"Innovative New Drugs: Long Wait from MFDS Approval to Health Insurance Coverage"

Survey of 100 Domestic Medical Professionals by KRPIA
Proposal to Introduce a "Rapid Listing Procedure" for Health Insurance Coverage

Domestic medical professionals believe that it is necessary to shorten the time required for innovative new drugs to be listed (covered) under the National Health Insurance and to expand patients' access to treatment opportunities.

The Korea Research-based Pharma Industry Association (KRPIA), led primarily by foreign pharmaceutical companies, announced on May 14 that it had commissioned Ipsos Research, a global polling agency, to conduct a survey in January on 100 domestic medical professionals regarding their views on access to new drugs. According to the results, all respondents unanimously answered that the period from Ministry of Food and Drug Safety (MFDS) approval to health insurance coverage is "long." Among them, 74% pointed out that it is "too long."

Regarding the appropriate period from approval to health insurance listing, 81% of medical professionals responded that it should be "up to 10 months," with 41% of them stating that "within 6 months" would be appropriate.

As of 2022, it took an average of 608 days in Korea for an innovative new drug to be listed under health insurance after receiving MFDS approval, which was longer than the same period in Germany (281 days), Japan (301 days), and France (311 days).

A total of 83% of medical professionals expected that "if drugs already commonly used overseas were covered by health insurance domestically, patient treatment outcomes would significantly improve." Additionally, 85% of respondents said that "even for drugs already listed under health insurance, if the reimbursement criteria were relaxed to allow for earlier or broader use, patient treatment outcomes would greatly improve."

Furthermore, 95% of medical professionals called for the Ministry of Health and Welfare to introduce a "rapid listing procedure or system" for health insurance coverage, similar to the Ministry of Food and Drug Safety's "Global Innovative Product Fast Track (GIFT)" system, which can shorten the drug approval review period by up to 75% for severe or life-threatening diseases.

A total of 94% of medical professionals pointed out that "access to new drugs in Korea is lower than overseas," and 97% responded that "the government should set appropriate and reasonable drug prices to prevent the 'Korea-passing' phenomenon, in which multinational pharmaceutical companies abandon the launch of innovative new drugs in Korea due to domestic pharmaceutical regulations."

Among respondents, 76% expressed concern that "the proportion of new drug spending in Korea's total pharmaceutical expenditure (13.5%) is 60% lower than the OECD average (33.9%)," and 88% said that "Korea's new drug reimbursement and access should be improved to the level of the top 10 OECD countries."

A KRPIA official stated, "Medical professionals caring for patients in the field are more aware than anyone of the difficulties patients face when the introduction of innovative new drugs is delayed, and they hope that new drugs will be listed under health insurance more quickly and broadly," adding, "We hope that the results of this survey will help create a patient-centered treatment environment and inform policy design."

This content was produced with the assistance of AI translation services.