Discussions on RWE utilization in reimb decisions

The research commissioned by the Health Insurance Review and Assessment Service (HIRA) is nearing completion…the list includes drugs for economic evaluation exemption

Companies have raised concerns about scope of application and financial burden…”overseas data should be included”

Guidelines for using Real World Evidence (RWE) in both the initial listing and subsequent reassessment of drug reimbursement status are expected to be announced in South Korea next year.

The research commissioned by the Health Insurance Review and Assessment Service (HIRA) is nearing completion, and the guidelines will be published after gathering industry feedback.

However, to use the guidelines for drug reimbursement, significant challenges remain related to securing the reliability of Real-World Data (RWD) and RWE. Furthermore, pushback is anticipated from pharmaceutical companies that are expressing concerns about the burden of generating RWE.

On the afternoon of December 12, HIRA officials, the National Health Insurance Service (NHIS), and pharmaceutical companies engaged in a lively debate on the use of RWE for reimbursement decisions at the Korean Society of Social Pharmacy conference.

Ra-Won Kang, Department Head of Drug Performance Assessment Management at HIRA.

The HIRA announced its plan to publicize the guidelines soon following the completion of research on the use of RWE.

Ra-Won Kang, Department Head of Drug Performance Assessment Management at HIRA, stated that the research on RWE utilization is nearing completion, and the guidelines will be published soon.

Kang said, "Many major international organizations utilize RWE. In countries like Canada and the UK, RWE is largely used as a crucial basis for decision-making during both initial listing and post-listing reassessment of evidence."

Kang emphasized, "The current challenge is how to ensure the reliability of the collection of RWD for the generation of RWE. Research into international cases shows that countries use guidelines tailored to their own circumstances for quality control. HIRA has also developed RWE guidelines research, and once it concludes this year, we plan to publish the guidelines next year after gathering input from stakeholders."

Se-Rim Oh, Department Head of Negotiation and Post-Management at the NHIS.

The statement conveys the message that RWE utilization is the government’s response to resolving uncertainties about increasing drugs subject to economic evaluation exemptions.

Se-Rim Oh, Department Head of Negotiation and Post-Management at the NHIS, explained that the government's interest in utilizing RWE stems from concerns about resolving uncertainties amid the increasing number of drugs subject to economic evaluation exemptions.

Oh stated, "Some responsibility lies with pharmaceutical companies. Many drugs have entered the market through the economic evaluation exemption route, even though an economic evaluation could have been conducted. Half of the risk-sharing agreement drugs approved this year and last year entered through this exemption," noting that this increases the uncertainty regarding cost-effectiveness. 

Oh stated, "RWE should be used if necessary. However, generating data can be expensive and difficult. There are concerns that predictability and acceptability might decrease," and added, "If necessary, establishing a legal basis and creating a government-wide registry would be appropriate." 

She also proposed that expanding performance-based refund agreements conducted by the NHIS and utilizing periodic performance reassessment data could be viable methods.

Industry "RWD data have not been standardized…overseas data should also be allowed"

The pharmaceutical industry expressed concern that the RWE guidelines could inadvertently become an additional layer of regulation, similar to clinical trials.

Companies have complained about the heavy burden of RWE generation, particularly since RWD standardization has not yet been achieved. They strongly advocated for the recognition of international RWE data.

Junghyun Na, Daiichi Sankyo Korea Head, stated, "First, the scope of application must be clearly defined. Also, the data in the field are varied and not standardized. Companies will inevitably face a substantial burden." Na emphasized that infrastructure, such as public platforms, must be built before implementation.

Furthermore, companies stressed that if the process by which RWE will be reflected in reimbursement and pricing decisions is not predictable, the investment risk for companies would be significant.

Jongryun An, Senior Director at Janssen Korea, explained, "Drugs entering through the economic evaluation exemption are reviewed without consideration for cost-effectiveness, but they typically enter at the lowest possible price. Furthermore, they are subject to total expenditure limits." An argued that measures to control high costs are already in place.

An also raised the issue that collecting sufficient domestic data for rare and severe disease treatments in South Korea is challenging due to the small patient pool. An requested, "Please be flexible in accepting global RWE data if it was used in the process of obtaining approval or reimbursement in other countries."

Additionally, An argued that the guidelines should be flexible, stating, "Overly detailed or strict guidelines could lead to a situation where no decisions can be made."