After stumbling in the all-important U.S. market, struggling Amarin has scored a needed win overseas.
The National Institute for Health and Care Excellence (NICE), the U.K.'s pricing watchdog, has endorsed Vazkepa for about 425,000 patients with elevated levels of triglycerides, a type of blood fat. In making the decision, the agency cited data showing that in certain patients, the drug lowered the risk of serious cardiovascular events such as heart attacks or strokes by more than 25% compared with placebo.
Per NICE's backing, only patients with elevated triglycerides alongside cardiovascular disease and whose LDL-cholesterol isn't controlled by statins will be able to receive the drug.
In a statement, NICE’s interim director of medicines Helen Knight said the agency worked with Amarin to identify the patients most likely to benefit, “striking a balance between effectiveness and the best use of public funding.”
In the U.K., Amarin’s medicine costs 144.21 pounds sterling per pack of 120 capsules, NICE documents show.
For Amarin, the decision brings a needed win. The U.K. has often served as a “reference market" on drug cost reviews in Europe, Amarin CEO Karim Mikhail said in a statement, so the NICE decision is a “major step toward unlocking the company’s multi-billion-dollar revenue opportunity outside of the U.S.”
But it comes after Amarin suffered a damaging defeat in the U.S. market. Earlier this week, Amarin said it was cutting 65% of its overall workforce in the country as early generics continue to take a toll on its drug's viability there. That move came less than a year after Amarin said it would cut its U.S. sales team from 750 reps to 300 and shift its focus to digital marketing.
In the U.S., Amarin’s Vescepa scored its original FDA nod back in 2012 to reduce triglyceride levels in adults with severe hypertriglyceridemia. In 2019, the drug won a coveted label expansion to reduce risk of cardiovascular events in patients with elevated triglycerides.
The company had big plans for the U.S. launch, but those were derailed after Amarin lost a key patent, which allowed a generic from Hikma to enter the U.S. market in late 2020.
Amarin reacted by shifting its U.S. strategy to digital and placing more emphasis on Europe, but now the company is cutting its U.S. commercial team by 90% compared with pre-generic levels.
Last month, Amarin reported $96 million in first quarter sales of its key med, a 33% drop from the same period in 2021.