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- Opinion
- [Reporter’s View] Be aware, be prepared
- by Eo, Yun-Ho Sep 3, 2025 06:10am
- Even if it seems premature, there is nothing wrong with being prepared. Following the Trump administration’s executive order on the Most-Favored-Nation (MFN) drug pricing policy, the deadline for major multinational pharmaceutical CEOs to submit their proposed drug price reduction plans is fast approaching&8212;September 29. The MFN drug pricing policy seeks to adjust U.S. drug prices to match the lowest price among advanced countries. Initially, this standard was set to apply to Medicaid&8212;health insurance for low-income patients&8212;and gradually expand to Medicare, the public health insurance program. In short, U.S. drug prices will be aligned with the lowest prices found among developed nations. Experts warn that South Korea could become that benchmark country. Given the already heightened concern about “Korea passing,” this may further push multinational companies to avoid listing their drugs in Korea’s reimbursement system altogether. The U.S. pharmaceutical market is the largest in the world and accounts for nearly half of the global market share, which is more than 20 times than that of Korea’s. For multinational firms pursuing profit, Korea becomes a market they can easily abandon. The signs are already visible. Since Trump’s drug pricing policy was announced, some multinational pharmaceutical companies have withdrawn evaluation applications for new drug listings, while others have temporarily halted headquarters’ approval for such applications. Even products already listed have been affected: in one case, a company withdrew authorization, leading to deletion from the reimbursement list. It is time to revisit solutions that have long remained at the “proposal” stage, such as list price preserving mechanisms and structural improvements in expenditure. For drugs already listed, policymakers need to explore alternatives to continuous post-listing price cuts imposed through current pricing mechanisms. Admittedly, dual pricing is an inherently self-serving policy that undermines transparency. By concealing actual country-to-country pricing, it widens the ambiguity of drug costs. Yet, it is also an unavoidable choice for a government seeking to protect its own citizens. Within this dilemma, Korea must now make its own rational choice. There is a chance the scope of Trump’s “bomb” will shrink compared to its initial form. But it remains a possibility nonetheless&8212;even if positive signals were received at the Korea&8211;U.S. summit. Being aware and being prepared is essential.
- Policy
- Luxturna shows signif improvement in 3 out of 6 patients
- by Lee, Tak-Sun Sep 3, 2025 06:09am
- Luxturna (voretigene neparvovec, Novartis), a one-shot gene therapy that costs approximately KRW 300 million, showed clinically significant changes set by reimbursement criteria in only half of the patients. As indicated in the performance evaluation results disclosed last year, the effectiveness was only 50%. The Health Insurance Review & Assessment Service (HIRA) disclosed the latest performance evaluation results for Luxturna on August 29. Luxturna is a gene therapy for patients with inherited retinal disease, administered as a single subretinal injection in each eye. The ceiling price for one vial is KRW 325.8 million, with a patient co-payment of approximately KRW 10.5 million per person. Due to its high cost, health authorities have a risk-sharing agreement (RSA) with three types of contracts (refund, expenditure cap, and performance-based refund) to manage the drug expenditure. The performance-based refund contract, in particular, requires a post-administration performance evaluation to adjust the refund rate. The detailed reimbursement criteria for this drug are as follows. 1. A clinical evaluation (light sensitivity, vision, visual field, etc.) must be performed before administration (within 90 days before the first eye's injection) and at 1-3 months, 12 months, and annually for up to 4 years after administration (after the second eye's injection if both eyes are treated). Objective records, such as medical charts, must be submitted. 2. Light sensitivity must be evaluated using a full-field light threshold test with white light. 3. A clinically significant change is defined as an improvement of 1 log unit (average value for both eyes) or more from the baseline in the full-field light threshold test. The first performance evaluation result was disclosed on October 31 of last year, following the reimbursement listing in February of that year. The first evaluation followed up on four patients 1-3 months after administration. The result showed that two patients had a significant improvement, while two did not, indicating a 50% success rate. The latest evaluation results are based on a total of six patient cases. The evaluation was conducted 1-3 months after administration for two patients and 12 months after for four patients. The results showed that one patient at 1-3 months and two patients at 12 months had a significant improvement. In contrast, it was evaluated that one patient at 1-3 months and two patients at 12 months did not meet the criteria for significant improvement. It means that half of the patients were successful, while the other half failed. Since Luxturna's performance evaluation will continue for up to 4 years, the efficacy is expected to be more accurately verified as more data accumulates. By adjusting the refund rate accordingly, the high cost of the drug can be controlled. HIRA is currently conducting performance evaluations for other high-cost drugs, including Kymriah, Zolgensma, and Qarziba.
- Company
- Moderna’s latest variant-targeted COVID-19 vaccine approved
- by Whang, byung-woo Sep 3, 2025 06:08am
- Moderna Korea announced on the 1st that its LP.8.1 variant-targeted COVID-19 vaccine, ‘Spikevax LP Inj’, has been approved by the Ministry of Food and Drug Safety (MFDS). Spikevax LP has been confirmed to induce broad cross-immune responses against currently circulating variants, including the LP.8.1 strain, and it is authorized for use in adolescents aged 12 and above as well as adults. Moderna plans to supply the newly approved vaccine in time for the government’s 2025&8211;2026 seasonal immunization program, which begins in October. The company noted that its COVID-19 vaccines have demonstrated strong immune effect and safety in large-scale Phase III clinical trials and extensive real-world evidence (RWE). A key feature is that elderly individuals aged 65 and above showed immune responses comparable to those in younger adults. Also, regardless of which vaccine type had been administered previously, the Moderna vaccine showed high immunogenicity when used as a subsequent dose. A domestic study conducted by the Korea Disease Control and Prevention Agency (KDCA) also confirmed that Moderna’s vaccine recorded the lowest breakthrough infection rate among the vaccines used in the early stages of the pandemic. According to the National Immunization Program guidelines, Spikevax LP will be provided free of charge to high-risk groups, including seniors aged 65 and over and residents of long-term care facilities. The Korean Society of Infectious Diseases has stressed that immunity acquired through infection or vaccination wanes over time, and with the emergence of new variants, periodic updated COVID-19 vaccination for high-risk groups is recommended. The LP.8.1 series vaccines supplied this season have already been recommended for use by the World Health Organization (WHO), the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA). Based on recommendations from its Vaccination Expert Committee, the KDCA decided to adopt the LP.8.1 vaccine, which demonstrated stronger neutralizing antibody responses compared to last season’s JN.1-based vaccines. Moderna is the only company manufacturing mRNA COVID-19 vaccines in Korea, through its partnership with Samsung Biologics, and continues to ensure a stable vaccine supply via ongoing cooperation with Boryung Biopharma. Sang Pyo Kim, General Manager of Moderna Korea, said, “COVID-19 remains a threat to high-risk groups, with hospitalizations on the rise for 7 consecutive weeks. Moderna is committed to delivering updated COVID-19 vaccines that address the latest variants in a timely manner, ensuring that people can be vaccinated safely.”
- Company
- 'Prevenar 20' now available at general hospitals
- by Eo, Yun-Ho Sep 2, 2025 06:11am
- The pneumococcal conjugate vaccine 'Prevenar 20,' which will soon be included in the National Immunization Program (NIP), is becoming available for prescription at general hospitals. According to industry sources, Pfizer Korea's Prevenar 20 has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center in Seoul, and Sinchon Severance Hospital, and medical institutes, including Kangnam Sacred Heart Hospital, Kyung Hee University Hospital at Gangdong, Pusan National University Hospital, Seoul National University Bundang Hospital, Ajou University Hospital, Pusan National University Yangsan Hospital, and Chungnam National University Hospital. Several of these hospitals, including Seoul National University Hospital, have approved codes for adult patients only. However, as Prevenar 20 will be included in the NIP effective October, more hospitals are expected to have pediatric vaccines. Prevenar 20 is a pneumococcal conjugate vaccine that was approved by the Ministry of Food and Drug Safety (MFDS) on October 31, 2024. Compared to the 13-valent vaccine, Prevenar 20 has added seven additional pneumococcal serotypes. Among domestically approved pneumococcal conjugate vaccines, it contains the most serotypes. In addition to existing serotype components in the 13-valent vaccine, Prevenar 20 contains seven additional serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F). It can be used to prevent invasive diseases and pneumonia in all ages, including infants aged six weeks and above. Pneumococcus is a major bacterial pathogen that causes various diseases in infants and young children, including otitis media, pneumonia, and meningitis. Vaccination is crucial, especially as it can cause life-threatening invasive pneumococcal disease (IPD) in immunocompromised children. Despite South Korea's NIP supporting the 23-valent pneumococcal polysaccharide vaccine (PPSV23) for adults aged 65 and older, this age group has the highest incidence of invasive pneumococcal disease (IPD). From September 2014 to mid-November 2023, a total of 3,734 cases of IPD were reported. The incidence rate for adults aged 65 and over was 32.1 cases per 100,000 people, accounting for 54.8% of all cases. This rate is the highest among all age groups under 65 years old. The inclusion of Prevenar 20 in the NIP was decided after a comprehensive review by the Korea Expert Committee on Immunization Practices (KECIP) on the vaccine's safety, immunogenicity, and cost-effectiveness. Meanwhile, Korea Vaccine is responsible for the domestic promotion of pediatric Prevenar 20, while Chong Kun Dang handles the promotion of the adult vaccine.
- Policy
- Kanarb and Faslodex to keep their price until ruling
- by Lee, Tak-Sun Sep 2, 2025 06:11am
- The drug prices for Boryung's hypertension treatment ‘Kanarb’ and AstraZeneca's anticancer drug ‘Faslodex,’ which were determined to be reduced by the MOHW due to the entry of generics, will be maintained at their previous levels for now. The court has decided to suspend the execution of the price reduction until the first-instance ruling. As a result, the industry’s eyes are on whether these pharmaceutical companies will be able to halt the price reduction disposition through the main lawsuit. According to industry sources on the 1st, the Seoul Administrative Court accepted an application on the 27th of last month to suspend the execution of the price reduction order for 11 items, including Kanarb Tab. Consequently, the previous insurance price ceiling for the drugs will be maintained until two months after the date of the final judgment of the main trial. The affected items are Boryung's Kanarb Tab (3 dosages), Kanarb Plus Tab (2 dosages), Dukarb Tab (4 dosages), and Dongwha Pharmaceutical's LaCor Tab (2 dosages). At the end of June, the MOHW announced an ex officio adjustment and termination of the premium for these items following the entry of generic drugs containing the active ingredient, the single-ingredient fimasartan. Implementation was scheduled for July 1st. Four pharmaceutical companies' Kanarb generic products were listed for reimbursement last May. Consequently, health authorities proceeded with the ex officio price reduction process for Kanarb. Despite Boryung's objection, the price adjustment was ultimately finalized. The price caps for Kanarb Plus Tab and LaCor Tab, which are combination drugs that contain fimasartan, were also administratively reduced due to the price adjustment. For Dukarb, the premium granted for incrementally modified new drug combinations ended as two or more fimasartan-based single-ingredient drugs became available. Kanarb’s price was reduced by 30%, Dukarb by 21%, and Kanarb Plus and LaCor by 47%. Given that Kanarb and Dukarb each generate sales in the KRW 60 billion range, the price adjustment is expected to lead to a significant decrease in Boryung's overall sales performance. Consequently, many believed Boryung would seek to provisionally maintain its drug prices through litigation. The first trial for the main suit will commence in earnest with the first hearing scheduled for November 13. Kim & Chang is representing Boryung. The drug price for AstraZeneca's anticancer drug Faslodex (fulvestrant) will also be maintained until 30 days after the ruling date of the main case. With more than three companies producing generic versions, Faslodex's price adjustment period was scheduled to end last July. As a result, its insurance price cap was set to decrease from KRW 376,724 to KRW 288,194 starting August 1. AstraZeneca was reportedly considering withdrawing from the domestic market due to the Faslodex price cut disposition. This issue also surfaced during the confirmation hearing for Minister of MOHW Eun-Kyung Jeong. Domestic pharmaceutical companies have also expressed the view that if the original anticancer drug withdraws, it would be difficult for patients to find a substitute, given the market characteristics. Fortunately, the company did not withdraw its product but opted for litigation. On the 29th of last month, the Seoul Administrative Court granted its application for a stay of execution of the price reduction order. The main lawsuit was filed on July 25th, and no hearing date has been set yet. AstraZeneca's legal representative is the law firm Sejong. Although both pharmaceutical companies chose litigation to maintain drug prices, the risk is not entirely absent. This is because the Act on Drug Price Litigation Recovery and Refund that was implemented last year allows the National Health Insurance Service to refund the claimed amount for the trial period if the company loses the case. Nevertheless, analysis suggests the companies ultimately chose litigation due to the significant immediate financial loss and the potential for dispute over the price reduction decision.
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