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2026-03-12 07:27:40

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‘Improve rare disease designations standards for equity'
by Lee, Jeong-Hwan Mar 07, 2023 05:38am
The claim that Korea’s rare disease designation standards should be improved and expanded to ease the disease burden borne by patients from drug costs, etc. The request arose with the rising need to address the irrationalities in the current rare disease designation system, such as those from the unclear diagnostic criteria set due to the extremely small number of patients or irrational standards set for acquired (secondary) rather than congenital diseases. On the 6th, Professor Hyun-Young Kim of Pediatric Surgery at Seoul National University Hospital claimed so during her presentation at the ‘Discussions for a national measure to manage life-threatening rare diseases’ that was held at the Members' Office Building of the National Assembly. The meeting was hosted by Rep. Sun-Woo Kang of the Democratic Party of Korea. Professor Kim's presentation was about ‘Limitations in the designation of rare diseases and application of special calculations.’ The Rare Disease Management Act defines a rare disease as a ‘disease that affects fewer than 20,000 people, or whose number of carriers is unknown because diagnosis of the disease is difficult, which is determined according to the procedures and standards prescribed by Ordinance of the Ministry of Health and Welfare.’ Most treatments for diseases that are designated as rare diseases can be applied the special calculation system, which allows the patient’s coinsurance rate to be reduced to 10% of all medical expenses. Due to this, the burden of treatment and drug expense among rare disease patients whose condition has not been designated as a rare disease increases significantly and is excluded from legal support Regarding the limitations in rare disease designations, Kim pointed out that there is a gap between the definition and designation of a rare disease, and the problem of equity in designation and non-designation exists even in the same disease depending on whether the condition is congenital or acquired. Also, she raised the issue of how patients with secondary conditions that suffer the same symptoms, disease burden, and pain as the congenital condition are not allowed designation as a rare disease. Professor Kim said, “It is necessary to designate rare diseases after comprehensive consideration of the characteristic of the disease, the pain suffered by the patients, and its effect on the quality of life. The authorities should provide ample opportunity for relevant academic societies and patient groups to submit opinions and actively review the designations.” As an example, Professor Kim pointed to short bowel syndrome to point out the issues that exist in Korea’s rare disease designation system. Short bowel syndrome is not designated as a rare disease as it affects over 20,000 patients and is an infectious and transient condition with a low socioeconomic cost. Also, the fact that it is a secondary disease and has unclear diagnostic criteria and diagnosis was also a reason for its non-designation as a rare disease. In other words, patients with congenital short bowel syndrome can receive special calculation benefits for their treatment expense with a rare disease designation, but patients with acquired short bowel syndrome are deprived of the same benefit. This non-designation of rare diseases has led to the non-application of reimbursement for a short bowel syndrome treatment. In Korea, teduglutide was approved to treat short bowel syndrome in 2018. However, the drug is unavailable for use due to its non-reimbursement. Without reimbursement, the drug costs KRW 50 million with 3-6 month administration, and KRW 100 million with 1-year administration. Professor Kim stressed, “In Korea, if the doctors work hard and save the patients, the patients cannot receive the benefit as they exceed the rare diseases designations standards. The standards need to be improved to provide benefit to these rare disease patients who are left unattended in the blind spot."

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