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Do you have a link to that article?
https://www.mdedge.com/familymedicine/article/262322/forget-fibrates-cardiovascular-risk-reduction-commentary-failure-and
Big article in my Family Practice news:Innovative Medicine-Best practices.
It's about Fibrates and the failure of the Prominent trial. The last paragraph reads:
"The results of the Prominent trial underscore that fibrates are NOT useful for reducing CV risk in patient treated with statins with well controlled LDL, even in the presence of DM"
"In short when it comes to TG levels, treating the number does not treat the risk. This requires a definitive paradigm shift in how clinicians approach the treatment of hypertriglyceridemia in patients with or at risk of CVD"
"Consistent with the guidelines of the AHA/ACC icosapent ethyl is a treatment option that should be considered for lowering persistent CV risk in patients treated with statin who have elevated TG levels with a high persistent risk of CV events"
AAHH, it's so simple. Stop using Fibrates and Lovaza as all the evidence shows and IPE sales triple overnight. What an unfortunate state of affairs in the medical community and for our patients!
PD
As you know Buproprion and Zyban -same med were used for 2 different indications (depression/smoking cessation) and it looks like British Columbia allowed the generic for depression but not for smoking cessation
https://www2.gov.bc.ca/gov/content/health/practitioner-professional-resources/pharmacare/prescribers/limited-coverage-drug-program/limited-coverage-drugs-bupropion
Thoughts?
No one on WS is expecting a Marjac victory. This would be the legal equivalent of the Miracle on Ice! The timing is perfect and our prayers are with you Marjac. Let's make it happen.
Raf - I assume you mean A-fib since that was the issue in RI
Someone much smarter than me said:
"Vascepa is Safe to Use Among Patients With Well-Controlled AFib. The increase in hospitalization risk seen with Vascepa was small vs the survival gains seen from decreased rates of heart attack, stroke, and revascularization, noted Deepak L. Bhatt, MD, MPH,"
Rose - HDL levels trend a bit lower with age but not by much. So when the levels are reported they don't age adjust.
Captain - a few comments on ISOLATED low HDL:
We know the risk for myocardial infarction increases by about 25 percent for every 5 mg/dL decrease in serum HDL cholesterol below median values for males and females
The risks associated with HDL varies by the LDL and triglyceride level. When compared with isolated low HDL cholesterol, CVD risks were increased when the low HDL cholesterol was accompanied by LDL cholesterol ≥100 mg/dL and triglycerides <100 mg/dL (odds ratio 1.3, triglycerides ≥100 mg/dL and LDL cholesterol <100 mg/dL (OR 1.3) or LDL cholesterol and triglycerides ≥100 mg/dL (OR 1.6)
Most causes of low HDL are inherited. Other causes include:
Drugs such as beta blockers, benzodiazepines, and anabolic steroids, acute infections and inflammation
Despite the substantial body of evidence of an inverse relationship between HDL and CV risk, low levels of HDL cholesterol have not been established as causative of this relationship or with the development of atherosclerosis.
Finally, interventions to raise HDL cholesterol (as the only therapeutic target) have not uniformly demonstrated benefit, thus making it difficult to prove causality.
So what to do?
As there is no firm evidence of benefit from attempts to target low HDL, most docs don't. The evidence presented supports the concept that LDL lowering should be pursued more vigorously when HDL cholesterol is low.
For all patients at increased cardiovascular risk, regular exercise, smoking cessation, attainment of target body weight, and a healthy diet. have been associated with increases in HDL cholesterol.
Not a satisfying answer but repeat the test at least once, and vigorously optimize LDL and other habits of healthy living.
Total respect for your efforts - win or lose. I'd want you in my foxhole.
Pharmacydude- Jelis used 1.8 grams and found significant benefits - granted the population was different. However, my gut feeling is that the benefit is a continuum of epa dosing and epa levels and taking 2 gm/day would not be a waste of money - it just may not give the maximum possible benefit.
Checking epa level is a good idea. I checked mine using 2-3 grams/day and was pretty much maxed out on my epa levels and ratio - likely because I eat a lot of fish and my diet is otherwise good. At some point the benefit maxes out - o/w why stop at 4 grams/day?
sts - not the pharmacy software, the insurance company formulary software. That's where the pharmacy gets information on what the insurer covers such as generic, tiering, PA requirement, cost etc. Sure it's a big ask and unlikely to happen but it could if they wanted to do it.
LBL - If you are correct and Pfizer is committed to a BO I wonder if they are pulling some of the strings at AMRN - like "recommended" pre conditions that will make a BO more likely to happen. Such as the reduced sales force, new marketing strategy, solid European launch and increased cash reserves?
Btw, contacted my V rep and she is very happy to have made the cut and excited about the new mgt. team.
JM
I visited the office in Dublin when I was there 2 years ago. They said I needed an appointment to see anyone and when I asked if I could see the office they refused and said nobody is there if there's no appointment!
It's all a tax scam.
Iryokabu - Interesting that you ask that question today. See below.
Exas has used Pfizer for years for Cologuard and are now bringing the old Pfizer reps in as Pfizer decreases their sale reps in Internal Medicine. Maybe they will move some over to the cardiology division with AMRN.
On September 15, 2021, Exact Sciences Corporation (“Exact Sciences”) announced it has expanded its primary care sales team to increase adoption of Cologuard®, the first and only FDA-approved, at-home colon cancer screening test, and its pipeline of innovative cancer screening tests. In late August, Pfizer Inc. (“Pfizer”) announced internally that it decreased the number of sales positions supporting its Internal Medicine therapeutic area. The displaced employees had been promoting Cologuard under an agreement between Exact Sciences and Pfizer (the “Promotion Agreement”). Exact Sciences offered the displaced Pfizer sales representatives opportunities to join its team in full-time sales roles promoting Cologuard, and the vast majority of those offers were accepted. Exact Sciences completed an expedited hiring process and onboarded approximately 400 sales representatives in September, increasing the size of its primary care field sales team to more than 850 representatives.
Exact Sciences expects the newly hired representatives to be more productive as its own employees, fully dedicated to its mission to eradicate cancer, and better able to coordinate interactions with health care providers as one team. Exact Sciences’ newly expanded team is in the field and interacting with health care providers in person, focused solely on Cologuard initially.
Pfizer is currently promoting Cologuard with a smaller team under the Promotion Agreement; however, due to its recent COVID-19 internal policies, which are different from Exact Sciences’, Pfizer is not making in-person sales calls in 41 states. Exact Sciences is in discussions with Pfizer that could result in material changes to the Promotion Agreement and its relationship with Pfizer.
New guidelines from the AHA and the American Stroke Association on the prevention of stroke in patient with a stroke or TIA
"Cholesterol management. Everyone who has had a stroke or TIA should receive atorvastatin 80 mg daily. The LDL goal is < 70 mg/dL. Many people, if not most, will need ezetimibe and/or a PCSK9 inhibitor in addition.
New in this guideline are recommendations for hypertriglyceridemia. For those who have fasting triglyceride levels > 135 mg/dL, we can consider treatment with icosapent ethyl (IPE) 2 g twice a day in addition to a statin, based on the results of the REDUCE-IT trial, but only in patients without AF, because it can increase the risk for AF.
Pretty significant new recommendation by 2 natl organizations.
Anyone see a PR on this???? If not why not?
https://www.medscape.com/viewarticle/955926?src=WNL_mdpls_210827_mscpedit_fmed&uac=49000DG&spon=34&impID=3597207&faf=1#vp_2
I understand the A-fib issue but they had a decrease risk of stroke as well with V!
I agree that Pfizer isn't doing this for free and HLS is likely paying Pfizer a fee based on a % of sales and rep visits in those areas of sales.
The other thing to know as it relates to the co-marketing agreement they have with Exact Sciences is that Pfizer pays for the advertising of the product in medical journals. Likely Pfizer gets a much better rate on advertising which is essential in marketing to providers and a big cost item.
That being said I would be shocked if this was an isolated move by Pfizer as the revenue is miniscule. I believe it is testing the waters for both potential of the product and the how best to engage providers as it considers a larger role or BO with AMRN.
Not sure if last weeks JAMA article was posted here. Fairly balanced and at least out there for a large readership.
Novel Lipid-Lowering Therapies to Reduce Cardiovascular Risk
https://jamanetwork.com/journals/jama/fullarticle/2782198
Not sure everyone can get in so here is the "V" section
Icosapent Ethyl
Icosapent ethyl is a highly purified from of eicosapentaenoic acid (EPA), which is a synthetic derivative of EPA, one of the predominant omega-3 fatty acids found in fish oil. The mechanism of action of icosapent ethyl in reducing ASCVD risk is unclear. When added to statin therapy in patients treated for secondary or high-risk primary prevention with triglycerides between 135 and 500 mg/dL, icosapent ethyl at a dose of 2 g orally, twice daily, reduced relative ASCVD risk by 25% (4.8% absolute risk reduction over 4.8 years of follow-up).8 Its effects on ASCVD risk do not appear to be explained through observed changes in lipid fractions, suggesting that alternative mechanisms may explain its cardioprotective effects. Major adverse effects were infrequent, with a slightly higher risk for atrial fibrillation (1.4% absolute risk). Current average price is $83 to $277/mo, with highly variable out-of-pocket costs for patients.9
The effects of icosapent ethyl do not appear to be generalizable to all fish oil preparations because other trials of fish oil and EPA/DHA formulations have not demonstrated ASCVD risk reductions when added to statin therapy. This may be due to either differences in the chemical composition of icosapent ethyl, or more likely differences in the higher effective dose of icosapent ethyl (4 g/d) when compared with fish oil or other DHA/EPA preparation regimens, which provide approximately 2 g/d of EPA.
Nuke - unfortunately the days of the weekend at the spa followed by a dinner with a 30 minute CME "talk" are over. :)
Now I have to fill out a 2 page disclosure to my boss if I accept a pen from a drug rep!
Nuke - Most specialties require a certain level of continuing medical education and board exams to remain "Board Certified". But, even if you are not board certified each state has CME requirements.
For example, WI is 30 hours every 2 years. But Family Medicine board certification is 150 hours every 3 years.
Ralphy - if you haven't watched the movie Idiocracy you should - straight to your point and a great laugh.
BTW Raf - I'm moving to NC. Aren't you in Raleigh?
I'll be visiting family in Raleigh frequently - maybe we can grab a coffee/beer sometime.
Whal - Yes since Ezetimide is generic so no PA problems with that.
Regarding inclusion in official Lipid guideline. As I was at the ACC conference in Chicago when RI and the new lipid guidelines were presented - I recalled being very concerned that because of the very unlucky timing of these 2 events occurring at the same time it would prevent V from getting included in the formal guidelines for possibly years. IMO that was a severe blow to uptake as it allowed insurers to play hardball and prevented the "standard of care" pressure on providers and did not allow AMRN to advertise this.
So, yes I think it will just take time. I was hoping they would make a definitive interim guideline within the past year but nothing yet. Maybe they are waiting for the next formal update which could be quite some time.
Maybe one of the board cardiologists has some insider info on this.
Roadkill - Zetia has shown a small benefit and is IN the ACC/AHA standard of care guidelines. That's why it sells 5M Rx's and that's why we need the same ACC inclusion in the guidelines!
We all knew it was a long shot, expectations were very low to us all and Wall Street was expecting nothing.
Thanks to all who put in a valiant effort- much appreciated by everyone here.
Humbled once again as an AMRN shareholder.
I can confirm from my rep that what Gbert says is correct about GV counting for the reps. It's not their fault if the insurer converts a script.
Sts - Almost as many 0's as the multiples of posts you have compared to the rest of us :)
And by the way the "Horrible" Chinese vaccine with a 50% efficacy rate is saving tens of thousands of hospitalizations and lives in third world countries who can't get the US vaccines and as research reports have shown:
"The Sinovac study (chinese vaccine) was to look at how the vaccine works against the entire range of clinical symptoms, from mild infections to severe ones, including death. The efficacy data of about 50% is for very mild disease, requiring no treatment. For infections requiring some medical intervention, it’s about 84% and for moderate-to-severe Covid cases, it’s 100%."
Isn't moderate to severe infection what we really want to prevent instead of no or minimal symptoms? Sound pretty good to me.
hump4 - Gardasil immunization if for the the highest risk serotypes that cause cervical cancer - including type 16 which causes 70% of cancers in the oropharynx. So, it should help prevent oral cancers as well.
Oral cancer is likely (not for sure) on the rise because of the significant increases in oral sex at very young ages. HPV can remain dormant for decades before it shows up as a cancer in the oropharynx.
NS - I think the point for requiring a PA for generic V is that it is more expensive than Generic L, so if your trigs are >500 they want you using L.
And, if they are infringing (they do own Healthnet) and the doc is prescribing for CV benefits they want to make sure they aren't using it off Label. Bottom line is to save $$.
NS
icosapent ethyl caps 1 PA; QL(4 ea
daily) Tier 1
LOVAZA CAPS (Use
omega-3-acid ethyl esters) NF QL(4 ea daily)
omega-3-acid ethyl esters tier 1
caps 1 QL(4 ea daily)
VASCEPA CAPS 0.5 GM 3 PA tier 3
VASCEPA CAPS 1 GM 3 PA; QL(4 ea
daily) tier 3
AMBETTER is Centene's Mcare product
So, they cover GV tier 1 with a PA
They cover V tier 3 with a PA
They cover GL Tier 1 no PA
They don't cover Lovaza
BTW, Centene is the company that owns HealthNet as well
Yes Miller you never know. But, you have to think this decision was under pressure from shareholders and the BOD. JT was stale and the company was going nowhere. A change had to be made - we'll see how it works out over the next 1-2 years.
Great words FFS - We rarely have significant personal growth without significant suffering and letting go. All is blessing.
UNH - UnitedHealthcare
Dear UNH Formulary committee,
As a Family Physician who has cared for thousands of patients with lipid disorders over my 35 year career and one who is intimately familiar with the FDA criteria for approval and all of the ACC/AHA/ADA/NLA/AACE/CCS/ENDO guidelines supporting the use of Icosopent ethyl (Vascepa) for CVD reduction, I am appalled and somewhat incredulous that your latest guidelines prohibit primary care providers like myself from prescribing this medication. To suggest that we are incapable of following standard of care guidelines for a very safe drug is a slap in the face to all dedicated primary care providers, pulmonologists, nephrologists, etc.
To say that only a cardiologist, endocrinologist or lipid specialist is capable of prescribing Vascepa is not only degrading to all other physicians but medically a large disservice to your patients, as Vascepa has been shown to be a very cost effective drug in reducing CV events.
For you to put such a roadblock on a life saving drug it is transparent that little thought other than saving money was put into this decision.
I sincerely hope that you will review this decision preventing me and tens of thousands of physicians who are entirely capable of following present medical guidelines from utilizing this life saving drug without having to refer them to a "specialist". I would appreciate a response to why you are limiting my scope of practice.
Sincerely,
xxxxx MD
I encourage all physicians on this board who are unable to have the intelligence to prescribe Vascepa to use this or a similar letter to let UNH know of of displeasure over their formulary criteria.