Concerns mounting over RWE for cutting reimb

Health Insurance Review and Assessment Service (HIRA) discusses the utilization of post-marketing evaluations at the RWE symposium

Park Seon-eun, coordinator at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), said, "Must leverage RWE to refine reimbursement sub-population"

Lee Eun-joo, a section chief from the Pharmaceutical Benefits Division at the MOHW, stated, "Balance between treatment access and national health insurance fiscal management is needed"

The Ministry of Health and Welfare (MOHW) announced that while it aims to accelerate patient access to critical therapies through its expedited listing pathway, subsequent fiscal management via reimbursement adjustments based on post-marketing evaluations remains unavoidable.

Addressing pharmaceutical industry anxieties regarding data limitations in Real-World Evidence (RWE)-driven post-listing price adjustments, the MOHW emphasized that "fiscal management is a core responsibility of the government."

The MOHW noted that while expanding patient access to breakthrough treatments is vital, managing the national health insurance budget is an equally binding statutory duty, thereby underscoring the necessity of adjusting reimbursement during post-evaluation.

During an RWE symposium hosted by the Health Insurance Review and Assessment Service (HIRA) at the aT Center on June 19, industry representatives proposed leveraging RWE to refine patient sub-populations rather than to enforce outright reimbursement cuts.

They explained that pharmacoeconomic evaluations utilizing RWE face inherent limitations regarding data reliability, making them sub-optimal for driving definitive pricing and coverage adjustments.

Park Seon-eun, coordinator at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), stated, "We fully align with the policy direction of prioritizing patient access to therapy first and subsequently accumulating additional clinical evidence from real-world practice. However, the industry harbors significant concerns regarding the prospect of utilizing accumulated RWE for ex-post pharmacoeconomic evaluations to recalculate drug prices."

Park emphasized, "RWE has significant value in identifying which specific patient subgroups derive the greatest clinical benefit, thereby allowing for a more sophisticated delineation of eligible reimbursement criteria."

Park further pointed out international precedents, noting that even in Europe, multiple attempts have been made to execute economic evaluations utilizing national registries, but decision-makers frequently failed to utilize the data due to fundamental gaps in data reliability.

​"Re-calculating the prices of novel therapies using RWE collected to resolve initial clinical uncertainty risks chilling the core legislative intent and policy objective of the expedited listing framework, which is to expand patient access," Park expressed concerns.

Conversely, the MOHW stated that utilizing RWE for reimbursement adjustments under the expedited listing and post-evaluation scheme is unavoidable, though it conceded the necessity of establishing clear frameworks to ensure the transparency and credibility of RWE methodologies.

The MOHW explained that post-marketing evaluations leveraging RWE possess clear advantages, such as ▲reflecting unique domestic patient phenotypes  ▲capturing local clinical environments ▲validating long-term therapeutic outcomes.

Lee Eun-joo, a section chief from the Pharmaceutical Benefits Division at the MOHW, stated, "Once a drug enters the expedited listing track, the evaluative paradigm shifts toward confirming whether the actual clinical value justifies the continuous infusion of health insurance funds. RWE will serve as the foundational data for executing these post-marketing evaluations and act as a critical performance indicator for real-world outcomes."

Lee added, "The government maintains a firm commitment to reducing structural delays that compromise patient access to therapies for rare and severe diseases when treatments exist. However, simultaneously, the government has an obligation to fulfill its role and responsibility in fiscal management, given that the National Health Insurance system is funded by the public."

Representatives from patient advocacy groups participating in the panel discussion highlighted the critical importance of upfront contracts to prevent friction during post-evaluation coverage adjustments.

Ahn Sang-ho, representative of the Korea Congenital Heart Disease Patient Association, said, "To prevent these concerns from turning into reality, we must establish a structural framework where evaluation commences concurrently with the listing," and added, "Data collection methodologies, post-evaluation price reductions, refund rate adjustments, and modifications to reimbursement criteria must be codified as pre-contractual conditions. We can mitigate conflicts and safeguard the national health insurance budget through this method."