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haha, I'll leave it to your guess
14:57-15:01
Source is the video link you shared.
Listen what Dr. Ambrosy said when he was explaining slide 18. He said the number was approaching 2,000.
Kiwi, PD, and NS
There is conflicting info, and I don't know if total enrollment is 1,500 or 3,600.
The following is the reason why I thought enrollment was 3.600.
Rose,
NS, I don't have low expectations for the VA study, but for obtaining the indication of Alzheimer's disease.
NS, I'm not excited about Alzheimer's disease which is a super long shot.
Next target of icosapent ethyl is cancer (eg, colon, breast cancer)
Thonn, good catch! I believe that icosapent ethyl is still in infant stage.
Kiwi, weak point of AMRN/Vascepa/Vazkepa is lack of strong evidence compared to statin/LDL. IMO, statin+Vascpea/Vazkepa is better than statin+ezetimib/PCSK-9, but they think LDL lowering is better than adding IPE, unfortunately.
How Drug Prices Are Negotiated in Germany
https://www.commonwealthfund.org/blog/2019/how-drug-prices-are-negotiated-germany
NS, thank you. I am not 100% sure, but whether the trial should stop for futility or not depends on its protocol whether it includes planned interim analysis or not.
NS,
FYI
"ASMR V" does not mean "no reimbursement".
The SMR, not ASMR, determines the reimbursement level. The reimbursement rate is as follows:
Important 65%
Moderate 30%
Mild 15%
Insufficient Not included on the positive list (not reimbursed)
Medical service rendered (SMR)
Important
The Commission considers that the medical service rendered by VAZKEPA (icosapent ethyl) for reducing the risk of cardiovascular events is IMPORTANT only in adult patients on maximum tolerated dose statin therapy, at very high cardiovascular risk due to established cardiovascular disease (secondary prevention) and with moderately elevated hypertriglyceridemia (= 150 and < 500 mg/dL).
Insufficient
The Commission considers that the medical service rendered by VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular events is INSUFFICIENT to justify reimbursement by national solidarity in the other populations of the indication including patients with severe hypertriglyceridemia (= 500 mg/dL) and those with diabetes and at least one other cardiovascular risk factor (primary prevention)
Thank you for sharing the info
PD, I agree with you. Will see how AMRN negotiates with U.K. gov
Other:
Both of meds have the same comments in guideline:
NICE: example of "not recommended" to "recommended":
https://www.nice.org.uk/guidance/ta748/history
https://www.nice.org.uk/guidance/ta534/history
When the Outcome of an Appraisal Is Not NICE: An Overview of the Appeal Process
https://www.xcenda.com/insights/htaq-spring-2017-outcome-of-appraisal-is-not-nice
jasbg,
Capt, thank you for your effort! I am really disappointed at their conclusions/view points/biases, etc
What can be done if NICE is incorrect?
Just because NICE reaches a decision with which you do not agree does not necessarily mean they have “got it wrong” from a legal perspective. Having said that, it is of course possible that your product may be excluded from guidelines because NICE made a mistake.
For example, their review of the science or the health economic benefits may be flawed, or they may have included irrelevant factors or excluded relevant factors in reaching their conclusions. If that is the case, it may be possible to challenge the guidelines through NICE’s internal systems or, alternatively, to seek judicial review of NICE’s decision through the court in an attempt to have the guidelines changed.
If the situation is critical, it may also be possible to seek urgent injunctive relief to prevent the guidelines being published.
An application for judicial review can be made to challenge a decision of a public body on relatively limited grounds. Put simply, it is NICE’s process that is challenged (including the factors considered when reaching its decision) rather than the merit of the decision itself. The timelines are short; typically, any application has to be made within 3 months of the decision, so legal advice should be sought swiftly.
The first step in seeking judicial review is to write to NICE, informing them of the planned application and setting out the detailed basis for the challenge. This gives NICE the opportunity to respond and, in some cases, accept that they have made a mistake and agree to adjust the guidelines or guidance.
If an initial letter does not produce the desired effect, a formal claim will need to be issued with a court fee being payable. The court process will then follow, with NICE and any interested parties being given the opportunity to respond. In judicial review cases, there is an initial review by the court to decide whether the case can proceed; this stage is not seen in general commercial litigation cases.
The process as a whole can be lengthy and expensive, so the decision to go ahead should not be taken lightly. Prime Minister Johnson has indicated an intention to amend the nature of judicial review, so this process might also change in the months and years to come.
If the matter is urgent, it may be possible to seek an injunction to prevent the publication of the guidelines. However, there is a high threshold to achieve this … and it is a notoriously expensive process.
Whether or not judicial review of NICE guidelines or guidance will be available is a complex question, and one on which specialist advice should be sought quickly. Given the enormity of the potential effects that unhelpful guidance or guidelines could have, however, it is likely to be a worthwhile investment of both time and money.
https://www.manufacturingchemist.com/news/article_page/Challenging_agency_guidance_what_to_do_when_NICE_gets_it_wrong/163425
At least, the majority of evidence review group members in NICE is Steven Nissen. I don't think Amarin can change their mind.
NICE:
NICE: I am comparing Vascepa and Inclisiran.
Did you hear what Dr. Ambrosy said when he was explaining slide 18? He said the number was approaching 2,000.
PD and all, my bad. You are right. Joint session does not necessarily mean simultaneous publication in JACC and JAMA.
Kiwi, why don’t you watch the presentation again. Dr. Ambrosy “said” the number was approaching to 2,000 as of June 18. (When he made the slide, the number was 12,44)
Deadline of submission for late breaking trials was at the beginning of December. At that point, nobody knew the result of MITIGATE.
MITIGATE at ACC
In the presentation on June 18, Dr. Ambrosy stated that the number of participants in IPE group was reaching to 2,000 (1,244 around June 1). Based on this, I think they finished the recruitment of 39,600 participants at the end of August (3,600 in IPE group).
Event rate was low at that time. Positive lab tests only (current primary end point) was 3.9 per 100 PY for 107 days of median follow up time. Study follow up time is at least 180 days, so 6.6 per 100 PY (107 --> 180 days) was expected. However, considering Delta and Omicron surge, the rate of positive lab tests should be much higher, and I expect 10-15 per 100 PY in the end.
If positive rate is 13.7% in V (493/3,107) and 15% (5,400/30,600) in usual care, it is p<0.05, which means we need about 10% of relative risk reduction because of V.
Thank you for the link!
If the result is not preliminary in April, it can be negative.
Kiwi,
Yes definitely, because MITIGATE also has cardiovascular outcomes.
I hope so too. We will see in April.
NS, this may help our understanding of preliminary research results. Again, it doesn't make any sense to publish "negative preliminary" results.
What's the Rush? The Dissemination and Adoption of Preliminary Research Results
https://academic.oup.com/jnci/article/98/6/372/2522017
ACC annual conference:
1)A Pragmatic Randomized Trial Of Icosapent Ethyl For High Cardiovascular Risk Adults (mitigate) In An Era Of Coronavirus Disease 2019
Andrew P. Ambrosy, Thida Tan, Rachel Thomas, Rishi Parikh, Daniel Stevens, Ryan Wi, Harshith Avula, Matthew Solomon, Van Selby, Jesse Fitzpatrick, Choon Goh, Jacek Skarbinski, Sephy Philip, Deepak Bhatt, Alan Go, Kaiser Permanente San Francisco Medical Center, San Francisco, CA, USA, Kaiser Permanente Northern California - Division of Research, Oakland, CA, USA
2) ICOSAPENT ETHYL REDUCES CARDIOVASCULAR RISK SUBSTANTIALLY AND CONSISTENTLY REGARDLESS OF WAIST CIRCUMFERENCE
Deepak L. Bhatt, Eliot A. Brinton, Michael Miller, Philippe Gabriel Steg, Terry A. Jacobson, Steven Ketchum, Lixia Jiao, Ralph T. Doyle, Jr, Jean Claude Tardif, Christie M. Ballantyne, on behalf of the REDUCE-IT Investigators, Brigham and Women’s Hospital, Boston, MA, USA
3) EICOSAPENTAENOIC ACID (EPA) COMBINED WITH HIGH INTENSITY STATINS REDUCE LIPID OXIDATION IN MODEL MEMBRANES
Samuel R. Sherratt, Peter Libby, Deepak L. Bhatt, R. Preston Mason, University of New Hampshire, Durham, NH, USA, Elucida Research LLC, Beverly, MA, USA
4) EICOSAPENTAENOIC ACID (EPA) INCREASES HEME OXYGENASE-1 EXPRESSION IN MACROPHAGES AND ENDOTHELIAL CELLS DURING INFLAMMATION
Samuel CR R. Sherratt, Peter Libby, Deepak L. Bhatt, Hazem Dawoud, Tadeusz Malinski, R. Preston Mason, University of New Hampshire, Durham, NH, USA, Elucida Research LLC, Beverly, MA, USA
5) EICOSAPENTAENOIC ACID (EPA) DECREASES ANGIOTENSIN CONVERTING ENZYME (ACE) EXPRESSION IN VASCULAR AND PULMONARY ENDOTHELIUM FOLLOWING CYTOKINE CHALLENGE
Samuel CR R. Sherratt, Peter Libby, Deepak L. Bhatt, Hazem Dawoud, Tadeusz Malinski, R. Preston Mason, University of New Hampshire, Durham, MA, USA, Elucida Research LLC, Beverly, MA, USA
6) EICOSAPENTAENOIC ACID (EPA) REDUCES INFLAMMATION AND IMPROVES NITRIC OXIDE BIOAVAILABILITY IN PULMONARY ENDOTHELIAL CELLS FOLLOWING EXPOSURE TO AIR POLLUTION PARTICLES
Samuel CR R. Sherratt, Hazem Dawoud, Peter Libby, Deepak L. Bhatt, Tadeusz Malinski, R. Preston Mason, University of New Hampshire, Durham, NH, USA, Elucida Research LLC, Beverly, MA, USA
7) EICOSAPENTAENOIC ACID (EPA) REDUCES J774 MACROPHAGE ACTIVATION AND CYCLOOXYGENASE (COX-1) EXPRESSION
Samuel CR R. Sherratt, Peter Libby, Deepak L. Bhatt, Hazem Dawoud, Tadeusz Malinski, R. Preston Mason, University of New Hampshire, Durham, NH, USA, Elucida Research LLC, Beverly, MA, USA
Publication or presentation of negative result is important scientifically and ethically, but publication of negative "preliminary" result does not make sense at all. We may see negative results of full data if they can finish collecting and analyzing data by April 2-4, but given that they finished recruitment in August (or December/January if they increased the number) and follow-up period is 12 months, the result should be preliminary.