ICER threshold for anticancer drugs set same as in 2024

Maximum limit set at the same level as in the previous year… did not reflect this year’s evaluation results

Maximum ICER threshold for anticancer drugs from 2019 to 2023 was KRW 47.92 million...KRW 36.1 million for general drugs

The Health Insurance Review and Assessment Service released the results of the incremental cost-effectiveness ratio (ICER) of drugs submitted for pharmacoeconomic evaluation from 2019 to 2023, which has shown a decrease in the maximum ICER threshold set for anticancer drugs.

 

The ICER threshold did not appear to have changed much from the previous year, as the review results of the breast cancer drug Enhertu, which was reimbursed in April and was known to have significantly exceeded the ICER threshold, were not reflected in the results.

 

On December 30, HIRA released the ICER threshold values of 19 drugs evaluated from 2019 to 2023.

 

At the end of every year, HIRA discloses the past 5-year ICER values from the previous year.

 

According to the evaluation results, the median threshold value of 8 general drugs was KRW 27.66 million, ranging from KRW 12.06 million to KRW 36.1 million.

 

In the case of the 8 anticancer drugs, the median threshold was KRW 39.93 million, ranging from KRW 25.88 million to KRW 47.92 million.

 

For the 3 rare disease drugs, the median threshold was not disclosed to avoid identifying individual drug evaluation results.

 

However, the minimum threshold was KRW 23.61 million and the maximum threshold was KRW 39.97 million.

 

Compared to the ICER threshold published in 2023, there is less fluctuation, around KRW 10 million.

 

The data released the previous year were based on ICER thresholds for 20 drugs evaluated from 2018 to 2022.

 

Its results showed that the median price of 5 general drugs was KRW 25.67 million, ranging from KRW 17.78 million to KRW 35.29 million.

 

At the time, the median ICER threshold of the 10 anticancer drugs was KRW 39.99 million, ranging from KRW 24.96 million to KRW 47.92 million, and the median ICER threshold of the 5 rare disease drugs was KRW 39.97 million, ranging from KRW 23.61 million to KRW 47.29 million.

 

Compared to this year's results, the median ICER threshold of general drugs increased by KRW 1.99 million, while the minimum threshold decreased by KRW 5.72 million.

 

The maximum value increased by KRW 0.81 million.

 

In the case of anticancer drugs, the median ICER threshold decreased by KRW 60,000, while the minimum ICER threshold increased by KRW 0.92 million.

 

The maximum remained the same.

 

For rare disease drugs, the minimum ICER threshold remained the same, while the maximum ICER threshold decreased by KRW 7.32 million.

 

The maximum ICER threshold for anticancer and rare disease drugs remained the same or decreased from the previous year.

 

In August, HIRA revised the detailed evaluation criteria for drugs subject to negotiations, including new drugs, to establish an innovativeness requirement for drugs subject to flexible ICER threshold evaluations.

 

Previously, the ICER threshold was “not to be used as an explicit threshold, but to be used flexibly for evaluations by referring to the results of previous deliberations that consider the severity of the disease, the burden of disease on society, the impact on quality of life, and innovation.” Upon revision, a new drug's innovativeness is recognized if it meets all 3 of the following requirements: ▲ there is no substitute or therapeutically equivalent product or treatment; ▲ a significant clinical improvement is identified in the outcome indicator, such as prolongation of survival; ▲ it falls under Article 35(4)(2) of the Pharmaceutical Affairs Act and is recognized by the MFDS as a new drug or equivalent drug approved through expedited review by the MFDS.

 

A flexible review of high-priced new drugs is expected with the clarification of the flexible ICER threshold evaluation requirements.

 

In April, HIRA reviewed and granted reimbursement for the breast and gastric cancer drug Enhertu Inj (trastuzumab deruxtecan, Daiichi Sankyo).

 

At the time, it was reported that Enhertu’s ICER threshold greatly exceeded the maximum value of the existing ICER threshold set for anticancer drugs.

 

Last year and this year, the maximum ICER threshold for anticancer drugs was KRW 47.92 million.

 

Accordingly, it is expected that the ICER value in 2025, which will reflect the results of this year's evaluations, will show a significant increase in the ICER threshold set for anticancer drugs.