like a significant increase around 10/2017 which corresponds to the jump in avg cost/rx in liane 's script data table. Hope the $4/day program can help with this overhang.
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Post by jred on Jan 29, 2019 15:44:01 GMT -5
Not only does the $4/day program dramatically drop the cash price per unit of insulin, it also appears to be a change in relative price modeling. When Mike and his team went through the repackaging and sku simplification, they made a point that pricing by sku was going to be more consistent per insulin unit. Right now on a cash basis (as quoted by GoodRx) the cost per insulin unit across all 5 active sku's is roughly $.92.
With only 2 price points ($120 and $199) the direct program deviates from a consistent price per unit.
(90) 4-UNIT - 360 total units - $120 - $.333 per unit
(90) 8-UNIT - 720 total units - $120 - $.167 per unit
(90) 12-UNIT - 1080 total units - $120 - $.111 per unit
(90) 4-UNIT, (90) 8-UNIT - 1080 total units - $199 - $.184 per unit
(60) 4-UNIT, (60) 8-UNIT, (60) 12-UNIT - 1440 total units - $199 - $.138 per unit
Will be interesting to hear subscriber numbers on this program. Even with the 1.5x increase factor, it makes Afrezza considerably cheaper than the Apidra/Humalog/Novolog pens on a cash retail basis.
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Post by lakers on Jan 29, 2019 16:22:55 GMT -5
I think we need large trial data proving Afrezza superior.. and in a class of it's own.. Cuz insurance doesn't want to pay for something unless they are forced to. At this point injectable controls market.. it's cheaper and in line with SOC... UGH!!!!! The truth hurts.. Here are the two Superiority Studies. We anticipate our pediatric program to be Phase III ready by the end of 2019. We also expect a few additional readouts this year from our One Drop study as well as our investigator trial type 2 patients with Dr. Phil Levine in Baltimore. We’re excited to see the interim analysis presented at the upcoming scientific conferences in 2019.” Superiority Study: Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients clinicaltrials.gov/ct2/show/NCT03324776?term=Afrezza&rank=1 Read more: mnkd.proboards.com/thread/10754/mannkind-corporation-hold-investor-conference?page=13#ixzz5e29XkbMYA Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone clinicaltrials.gov/ct2/show/NCT03313960?term=Afrezza+one+drop&cntry=US&rank=1 “We have been working diligently with our partner in Brazil and regulatory authorities to secure our first approval outside the U.S. and hope to have an update for you on this surely as the holidays slowed down our review unfortunately. We need to finish our part one of our pediatric program to file what is known as a PIP in the EU before we can engage in a meaningful filing application for Europe. We anticipate filing in Canada in the first half of 2019 and meeting with the European regulatory authorities to start a [indiscernible] over there as these are the two most common places where we get requests for Afrezza from our international inquiries. We know it takes time to gain regulatory approval in these markets and we’ll make appropriate call to look for one go-to-partner ex-U.S. or continue to find key partners in each market like we did with Brazil and India.” |
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Post by agedhippie on Jan 29, 2019 16:59:06 GMT -5
Here are the two Superiority Studies. ... Superiority Study: Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients clinicaltrials.gov/ct2/show/NCT03324776?term=Afrezza&rank=1 ... A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone clinicaltrials.gov/ct2/show/NCT03313960?term=Afrezza+one+drop&cntry=US&rank=1 Neither of those is a superiority study. The first study does not have a control arm so there is nothing to compare it against so it cannot be a superiority study, and the second study has One Drop coaching so it would also fail as a superiority study. In the second study since the Phase 3 trial established that Afrezza and RAA were equivalent all this trial shows is whether One Drop is more effective coaching Afrezza or RAA. A superiority trial has two arms; one Afrezza and the other RAA - plain and simple. Anything else is fluff and distraction, and will disqualify the trial in the eyes of the ADA. There is a reason nobody on the Mannkind side has claimed them as superiority studies. |
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Post by peppy on Jan 29, 2019 17:06:15 GMT -5
Not only does the $4/day program dramatically drop the cash price per unit of insulin, it also appears to be a change in relative price modeling. When Mike and his team went through the repackaging and sku simplification, they made a point that pricing by sku was going to be more consistent per insulin unit. Right now on a cash basis (as quoted by GoodRx) the cost per insulin unit across all 5 active sku's is roughly $.92.
With only 2 price points ($120 and $199) the direct program deviates from a consistent price per unit.
(90) 4-UNIT - 360 total units - $120 - $.333 per unit
(90) 8-UNIT - 720 total units - $120 - $.167 per unit
(90) 12-UNIT - 1080 total units - $120 - $.111 per unit
(90) 4-UNIT, (90) 8-UNIT - 1080 total units - $199 - $.184 per unit
(60) 4-UNIT, (60) 8-UNIT, (60) 12-UNIT - 1440 total units - $199 - $.138 per unit
Will be interesting to hear subscriber numbers on this program. Even with the 1.5x increase factor, it makes Afrezza considerably cheaper than the Apidra/Humalog/Novolog pens on a cash retail basis.
darn good price. Now we need it over the counter. insulin regular human (Rx, OTC) reference.medscape.com/drug/humulin-r-novolin-r-insulin-regular-human-999007 MNKD has unit pricing. 1.27 units afrezza/dollar .79 a unit. |
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Post by lakers on Jan 29, 2019 18:56:42 GMT -5
Here are the two Superiority Studies. ... Superiority Study: Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients clinicaltrials.gov/ct2/show/NCT03324776?term=Afrezza&rank=1 ... A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone clinicaltrials.gov/ct2/show/NCT03313960?term=Afrezza+one+drop&cntry=US&rank=1 Neither of those is a superiority study. The first study does not have a control arm so there is nothing to compare it against so it cannot be a superiority study, and the second study has One Drop coaching so it would also fail as a superiority study. In the second study since the Phase 3 trial established that Afrezza and RAA were equivalent all this trial shows is whether One Drop is more effective coaching Afrezza or RAA. A superiority trial has two arms; one Afrezza and the other RAA - plain and simple. Anything else is fluff and distraction, and will disqualify the trial in the eyes of the ADA. There is a reason nobody on the Mannkind side has claimed them as superiority studies. Both (1) and (2) use One Drop | Premium 'On Track'. The difference is Afrezza vs Injected RAA. Therefore, it qualifies as a Superiority Study. Detailed Description: Eligible participants (N=400) with an A1c > 7.0% already prescribed a rapid-acting insulin will be randomized to one of two groups: (1) One Drop | Premium 'On Track' (i.e., use the One Drop | Mobile app with in-app diabetes education accredited by the American Diabetes Association with supplemental Afrezza content and a live Certified Diabetes Educator messaging in the app, the 'Chrome' Bluetooth-connected blood glucose meter that uploads blood glucose values in the app, and 150 test strips per month) in combination with Afrezza treatment (n=200) or (2) One Drop | Premium 'On Track' plus their current rapid-acting insulin (n=200). Intervention Model: Parallel Assignment clinicaltrials.gov/ct2/show/NCT03313960?term=Afrezza+one+drop&cntry=US&rank=1The other trial is significant bc it measures A1C using adaptive Afrezza titration algorithm (ATA) on out of control T2 who have used other RAAs. Think of it as speeding up Time To A1C Target (TTT). clinicaltrials.gov/ct2/show/NCT03324776?term=Afrezza&rank=1Brief Summary: To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use. Detailed Description: Clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. The investigator proposes treating patients with Afrezza who have an index HbA1c between 7.5% and 11.5% despite being treated with diabetes medications for at least 6 months. The response to Afrezza will be assessed with Continuous Glucose Monitoring Systems (CGMS) studies and initial and follow-up HbA1cs. The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur. Afrezza Inhalant Product Patients will be instructed to follow a Weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm. |
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Post by agedhippie on Jan 29, 2019 23:25:14 GMT -5
Both (1) and (2) use One Drop | Premium 'On Track'. The difference is Afrezza vs Injected RAA. Therefore, it qualifies as a Superiority Study. ... The other trial is significant bc it measures A1C using adaptive Afrezza titration algorithm (ATA) on out of control T2 who have used other RAAs. Think of it as speeding up Time To A1C Target (TTT). ... I clipped out the bits where you repeated the trial description from the filing. However, you left out the brief description of the One Drop trial which is a shame because it shows the problem in a nutshell so here is is; Brief Summary:
The A-One study is a prospective, randomized controlled trial evaluating the use of the One Drop | Premium 'On Track' in combination with Afrezza treatment on the glycemic control, treatment adherence, social-cognitive barriers to adherence, and treatment satisfaction of people with Type 2 diabetes (T2D) and a hemoglobin A1c (A1c) > 7.0% already prescribed an injectable rapid-acting insulin.That phrase, "evaluating the use of the One Drop | Premium 'On Track' in combination with Afrezza" is what kills it as a superiority trial. Once One Drop is added in it can no longer be say that Afrezza outperforms RAA. It becomes a comparison of Afrezza + One Drop vs. RAA + One Drop coaching. Since Affinity-1 established that Afrezza as non-inferior to RAA the best that can be said about this trial is that One Drop active coaching works better with Afrezza than it does with RAA. That's not to be sniffed at, but it does not establish that Afrezza alone is superior to RAA alone. The other trial is irrelevant. You cannot show superiority without a comparison. Besides which that the trial explicitly excludes anyone using an RAA is just the nail in the coffin! What is needed is a proper superiority study for Type 1 and 2 (those trials were Type 2 only so would have had no influence on Type 1 recommendations anyway) and that trial is needed sooner rather than later. Run a 400 person trial like the One Drop trial, run it for 6 months, and run it using the STAT protocols and we are there. Playing games with oddball trials is not going to cut it with insurers (to return to the topic of the thread). |
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Post by cjm18 on Jan 30, 2019 0:07:50 GMT -5
How much does a true superiority trial cost?
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Post by lakers on Jan 30, 2019 1:50:54 GMT -5
Afrezza usage is different from other RAA - for instance, a few mins into a meal, one or more follow-up dosages, unit conversion. Afrezza needs to be optimally used according to ATA (Different titration) to showcase TIR, TTT which are measurable outcomes to improve insurance coverage.
In a nutshell, Superiority study needs to also incorporate usage. It’s pretty common that different meds have different usages as normally shown on the labels.
The out of control T2 successful Study may potentially reduce some Step Therapy, PA requirements.
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Post by hellodolly on Jan 30, 2019 10:57:39 GMT -5
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