South Korea’s HIRA reimbursement process works through a structured, multi-agency review that begins after a drug receives marketing authorization and ends with a negotiated price listed on the National Health Insurance (NHI) formulary. The Health Insurance Review and Assessment Service (HIRA) evaluates clinical and economic evidence to determine whether a new medicine qualifies for public reimbursement. The process involves several sequential steps, and understanding each one is essential for pharmaceutical companies planning a market access strategy in South Korea.
Who decides what gets reimbursed in South Korea?
Reimbursement decisions in South Korea involve two main bodies: HIRA and the National Health Insurance Service (NHIS). HIRA conducts the scientific and economic review, assessing whether a medicine offers sufficient clinical value and cost-effectiveness. The NHIS then negotiates the reimbursement price directly with the manufacturer before a final listing decision is made.
The Ministry of Health and Welfare (MoHW) holds ultimate authority and issues the formal approval for NHI listing. This three-tier structure means that a positive HIRA recommendation does not automatically guarantee reimbursement. Price negotiation with the NHIS is a separate and equally important hurdle, and the MoHW can override or delay a listing even after a successful negotiation, in exceptional circumstances.
For pharmaceutical companies, this means engaging with multiple stakeholders, each with distinct priorities. HIRA focuses on evidence quality and economic justification, while the NHIS is primarily concerned with budget impact and affordability within the national insurance system. Understanding how these priorities interact is a core part of any effective market access and regulatory services strategy for South Korea.
What are the steps in the HIRA reimbursement review process?
The HIRA reimbursement process follows a defined sequence of stages that a pharmaceutical company must complete in order. Each stage has its own documentation requirements, timelines, and decision criteria.
- Marketing authorization: A product must first receive approval from the Ministry of Food and Drug Safety (MFDS) before a reimbursement application can be submitted.
- HIRA submission: The manufacturer submits a reimbursement application package to HIRA, including clinical and pharmacoeconomic dossiers.
- HIRA review: HIRA’s Drug Benefit Coverage Assessment Committee evaluates the clinical benefit and cost-effectiveness of the product, typically over 150 days.
- NHIS price negotiation: If HIRA issues a positive recommendation, the manufacturer enters price negotiations with the NHIS. This stage lasts up to 60 days but can be extended.
- MoHW listing decision: Following a successful negotiation, the Ministry of Health and Welfare formally approves the NHI listing.
- Formulary inclusion: The product is added to the NHI drug list and becomes reimbursable for eligible patients.
Each step must be completed before the next begins, so delays at any stage extend the overall timeline. Companies that prepare thoroughly before submission tend to move through the process more efficiently.
What documents does HIRA require for a reimbursement application?
A HIRA reimbursement application requires a comprehensive dossier covering clinical evidence, pharmacoeconomic analysis, and budget impact data. The core submission package typically includes clinical trial data demonstrating efficacy and safety, a comparative effectiveness analysis against existing standard-of-care treatments, a cost-effectiveness model, and a budget impact analysis for the Korean NHI system.
Beyond these core components, HIRA also requires product information aligned with the MFDS-approved label, pricing information from reference countries, and supporting literature. For biologics or specialty medicines, additional data on the target patient population in Korea may be requested.
The pharmacoeconomic dossier is often the most demanding element to prepare. HIRA expects cost-effectiveness models to use Korean-specific unit costs, epidemiological data, and utility values where available. Submissions that rely entirely on data from other markets without local adaptation are frequently subject to additional questions or requests for supplementary information.
How does HIRA evaluate cost-effectiveness for new medicines?
HIRA evaluates cost-effectiveness using an incremental cost-effectiveness ratio (ICER), which compares the additional cost of a new treatment against the additional health benefit it provides relative to the current standard of care. The benchmark threshold in South Korea is generally considered to be around one to two times the country’s GDP per capita per quality-adjusted life year (QALY) gained, though HIRA applies this flexibly rather than as a rigid cutoff.
The assessment committee examines whether the submitted economic model is methodologically sound, whether the comparator used reflects actual clinical practice in Korea, and whether the assumptions in the model are transparent and justifiable. HIRA may request scenario analyses or sensitivity analyses to test how robust the conclusions are under different assumptions.
For medicines targeting rare diseases, severe conditions, or unmet medical needs, HIRA can apply more flexible criteria. In these cases, a higher ICER may still result in a positive recommendation if the clinical benefit is considered substantial and no comparable alternatives exist.
What is the risk-sharing agreement option under HIRA?
A risk-sharing agreement (RSA) is a managed entry arrangement between the manufacturer and the NHIS that links reimbursement conditions to real-world performance or financial outcomes. RSAs are available in South Korea as a mechanism to support coverage for medicines where there is uncertainty around long-term clinical effectiveness or budget predictability.
There are two main types of RSA used in the Korean system. Financial-based agreements cap the total expenditure the NHI pays, for example through rebates if utilization exceeds a defined threshold. Outcomes-based agreements tie continued reimbursement or pricing to evidence generated after listing, such as registry data showing the medicine performs as expected in real-world Korean patients.
RSAs are particularly relevant for oncology medicines, rare disease treatments, and innovative therapies where pivotal trial data may be limited at the time of submission. Agreeing to an RSA can sometimes unlock a positive listing decision that might otherwise be delayed pending additional evidence. However, these agreements require careful negotiation and robust post-marketing data collection commitments from the manufacturer.
How long does the full HIRA reimbursement process take?
The full HIRA reimbursement process, from initial submission to NHI formulary listing, typically takes between 12 and 18 months in total, though this can vary depending on the complexity of the product and whether additional information is requested during the review. The formal HIRA review alone takes up to 150 days, and the NHIS price negotiation adds up to 60 days on top of that.
In practice, preparation time before submission is significant. Companies often spend six months or more developing the pharmacoeconomic model, gathering Korean-specific data, and aligning their submission strategy with HIRA’s methodological guidelines. Delays during the review, such as requests for additional data or model revisions, can push the overall timeline well beyond 18 months.
Planning the HIRA submission in parallel with the MFDS marketing authorization process, where feasible, can help reduce the time between regulatory approval and reimbursement. Early scientific advice meetings with HIRA are also available and can help manufacturers understand evidence requirements before committing to a full submission.
How Starodub supports your South Korea reimbursement strategy
Navigating the HIRA reimbursement process requires a clear understanding of Korean regulatory expectations, pharmacoeconomic methodology, and multi-stakeholder dynamics. At Starodub, we help biopharmaceutical companies prepare and execute their market access strategies for South Korea with the same rigour we apply across all our regulatory projects. You can learn more about our background and approach on our company page.
Our support for HIRA submissions and Korean health insurance review processes includes:
- Gap analysis of your existing clinical and economic evidence against HIRA requirements
- Development and review of pharmacoeconomic models adapted to the Korean context
- Preparation of the full HIRA submission dossier, including budget impact analysis
- Strategic advice on risk-sharing agreement options and managed entry approaches
- Coordination with local Korean partners and regulatory authorities where needed
- Support for post-listing requirements, including outcomes-based data collection commitments
With over 400 completed projects and a team that combines regulatory depth with practical market access experience, we are well positioned to guide your product through the South Korea reimbursement process efficiently. Contact us today to discuss how we can support your HIRA submission and help you achieve a timely listing on the Korean NHI formulary.
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