The Ministry of Health and Welfare said it would reassess whether choline alfoscerate, a dementia treatment, was worth receiving the national health insurance benefit.
The Health Insurance Policy Review Committee under the ministry said Friday it would review the drug’s reimbursement.
The ministry cited the reasons for the reevaluation as following: the insurance claims have recently increased significantly; no other country grants reimbursement as the drug is used as a health functional food, and the treatment lacks clinical evidence.
The government has registered 229 medicines that use choline alfoscerate as the main ingredient, including Chongkundang Gliatirin Soft Cap. The reimbursement claims for choline alfoscerate surged to 352.5 billion won ($286.1 million) in 2019 from 167.6 billion won in 2016, according to the health and welfare ministry.
Except for Italy, eight advanced countries that Korea refers to a reimbursement decision (U.S., U.K., France, Italy, Japan, Germany, Switzerland, and Canada) do not consider choline alfoscerate a prescription drug.
Also, the agent lacks literature evidence for the overall effectiveness, except for materials for the effect on dementia, given the existing approval conditions and the scope of the reimbursement, the ministry said.
The reevaluation will focus on the evidence-based clinical usefulness of choline alfoscerate, also considering the cost-effectiveness and the social demand, the government said.
The government’s decision came after lawmakers and civic groups requested the review of the drug’s effectiveness.
In August last year, the Korean Pharmacists for Democratic Society criticized the health and welfare ministry for “wasting the national health insurance cost” and requested an audit.
In a parliamentary audit in October, lawmakers pointed out that the agent needed a reevaluation on its clinical usefulness to make health insurance expenses more efficient.
However, the ministry has yet to establish a system to change the financing of health insurance spending by reevaluating a reimbursable drug’s clinical usefulness. The Ministry of Food and Drug Safety’s post-reevaluation system involves in approval, not reimbursement.
The health and welfare ministry said it had established the criteria for a re-evaluation of a drug reimbursement by forming a subcommittee under the Drug Reimbursement Review Committee.