RWE Readiness in Korea: What New Post-Listing Evidence Expectations Mean for Pharmaceutical Companies

Explore how pharmaceutical companies can prepare for Korea's evolving reimbursement and post-listing performance assessment environment

Korea's pharmaceutical market is entering a period of significant change. As policymakers pursue faster access to innovative therapies, expectations for evidence generation after reimbursement are increasing.

For manufacturers, one key implication is that market access strategies may increasingly depend not only on obtaining reimbursement, but also on demonstrating real-world value over time. Recent policy developments and new guidance from the Health Insurance Review and Assessment Service (HIRA) suggest that real-world evidence (RWE) may play a growing role in post-listing assessment and reimbursement decision-making.

What does this mean for pharmaceutical companies operating in Korea? And how can organizations begin preparing now?

As Korea's reimbursement environment continues to evolve, the challenge for pharmaceutical companies is no longer simply obtaining market access. Some organizations may increasingly need to demonstrate how they will continue generating evidence after listing to support long-term value discussions with payers and other stakeholders.

Why RWE Matters More Than Ever in Korea

RWE helps complement clinical trial data by showing how treatments perform in routine clinical practice. In Korea, this is becoming especially relevant for products considered under the expedited listing pilot, where clinical usefulness may be assessed before reimbursement while cost-effectiveness and broader performance assessment are addressed after listing.

The pilot currently focuses on eligible rare disease medicines.

Post-listing assessment can evaluate treatment effectiveness, durability, and safety in real-world patients. Because RWD may include missing data, measurement error, confounding, and variation in clinical practice, RWE should be generated using fit-for-purpose data, valid study design, and transparent methods.

What the New Guidance Means in Practice

According to the guidelines, RWE should be planned as a structured evidence-generation process, not simply an analysis of available data. While the HIRA guidelines do not determine when RWE must be used or which products will be subject to performance assessment, they provide a reference framework for generating and reporting RWE. This requires clear planning, fit-for-purpose data, appropriate methods, and transparent reporting from the outset.

First, the research question must be aligned with the intended decision-making purpose. The study population, treatment exposure, comparator, outcomes, and observation period should be clearly defined, with a specific focus on the uncertainty the study is intended to address.

Second, data suitability should be assessed before study initiation. The key consideration is whether the available data can reliably identify the target population, measure treatment exposure and outcomes, capture key confounders, and provide sufficient sample size and follow-up, particularly in rare diseases or small patient populations.

Third, the comparator strategy should be carefully justified. When an internal comparator is not feasible, external control may be considered, but comparability in patient characteristics, treatment timing, outcome definitions, and data collection methods should be assessed and any remaining limitations transparently described.

Fourth, documentation and reporting should make the evidence-generation process clear. Protocols, analysis plans, variable definitions, data handling procedures, sensitivity analyses, and any deviations from the original plan should be documented so decision-makers can interpret both the results and their limitations.

Five Questions Pharmaceutical Companies Should Be Asking Now

For pharmaceutical companies, a key takeaway is that RWE readiness should begin before reimbursement submission and long before any post-listing assessment request is received. Organizations should consider five key questions:

• Which outcomes are most likely to be evaluated during future post-listing assessments?
• Can those outcomes be measured using available Korean real-world data sources?
• Can the target patient population and treatment exposure be identified reliably?
• Is an appropriate comparator strategy available?
• Will sufficient follow-up be available to answer stakeholder questions?

Addressing these considerations early can reduce uncertainty, strengthen evidence-generation plans and help ensure alignment between reimbursement strategy and future evidence requirements.

Korea's evolving reimbursement environment is creating a closer connection between patient access and evidence generation. Companies that begin planning RWE strategies earlier may be better positioned to respond to future post-listing evidence expectations.

Syneos Health Perspective and Recommendations

At Syneos Health, in our view, successful RWE generation starts with a decision-making question rather than a data source. The most effective evidence programs align scientific objectives, market access needs, regulatory expectations and operational realities from the beginning.

This integrated approach helps ensure that evidence generation supports both immediate reimbursement objectives and longer-term value demonstration requirements.

How Companies Can Start Preparing Today

While every organization will face different evidence-generation challenges, several practical steps can help establish stronger RWE readiness and reduce future uncertainty:

• Review current evidence-generation plans against potential post-listing assessment requirements
• Evaluate the suitability of available Korean real-world data sources
• Identify evidence gaps that may affect future value demonstration
• Align RWE planning with broader market access and HEOR strategy

Early preparation may help reduce future uncertainty and support a more proactive approach to evidence generation.

Conclusion: RWE Readiness as a Strategic Market Access Capability

The evolution of Korea's reimbursement environment reflects a broader shift occurring across global healthcare systems: faster access is increasingly accompanied by greater expectations for ongoing evidence generation.

For pharmaceutical companies, this means that RWE readiness is becoming a strategic capability rather than a post-listing activity. Organizations that establish clear evidence-generation plans, identify fit-for-purpose data sources and align RWE with market access strategy early may be better positioned to demonstrate value throughout the product lifecycle.

As expectations continue to evolve, companies that prepare now will be in a stronger position to support patient access, address stakeholder uncertainty and respond confidently to future evidence expectations.

What comes next?

As pharmaceutical companies assess the implications of Korea's evolving RWE landscape, the key question is no longer whether post-listing evidence generation will matter. The more important question is whether organizations are building the evidence strategy, data infrastructure and planning processes needed to support future reimbursement and value discussions.

Those that begin preparing now may be better positioned to navigate the next phase of Korea's market access evolution.

Contributors

Haenam Kang

Research Manager, Real World Evidence

Syneos Health

Leejung Choi

Sr. Research Associate, Real World Evidence

Syneos Health

Russell Miller

Associate Director, Real World Evidence

Syneos Health