Will drugs subject to reimbursement reevals be expanded?

Discussions on strengthening criteria to increase the scope of subject ingredients in progress

Current criteria of drugs with annual claims of KRW 20 billion or more and are reimbursed in 1 country or less may be changed to drugs with annual claims of KRW 10 billion or more and are reimbursed in three countries or less

The government is reportedly planning to tighten the selection criteria ahead of the second phase of the drug reimbursement adequacy reevaluations, which is set to begin next year.

 

As a result, it is expected that the number of ingredients subject to reassessment may be expanded.

 

According to industry sources on the 10th, the Health Insurance Review and Assessment Service (HIRA) is currently collecting feedback from the pharmaceutical industry before finalizing its second-phase drug reimbursement adequacy reevaluation plan.

 

The first phase will conclude this year.

 

Since the pilot reevaluation was conducted for choline alfoscerate in 2020, HIRA has completed four full reevaluation rounds from 2021 to 2024, and the fifth round is currently underway.

 

Thus far, the reassessment has focused on ingredients listed for reimbursement from 1998 to 2006, before the positive listing system was implemented, and ingredients currently undergoing clinical reevaluation by the Ministry of Food and Drug Safety.

 

Also, ingredients with an annual total reimbursement claim exceeding 0.1% (approximately KRW 20 billion), and those reimbursed in only one foreign country among the A8 reference countries was the criteria.

 

Industry observers anticipate that the selection criteria stated above will change significantly from the second phase of reevaluations.

 

In particular, the strengthened criteria may lead to the inclusion of ingredients that were previously excluded from reevaluations.

 

It is reported that authorities are considering expanding the annual claims threshold to identify ingredients that have remained in a regulatory blind spot.

 

The criteria under discussion include lowering the reimbursement claim threshold from KRW 20 billion to KRW 10 billion, and expanding the eligibility from being listed in only one A8 country to fewer than three.

 

As in the first phase of reevaluations, the second phase will also continue to target drugs listed before the implementation of the positive listing system, making it likely that previously excluded products will be included.

 

If the criteria are expanded as proposed, pharmaceutical companies will likely begin reviewing their product portfolios to identify those that may be subject to reevaluation.

 

Unlike in the first phase, drugs with lower claims may also be included, posing new challenges for the companies preparing for reevaluations.

 

However, as the selection criteria are still under review, companies are expected to limit their response until the final criteria are confirmed.

 

Given the delay in finalizing the criteria and scope for the second phase, the industry is calling for the 2025 revisions to be postponed to allow sufficient preparation time.