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KMID : 1154920230180020185
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Korean Journal of Insurance Medicine
2023 Volume.18 No. 2 p.185 ~ p.195
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Kim Eun-Seog
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Abstract
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Purpose: Since 2012, Pre-approval system for drug was introduced and become the one of pathways for reimbursement of high-price drugs. The purpose of this study is to analyze the review results of all submitted patients’ cases and changes
through this system over the past 10 years and to find areas for improvement.
Materials and Methods: This study is a retrospective, historical analysis study, and analyzes the pre-deliberation results of all patients based on the monthly review result data officially announced by Health insurance review and assessment service (HIRA) from 2012 to 2022. For each patient, age, gender, disease, and dugs requested to review, whether initial or extended review was passed, etc. were investigated. The approval rate for each drug, disease, initial review, and extended review was analyzed.
Result: From 2012 to 2022, five drugs for four indications (Paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, hypophosphatasia, spinal muscular atrophy) were being prescribed to patients through this system. In the
treatment initiation review, more than 60% of cases were approved and treated for all indications except atypical hemolytic uremic syndrome (aHUS). aHUS was relatively difficult to access with 20% of an initial approval rate (45 out of 220
cases). It was also confirmed that most of the appeals against the review results were rejected (14 out of 17 cases rejected through 2022).
Conclusion: HIRA’s pre-approval system has been established as a reasonable administration system for high-cost drugs over the past decade. It is also becoming an important option for several newly introduced rare disease drugs. It is necessary to be improved that the approval rate for each drug varies greatly and that the process for objecting and re-submitting for rejected patients’ cases.
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KEYWORD
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Rare diseases, Prior authorization, High-cost drug, Paroxysmal nocurnal hemoglobinuria, Atypical hemolytic uremic syndrome, Spinal muscular atrophy, Hypophosphatasia
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