68% Support Expedited Listing for Rare Diseases and Shorter Review Periods

"Patients' Quality of Life and Social Value Must Be Reflected"

It was found that 7 out of 10 Koreans believe the time it takes for new drugs to be registered for national health insurance coverage is excessively long. While the current process takes an average of about 23 months from the Ministry of Food and Drug Safety approval to health insurance coverage, the public considers an appropriate period to be around 8.5 months on average.


7 Out of 10 Koreans Say "New Drugs Take Too Long for Health Insurance Listing"... Appropriate Period Is 8.5 Months View original image

The Korea Medical Bio Journalists Association and the Korea Research-based Pharmaceutical Industry Association (KRPIA) held a forum titled "New Drug Accessibility: Asking the People - Challenges After Drug Pricing System Reform Seen Through Public Perception Survey" on the 15th at the Korea Press Center in Jung-gu, Seoul, and released these survey results. The survey was conducted by Gallup Korea Healthcare from July 1 to July 10, targeting 3,055 men and women aged 19 to 69 living in all 17 metropolitan cities and provinces nationwide.


According to the survey, the core value the public expects from innovative new drugs is more closely related to actual patient treatment and health restoration, rather than "technological advancement." The image most closely associated with innovative new drugs was "treatment for severe and intractable diseases" at 25.5%, and the most important value of such drugs was cited as "disease treatment and health restoration" at 31.9%.


The problem is that it takes considerable time for innovation in new drugs to translate into actual treatment opportunities for patients. For the current process, which takes about 23 months on average from approval by the Ministry of Food and Drug Safety to health insurance coverage, 67.6% of respondents said this period is "too long." The average period the public considers appropriate was 8.5 months. By interval, the most common response was 7-12 months (36.1%), followed by 4-6 months (31.5%), and under 3 months (20.3%). Meanwhile, only 10.7% thought 13 months or more was reasonable.


Respondents supported institutional improvements to expedite health insurance coverage of new drugs. A total of 74.7% agreed with the introduction of an expedited listing system for orphan drugs, and 73.5% supported shortening the review period to within 100 days. An expansion of the target scope for expedited listing was supported by 71.5%, and 69.9% agreed with increasing the budget share for innovative new drugs by adjusting and reallocating the national health insurance funds.


In addition, 71.5% of respondents agreed with extending the expedited listing process for innovative new drugs not only to treatments for rare diseases but also to other disease groups. Furthermore, 68.3% believed that value assessments of new drugs should also take into consideration improvements in patients’ quality of life and reduction of social costs.


Lim Seong-Soo, head of research at Gallup Korea Healthcare, explained, “The public shows high consensus for improving access to innovative new drugs, but rather than demanding unconditionally fast processes, they call for ‘reliable acceleration’ that includes expertise, patient-centeredness, and fiscal sustainability.”


The Korean Medical Biojournalists Association and the Korea Research-based Pharmaceutical Industry Association (KRPIA) held a forum titled "New Drug Accessibility, Asking the Public for Answers – Challenges After the Drug Pricing System Reform Seen Through a Public Awareness Survey" on the 15th at the Korea Press Center in Jung-gu, Seoul. Korean Medical Biojournalists Association

The Korean Medical Biojournalists Association and the Korea Research-based Pharmaceutical Industry Association (KRPIA) held a forum titled "New Drug Accessibility, Asking the Public for Answers – Challenges After the Drug Pricing System Reform Seen Through a Public Awareness Survey" on the 15th at the Korea Press Center in Jung-gu, Seoul. Korean Medical Biojournalists Association

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Beyond Survival Time to 'Quality of Life'... Drug Pricing Assessment Standards Also Need Reform

The ensuing discussion emphasized that simply reducing the registration process is not enough to improve access to new drugs; a predictable, patient-centered operational system that can have real impact in the field is necessary. Mingul Kim, director of the Clinical Pharmacology Center at Chonbuk National University Hospital, stated, “Improving access to new drugs should go beyond shortening registration timeframes; it must enable patients to begin and continue necessary treatments in a timely and stable manner. From before listing, post-marketing evaluations should be designed based on Real World Evidence (RWE), and a patient-centered value assessment system that reflects both survival and quality of life should be established.”


Eunyoung Lee, director at the Korea Alliance of Patient Organizations, pointed out that the realities patients face regarding access to new drugs are still very challenging. According to their analysis, for 32 anticancer drugs listed from 2021 to 2025, the average time from Ministry of Food and Drug Safety approval to health insurance listing was 1 year and 10 months; for 20 orphan drugs listed from 2022 to 2025, it took an average of 2 years and 11 months. Lee stressed, “While waiting for health insurance coverage, patients may be unable to access treatment due to the financial burden or miss the opportunity for appropriate treatment. Patients' opinions and their perceived value of treatments must be substantially reflected in reimbursement criteria and post-marketing evaluation, and there must be swift and transparent listing processes, along with safeguards to ensure continuity of treatment for existing patients.”



Inhwa Choi, executive director of KRPIA, stated, "This survey shows that securing rapid access to innovative new drugs is not just an industry demand, but a national expectation. Rationally assessing the value of innovative new drugs and creating a patient-centered healthcare environment are key tasks for promoting public health and strengthening the competitiveness of the biohealth industry."


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