韩国医保机构推进胆碱阿法酯药品报销追缴审查

Health authorities are accelerating their scrutiny of "choline alfoscerate," a brain function improvement drug that has formed an annual prescription market of around 600 billion won. As the Ministry of Food and Drug Safety has begun reviewing the first results of a clinical reevaluation submitted by pharmaceutical companies, the National Health Insurance Service (NHIS) has also launched a working review to enforce conditional clawbacks.
According to the industry on the 26th, the NHIS recently held an internal working meeting on the theme of clawing back reimbursements for choline agents. As five years have passed since it signed conditional clawback contracts with pharmaceutical companies, the service appears to have reviewed the contract terms of each company and the scale of clawbacks that would be required if enforcement takes place. An NHIS official said, "It is true that a meeting was held on the theme of choline agents," adding, "We plan to proceed with future procedures depending on the results from the Ministry of Food and Drug Safety."
The Ministry of Food and Drug Safety also plans to coordinate the schedule of the Central Pharmaceutical Affairs Advisory Committee after reviewing the companies' materials. This is to decide whether to maintain the indications, now that the clinical results for choline agents have been submitted.
After a controversy over the efficacy of choline agents emerged, the Ministry of Food and Drug Safety in 2020 required pharmaceutical companies to prove efficacy through clinical trials, and the NHIS signed conditional contracts to claw back 20% of the reimbursement amount if proof failed.