The Ministry of Food and Drug Safety has requested drugmakers to submit efficacy data of choline alfoscerate drugs to consider re-classifying them as health functional food. To date, choline alfoscerate has been a prescription drug for dementia treatment.
A change in the classification of choline alfoscerate would have a significant impact on the pharmaceutical companies because they received over 270 billion won ($233.1 million) from the government in insurance claims for the agent last year.
The food and drug safety ministry recently sent a notification to pharmaceutical firms, saying it was reviewing whether it should take a measure related to the efficacy of choline alfoscerate. The regulator requested the companies to submit related data by Nov. 11.
Materials the ministry requested include data demonstrating the efficacy of choline alfoscerate as approved, domestic and foreign use status, comments on changes to licensing approval conditions and proposed changes to the license (draft), and general opinions on the agent’s effectiveness and the company’s plan.
“If companies do not submit the relevant materials by the due date without any specific reason, we will take action according to the result of the comprehensive review,” the ministry said.
Choline alfoscerate won the nod as a treatment for cognitive improvement. However, many have questioned whether it was necessary to designate it as a prescription drug. In most countries, including the U.S., the agent is being sold as a health functional food.
Critics said classifying it as prescription medicine in Korea was a waste of the national health insurance cost.
In a parliamentary audit in October, choline alfoscerate was at the center of the controversy.
Lawmakers pointed out that the agent needed a re-evaluation on its clinical usefulness and efficacy and that the government should revise the criteria for reimbursement for choline alforscerate.
In response, the Ministry of Health and Welfare said it would re-assess the reimbursement of the drug.
Not only the health and welfare ministry, but the food and drug ministry started reviewing the efficacy of the agent. The pharmaceutical industry is paying attention to whether the authorities will re-classify it from a prescription drug to a health functional food.
In Korea, Daewoong Bio’s Gliatamin and Chong Kun Dang’s Gliatilin account for about 70 percent of the choline alfoscerate market
As the sales license agreement over the original drug Gliatilin between Daewoong Pharmaceutical and the drug developer Italfarmaco expired, Chong Kun Dang bought the license and is selling it under the brand name Gliatilin.
Daewoong and Chong Kun Dang once fought for reference-listed drug (RLD) status for Gliatilin.