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- 2025-12-17 23:40:17
- Policy
- No companies apply for domestic API pricing premium
- by Lee, Jeong-Hwan Oct 13, 2025 06:07am
- Although the Ministry of Health and Welfare has implemented a policy since March this year offering a 68% pricing premium on essential medicines made with domestic APIs, it has been confirmed that as of October—7 months after implementation—not a single pharmaceutical company has benefited. Criticism is mounting that the Ministry's overly stringent criteria for applying the pricing premium to domestically produced raw materials severely undermine the policy's effectiveness and hinder the development of the domestic API industry, which is directly linked to public health and national security. According to the ‘Status of Domestic API Drug Price Preferential Treatment’ submitted to People Power Party lawmaker Jong-heon Baek by the Ministry of Health and Welfare on the 10th, despite several months since the policy's implementation, not a single pharmaceutical company has applied for the preferential treatment. The MOHW stated that since the relevant regulations were revised last December and the policy took effect this March, the number of applications for the ‘68% pricing premium for domestically produced active pharmaceutical ingredients used in national essential drugs’ and the number of drugs receiving the benefit are both zero. Although the system aims to promote the use of domestically produced APIs, reduce dependence on foreign APIs, and foster the development of the pharmaceutical industry, it has effectively failed 7 months after its implementation. The domestic pharmaceutical industry is voicing concerns that unless the Ministry revises the relevant price discount regulations, the policy will become a dead letter, effectively meaningless. Reasons behind the domestic API price preferential policy fail National Essential Medicines are defined under the Pharmaceutical Affairs Act as ‘medicines essential for public health, such as disease management and radiation disaster prevention, but for which stable supply is difficult through market mechanisms alone, which are designated by the Minister of Health and Welfare and the Minister of Food and Drug Safety in consultation with the heads of relevant central administrative agencies.’ As of August this year, 473 drugs are designated as National Essential Drugs in Korea. Despite how a policy is in place that adds 68% to the drug price when domestic APIs are used to manufacture these National Essential Drugs, with the benefit lasting up to 10 years, domestic pharmaceutical companies claim the reason there are no applicants or items is because the Ministry of Health and Welfare's standards are excessively stringent. The domestic pharmaceutical industry has long demanded that the 68% drug price advantage be applied even to pharmaceutical companies already producing essential medicines using domestic APIs. They are also calling for regulations to be established that would allow the benefits to be applied retroactively to drugs manufactured before the pricing premium policy was implemented this March. Notably, compound drugs that use both domestic and imported APIs from multiple sources, not just one, are excluded from the 68% price discount. The MOHW currently requires that all major active ingredients contributing to pharmacological efficacy must be individually recognized as domestic APIs to qualify for the price advantage. Pharmaceutical companies criticized that such conditions are unrealistic, warning that very few medicines could ever meet the 68% incentive criteria under the current framework. Politicians agree on the need to improve drug pricing system regulations Some political circles also agree with the domestic pharmaceutical industry's arguments and are urging the Ministry of Health and Welfare to improve the system. Rep. Jong-heon Baek plans to summon Ssang-Soo Han, CEO of Inist ST, as a witness during the upcoming National Assembly audit of the Ministry of Health and Welfare on the 15th. He intends to question him about the inadequacies of the domestic API drug price premium policy and measures to foster the domestic API drug industry. Baek emphasized that in the wake of the COVID-19 pandemic, global protectionism in pharmaceutical supply chains has intensified, and the Korean government must treat the domestic API sector as a matter of public health and national security, not merely industrial policy. Accordingly, Rep. Baek urged the Ministry to prepare countermeasures against the risk of the domestic API preferential pricing policy becoming obsolete. The Ministry has only stated a general position, indicating it will seek solutions by thoroughly gathering opinions from the industry, experts, and the field regarding the demands of the pharmaceutical sector and Rep. Baek. This includes exploring new measures such as retroactive application rules or preferential regulations for compound drugs. Rep Baek pointed out, “The fact that not a single pharmaceutical company has applied for the preferential pricing as essential medicines with domestically produced APIs for 7 months is proof that this is a nominal system. Despite ongoing complaints from the pharmaceutical industry that the application criteria are excessively stringent, if the Ministry of Health and Welfare does not move to make the regulations more realistic, the policy to foster the domestic API drug industry will fail.” He added, “During the NA audit, I plan to question the Minister of Health and Welfare's perception of the API industry and demand that the system be revised, viewing it as an issue concerning public health and national security.”
- Policy
- Demands for expanded reimbursement for NMOSD
- by Jung, Heung-Jun Oct 13, 2025 06:02am
- The demand to improve reimbursement to enhance treatment accessibility for Neuromyelitis Optica Spectrum Disorder (NMOSD) is anticipated to heat up again in this year's parliamentary inspection. During the parliamentary inspection of the Health Insurance Review & Assessment Service (HIRA), on October 17, a NMOSD will attend as a testifier, urging improvements to reimbursement for new drug insurance. NMOSD treatments are gradually receiving reimbursement and expanded criteria. The scope of reimbursement for Roche Korea's Enspryngg (satralizumab), listed for reimbursement in 2023, was expanded in August this year after the symptom relapse criteria had been eased. Uplizna (inebilizumab) recently received conditional reimbursement decision from the Drug Reimbursement Evaluation Committee (DREC) on the 2nd and is awaiting drug price negotiation. AstraZeneca Korea's Soliris (eculizumab) has been covered by reimbursement since April of last year, and Ultomiris (ravulizumab) added the NMOSD indication in July last year but is not yet covered by reimbursement. While access to pharmaceuticals is gradually improving with expanded reimbursement coverage, there are ongoing demands to relax the stringent criteria associated with expensive orphan drugs. In August, a caregiver of an NMOSD patient had requested a lowering of reimbursement hurdles, such as the relapse criteria, through a National Assembly petition. Rep. Seo Mi-hwa of the Democratic Party last month also pointed out the unreasonableness of the new drug reimbursement criteria being conditional on relapse and being preconditioned. Furthermore, there were several arguments that accessibility must be increased for drugs that could prevent relapse. The reimbursement criteria are based on symptom relapse for Enspryngg and Soliris and they also include a conditional clause requiring the administration of MabThera (rituximab) with reimbursement. Since Rep. Seo has requested a NMOSD patient as a testifier for the upcoming parliamentary inspection, more attention is likely to be paid to requests for expanded reimbursement and criteria improvement. Strengthening access to orphan drugs is a key issue that has frequently been raised during the Health and Welfare Committee's parliamentary inspection. Following last year's criticism of the low prio-approval rate for Soliris, the prior-review criteria for its use in Atypical Hemolytic Uremic Syndrome (AHUS) were improved this month.
- Policy
- Ozempic nears reimb approval…next is Mounjaro
- by Jung, Heung-Jun Oct 13, 2025 06:02am
- With Novo Nordisk’s GLP-1 injectable Ozempic (semaglutide) deemed adequate for reimbursement for diabetes, attention is now turning to whether Eli Lilly’s Mounjaro (tirzepatide) will be reviewed next by the Health Insurance Review and Assessment Service (HIRA). At the same time, voices are growing in favor of extending insurance coverage—at least partially—to high-risk obesity treatment, based on body mass index (BMI) criteria. On the 2nd, the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee recognized the appropriateness of coverage for Ozempic 2mg/1.5mL and 4mg/3mL, used for diabetes patients. Following price negotiations, the final listing procedure will be complete.. Lilly Korea’s Mounjaro, which was being prepared for reimbursement evaluation simultaneously with Ozempic, was not included in the list of drugs submitted to DREC this time. However, Lilly has reportedly been actively pursuing reimbursement for Mounjaro as a diabetes treatment since before its launch, submitting supplementary data. The key question is whether Mounjaro will be submitted to the next DREC meeting while Ozempic undergoes the price negotiation process. Apart from the push for the drugs’ reimbursement as a diabetes treatment, calls for the drugs’ reimbursement as an obesity treatment continue. A reimbursement plan limited to high-risk obesity treatment was mentioned in review materials on GLP-1 reimbursement that Representative Mi-hwa Seo of the Democratic Party of Korea received from the National Assembly Research Service. The review contained an opinion suggesting restricting the target population to patients with severe obesity and those at risk of complications. Furthermore, Representative Seo emphasized the need for public support, citing the higher obesity incidence rate among low-income groups compared to higher-income groups. The Korean Society for the Study of Obesity is also pushing for coverage. At a symposium on health insurance policies for obesity management last September, the society proposed a tiered coverage system based on BMI. Their stance is to prioritize improving treatment access for severe obesity, not cosmetic concerns. However, opinions on introducing coverage remain divided, citing concerns about misuse of obesity drugs and the current state of Korea’s health insurance finances. Furthermore, even if a phased coverage approach based on severity is implemented, challenges remain, including establishing appropriate criteria.
- Policy
- 'Low-price purchase incentive ineffective and detrimental'
- by Lee, Jeong-Hwan Oct 10, 2025 06:05am
- Rep. Joo-young Lee There is growing criticism that the government’s low-price drug purchase incentive policy should be overhauled due to its structural contradictions and low effectiveness. The low-price purchase incentive, which is linked to the market-based actual transaction price reduction system, focuses on price rather than quality. From the pharmaceutical companies’ perspective, the lower the actual transaction price (purchase price), the higher the likelihood of a price cut, rendering it difficult for them to actively participate in the policy. Some critics have also raised concerns that the system could be exploited for illegal drug rebate practices, calling for a review of whether it should be fundamentally reformed or even abolished. On the 3rd, Rep. Joo-young Lee of the Reform Party, who is also a member of the National Assembly’s Health and Welfare Committee, said, “The low-price purchase incentive system was designed to enhance the financial soundness of the national health insurance and reduce patient drug costs, but it has become an outdated policy that no one welcomes anymore.” Rep. Lee emphasized that if the government wants to establish a reasonable drug pricing system that both strengthens the pharmaceutical industry and ensures the stability of health insurance finances, it must first abolish policies that do not function in the actual healthcare field, such as low-price purchasing incentives. Under Article 22 of the Enforcement Decree of the National Health Insurance Act, the Health Insurance Review and Assessment Service (HIRA) currently operates the incentive system that pays medical institutions (hospitals, clinics, and pharmacies) 70% of the difference between the reimbursement ceiling price and the actual purchase price when they buy drugs of the same ingredient, dosage, and formulation at a lower price than the insurance ceiling. The program aims to reduce national health insurance expenditures, expand the use of generic drugs, curb excessive use of high-priced medications, and lower patient out-of-pocket costs. It has been in effect since 2010. However, Korean pharmaceutical companies and wholesalers argue that the system has failed to achieve these goals and contains inherent contradictions. They have consistently demanded major reforms or the abolition of the policy. Rep. Lee saw eye to eye on these concerns, urging the government to make substantive policy changes. At the industry level, critics argue that low-price purchasing incentives risk promoting an industry structure that prioritizes price over quality. This is because such incentives reward companies based on how cheaply they can procure drugs, rather than rewarding them for the quality of the drugs themselves. As long as the government maintains a policy that rewards cheaper supply, manufacturers will be incentivized to cut production costs and quality to produce low-cost drugs, sustaining a downward spiral in the market. The pharmaceutical industry and drug wholesalers argue that the low-price purchase incentive system inherently contains a contradiction, as it links incentives to reductions in actual transaction drug prices. They point out that the lower the actual transaction drug price becomes to qualify for the low-price purchase incentive, the greater the likelihood it will later be targeted for price reduction. Consequently, no one is willing to trade at lower drug prices. Healthcare institutions have long pointed out that for small and medium-sized hospitals, neighborhood clinics, and pharmacies—not large tertiary hospitals—the actual volume of low-price purchases is too small, resulting in a low perceived incentive effect. Critics note that over 80% of incentives are concentrated in large tertiary hospitals and mid-sized facilities, often benefiting institutions engaging in “one-won bidding” practices. Rep. Lee stated, “Both the low-price purchase incentive and the actual transaction price reduction systems are built on a price-based structure, not on generic drug quality. They contradict the government’s stated goal of fostering the pharmaceutical industry as a national growth engine and supporting global expansion.” Lee also warned of potential abuse of the system through illegal rebates or manipulation of prescription volumes to maintain sales of specific drugs. Rep. Lee concluded, “If the system has neither achieved its original goal of reducing health insurance expenditures nor contributed to the development of the pharmaceutical industry, the government should not leave it as is. Rather, the government should actively consider abolishing it. There is no reason to maintain a policy that no one supports and that only invites calls for reform or repeal.”
- Policy
- GLP-1 drug Ozempic passes reimbursement review
- by Jung, Heung-Jun Oct 10, 2025 06:05am
- Novo Nordisk’s GLP-1 receptor agonist Ozempic (semaglutide) has passed review by the Health Insurance Review and Assessment Service (HIRA)’s Drug Reimbursement Evaluation Committee, which acknowledged the drug as adequate for reimbursement. Ozempic contains the same active ingredient as the obesity drug Wegovy, but is indicated for diabetes. Meanwhile, the reimbursement scope for Janssen Korea’s prostate cancer drug Erleada (apalutamide) will be expanded. In addition to the existing indication of “metastatic hormone-sensitive prostate cancer (mHSPC),” the new coverage will include treatment for “high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).” On October 2, HIRA held its 10th Drug Reimbursement Evaluation Committee meeting of 2025 to review applications for new drug reimbursement and expanded indications for drugs under risk-sharing agreements. Three drugs - Novo Nordisk’s Ozempic pre-filled pen (semaglutide 2 mg/1.5 mL, 4 mg/3 mL); Shinpoong Pharm’s Hyalflex Inj (hexamethylenediamine dihydrochloride bridged sodium hyaluronic acid gel) for knee osteoarthritis; and Mitsubishi Tanabe Pharma Korea’s Uplizna Inj (inebilizumab) for neuromyelitis optica spectrum disorder (NMOSD) – were reviewed. Ozempic was recognized as adequate for reimbursement “as an adjunct to diet and exercise for adults with type 2 diabetes inadequately controlled by existing therapies (in combination with other antidiabetic agents).” This marks the second time the drug has cleared reimbursement evaluation since 2023. While the first approval included a condition to accept a price below the assessed value, this latest decision carries no such condition. Novo Nordisk reportedly made substantial efforts by submitting supplementary data to HIRA for reimbursement and will now proceed to price negotiations with the National Health Insurance Service (NHIS). Uplizna was recognized as adequate for conditional reimbursement – allowed reimbursement when the company accepts a price below the assessed value—for treating “adult patients positive for anti-aquaporin-4 (AQP4) antibodies with neuromyelitis optica spectrum disorder.” The final listing will follow after the company completes price negotiations with the NHIS. Erleada’s reimbursement will expand to include “high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).” The drug has been reimbursed since April 2023 for “metastatic hormone-sensitive prostate cancer (mHSPC).”
- Policy
- "Why are pharma developing salt changes called innovative?"
- by Lee, Jeong-Hwan Oct 01, 2025 06:10am
- Professor Yong Jin Kwon "There are no developed countries that provide public funds and National Health Insurance resources to pharmaceutical companies for simply changing salt formation. South Korea is the only country in the world that recognizes incrementally modified drugs as having the value of innovative new drugs. (If we want to call incrementally modified drugs innovative new drugs), The government should establish the concept of a super-innovative new drug and allocate funds to companies that develop truly innovative treatments. The National Health Insurance authorities shouldn't be worrying about Korean pharmaceutical companies; they should be preparing to spend hundreds of millions, or billions, of KRW from the NHI budget when a genuine domestic innovative treatment is developed." Criticism calls for a major shift in perspective among domestic pharmaceutical companies in Korea, the Ministry of Health and Welfare (MOHW), and the National Health Insurance Service (NHIS) to foster the Korean pharmaceutical industry and develop new domestic drugs into global blockbusters. The argument is that to produce domestic new drugs that meet the standards of the global market, the NHI authorities must establish an environment that invests limited national budgets and NHI funds into genuine new drugs, rather than salt-changed, incrementally modified drugs. Pharmaceutical companies must step up their investments in New Drug Research and Development (R&D). Immediately after the parliamentary forum, held on September 26, on improving NHI financial management, Professor Yong Jin Kwon of the Public Healthcare Center at Seoul National University Hospital met with DailyPharm and sharply criticized the government's new drug administration and the R&D direction of domestic pharmaceutical companies. Professor Kwon asserted that the current innovative new drug support policy of the Korean government is fundamentally flawed. He pointed out that Korea is the only country in the world to support these efforts with national budgets and NHI funds, recognizing the value of incrementally modified drugs based on salt changes. Professor Kwon emphasized that the Korean pharmaceutical industry must deeply reflect on the fact that it has grown significantly over the past 25 years, driven mainly by public health insurance premiums, yet failed to produce innovative new drugs during that period. "I believe that the presidential pledge for a drug price premium based on innovative new drug value is someone's lobbying work," Professor Kwon stated. "We need to have a conversation with the public about whether there is any developed country that gives NHI funds to companies that just change salt formation. I don't think (the domestic pharmaceutical industry) should be operating this way." He further pointed out, "Twenty-five years ago, when the National Health Insurance Act was introduced and the separation of prescribing and dispensing was implemented, domestic pharmaceutical companies made enormous net profits, eliminating all their debt until generic prices were cut in 2013." He criticized, "That's why structural reform of the pharmaceutical industry failed. There are no studies on how much of the R&D funding provided to pharmaceutical companies, which includes high generic drug prices paid by the public and government support from the MFDS, actually led to tangible results, and no one is looking into it." Professor Kwon said, "The R&D support budget for pharmaceutical companies is public tax money and insurance premiums. So, how much has the domestic pharmaceutical industry truly developed over the past 25 years?" He added, "We need to evaluate this before talking about developing the pharmaceutical industry. The NHIS shouldn't be worrying about domestic pharmaceutical companies. The NHIS should be pushing them to create proper rare disease drugs (new drugs)." Professor Kwon also proposed improving the financial soundness of the NHI by rationalizing the prices of generic drugs. It is to lower generic drug prices to an appropriate level relative to the original price and use the saved resources to support and expand investment in innovative drug development. Specifically, Professor Kwon suggested unilaterally reducing generic drug prices, which currently account for 53.55% of the original drug price, to a level of 30% to 40%, and mitigating the market shock through phased adjustments. It is believed that this redistribution of NHI finances could expand investment in innovative new drugs by two to three times without increasing the total medical expenditure. Professor Kwon said, "I strongly disagree with the NHIS's remark that we should reconsider the structural reform (reduction) of generic drug prices. The NHIS is the public's agent. If they look into where the public's NHI money has been wasted, I absolutely want to tell them that this is not the time to worry about domestic pharmaceutical companies," he asserted. "The Korean government and pharmaceutical companies must raise the competitiveness of the domestic pharmaceutical industry and be prepared to spend hundreds of millions, or billions, of KRW from the NHI budget when an innovative new drug is developed." Finally, Professor Kwon said, "How long will we continue to out-license all our new drug candidates and then have to slash prices when we bring them back from overseas markets? We are a developed country now." He added, "(The government) should improve the system by modifying the current actual transaction price reimbursement system and introducing a dual pricing system so that our new drugs can command high prices when exported to foreign markets."
- Policy
- First lot of returning nasal spray flu vaccine approved
- by Lee, Tak-Sun Sep 30, 2025 06:12am
- FluMist labelThe nasal spray flu vaccine ‘FluMist Intranasal Spray (AstraZeneca Korea)’ has received shipment approval from the Ministry of Food and Drug Safety (MFDS) and is preparing for sales. This product was previously sold by GC Biopharma, but it did not gain significant popularity at the time. With expected demand from children who dislike injections, attention is on whether it will avoid repeating its past failure. On the 26th, the Ministry of Food and Drug Safety granted shipment approval for FluMist Intranasal Spray (live attenuated influenza vaccine), lot number YK2763C (expiration date January 8, 2026). This is the first shipment approval since it was licensed in April this year, signaling the start of full-scale supply ahead of the flu season. FluMist Intranasal Spray is a trivalent vaccine preventing three viruses (influenza A H1N1, H3N2, and influenza B Victoria). It can be administered to children and adults aged 24 months to 49 years. Safety has not been established for children under 24 months. For those aged 50 and older, administration is prohibited in high-risk groups with underlying conditions, as the incidence of pharyngitis was higher compared to placebo. Nevertheless, this vaccine is gaining attention because it offers convenience in administration, particularly for children who dislike injections. This vaccine is a spray product that delivers the solution into the nose, which is expected to improve acceptability among children and make administration easier for providers. At a press conference celebrating the vaccine’s approval in June, Professor Yoon-Kyung Kim (Pediatrics, Korea University Ansan Hospital) said, “FluMist is a painless vaccine delivered by nasal spray that can contribute to increasing flu inoculation rate among children.” However, as it is not included in the National Immunization Program (NIP), demand is expected to fluctuate depending on pricing. When GC Biopharma launched the product in 2009, demand was low because it cost KRW 5,000–10,000 more than injectable vaccines. As a result, its license was revoked in July 2020 after the validity period expired. Another barrier is that intranasal vaccines are not yet familiar to the public, which could also affect uptake. Still, expectations remain that it could raise pediatric flu vaccination rates and contribute to herd immunity, thereby protecting the elderly from infection. A pharmaceutical industry official said, “Ultimately, pricing will impact sales volume. But unlike in the past, there is now demand for non-reimbursed vaccines that emphasize quality, so if the price gap is small, FluMist could gain a foothold in the market.”
- Policy
- MFDS, GLP-1 obesity drug + diabetes med combo hypoglycemia↑
- by Lee, Tak-Sun Sep 30, 2025 06:11am
- GLP-1 obesity drugs Wegovy(left) and Mounjaro.The Ministry of Food and Drug Safety (MFDS) announced that patients with diabetes using GLP-1 obesity treatments, which have recently become popular, must consult with their healthcare provider, as the co-administration of these drugs with diabetes medication significantly increases the risk of hypoglycemia. The MFDS also stressed that the use of obesity treatments must be avoided during pregnancy and lactation. Popular GLP-1 obesity drug brands include 'Wegovy' and 'Mounjaro.' The MFDS (Minister Yu-Kyoung Oh) and the Korea Institute of Drug Safety and Risk Management (KIDS)(President Soojung Sohn) announced on September 29 that they have distributed a 'Guidelines to Safe Use of GLP-1 Obesity Treatments' to regional medical associations and drug safety centers nationwide. This guide contains information on ▲the diseases for which the obesity treatments are used ▲correct administration methods, storage and disposal ▲precautions for use ▲reporting of adverse reactions (side effects). GLP-1 obesity treatments are prescription drugs prescribed to: obese patients with an initial Body Mass Index (BMI) of 30kg/m2 or higher, or overweight patients with a BMI of 27kg/m2 to less than 30kg/m2 who have one or more weight-related comorbidities. The MFDS emphasized that patients taking diabetes medication who are also taking GLP-1 obesity treatments are at a higher risk of hypoglycemia and should consult with their healthcare provider about whether to adjust drug dosages. They also added that the use of obesity treatments is prohibited during pregnancy and lactation, and it is advisable to plan pregnancy considering the drug's residual period in the body. Depending on the specific obesity treatment, contraception may be necessary for at least 1-2 months after discontinuing the medication. Obesity treatments should not be started at a high dose immediately. Instead, patients should initiate treatment with the dose specified by their physician, according to the approved regimen, and gradually increase it, strictly adhering to the dosage and administration instructions provided by both the physician and pharmacist. When administering the obesity treatment, patients should inject into the abdomen, thigh, or upper arm, whichever site is most convenient, and rotate the injection site with each dose. Patients must inform their healthcare professional before administration about ▲any known drug hypersensitivity ▲all currently administered medications, medical history ▲whether they are pregnant or breastfeeding. Additionally, obesity treatments should be stored in the refrigerator away from light. If the medication is frozen, contains particles, or has changed color, it should not be used and must be disposed of. The MFDS stressed that even when GLP-1 obesity treatments are used within the approved scope, adverse events such as gastrointestinal disorders, injection site reactions, fatigue, and dizziness can commonly occur. More clinically significant adverse events, such as hypersensitivity reactions, acute pancreatitis, cholelithiasis, and cholecystitis, may also occur. In such cases, patients should notify their healthcare team or visit the hospital. The MFDS stated that GLP-1 obesity treatments, as prescription drugs, must be used strictly following a physician's prescription and a pharmacist's dispensing and guidance, ensuring safe use within the authorized indications for obesity treatment. It was also stressed that purchasing or distributing these drugs through overseas direct purchases or person-to-person sales online should be avoided, as the product's safety cannot be guaranteed. An MFDS official said, "We hope this guide helps patients using GLP-1 obesity treatments to administer their medication safely." The educational material is available on the MFDS website (www.mfds.go.kr) → Law/Data → Promotional Materials → General Promotional Materials section, on the KIDS website (www.drugsafe.or.kr) → Education/Promotion → Resources section.
- Policy
- MoHW and NHIS agree on need to expand expedited listing
- by Jung, Heung-Jun Sep 29, 2025 06:08am
- The Ministry of Health and Welfare (MoHW) expressed consensus on the need to expand fast-track reimbursement to improve access to treatments for rare and severe diseases. As the government agenda already includes system improvements to reflect the innovative value of new drugs, the ministry stated its intent to support these reforms. On the 26th, at a forum on improving the operation of the National Health Insurance finance hosted by Representatives Mi-hwa Seo and Jong-tae Jang, the government, industry, and academia all voiced the need to expand fast-track reimbursement for rare disease treatments. Yeon-sook Kim, Director-General of the Pharmaceutical Management Division at MOHWYeon-sook Kim, Director-General of the Pharmaceutical Management Division at MOHW, said, “Rare and severe diseases are difficult to diagnose, and the small patient population leads to insufficient data. We do regret how the listing process takes a long time, and communication regarding system improvements has been slow. We will gather opinions to develop the system rationally.” Kim added, “This is also included in the government's national agenda. We have decided that the drug pricing system will support the creation of an ecosystem for innovative new drug development by reflecting the innovative value of new drugs. This also includes alleviating the burden of rare and intractable diseases.” "Our goal is to ensure that more necessary drugs are covered quickly through expedited listing and to broaden coverage. Currently, we are also attempting to accelerate the process by concurrently handling approval and listing. The national agenda also comprehensively includes improvements to the drug pricing system. However, as it requires significant social consensus and careful consideration, we will need time to discuss improvement measures." The National Health Insurance Service (NHIS) emphasized the need for a roadmap to prioritize reimbursement and use resources more efficiently. Yoo-kyung Yoon, Director of Pharmaceutical Management at NHISYoo-kyung Yoon, Director of Pharmaceutical Management at NHIS, said, “There are limitations in terms of budget and review manpower, but I agree expansion is necessary. We recognize the importance of prioritization. We need to review reimbursed drugs, set reimbursement priorities, and establish a roadmap for efficient fiscal use.” “We must determine how to select drugs eligible for fast-track, identify issues as the system is implemented, and continuously improve it to ensure prompt reimbursement can be achieved. Adjusting the reimbursement scope requires social consensus, so we will thoroughly gather opinions from stakeholders.” Yoon also emphasized, “Improvements to the generic drug pricing system must also be considered alongside measures to foster a virtuous cycle in the industry. Rapid listing of rare and intractable disease drugs is included in national policy tasks, and we will strive to develop solutions.” The industry expressed that establishing a virtuous cycle structure is urgently needed to enable the development of innovative new drugs for rare and severe diseases. Jae-won Heo, Executive Director at Gilead Sciences Korea Jae-won Heo, Executive Director at Gilead Sciences Korea, noted, “Hepatitis C, which can progress to liver cancer, already has curative treatments. If patients are treated early, it can actually reduce the financial burden on the NHIS. Data also shows that 20% of cancer patients give up economic activity, devoting much of their time to caregiving. Supporting their return to society carries significant value.” Heo explained, “The number of patients is small, but development is extremely difficult, and companies inevitably face heavy burdens. Even after more than 10 years of research, it is not uncommon to see results showing no clinical effect. Despite failures, companies continue to develop treatments because patients exist. A virtuous cycle must be established so development is feasible,” urging expansion of new drug access. Professor Yong-jin Kwon of Seoul National University Hospital Criticism also emerged that the government should not show a passive attitude toward coverage for rare and severe diseases, and that Aative review of the generic drug pricing system is also necessary. Professor Yong-jin Kwon of Seoul National University Hospital's Public Healthcare Center pointed out, "New drugs are approved, but they aren't even used as non-reimbursed treatments, so they don't show up in the statistics. The coverage rate appears high, but that's because no treatment exists. In reality, the coverage rate for rare diseases isn't high. Furthermore, care costs are not factored in.“ Kwon further criticized, “NHIS does not examine how much value has been generated (so far) from the high prices paid for generics and the development of innovative R&D treatments. How much have domestic pharmaceutical companies advanced over the past 25 years? We need to evaluate the outcomes and discuss the development of the pharmaceutical industry.” stressing the need to reform the generic pricing system.
- Policy
- “Cut prices of generic drugs across the board”
- by Jung, Heung-Jun Sep 29, 2025 06:07am
- A proposal has been made to establish reimbursement priority for treatments targeting rare/serious diseases versus mild conditions, thereby expanding access to new drugs. There were also calls to reform the distorted pharmaceutical budget structure by cutting generic prices across the board and canceling approvals for products lacking bioequivalence data. At a National Assembly forum on improving the operation of health insurance finances for rare and severe diseases, hosted on the 26th by lawmakers Mi-hwa Seo and Jong-tae Jang, participants stressed the need to allocate limited insurance resources more effectively to improve access to new drugs. Prof. Yong-jin Kwon of Seoul National University Hospital’s Public Healthcare Center Professor Yong-jin Kwon of Seoul National University Hospital’s Public Healthcare Center said, “The National Health Insurance system has reached a structural contradiction. While pharmaceutical spending exceeds the OECD average, access to innovative drugs remains restricted, depriving patients of treatment opportunities. Coverage for rare and severe diseases should have expanded, but instead, it has regressed.” Professor Kwon called for ▲Reestablishing reimbursement priorities, ▲reforming the drug management system , and ▲expanding access to new drugs. He explained that a survey conducted last July of 1,000 citizens showed significant public agreement on prioritizing coverage for patients with rare and severe diseases. According to the results, 46.7% agreed with prioritizing severe disease patients, and 52.7% supported prioritizing rare disease patients. However, 76.9% responded that while premiums should be maintained at the current level, coverage should be differentiated. Prof. Kwon said, “This suggests there is sufficient basis to regard reprioritization as being highly feasible.” Professor Kwon proposed the following improvement measures ▲establishing a National Health Insurance Priority Committee with public participation ▲implementing blanket price reductions for generic drugs and fostering competition, and ▲introducing a fast-track system for rapid listing and flexible benefit determination. Prof. Kwon said, “The share of pharmaceutical expenditures is already high, but the portion spent on new drugs is low. The generic market is driving distortion. We should consider whether this is due to high prescription volumes or high generic prices,” stressing the need to shift reimbursement priorities from mild to severe conditions. He added, “Prioritization should consider disease severity and social costs, as well as risks of treatment delays and potential market failures.” He also argued that generic drug prices should be cut across the board, and generics lacking bioequivalence testing should have their approvals revoked. He stated, “It is unworthy of our national standing that drugs without bioequivalence certification are still circulating. Bioequivalence test results should be made public. Citizens must be convinced that the efficacy and composition are identical.” Furthermore, he called for expanding fast-track reimbursement and flexible decision-making for rare disease drugs. Suggestions included accelerating reviews, granting conditional approvals, and enhancing post-marketing management through fast-track pathways. He concluded, “We must streamline the health technology assessment process and implement conditional approvals. If MFDS approval represents the product, insurance reimbursement represents the technology. Even if not yet officially authorized, reimbursement should be possible based on technological appropriateness. For rare diseases, conditional approval and reimbursement must be adopted, and real-world evidence (RWE) should be leveraged for more sophisticated post-market management.” He added, “Flexible reimbursement frameworks must be expanded. Risk-sharing agreements (RSA) should be applied diversely, such as on a performance-based basis. Patients should also understand that the limited coverage can be gradually expanded over time.”
