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2026-06-22 12:26:15

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Opinion
[Reporter's View] Restricting vs expanding access
by Eo, Yun-Ho Dec 05, 2024 05:53am
The addition of a post-listing control system seems to be a fixed deal. The establishment of the Drug Performance Evaluation Office under the Health Insurance Review and Assessment Policy Research Institute has already taken place, and government officials have been publicly discussing using RWD (Real-world data) for drugs subject to the exemption from submission of pharmacoeconomic evaluation data. So the key to its implementation will be in the contents of the ‘dialogue.’ Will the system act as another mechanism to lower drug prices and cause much friction, or will it be a reasonable 'uncertainty resolution' device per government claims? Is the PE exemption system necessary? Its need is one question both the government and industry see eye to eye on. Only some academics and civil society organizations are opposed to its need in itself. In Korea's insurance policy environment, the pharmacoeconomic evaluation exemption system is the only way to ensure that the treatments needed by patients with rare diseases and rare cancers are listed for insurance reimbursement. Based on the evaluation results in major HTA countries (UK, Australia, Canada, Germany, and France) of the 37 drugs that have been approved through the PE exemption system, foreign countries either recognize single-arm clinical studies as indirect comparisons or regard the clinical needs of patients and healthcare providers, innovation, and urgency of treatment, to promptly approve drugs even if its cost-effectiveness is somewhat uncertain under the Korean criteria. If the uncertainty about the long-term effectiveness and cost-effectiveness of these new drugs had to be reviewed within the pharmacoeconomic evaluation system, they would have been reimbursed later than other countries or would have remained non-reimbursed. It is true that there is much to discuss, such as the methodology for implementing RWD and who should bear the expense. But as the agenda is already on the plate, it is clear that something has to be done. If so, to address the growing concerns over the rise in PE exemption drugs, a measure needs to be set in place to address the diminishing benefits. The time has come to revitalize the indirect comparisons that the industry has been advocating for so long, compensate for the lower prices of substitutes that have been lowered by years of post-listing control measures, and at least consider a flexible approach to the ICER thresholds. In the same context, the amendments to the ‘Detailed Evaluation Criteria for Drugs subject to Negotiations, including New Drugs,’ which was announced in August need to be finalized and implemented quickly to ensure the provision of benefits. Both sides, those who want to restrict and those who want to extend reimbursement, cannot be satisfied at once. The key is compromise. The fact that more taxes are spent on people with serious illnesses is no excuse to neglect them.

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