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Post by factspls88 on Jun 3, 2016 8:31:29 GMT -5
Is Mannkind working on getting Afrezza approved in the UK or do they have a temporary solution just for Brendan Hyland who lives in the UK and has used Afrezza? Hyland has been a regular on Twitter. Stay tuned.
@brendanphyland:
I had a friend at house last night crying because of inadequate control and no energy. She asked me to explain #Afrezza I did. We wait....
@castagna2011:
@brendanphyland @jstokcton working on something for July. Keep you posted
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Post by peppy on Jun 3, 2016 8:47:33 GMT -5
Is Mannkind working on getting Afrezza approved in the UK or do they have a temporary solution just for Brendan Hyland who lives in the UK and has used Afrezza? Hyland has been a regular on Twitter. Stay tuned. @brendanphyland: I had a friend at house last night crying because of inadequate control and no energy. She asked me to explain #Afrezza I did. We wait.... @castagna2011:@brendanphyland @jstokcton working on something for July. Keep you posted Outsulin. let me out.
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Post by Deleted on Jun 3, 2016 10:29:36 GMT -5
Is Mannkind working on getting Afrezza approved in the UK or do they have a temporary solution just for Brendan Hyland who lives in the UK and has used Afrezza? Hyland has been a regular on Twitter. Stay tuned. @brendanphyland: I had a friend at house last night crying because of inadequate control and no energy. She asked me to explain #Afrezza I did. We wait.... @castagna2011:@brendanphyland @jstokcton working on something for July. Keep you posted u do know the time lines for that right?Apply and getting approved and then something to do about NICE? i had recommended to make Afrezza available @ a price that international users can just order for personal use and by pass regulatory bodies for a small volume of users... not sure if thats possible |
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Post by factspls88 on Jun 3, 2016 11:50:36 GMT -5
iam2sek:
"u do know the time lines for that right?Apply and getting approved and then something to do about NICE?"
Me:
Yes, I do recognize time lines, which is why I would guess it's likely a temporary solution. That said, you never know what may have been going on behind the scenes.
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Post by agedhippie on Jun 3, 2016 12:46:46 GMT -5
Is Mannkind working on getting Afrezza approved in the UK or do they have a temporary solution just for Brendan Hyland who lives in the UK and has used Afrezza? Hyland has been a regular on Twitter. Stay tuned. @brendanphyland: I had a friend at house last night crying because of inadequate control and no energy. She asked me to explain #Afrezza I did. We wait.... @castagna2011:@brendanphyland @jstokcton working on something for July. Keep you posted u do know the time lines for that right?Apply and getting approved and then something to do about NICE? i had recommended to make Afrezza available @ a price that international users can just order for personal use and by pass regulatory bodies for a small volume of users... not sure if thats possible If the Afrezza has EMA approval then you can buy Afrezza in the UK regardless of NICE approvals. NICE decisions are only binding on the NHS so you can use the private health system in the UK (the NHS is not a monopoly) to buy non-NICE approved drugs and treatments. Obviously you have to pay for this yourself as the NHS is out of the picture. |
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Post by victoria on Jun 3, 2016 18:52:20 GMT -5
It is also I believe possible to obtain approval from the MHRA, the uk Medicines and Healthcare Products Regulatory Agency, if what is wanted is only approval for the UK. That is an alternative to the EMA but is of course only UK wide. However once authorised in the UK there is a 90 day (excluding time answering questions) process to get mutual recognition of a drug in the rest of the EU based on mutual recognition of the UK approval. See www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk#MRPThere is also a special procedure within the UK MHRA for fast licensing of Promising Innovative Medicines, "The early access to medicines scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need." Such as imho might apply to eg elderly patients less able to inject, or seriously needle phobic patients etc. www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eamsAnd of course Agedhippie is right, the nhs is a tax funded healthcare provider open to all, free at the point of delivery of the service save for minimal outpatient drug charges, but is by no means a monopoly, though you cant opt out of paying taxes, (sadly!) so you have to fund the nhs even if separately insured. Edit to add: UK is 5th largest economy in world, getting obese, and a large market. If I were mnkd I would get MHRA approval, try the Promising medicines route for some purposes, and negotiate cover with the main UK health insurers so as to get a foot in the door. Basically all doctors who work for private healthcare insurers are also doing NHS work for the day job, since the nhs is so large, and that would spread awareness wthin the nhs rapidly with minimal effort so that pressures arise for afrezza to be made available on the nhs by the various commissioning groups. |
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Post by victoria on Jun 3, 2016 19:14:03 GMT -5
... and I am very excited by Dr Castagna's tweet about July, if something materialises, even only an application being made, it will be a very good sign in my view not least for shareholder optimism among the 'I cant believe Im 90% down on a six figure investment oh well it was in a good cause better hang on and hope it explodes upwards' community....
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Post by Deleted on Jun 3, 2016 19:45:02 GMT -5
It is also I believe possible to obtain approval from the MHRA, the uk Medicines and Healthcare Products Regulatory Agency, if what is wanted is only approval for the UK. That is an alternative to the EMA but is of course only UK wide. However once authorised in the UK there is a 90 day (excluding time answering questions) process to get mutual recognition of a drug in the rest of the EU based on mutual recognition of the UK approval. See www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk#MRPThere is also a special procedure within the UK MHRA for fast licensing of Promising Innovative Medicines, "The early access to medicines scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need." Such as imho might apply to eg elderly patients less able to inject, or seriously needle phobic patients etc. www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eamsAnd of course Agedhippie is right, the nhs is a tax funded healthcare provider open to all, free at the point of delivery of the service save for minimal outpatient drug charges, but is by no means a monopoly, though you cant opt out of paying taxes, (sadly!) so you have to fund the nhs even if separately insured. Edit to add: UK is 5th largest economy in world, getting obese, and a large market. If I were mnkd I would get MHRA approval, try the Promising medicines route for some purposes, and negotiate cover with the main UK health insurers so as to get a foot in the door. Basically all doctors who work for private healthcare insurers are also doing NHS work for the day job, since the nhs is so large, and that would spread awareness wthin the nhs rapidly with minimal effort so that pressures arise for afrezza to be made available on the nhs by the various commissioning groups. great info. If this can be filed and gotten approval, it will be an advantage to mannkind in arbitration with sanofi... any idea how long does it take for review and approval? based on only 1 current pending application, it seems to be quick? |
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Post by factspls88 on Jun 3, 2016 20:10:11 GMT -5
... and I am very excited by Dr Castagna's tweet about July, if something materialises, even only an application being made, it will be a very good sign in my view not least for shareholder optimism among the 'I cant believe Im 90% down on a six figure investment oh well it was in a good cause better hang on and hope it explodes upwards' community.... You are not alone. |
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Post by steve on Jun 3, 2016 20:18:25 GMT -5
You are not alone either.
Red |
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Post by agedhippie on Jun 3, 2016 21:15:12 GMT -5
It is also I believe possible to obtain approval from the MHRA, the uk Medicines and Healthcare Products Regulatory Agency, if what is wanted is only approval for the UK. That is an alternative to the EMA but is of course only UK wide. However once authorised in the UK there is a 90 day (excluding time answering questions) process to get mutual recognition of a drug in the rest of the EU based on mutual recognition of the UK approval. See www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk#MRPBecause of the single market if a drug is approved in one country it is approved in all, you just need to register. The role of EMA is to facilitate. Once it is approved it can be prescribed but is not necessarily provided by the national health system. Tresiba is a good example, it is approved and can be prescribed throughout the EU. However in Germany the national health system does not provide it, and in the UK although NICE approved it as well most of the regional trust commissioning committees do not provide it. |
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Post by victoria on Jun 4, 2016 3:27:25 GMT -5
One potential snag on the horizon re EU wide mutual recognition based on UK approal is the referendum on 23 June in the UK which may well mean the UK leaves the EU: the vote could truly go either way on that, and could trigger the ultimate break up of the UK itself or of the remainder of the EU potentialy. Will be very volatile markets around the 23rd June I expect.
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Post by victoria on Jun 4, 2016 3:38:32 GMT -5
It is also I believe possible to obtain approval from the MHRA, the uk Medicines and Healthcare Products Regulatory Agency, if what is wanted is only approval for the UK. That is an alternative to the EMA but is of course only UK wide. However once authorised in the UK there is a 90 day (excluding time answering questions) process to get mutual recognition of a drug in the rest of the EU based on mutual recognition of the UK approval. See www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk#MRPThere is also a special procedure within the UK MHRA for fast licensing of Promising Innovative Medicines, "The early access to medicines scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need." Such as imho might apply to eg elderly patients less able to inject, or seriously needle phobic patients etc. www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eamsAnd of course Agedhippie is right, the nhs is a tax funded healthcare provider open to all, free at the point of delivery of the service save for minimal outpatient drug charges, but is by no means a monopoly, though you cant opt out of paying taxes, (sadly!) so you have to fund the nhs even if separately insured. Edit to add: UK is 5th largest economy in world, getting obese, and a large market. If I were mnkd I would get MHRA approval, try the Promising medicines route for some purposes, and negotiate cover with the main UK health insurers so as to get a foot in the door. Basically all doctors who work for private healthcare insurers are also doing NHS work for the day job, since the nhs is so large, and that would spread awareness wthin the nhs rapidly with minimal effort so that pressures arise for afrezza to be made available on the nhs by the various commissioning groups. great info. If this can be filed and gotten approval, it will be an advantage to mannkind in arbitration with sanofi... any idea how long does it take for review and approval? based on only 1 current pending application, it seems to be quick? I dont have direct experience but the mhra website says 'up to 210' days for the standard UK process (which will be much the same as the EU one of course) excluding pauses to answer questions. The rapid process for innvative medicines says up to 90 days. I havent yet found any stats published on actual time taken. |
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Post by avichen on Jun 4, 2016 9:21:21 GMT -5
don't play too much guessing... the more you expect, the more pain you might get. just stay tuned that's enough. The more guessing game played, the more people fear of it.
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Post by matt on Jun 4, 2016 14:24:19 GMT -5
It is also I believe possible to obtain approval from the MHRA, the uk Medicines and Healthcare Products Regulatory Agency, if what is wanted is only approval for the UK. That is an alternative to the EMA but is of course only UK wide. However once authorised in the UK there is a 90 day (excluding time answering questions) process to get mutual recognition of a drug in the rest of the EU based on mutual recognition of the UK approval. See www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk#MRPYou are correct that there is still a country by country licensing procedure available, but it is very rarely used these days. While, in principle, every other EU country is supposed to review and rubber stamp an approved dossier from the originating country, it is significantly more cumbersome and expensive than the centralized approval process which is why it isn't used any more.
On your other point, regarding physician working for both the NHS and taking private patients, that is the way it is in most EU countries. The private patients make up 10-20% of the patients seen, but can represent 80-90% of the physician's revenue (especially in places like Spain). Focused marketing on private hospitals is the way to go to launch anything that is novel, more expensive, and needs some serious sales attention since the national insurers aren't likely to cover a new and more expensive treatment in most of the countries (there will be exceptions).
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