11,959 listed drugs to receive 1st round reassessment

Additional exemptions reflected from the list of 14,013 products released earlier this month

Sole-listed drugs, previously repriced products and essential medicines with three or fewer suppliers among exemptions

Second-round reassessment to cover 8,087 products...Further changes possible following appeals

The number of products subject to the first round of reassessment of previously listed drugs has fallen to 11,959 from 12,437 earlier this month after additional exemptions were reflected in the list.

The decrease reflects the exemption of products that had not initially been classified as exempt, such as sole-listed drugs, products that had previously undergone price increases, and national essential medicines supplied by 3 or fewer companies.

According to the final list of drugs subject to the first round of reassessment released by the Health Insurance Review and Assessment Service (HIRA) on the 22nd, 11,959 products remain subject to reassessment after exempt products are excluded.

HIRA had previously released a list of 14,013 products on the 8th. Of these, 1,576 products, including drugs protected from market withdrawal and narcotics, were exempt, leaving 12,437 products effectively subject to price adjustments.

At the time of the initial announcement, some products eligible for exemption—including sole-listed drugs and products whose prices had previously been raised through negotiations since 2020—had not yet been reflected. At the time, HIRA had said it would release an additional list after reflecting the final change.

With the additional inclusion of sole-listed drugs, previously repriced products, and other exemptions, the number of exempt products increased from 1,576 to 1,999. (AI-generated image)

While 1,576 products were marked as exempt in the initial release, the number increased by 423 to 1,999 in the final list. Another 55 products, including Hanmi Pharmaceutical’s Amosartan, were moved from the first to the second round of reassessment.

Taken together, the additional exemptions and products moved to the second round reduced the previously announced first-round reassessment list by 478 products.

This has also clarified the scope of the second-round reassessment, for which price cuts will begin in 2030. All drugs on the September reimbursement list that are not included in the first round will be subject to the second round.

The products assigned to the first and second rounds may still be subject to change, however, depending on submissions and appeals from pharmaceutical companies.

The government will allow companies to apply to have reassessment deferred from the first to the second round for products that require a stable supply for patient care and whose prices have already been reduced substantially from previous levels.

Pharmaceutical companies must submit supporting materials by Oct. 31 to demonstrate eligibility for reassessment exemptions, add-on payments or special case provision, reassignment of the reassessment round, or compliance with the applicable criteria.

HIRA plans to provide companies with a preliminary review in November, allowing them to check reassessment results and adjusted prices for each product, before referring the matter to the Drug Reimbursement Evaluation Committee in December.

After the final products are determined following appeals and other subsequent procedures, phased adjustments of the price ceiling of first-round drugs will begin in April 2027.