|
Post by agedhippie on Mar 22, 2018 8:51:31 GMT -5
ADA can make the insurers cover CGMs by making it part of the Standard of Care. That's what they did in the end with pumps after years of obstruction by the insurers. The STAT study is interesting, but there needs to be a study to prove that time in range matters. Without that it's going to take a long time to gain traction. A comparison would be CGMs - for years insurers would not cover them even though everyone knew they made sense. It was only after Kaiser bit the bullet and sponsored a large scale trial that it became indisputable (at which point the insurers tried moving to prior authorization and step therapy to limit cover). Same thing when pumps came out. According to this fairly recent article, insurers still require a letter of medical necessity -- insulinnation.com/treatment/how-to-get-approved-for-pump-therapy/ They do, but its a formality if you are a Type 1. It's still very hard to get a pump if you are a Type 2 and that's why the requirement is there - a pump isn't considered a medical necessity for most Type 2.
|
|
|
Post by #NoMoreNeedles on Apr 16, 2018 8:19:30 GMT -5
Someone noticed that Eli Lilly is the only big player not exhibiting/presenting at upcoming ADA.
|
|
|
Post by akemp3000 on Apr 16, 2018 9:30:01 GMT -5
As for insurance payment I agree that insurers are not going to get out ahead with regard to trying to avoid long term complications due to exactly what you say. However, if solid science comes out showing how CGMs can significantly reduce reduce long term complications and advocacy groups like ADA get behind demanding insurance make them available, I think payers can be pressured into doing it even if it doesn't benefit them financially in the short term. It's not going to happen over night though. ADA can make the insurers cover CGMs by making it part of the Standard of Care. That's what they did in the end with pumps after years of obstruction by the insurers. The STAT study is interesting, but there needs to be a study to prove that time in range matters. Without that it's going to take a long time to gain traction. A comparison would be CGMs - for years insurers would not cover them even though everyone knew they made sense. It was only after Kaiser bit the bullet and sponsored a large scale trial that it became indisputable (at which point the insurers tried moving to prior authorization and step therapy to limit cover). Same thing when pumps came out. Excellent point. I can't imagine anyone that would know how to expedite this better by working with CGM suppliers than the former ADA Chief Scientific Medical Officer, Dr. David Kendall
|
|
|
Post by mnholdem on Apr 16, 2018 11:04:41 GMT -5
|
|
|
Post by akemp3000 on Apr 16, 2018 11:25:14 GMT -5
Only a year ago CGMs and time-in-range were just beginning to move into some mainstream discussions. Hopefully, the coming ADA conference will be buzzing about CGMs, the STAT study and Afrezza. Since many of us follow message boards and the market multiple times a day, it appears the shift is moving at glacial speed but it's actually starting to happen fairly quickly considering the magnitude of importance. Hopefully, Dr. Kendall heard Mike's pitch and decided to join Mannkind to implement a plan to accelerate the shift. IMO, he wouldn't have climbed aboard for any other reason.
|
|
|
Post by zuegirdor on Apr 16, 2018 12:27:19 GMT -5
Even if its only to keep diabetics alive and complication free until the cure arrives, I hope for all of our sakes that Afrezza catches on as soon as possible. We head to the first "Adult" endocrinology appointment for my son today to see if Kaiser will write and pay for an Afrezza Rx. His new adult GP already remarked that he had never seen a T1D with hba1c as low as son's. Will follow up. Now, back to the cure news: www.nature.com/articles/s41467-018-03943-0time to sell some insulin!
|
|
|
Post by dreamboatcruise on Apr 16, 2018 12:57:44 GMT -5
Even if its only to keep diabetics alive and complication free until the cure arrives, I hope for all of our sakes that Afrezza catches on as soon as possible. We head to the first "Adult" endocrinology appointment for my son today to see if Kaiser will write and pay for an Afrezza Rx. His new adult GP already remarked that he had never seen a T1D with hba1c as low as son's. Will follow up. Now, back to the cure news: www.nature.com/articles/s41467-018-03943-0time to sell some insulin! Which regional Kaiser are you with?
|
|
|
Post by zuegirdor on Apr 17, 2018 17:34:30 GMT -5
Even if its only to keep diabetics alive and complication free until the cure arrives, I hope for all of our sakes that Afrezza catches on as soon as possible. We head to the first "Adult" endocrinology appointment for my son today to see if Kaiser will write and pay for an Afrezza Rx. His new adult GP already remarked that he had never seen a T1D with hba1c as low as son's. Will follow up. Now, back to the cure news: www.nature.com/articles/s41467-018-03943-0time to sell some insulin! Which regional Kaiser are you with? California North Bay
|
|
|
Post by lakers on Apr 19, 2018 2:00:37 GMT -5
|
|
|
Post by goyocafe on Apr 19, 2018 2:10:28 GMT -5
|
|
|
Post by peppy on Apr 19, 2018 8:25:45 GMT -5
the first ADA Standards of Care, published in 1989, provided recommendations based on the available evidence at that time and filled only four pages in Diabetes Care (2). In the most recent update, 28 years later, the document is well over 170 pages! Over 40 new type 2 diabetes treatment options have been approved since 2005 (3), not even counting advances in technology, such as continuous glucose monitoring. beginning in 2018, the ADA will update and revise the online version of the Standards of Care throughout the year, =========================================================================================== Because the document can be changed during the year, the article said, "the Standards of Care are now a “living” document,"
|
|
|
Post by mnholdem on Apr 19, 2018 11:28:55 GMT -5
Excerpt from ADA article about the living Standard of Care:
To underline the need for a living Standards of Care, two specific examples faced the PPC in December 2017, just days after the 2018 Standards of Care was publicly released. First, semaglutide was approved for use in type 2 diabetes on December 5, just days prior to the release of the Standards of Care. Semaglutide is a glucagon-like peptide 1 receptor agonist with apparent cardiovascular benefits for people with type 2 diabetes. As this was not an approved agent at the time the PPC reviewed the data for 2018, a recommendation could not be made in the 2018 Standards of Care. Second, a consensus report on clinically meaningful outcome measures beyond A1C for type 1 diabetes representing a consensus from the diabetes community (including the ADA) was published in the December issue of Diabetes Care (5), again too late to be incorporated into the Standards of Care by the PPC.
---
Here is a link to the article referred to in the December 2017 issue of Diabetes Care: care.diabetesjournals.org/content/40/12/1622
OBJECTIVE
To identify and define clinically meaningful type 1 diabetes outcomes beyond hemoglobin A1c (HbA1c) based upon a review of the evidence, consensus from clinical experts, and input from researchers, people with type 1 diabetes, and industry. Priority outcomes include hypoglycemia, hyperglycemia, time in range, diabetic ketoacidosis (DKA), and patient-reported outcomes (PROs). While priority outcomes for type 1 and type 2 diabetes may overlap, type 1 diabetes was the focus of this work.
---
Take a look at the Primary and Secondary Outcomes in the STAT study (endpoint results to be presented at ADA-2018): Primary Outcome Measures:
1. Improved time in range (70-180 mg/dl) with TI on CGM [ Time Frame: 4 weeks ]
2. Better post-prandial glucose excursion (1-4 hours after meals) with TI [ Time Frame: 4 weeks ]
Secondary Outcome Measures:
1. Less glucose variability (GV) (standard deviation and/or coefficient variation) [ Time Frame: 4 weeks ]
2. The area under the curve calculation (AUC) in the PPBG and PPGE, [ Time Frame: 4 weeks ]
3. Change in HbA1c in one-month treatment [ Time Frame: 4 weeks ]
4. above the target time (>180 mg/dl) on CGM [ Time Frame: 4 weeks ]
5. hypoglycemia frequency (below the target <70, <60, <50 mg/dl) on CGM [ Time Frame: 4 weeks ]
---
I'm eager to learn what the newest updates to the ADA's living Standard of Care will be.
|
|
|
Post by centralcoastinvestor on Apr 19, 2018 11:37:57 GMT -5
Excerpt from ADA article about the living Standard of Care:
To underline the need for a living Standards of Care, two specific examples faced the PPC in December 2017, just days after the 2018 Standards of Care was publicly released. First, semaglutide was approved for use in type 2 diabetes on December 5, just days prior to the release of the Standards of Care. Semaglutide is a glucagon-like peptide 1 receptor agonist with apparent cardiovascular benefits for people with type 2 diabetes. As this was not an approved agent at the time the PPC reviewed the data for 2018, a recommendation could not be made in the 2018 Standards of Care. Second, a consensus report on clinically meaningful outcome measures beyond A1C for type 1 diabetes representing a consensus from the diabetes community (including the ADA) was published in the December issue of Diabetes Care (5), again too late to be incorporated into the Standards of Care by the PPC.
---
Here is a link to the article referred to in the December 2017 issue of Diabetes Care: care.diabetesjournals.org/content/40/12/1622
OBJECTIVE To identify and define clinically meaningful type 1 diabetes outcomes beyond hemoglobin A1c (HbA1c) based upon a review of the evidence, consensus from clinical experts, and input from researchers, people with type 1 diabetes, and industry. Priority outcomes include hypoglycemia, hyperglycemia, time in range, diabetic ketoacidosis (DKA), and patient-reported outcomes (PROs). While priority outcomes for type 1 and type 2 diabetes may overlap, type 1 diabetes was the focus of this work.
---
Take a look at the Primary and Secondary Outcomes in the STAT study (endpoint results to be presented at ADA-2018): Primary Outcome Measures:
1. Improved time in range (70-180 mg/dl) with TI on CGM [ Time Frame: 4 weeks ]
2. Better post-prandial glucose excursion (1-4 hours after meals) with TI [ Time Frame: 4 weeks ]
Secondary Outcome Measures:
1. Less glucose variability (GV) (standard deviation and/or coefficient variation) [ Time Frame: 4 weeks ]
2. The area under the curve calculation (AUC) in the PPBG and PPGE, [ Time Frame: 4 weeks ]
3. Change in HbA1c in one-month treatment [ Time Frame: 4 weeks ]
4. above the target time (>180 mg/dl) on CGM [ Time Frame: 4 weeks ]
5. hypoglycemia frequency (below the target <70, <60, <50 mg/dl) on CGM [ Time Frame: 4 weeks ]
---
I'm eager to learn what the newest updates to the ADA's living Standard of Care will be.
The primary and secondary outcomes almost perfectly describe the STAT study. Wow.
|
|
|
Post by mannmade on Apr 19, 2018 11:43:29 GMT -5
And don’t forget who is presenting at ADA on behalf of Mannkind. Our very own Dr. K. Perhaps this was MK third catalyst?
|
|
|
Post by dreamboatcruise on Apr 19, 2018 12:02:45 GMT -5
And don’t forget who is presenting at ADA on behalf of Mannkind. Our very own Dr. K. Perhaps this was MK third catalyst? I don't remember that, but I think that is because it is incorrect information. The study wasn't conducted by Mannkind. The lead author was Dr. Satish Garg of Univ of CO who will presumably be the one presenting. Where did you read/hear that Kendall would be presenting?
|
|