HIRA starts preparing for RWE-based reimb reevaluations

will study Taiwanese model

Working-level officials will visit Taiwan earlier next month to benchmark the country’s system

Found consensus on the need at a public hearing on the 21st... seeks institutionalization

The Health Insurance Review and Assessment Service are accelerating the establishment of a plan to reevaluate Korea’s reimbursed drugs based on RWD (Real World Data)/RWE (Real World Evidence).

 

The idea of RWD/RWE-based reimbursement reevaluations took shape at the public hearing for the ‘Performance-based reimbursement management plan for drugs using RWD/RWE’ that was held on the 21st.

 

The plan is to reevaluate high-priced drugs or those that did not undergo pharmacoeconomic evaluations using RWD/RWE data.

 

According to the industry on the 28th, HIRA's working-level officials will go on a business trip to Taiwan early next month as part of establishing the plan for RWD/RWE-based reimbursement reevaluations in Korea.

 

Taiwan has been conducting RWD/RWE-based reimbursement reevaluations.

 

Therefore, HIRA’s working-level officials plan to visit Taiwan's Ministry of Health and Welfare and benchmark Taiwan's RWE-based reevaluation system.

 

RWD refers to a patient’s actual clinical data that is collected after reimbursement, such as health insurance claims data, hospital medical records, surveys, and post-marketing surveillance data.

 

The clinical evidence based on such data is referred to as RWE (Real-World Evidence).

 

At a public hearing that was held on the 21st, Ji-Hye Byun, associate researcher at HIRA presented the ‘Use RWE: reimbursement listing to reevaluation.’ Byun said, “For high-cost drugs that have submitted pharmacoeconomic evaluation data but have great uncertainty in its cost-effectiveness evaluation results (ICER), or for drugs that did not or cannot submit pharmacoeconomic evaluation data, we can conduct reevaluations after listing the drugs with RWD.” Associate researcher Byun is also known to be participating in the Taiwan business trip.

 

Insurance authorities believe that there is a rising need for RWE-based reimbursement management based on RWD analysis due to the rising number of reimbursed high-priced drugs that have unclear treatment effects.

 

Mi-Young Yoo, Director-General of the Pharmaceutical Benefits at HIRA, said, “Since the introduction of the positive listing system in 2006, many drugs have been listed for reimbursement through various systems including the PE exemption system to enable better patient access.

 

So this is now the time a post-listing measure needs to be implemented.

 

Although social consensus should be made on its need, such a management system can be a way to ensure an appropriate level of financial soundness within limited insurance.” Chang-Hyun Oh, Director of Pharmaceutical Benefits at MOHW, added, “Addressing the uncertainty that follows the listing of high-priced drugs reimbursed with PE exemption is a pending task for all.

 

As a tool, I expect RWD to become a good way to cover the uncertainties that remain in the area,” and expressed a positive attitude towards the introduction.

 

The number of drugs that are exempt from submitting pharmacoeconomic evaluation data has been on the rise ever since the system was implemented in 2015.

 

Last year, 87.5% of anticancer drugs and rare disease treatments reimbursed as new drugs were drugs that were exempt from submitting pharmacoeconomic evaluation data.

 

In this context, RWE is rising as an alternative and appropriate follow-up management tool to verify cost-effectiveness.

 

As HIRA held public hearings and has set out to conduct field surveys, an RWE-based reevaluation system is expected to surface soon in Korea as well.