Amarin scores much-needed NICE win for cholesterol drug

June 13, 2022

The UK’s National Institute for Health and Care Excellence (NICE) has agreed to cover Amarin’s cholesterol drug, Vascepa, amid rough times for the Dublin-based company.

The decision means that Amarin's only marketed drug, which will be known as Vazkepa in the UK, will be recommended for reimbursement and use across the National Health Service (NHS) in England and Wales to reduce the risk of cardiovascular events in certain adult statin-treated patients at high cardiovascular risk. The price for 120 soft capsules — a 30-day supply — was set at $181.

“This is another important step forward in successfully executing our European growth strategy, and considering that the UK has historically served as a reference market with regard to Health Technology Assessments, it is a major step toward unlocking the company’s multi-billion-dollar revenue opportunity outside of the U.S.," said Karim Mikhail, Amarin's president and CEO.

The good news follows last week's announcement that the struggling Amarin planned to cut its workforce in the U.S. by 65% in a restructuring plan designed to reduce operating costs by approximately $100 million over the next year.

In recent years, the pharma industry has been testing the waters with prescription omega-3 treatments. Investors had high hopes for Vascepa, especially following the drug's 2019 approval expansion, which made the treatment the first and only drug approved to reduce cardiovascular risk among patients with elevated triglyceride levels — and greatly widening the treatment population. Analysts anticipating the FDA’s favorable decision on Vascepa’s label expansion had been abuzz about a potential buyout of the small biopharma company, with several big names in pharma on the possible suitor list.

However, after a huge first-quarter revenue bump, Amarin hit a snag this 2020, losing a patent trial against two generic drugmakers. This ruling subsequently cleared the way for Hikma Pharma’s approval for a generic version of Vascepa. Amarin found itself in a sea of litigation challenging the patent decisions, but ultimately three generic versions of the drug have entered the U.S. market.

NICE’s final guidance on Vazkepa is expected to be published in mid-July, after which all local NHS formularies are expected to make the product available within three months.

>>>>>Read more about prescription Omega-3s. Beyond the surface: For pharma, the omega-3 fatty acid waters could run deep