OTC Insulin

[sayhey24]

They say the rule of thumb for over the counter insulin is whether its human insulin or an analog.  It would seem there would be a big advantage if afrezza was on the OTC list being a human insulin.  I can't remember MNKD ever discussing this but maybe they have especially since there seems to be a lot of use for corrections.   aetnabetterhealth.com/illinois/assets/pdf/pharmacy/OTC-IL.pdf

[kc]

Interesting thought. Low is the symbol for mission from a website on over the counter insulin. It seems that most of the insulin sold today is designer insulin that requires serious dosing and prescription information. Afrezza being just a human insulin might fit that particular niche for being an over-the-counter product. That would be an easy for T2 diabetics.

insulinnation.com/treatment/medicine-drugs/insulin-over-counter/

[peppy]

Feb 11, 2017 12:22:18 GMT -5 kc said:

Interesting thought. Low is the symbol for mission from a website on over the counter insulin. It seems that most of the insulin sold today is designer insulin that requires serious dosing and prescription information. Afrezza being just a human insulin might fit that particular niche for being an over-the-counter product. That would be an easy for T2 diabetics.

insulinnation.com/treatment/medicine-drugs/insulin-over-counter/

This would be a remarkable turn of events

Like buying Rolaids

Non invasive continuous glucose monitors .... a watch, or on the cell phone would take us there.

Out of site out of mind.

Notice how the powers than be really do not want us to know our blood glucose levels.

[agedhippie]

Feb 11, 2017 12:04:15 GMT -5 sayhey24 said:

They say the rule of thumb for over the counter insulin is whether its human insulin or an analog.  It would seem there would be a big advantage if afrezza was on the OTC list being a human insulin.  I can't remember MNKD ever discussing this but maybe they have especially since there seems to be a lot of use for corrections.   aetnabetterhealth.com/illinois/assets/pdf/pharmacy/OTC-IL.pdf

Now that is an interesting idea and may well be possible based on the Regular API. It would certainly be a game changer if priced right. It would need work by Mannkind to argue the case but they should be all over that (15% of US insulin sales by volume is OTC)

[mnkdfann]

I started a thread over a year ago in which I asked about the possibility of making Afrezza OTC.

mnkd.proboards.com/thread/5016/otc-insulin

People gave me various reasons why this wouldn't work and / or was a bad idea.

[peppy]

Feb 12, 2017 0:31:36 GMT -5 mnkdfann said:

I started a thread over a year ago in which I asked about the possibility of making Afrezza OTC.

mnkd.proboards.com/thread/5016/otc-insulin

People gave me various reasons why this wouldn't work and / or was a bad idea.

I have changed my mind.

[lakon]

Me too. I mentioned OTC insulin on this board over the last year or so, at least. I've been talking and thinking about it longer. I think that the long-term safety study is the FDA response. If results are good, it will be nearly impossible for the FDA to justify prescription-only. For now, the FDA can use the long-term safety study to protect the patients from unknowns and as cover to protect the incumbents. MNKD probably went for this because they felt that they could compete with all the RAA at comparable prices. MNKD has not proven competitive YET. IF they can become competitive with RAA at near RAA prices, MNKD could grow much faster. I think that's the initial plan. IMO, OTC Afrezza is a part of the solution to reaching the 400+ million global PWD's population.

[sayhey24]

Feb 12, 2017 6:48:30 GMT -5 lakon said:

Me too. I mentioned OTC insulin on this board over the last year or so, at least. I've been talking and thinking about it longer. I think that the long-term safety study is the FDA response. If results are good, it will be nearly impossible for the FDA to justify prescription-only. For now, the FDA can use the long-term safety study to protect the patients from unknowns and as cover to protect the incumbents. MNKD probably went for this because they felt that they could compete with all the RAA at comparable prices. MNKD has not proven competitive YET. IF they can become competitive with RAA at near RAA prices, MNKD could grow much faster. I think that's the initial plan. IMO, OTC Afrezza is a part of the solution to reaching the 400+ million global PWD's population.

I was thinking the limitation would be the spirometry but you raise another issue. For the spirometry I was reading where it would seem a pharmacist would only need a letter from a doctor saying a successful spirometry test was given.  It would seem to me some place like a MediClinic in a CVS could provide this service.  However, the big concern at the Adcom was long term use for the kids even though the kids are not yet approved.  I would think if Mannkind created an OTC product, basically a new box configuration and call it "afrezza On-Demand" which was for occasional use like corrections they should be able to get that approved without the spirometry and even the COPDs and smokers.  Maybe that would also sidestep the long-term argument.  On pricing, clearly afrezza is way over priced.  Steve Edelmans latest newletter talks about follow-up dosing which is needed much of the time.  Mike needs to cut current price by 50% just for this issue.  Hopefully Mike has re-thought his position factoring in the need for second dosing.

[sayhey24]

Feb 12, 2017 0:31:36 GMT -5 mnkdfann said:

I started a thread over a year ago in which I asked about the possibility of making Afrezza OTC.

mnkd.proboards.com/thread/5016/otc-insulin

People gave me various reasons why this wouldn't work and / or was a bad idea.

Thanks for pointing me to your thread.  It seems the issues raised were; insurance; no current RAA are OTC; current pricing.  It seems at least Atena covers OTC.  Health savings accounts do too.  Maybe other insurances cover too but I have not checked. Of course Medicare/Medicaid/VA are key.  Concerning pricing, its way off and someone needs to have that discussion with Matt and Mike asap, like today. They need to cut by 50% if afrezza is to be used properly for second dosing.  For OTC they would need to make a new box configuration and properly price.  Concerning RAAs, afrezza is not an RAA.  Its not an analog.  Currently only human insulin is available OTC and afrezza is human insulin.  Maybe its a loophole MNKD can exploit.  I am sure when they allowed human insulin to be OTC they never thought it would be better than the RAAs and actually work like pancreatic insulin.  The BP lobbyists probably assumed it would always be a hexamer and their RAAs would be better.  Too bad for them if MNKD can make something happen.

[lakon]

Feb 12, 2017 8:49:47 GMT -5 sayhey24 said:

Feb 12, 2017 6:48:30 GMT -5 lakon said:

Me too. I mentioned OTC insulin on this board over the last year or so, at least. I've been talking and thinking about it longer. I think that the long-term safety study is the FDA response. If results are good, it will be nearly impossible for the FDA to justify prescription-only. For now, the FDA can use the long-term safety study to protect the patients from unknowns and as cover to protect the incumbents. MNKD probably went for this because they felt that they could compete with all the RAA at comparable prices. MNKD has not proven competitive YET. IF they can become competitive with RAA at near RAA prices, MNKD could grow much faster. I think that's the initial plan. IMO, OTC Afrezza is a part of the solution to reaching the 400+ million global PWD's population.

I was thinking the limitation would be the spirometry but you raise another issue. For the spirometry I was reading where it would seem a pharmacist would only need a letter from a doctor saying a successful spirometry test was given.  It would seem to me some place like a MediClinic in a CVS could provide this service.  However, the big concern at the Adcom was long term use for the kids even though the kids are not yet approved.  I would think if Mannkind created an OTC product, basically a new box configuration and call it "afrezza On-Demand" which was for occasional use like corrections they should be able to get that approved without the spirometry and even the COPDs and smokers.  Maybe that would also sidestep the long-term argument.  On pricing, clearly afrezza is way over priced.  Steve Edelmans latest newletter talks about follow-up dosing which is needed much of the time.  Mike needs to cut current price by 50% just for this issue.  Hopefully Mike has re-thought his position factoring in the need for second dosing.

Good point. Spirometry requirement should get removed by long-term safety.

Instead of cutting price, how about increasing the number of cartridges per box at the same price? (I think that's the direction of the company, based on the titration pack. As long as an Afrezza prescription lasts as long as its competition at a similar or better price, MNKD should gain traction. They just need to account for extra cartridges until patients are dialed in. Feedback would be good. Provide ways for patients to say if they are running out of cartridges too soon. Provide a guarantee of enough cartridges per month...)

[liane]

Feb 12, 2017 9:23:24 GMT -5 sayhey24 said:

Thanks for pointing me to your thread.  It seems the issues raised were; insurance; no current RAA are OTC; current pricing.  It seems at least Atena covers OTC.  Health savings accounts do too.  Maybe other insurances cover too but I have not checked. Of course Medicare/Medicaid/VA are key.  Concerning pricing, its way off and someone needs to have that discussion with Matt and Mike asap, like today. They need to cut by 50% if afrezza is to be used properly for second dosing.  For OTC they would need to make a new box configuration and properly price.  Concerning RAAs, afrezza is not an RAA.  Its not an analog.  Currently only human insulin is available OTC and afrezza is human insulin.  Maybe its a loophole MNKD can exploit.  I am sure when they allowed human insulin to be OTC they never thought it would be better than the RAAs and actually work like pancreatic insulin.  The BP lobbyists probably assumed it would always be a hexamer and their RAAs would be better.  Too bad for them if MNKD can make something happen.

Most insurance does NOT cover OTC. I have Aetna, and am not aware that they do. Maybe certain plans... As for HSA's, that's money that an individual has set aside, although sometimes it is an employer contribution. There's a big difference between paying several hundred dollars out of your HSA every month for OTC insulin vs paying whatever your copay is and having your insurance pick up the remainder of the tab. If Afrezza were available OTC, it would create a huge financial obstacle for many potential users.

[sayhey24]

Feb 12, 2017 11:01:32 GMT -5 lakon said:

Feb 12, 2017 8:49:47 GMT -5 sayhey24 said:

I was thinking the limitation would be the spirometry but you raise another issue. For the spirometry I was reading where it would seem a pharmacist would only need a letter from a doctor saying a successful spirometry test was given.  It would seem to me some place like a MediClinic in a CVS could provide this service.  However, the big concern at the Adcom was long term use for the kids even though the kids are not yet approved.  I would think if Mannkind created an OTC product, basically a new box configuration and call it "afrezza On-Demand" which was for occasional use like corrections they should be able to get that approved without the spirometry and even the COPDs and smokers.  Maybe that would also sidestep the long-term argument.  On pricing, clearly afrezza is way over priced.  Steve Edelmans latest newletter talks about follow-up dosing which is needed much of the time.  Mike needs to cut current price by 50% just for this issue.  Hopefully Mike has re-thought his position factoring in the need for second dosing.

Good point. Spirometry requirement should get removed by long-term safety.

Instead of cutting price, how about increasing the number of cartridges per box at the same price? (I think that's the direction of the company, based on the titration pack. As long as an Afrezza prescription lasts as long as its competition at a similar or better price, MNKD should gain traction. They just need to account for extra cartridges until patients are dialed in. Feedback would be good. Provide ways for patients to say if they are running out of cartridges too soon. Provide a guarantee of enough cartridges per month...)

Two boxes wrapped together or any way to get the price cut needs to be done.  Either Mike didn't understand the need for second dosing or was just confused when he said afrezza was less than the RAAs, its not.  Putting 4's and 8's in the same box IMO is not the way to go.  These should be priced separate, same with the 12's.  Everyone will have different needs and should be able to buy what they need OTC.  For tight control and the kids they will also need the 2's but the main thing now is just telling the proper story on why afrezza is like a healthy pancreas and is nothing like an Analog and most important to get this thing selling.  The more I think about what Al Mann developed and how afrezza works and the fact they have not already replaced every meal-time analog, its IMO crazy.   It would be nice to sit down with some of these new sales guys and hear their pitch.

[zuegirdor]

Feb 12, 2017 8:49:47 GMT -5 sayhey24 said:

Feb 12, 2017 6:48:30 GMT -5 lakon said:

Me too. I mentioned OTC insulin on this board over the last year or so, at least. I've been talking and thinking about it longer. I think that the long-term safety study is the FDA response. If results are good, it will be nearly impossible for the FDA to justify prescription-only. For now, the FDA can use the long-term safety study to protect the patients from unknowns and as cover to protect the incumbents. MNKD probably went for this because they felt that they could compete with all the RAA at comparable prices. MNKD has not proven competitive YET. IF they can become competitive with RAA at near RAA prices, MNKD could grow much faster. I think that's the initial plan. IMO, OTC Afrezza is a part of the solution to reaching the 400+ million global PWD's population.

I was thinking the limitation would be the spirometry but you raise another issue. For the spirometry I was reading where it would seem a pharmacist would only need a letter from a doctor saying a successful spirometry test was given.  It would seem to me some place like a MediClinic in a CVS could provide this service.  However, the big concern at the Adcom was long term use for the kids even though the kids are not yet approved.  I would think if Mannkind created an OTC product, basically a new box configuration and call it "afrezza On-Demand" which was for occasional use like corrections they should be able to get that approved without the spirometry and even the COPDs and smokers.  Maybe that would also sidestep the long-term argument.  On pricing, clearly afrezza is way over priced.  Steve Edelmans latest newletter talks about follow-up dosing which is needed much of the time.  Mike needs to cut current price by 50% just for this issue.  Hopefully Mike has re-thought his position factoring in the need for second dosing.

Long term use by kids is a sort of non-sequitor, non? they don't stay kids long...