Reevaluation of foreign drug price comparisons

With aims to adjust drug prices in the second half of next year

HIRA President Jung-Gu Kang said, "There will be a reevaluation this year…the final plan will be shared with the industry."

HIRA President Jung-Gu Kang

The Health Insurance Review and Assessment Service (HIRA) announced that drug prices will be adjusted in the second half of next year by reevaluating foreign drug price comparisons.

 

This year, an announcement about reevaluation will be made, and the HIRA will conduct the evaluation in the first half of next year.

 

On August 20th, President of the HIRA Jung-Gu Kang announced this during a meeting with journalists.

 

Kang said, "We have had ten meetings so far to discuss about detailed criteria related to the reevaluation of foreign drug price comparisons with the pharmaceutical industry." Kang explained, "Based on discussions, the final plan for reevaluation will be shared with the industry when prepared." The plan for reevaluation of foreign drug price comparisons is under review after the tenth meeting on August 5th.

 

The products to be compared in the first year include 6467 items, including gastrointestinal medications, hypertension medications, and antibiotics.

 

The average adjusted price, excluding the highest and the lowest, from A8 countries (U.S., U.K., France, Germany, Japan, Italy, Switzerland, and Canada) will be used as the reference price.

 

The pharmaceutical company has suggested taking a 50% reduction from the drug price reduction portion and excluding Germany and Canada, which employ reference-pricing systems.

 

Whether the final plan would reflect the industry's opinion garners attention.

 

Kang said, "There will be a reevalutation this year." Kang added, "After the final evaluation, drug price adjustments will be implemented in the second half of next year." He drew a line to further delays in reevaluating foreign drug price comparisons.

 

Kang explained the new drug innovative value revisions reflected in the recent Drug Reimbursement Evaluation Committee (DREC) review on August 8th.

 

He stated, "The risk-sharing agreement (RSA) scope has been expanded to include drugs used for severe, difficult-to-treat diseases.

 

Additionally, when expanding the reimbursement criteria for RSA-designated drugs, if the additional claim amount is less than KRW 1.5 billion, the evaluation by the DREC can be waived, allowing for faster reimbursement processing." Additionally, "The scope and criteria for assessing 'innovativeness,' which is one of the ICER value evaluation factors, will be specified for drugs that 'cannot be substituted or have no therapeutic equivalent products or treatments available.

 

We have also clarified the process for evaluating the clinical value of drugs receiving RSA of outcome-based and reimbursable type." In answering the maximum ICER value to be applied, Kang said, "We will consider the individual drug's nature, and the maximum price has not been set." Regarding the second round of the pilot project for concurrent approval-reimbursement evaluation-drug price negotiations, Kang explained that the selection of drugs for the second round of the pilot project would be based on careful consideration of disease severity, the availability of alternative treatments, and treatment efficacy.

 

This process will involve discussions with the government agencies (Health Insurance Review & Assessment Service (HIRA), the Ministry of Health and Welfare (MOHW), the Ministry of Food and Drug Safety (MFDS), and the National Health Insurance Service (NHIS)), as well as consultations with experts.

 

The first round of the pilot project included Bilberry capsule and Qarziba, which are under review for reimbursement evaluation.

 

However, the drug price listing of Qarziba has been delayed due to receiving the non-reimbursement decision from the DREC review in August.

 

Kang explained, "There have been achievements such as reduced supplementary periods," and added, "Although there had been variables, we will make efforts to expedite the timing of reimbursement listings through concurrent evaluations by the MFDS, the HIRA, and the NHIS." Meanwhile, the HIRA plans to strengthen the DUR service for the safe use of narcotic drugs.

 

Information on 471 narcotic drugs has been provided already, and the HIRA has expanded the assessment of the use of propofol overuse and antidepressants beyond the specified period.

 

Kang said, "To solve issues related to long-term administration and overdose of narcotic drugs, we plan to improve the system by asking for the reasons for prescribing and dispensing that exceed the maximum dosage or duration limits," and explained, "The DUR should be mandatory for narcotic and antidepressant drugs, and we will continue to manage these drugs to resolve drug safety issue." This implies that the HIRA will make efforts to ensure that the mandatory DUR legislation passes the National Assembly."