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By Himani Jaiswal

This Expert View analyzes the key clinical and economic rationales affecting the agency’s decisions on the benefit assessment across 15 oncological indications published by HIRA in the last 5 years (2015 - 2019).

In South Korea, drug reimbursement decision-making is done by Health Insurance Review Agency (HIRA) based on the potential role and use of the medicine in the context of the country’s national health system. Understanding this market allows pharmaceutical manufacturers to plan clinical trials and evidence submission in South Korea for oncology products and gain quicker market access. South Korea represents an important market for industry because of its advanced economy and sizeable population. However, the country’s implicit cost-effectiveness thresholds may lead to either lack of reimbursement or requirement for a risk-sharing agreement that limits South Korea’s financial risk. Understanding the evidence requirement by the reimbursement agency for clinical and economic decision-making could possibly result in quicker patient access to innovative treatments and hence would benefit overall public health.

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