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- 2025-12-17 23:39:30
- Policy
- HIRA, "Will enhance the monitoring of rare disease drugs"
- by Jung, Heung-Jun Sep 26, 2025 06:12am
- With the rapid increase in newly emerging treatments for rare and severe diseases, there have been suggestions for establishing sustainable systems, such as strengthening post-market management and creating a separate dedicated fund. It was explained that monitoring uncertain evidence resulting from expedited approvals and improving patient access through a separate fund, similar to overseas models, are necessary steps. On September 25, the Health Insurance Review & Assessment Service (HIRA) hosted a symposium at the St. Mary's Hospital Seong-ui Hall in Seoul on the future direction and social ethics of rare and severe disease treatment. Lee So-young, Director of HIRADuring the symposium Lee So-young, Director of HIRA's Pharmaceutical Performance Assessment Division, said that as rare disease treatments rapidly increase, not only Korea but also other countries are deliberating on management strategies. In the United States, 52% of new drug approvals are for rare disease treatments, and the FDA operates four expedited tracks to address unmet medical needs. However, Lee pointed out that problems are arising where expedited approval, often based on surrogate endpoints, does not ultimately improve patient access or where research finds the drug provides no actual benefit. Lee explained, "The FDA is also aware of the problem. Since the year before last, they have required that when approval is based on surrogate index, a confirmatory clinical trial must be initiated or clearly planned," and added, "They have also reinforced measures to allow for rapid withdrawal of approval if the requirements are not met or if the anticipated clinical benefit is not realized." Lee emphasized that it is time for Korea to move beyond viewing rare disease treatment as an exceptional case and start considering a sustainable system. Lee proposed three strategies: ▲Conditional reimbursement based on evidence generation ▲Establishing a separate dedicated fund ▲Improving reimbursement criteria and pre-and post-market management. Regarding conditional reimbursement, Lee said, "The legal basis is established, and the guidelines will be released in November this year. This is a structure where a drug is listed and covered on the condition that post-market evaluation is conducted, and the post-market management tracks the extent of evidence uncertainty and whether that uncertainty can be eliminated." Lee added, "The UK classifies drugs into those that should or should not be listed through the Cancer Drug Fund. They have also established an Innovative Medicines Fund. Taiwan and Australia operate similar funds," proposing the establishment of a separate fund in Korea. Lee concluded, "Currently, reimbursement management is conducted at the patient level. There is a need for monitoring at the drug and disease level, with performance management based on those results,"and added, "It's difficult for pharmaceutical companies alone to gather and compile all the data. The EU also operates its system through transnational cooperation," and stressed the importance of a cooperative framework for strengthening post-market management.
- Policy
- Legislation of restricted INN Prescriptions gain momentum
- by Lee, Jeong-Hwan Sep 26, 2025 06:11am
- With the ruling party accelerating legislation of “restricted international nonproprietary name (INN) prescriptions,” which was one of President Jae-myung Lee’s campaign pledges, the medical community is showing visible unease. Democratic Party of Korea lawmakers In-soon Nam, Young-seok Seo, Yoon Kim, and Jong-tae Jang, along with Rebuilding Korea Party lawmaker Sun-min Kim, announced that they will host a policy forum on September 30 at the National Assembly under the theme “Introducing a Korean Model for INN Prescriptions.” In response, doctors’ associations have directly talked with Rep. Joo-min Park, chair of the NA Health and Welfare Committee, and are planning a protest rally. On the 24th, the Seoul Medical Association said it would hold a “Seoul Medical Association Representatives’ Rally Against INN Prescriptions” on September 26 at 7:30 a.m. at its headquarters. Participants will include the members of its executive board, auditors, the council’s steering committee, and presidents and executives of local medical associations. The day before, the Seoul Medical Association President Kyu-Seok Hwang visited NA Health and Welfare Committee Chair Joo-min Park's office on the 23rd for a meeting and conveyed their position on how the INN-based prescription policy threatens the sustainability of primary care. Doctors argue that since generic substitution is already legally guaranteed, further mandating INN prescriptions would jeopardize patient safety and undermine the foundation of Korea’s doctor-pharmacist separation system. They also contended that trying to address drug supply shortages through INN prescriptions is not a fundamental solution, and that the clause stipulating penalties of up to 1 year imprisonment or fines up to KRW 10 million is excessive. Nonetheless, the ruling party maintains the position that legislation is inevitable to resolve the harm to patients caused by shortages of essential and unstable supply of medicines. The lawmakers co-hosting the INN prescription forum with the Korean Pharmaceutical Association and the Korea Institute for Pharmaceutical Policy Affairs include not only pharmacist-turned-lawmaker Young-Seok Seo but also physician-turned-lawmakers Yoon Kim and Sun-min Kim, indicating broad support on the need for its institutionalization. The ruling party lawmakers recognize that the bill on restricted INN prescribing (led by Representative Jong-tae Jang), which is currently pending in the National Assembly, is far removed from undermining the intent of the separation of medical and pharmaceutical practices or threatening patient safety. This is because the bill proposes establishing a ‘Supply Management Committee for Medicines with Unstable Supply’ under the Ministry of Health and Welfare, involving both pharmacists and doctors, to designate out-of-stock drugs and permit generic prescribing only for those designated drugs. Lawmakers argue that legislation on restricted INN prescriptions must focus on easing patient inconvenience and improving access to medicines, rather than fueling conflicts over professional boundaries between doctors and pharmacists. A ruling party official said, “The restricted INN prescription bill should prioritize the public over doctors and pharmacists. The bill establishes a new committee to designate medicines with supply shortages subject to INN prescribing, and institutionalizes a management system requiring pharmaceutical companies, wholesalers, pharmacies, and physicians to submit information on such shortages. The goal is to resolve the long-standing inconvenience faced by the public.”
- Policy
- PVA monitoring for high-priced drugs conducted in Q4
- by Jung, Heung-Jun Sep 25, 2025 06:12am
- High-priced anticancer drugs, including Keytruda and Opdivo, have been placed under monitoring for price-volume agreements (PVA, Type A·B) in the 4th quarter. On the 23rd, the National Health Insurance Service (NHIS) released ‘prior information on the Q4 monitoring list for drugs subject to PVA (Type A·B).’ A total of 111 items were listed, including many blockbuster products from multinational pharma companies such as ▲ Novartis Korea’s Zolgensma (onasemnogene abeparvovec), ▲ MSD Korea’s Keytruda (pembrolizumab), ▲ Ono Pharmaceutical Korea’s Opdivo (nivolumab) 20mg, 100mg, 240mg, ▲ Roche Korea’s Alecensa (alectinib HCl) 150mg, ▲ Sanofi-Aventis Korea’s Dupixent (dupilumab) 200mg, 300mg. Also, products from Korean pharmaceutical companies on the list include: ▲ Celltrion’s Donerion Patch (donepezil) 87.5mg, 175mg, ▲ GC Biopharma’s Denol (bismuth subcitrate potassium), ▲ Bukwang Pharma’s Agio Granule, ▲ Dongindang Pharma’s LecClean Solution (sodium phosphate) 133ml, 1000ml, ▲ Ildong Pharmaceutical’s Pirespa Tab (pirfenidone) 200mg, and ▲ Boryung Corp’s Kanarb (fimasartan potassium trihydrate) 30mg, 60mg, 120mg. The NHIS said, “Claims filed for the monitored drugs will be analyzed, and if they meet the negotiation criteria, they will be designated as subjects for price-volume agreement negotiations.”
- Policy
- Parties disagree with non-face-to-face medical service bill
- by Lee, Jeong-Hwan Sep 24, 2025 06:25am
- Lee Su-jin, the chief secretary of the Democratic Party of Korea (left), requested that Kim Mi-ae, the Chief Secretary of the People Power Party, hold a review committee for the "one-point" bill on non-face-to-face medical services.The government's effort to pass a "one-point" bill on non-face-to-face medical services through the National Assembly's Health and Welfare Committee, Judiciary Committee, and plenary session this month has failed. The chief secretary of the Democratic Party of Korea, Lee Su-jin, on behalf of Vice Minister of Health and Welfare Lee Hyung-hoon, requested that Kim Mi-ae, the Chief Secretary of the People Power Party and chair of the First Legislative Subcommittee, hold an additional subcommittee meeting today (September 24). However, they failed to reach an agreement. An official from the Democratic Party of Korea's office on the Health and Welfare Committee explained, "We continued to negotiate with Chief Secretary Kim Mi-ae's office to hold an additional one-point subcommittee on the non-face-to-face medical service bill, but they ultimately did not agree so that it won't be held." Consequently, this means that the amendment to the Medical Services Act, which includes: ▲The formal institutionalization of the non-face-to-face medical service pilot program ▲The legalization of a public electronic prescription delivery system for medical services ▲Allowing first-time medical consultations within a broader metropolitan area ▲Limiting drugs and prescription days for first-time non-face-to-face medical consultations ▲Allowing drug delivery for a limited group of patients within their residential area ▲Mandating doctors to confirm the DUR (Drug Utilization Review) during non-face-to-face medical services. It is now expected to get another chance for review in November, after the National Assembly's annual audit concludes next month. During the legislative subcommittee meeting on the afternoon of September 22, the non-face-to-face medical service bill was reportedly nearing passage, as most contentious points had been resolved. Kim Mi-ae, the chair of the legislative subcommittee, even hinted at bill passage, saying immediately after the meeting, "We've reached over 80% agreement. It will be possible to pass it within the regular session." The Ministry of Health and Welfare's request for an additional subcommittee meeting to expedite the bill's passage was not realized due to the legislative subcommittee chair's disagreement. An official from the Democratic Party's office said, "We tried to negotiate with the People Power Party's office, but we ultimately received a no," and added, "We were told that there was an internal party directive to halt all bill discussions due to the planned filibuster at the plenary session this month." Meanwhile, the People Power Party has announced its plan to filibuster all bills scheduled to be introduced at the plenary session on September 25, which is a legal method of obstructing legislative proceedings under the National Assembly Act. This is the People Power Party's response to the Democratic Party proposed amendments to the Government Organization Act along with key bills.
- Policy
- MFDS to review Tylenol safety following Trump’s remarks
- by Lee, Tak-Sun Sep 24, 2025 06:24am
- The Ministry of Food and Drug Safety (MFDS) announced that it will carefully review safety concerns regarding Tylenol, following remarks made by US President Donald Trump. On the 22nd (local time), President Trump held a press conference at the White House, stating, “Acetaminophen, widely known as Tylenol, may increase the risk of autism in children when taken during pregnancy. The US Food and Drug Administration will inform physicians about this and, if necessary, recommend restricting Tylenol use during pregnancy.” According to reports, the FDA is currently considering relabeling acetaminophen. Trump’s announcement has fueled debate about Tylenol’s safety, especially since the drug has long been considered a safer option for pregnant women and fetuses compared to other pain relievers. The MFDS also plans to conduct its own review. In an official statement released in the afternoon, MFDS said: “Regarding the US government’s announcement on Tylenol, we will request the company to submit its opinions and data on this matter and carefully review the relevant evidence and materials.”
- Policy
- Contraindication guidelines to flu vaccine cut down in KOR
- by Lee, Tak-Sun Sep 23, 2025 06:07am
- The Ministry of Food and Drug Safety (MFDS) plans to significantly reduce the list of contraindications for influenza (flu) vaccines. The MFDS has decided to create a new set of recommended guidelines because the previous contraindications were deemed inconsistent with current clinical practice and international standards. The MFDS collected public opinion on the recommended guidelines for contraindications and precautions for inactivated influenza vaccines until September 19. Most flu vaccines are inactivated vaccines (made from killed viruses). The new recommendations reduced the number of contraindications to two: ▲Individuals with a severe hypersensitivity reaction to any of the vaccine's components (active ingredients and excipients) or to egg ingredients (ovalbumin, egg protein), formaldehyde, or polysorbate ▲Individuals who have previously had a severe hypersensitivity reaction (e.g., anaphylaxis) to an influenza vaccine. In addition to contraindications, a new category for cautious administration group was also established. This category includes three key points: ▲Caution should be exercised when administering intramuscular injections to individuals with thrombocytopenia or coagulation disorders, as bleeding may occur ▲For individuals who have a history of developing Guillain-Barre syndrome or other neurological disorders within six weeks of a previous influenza vaccination, the benefits and risks of vaccination should be carefully considered ▲Vaccination should be postponed for individuals with a severe febrile illness or acute illness. According to the current vaccination approval, the listed contraindications are over 10, where items may vary. For example, ▲Individuals with fever or severe malnutrition ▲Patients with cardiovascular diseases, kidney disease or liver disease whose disease states are in aggressive state, middle state, or active state ▲Patients with acute respiratory disease or active infectious disease. However, in clinical practice, these patient groups, particularly those with chronic diseases, are strongly encouraged to get vaccinated. The MFDS official explained, "The influenza vaccines were approved a long time ago, so they don't align with today's reality or international standards. This is why we have prepared these new recommendations." The new recommendations were established at the request of pharmaceutical companies. Meanwhile, approximately 28 million doses of flu vaccine are scheduled to be supplied in the second half of this year. Seven domestically manufactured products, including those from companies such as Green Cross and SK Bioscience, as well as seven imported products from companies like GSK and Sanofi, will be available. Sanofi announced that it has been supplying its trivalent flu vaccine, 'Vaxigrip,' nationwide since September 3.
- Policy
- Will access to aHUS drugs improve in Korea?
- by Jung, Heung-Jun Sep 23, 2025 06:06am
- The prior approval criteria for receiving reimbursement of atypical hemolytic uremic syndrome (aHUS) drugs, which had long been criticized for impeding patient access, have been improved. This issue was raised during last year’s National Assembly audit as well. At that time, Rep. Yoon Kim (Democratic Party of Korea) pointed out the low approval rate for Soliris (eculizumab). With approval rates hovering at only 30–40% annually, patient access was significantly limited, leading to calls for easing the pre-approval requirements. The Ministry of Health and Welfare (MOHW) is currently collecting public opinion on the proposed partial amendment to the ‘Detailed Rules on the Standards and Methods for Applying Health Insurance Benefits (Drugs),’ from September 18 to 22. The revised proposal specifies the criteria for insurance reimbursement and relaxes or adds detailed requirements on hemoglobin and haptoglobin levels, etc. Previously, the reimbursement criteria required meeting all of the following: ▲ Platelet count below the lower limit of normal at the institution, ▲Presence of schistocytes, ▲ Hemoglobin < 10 g/dL, ▲and Lactate dehydrogenase (LDH) ≥ 1.5 times the upper limit of normal. The revised criteria are as follows: ▲Platelet count < 150×10⁹/L, ▲ Presence of schistocytes, ▲ Hemoglobin < 12 g/dL (or < 11 g/dL for children under 5), ▲ LDH above the upper limit of normal, ▲Haptoglobin below the lower limit of normal. For renal impairment, the wording was changed from “patients” to “cases,” but the thresholds remain the same: ▲≥20% decline in eGFR, ▲Serum creatinine above the age- and sex-specific upper limit of normal. The ADAMTS-13 testing requirement was also specified. Tests must be conducted before plasma exchange or plasma infusion, before the 4th treatment session, or at least 7 days after stopping treatment. However, the criterion based on serum creatinine levels was removed. In addition, a new criterion was added to allow reimbursement even if other requirements were not met. Specifically, if end-stage renal disease due to aHUS is suspected and the drug is required before or after kidney transplantation, coverage may be granted on a case-by-case basis. In addition, the following conditions were removed from the exclusion criteria: ▲ Hemolytic uremic syndrome caused by Shiga toxin, ▲Transplantation, ▲Fibrin thrombosis, ▲paroxysmal nocturnal hemoglobinuria, catastrophic hyperlipoproteinemia, ▲ Sepsis, ▲and other secondary hemolytic uremic syndromes. The revised proposal applies identical detailed recognition criteria to eculizumab (Soliris) and ravulizumab (Ultomiris). The MOHW plans to implement the revised criteria starting October 1, after completing the public opinion collection period.
- Policy
- Bylvay will be reimbursed from next month in Korea
- by Lee, Jeong-Hwan Sep 19, 2025 06:12am
- Bylvay Cap (odevixibat), a treatment for progressive familial intrahepatic cholestasis (PFIC), will be covered by Korea’s National Health Insurance starting on October 1. Bylvay Cap was selected as the first drug for the “Approval–Evaluation–Negotiation parallel pilot program,” and underwent an expedited reimbursement process. The preterm labor prevention drug Tractocile Inj (atosiban) will also be reimbursed starting at the same time. The Ministry of Health and Welfare announced on the 18th a partial amendment to the Detailed Rules on the Standards and Methods for the Application of Medical Care Benefits. Tractocile Inj will be reimbursed for up to 4 cycles within its approved indication. If administered beyond the recognized cycles, the full drug cost must be borne by the patient. Bylvay Cap 200mg will be reimbursed for PFIC patients aged 3 months or older who meet all of the following conditions: Patients with moderate or severe pruritus who have serum bile acid (sBA) concentrations of 100μmol/L or higher and a CGIS score of 2 or higher. Reimbursement will be excluded if any of the following conditions apply at treatment initiation or during treatment: Patients who have undergone liver transplantation, patients with decompensated cirrhosis, patients with hepatic decompensation (such as variceal bleeding, ascites, hepatic encephalopathy) Reimbursement for an additional 6 months is granted if the treatment response is satisfactory at the 6-month evaluation following the first dose. Thereafter, evaluation is conducted every 6 months, and continued administration is approved if the treatment response is maintained. Combination drugs containing empagliflozin (SGLT-2 inhibitor) and sitagliptin — such as Empasita M SR Tab 10·100·1000mg — will also be reimbursed, starting October 24. Cypol-N Soft Cap, Cellcept Capsules, Prograf Cap/Inj, and MTX will have their reimbursement scope expanded starting October 1. In addition to the existing indications, they will now be covered for polymyositis and dermatomyositis. Mabthera Inj (lituximab) and other agents will receive extended reimbursement, now covering “adult refractory nephrotic syndrome, polymyositis, and dermatomyositis.”
- Policy
- MFDS, "Increase in fees will expedite biosimilar approval"
- by Lee, Tak-Sun Sep 18, 2025 06:02am
- The Ministry of Food and Drug Safety (MFDS) has announced that it will expedite biosimilar approvals in relation to a recent "increase in approval fees." The MFDS plans to establish a dedicated review team to provide approval and review services commensurate with the new fees. The MFDS issued an administrative announcement on September 12 regarding a partial amendment to the 'Regulations on Fees for Pharmaceutical Approvals, etc.', which primarily details the reorganization of approval fees for biosimilars (biological medicines). According to the amendment, the approval fee for biosimilars will increase to KRW 310 million, a significant jump from the previous KRW 8.031 million. Also, the MFDS announced that it will shorten the approval period from the current 406 days to 295 days. According to the amendment, the approval fee for biosimilars will increase to KRW 310 million, a significant jump from the previous KRW 8.031 million. An MFDS official stated on September 16 to a group of specialized journalists, "Similar to our innovative plan for new drug approvals, we will expand customized consultations through the operation of a dedicated review team." The MFDS plans to establish a dedicated review team (10-15 reviewers) from various fields to conduct biosimilar reviews in areas such as ▲safety and efficacy ▲quality management ▲Good Manufacturing Practice (GMP) ▲Good Clinical Practice (GCP). Specifically, the teams will be organized by product, centered around the Biopharmaceutical Policy Division's 'Bio Approval TF' within the Biopharmaceuticals and Herbal Medicines Bureau. An official from the Bio Approval TF said, "We have received positive feedback from the industry since implementing the innovative plan for new drug approvals in January," and added, "The dedicated teams will be structured similarly to the new drug innovation plan and are expected to provide swift and accurate approval reviews for biosimilar products." The MFDS also announced plans to prioritize GMP inspections for biosimilar products. The core of this initiative is to conduct GMP evaluations and on-site inspections within 90 days of submitting the approval application. The agency also plans to recruit highly qualified reviewers. Another MFDS official stated, "This matter has not yet been finalized, so I must be cautious in expressing an opinion," and added, "If the biosimilar approval fee increase is finalized, we plan to supplement our staff with highly qualified reviewers to enhance our approval and review capabilities, thereby improving patient access to treatment in Korea. We will do our utmost to respond to the growing demand for biosimilar products." The industry believes that if GMP inspections are completed within 90 days, the approval speed could increase even further. An industry official said, "The demand for biosimilar products has been increasing recently due to the rise in chronic diseases and the aging population," and added, "Because of this, pharmaceutical companies are seriously beginning the development and approval applications for biosimilar products. If the fee increase becomes a reality, the shortened approval timeline will likely accelerate product launches." According to the '2024 Drug Approval Report' released by the MFDS, biosimilar products (equivalent biological medicines) recorded a total of 18 items (10 APIs), an increase of 6 items from the previous year, marking the highest number of approvals since the first product approval in 2012. More than half of these (13 items, 7 APIs) were domestically developed in Korea, suggesting that the domestic biosimilar industry, led by Celltrion and Samsung Biologics, has gained global competitiveness.
- Policy
- Reimb listing a hurdle for Dutasteride + Tadalafil combos
- by Jung, Heung-Jun Sep 18, 2025 06:02am
- The dutasteride-tadalafil combination was approved in January for the treatment of benign prostatic hyperplasia (BPH), but has failed to clear the reimbursement hurdle, which is delaying the drug’s market launch. Four companies – Dongkook Pharmaceutical, Dong-A ST, DongKoo Bio&Pharma, and Shinpoong Pharm - are reportedly discussing a non-reimbursed launch, though some differences in opinion remain. According to industry sources on the 16th, the four companies are debating whether a non-reimbursed launch would have sufficient market potential or whether it would be better to attempt another reimbursement bid. If they proceed with a non-reimbursed launch, they must also decide on the appropriate timing. Dongkook Pharmaceutical (Uresco Tab), Dong-A ST (Dutana Tab), DongKoo Bio&Pharma (Uroguard Tab), and Shinpoong Pharm (Avocial Tab) drew attention in January for obtaining the world’s first approval of fixed-dose dutasteride-tadalafil combinations. Although the companies applied for reimbursement listing, concerns over potential misuse became an obstacle. In particular, the non-reimbursed component of tadalafil was said to have been the sticking point. An industry official commented, “If launched without reimbursement, we need to assess how much market potential it would really have. Some companies also favor making another reimbursement attempt, so consensus must be reached.” The companies are in a difficult position, as launching without reimbursement and then reapplying for listing is not an easy path. The dutasteride-tadalafil combination was first developed by Dongkook Pharmaceutical in 2012 and has come to fruition after 13 years of research. A Dongkook Pharmaceutical representative said, “No definite timeline has been set for a non-reimbursed launch yet, and discussions are still ongoing with the three partner companies.” The companies hold exclusive sales rights for 6 years following approval. The longer the launch is delayed, the shorter the effective exclusivity period becomes. According to IQVIA, the market for dutasteride has been steadily growing alongside the hair loss treatment market. Last year, sales of the original product Avodart reached KRW 42.9 billion, while generics totaled KRW 49.4 billion.
