AI
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| Alias Born | 06/15/2013 |
Thursday, June 13, 2024 10:45:04 PM
Setting aside the obvious motive to knock down the price of Vazkepa, and doing my best to follow the G-BA's logic:
They claim that IPE's efficacy is unproven for patients who have lowered their LDL-c to 55mg/dL (Reduce-IT's median LDL-C before and after was roughly 70mg/dL IIRC). If this claim is true, IPE's benefit would not "stack" with ezetimibe, and the two compete. This still leaves a problem for the German argument, because IPE confers 25%RRR vs ezetimibe's 6% RRR. This is the part where they throw in the mineral oil uncertainty to further "level the playing field" between the two agents.
Anyways, regarding the LDL-c arguments, I believe at the time of submission and discussion, there wasn't an official < 55mg/dL subgroup analysis. Looking at the NEJM article for Reduce-IT, I see this tertile breakdown, where the lowest tertile is <67 mg/dL. The trend strongly suggests <55mg/dL wouldn't make a difference, but that info hasn't been analyzed and published.
That's why Bhatt's presentation in April is so important, it directly challenges the G-BA's point, to the digit. As for the mineral oil arguments, we've accumulated more evidence since (RESPECT, Bhatt's mediation analysis at ESC 2023, in vitro studies by Mason comparing corn oil/MO/epa/dha). I'd love to see something become of the real world data done by the VA hospital researchers, and obviously you and I both want to see MITIGATE.
I'm with you that UK/EU is what will drive the valuation for the eventual BO. Italy/France/Germany and then sold.
They claim that IPE's efficacy is unproven for patients who have lowered their LDL-c to 55mg/dL (Reduce-IT's median LDL-C before and after was roughly 70mg/dL IIRC). If this claim is true, IPE's benefit would not "stack" with ezetimibe, and the two compete. This still leaves a problem for the German argument, because IPE confers 25%RRR vs ezetimibe's 6% RRR. This is the part where they throw in the mineral oil uncertainty to further "level the playing field" between the two agents.
Anyways, regarding the LDL-c arguments, I believe at the time of submission and discussion, there wasn't an official < 55mg/dL subgroup analysis. Looking at the NEJM article for Reduce-IT, I see this tertile breakdown, where the lowest tertile is <67 mg/dL. The trend strongly suggests <55mg/dL wouldn't make a difference, but that info hasn't been analyzed and published.
That's why Bhatt's presentation in April is so important, it directly challenges the G-BA's point, to the digit. As for the mineral oil arguments, we've accumulated more evidence since (RESPECT, Bhatt's mediation analysis at ESC 2023, in vitro studies by Mason comparing corn oil/MO/epa/dha). I'd love to see something become of the real world data done by the VA hospital researchers, and obviously you and I both want to see MITIGATE.
I'm with you that UK/EU is what will drive the valuation for the eventual BO. Italy/France/Germany and then sold.
