Labeling changes for Vascepa? Who will now pay for the drug?

Have you heard about the REDUCE-IT study?

For those attending the American Heart Association meeting in Chicago By James Joseph Rybacki, Pharm.D. 1/8/19

On November 10-14 2018, you could have heard a pin drop in the large conference room when Dr. Deepak Bhatt presented the results. The results showed a relative risk reduction of 25% in Major Cardiac Adverse Events (MACE). This study looked at more than 8,000 people who were already taking statins, had heart disease and may also have been diabetic.

It’s not my first rodeo and even I was impressed by these results. Interestingly, many of you know I have a history of heart disease and suffered an early heart attack in 2005. Despite this, and despite the new REDUCE-IT data, my insurance carrier REFUSED to pay for Vascepa, although my doctor sent in two requests saying that the medicine was warranted.

The problem stems from the product labeling (although huge numbers of prescriptions are written off-label in the US). Who will pay for the drug? For now, me. I have been absorbing the two hundred dollar expense because I think that the data are simply that good. Will the label for Vascepa change? This remains a decision for the FDA. In the interim, I think US insurance companies who attempt to deny heart patients this valuable medicine are short sighted and are WRONG. We have a new video on Vascepa on www.EssentialGuideToPrescriptionDrugs.com.

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