'Need patient engagement for reimb of high-priced drugs'

'Comparative Research on the Reimbursement Management Systems for High-Priced Drugs in Korea and Abroa

HIRA suggests the need through comparative research on high-priced drugs in Korea and abroad

Establish a follow-up system...Separate fund needed

A study has shown that there is a need for a formal process for patient organizations and patients to participate in discussions for the reimbursement of high-priced drugs in Korea.

 

With the reimbursement of high-priced drugs rising as a social issue and patient organizations and others raising concerns, the opinion has risen on the need for an official window for the patients’ participation.

 

These findings were presented in the Health Insurance Review and Assessment Service's own 'Comparative Research on the Reimbursement Management Systems for High-Priced Drugs in Korea and Abroad' (Principal Investigator: Associate Researcher Yoo-Jung Kim).

 

The results of the study were released on HIRA's website on April 4.

 

After reviewing the cases of high-priced drugs Spinraza, Hemlibra, Enhertu, and Jakavi that arose as issues through press conferences or public petitions by patients or patient organizations, and explained the need for an official window that allows patient participation.

 

In the final report, the research team wrote, "While domestic patients are represented by members of the Drug Reimbursement Evaluation Committee, there is no formal process for patient organizations to participate in the decision-making process for drugs.

 

There needs to be a formal administrative process for domestic patient organizations and patients to formally submit their opinions and participate in the decision-making process.

 

"Until now, Korean patient organizations have made demands in a one-time, informal manner in the form of complaints or petitions.

 

Due to the large amount of pressure the media puts on the government to accept such demands, and the fact that the Health Insurance Review and Assessment Service responds to complaints on a case-by-case basis rather than through a formal process, the one-time complaints increase the workload and stress of HIRA employees." The researchers added, “The lack of a formal process means that the opinions of all patient organizations cannot be objectively and fairly reflected, and only the demands of some patient organizations may be expressed.” Other countries had formal processes for patient organizations’ input.

 

The UK, France, Germany, Canada, Australia, and Taiwan all had such processes, leaving only Italy and South Korea without.

 

Excerpt from the

As policy recommendations for managing high-cost drugs, the researchers suggested the need to internalize the price-volume agreement system, evaluate the effectiveness of high-priced drugs, and expand the outcome-based risk-sharing system in the short term.

 

In particular, this should be preceded by the establishment of a high-priced drug follow-up management system.

 

In addition, the research team added that a pharmacoeconomic evaluation exemption system needs to be changed into a pharmacoeconomic evaluation deferral system, and the existing PE exemption drugs should also undergo reevaluations.

 

In addition, improving the pre-approval system was also cited as a short-term improvement task.

 

Based on the research results, HIRA has recently started implementing the improvements.

 

In the long term, the team emphasized that early access to rare diseases and anticancer drugs should be improved through a separate fund outside of health insurance finances to generate evidence to confirm the effectiveness and safety of new drugs.