Patients with sleep disorders in Korea face limited treatment options due to drug pricing system

Patients with sleep disorders such as narcolepsy, insomnia, restless legs syndrome, and REM sleep behavior disorder are missing out on effective treatment options due to the Korean drug pricing system.

Global pharmaceutical companies are increasingly choosing not to apply for licenses in Korea, and drugs that were once covered by health insurance are being removed from the market due to pricing issues, creating a form of reverse discrimination. 

And this is not just a problem for multinational pharma.

Korean drugmaker SK Biopharmaceuticals has also developed effective treatments for narcolepsy, but it sells them only outside of Korea.

“Sleep disorders are serious conditions that can lead to a variety of health problems, including cardiovascular diseases, metabolic diseases, dementia, and mental health issues,” said Professor Jun Jin-sun, of the Department of Neurology at Kangnam Sacred Heart Hospital and public relations director of the Korean Sleep Research Society. “However, the importance of sleep disorders is still overlooked in Korea, and patients are increasingly unable to receive adequate treatment due to insurance coverage issues and the phenomenon of global pharmaceutical companies excluding Korea from product launches.”

In recent years, the introduction of innovative new drugs in Korea has been delayed, and existing treatments have not been covered by insurance, increasing the burden on patients, Jun noted. Even some existing treatments have been withdrawn from the market due to price issues. Some companies are even discontinuing supply due to low drug prices in the Korean market.

According to Jun, insomnia is one of the most common sleep disorders, and most people rely on benzodiazepine and non-benzodiazepine sleep medications. However, these drugs are difficult to use long-term due to side effects such as dependence, memory impairment, and daytime drowsiness.

Therefore, internationally, dual orexin receptor antagonists (DORAs) such as suvorexant, lemborexant, and daridorexant are used because they are less addictive and help restore a more normal sleep structure. However, these drugs are not yet licensed in Korea, let alone covered by insurance.

For restless legs syndrome, which affects about 7 percent of the Korean population, the 2016 treatment guidelines recommend the alpha2-delta ligands pregabalin and gabapentin as first-line treatments, instead of dopamine agonists, which may worsen symptoms with long-term use. However, pregabalin and gabapentin are not covered by health insurance, leaving patients to pay hundreds of thousands of won per month for these medications.

Wakix (pitolisant), a treatment for the rare disease narcolepsy, was withdrawn from the Korean market on Sept. 16, 2024, after the drugmaker voluntarily revoked its license. Unlike other stimulant-based treatments, Wakix induces wakefulness by modulating histamine H3 receptors. It is the only drug effective against both daytime sleepiness and tonic-clonic seizures simultaneously, and has been prescribed to patients who experience side effects from other medications.

However, the pharmaceutical company stopped supplying the drug because the domestic price was “too low” compared to the global market. In France, where it is available at a relatively low price, it costs more than 10,000 won, but in Korea, it is priced at only 2,500 won under health insurance.

The problem is that for narcolepsy patients, there is no substitute drug with the same ingredients, leaving a gap in treatment. While the drug can be imported individually through the Korea Orphan and Essential Drug Center (KOEDC), the cost for patients is several times higher.

For REM sleep behavior disorder, clonazepam and melatonin are available for treatment. However, clonazepam carries a high risk of side effects such as falls, cognitive decline, and dependence, which requires caution in older adults. Melatonin is recommended as a safer alternative due to its lower risk, especially in the elderly. However, it is not reimbursed by insurance, making it costly for patients who need ongoing treatment, according to Jun.

Treatment is not the only thing that sleep disorder patients are struggling with. 

“In the case of polysomnography, which has been covered by health insurance since July 2018 to diagnose sleep apnea and hypersomnia, health insurance has recently been applied to patients with obstructive sleep apnea, improving treatment outcomes. However, central sleep apnea, which can impact survival rates in severe conditions like heart failure, stroke, and chronic kidney failure, is not covered by health insurance. This has led to blind spots in diagnosis and treatment,” said Jun.

Access to treatment for various sleep disorders is limited, according to Jun. To address the blind spots in the treatment of sleep disorders, she emphasized the need for the government to expand insurance coverage for treatments and provide practical support to patients so they can continue their treatment without interruption.