It takes 218 days to register after applying for a new drug

The MOHW submits a written answer to the National Assembly's Health and Welfare Committee

It's similar to the legal processing period

Among the new drugs introduced in Korea, drugs that started the payroll process from insurance application to registration last year took an average of 218 days.

 

Among them, the treatment for rare diseases took 238 days and the anticancer drug took 227 days.

 

Considering that the legal processing period is 7 months (210 days), the government emphasized that it is relatively quickly registered.

 

The Ministry of Health and Welfare submitted the results of the tally to the question of the duration of new drug benefits demanded by Kang Ki-yoon, a member of the National Assembly's Health and Welfare Committee, during the last comprehensive parliamentary audit.

 

According to the Ministry of Health and Welfare, the government has been operating Approval-Patent Linkage Systems, RSA, PE system, and drug price negotiation training system to strengthen access to new drug patients.

 

Looking at the aggregated data, the actual average registration period from application for drug decisions to benefit registration over the past five years was about 6.2 months.

 

This is the average value after calculating the time it takes to complete the notification from the application for the HIRA drug benefit adequacy to the passage of the Health Insurance Policy Review Committee for each drug.

 

The Ministry of Health and Welfare evaluated, "Considering the seven months (210 days) of the legal processing period for drug registration, it is being registered relatively quickly." It took 227 days for anticancer drugs and 238 days for rare diseases.

 

Comparing the recent five-year trend, there were delays by year or ups and downs in the required period.

 

It is analyzed that this is because it varies depending on the appearance of ultra-high-priced drugs, the difficulties of benefits review (ICER value and acceptance of companies), and the number and type of drugs applied for registration.

 

Even if the number of days is prolonged, it means that it is difficult to simply compare the period required by year, but it can be seen that new drugs are generally being paid at a level similar to the legal processing period.

 

The MOHW said, "The new government is also revising related regulations to shorten the evaluation period by selecting 'quick registration of anticancer drugs, severe disease treatments, and applying risk-sharing drugs' as state tasks" and the government said it will collect opinions from various stakeholders on the "improvement of reference standards for foreign drug prices (A7) adjusters" that are being discussed so far.

 

In the case of the A7 adjustment price reference standard, the government is using the adjustment price converted from foreign drug prices in the evaluation of new drug benefit adequacy to determine insurance drug prices.

 

However, due to the long-standing and insufficient evidence of the foreign drug price reference standard, long-term improvement reviews are underway to enhance transparency and clarity of the adjusted price and supplement its validity.

 

Earlier, the government held expert advisory meetings based on related research services from 2019 to 2020, and formed a public-private working-level consultative body, including related associations, to discuss improvement measures by holding six working group meetings.

 

The Ministry of Health and Welfare said, "In the process of improving reference standards, such as revising related guidelines, we will fully collect opinions from various stakeholders such as patients, experts, and pharmaceutical companies."