Industry requests postponement of drug reimbursement reevals

Delayed discussions on selecting target substances... Insufficient time to prepare data

Items registered before the implementation of the positive listing system may become targets due to expanded criteria

The pharmaceutical industry has expressed the need to postpone next year's drug reimbursement reevaluations to the government.

 

The reason is that the reevaluation targets have not been decided by the second half of the year, leaving insufficient time for the target companies to prepare the necessary data.

 

As a result, some are even suggesting that the reevaluations be skipped next year.

 

According to industry sources on the 7th, the Health Insurance Review and Assessment Service held a meeting with pharmaceutical organizations, including the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, on the 4th to discuss the drug reimbursement adequacy reevaluations for 2026 and thereafter.

 

The first phase of the drug reimbursement adequacy reevaluations will be completed this year.

 

A pilot project was launched in 2020 targeting choline alfoscerate, for which reevaluations have been ongoing for 6 years.

 

The ingredients subject to reevaluation were drugs that were listed for reimbursement from 2006 to 1990, before the implementation of the positive listing system.

 

Accordingly, it is expected that the second phase of reimbursement reevaluation will focus on ingredients registered after the positive listing system was implemented.

 

In fact, in a study on “Measures to Rationalize the Drug Reimbursement Adequacy Reevaluations” that was conducted by HIRA, the researchers presented a plan for the second phase of reimbursement adequacy reevaluations, focusing on ingredients registered between 2007 and 2013.

 

However, it is known that some government officials are planning to strengthen the selection criteria and re-examine products that were registered before the positive listing system was introduced.

 

The current criteria for drugs with annual claims of KRW 20 billion or more may be lowered to KRW 10 billion or more, and drugs whose reimbursement adequacy was controversial will be selected.

 

However, as discussions with the pharmaceutical industry have only just begun, it is expected to take more time before the target ingredients are finalized.

 

The pharmaceutical industry believes that it will be difficult to conduct a normal drug reimbursement adequacy reevaluation next year due to delays in discussions on target ingredients.

 

An industry official said, “In the first phase, the ingredients to be reviewed for the following year were announced in March of the previous year, but this year, the ingredients have not been decided even after the start of the second half of the year, so it will be difficult to prepare data.

 

The industry hopes that the data submission period will be extended or that the review will be postponed until the year after the next.” The ingredients to be reviewed for reimbursement adequacy in 2025 were announced in March last year.

 

These opinions were delivered to HIRA by industry representatives at a meeting held on the 4th.

 

Meanwhile, the first results of this year's reimbursement adequacy reevaluation will likely be announced after the DREC meeting in August.

 

This year's reevaluation includes domestically produced natural drugs such as styrene and Joins, and the industry is paying close attention to the first results.