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Post by mnholdem on Oct 20, 2015 13:19:33 GMT -5
What makes me go "hmmmm' is that screenshots 1 & 2 of peppy's three screenshots for Afrezza and Toujeo both list UK Availability in 2015.
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Post by rrtzmd on Oct 20, 2015 20:20:19 GMT -5
What makes me go "hmmmm' is that screenshots 1 & 2 of peppy's three screenshots for Afrezza and Toujeo both list UK Availability in 2015. I believe this is the most recent document: 2015PrescribingOutlook-NewMedicines-FINALIt says, "UK availability: Uncertain," on page 37. They also add: "Implications: Needle-free insulin will be attractive to patients, especially those with needle phobia or problems injecting. Exubera (an inhaled insulin formulation launched in 2006 but discontinued due to poor sales) was not approved for use by NICE on cost-effectiveness grounds. Financial: Cost of Afrezza in US is $7.54/day (based on 12units/day). In 2006, Exubera cost £1,100 annually." That seems to imply a potential cost barrier to approval.
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Post by EveningOfTheDay on Oct 21, 2015 2:57:43 GMT -5
I believe this is the most recent document: ... That seems to imply a potential cost barrier to approval. So you are speculating that because in 2006, almost 10 years ago, Exubera's cost was $2,100 a year in the UK (I applied an average of 1.9 dollars per pound, which is a fairly accurate exchange average for 2006, to the £1,100), Sanofi will have a hard time getting Afrezza approved in the UK based on cost-effectiveness. Maybe you need to consider the fact that Exubera offered really no advantages whatsoever other than being inhaled. This is to say Exubera was, at the time, actually less effective that other available fast acting insulins. Therefore, under the circumstances I do not think it much of a surprise that the National Institute for Health and Care Excellence would have turned it down. Now, 10 years later, Afrezza offers the possibility to obtain outcomes never before though possible in diabetes, so allow me to disagree with your assessment regarding a cost-effectiveness barrier for approval. The key word here being "effectiveness". Finally, I will also say that neither you or me have any idea what the price for Afrezza will be in the UK, although we both know it is unlikely to be the same as in the US. Different countries, different systems, different pricing, and if anybody is well qualified to assess what kind of pricing will gain quick approval in the EU countries, I think it would be fair to say that Sanofi, being a Europe based company, definitely is.
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Post by anims515 on Oct 21, 2015 12:01:06 GMT -5
This would go hand in hand with the delayed launch in Europe. If sanofi applied with the studies done to show non inferiority then why would Europe approve a higher cost option other than for needle phobic patients? Wait for the data to show superiority then get the regulatory agencies to approve the higher cost with no prior authorization needed.
edit: just thinking about it...in the us you can constantly change who what and where drugs are discounted covered etc. in other countries around the world it seems you have one shot to set your price and then it's either a yes or no. This would be another reason to delay world launch for more data and achieving approval of a higher price point
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Post by mnholdem on Oct 21, 2015 13:37:30 GMT -5
That does make an awful lot of sense.
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Post by parrerob on Oct 22, 2015 5:27:29 GMT -5
This would go hand in hand with the delayed launch in Europe. If sanofi applied with the studies done to show non inferiority then why would Europe approve a higher cost option other than for needle phobic patients? Wait for the data to show superiority then get the regulatory agencies to approve the higher cost with no prior authorization needed. edit: just thinking about it...in the us you can constantly change who what and where drugs are discounted covered etc. in other countries around the world it seems you have one shot to set your price and then it's either a yes or no. This would be another reason to delay world launch for more data and achieving approval of a higher price point Very nice comment. It make sense and could explain also the change for 2015 availability (in 2014 document) to "uncert" in the recent update. The site explain that availability dates in UK are just estimation based on timing since relative phase started. So the process was started in 2014 and the estimation was around 1 year for the availability. Probably until now SNY did not closed the Phase III (may be for the reason You explained) and probably presented some amendments. So timing now is uncertain as the process deviated from standard route.
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Post by mnholdem on Oct 22, 2015 8:02:53 GMT -5
I believe this is the most recent document: ... That seems to imply a potential cost barrier to approval. So you are speculating that because in 2006, almost 10 years ago, Exubera's cost was $2,100 a year in the UK (I applied an average of 1.9 dollars per pound, which is a fairly accurate exchange average for 2006, to the £1,100), Sanofi will have a hard time getting Afrezza approved in the UK based on cost-effectiveness.
Based on today's exchange rate of 1.55, the $2,759 annual cost of Afrezza in the U.S. would be £1,786 in the U.K. That seems to be a very modest increase from 2006 when you consider that the cost of many diabetes drugs have tripled in the past decade.
There have been numerous articles about the increasing cost of diabetes meds, so I won't quote any one in particular or provide a link. However, I think would be useful to better understand WHY costs have been increasing, since NICE and other European drug agencies will take these into consideration when evaluating Sanofi's pricing for Afrezza throughout Europe.
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Why Diabetes Drugs Are Expensive July 16th, 2015
Practically everyone who has diabetes uses one or more drugs to help to manage it. But most of these medications are expensive, and the U.S. Food and Drug Administration approved far fewer diabetes drugs in the past 10 years than between 1995 and 2004.
At the annual meeting of the American Diabetes Association in Boston earlier this month, thousands of diabetes professionals listened with interest as four experts explained why. I represented HealthCentral.com during the entire conference and made a point to be in the audience as four experts brought us up to speed about the “Costs of Medications for Diabetes.”
One of the most interesting and important talks of the entire conference was the first of these. Joseph DiMasi, PhD, the director of economic analysis at the Tufts Center for the Study of Drug Development, is the expert in this area.
Article continues at: www.mendosa.com/blog/?p=3521
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Post by lakers on Nov 16, 2015 20:16:02 GMT -5
www.ema.europa.eu/docs/en_GB/document_library/Agenda/2015/11/WC500196619.pdfAgenda - CHMP agenda of the 16-19 November 2015 meeting (English only) draft 16/11/2015 3.1.11. - insulin human - EMEA/H/C/003858 treatment of diabetes Committee for medicinal products for human use (CHMP) EMA/CHMP/754777/2015 Page 11/31 Scope: Opinion Action: For adoption Oral explanation was held on 20 October 2015. List of Outstanding Issues adopted on 25.06.2015. List of Questions adopted on 23.10.2014.
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Post by fedakd on Nov 16, 2015 21:27:00 GMT -5
I thought it was already proven that this isn't Afrezza?
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Post by prolux on Nov 16, 2015 22:27:20 GMT -5
My first post here: it's definitely not Insuman. I posted over on Yahoo (likely deleted during the purges), under proulxra59 that Insuman has its own application number, which differs from that of the unknown Insulin Human. I can't say for certain it's Afrezza, but unless Insuman has multiple application numbers, it's not Insuman.
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Post by cathode on Nov 16, 2015 22:32:10 GMT -5
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Post by goyocafe on Nov 16, 2015 22:48:27 GMT -5
I would have liked Nostradamus to explain himself, too!
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Post by jeremg on Nov 16, 2015 23:03:58 GMT -5
I'm unfamiliar with the EMA process. Does "Action: For Adoption" mean they are taking up the issue of approval OR does it mean they are beggining the process of introducing the drug into their meeting? In other words, what stage is "For Adoption"?
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Post by cathode on Nov 16, 2015 23:17:39 GMT -5
I'm unfamiliar with the EMA process. Does "Action: For Adoption" mean they are taking up the issue of approval OR does it mean they are beggining the process of introducing the drug into their meeting? In other words, what stage is "For Adoption"? From this thread on the EMA approval process, I think this is the step at day 210. From what I recall reading somewhere, which I cannot source right now, the results become public on Nov 25.
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Post by jeremg on Nov 16, 2015 23:29:22 GMT -5
I'm unfamiliar with the EMA process. Does "Action: For Adoption" mean they are taking up the issue of approval OR does it mean they are beggining the process of introducing the drug into their meeting? In other words, what stage is "For Adoption"? From this thread on the EMA approval process, I think this is the step at day 210. From what I recall reading somewhere, which I cannot source right now, the results become public on Nov 25. You are exactly right! I just answered my own question by reading through the last few pages of the EMA information. This is the "Opinion" step for "Adoption" which means they will give a verdict on whether to adopt the drug or not during this meeting. So the good news is we will know in short order. The bad news, I just somehow don't think this is Afrezza based on the "Insulin Human" tag alone and the fact this is already judgment day for this drug. I would expect Technosphere itself would need to be reviewed with some "FDKP" tag as opposed to just "Insulin Human" and SNY surely didn't start this process 210 days ago while keeping things hush hush up until EMA approval as MNKD burns.
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