'Trump's drug pricing policy could block new IBD treatments in Korea'

The intestine is the longest and most complex organ in our body. Though not visible on the surface, the health signals originating from the intestine are by no means insignificant.

In particular, inflammatory bowel disease (IBD), which has rapidly increased recently, is threatening the quality of life for numerous patients.

According to the Health Insurance Review and Assessment Service, the number of IBD patients in Korea increased from 70,814 in 2019 to 92,665 in 2023, representing a 30 percent increase over the five-year period. Notably, those in their 20s and 30s account for 25.8 percent of the total.

IBD is broadly categorized into Crohn's disease and ulcerative colitis. While the exact cause remains unknown, it is believed to result from a combination of genetic predisposition, abnormal immune responses, intestinal microbiota imbalance, and environmental factors such as diet and stress.

In the past, when there were no effective treatments for IBD, a group of gastroenterologists foresaw the arrival of the “era of the gut” and dedicated themselves to clinical care and research. This group established the Korean Association for the Study of Intestinal Diseases (KASID). Now celebrating over 20 years since its establishment, the KASID has expanded its role beyond clinical care and research to serve as a bridge for improving disease awareness and promoting a patient-centered treatment paradigm.

Korea Biomedical Review sat down with Professor Jung Sung-ae of the Department of Gastroenterology at Ewha Womans University Seoul Hospital, who has been leading the KASID since March this year, to discuss the current state of IBD treatment in Korea, the role of the academic society, and the direction that patients and medical professionals should follow.

Question: Please introduce the KASID.

Answer: The Korean Association for the Study of Intestinal Diseases began as an IBD research group within the Korean Society of Gastroenterology. It began as a research group formed by gastroenterologists interested in the intestines, particularly inflammatory bowel disease (IBD). At the time, hepatitis and stomach cancer were prevalent in Korea, so there were very few doctors interested in IBD. A group of three to five doctors formed a study group, where they studied and held seminars. As more people joined, the group continued to grow. In November 2002, we officially established the KASID.

Q: You became the KASID president in March this year. What are your plans?

A: The KASID has four research committees: the IBD Research Committee, the Intestinal Tumor Research Committee, the Microbiome Research Committee, and the Small Intestine Nutrition Research Committee. When collaborative research is needed on specific topics, it will be conducted through these committees.

The reason why medical societies in Europe and the United States are so influential is that they establish guidelines and continuously update them. Therefore, we have established a guideline task force (TFT) within the society. Through the TFT, we plan to update guidelines tailored to patients in our country. Additionally, there is an Asian-focused IBD society called the “Asian Organization for Crohn’s and Colitis (AOCC),” and one member from our society is participating in their guideline team to help create and update Asian guidelines. However, data is crucial for such research. We plan to create a platform for each research society to collect data.

Recently, the government-doctor conflict has caused considerable fatigue among professors. There is a growing perception that professors are not respected. That’s because the rewards do not match the hard work. I believe it is the role of this society to reassure members about the importance and value of the work we are doing. With this in mind, I have set the slogan for my term as “Hamseong Market.” It means “a place to grow together and study the field,” with the intention of growing together over the next two years. I plan to actively support members who are committed to their studies and want to invest in the future of patient care.

We also operate a program called “Jump.” This is an upgraded version of the Young Leaders Camp we created in 2013, called the “Junior Upgrade Mentoring Program.” If members wish to experience the clinics or laboratories of senior physicians, our society will connect them to the desired location for one or two weeks, with accommodation costs covered by the society. Currently, our association is considering matching young physicians with AI experts to provide guidance tailored to the younger generation. Some of our gastroenterology professors are experts in AI, so we plan to have them teach participants how to find and write papers using AI. This will help reduce the time and effort required to write papers.

Q: In recent years, there has been a significant increase in the number of patients with IBD. What is the reason?

A: Looking at this planet, this disease is more prevalent in the northern hemisphere. This means it is more common in developed countries. However, it is growing in Asia. There are two possible explanations. The first is the “hygiene hypothesis.” The hygiene hypothesis suggests that growing up in an overly clean environment during childhood prevents the immune system from being properly trained, leading to an excessive immune response to novel stimuli. This is similar to the increase in autoimmune diseases, such as atopic dermatitis, psoriasis, and rheumatoid arthritis.

The second cause is food. However, food is very difficult to study. It is impossible to conduct experiments or feed people unhealthy food to see if they develop the disease. Therefore, epidemiological studies are conducted on food. This involves investigating the foods consumed in large quantities in countries with high rates of the disease, as well as those consumed in smaller quantities and those consumed in greater quantities. It has been discovered that ingredients commonly found in processed foods, including carrageenan and emulsifiers, are consumed in higher quantities in countries with high rates of inflammatory bowel disease. As a result, efforts are being made to reduce the consumption of processed foods as much as possible, and mothers are encouraged to cook meals from scratch for their children, despite the challenges this may present.

Q: Recently, many new drugs have been introduced in IBD. Do you anticipate any changes in treatment goals?

A: In the past, the goal of treatment was to alleviate symptoms. However, since IBD requires long-term treatment, it was discovered that patients who showed endoscopic improvement maintained remission for longer periods and had better outcomes when inflammatory markers in blood and stool tests completely normalized. This led to a shift in treatment goals from symptom improvement to histological remission. Therefore, in the short term, the goal is to improve symptoms, followed by reducing inflammatory markers in blood and stool tests within three to six months, and achieving endoscopic improvement within approximately a year through a patient-tailored treatment strategy — Treat to Target.

Q: IBD tends to recur frequently. If a patient has achieved remission but then relapses, does that mean they did not achieve histological remission?

A: Since the length of the intestine is approximately 1.5 meters, there are limitations in that the results may vary, depending on which part of the tissue is removed for testing. Additionally, even individuals who appear endoscopically clear may experience recurrence. This is referred to as the natural course of IBD, where some individuals may start with severe symptoms but remain in remission for life, while others may experience fluctuations between remission and flare-ups even after achieving remission. Some people start with mild symptoms but later become so ill that they require bowel resection. Although it is rare, there are instances where symptoms persist without improvement. In other words, even if remission occurs, it does not guarantee that the condition will not recur, making IBD a condition that requires ongoing treatment and monitoring.

Q: Are treatment goals set differently for each patient, then?

A: These days, we use targeted therapy, which involves setting individual goals for each patient and selecting the most appropriate treatment method. Since each person's genetic and environmental circumstances are different, we develop personalized therapy, which is an optimized treatment strategy tailored to each patient.

Q: What are the unmet needs of IBD patients in Korea?

A: The level of treatment for IBD in Korea is on par with other countries. As a result, Korean medical professionals are actively participating in clinical trials worldwide. When Korean medical professionals participate in clinical trials, Korean patients also have the opportunity to try new drugs. The problem is that drug prices in Korea are too low, which may prevent them from entering the market. In particular, if the Donald Trump administration's “Most-Favored-Nation” (MFN) drug pricing policy is implemented, multinational pharmaceutical companies will be more reluctant to enter the Korean market due to the impact on drug prices in other countries. If the “Korea passing” phenomenon becomes a reality, Korean patients may find themselves in a situation where they cannot access good drugs despite their availability. A case in point is Eli Lilly’s Omvoh, a treatment for adult patients with active ulcerative colitis, which was scheduled to be introduced last year.

Q: The KASID is also well known for its good communication with patient groups.

A: The KASID first met with patient groups in 2013 to communicate with them. Through this, we realized the importance of patient education and that patients had stories they couldn't share in the clinic. As a result, the headquarters office now runs educational programs for patients and their families once or twice a year, and regional branches also organize similar programs.

Q: Recently, enteral support for pediatric Crohn's disease patients has been significantly reduced. This policy was introduced because it was deemed necessary, but its sudden reduction has sparked ongoing controversy. What is the KASID's stance on this?

A: We also find this situation deeply regrettable. Enteral nutrition therapy is one of the most effective and important treatment support methods for pediatric patients with Crohn's disease. However, while research data support total enteral nutrition therapy, partial enteral nutrition therapy lacks sufficient research, leading to the conclusion that it is not yet supported by adequate evidence. At a recent academic conference in Japan, Israeli medical professionals gave a lecture on the importance of enteral nutrition therapy. It would be beneficial to investigate and present cases from other countries as well. As an academic society, we will do our part.

Q: Do you have any message for the government and patients?

A: Inflammatory bowel disease is a chronic and intractable disease that is steadily increasing, especially among young people. As it is a disease that requires lifelong management, I believe that the government, medical professionals, and academic societies must collaborate to ensure that patients do not face this long journey alone. I would like to ask the government to improve access to new drugs. Policy support is urgently needed to improve the health insurance system and enhance the quality of life for patients, thereby alleviating the social burden.

I keep a small medicine box on my desk in the clinic and show it to patients at the end of each consultation. Inside the box is the word “worry,” with the message: “There's not much you can do at home, so leave your worries here, and I'll take care of them for you. Come back in good health until your next visit.” If patients trust their doctors and follow their guidance, they can overcome this challenge. Please stay strong.