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- [Reporter's View] Korea’s vaccination space: ups and downs
- by Eo, Yun-Ho May 15, 2025 06:23am
- Vaccines are at the forefront of localized pharmaceuticals in Korea. Leading domestic companies such as GC Biopharma and SK Bioscience are now responsible for vaccine production and supplying preventive vaccines for various diseases, including influenza. The commercialization of so-called “premium homegrown vaccines,” such as pneumococcal protein vaccines, cervical cancer vaccines, and shingles vaccines, is also progressing steadily and is set to be completed soon. However, despite the improvement in vaccine competitiveness, the vaccination fee cartel among doctors in South Korea remains unchanged. For example, if the purchase price of a vaccine (the price at which doctors buy vaccines from pharmaceutical companies) is KRW 100,000, the implicitly accepted appropriate inoculation fee among doctors is around KRW 200,000. However, after some time passes, some local clinics lower the vaccination fee to as low as KRW 150,000 in an attempt to sell more at lower prices. Some even abandon their margins altogether, offering even lower prices through promotional events. These clinics then face criticism from neighboring doctors. They are labeled as traitors who betrayed their colleagues for their own gain. Such controversies can escalate into disputes between different medical specialties. The medical society of the relevant specialty may launch a campaign claiming that people should be vaccinated by specialists in their respective field. The interesting point lies in the margins. For vaccines, the difference between the inoculation fee and the purchase price, minus approximately 30% tax, constitutes the doctors' income. If they receive the “appropriate price” they claim&8212;KRW 200,000 per vaccination&8212;the actual income may vary depending on tax reporting, but amounts to roughly 70,000 won. For some workers, this is equivalent to a day's wage. Even if they receive KRW 150,000, approximately KRW 35,000 margin remains. This is by no means a small amount. Private practitioners claim that after including vaccination fees and labor costs, nothing remains. Meanwhile, during the flu season, they engage in fierce competition to secure supplies of flu vaccines, where the purchase price is KRW 10,000, and an approximately KRW 12,000 margin remains per inoculation. Private practice doctors are self-employed. This is a fact. Therefore, it is understandable that they want a high income that commensurates with the effort they put into obtaining their medical license. Additionally, since vaccine prices are not fixed, they have the right to set their own prices. However, they should refrain from claiming that twice the purchase price is the “appropriate price” and form a cartel. I earnestly hope they will finally “recognize” that the era when doctors' words were unquestioningly accepted is now over.
- Company
- Doctors ‘Reimb too slow for new drugs in Korea’
- by Eo, Yun-Ho May 15, 2025 06:23am
- Most doctors were found to believe that the speed of reimbursement for new drugs in Korea is too slow. The Korean Research-based Pharmaceutical Industry Association (KRPIA) released the results of a survey of 100 domestic medical professionals on the 14th. In January, the global polling agency Ipsos Research surveyed domestic clinical experts from various medical departments to ask their opinions on access to new drugs. According to survey results, all medical professionals unanimously answered that the period from the Ministry of Food and Drug Safety approval to health insurance reimbursement listing is “long,” with 74% stating it is “too long.” Regarding the appropriate period from approval to health insurance listing, 81% of medical professionals answered “up to 10 months,” with 41% deeming “within 6 months” as appropriate. As of 2022, it takes an average of 608 days (approximately 20 months) for innovative new drugs to be approved by the MFDS and listed for health insurance reimbursement in Korea. This is twice the appropriate period cited by most medical professionals (10 months) and significantly longer than in major overseas countries such as Germany (281 days), Japan (301 days), and France (311 days) during the same period. Furthermore, experts directly treating patients in the clinical settings anticipate that the swift and widespread introduction of innovative new drugs will provide substantial benefits for patient care. Eighty-three percent of medical professionals expected that “if drugs already in common use overseas are covered by health insurance in Korea, patient treatment outcomes will improve significantly.” A large proportion of medical professionals (85%) responded that “even for drugs already covered by health insurance, if reimbursement standards are eased to enable early or wider use, patient treatment outcomes will improve significantly.” In addition, 95% of medical professionals urged the MOHW to introduce a “fast-track listing procedure or system” for health insurance coverage, similar to the MFDS's Global Innovate Products on Fast Track (GIFT) system, which shortens the drug approval review period for severe or life-threatening diseases by up to 75%. Medical professionals who participated in the survey also expressed concerns about Korea's low access to new drugs. Ninety-four percent of medical professionals pointed out that “Korea's access to new drugs is lower than overseas,” and 97% answered that “the government must set appropriate and reasonable drug prices to prevent the ‘Korea passing’ phenomenon, where multinational pharmaceutical companies give up the launch of innovative new drugs in Korea due to domestic regulations on pharmaceuticals.” Seventy-six percent of medical professionals were concerned that the proportion of new drug expenditures (13.5%) in total domestic drug expenditures is 60% lower than the OECD average (33.9%), and 88% believed that reimbursement and access to new drugs in South Korea need to be improved to the level of the top 10 OECD countries. Medical professionals identified “enhancing access to innovative new drugs” as the top priority among the four key strategies of the government's Second Comprehensive&160;National Health Insurance Plan (2024-2028). As the government pushes policies to reduce drug costs in response to an aging society, 67% of medical professionals expressed the view that “the budget savings should be reinvested into the health insurance fund.” As the survey respondents were clinical experts, they also requested that the opinions of those working on-site be more actively taken into account in the reimbursement decision-making process. Eighty-eight percent of medical professionals responded that “the opinions of medical professionals should be better reflected in the process of registering drugs for health insurance coverage,” and 80% said that “medical professionals should also be involved in the process of selecting patient population eligible for health insurance coverage.” A KRPIA official stated, “Medical professionals who care for patients on the front lines are deeply concerned about the difficulties patients face in receiving treatment due to delays in the introduction of innovative new drugs. They hope that new drugs will be listed for health insurance reimbursement more swiftly and with a broader scope. We anticipate that the results of this survey will contribute to the government’s fostering of a patient-centered treatment environment and policy design.”
- Company
- Arexvy opening the era of RSV vaccine
- by Whang, byung-woo May 15, 2025 06:22am
- As GSK launches the respiratory syncytial virus (RSV) vaccine Arexvy in South Korea, it will challenge the market on a full-scale. Arexvy is already expanding its market dominance in the global market with its strength as the first RSV vaccine. The company will likely focus on expanding vaccine awareness as it opens the RSV vaccine market for the first time. On May 14, GSK Korea convened a press conference celebrating the launch of Arexvy, the world's first RSV vaccine. The company showcased a preventative strategy for seniors against RSV and Arexvy's clinical significance. Arexvy received approval from the Ministry of Food and Drug Safety (MFDS) at the end of December 2024 for the 'Prevention of lower respiratory tract disease (LRTD) caused by RSV in adults over 60 years of age and older.' Approval of Arexvy was based on results from two Phase 3 studies, 'RSV OA=ADJ-006' and 'RSV OA=ADJ-004,' involving adults 60 years of age and older. The study results showed that during the first RSV season, Arexvy significantly lowered the RSV-LRTD risk by 82.6% and severe RSV-LRTD risk by 94.1% in participants 60 years of age and older compared to placebo. Furthermore, the efficacy of the vaccine regarding RSV-A-associated LRTD increases and RSV-B-associated LRTD increases were 84.6% and 80.9%, respectively. Dr. Ji-Yong Moon, Professor of Konkuk University's Department of Respiratory-Allergy and Clinical Immunology, explained, "RSV infection causes complications, such as pneumonia, in adults aged 60 years or older and it may require hospitalization or lead to death in severe cases," and added, "Based on a retrospective study, 56.8% of the hospitalized adults over age of 65 had pneumonia and 10.6% of those died." Dr. Moon added, "Despite the high disease burden, awareness of RSV infection is poor, and differential testing is not well implemented, so the disease burden of RSV infection has been underestimated." He said, "RSV infection is as contagious as influenza, but there is no specific treatment other than supportive care, so prevention is most important." Experts consider that the launch of the first RSV vaccine, Arexvy, is expected to be significant from a preventive standpoint. Professor Jacob Lee, Professor of the Division of Infectious Disease at Hallym University Kangnam Sacred Heart Hospital, reported that RSV vaccination is already recommended in the United States. Dr. Lee said, "Arexvy showed a preliminary efficacy of 94.6% against RSV-LRTD in adults with one or more comorbidities," and emphasized, "Considering that 84% of domestic adults aged 65 and over have one or more chronic diseases, these data are noteworthy." Dr. Lee stated, "Arexvy was approved in the U.S. in 2023, real-world data on its use have accumulated, and excellent preventive efficacy has been confirmed in actual clinical settings." He said, "The U.S. Advisory Committee on Immunization Practices (ACIP) recommends RSV vaccination for high-risk individuals aged 60&8211;74 and all adults aged 75 and older." Cost and awareness remain challenges… "NIP is necessary from a long-term perspective" Regardless of the preventive value of RSV through Arexvy, it remains uncertain how much influence it will exert in the market. Currently, Arexvy remains non-reimbursed in South Korea. Without a recommendation like that of the U.S. ACIP, there is a need to improve awareness. In particular, the fact that the recommended vaccination age in the U.S. is higher at 75 years old, compared to the domestic approval age of 60 and over, also raises questions. Regarding this, Dr. Lee explained, "In South Korea, the Korean Society of Infectious Diseases is expected to announce a recommendation within this year, but it is unlikely to differ significantly from the U.S.," and added, "To enter the National Immunization Program (NIP), sufficient disease burden research needs to be conducted." Dr. Lee continued, "There is a cost burden and domestic data are lacking, but as the population structure changes, the number of vaccination targets will also increase. Through research data and cost-effectiveness, we can hope for RSV prevention through the NIP in the long term." GSK Korea has stated that it will work to improve awareness through TV advertisements and other means alongside the launch of Arexvy. Hyunji Kwon, Business Unit Head at GSK, added, "RSV is a disease with a great unmet medical need yet remains unfamiliar, so we will work to improve awareness among medical staff and high-risk patients," and added, "In a super-aged society in which, for the first time, the population in their 60s exceeds that in their 40s, we will collaborate with the medical community and the government to increase patient access."
- Company
- Will a new trend emerge for liver cancer treatment?
- by Moon, sung-ho May 15, 2025 06:22am
- With new anticancer drugs entering the liver cancer treatment market, where combination therapy has been gaining prominence, attention is focused on whether a paradigm shift will occur. This is because a new competitive landscape is forming with the arrival of newly approved drugs and newly reimbursed drugs. According to industry sources on the 7th, the US Food and Drug Administration (FDA) recently approved the combination therapy of Bristol Myers Squibb (BMS) and Ono Pharmaceutical's Opdivo (nivolumab)+Yervoy (ipilimumab) combination as a first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). The approval was based on the results of a randomized, open-label, global Phase III clinical trial (CheckMate-9DW) comparing the combination therapy of Opdivo and Yervoy (335 patients) with either lenvatinib or sorafenib monotherapy (333 patients). The trial was conducted on patients with unresectable or metastatic HCC who had not previously received systemic therapy. The CheckMate-9DW results showed that the median overall survival (mOS) in the Opdivo+Yervoy combination therapy group was 23.7 months (95% CI: 18.8-29.4), compared to 20. 6 months (95% CI: 17.5-22.5) in the control group (n=333), reducing the risk of death by 21% (HR=0.79; P=0.0180). In addition, the 3-year survival rate was 38% in the Opdivo+Yervoy combination therapy group, higher than the 24% in the control group. The objective response rate (ORR) was also significantly higher in the combination therapy group at 36.1% (95% CI: 31&8211;41.5) compared to 13.2% (95% CI: 9.8&8211;17.3; P<0.0001) in the control group. The median duration of response (mDOR) was also longer in the combination therapy group at 30.4 months (95% CI: 21.2-NR) compared to 12.9 months (95% CI: 10.2-31.2) in the control group. With such promising data, attention is now on the timing of its domestic approval. This is because, similar to the global situation, there are limited treatment options for liver cancer in domestic clinical settings. Currently, the representative treatment option on-site is Roche's Tecentriq (atezolizumab) and Avastin (bevacizumab) combination therapy. In Korea, this combination therapy is covered by health insurance and is the first-line combination treatment used for HCC on-site. In addition, AstraZeneca's ‘Imfinzi (durvalumab)-Imjudo (tremelimumab)’ combination therapy, which improves the risk of bleeding, a representative side effect of existing treatments, has been approved by the Ministry of Food and Drug Safety, but is not reimbursed by health insurance and can only be used without reimbursement. &160;AstraZeneca, which owns the treatment, pushed for reimbursement and cleared the Health Insurance Review and Assessment Service's Cancer Disease Review Committee review in November last year, but the drug’s approval is still in the pharmacoeconomic evaluation stage by the Drug Reimbursement Evaluation Subcommittee. However, the industry believes that there is a possibility that it will pass pharmacoeconomic evaluation in the second half of this year and be reimbursed by health insurance. Ultimately, the Opdivo+Yervoy combo will likely be approved in Korea at a time when competing options are already covered by reimbursement. Still, what is promising is that the MOHW improved its reimbursement policy for combination therapy in May. Given that no specific guidelines have been issued, at least one of the drugs used in combination therapy may be covered by reimbursement. For reference, Opdivo is currently approved in Korea as part of various combination therapies for melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, urothelial carcinoma, gastric cancer, and esophageal cancer, and has various treatment options that can be covered by the government's new reimbursement plan for combination therapies. A pharmaceutical industry insider who requested anonymity stated, “We expect the Opdivo+Yervoy combination therapy to receive domestic approval in the second half of the year. In the meantime, the Imfinzi-Imjudo combination therapy may pass the cost-effectiveness evaluation. The importance of using these therapies is being emphasized through the National Assembly and other channels. We anticipate intense competition in the HCC treatment market in the future.” Meanwhile, major medical societies led by the Korean Liver Cancer Association have submitted proposals to HIRA to improve reimbursement standards due to frequent cuts made in reimbursements for HCC treatments. The reason is that there is a discrepancy between the indications and clinical studies for each treatment and the reimbursement standards. Professor Hyun Yang from Eunpyeong St. Mary's Hospital (Gastroenterology) said, “There is a gap between reality and the application of reimbursement benefits for systemic treatment of HCC. There is ambiguity in the reimbursement criteria for the combination therapy of Tecentriq and Avastin, which states its use for ‘patients not eligible for local therapy’. There is also a discrepancy between the reimbursement standards and the indications set during the Phase III clinical trial for the Imfinzi+Imujudo combination therapy.” Professor Soon Sun Kim, Insurance Director of the Korean Liver Cancer Association (Gastroenterology, Ajou University Hospital), said, “We submitted the consensus opinion statement collected by experts from the Liver Cancer Association, the Korean Association for the Study of the Liver, and the Koeran Society of Medical Oncology to HIRA regarding the application of medical reimbursement for systemic treatment of HCC,” adding, “We submitted the opinion to improve the ambiguity in the reimbursement criteria for the use of HCC treatments.”
- Company
- 'Adempas' for pulmonary hypertension closer to obtain reimb
- by Eo, Yun-Ho May 14, 2025 06:11am
- A new reimbursable treatment option for pulmonary hypertension is anticipated to be introduced. According to industry sources, Bayer Korea has finally reached an agreement with the National Health Insurance Service (NHIS) for its 'Adempas (riociguat).' Accordingly, after 10 years since it was approved in South Korea, Adempas will likely be included in the reimbursement list. Adempas' negotiation was a dosage negotiation, rather than a ceiling price negotiation. Bayer accepted the price 100% below the weighted average price (WAP) of a substitute drug and passed the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) in February. Adempas was exempted from the drug pricing negotiations. This drug obtained approval in South Korea as an orphan drug in June 2014. Five products with different doses are available, and it has the efficacy and the effect in ▲patients with persistent/recurrent chronic-thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) after surgical treatment or inoperable CTEPH, to improve exercise capacity ▲adult patients with arterial pulmonary hypertension (PAH, WHO Group 1) who have WHO functional class 2-3, to improve exercise capacity. Adempas has been known as the first novel drug to treat CTEPH. CTEPH occurs in patients with chronic pulmonary embolism who progress to chronic obstructive pulmonary disease (COPD) and develop fibrotic stenosis and occlusion, leading to pathological vascular remodeling and increased resistance in the pulmonary arteries. CTEPH is a chronic disease that causes progressive shortness of breath and right heart failure. Symptoms include dyspnea, fatigue, chest pain, dizziness, peripheral edema, cough, and hemoptysis, significantly impacting quality of life. Ultimately, it can progress to heart, kidney, and liver failure, potentially leading to death. Meanwhile, Adempas is a stimulator of soluble guanylate cyclase (sGC), an enzyme found in cardiovascular organs. The efficacy of the drug in patients with chronic thromboembolic pulmonary hypertension (CTEPH) was confirmed in Phase 2 and Phase 3 clinical trials. The clinical trial results showed that Adempas improved the study's primary endpoint physical activity and demonstrated superior tolerability. No unusual adverse reactions were reported. In the CHEST-1 study, results from comparing the 6 Minute Walking Test (6MWT) at 16 weeks from baseline showed that the patient group treated with riociguat had statistically significant improvement compared to the placebo group. In the PATENT-1 study, comparison of changes in 6MWT values at 12 weeks to the placebo group demonstrated statistically significant improvement, meeting the primary endpoint.
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