This article was published on May 15, 2025, at 5:17 p.m. on the ChosunBiz RM Report site.
The government is considering measures to lower the health insurance coverage threshold for the medical cannabis compound used in epilepsy treatment, "Epidiolex." The main focus is to expand the types of eligible diseases from two rare and intractable epilepsy disorders to three, and to relax the stringent requirement that patients must have used a certain number of existing epilepsy treatments to qualify for insurance coverage.
According to the medical community on the 15th, the Ministry of Health and Welfare has started reviewing a proposal for revising the coverage criteria for the medical cannabis treatment Epidiolex, which was reported by the Health Insurance Review and Assessment Service (HIRA) last month. Previously, HIRA held an expert advisory meeting and prepared a proposal for changing the coverage criteria. The Ministry plans to announce the final revision after discussions.
Epidiolex is an epilepsy treatment developed from cannabidiol (CBD) extracted from the flowers and leaves of the cannabis plant by the British pharmaceutical company GW Pharmaceuticals. CBD relieves pain without being addictive and suppresses excessive excitement, as well as enhances the function of gamma-aminobutyric acid (GABA) receptors in the brain, reducing seizures.
Epidiolex received approval from the U.S. Food and Drug Administration (FDA) in 2018, making it the first CBD medication to gain such approval. Clinical trial results showed that Epidiolex reduced seizure frequency by over 50% in patients with pediatric rare and intractable epilepsy, including "Dravet syndrome" and "Lennox-Gastaut syndrome." The FDA also approved its use for "tuberous sclerosis," which has the highest number of patients, in 2021.
Epidiolex was also approved in South Korea in 2019. The Ministry of Food and Drug Safety regulates that Epidiolex can be imported through the Korea Rare and Essential Drugs Center only for patients with rare and intractable epilepsy, including Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis.
However, very few patients benefit from insurance coverage. The stringent criteria for recognition of coverage create significant realities of difficulty among patients and guardians.
The cost of a single bottle of Epidiolex exceeds 1.2 million won, resulting in monthly expenses that surpass 3 million won. As a result, the government has applied health insurance coverage since 2021 to reduce the burden on patients, lowering the cost to about 200,000 won per bottle.
HIRA designated only Dravet syndrome and Lennox-Gastaut syndrome among the three diseases for which Epidiolex is approved as eligible for coverage. These two diseases account for less than 10% of all epilepsy patients. Many more patients with tuberous sclerosis still have to receive treatment without insurance coverage. Tuberous sclerosis is a hereditary rare disease often accompanied by neurological symptoms such as seizures.
There is one more barrier to coverage. To be eligible, patients must demonstrate that they have used five or more of 11 existing epilepsy medications and that their seizure frequency has not reduced by more than 50%. Guardians state that "it often takes years to try five harsh medications, and in the process, there are many instances where children cannot endure the side effects."
At a recent advisory meeting held by HIRA, neurologists and experts from the Epilepsy Society gathered in agreement that regulations should be relaxed to benefit more patients. They agreed to expand the eligible diseases to all three approved diseases, including tuberous sclerosis, and to reduce the proof standard for the failure of existing drugs for Dravet and Lennox-Gastaut syndromes from five to three. The proof standard for the failure of existing drugs for newly added tuberous sclerosis is five.
Experts welcomed the proposed changes. Hong Seung-bong, honorary president of the Korean Epilepsy Society (Director of Gangnam Bedoro Hospital Neurology), noted, "Epidiolex is a proven medication that significantly reduces seizure symptoms in epilepsy patients," and added, "If this proposal is implemented as is, the number of patients who will benefit is expected to increase."
However, Hong expressed concern over the deteriorating financial conditions of the national health insurance system. He said, "Through the domestic production of CBD, we need to reduce the burden on health insurance and the public so that more patients can benefit from fundamental regulatory reforms."
Worldwide, there are 65 million epilepsy patients, with around 500,000 in South Korea. Repeated epilepsy seizures can cause inflammation in the brain and damage to nerve cells, and CBD also plays a protective role for nerve cells due to its anti-inflammatory effects. Medical cannabis undergoes a purification process that reduces the tetrahydrocannabinol (THC) component, which induces hallucinations and addiction, to less than 0.3%.