Cenobamate, an epilepsy drug developed by South Korea’s SK Biopharmaceuticals and sold under the brand name Xcopri, has been making strides in the U.S. but is unavailable in Korea. The drug generated 105.2 billion won in U.S. sales in the second quarter of this year, up 66% from a year ago, marking the first time its quarterly sales have surpassed the 100 billion won mark.
Since its U.S. launch in May 2020, Cenobamate’s total U.S. sales have reached 726.3 billion won ($530 million) over the past four years, with 270.8 billion won in sales last year alone, according to SK Biopharmaceuticals on August 13.
Cenobamate has gained recognition in the U.S. as a game changer in the treatment of epilepsy, a brain condition that causes recurring seizures, particularly for patients who have not responded to other medications. Despite its success as one of the most effective epilepsy treatments in the U.S., Cenobamate is not yet available in Korea. Korean patients have been demanding the drug be imported from the U.S.
Although Cenobamate was approved by the U.S. Food and Drug Administration (FDA) in November 2019 and the European Medicines Agency (EMA) in January 2021, it has not even been submitted for approval at home. The official explanation for the delay is the incomplete clinical trials on Asian populations. But industry insiders believe that the real issue lies in the notoriously low pricing of new drugs in Korea. Pharmaceutical companies are reluctant to launch new drugs in Korea first because their prices in other countries are usually set based on lower Korean prices.
The price of new medication in Korea is about half the average of OECD countries, largely due to government efforts to lower drug prices to reduce the financial burden on patients. While lower prices can benefit patients in the short term, it can also delay the introduction of new treatments in Korea. Launching a new drug at a low price in Korea can put the company at a disadvantage in price negotiations in other markets, which is why many pharmaceutical companies prioritize other countries over Korea.
“Cenobamate is priced between 50,000 and 60,000 won per pill in the U.S., while in Europe, the average price is 7,000 to 9,000 won. In Korea, it is estimated to cost just 3,000 won per pill,” said Dr. Heo Kyung, chairman of the Korean Epilepsy Society and professor of neurology at Severance Hospital. He warned that such low pricing could exacerbate the “Korea passing” phenomenon, where new drugs are introduced last in Korea, ultimately harming patients who need new treatment.
The time it takes for global new medication to be covered by insurance in Korea is 46 months, 11 times longer than in the U.S. (4 months) and more than twice as long as in Japan (17 months), according to the American Pharmaceutical Association. The adoption rate of new global drugs within a year in Korea is only 5%, far below the OECD average of 18%. “Policies hindering the introduction of new drugs are leading both global pharmaceutical companies and Korean companies to overlook the domestic market,” said an industry insider.
This issue is not unique to Cenobamate. Other innovative treatments developed by Korean companies have faced similar obstacles. Sivextro, an oxazolidinone-class antibiotic developed by Dong-A ST, was approved by the FDA in June 2014 and recorded global sales of $44.6 million last year. Although Sivextro was approved by the Ministry of Food and Drug Safety of Korea in 2015 and listed for health insurance coverage, the company voluntarily withdrew the drug from the domestic market in 2020 after the price was set at just one-third of the U.S. price.
