LETTER TO THE INSURANCE PROVIDER:
** my mother told me that ssince January 1, her insurance provider needs an authorization from her Doctor but the Doctor can't send
the authorization since her triglycerides are normal. As a result, I sent her CATPBEER's letter (see below) to send to the doc. Hopefully that works.
I am stickying this post, in case others need this letter. Can only sticky posts these were written not more than 48 hours ago. Thanks, CAPTBEER **
"To: The Formulary Manager & The P&T Committee
Re: VASCEPA: An FDA approved drug (2012) for hypertriglyceridemia should be the preferred drug for this indication in your formulary
Dear Formulary Manager,
As the Formulary Manager for xxxxxxxxx I wanted to bring to your committee’s attention the recent results of a clinical cardiovascular outcomes trial called REDUCE-IT.
REDUCE-IT was a global study of 8,179 statin treated adults with elevated CV risk. The study was designed under a Special Protocol Agreement, (SPA) with the FDA to detect a 15% Relative Risk Reduction (RRR) in a Major Adverse Cardiovascular Event (MACE) in an outcome study. The results of this trial were presented on November 10, 2018 to the scientific sessions of the 2018 annual meeting of The American Heart Association (AHA) and simultaneously published in the New England Journal of Medicine (NEJM). https://www.nejm.org/doi/full/10.1056/NEJMoa1812792
SUMMARY; REDUCE-IT RESULTS
The primary endpoint achieved a composite 25% RRR in MACE such as:
• CV death 20% RRR
• Fatal or nonfatal heart attack 31% RRR
• Fatal or nonfatal stroke 28% RRR
• Urgent revascularization 35% RRR
• Hospitalization for unstable angina 32% RRR
• Total mortality, nonfatal heart attack or nonfatal stroke 23% RRR
• The clinical benefits shown above were consistent and equal in patients regardless of median triglyceride levels. i.e., it didn’t matter if the patient was in the current VASCEPA hypertriglyceridemia indication (very high; >500 mg/dl, or (high: between 150-499 mg/dl)
• REDUCE-IT is the first CVD outcome trial to show preventative efficacy in both primary and secondary endpoints
WHY AM I WRITING TO YOU?
1) To Inform the committee about the clinical benefits of VASCEPA as demonstrated by the REDUCE-IT Study results.
2) To bring to the committee’s attention that VASCEPA has no clinical or chemical equivalence and should be the preferred drug (not LOVAZA) in your formulary for the current hypertriglyceridemia indication. Furthermore, the study proved that CVD Risk Reduction is not controlled simply by lipid modification and is achieved with VASCEPA regardless of triglyceride levels in the patient. It should therefore be prescribed preferentially to LOVAZA in all cases.
3) Also, of note are two recently completed cardiovascular outcome trials (ASCEND & VITAL) that were conducted with Lovaza as the control arm. These trials failed to show clinical benefit. So, if Lowering Triglycerides with LOVAZA provides no clinical benefit then what’s the point of prescribing it?
It is important that patients with CVD risk factors whether lipids based, or medical history based be prescribed with the appropriate medication for treatment or prevention.
Unfortunately, as you know, the process to educate clinicians, pharmacists and insurance companies is long and arduous. This is my effort to start the process. Until the FDA approves VASCEPA for other indications or expands the current indication many thousands of lives will be lost. Your committee’s forward thinking in covering VASCEPA in the Top Tiers and preferred to other substitutes or equivalents (of which there are none), will make a huge difference in the lives of millions. Personally, my PCP prescribes VASCEPA off label for me and that gives me peace of mind. As to the cost of VASCEPA a 30-day supply of VASCEPA can be obtained with a coupon for as little as $9. A generic version of Lovaza runs about $50. However, keep in mind that “the most expensive drug is the one that doesn’t work.”
Thank You for your consideration and attention."