Biz Chosun
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.
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