Independent Drug-Pricing Assessment Finds Vascepa Cost-Effective as an Adjunct to Statins in Treating Patients at High Risk of Cardiovascular Events, such as Heart Attack, Stroke and Cardiac Death
Posted on October 17, 2019 by Medtech[y] Staff
Amarin Corporation plc (NASDAQ: AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that an independent organization that evaluates pricing of prescription drugs has issued its final report assessing the cost-effectiveness of Vascepa (icosapent ethyl) capsules. The final assessment confirms the cost-effectiveness of Vascepa across all the non-profit organization’s analyses, including its most stringent criteria.1
The review was derived from results of the landmark phase 3 clinical trial REDUCE-IT®2, focusing on the clinical benefit-risk profile of Vascepa and its value as an additive therapy for cardiovascular disease. The conclusion from the report is that Vascepa easily meets “commonly cited thresholds for cost-effectiveness and therefore represent a high long-term value for money,” based on the organization’s value assessment framework.3
“We are proud to have priced Vascepa to be cost-effective, and we appreciate this positioning being recognized by third-parties,” said Craig Granowitz, M.D., Ph.D., chief medical officer, Amarin. “However, despite the report’s positive conclusion that Vascepa is cost-effective, we believe that it understates the true value of Vascepa. For example, the report’s base-case analyses reflect only the costs of heart attack, stroke and cardiovascular death and exclude other high costs associated with other cardiovascular events demonstrated to be lowered by Vascepa in the REDUCE-IT cardiovascular outcomes study (e.g., revascularization procedures and hospitalization for unstable angina) as well as lower rates of recurring cardiovascular events in patients treated with Vascepa during the study.”
Another Cost-Effectiveness Analysis of Vascepa to Be Presented at AHA
A separate independent, academic cost-effectiveness analysis of Vascepa based on patient-specific data from the REDUCE-IT study will be presented at the American Heart Association Scientific Sessions 2019 on November 16 by William S. Weintraub, M.D., Director of Outcomes Research, MedStar Cardiovascular Research Network. Amarin provided an unrestricted grant for this academically driven analysis, titled “Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT.”
Cardiovascular Disease, an Urgent Public Health Issue
“There is no doubt that cardiovascular disease is an urgent and growing public health issue, with more than half of U.S. adults impacted,” Dr. Granowitz added. “The U.S. spends approximately $555 billion on cardiovascular disease each year, and it is projected that these direct and indirect costs could increase to more than $1.1 trillion by 2035.4 Amarin has worked for over a decade to develop and test Vascepa to create a new preventative care solution that will potentially help many of our family, friends and neighbors within this population. Our goal is to make Vascepa accessible to as many patients as possible who can benefit.”
Vascepa is currently approved in the United States as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Amarin has submitted a supplemental new drug application (sNDA) to the U.S. FDA for a label expansion based on the REDUCE-IT study results showing reduction of cardiovascular events in high-risk patients. The Prescription Drug User Fee Act (PDUFA) target action date set by the FDA to act on the sNDA is December 28, 2019. Assuming FDA approval, Vascepa is positioned to become the first drug indicated to reduce persistent residual cardiovascular risk in statin-managed patients with elevated triglycerides (135 mg/dL or greater) and other risk factors for cardiovascular disease. The approval of such label expansion and the wording of the indication statement is under regulatory review.
Today, many insurance plans, or payers, already broadly cover Vascepa. Upon assumed FDA label expansion, Amarin plans to use the results of the REDUCE-IT study, further objective health-economic analyses, and other medical information and data in negotiations with payers to seek expanded Vascepa insurance coverage.