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2026-04-13 01:42:36

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Policy
Discord in system hinder coverage of rare disease drugs
by Lee, Jeong-Hwan Jan 18, 2022 06:06am
A suggestion has been raised that it is irrational for a drug that received an orphan drug designation to be ineligible for insurance benefits that were set for rare disease treatments to improve patient accessibility because its disease was not designated as a rare disease or set for special exemption of calculation. In other words, the treatment and disease burden born by the patients are worsening because the tools for orphan drug reimbursement evaluations such as the risk-sharing agreement system (RSA) and the pharmacoeconomic evaluation exemption system cannot be applied due to discord between the designation of orphan drugs and rare diseases, and this issue must be resolved. In particular, the benefits of reimbursement tools such as the RSA are too concentrated on anticancer drugs, leaving orphan drugs to be neglected from the system. Criticism also followed that the national orphan drug policy is more focused on providing convenience to the administrative system rather than being patient-focused in its operations. On the 17th, Jong Hyuk Lee, Professor of Chung-ang University’s College of Pharmacy, wrote so in a special column of ‘Angel Spoon,’ a magazine published by the Korean Organization for Rare Disease. Professor Lee argued that Korea should spend more on rare drugs as the current rate falls much below the global rate. As of 2018, Korea spent 370 billion won on rare disease drugs, which is 2.1% of its total drug expenditure. The global rate of expenditures on rare disease drugs exceeds 14%. Lee added that there is a need to improve the reality that stops patients from benefitting from systems that can reduce their medical costs, such as the RSA and the pharmacoeconomic evaluation exemption system that are in place in Korea. Patients cannot receive these benefits if their condition is not designated as a rare disease. Even if a drug is designated as an orphan drug used to treat rare diseases, the drug may not go through the RSA or pharmacoeconomic evaluation exemption track when undergoing evaluation for reimbursement benefits if its indicated disease is not recognized as a rare disease. This in turn triggers failure in reimbursement and increases the burden borne by patients. Also, the operation of the NHI coverage enhancement policy is too focused on anticancer drugs, harming the reimbursement of rare disease drugs in the process. 78%, or 32 of the 41 drugs that are applied RSA, a system that plays the biggest role in enhancing coverage of new drugs, were anticancer drugs. Another issue that was raised was that the system for rare disease drugs was designed to convenience government ministries rather than the patients. Orphan drug designation/approval is carried out by the Ministry of Food and Drug Safety; rare disease designation/ insurance registration/ special exemption of calculation by the Ministry of Health and Welfare and operated by the Korea Disease Control and Prevention Agency, the Health Insurance Review and Assessment Service, and the National Health Insurance Service; medical expenses support by each city/town/district; and the catastrophic medical expense support project operated by NHIS, rendering the processes too complicated for patients to follow. In the column, Lee emphasized that we need to expedite the approval of rare disease treatments to increase accessibility for the patients and increase special systems like the pharmacoeconomic evaluation exemption system for such diseases in the course of granting their reimbursement. Also, Lee added that social discussion should be held on diversifying finances for the coverage of rare diseases that are mainly sourced by NHI finances by raising funds for rare diseases, etc. Lee said, “We need to carefully examine whether any patients are left neglected due to institutional issues that create gaps between the designation of rare diseases and orphan drugs. The entities that operate such systems for rare diseases vary and the procedures are also very complicated. Therefore, the system should move away from such convenience-focused administrative practices and become more patient-centered.”

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