Next year’s reimb reevaluations to be discussed further

Will likely reflect the result of the integrated research on the post-listing control of drugs

2026 reevaluation targets include ginkgo leaf extract... Pharmaceutical industry pushes back

The government has decided to continue discussions on the 2026 reimbursement adequacy reevaluation plan.

 

While the reevaluation was initially expected to be approved this month through the Health Insurance Policy Deliberation Committee review, it is reported that disagreements remain unresolved regarding selection criteria, procedural improvements, and the ingredients targeted for 2026.

 

Some suggest the findings from an ongoing post-listing drug control study commissioned by the MOHW may be incorporated.

 

According to industry sources on the 28th, the ‘Plan to Promote Drug Reimbursement Adequacy Reevaluations’ reported to the HIPDC subcommittee was not placed on the agenda for the HIPDC plenary session on the 28th.

 

The government stated it would continue discussions.

 

The plan reported to the subcommittee shows that the selection criteria for evaluation will change from the current threshold of an increase of 0.1% or more of the average claim amount over three years (approximately KRW 20 billion) to claims of KRW 10 billion or more.

 

Furthermore, the condition for “'listed reference countries' will be expanded from the current requirement of fewer than 2 countries to fewer than 3 countries.

 

The seven drug ingredients subject to reevaluation in 2026 are: Ginkgo biloba extract that was approved in 1989, Calcium dobesilate hydrate, Calladinogenase, Meglumine gadoterate, Diacerein, Afloqualone, and Octilonium bromide.

 

The level of reimbursement will also be differentiated based on evaluation results.

 

For drugs with unclear clinical utility but high social necessity, a 50% selective reimbursement rate will apply; for those with low social necessity, an 80% selective reimbursement rate will apply.

 

Additionally, if the drug cost is high compared to its alternatives, an additional price cut will be applied.

 

Previously, decisions only excluded drugs from reimbursement or maintained reimbursement, with drug prices adjusted through voluntary reductions by manufacturers to demonstrate cost-effectiveness.

 

The pharmaceutical industry has clearly stated its opposition to this plan.

 

Specifically, the argument is that the late selection of next year's reevaluation targets has rendered insufficient time to prepare data, making the 2026 reevaluation unfeasible.

 

This is because it takes about a year for drug efficacy to be included in textbooks.

 

Additionally, opinions have emerged that the selection of ginkgo biloba extract preparations as next year's target ingredients is unreasonable.

 

So the pharmaceutical industry has expressed temporary relief as the government decided to further discuss the reevaluation plan.

 

It is known that the government authorities were not in agreement regarding this reevaluation plan at the Drug Reimbursement Evaluation Committee and the Health Insurance Review and Assessment Service subcommittee level.

 

Particularly, it is reported that further discussion would be needed regarding changes to the criteria.

 

Some predict that the reimbursement reevaluation plan will be revisited based on the ‘Study on Integrated Post-listing Control of Drug Prices’ currently underway as an MOHW research project.

 

This study is scheduled to be conducted by the Catholic University of Daegu Industry-Academic Cooperation Foundation (Director Hyeop-sang Yoon) until November.

 

It is anticipated that the study conducted last year by the Korea Institute for Health and Social Affairs will include implementation plans related to integrated post-listing control measures.

 

An industry official explained, “Given that the post-listing control study is currently underway, it appears the new administration will comprehensively review the post-listing control system.

 

Consequently, there are projections that the finalization of the reevaluation plan may extend beyond this year.”