HIRA establishes new Pharmaceutical Benefits Dept

for post-management of listed high-priced drugs...changes drug review paradigm

HIRA newly establishes a Pharmaceutical Performance Evaluation Department … for post-listing management of high-priced drugs

Will serve as a ‘double-headed carriage' and drive drug reimbursement decisions with the Pharmaceutical Benefits Department that was established in 2006 with the positive list system

High-priced drugs are changing the drug expenditure review paradigm in Korea.

 

The high cost borne from the use of high-price drugs is increasing the importance of post-listing evaluation of high-priced drugs.

 

To address this shift, the Health Insurance Review and Assessment Service established a ‘Pharmaceutical Performance Evaluation Department’ earlier this year, which is in charge of the post-listing management of high-priced drugs.

 

This is the first time another pharmaceutical department has been established in HIRA since the Pharmaceutical Benefits Department was separately established from the Benefits Listing Department in 2006.

 

According to industry sources on the 9th, HIRA had newly established a Pharmaceutical Performance Evaluation Department under its Health Insurance Review and Assessment Research Institute through restructuring earlier this year.

 

The Pharmaceutical Performance Evaluation Department will be led by Director-General So-young Lee, who also serves as the Head of the Health Insurance Review and Assessment Research Institute.

 

Lee graduated from Chung-Ang University College of Pharmacy and has a strong background in pharmaceutical listing management, including experience as the Director-General of HIRA's Benefits Listing Department.

 

Also, Director Mi-Kyung Kim was appointed to the Pharmaceutical Performance Evaluation Department, who returned after receiving education at the Seoul National University School of Public Health.

 

The Pharmaceutical Performance Evaluation Department will take over duties of the New Drug Performance Management Department that was established as a temporary organization under the Pharmaceutical Benefits Department in September 2022.

 

That department had been temporarily established to address the need for post-listing management of high-priced drugs in line with the reimbursement listing of Kymriah, which costs KRW 360 million per dose.

 

Specifically, the new department will be responsible for evaluating and analyzing the outcomes of patients receiving high-priced drugs at medical institutions.

 

The number of items that are subject to performance evaluations has increased to 4, and includes Kymriah Zolgensma, Spinraza, and Evrysdi.

 

Kymriah (above) and Zolgensma, drugs receiving post-marketing evaluation as high-priced drugs

The Drug Performance Evaluation Department currently consists of 9 people under the Director-Genral and plans to expand its workforce in the future.

 

For now, it is in charge of evaluating the performance of high-priced drugs, but in the future, it is expected to serve as a window for the post-listing management of PE exemption drugs that waived submission of pharmacoeconomic evaluation data.

 

HIRA’s webpage introduces the duties of the Pharmaceutical Performance Evaluation Department as ▲ matters related to preparing the basis for performance management of high-priced drugs and system operations ▲ matters related to RWD utilization (E-form, etc.), and post-listing management ▲ matters related to cost-effectiveness evaluation and economic evaluation (reevaluation) of high-priced drugs ▲ matters related to research on the price, listing, and usage of drugs subject to performance evaluations.

 

The post-listing management PE exemption drugs were also mentioned in the recently concluded report on ''Measures to improve the PE exemption system.' In the report, the researchers said, "The economic feasibility of listed PE exemption drugs were evaluated in all other HTA-based major countries,” suggesting the need for reevaluation of these listed drugs for the proper management of the price of drugs that will potentially be used as comparators for the listing of latecomers.

 

The need for post-listing evaluation of PE exemption drugs based on RWE data was also mentioned during a public hearing on 'Measures to Manage Performance-based Reimbursement of Drugs using RWD/RWE' that was held in November last year.

 

Ji-hye Byun, an associate researcher who published the RWE guideline for performance-based reimbursement management, is also in the Drug Performance Evaluation Department.

 

When the plan to improve the post-management of PE exemption drugs is prepared, which is being promoted in earnest this year, the Pharmaceutical Performance Evaluation Department is likely to take the lead and take over the post-listing management work.

 

The establishment of the Pharmaceutical Performance Evaluation Department holds significance as it serves as proof that the drug review paradigm has been changing.

 

HIRA’s Pharmaceutical Benefits Department was separately established from the Benefits Listing Department in 2006 in response to the need to strengthen the management of drug prices and drug expenses.

 

At the time, the measure was made in preparation for the positive-list system set to be introduced in December of the same year.

 

If the positive-list system, which selects and applies reimbursement benefits to only clinically and economically high-value drugs, has led to changes in drug management work, it is interpreted that the new department opened a new paradigm in drug management that complements areas missed by the positive-list system, extending its work to post-management of high-value drugs.

 

in his New Year's speech, Jung-Gu Kang, Director of HIRA, said, “Reimbursement for ultra-high-priced drugs and rare and incurable diseases has been rising as an ongoing issue recently.

 

The entry of rapidly listed ultra-high-priced drugs into Korea’s reimbursement system after waiving economic evaluation has raised the need for post-management of drugs.” He added, “We want to create a mechanism that can monitor the treatment performance of a drug on each patient so that effective drugs can be administered to the public, and also reduce the risk of wasting major health insurance financial expenditures by strengthening post-listing management of drugs based on performance management."