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Post by dreamboatcruise on Apr 27, 2018 13:58:27 GMT -5
I hope you are right. Son's new endo did not have any problem with the REM or pulmonary risk (none). He only mentioned price as a concern. And that it is not covered by our plan. Still waiting for word on his efforts... meanwhile I am swinging for the next box at $600 out of pocket thanks to the coupon. But he needs closer to a box and a half to get through the month. I just paid $829.56 for ONE box of 180 cartridges (previously had incorrectly said $816). I'm in Medicare in a couple months with absolutely NO COVERAGE whatsoever. Afrezza NOT on the formulary of ANY plan Medicare Supplement Plan available in my part of the state. A box and a half will cost me about $1,200. Clever marketing Mike. Nice job. You are only excluding the biggest segment of Type 2's in the entire country (Medicare participants). Nice move. And thanks for helping diabetics. Al would be so pleased. It is a disappointment. About a year ago we were led to believe that significant Medicare coverage improvement would be coming Jan 2018. Yet, on formularylookup.com we still sit at 88% NOT covered. 18% isn't nothing, but the glass certainly isn't half full when it comes to Medicare. Too bad Afrezza (for Medicare purposes) isn't a device like CGMs. It seems because of having the insurers/PBMs in control of the formularies, the bar is much higher for drugs. |
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Post by sayhey24 on Apr 27, 2018 18:10:56 GMT -5
Digger - it seems what happened was MNKD had already submitted an sNDA for "something" which included removal of the REMs and it was approved prior to 4/17. On 4/17 the FDA sent a notice about changes needed to the REMS communication plan because of "Government Streamlining". On 4/19 MNKD responded with a new sNDA saying "Hey - we don't need the REMS anymore per prior approval". On 4/24 the FDA said that is correct the REMS was already removed forget the communication plan. Per the 4/24 letter "This Prior Approval sNDA (NDA 022472/S-017) provides for proposed modifications to the approved Afrezza risk evaluation and mitigation strategy (REMS). This supplement is in response to our April 17, 2018, REMS Modification Notification letter." What we don't know is all of what was in the sNDA submitted and approved prior to 4/17. We will just have to wait and see. What we do know is the REMS is gone along with the required communication plan. Bottom line - more to come, it could be interesting Per the FDA website regarding the REMS requirement: "Timetable for assessments must be at least by 18 months, 3 years, and in the 7th year after the REMS is approved Can be eliminated after 3 years" The letter Mannkind received said: "Please refer to your supplemental New Drug Application (sNDA) dated and received April 19, 2018, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Afrezza (insulin human) inhalation powder. This Prior Approval sNDA provides for proposed modifications to the approved Afrezza risk evaluation and mitigation strategy (REMS). This supplement is in response to our April 17, 2018, REMS Modification Notification letter. We have completed our review of this supplemental application." I think on April 17 the FDA noted to Mannkind the possibility, now that 3 years had passed, of "modifying" -- i.e. removing -- removing the REMS and on April 19, Mannkind requested such -- no more, no less. The letter on April 17th was sent as part of the government streamlining and modernization processes and states "In order to minimize burden on the healthcare delivery system of complying with the REMS, we determined that you were required to make the REMS modifications outlined in our REMS Modification Notification letter dated April 17, 2018. " MNKD responds 2 days later and the FDA responds in 5 days and says "we have evaluated your sNDA and the communication plan is no longer necessary to ensure the benefits of the drug outweigh the risks, a REMS is no longer required for Afrezza (insulin human) inhalation" The big question is how was this done in 5 days? My experience is it takes the FDA 5 days just to open and catalog the mail. Does it seem unusual that the FDA says on 4/17 you need to update your plan and MNKD responds on 4/19 with "Hey, its been 3 years so let just drop it". Then without time for discussion and review at the FDA they say "great idea, forget updating the communication plan because we really don't even need the REMS because you are just great guys with a great product". To me there seems a bit more. Is it unusual for an sNDA approval in 5 days? I would think another sNDA which was marked "Confidential" was already in the works and was already approved which provided the data to justify dropping the REMS. Maybe not but the FDA just being nice to MNKD seems a bit out of character. More important now that the REMS is gone, what comprised the REMS? We know the communication plan. Is the spirometry a requirement of the REMS? Its discussed in the REMS document. Is the black box a requirement of the REMS? Communication of the bronchial risks is in the REMS document? Is the black box part of that? I kind-of remember Al saying something about that. With the REMS gone, what else is gone? Sure, it may take another sNDA filing for the label change or maybe, that filing had already been done before the April 19th filing. Hopefully this will be explained soon. It sure would be nice if MNKD has to submit another sNDA for the label change the FDA approves that too in 5 days. |
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Post by digger on Apr 27, 2018 19:06:13 GMT -5
Per the FDA website regarding the REMS requirement: "Timetable for assessments must be at least by 18 months, 3 years, and in the 7th year after the REMS is approved Can be eliminated after 3 years" The letter Mannkind received said: "Please refer to your supplemental New Drug Application (sNDA) dated and received April 19, 2018, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Afrezza (insulin human) inhalation powder. This Prior Approval sNDA provides for proposed modifications to the approved Afrezza risk evaluation and mitigation strategy (REMS). This supplement is in response to our April 17, 2018, REMS Modification Notification letter. We have completed our review of this supplemental application." I think on April 17 the FDA noted to Mannkind the possibility, now that 3 years had passed, of "modifying" -- i.e. removing -- removing the REMS and on April 19, Mannkind requested such -- no more, no less. The letter on April 17th was sent as part of the government streamlining and modernization processes and states "In order to minimize burden on the healthcare delivery system of complying with the REMS, we determined that you were required to make the REMS modifications outlined in our REMS Modification Notification letter dated April 17, 2018. " MNKD responds 2 days later and the FDA responds in 5 days and says "we have evaluated your sNDA and the communication plan is no longer necessary to ensure the benefits of the drug outweigh the risks, a REMS is no longer required for Afrezza (insulin human) inhalation" The big question is how was this done in 5 days? My experience is it takes the FDA 5 days just to open and catalog the mail. Does it seem unusual that the FDA says on 4/17 you need to update your plan and MNKD responds on 4/19 with "Hey, its been 3 years so let just drop it". Then without time for discussion and review at the FDA they say "great idea, forget updating the communication plan because we really don't even need the REMS because you are just great guys with a great product". To me there seems a bit more. Is it unusual for an sNDA approval in 5 days? I would think another sNDA which was marked "Confidential" was already in the works and was already approved which provided the data to justify dropping the REMS. Maybe not but the FDA just being nice to MNKD seems a bit out of character. More important now that the REMS is gone, what comprised the REMS? We know the communication plan. Is the spirometry a requirement of the REMS? Its discussed in the REMS document. Is the black box a requirement of the REMS? Communication of the bronchial risks is in the REMS document? Is the black box part of that? I kind-of remember Al saying something about that. With the REMS gone, what else is gone? Sure, it may take another sNDA filing for the label change or maybe, that filing had already been done before the April 19th filing. Hopefully this will be explained soon. It sure would be nice if MNKD has to submit another sNDA for the label change the FDA approves that too in 5 days. What comprised the REMS: 1. REMS Letters -- "send a REMS Letter for Healthcare Providers and REMS Letter for Professional Societies within 60 days of this REMS approval (June 2014) and again after one year from the date of the REMS approval....Email will be the primary method to disseminate the REMS Letters. 2. REMS Factsheet -- m.pdr.net/labels/Communications/1000206/REMS%20FACT%20SHEET.pdf -- "A REMS Factsheet will be distributed with the REMS Letter for Healthcare Providers and made available to healthcare providers through Mannkind sales and medical representatives during the initial discussion with healthcare providers during the first 12 months after approval of this AFREZZA REMS. 3. REMS Website -- The AFREZZA REMS website for healthcare professionals (www.AfrezzaREMS.com) will continue for the duration of the REMS. 4. Dissemination of REMS information at scientific meetings -- The AFREZZA REMS Factsheet will be prominently displayed at relevant scientific meetings... Mannkind accomplished all this and was able to prove it, hence the REMS is no longer required. I doubt that it took much effort. I don't see how it could be any plainer. |
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Post by mnholdem on Apr 28, 2018 6:24:34 GMT -5
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Post by sayhey24 on Apr 28, 2018 6:34:00 GMT -5
Digger - yes, what you sited above is no longer needed and comprises the communication plan. They are listed in Section II.A items 1 through 4 and the timetable is section B. However if you look at NDA 022472 www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2016-04-01_REMS_full.pdf On page 4 titled "FDA Required REMS Safety Information" it starts talking about the need to tell doctors they must do the spirometry and they must notify for the risk of acute bronchoplasm. Since the REMS is no longer required MNKD no longer needs to do whats on page 4; tell doctors they must do the spirometry; nor the info in the black box. My question is are both these requirements now gone? It appears so. This seems like a big deal to me, actually huge unless the spirometry and black box are required by something in addition to the REMS which I am not aware of, are they? If so by what? It sure looks like another sNDA is coming for another label update, unless I am misreading NDA 022472 or the spirometry and black box are required some where else. If so I sure hope the FDA can turn the new sNDA around in 5 days too, unless of course its already approved and marked confidential. |
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Post by mnholdem on Apr 28, 2018 6:59:42 GMT -5
From the San Fernando Business Journal - Thursday, April 26, 2018
[Clipped]
Source: San Fernando Business Journal. sfvbj.com/news/2018/apr/25/mannkind-stock-jumps-fda-news/ --- [Clipped] In a similar fashion, the Afrezza sales force has an entirely new sales package for indoctrinating physicians, pharmacists and other health care professionals. I realize now that CEO Castagna's strategy has been to limit sales efforts to target areas until the cumbersome REMS plan was lifted by the FDA. Now, MannKind is free to market Afrezza in a big way.  The logic behind my opinion will become clearer if you do some DD and dig deeper into the REMS documents on file with the FDA. This is the section that caught my attention:
II. REMS ELEMENTS
A. Communication Plan
1. REMS Letters
a. REMS Letter for Healthcare Providers
"The intended audience for the REMS Letter for Healthcare Providers will be healthcare providers likely to prescribe AFREZZA and healthcare providers targeted by AFREZZA marketing activities."--- Now that the REMS has been lifted by the FDA, I think Castagna will significantly expand the marketing of Afrezza from what has been, until now, small and limited to targeted areas & physicians. ProBoards members occasionally post their experiences of talking with doctors and hospital workers who say that they've never heard of Afrezza. IMHO, that's about to change. |
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Post by akemp3000 on Apr 28, 2018 7:24:18 GMT -5
mnholdem - Your perspective coincides nicely with the new article titled, "Mannkind's Afrezza is a Game Changer to Manage Blood Sugar", by Riva Greenberg dated April 25, 2018. She along with about a dozen other online diabetes advocates, were invited to Danbury for a two-day meeting to learn about inhaled insulin. Riva states, "Readying themselves to get the word out about Afrezza in a much bigger way, they wanted to familiarize us with the product and learn from us about how they should use social media".
Wikipedia: Riva Greenberg is a recognized diabetes patient-expert, inspirational speaker, author, and health coach, who has lived successfully with type 1 diabetes for more than forty years. Riva is a trusted KOL for pharmaceutical companies bringing the patient voice to health care, and an international speaker at conferences, health expos, hospitals and corporations. Riva also writes on The Huffington Post and in 2011 SharecareNow cited Riva as number six among the Top Ten online diabetes influencers. Riva is an advisory member of the Diabetes Hands Foundation and a member of the American Association of Diabetes Educators and Diabetes Advocates.
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Post by digger on Apr 28, 2018 8:01:38 GMT -5
From the San Fernando Business Journal - Thursday, April 26, 2018
[Clipped]
Source: San Fernando Business Journal. sfvbj.com/news/2018/apr/25/mannkind-stock-jumps-fda-news/ --- [Clipped] In a similar fashion, the Afrezza sales force has an entirely new sales package for indoctrinating physicians, pharmacists and other health care professionals. I realize now that CEO Castagna's strategy has been to limit sales efforts to target areas until the cumbersome REMS plan was lifted by the FDA. Now, MannKind is free to market Afrezza in a big way. The logic behind my opinion will become clearer if you do some DD and dig deeper into the REMS documents on file with the FDA. This is the section that caught my attention:
II. REMS ELEMENTS
A. Communication Plan
1. REMS Letters
a. REMS Letter for Healthcare Providers
"The intended audience for the REMS Letter for Healthcare Providers will be healthcare providers likely to prescribe AFREZZA and healthcare providers targeted by AFREZZA marketing activities."--- Now the the REMS has been lifted by the FDA, I think Castagna will significantly expand the marketing of Afrezza from what has been, until now, small and limited to targeted areas & physicians. ProBoards members occasionally post their experiences of talking with doctors and hospital workers who say that they've never heard of Afrezza. IMHO, that's about to change. The REMS didn't limit MNKD's marketing one way or another. It was all just stuff that needed to be done to insure distribution of the risk warnings to the healthcare community. It only makes sense that the FDA asked Sanofi and Mannkind to target primarily those healthcare providers that would be most likely to use afrezza -- they're the ones that most needed to know risk warnings ASAP. And of course, who does Mannkind "target" with its "marketing activities" but those physicians most likely to use afrezza. But marketing was never restricted to just that group; Mannkind could have marketed to Donald Trump if they wanted. And when I look at what was required, I suspect that Sanofi met most of the requirements while they had it that first year. |
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Post by digger on Apr 28, 2018 8:11:07 GMT -5
Digger - yes, what you sited above is no longer needed and comprises the communication plan. They are listed in Section II.A items 1 through 4 and the timetable is section B. However if you look at NDA 022472 www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2016-04-01_REMS_full.pdf On page 4 titled "FDA Required REMS Safety Information" it starts talking about the need to tell doctors they must do the spirometry and they must notify for the risk of acute bronchoplasm. Since the REMS is no longer required MNKD no longer needs to do whats on page 4; tell doctors they must do the spirometry; nor the info in the black box. My question is are both these requirements now gone? It appears so. This seems like a big deal to me, actually huge unless the spirometry and black box are required by something in addition to the REMS which I am not aware of, are they? If so by what? It sure looks like another sNDA is coming for another label update, unless I am misreading NDA 022472 or the spirometry and black box are required some where else. If so I sure hope the FDA can turn the new sNDA around in 5 days too, unless of course its already approved and marked confidential. The REMS indicates the risk information and requirements that the FDA thought important that healthcare providers know before prescribing afrezza. Removing the REMS requirement means only that this information has now been adequately distributed and that the REMS activities are no longer needed. However, the black box, the spirometry requirement, and the COPD contraindication because of possible bronchospasm all remain unchanged. The purpose of the REMS was to insure that the healthcare community was made broadly aware of those risks and warnings. However, removing the necessity to conduct activities to insure that broad awareness was achieved does not remove the information itself. I'm quite sure that had the FDA actually removed the black box warnings and spirometry requirement, you would have seen a much more enthusiastic press release. |
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Post by mnholdem on Apr 28, 2018 8:21:01 GMT -5
In sales, the first few minutes of an introductory presentation of a product are critical. One of the family of healthcare companies I work for recently introduced an innovative new product which became our #1 revenue generator within 18 months. The advantages over competing products immediately captures the doctors' attention. I can say with certainty that if our saleforce was forced to also include a facts sheet highlighting potential risks, sales of this product would not have rocketed to #1. |
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Post by digger on Apr 28, 2018 8:31:53 GMT -5
In sales, the first few minutes of an introductory presentation of a product are critical. One of the family of healthcare companies I work for recently introduced an innovative new product which became our #1 revenue generator within 18 months. The advantages over competing products immediately captures the doctors' attention. I can say with certainty that if our saleforce was forced to also include a facts sheet highlighting potential risks, sales of this product would not have rocketed to #1. The REMS did not force the sales people to mention anything regarding the "facts sheet" after afrezza had been on the market 12 months: "A REMS Factsheet will be distributed with the REMS Letter for Healthcare Providers and made available to healthcare providers through MannKind Corporation’s sales and medical representatives during the initial discussion with healthcare providers during the first 12 months after approval of this AFREZZA REMS." Like I said, I suspect Sanofi fulfilled most of that requirement while they had it. |
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Post by sayhey24 on Apr 28, 2018 9:26:28 GMT -5
Digger - yes, what you sited above is no longer needed and comprises the communication plan. They are listed in Section II.A items 1 through 4 and the timetable is section B. However if you look at NDA 022472 www.accessdata.fda.gov/drugsatfda_docs/rems/Afrezza_2016-04-01_REMS_full.pdf On page 4 titled "FDA Required REMS Safety Information" it starts talking about the need to tell doctors they must do the spirometry and they must notify for the risk of acute bronchoplasm. Since the REMS is no longer required MNKD no longer needs to do whats on page 4; tell doctors they must do the spirometry; nor the info in the black box. My question is are both these requirements now gone? It appears so. This seems like a big deal to me, actually huge unless the spirometry and black box are required by something in addition to the REMS which I am not aware of, are they? If so by what? It sure looks like another sNDA is coming for another label update, unless I am misreading NDA 022472 or the spirometry and black box are required some where else. If so I sure hope the FDA can turn the new sNDA around in 5 days too, unless of course its already approved and marked confidential. The REMS indicates the risk information and requirements that the FDA thought important that healthcare providers know before prescribing afrezza. Removing the REMS requirement means only that this information has now been adequately distributed and that the REMS activities are no longer needed. However, the black box, the spirometry requirement, and the COPD contraindication because of possible bronchospasm all remain unchanged. The purpose of the REMS was to insure that the healthcare community was made broadly aware of those risks and warnings. However, removing the necessity to conduct activities to insure that broad awareness was achieved does not remove the information itself. I'm quite sure that had the FDA actually removed the black box warnings and spirometry requirement, you would have seen a much more enthusiastic press release. Digger - I thought the same as you and assumed both spirometery and black are still needed. However then I started reading the REMS info. I can't find anywhere else aside from the REMS these were required. If the REMS is gone it seems the REMS requirements are gone too. The 5 day approval of the sDNA also seemed very odd. Maybe its not but 5 days seems unusual like they had already been working with MNKD on something else. If another sNDA which was marked "confidential" had already been submitted with the data justifying the REMS is no longer needed then the 4/24 5 day approval makes sense. If so its probably as simply as an oversight and MNKD did not check the box to keep the 4/19 sNDA confidential, so it leaked. Clearly MNKD did not seem prepared to issue the PR on 4/24 nor 4/25 when it came out after hours. At this point I am going to believe my theory is correct because it would be better news than the original approval and believing this through the weekend will make me happy. If you can point to a document where the spirometry is required aside from the REMS, let me know and I will come back to reality. |
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Post by goyocafe on Apr 28, 2018 9:33:56 GMT -5
The REMS indicates the risk information and requirements that the FDA thought important that healthcare providers know before prescribing afrezza. Removing the REMS requirement means only that this information has now been adequately distributed and that the REMS activities are no longer needed. However, the black box, the spirometry requirement, and the COPD contraindication because of possible bronchospasm all remain unchanged. The purpose of the REMS was to insure that the healthcare community was made broadly aware of those risks and warnings. However, removing the necessity to conduct activities to insure that broad awareness was achieved does not remove the information itself. I'm quite sure that had the FDA actually removed the black box warnings and spirometry requirement, you would have seen a much more enthusiastic press release. Digger - I thought the same as you and assumed both spirometery and black are still needed. However then I started reading the REMS info. I can't find anywhere else aside from the REMS these were required. If the REMS is gone it seems the REMS requirements are gone too. The 5 day approval of the sDNA also seemed very odd. Maybe its not but 5 days seems unusual like they had already been working with MNKD on something else. If another sNDA which was marked "confidential" had already been submitted with the data justifying the REMS is no longer needed then the 4/24 5 day approval makes sense. If so its probably as simply as an oversight and MNKD did not check the box to keep the 4/19 sNDA confidential, so it leaked. Clearly MNKD did not seem prepared to issue the PR on 4/24 nor 4/25 when it came out after hours. At this point I am going to believe my theory is correct because it would be better news than the original approval and believing this through the weekend will make me happy. If you can point to a document where the spirometry is required aside from the REMS, let me know and I will come back to reality. Sey, are you saying neither the spirometry or black box are in the label? Section 5.1 and 5.4 seem to call out both the bronchospasm (Black box) and spirometry respectively. Help me understand, please. I would like to share your enthusiasm. |
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Post by ilovekauai on Apr 28, 2018 9:56:47 GMT -5
I see a MNKD referred endo on May 4 to try and get started on Afrezza, and plan to document my experience(s) to the board. We'll see if those tests are still required.
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Post by digger on Apr 28, 2018 11:07:15 GMT -5
The REMS indicates the risk information and requirements that the FDA thought important that healthcare providers know before prescribing afrezza. Removing the REMS requirement means only that this information has now been adequately distributed and that the REMS activities are no longer needed. However, the black box, the spirometry requirement, and the COPD contraindication because of possible bronchospasm all remain unchanged. The purpose of the REMS was to insure that the healthcare community was made broadly aware of those risks and warnings. However, removing the necessity to conduct activities to insure that broad awareness was achieved does not remove the information itself. I'm quite sure that had the FDA actually removed the black box warnings and spirometry requirement, you would have seen a much more enthusiastic press release. Digger - I thought the same as you and assumed both spirometery and black are still needed. However then I started reading the REMS info. I can't find anywhere else aside from the REMS these were required. If the REMS is gone it seems the REMS requirements are gone too. The 5 day approval of the sDNA also seemed very odd. Maybe its not but 5 days seems unusual like they had already been working with MNKD on something else. If another sNDA which was marked "confidential" had already been submitted with the data justifying the REMS is no longer needed then the 4/24 5 day approval makes sense. If so its probably as simply as an oversight and MNKD did not check the box to keep the 4/19 sNDA confidential, so it leaked. Clearly MNKD did not seem prepared to issue the PR on 4/24 nor 4/25 when it came out after hours. At this point I am going to believe my theory is correct because it would be better news than the original approval and believing this through the weekend will make me happy. If you can point to a document where the spirometry is required aside from the REMS, let me know and I will come back to reality. You are reading way too much into the letter. The short approval was likely simply because all the requirements were basically very simple -- letters, distributing a fact sheet, and maintaining a website-- and most of that was likely already completed under Sanofi. I doubt that it would take five minutes to show that everything had been done. Spirometry is required because the black box dictates the doctor do a full physical exam so as to rule out all lung disease. Spirometry is required to do that. The black box has not changed; all that has happened is that Mannkind met the requirements dictated by the FDA to spread the word ABOUT the black box. And if you just think about it, the black box must continue to exist because some COPD patients experienced some sort of severe bronchospasm. There is no evidence to suggest that situation has changed, hence the need to continue the black box. |
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