The average time required to register an innovative new drug health insurance is 608 days...More than twice the number of Germany and Japan
May 14, 2025
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This is the result of a survey of 100 domestic medical staff conducted by the Korea Global Association of Drug Industry (KRPIA).
According to KRPIA, it takes an average of 608 days in 2022 for innovative new drugs to be listed on health insurance after obtaining approval from the Ministry of Food and Drug Safety, which is about twice the time required for Germany (281 days), Japan (301 days), and France (311 days).
In this regard, KRPIA commissioned Ipsos Research, a global polling agency, in January to ask domestic clinical experts from various medical departments about their position on the accessibility of new drugs, and all medical staff unanimously answered that the period from approval from the Ministry of Food and Drug Safety to health insurance coverage is 'Long', and 74% pointed out that 'Too Long'. Regarding the appropriate period from permission to health insurance registration, 81% of medical staff said 'maximum 10 months', and 41% of them judged that 'within 6 months' was appropriate.
There were also deep concerns about low access to new drugs. 94% of medical staff pointed out that 'Korea's access to new drugs is lower than that of overseas countries', and 97% answered that the government should set appropriate and reasonable drug prices to prevent the phenomenon of 'Korea-passing' in which multinational pharmaceutical companies abandon the launch of innovative new drugs due to domestic drug-related regulations. Seventy-six percent of the respondents were concerned that the proportion of new drug spending (13.5%) out of total domestic drug costs was 60% lower than the OECD average (33.9%)Eighty-eight percent of the respondents said '.
83% of medical staff expected that patient treatment results would improve significantly if drugs already commonly used overseas were covered by health insurance benefits in Korea. 85% of medical staff responded that 'if the benefit standard is eased even for drugs already listed on health insurance and the drug is available for early or wide use, patient treatment results will improve significantly'.
In addition, 95% of medical staff urged the Ministry of Health and Welfare to introduce a 'quick registration procedure or system' for health insurance coverage, similar to the Ministry of Food and Drug Safety's"Global Innovation Product Rapid Review (GIFT)" system, which shortens the drug license review period for severe or life-threatening diseases by up to 75%.
A KRPIA official said, "Medical staff caring for patients in the field regret the fact that patients are having difficulty in treatment due to the delay in introducing innovative new drugs, and we hope that new drugs will be listed on the health insurance more quickly and to a wider extent." We hope that the results of this survey will help create a patient-centered treatment environment and design policies," he said.
This article was translated by Naver AI translator.
