Amarin has earned a much-needed triumph internationally after faltering in the crucial US market. Vazkepa has been approved by the National Institute for Health and Care Excellence (NICE), the United Kingdom’s pricing watchdog, for around 425,000 people with high triglyceride levels, a form of blood fat. The agency based its decision on statistics indicating that the medicine reduced the risk of major adverse cardiovascular events such as heart attacks or strokes by much more than 25% in some individuals when compared to placebo.
According to NICE, only individuals with increased triglycerides who also have cardiovascular disease or whose LDL-cholesterol isn’t managed by statins will be eligible for the medicine.
NICE’s interim director of pharmaceuticals, Helen Knight, said in a statement that the organisation collaborated with Amarin to select the patients who would benefit the most, striking a balance between efficacy and the optimal use of public funds. According to NICE documents, Amarin’s medicine costs £144.21 for nearly every box of 120 capsules in the United Kingdom.
The ruling provides Amarin with a much-needed victory. According to Amarin CEO Karim Mikhail, the U.K. has historically functioned as a “reference market” for medication cost evaluations in Europe, and thus the NICE ruling is a significant step toward unleashing the company’s multibillion-dollar source of revenue outside of the United States. However, it follows after Amarin’s devastating loss in the US market. Amarin announced earlier this week that it would be laying off 65% of its personnel in the country as premature generics continue to wreak havoc on its drug’s sustainability in the country. Amarin said less than a year ago that it would reduce its US sales force from 750 to 300 people and focus on digital marketing.
Vescepa, developed by Amarin, received FDA approval in 2012 to lower triglyceride levels in people with severe hypertriglyceridemia. The medicine received a coveted label expansion in 2019 for lowering the risk of cardiovascular events in subjects with elevated triglycerides. Amarin’s grandiose ambitions for the US launch were thwarted when the business lost a critical patent, allowing a generic from Hikma to hit the market in late 2020.
Amarin replied by moving its US strategy to digital and concentrating more on Europe, but the business is now slashing its US commercial team by 90% compared to the pre-levels. Amarin posted $96 million in first-quarter sales of its major drug last month, down 33% from the same period last year.