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Our Take: New Vascepa indication broadens potential use in millions of new patients

Dec 23, 2019

The FDA has approved Amarin Pharma’s Vascepa (icosapent ethyl) as a secondary therapy to reduce the risk of cardiovascular events in adults with elevated triglyceride levels. The FDA said patients who are prescribed Vascepa must also have cardiovascular disease (CVD) or diabetes plus at least two additional risk factors for CVD.

“The FDA recognizes there is a need for additional medical treatments for cardiovascular disease,” said Dr. John Sharretts, acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will give patients with elevated triglycerides and other important risk factors, including heart disease, stroke, and diabetes, an adjunctive treatment option that can help decrease their risk of cardiovascular events.”

Vascepa is a novel compound derived from fish oil. It consists of the omega-3 fatty acid EPA in ethyl-ester form and was previously indicated as an adjunct to diet to lower triglyceride levels in adults with hypertriglyceridemia.

Our Take
This latest approval is big news for a broad cohort of patients, if not a big win for Amarin. In a press release, Amarin noted that Vascepa is the first and only FDA-approved medication for reducing cardiovascular risk beyond cholesterol-lowering therapy in high-risk patients approved for treatment.

Readers may recall that we’ve written about Vascepa previously, regarding positive findings from REDUCE-IT, a global study of 8,179 statin-treated patients with elevated cardiovascular risk. Last September, Amarin reported that patients in the Vascepa cohort had a 25% relative risk reduction in major cardiovascular events — a major finding. The results were subsequently published as a lead article in The New England Journal of Medicine.

Then, in March, Amarin announced that in the same trial, patients in the Vascepa cohort had a 30% reduction in the combined rate of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, coronary revascularization, and hospitalizations for unstable angina.

Vascepa also cut the rate of second events by 32% and the rate of four or more events by 48%.

Now, with the new indication, the drug could be used to treat millions of new patients.

At $250 per month, Vascepa is pricier than your average fish oil, but of course it’s not your average fish oil. (And of course insured patients won’t pay retail.) Two recent independent studies tell its value story.

A study presented last month at the American Heart Association 2019 Scientific Sessions showed that use of Vascepa offers net cost savings for the overall health care system — meaning that the cost of Vascepa was offset by savings from reduced cardiovascular events.

“Icosapent ethyl was a dominant strategy (i.e., cost saving) in 70% of simulations … offering the rare finding of better outcomes at lower health care costs,” the authors wrote. “In probabilistic sensitivity analysis, >85% of simulations indicated that icosapent ethyl would be cost-effective (i.e., below $50,000 per QALY gained) compared with placebo.”

ICER also recently weighed in: “Icosapent ethyl’s annual WAC of $3,699 and estimated rebated price of $1,625 are both significantly lower than ICER’s value-based price benchmark range of $6,300–$9,200 per year.”

Dr. Craig Granowitz, chief medical officer at Amarin, told Medscape: “It is difficult to precisely define the size of the population now eligible for Vascepa, but it is big.”

Amarin says it’s on track to double its sales force to a total of 800 representatives by the beginning of the year. Sales are projected to be between $600 million and $700 million in 2020, but with the new indication, expect Vascepa to achieve blockbuster status sooner than you think.

What else you need to know
This latest approval is big news for a broad cohort of patients, if not a big win for Amarin. In a press release, Amarin noted that Vascepa is the first and only FDA-approved medication for reducing cardiovascular risk beyond cholesterol-lowering therapy in high-risk patients approved for treatment.

Readers may recall that we’ve written about Vascepa previously, regarding positive findings from REDUCE-IT, a global study of 8,179 statin-treated patients with elevated cardiovascular risk. Last September, Amarin reported that patients in the Vascepa cohort had a 25% relative risk reduction in major cardiovascular events — a major finding. The results were subsequently published as a lead article in The New England Journal of Medicine.

Then, in March, Amarin announced that in the same trial, patients in the Vascepa cohort had a 30% reduction in the combined rate of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, coronary revascularization, and hospitalizations for unstable angina.

Vascepa also cut the rate of second events by 32% and the rate of four or more events by 48%.

Now, with the new indication, the drug could be used to treat millions of new patients.

At $250 per month, Vascepa is pricier than your average fish oil, but of course it’s not your average fish oil. (And of course insured patients won’t pay retail.) Two recent independent studies tell its value story.

A study presented last month at the American Heart Association 2019 Scientific Sessions showed that use of Vascepa offers net cost savings for the overall health care system — meaning that the cost of Vascepa was offset by savings from reduced cardiovascular events.

“Icosapent ethyl was a dominant strategy (i.e., cost saving) in 70% of simulations … offering the rare finding of better outcomes at lower health care costs,” the authors wrote. “In probabilistic sensitivity analysis, >85% of simulations indicated that icosapent ethyl would be cost-effective (i.e., below $50,000 per QALY gained) compared with placebo.”

ICER also recently weighed in: “Icosapent ethyl’s annual WAC of $3,699 and estimated rebated price of $1,625 are both significantly lower than ICER’s value-based price benchmark range of $6,300–$9,200 per year.”

Dr. Craig Granowitz, chief medical officer at Amarin, told Medscape: “It is difficult to precisely define the size of the population now eligible for Vascepa, but it is big.”

Amarin says it’s on track to double its sales force to a total of 800 representatives by the beginning of the year. Sales are projected to be between $600 million and $700 million in 2020, but with the new indication, expect Vascepa to achieve blockbuster status sooner than you think.

What we’re reading
Primary Care Spending in the Commercially Insured Population. JAMA, 12.10.19 (subscription required)
MedPAC Chief Expects Waning Support for Medicare’s MIPS. Medscape, 12.13.19 (registration required)
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