lizzy241
9 hours ago
Someone recently posted this idea or option to increase PBM's coverage for V and drop GV. So, while CVS has changed its formulary as of 7/1/25, Rebates from Amarin to PBM's has turned the tables in favor of brand V.
Copilot reply.
Pharmacy Benefit Managers (PBMs) have recently shifted to covering brand-name Vascepa® while dropping generic icosapent ethyl from many formulariesโa move that seems counterintuitive at first glance. But hereโs whatโs driving it:
💸 1. Rebate Economics Favor the Brand
Amarin, the maker of Vascepa, offers substantial rebates to PBMs in exchange for exclusive formulary placement. These rebates can make the net cost of branded Vascepa lower than the generic, which typically doesnโt offer rebates at all. So even though the list price of the brand is higher, the PBM and plan sponsor may actually pay less.
📉 2. Generic Supply and Pricing Issues
Generic manufacturers of icosapent ethyl have struggled with:
High production costs (due to the complex purification process)
Limited supply capacity
Lower profit margins, making them less competitive on price
This has led to inconsistent availability and higher acquisition costs for some generics, undermining their usual cost advantage.
🧾 3. Patient Out-of-Pocket Costs
Because of the rebate structure, patients may pay less for branded Vascepa than for the genericโespecially if the generic is non-preferred or not covered. This makes the brand more attractive from a patient affordability standpoint.
📋 4. Formulary Strategy and Simplicity
PBMs often prefer to streamline formularies by selecting a single preferred product. With Amarinโs aggressive contracting, Vascepa has become the exclusive product for many commercial and Medicare Part D plans.
So while it bucks the usual trend of favoring generics, this shift is a classic case of rebate-driven formulary design. If youโd like, I can show you which PBMs or plans currently list Vascepa as preferred, or help compare out-of-pocket costs across plans.
Whalatane
1 day ago
N7. thx for bringing this trial to our attention .
Its an important trial for patients and anyone owning shares in AMRN .
Because its a P 3 trial with over 400 patients theres significant expense in recruiting , follow up , blood tests etc .
They will want to chk and double chk the data before releasing anything .
I notice they have follow ups every 6 mths at which time they probably ask those enrolled if they stuck to the dosing schedule and then do random blood tests , probably to chk for EPA blood levels to see if they have , then dispense the next 6 mths of Vascepa or placebo .
The issues raised by Dr Nissen re the placebo ..if using mineral oil ....dont really apply for the first 2 yrs IRRC from the R-IT data .
Theres long been a belief that those on mainly fish / vegetarian diets have a lower incidence of colorectal cancer then those on red meat diets .
Studies suggest that diets high in fish, particularly fatty fish rich in omega-3 fatty acids, are associated with a lower risk of colorectal cancer compared to diets high in red meat. A 2019 meta-analysis found that higher fish consumption was linked to a reduced risk of colorectal cancer, with a relative risk reduction of about 12% for each 100g/day increase in fish intake. Omega-3s may have anti-inflammatory and anti-carcinogenic effects that contribute to this.
In contrast, high red meat consumption, especially processed meats, is consistently linked to an increased risk of colorectal cancer. A 2015 World Health Organization report classified processed meats as a Group 1 carcinogen and red meat as a Group 2A probable carcinogen, citing evidence that 50g/day of processed meat increases colorectal cancer risk by about 18%.
EPA ( Vascepa since AMRN is involved in this trial ) may be the secret sauce !!!
Please post any updates on this trial that you become aware of
thx
Kiwi
Whalatane
1 day ago
https://www.sciencedirect.com/science/article/abs/pii/S0952327816301284
Highlights
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Individual red blood cell (RBC) and tumour polyunsaturated fatty acid (PUFA) levels have not previously been reported in a randomised trial of omega-3 PUFA supplementation in cancer patients.
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Our data highlight the high inter-patient variability in eicosapentaenoic acid (EPA) incorporation in cells that occurs during oral dosing in colorectal cancer (CRC) patients.
โข
Importantly, we demonstrate, for the first time, that the RBC EPA level predicts CRC liver metastasis EPA exposure during EPA treatment, suggesting a role for RBC PUFA analysis as a non-invasive biomarker of tumour EPA exposure in future phase III trials.
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A fascinating preliminary observation is that RBC EPA content, irrespective of randomisation to either EPA or placebo, was related to post-trial overall survival.
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Future trials of omega-3 PUFA supplementation should incorporate secondary analysis of blood omega-3 PUFA levels as a predictor of clinical outcomes, especially as background dietary intake of omega-3 PUFA can vary significantly and widespread use of โownโ omega-3 PUFAs may โcontaminateโ the placebo group.
From the phase 2 trial
EPA Incorporation: Analysis of red blood cell (RBC) and CRCLM tissue confirmed that orally administered EPA was incorporated into target tumor tissue, with a mean 1.26% increase in RBC EPA content during treatment (p<0.001), not observed in the placebo group.
So looks like an increase in RBC ( red blood cell ) EPA content, may increase disease free survival
Kiwi
Whalatane
1 day ago
N7. Good find
The Phase II randomized controlled trial (RCT) of eicosapentaenoic acid (EPA) 2 g daily in patients (n=88) undergoing liver resection surgery for colorectal cancer liver metastases (CRCLM), known as the EMT study, yielded the following results:
Primary Endpoint (Tumor Proliferation Index): There was no significant difference in the histological tumor proliferation index between the EPA and placebo groups.
Secondary/Exploratory Endpoints:
Tumor Vascularity: Metastases from the EPA arm showed a lower vascularity score, suggesting potential anti-angiogenic activity compared to placebo-treated tumors.
Disease-Free Survival (DFS): Median DFS was 22.6 months in the EPA group compared to 14.7 months in the placebo group, indicating a potential benefit, though this was an exploratory endpoint.
Overall Survival (OS): OS was also specified as an exploratory endpoint, with preliminary observations suggesting a possible prolonged survival benefit in the EPA group, though specific data were not detailed in the provided references.
EPA Incorporation: Analysis of red blood cell (RBC) and CRCLM tissue confirmed that orally administered EPA was incorporated into target tumor tissue, with a mean 1.26% increase in RBC EPA content during treatment (p<0.001), not observed in the placebo group.
Safety and Tolerability: EPA at 2 g daily (as EPA-free fatty acid) was safe and well-tolerated during the preoperative period.
Study Limitations: The trial intervention was limited to the preoperative period, and tissue samples were only obtained at surgery, preventing longitudinal analysis of EPA incorporation and washout in CRCLM tissue.
The trial provided preliminary evidence of EPAโs potential anti-angiogenic effects and possible survival benefits, supporting further investigation in the larger Phase III EMT2 trial.
The P 3 trial ClinicalTrials.gov ID NCT03428477
Randomisation will be 1:1 to receive either IPE capsules or placebo capsules. 4 capsules per day containing IPE (equivalent to 4 g EPA-ethyl ester [EE] daily) or 4 placebo capsules per day.
Participants will start treatment a prior to CRCLM surgery and will continue to receive treatment for a minimum of 2 years and a maximum of 4 years post-liver resection.
So double the dose of EPA ( I'm assuming its Vascepa ) from prior to surgery for at least 2 yrs following surgery .
I'll be a big deal if this prolongs DFS ( disease free survival ) significantly
Kiwi
JRoon71
2 days ago
RMB, the reason I was curious, is because I was one fo those people that asked about it, probably a year or so ago. When I asked if it was possible to withdraw an indication, I was told "yes", but that we could only withdraw our own product from the indication, but unless the FDA somehow rescinded approval of the drug for the indication, that generics could continue to sell into it.
I honestly don't know who told me that, but recall it may have been Chromosome or Kiwi, or possibly Tatsumaki.