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The Korean public body that decides whether national health insurance should pay for a new cancer drug, by judging how well it works and whether it is worth its price.
HIRA reviews what providers bill to the National Health Insurance and assesses whether medicines, procedures and devices should be covered by it. Its English pages describe the drug route: a company with an MFDS-approved drug applies for coverage, HIRA's Pharmaceutical Benefit Assessment Committee assesses clinical efficacy and cost-effectiveness, and the price of a newly listed drug is then negotiated between the company and the National Health Insurance Service. Cancer drugs are first considered by HIRA's cancer disease deliberation committee (암질환심의위원회), which sets the criteria for when a drug is reimbursed.
HIRA's detailed evaluation rules state that it uses no explicit cost-effectiveness threshold, judging each case against earlier decisions in the light of severity, burden of disease, quality of life and innovation; an amendment in August 2024 wrote down three conditions, all of which must be met, for a new drug to be judged innovative enough for flexible treatment of its ratio. Each December HIRA publishes the range of the incremental cost-effectiveness ratios it accepted over the previous five years. As reported by the trade press, anticancer drugs evaluated in 2019 to 2023 had a median of 39.93 million won per quality-adjusted life year and a maximum of 47.92 million won, and those evaluated in 2020 to 2024 a median of 42.94 million won and a maximum of 55.36 million won, the first time the maximum in the series HIRA has published since 2022 passed 50 million won.
The listed price of a new cancer drug in Korea is often not the price the insurer pays: the difference sits in a confidential contract. That has made more drugs available, but it means the public cannot see what is being paid or whether the drug delivered what was promised.
In this period a new cancer drug typically took about three years after approval to be covered by Korean insurance, and the faster route was a lower price.
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