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Re: ggwpq post# 355352

Thursday, 09/23/2021 2:11:08 PM

Thursday, September 23, 2021 2:11:08 PM

Post# of 427219
US Strategies:

"We must engage effectively and efficiently with all 4 key stakeholders in the market. Firstly physicians, we continue to inform and reinforce the unprecedented REDUCE-IT results, the broad managed care access that branded VASCEPA is the only available product FDA approved for cardiovascular risk reduction in at-risk patients with elevated triglyceride, that generics do not have an approval for the cardiovascular risk reduction indication, and that the FDA revoke the indication of older triglyceride lowering classes, such as fenofibrates with statin to reduce cardiovascular risk.

Secondly with payors, we continue to make inroads with additional favorable managed care wins and enhancements that help to validate VASCEPA value proposition in persistent cardiovascular risk. Thirdly, pharmacists, we have been working with major national and regional chains to ensure that CV risk patients obtain proper FDA approved VASCEPA. Many of these major chains have confirmed significant difficulties and disruption as a result of limited inconsistent supply of generic IPE. This disruption has not only caused patients to leave the pharmacy without needed medication, but the pharmacy retailers have faced lost sales.

In addition, we are working diligently within the total prescribing ecosystem to ensure that all references such as the key compendia retail pharmacy systems and e-prescribing platforms used by HCPs accurately reflect the VASCEPA cardiovascular risk reduction indication. And importantly, understand that the generic products do not share this indication, and are limited to lowering triglyceride in patients with triglycerides equal to or above 500 milligram per deciliter, which is effectively less than 10% of the patients in need of VASCEPA.

Finally, with persistent CV risk patients, we are working to efficiently educate patients about the benefits of VASCEPA to drive patients to ask their doctor about VASCEPA, especially when they search out information on statins triglyceride CV risk reduction. We also inform them that VASCEPA is widely covered by Medicare and commercial providers, and that our $9 for 90-day supply copay program for commercially insured patients is still available to them."
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