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Wednesday, September 25, 2024 6:24:09 PM
Thank you NS for sharing this.
Those who have been around the MB for a lengthy period know that I am a huge advocate of Vascepa/Vaskepa.
When I read the article the use of V in this setting is very specific. Notice it is an update from its 2021 meeting.
It is for a condition where the arteries in the extremities of the body build up plaque and restrict blood flow. This can lead to increased blood clots which can lead to strokes, mitral infarction, obvious pain and even death of a portion of the extremity if blood flow cannot get to it. It was very promising that over 80% of these distinguished experts recommended " For LEAD patients treated by statin and who have elevated triglyceride level between ≥150 mg/dL and ≤500 mg/dL, we suggest adding Icosapent Ethyl. 3. Before adding Icosapent Ethyl in LEAD patients treated with statin, we suggest looking for symptoms that may suggest atrial fibrillation. 4. For LEAD patients treated by Icosapent Ethyl and who have symptoms that suggest atrial fibrillation, we recommend performing an electrocardiogram."
Getting 80% or greater of these French experts to agree is extremely positive. So as the article says, now the experts have a standard to use with this particular condition and when certain blood values are still not in alignment even after being on max statins etc. It is promising that it says "Icosapent ethyl should obtain reimbursement soon in France."
I am not trying to be pessimistic but realistic. I have heard different things however the status in these countries is always dynamic and flowing. My understanding was that we will eventually get approval but it most likely will be well into the second half of 2025. I would love nothing more than to have this time line moved up. One thing which the French government looks upon for renewal is not only the medicinal value of the product but also how the company plans to help in the boosting of the economy as well. It could very well be that some of this infrastructure has taken place. Are there any manufacturing facilities in France producing or encapsulating IE? I'm not smart enough to find this but I know you watch this closely.
Bottom line at least for me is that I love the statement but until I can hear an update at the next CC from Berg, I'm going to be critically optimistic if that makes sense. What does make sense is that IE should be used for those with LEAD. Many more patients would be blessed with less strokes, heart attacks, pain, surgery and amputations.
As a side note, I have no clue on how the Chinese situation is going with Edding moving through with all the paperwork hoping for V to be on the government formulary for CVD in January. If anyone can see progress in this area it would be appreciated.
Germany is miles away still. The Germans are irrational not tying V into their healthcare. I understand the budget restraints but they would make up the difference in the 5 plus years with lack of 5 CVD conditions.
We are in good shape in Italy. It is a formality now but will have to wait until officially announced.
As always appreciate your posts and comments. Hopefully this does not come across as some "know it all" posting. Just typing as I'm processing this in my brain. Let's cross our fingers and hope we get a positive SPECIFIC update about France at the next CC and not just a "we hope to have reimubursement decisions in 2025 for France". Take care brother!
Those who have been around the MB for a lengthy period know that I am a huge advocate of Vascepa/Vaskepa.
When I read the article the use of V in this setting is very specific. Notice it is an update from its 2021 meeting.
It is for a condition where the arteries in the extremities of the body build up plaque and restrict blood flow. This can lead to increased blood clots which can lead to strokes, mitral infarction, obvious pain and even death of a portion of the extremity if blood flow cannot get to it. It was very promising that over 80% of these distinguished experts recommended " For LEAD patients treated by statin and who have elevated triglyceride level between ≥150 mg/dL and ≤500 mg/dL, we suggest adding Icosapent Ethyl. 3. Before adding Icosapent Ethyl in LEAD patients treated with statin, we suggest looking for symptoms that may suggest atrial fibrillation. 4. For LEAD patients treated by Icosapent Ethyl and who have symptoms that suggest atrial fibrillation, we recommend performing an electrocardiogram."
Getting 80% or greater of these French experts to agree is extremely positive. So as the article says, now the experts have a standard to use with this particular condition and when certain blood values are still not in alignment even after being on max statins etc. It is promising that it says "Icosapent ethyl should obtain reimbursement soon in France."
I am not trying to be pessimistic but realistic. I have heard different things however the status in these countries is always dynamic and flowing. My understanding was that we will eventually get approval but it most likely will be well into the second half of 2025. I would love nothing more than to have this time line moved up. One thing which the French government looks upon for renewal is not only the medicinal value of the product but also how the company plans to help in the boosting of the economy as well. It could very well be that some of this infrastructure has taken place. Are there any manufacturing facilities in France producing or encapsulating IE? I'm not smart enough to find this but I know you watch this closely.
Bottom line at least for me is that I love the statement but until I can hear an update at the next CC from Berg, I'm going to be critically optimistic if that makes sense. What does make sense is that IE should be used for those with LEAD. Many more patients would be blessed with less strokes, heart attacks, pain, surgery and amputations.
As a side note, I have no clue on how the Chinese situation is going with Edding moving through with all the paperwork hoping for V to be on the government formulary for CVD in January. If anyone can see progress in this area it would be appreciated.
Germany is miles away still. The Germans are irrational not tying V into their healthcare. I understand the budget restraints but they would make up the difference in the 5 plus years with lack of 5 CVD conditions.
We are in good shape in Italy. It is a formality now but will have to wait until officially announced.
As always appreciate your posts and comments. Hopefully this does not come across as some "know it all" posting. Just typing as I'm processing this in my brain. Let's cross our fingers and hope we get a positive SPECIFIC update about France at the next CC and not just a "we hope to have reimubursement decisions in 2025 for France". Take care brother!
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