ICER of general drugs KRW 15.97 mil for the past 15 yrs

...KRW 45.15 mil for anticancer drugs

HIRA discloses ICER results for the first time since the introduction of the positive-listing system in Korea

The median ICER (Incremental Cost-Effective Ratio) value of general drugs from 2007 to 2021 was KRW 15.97 million in Korea.

 

The ICER value of anticancer drugs was KRW 45.16 million, and rare diseases KRW 15.97 million in the same period.

 

This was the first time that the ICER results were disclosed, and the disclosed results are expected to be useful for pharmaceutical companies that seek to reimburse new drugs.

 

On the 16th, the Health Insurance Review and Assessment Service announced that it had disclosed the cost-effectiveness evaluation results of drugs that are required to submit pharmacoeconomic evaluation data (ICER) for the past 15 years (2007-2021) since the positive-listing system was first introduced to Korea.

 

ICER is a value used to evaluate the economic feasibility of a new drug that offers an improved effect and shows the additional cost required per unit of increased effect or efficacy of a new drug compared to its alternative.

 

Accordingly, a new drug is interpreted as being cost-effective compared to its alternative if the ICER of a certain drug is lower than a certain threshold.

 

However, instead of using an explicit threshold, Korea flexibly refers to the results of previous deliberations in consideration of the severity and social burden of the disease, its impact on quality of life, and innovativeness.

 

The disclosure follows the deletion of the 'GDP per capita' standard and the addition of the ‘existing review results' standards in the revised regulations for the ICER threshold in the ‘Detailed Evaluation Standards for Drugs Subject to New Drugs, Etc.’ in September last year.

 

HIRA explained that the revision specifies the use of the alternative reference value that is used in Korea, as Korea does not use an explicit threshold value.

 

After the initial disclosure this year, HIRA plans to disclose the 5-year ICER data every December, but in consideration of the number of ingredients in each drug category each period to prevent specifying the evaluation results of individual drugs.

 

In the case of the ICER results of rare disease drugs from 2007 to 2013, HIRA disclosed the minimum and maximum ICER values, but not the median value to prevent the evaluation results of individual drugs from being specified.

 

The ingredients subject to disclosure are ingredients deemed cost-effective by the Drug Reimbursement Evaluation Committee and evaluated for reimbursement.

 

Only for 2022, all data from 2007 to 2021 were disclosed at once.

 

Also, the evaluation results from 2007 to 2013 and 2014 to 2021 were separately disclosed in consideration of the major policy changes that had been made in 2014, such as the ▲increased ICER limit to strengthen coverage for severe diseases (from November 2013) and the ▲ implementation of the risk-sharing system (from December 2013), etc.

 

HIRA explained that the data disclosed are divided into three categories: general drugs, anticancer drugs, and rare disease drugs, and the number of ingredients and cost-effectiveness evaluation results for each category are disclosed.

 

In the case of anticancer and rare disease drugs, the classification is made according to the classifications made during DREC evaluations, and all other drugs are included in the general drug category.

 

The number of ingredients was calculated based on the results of the cost-effectiveness analysis and subject ingredients, and HIRA will be disclosing the median, minimum, and maximum values based on drug category.

 

The ICER results of drugs that submitted data for economic evaluations showed that the median ICER of generic drugs from 2007 to 2021 was KRW 15.97 million.

 

Also, the ICER value of anticancer drugs was KRW 45.16 million, and rare disease drugs KRW 32.32 million.

 

The ICER results of drugs subject to PE data submissions can be found on HIRA’s webpage.

 

Mi-Young Yoo, Deputy Minister of HIRA's Pharmaceutical Benefits Management Department, said, “The ICER results that were disclosed this time are meaningful as this is the first time the data had been disclosed since the introduction of the positive-listing system, and the annual regular disclosure of the data is expected to be used as an alternative reference value related to ICER.” Yoo added, “However, in evaluating the reimbursement adequacy of drugs, not only the ▲cost-effectiveness from PE evaluation results, but also the ▲clinical effectiveness, and ▲its impact on NHI finances, are comprehensively considered.

 

Korea does not use an explicit ICER threshold value; it rather evaluates the value in consideration of the uncertainties based on the results of the sensitivity analysis in addition to the basic analysis results.

 

Therefore, we ask people to play caution in interpreting the published cost-effectiveness evaluation results.”