- LOGIN
- MemberShip
- 2026-06-14 08:30:07
- InterView
- [Reporter’s View] MOHW-Industry clash over reform plan
- by Lee, Jeong-Hwan Mar 17, 2026 09:22am
- The biggest justification for the drug pricing reform plan, which the Ministry of Health and Welfare is accelerating, is “improving the structure of the domestic pharmaceutical industry with a focus on domestically developed new drugs.”Minister Eun Kyoung Jeong and Second Vice Minister Hyung-Hoon Lee have expressed their ambition to create a drug pricing environment that properly rewards pharmaceutical companies that generate innovative value through new drugs, as well as those that are willing to develop medicines essential for public health and life despite low profitability.The ministry has also emphasized the need for a swift overhaul of Korea’s pharmaceutical ecosystem, in which more than 100 companies obtain generic approvals for each active ingredient in a scattered and individual manner, resulting in excessive sales-promotion competition.The domestic pharmaceutical industry, however, is strongly opposing the reform plan, questioning its effectiveness. Companies that have built clinical achievements in new drugs and improved drugs and contributed to the development of Korean new drugs argue that the reform plan, which centers on price cuts for already listed generics and preferential pricing for innovative pharmaceutical companies, will, in fact, bring considerable regression to the domestic pharmaceutical industry.They point out that both the reform plan first unveiled by the Ministry on November 28 of last year and the revised version presented at the Health Insurance Policy Deliberation Committee’s subcommittee meeting on the 11th of this month are far removed from policies that genuinely benefit the “real pharmaceutical companies” that have demonstrated tangible achievements in advancing the domestic pharmaceutical industry and improving public health.A closer look at the domestic industry’s position shows that there is no disagreement with the broad policy direction of rewarding companies that have produced new drug R&D outcomes and contributed to manufacturing drugs vulnerable to supply instability, while cutting prices for those that have not, thereby encouraging new drug creation and a stable supply of essential medicines.The problem is that the Ministry of Health and Welfare’s reform plan cannot escape criticism that “the devil is in the details”—a cliché, but one that rings true.The main point of criticism from pharmaceutical companies regarding the Ministry’s reform plan is the “price cuts for already listed generics.”The Ministry has proposed a policy that uniformly cuts the prices of already listed generics without significant differentiation between pharmaceutical companies that have consistently maintained innovation and continued financial investment, and those that have relied on contract manufacturing of generics to generate profits.That is precisely the clause in the reform plan first disclosed on November 28 last year, which proposed lowering the current generic pricing ratio of 53.55% uniformly to the 40% range.Later, in the revised proposal presented at the HIPDC subcommittee on the 11th, the ministry adjusted the generic pricing ratio from the 40% range to the low-to-mid 40% range, while at the same time establishing a provision to temporarily defer price cuts for already listed generics for certified innovative pharmaceutical companies and companies deemed equivalent to innovative pharmaceutical firms.However, this was accompanied by a proviso stating that the deferment would not apply to ingredients with ‘21 or more listed products.’Pharmaceutical companies argue that the price reduction deferral for innovative pharmaceutical companies does not offer significant merit or benefit, and that, given the proviso regarding the 21-product threshold, the actual benefit effectively converges to zero.They argue that the price reduction deferral provision for innovative pharmaceutical companies appears, at first glance, to be a perfectly fine and sweet piece of fruit, but when you cut it open and look inside, it is rotten to the core—a regulation that has no real substance.Pharmaceutical companies also express dissatisfaction with the preferential drug pricing regulations designed by the Ministry of Health and Welfare, claiming that they are constrained by a piecemeal surcharge system and cannot generate any substantial price benefits, no matter how hard they try. The logic goes that if the government truly wants to build an innovative pharmaceutical ecosystem, it must go beyond mere drug price markups. Through inter-ministerial consultations, the government needs to dramatically strengthen tax benefits and create policies that allow pharmaceutical companies to see tangible benefits, such as regulatory exemptions for those contributing to the production of high-quality medicines, so that companies can generate profits that can then be reinvested into new drug R&D.Then why are the Ministry of Health and Welfare and the pharmaceutical industry clashing so sharply over the same reform plan when they share the same policy objective?Ultimately, it is due to insufficient public-private consultation between the government and the industry before the draft reform plan was disclosed on November 28, resulting in a drug pricing system that started strong but fizzled out.Despite growing backlash from the pharmaceutical industry immediately after the draft was released, the Ministry of Health and Welfare did not engage in any meaningful consultations with pharmaceutical companies until the revised proposal was prepared. The only face-to-face case between the ministry and the pharmaceutical industry was a single working-level consultation in which officials from around 20 pharmaceutical companies were gathered and asked to submit fragmented opinions.Multiple pricing managers at pharmaceutical companies say, “We have worked in market access and drug pricing policy for 10 or even over 15 years, but we have never seen the ministry put forward such a sweeping and unilateral drug pricing reform plan and then make so little effort at mutual consultation.”There is also strong criticism saying, “We don’t understand why the Ministry is turning a deaf ear and continuing with unilateral administration. If this continues, a pricing system will be established in which generic prices for domestic pharmaceutical companies are cut in order to fund innovative new drugs from global pharmaceutical companies. That would be the exact opposite of the ministry’s stated policy goal of fostering the domestic pharmaceutical industry and building a pharmaceutical environment based on new drugs.”There are even accusations that the ministry is merely kowtowing to the Trump administration’s pressure regarding reciprocal drug tariffs, having drafted a drug pricing reform plan out of fear of offending the US, and is now refusing to respond to any requests for revisions.The one thing the domestic pharmaceutical industry is asking of the ministry is a pause on the drug pricing reform plan that has been pushed forward hastily without mutual consultation.Pharmaceutical companies are calling on the ministry that, if it truly intends to design and operate the reform plan with the real goal of pharmaceutical industry innovation, it should stop insisting on a unilateral and coercive proposal and instead set a final timetable even now, promptly launch a public-private joint governance framework on the drug pricing reform plan, and derive a fully revised version.The unwavering stance of solid domestic pharmaceutical companies dedicated to innovation is that the reform plan and amendments presented by the Ministry of Health and Welfare to date are absolutely insufficient to create global blockbuster-level domestic new drugs, resolve crises involving essential medicines and medicines with unstable supply, solve the problem of generic drug proliferation, and eradicate rebate competition caused by pharmaceutical companies trapped in contract generic manufacturing, all of which are necessary to protect both a healthy domestic pharmaceutical environment and the public’s right to health.The words of one pricing manager that I heard while covering the reform continue to ring in my ears. “If the goal of this price cut is simply to reduce drug spending in the National Health Insurance budget, then there is nothing more to say. But we cannot agree at all with the ministry’s claim that its administrative rationale is preferential treatment for innovative pharmaceutical companies and building a new drug ecosystem. If the goal is to foster the pharmaceutical industry and reward real pharmaceutical companies, why are drug prices being cut across the board? Why does the ministry insist on turning a blind eye to the reality where only global big pharma companies end up laughing while domestic pharmaceutical companies are sweating bullets, calculating their losses? Rather than engaging in media stunts, wouldn’t it be the proper attitude for an administrator to put their heads together with industry practitioners and design a proper system?”
- Policy
- Boehringer discontinues original meloxicam 'Mobic Capsules' in KOR
- by Lee, Tak-Sun Mar 17, 2026 09:22am
- Product photo of 'Mobic Capsules''Mobic Capsules,' the original drug of the Non-Steroidal Anti-Inflammatory Drug (NSAID) meloxicam, is set to discontinue its supply in South Korea.Boehringer Ingelheim's headquarters has decided to stop imports, with product stocks expected to be depleted by April next year. The decision to withdraw from the Korean market is interpreted as a result of low sales performance and a market saturated with numerous alternatives of the same ingredient and class.According to industry sources on the 16th, Boehringer Ingelheim Korea has notified distributors regarding the discontinuation of Mobic Capsules.Boehringer Ingelheim stated, "The company has decided to discontinue the supply after recognizing that a wide variety of alternative treatments are already available in the Korean market." The company added, "Currently imported stocks will be supplied until they are exhausted, noting that the expected depletion date may vary depending on usage volume. The projected depletion for Mobic Capsules 7.5mg is around April next year, while Mobic Capsules 15mg is expected to run out by March next year."Mobic is an NSAID containing meloxicam as its active ingredient. It is effective in alleviating inflammation and pain associated with rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis by selectively inhibiting COX-2. While it tends to have fewer gastrointestinal side effects compared to traditional anti-inflammatory drugs, it carries risks of blood clots and cardiovascular issues; therefore, it should be taken at the lowest effective dose for the shortest duration possible.Currently, there are 82 meloxicam products in South Korea at the 7.5mg dose and 15 at the 15mg dose. Even with the withdrawal of the original brand, the impact of the supply disruption is expected to be minimal due to the abundance of substitute medications.Mobic's sales have also been decreasing. According to UBIST, its outpatient prescription sales last year were KRW 1.5 billion, a 2% decrease from the previous year. This is a significant gap compared to Celebrex, another drug in the same NSAID class, which recorded KRW 41.7 billion in outpatient prescriptions last year.Consequently, Boehringer Ingelheim may have decided to halt supply to focus on other pharmaceutical products, given Mobic's low profitability in the Korean market.
- Policy
- Generics companies challenge ₩100B Lixiana·Livalozet mkt
- by Lee, Tak-Sun Mar 17, 2026 09:22am
- LixianaGeneric drug development is accelerating for Lixiana (edoxaban tosylate hydrate, Daiichi Sankyo Korea) and Livalozet (pitavastatin calcium + ezetimibe, JW Pharmaceutical), both of which are approaching the end of their exclusivity periods.Because both drugs have recorded more than KRW 100 billion in prescription sales, they are emerging as major targets for generic manufacturers this year and next.In the case of Lixiana, it has been disclosed that 13 products have applied for approval this year alone.According to the Ministry of Food and Drug Safety on the 16th, under the approval-patent linkage system, the original company was notified of marketing authorization applications filed for 13 generic products containing edoxaban tosylate hydrate in 2026.The recent increase in Lixiana generic approval applications is due to the fact that its substance patent is scheduled to expire on November 10 of this year.As for the pharmaceutical composition patent, which is scheduled to expire on August 21, 2028, most generic manufacturers have already succeeded in circumventing it through passive scope-of-rights confirmation trials. Once the patent expires, there will be no obstacles to launching generic drugs on the market.Lixiana is a direct oral anticoagulant (DOAC) whose prescription volume has continued to expand as it replaces warfarin. According to UBIST, its outpatient prescription sales alone reached KRW 117.5 billion last year.Generic companies had made attempts to invalidate the substance patent due to its strong commercial value, but failed. In addition to the original product, nine follow-on companies have already obtained product approvals, and their generic versions are expected to be launched after the substance patent expires.Since no follow-on product has secured first generic exclusivity, it appears that many products will flood the market simultaneously upon expiry of the substance patent, without restrictions on sales.LivalozetThere is also a strong possibility that a large number of generics will emerge for Livalozet, which posted KRW 117 billion in outpatient prescription sales last year. On the 13th, Nelson Korea, Pharmbio Korea, and Austin Pharmaceuticals all received approval on the same day for their bioequivalence study protocols for generic development.Generic development has already begun in earnest since 2024, with many pharmaceutical companies aiming to file applications. Applications can be submitted after the Livalozet re-examination period ends on July 27 next year.Livalozet is a dyslipidemia treatment combining pitavastatin and ezetimibe, and it has gained popularity due to its lower risk of diabetic side effects and strong lipid-lowering efficacy.In addition to the original company, JW Pharmaceutical, 5 companies have directly launched products with the same active ingredients through their own clinical trials. Ahn Gook Pharmaceutical, Boryung Pharmaceutical, Dongkwang Pharmaceutical, Hanlim Pharm, and Daewon Pharmaceutical launched related products in the second half of 2023 and have continued rapid growth. Last year, Ahn Gook Pharmaceutical’s Pevarozet recorded KRW 29.2 billion in outpatient prescription sales, while Daewon’s Tavalozet recorded KRW 18.2 billion. These companies also succeeded in launching their products early by invalidating Livalozet’s use patent.More recently, low-dose products combining pitavastatin 1 mg and ezetimibe 10 mg have also appeared. In January, Ilsung IS, Ildong, Daewoong, and Hanlim obtained approvals for related products, and this month, JW Pharmaceutical also received approval for a new product.Given recent sales trends, there is a high likelihood that generic drugs will flood the market once the re-evaluation period ends next July.
- Company
- Adjuvant immunotherapies shift gastric cancer trt paradigm
- by Son, Hyung Min Mar 17, 2026 09:22am
- Cancer immunotherapy 'Imfinzi'Major immune checkpoint inhibitors have demonstrated effects in pre- and post-operative adjuvant therapy. A paradigm shift in the treatment of gastric cancer is expected.According to industry sources on the 17th, the addition of an indication for the immunotherapy 'Imfinzi (durvalumab)' in advanced gastric cancer is imminent. AstraZeneca Korea anticipates approval within this month.While East Asia is notable for excellent early diagnosis and surgical outcomes, the risk of recurrence due to residual micrometastases remains high for patients with Stage 2–3 locally advanced disease. A perioperative treatment strategy, administering anticancer drugs both before and after surgery, has emerged as a solution to improve clinical outcomes.According to the final analysis of the Phase 3 MATTERHORN trial presented at the European Society for Medical Oncology (ESMO 2025) in Berlin last October, Imfinzi's perioperative adjuvant therapy significantly improved overall survival (OS) with statistical significance. Furthermore, clinical results for Asian patients, including South Koreans, were introduced at ESMO ASIA 2025.A total of 180 Asian patients participated in this analysis. The Asian cohort had a higher proportion of high-risk patients, with a greater frequency of T4 staging and lymph node positivity compared to the overall study population.Despite this, the Imfinzi combination therapy showed positive results, reducing the risk of disease progression by 26% in the event-free survival (EFS) endpoint compared with the placebo combination group. The 24-month EFS rate was 72.1% for the Imfinzi group, higher than the 64.2% in the placebo group. As the median EFS has not yet been reached in either group, the treatment benefit may become even more pronounced during long-term follow-up. The OS benefits were also consistent with the previous global clinical data.A particularly striking result was the pathological complete response (pCR). In the Asian cohort, the Imfinzi combination increased the proportion of patients whose tumors completely disappeared at the time of surgery to 18.9%, more than triple the 5.6% recorded in the placebo group. This level is similar to the overall analysis results, demonstrating that Imfinzi can significantly enhance tumor shrinkage effects during the preoperative phase.Safety was also confirmed to be at a manageable level, with no specific increase in toxicity compared to the standard FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) regimen. There was no significant difference in Grade 3 or higher adverse events between the two groups, and treatment discontinuation rates were similar, indicating no new safety concerns arising from the addition of Imfinzi. Given that FLOT itself is an intensive regimen, this is interpreted as an important finding.Based on these clinical results, the U.S. Food and Drug Administration (FDA) last month approved Imfinzi monotherapy as maintenance treatment following FLOT combination therapy in adult patients with resectable gastric and gastroesophageal junction adenocarcinoma.While surgery remains the cornerstone of curative treatment for gastric cancer, there is a growing global consensus, including in Asia, that surgery alone is often insufficient for a full cure. The MATTERHORN study has shown that administering immunotherapy in combination with FLOT before surgery, followed by radical resection and subsequent treatment, can meaningfully improve long-term outcomes.Clinical trials of major immunotherapies in perioperative adjuvant therapyCancer immunotherapy 'Keytruda'The attempt to integrate immunotherapy into perioperative care is not limited to Imfinzi. Various studies combining different immunotherapies with chemotherapy are confirming the potential for expanding gastric cancer treatment strategies.For example, improvements in preoperative pathological response rates have been reported in several studies, including studies involving avelumab + FLOT (MONEO), sintilimab + FLOT, toripalimab + SOX, and tislelizumab + SOX. Some studies are also exploring strategies that combine immunotherapy with anti-angiogenic agents or radiation therapy.Recently, the potential to improve tumor response rates has also been identified in preoperative adjuvant strategies involving the PD-1 inhibitor Tevimbra (tislelizumab), further raising the possibility of expanding preoperative immunotherapy.However, not all immunotherapies have achieved the same level of success.MSD's Keytruda (pembrolizumab) demonstrated improved pCR in the Phase 3 KEYNOTE-585 study evaluating a perioperative adjuvant strategy but failed to improve EFS, thus failing to meet its primary endpoints.
- Policy
- The key elements of government’s drug pricing reform plan
- by Jung, Heung-Jun Mar 17, 2026 09:22am
- Under the government’s new drug pricing reform, price cuts for already listed drugs are expected to begin in the third quarter, with preferential treatment for innovative companies’ new listings expected to begin next year.Innovative companies are set to receive a temporary exception from price cuts for existing drugs. However, the duration of these exceptions is scheduled to be finalized at the Health Insurance Policy Deliberation Committee meeting on the 26th.In addition, the fast-track listing–post-evaluation and adjustment track is planned for 2028, and its criteria will be established to select which products are eligible.According to industry sources on the 16th, the Ministry of Health and Welfare plans to finalize the drug pricing reform at the HIPDC plenary meeting on the 26th. Based on the discussions at the subcommittee, the direction of the reform will be fixed after some further adjustments.AI-generated image◆ Generic pricing ratio in low-to-mid 40% range…failure to meet required criteria: 85% → 80% = The pricing ratio, which had been described as “in the 40% range” last November, has recently narrowed to the low-to-mid 40% range at the HIPDC subcommittee.The industry expects it to fall somewhere between 43% and 45%. Since many had hoped for the high 40% range, the industry had expressed disappointment. However, because time remains before the HIPDC meeting, the final rate still remains to be seen.If the required conditions for generic pricing are not met, the pricing level is expected to be lowered from 85% to 80%. If a company does not submit its own bioequivalence data or fails to use APIs registered with the MFDS, the reduction rate will become greater.◆ Price cuts for already listed drugs to begin in Q3…cuts will be deferred for innovative companies, but duration undecided=The government plans to begin price cuts for already listed products in Q3. It intends to divide companies into groups based on their listing dates and implement sequential adjustments using varying calculation rates.Innovative pharmaceutical companies will be granted a deferral period under a separate pricing calculation rule. However, an exception is being discussed for ingredients with 21 or more listed products. A deferral period of 4 to 5 years has been mentioned, but it will be finalized at the HIPDC meeting on the 26th.For innovative companies, their reduction ratio under the price-volume agreement will be raised from 30% to 50%, with application expected to start at the end of this year.◆ New “innovation-equivalent” category to be established next year…50% preferential pricing=When newly listing drugs, innovative companies will receive a 60% pricing add-on. The period for this premium will be 1+3 years. If the product is manufactured domestically, an additional 3 years will be granted.In addition, the government is considering adding a category of companies equivalent to innovative firms, with 50% preferential pricing. These “quasi-innovative” companies would be defined based on annual sales above or below KRW 100 billion, with R&D investment ratios of at least 5% or 7% of sales, respectively.However, companies that have received administrative sanctions for rebates within the past 5 years will be excluded. The preferential period for quasi-innovative companies is expected to be the same as that for certified innovative companies.The preferential measures for innovative and quasi-innovative companies are expected to take effect starting next year.◆ Stepwise price reduction from the 13th product onward…15% reduction rate maintained=To manage multiple generic listings, the government plans to strengthen the stepwise reduction system. The stepwise reduction, which currently begins from the 21st product, is expected to shift to the 13th listed product.The reduction rate itself is expected to remain unchanged, with the price set at 85% of the previous lowest price. However, if multiple products are listed at the point when the 13th product is entered, the price of those products will be adjusted to the 85% level one year later.The strengthened stepwise reduction and multi-product listing management are expected to take effect next year.◆ 100-day fast-track listing to be institutionalized next year…selection criteria for ‘innovative new drugs’ to be established=The government plans to institutionalize fast-track listing for innovative new drugs next year. It also plans to establish post-evaluation and price-adjustment mechanisms.Selection criteria will also be established for determining which innovative new drugs will qualify for fast-track listing. The operation of a grading system is also under review.The government plans to operate a performance-based evaluation model incorporating digital healthcare elements such as hospital EMR systems and AI data, and is also reviewing the creation of a specialized agency.It appears that decisions to delist drugs will be made through post-market evaluation. The plan is to establish an evaluation and adjustment system to determine selective reimbursement coverage and appropriate drug prices.◆ Flexible drug pricing contract system to expand in Q2…will prepare measures to prevent inconvenience to patients =The expansion of the so-called ‘flexible drug pricing contract system,’ which allows for contract prices different from the listed price, is expected to be implemented in Q2.The expanded scope is expected to include listed new drugs, already listed off-patent originals, new drugs whose RSA refund period has ended, incrementally modified new drugs, and biosimilars.As the number of products subject to dual pricing increases, the government is preparing measures to prevent inconvenience to patients. One approach under review is to charge patients based on the separately contracted price rather than the listed price, thereby preventing the need for refunds.◆ Price evaluation and adjustment every 3–5 years…targeting ingredients 5 years after first generic entry=The government is establishing a system for evaluating and adjusting drug prices every 3–5 years. This involves comparing, by ingredient, ▲the number of products, ▲market structure, and ▲drug prices in major countries.The target appears to be ingredients for which 5 years have passed since the first generic entered the market. The specific operational model will be established and implemented after gathering industry feedback.The Ministry of Health and Welfare is reportedly expected to revise and supplement the reform plan containing these elements and approve it at the HIPDC meeting on the 26th.
- Policy
- Approval of HER2-bispecific Ab 'zanidatamab' in KOR imminent
- by Lee, Tak-Sun Mar 16, 2026 09:25am
- BeOne Medicines' 'zanidatamab (product name: Ziihera 300mg),' a HER2-targeted bispecific antibody, is likely to be approved soon.Zanidatamab is the first HER2-targeted therapy for biliary tract cancer (BTC) approved by the U.S. FDA. Once it is introduced to the Korean market, this drug is expected to improve treatment outcomes for local patients significantly.According to industry sources on the 12th, the Ministry of Food and Drug Safety (MFDS) recently completed the safety and efficacy evaluation for zanidatamab. Once a "suitable" decision is made from this review, only the final administrative granting of the license remains. Furthermore, under the "Approval-Reimbursement Linkage System," the company can apply for insurance coverage through the Health Insurance Review and Assessment Service (HIRA) immediately following the completion of the safety/efficacy review.In November 2024, the U.S. FDA granted accelerated approval of zanidatamab for patients with previously treated HER2-positive advanced or metastatic BTC. There has been a high unmet medical need in HER2-positive BTC patients.Treatment options for HER2-positive BTC have been extremely limited. BTC is known for its poor prognosis, with a 5-year survival rate of less than 5% once metastasized. In the pivotal HERIZON-BTC-01 clinical trial, the zanidatamab group showed an objective response rate (ORR) of approximately 52%, and a median duration of response (DOR) of approximately 14.9 months.Following its FDA approval, launch in Korea was expedited after the drug was selected for the Global Innovative products Fast Track (GIFT) program in December 2024. In Korea, the specific indication was submitted for approval for the treatment of adult patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive (IHC 3+) biliary tract cancer.Unlike conventional monoclonal antibodies, zanidatamab is a bispecific antibody that binds simultaneously to two distinct sites on the HER2 (Human Epidermal Growth Factor Receptor 2) protein. This dual-binding mechanism allows for more potent inhibition of cancer cell growth.Beyond BTC, clinical development is currently expanding into gastric and gastroesophageal junction (GEJ) adenocarcinomas.BeOne Medicines underwent a global corporate rebranding last year. Beigene Korea was originally a China-based oncology developer; the company later changed its name to BeOne Medicines and moved its legal registration to Switzerland. In Korea, the company already supplies innovative oncology drugs, including Brukinsa (zanubrutinib) and Tevimbra (tislelizumab).Ziihera is a new drug originally developed by Jazz Pharmaceuticals. BeOne Medicines holds the commercialization rights for the Asia-Pacific region.
- Policy
- Bill proposed to apply 5% coinsurance for follow-up tests
- by Lee, Jeong-Hwan Mar 16, 2026 09:25am
- An amendment to the National Health Insurance Act is being proposed to reduce the patient coinsurance rate to 5% for follow-up examinations for patients with cancer, rare diseases, and severe or intractable illnesses.A bill to amend the Patient Safety Act has also been introduced in the National Assembly. It imposes an obligation on doctors to fully explain the details and circumstances of medical accidents to patients, while stipulating that expressions of consolation, empathy, or regret made by doctors during this process cannot be used as evidence of the doctor’s liability or to their disadvantage in medical malpractice lawsuits.On the 13th, Rep. Kyo-heung Kim of the Democratic Party and Representative Cheol-soo Ahn of the People Power Party each introduced a bill to amend the National Health Insurance Act and the Patient Safety Act, respectively, containing these provisions.Bill to reduce patient coinsurance for follow-up tests for serious diseases to 5%Representative Kim’s bill proposes reducing the patient coinsurance rate to 5% for follow-up examinations for cancer, rare diseases, and severe or intractable diseases that have a high risk of recurrence.Under the current law, insured individuals and their dependents are required to bear part of the cost of medical services when receiving healthcare benefits.For certain diseases with high treatment costs, a special calculation system is applied in which the patient’s share of medical costs is reduced to 5–10% of the total medical benefit costs for a specified period.Rep. Kim pointed out that while cancer, rare diseases, and severe or intractable diseases carry a high risk of recurrence even after treatment, making continuous monitoring and follow-up examinations essential, patients face high testing costs once the special calculation exception ends after the disease is cured.He argued that this creates a problem where patients are unable to receive proper follow-up examinations due to such a financial burden.To address this, accordingly, Representative Kim introduced a bill that reduces the patient cost-sharing rate to 5% when cancer patients, rare disease patients, or patients with severe or intractable diseases undergo follow-up examinations for their respective conditions.Bill preventing doctors’ expressions of sympathy after medical accidents from being used as evidence in lawsuitsRepresentative Cheol-soo Ahn introduced a bill requiring heads of healthcare institutions or healthcare professionals to make efforts to sufficiently explain the details and circumstances of patient safety incidents. The bill also stipulates that expressions of consolation, empathy, or regret made by doctors during this process cannot be used as evidence regarding the doctor’s liability in medical malpractice lawsuits or other legal proceedings.Under the current law, there is no separate provision requiring doctors to explain the details or circumstances of patient safety incidents.In particular, doctors sometimes avoid providing explanations or maintain a defensive stance regarding patient safety incidents, as expressions of humanitarian regret or explanations could later be used as evidence of the healthcare institution’s or healthcare professional’s liability in future trials related to the incident.Representative Ahn expressed concern that the information gap and lack of communication between doctors and patients deepen distrust among patients and their guardians toward healthcare institutions, turning simple incidents into complex legal disputes.He also noted that this situation creates excessive psychological pressure and litigation burdens on healthcare professionals, contributing to instability in the medical environment.The proposed bill would therefore require doctors to provide detailed explanations about medical accidents, while explicitly stating that expressions of sympathy, empathy, or regret cannot be used as evidence of liability in medical lawsuits.Rep. Ahn explained, “This bill aims to restore trust between healthcare professionals and patients and minimize unnecessary social costs, such as those arising from litigation.”
- Company
- Facing the era of low-priced generics…diabetes drug competition
- by Chon, Seung-Hyun Mar 16, 2026 09:25am
- Dong-A ST is adding two more combination therapies that utilize its in-house-developed diabetes drug, Suganon. Having completed the development of these new combinations, the company has entered the regulatory approval stage. Once these two combination drugs are approved, six types of Suganon lineups will be secured.Chong Kun Dang has also expanded its Duvie line, new diabetes drugs, to six products. While competing drugs are seeing stagnant growth due to overheated market competition from hundreds of generics, Chong Kun Dang has strengthened its competitiveness by securing new growth engines through the concentration of its research and development (R&D) capabilities. Analysis suggests that establishing new, incrementally modified drugs (IMDs) will be a powerful driving force for profitability in preparation for the upcoming era of low-priced generics.Dong-A ST files for two Suganon combination drugs...establishing new growth engines amid slow growth in over-saturated marketAccording to the Financial Supervisory Service (FSS) on the 16th, Dong-A ST submitted applications for the marketing authorizations of “Sugaempa” and “Suganova SR” to the Ministry of Food and Drug Safety on the 13th. Both “Sugaempa” and “Suganova” are combination drugs made using Dong-A ST's diabetes drug, Suganon.Suganon, approved in October 2015 as the 26th Korea-developed new drug, is a DPP-4 inhibitor diabetes treatment. Suganon has an outstanding blood glucose-lowering effect even at low doses due to its high selectivity for the DPP-4 enzyme. It has a low impact on the metabolism of other drugs, resulting in high medication convenience and compliance for patients with chronic diseases who must take multiple medications. Furthermore, it can be used without dose adjustment, even in patients with decreased renal function."Sugaempa" is a combination drug that joins Suganon with empagliflozin, an SGLT-2 class diabetes drug. The original drug for the empagliflozin component is Jardiance. "Suganova" is a triple combination drug consisting of Suganon, empagliflozin, and metformin.Yearly outpatient prescriptions for Suganon products (unit: KRW 100 million, source: UBIST)If Dong-A ST receives approval for "Sugaempa" and "Suganova," the Suganon family lineup will expand to six types.In July 2016, Dong-A ST launched Sugamet, a combination containing Suganon and metformin. In May 2023, it released Sugadapa, combining Suganon with the SGLT-2 inhibitor dapagliflozin, and in January 2024, it added a triple combination drug comprising Suganon, dapagliflozin, and metformin.By combining two different SGLT-2 inhibitor components, Dong-A ST will offer two types of Suganon + SGLT-2 inhibitor combinations and two types of Suganon + SGLT-2 inhibitor + metformin combinations. This strategy aims to equip the maximum number of combinations possible so that patients taking individual component drugs separately can utilize a Suganon combination drug. The Suganon family is evaluated to have successfully settled into the prescription market, recording annual sales of approximately KRW 30 billion.According to the pharmaceutical research organization UBIST, the four types in the Suganon family recorded KRW 31.5 billion last year. Sugamet and Suganon recorded prescription amounts of KRW 17.4 billion and KRW 11.1 billion, respectively. Sugatree and Sugadapa recorded KRW 1.6 billion and KRW 1.4 billion, respectively.However, recent growth has been slow. Last year's prescription amount for Sugamet decreased by 3.5% compared to the previous year, and Suganon decreased by 7.7%. Sugamet recorded prescription sales of KRW 20.6 billion in 2022, but they have decreased by 15.6% over the last three years. Suganon has shown a downward trend for three consecutive years, following KRW 14.1 billion in 2022, a 20.9% decline. While Suganon and Sugamet combined for KRW 34.7 billion in 2022, the prescription amount for the four Suganon family products, including Sugatree and Sugadapa, decreased by 9.0% compared to three years ago.With both the DPP-4 inhibitor and SGLT-2 inhibitor markets in Korea entering a state of oversaturation due to the entry of generics, it is a difficult environment to sustain growth. While most domestic pharmaceutical companies compete by offering generics, Dong-A ST's move is to strengthen its competitiveness in the oversaturated market by investing in its self-developed new drugs and additional R&D capabilities. 174 subjects participated in the clinical trials for Dong-A ST's "Sugaempa" and "Suganova."Chong Kun Dang establishes 6 Duvie lineup... Securing profitability weapon against low-priced generic eraChong Kun Dang is also strengthening its competitiveness in a stagnant market by steadily adding to its self-developed diabetes drug Duvie lineup.On the 11th, Chong Kun Dang received marketing authorization approval from the Ministry of Food and Drug Safety for Duviempol XR. Duviempol XR is a triple combination drug comprising lobeglitazone, empagliflozin, and metformin. Lobeglitazone is the main component of Duvie, the diabetes drug independently developed by Chong Kun Dang.Chong Kun Dang stated, "We expect to increase administration convenience by providing a new treatment therapy with the fixed-dose combination of lobeglitazone, empagliflozin, and metformin for type 2 diabetes patients whose blood sugar is not appropriately controlled by the dual therapy of empagliflozin and metformin."Duviempol XR is the sixth lineup developed based on Duvie. Approved in 2013 as the 20th Korea-developed new drug, Duvie is a thiazolidinedione (TZD) class diabetes treatment.Starting with Duvie, Chong Kun Dang currently sells four Duvie lineups: Duviemet SR, Duviemet S, and Duet S. Duviemet SR, approved in 2016, is a combination drug combining Duvie and metformin.Duviemet S, approved in May 2023, is a combination drug containing Duviemet and the DPP-4 inhibitor sitagliptin. The original drug for sitagliptin is Januvia. In June 2023, Chong Kun Dang received additional approval for Duet S, a dual combination drug joining lobeglitazone and sitagliptin.In January, it equipped its fifth lineup by receiving approval for Duviempa, which joins Duvie and empagliflozin. Duviempa can be used for adult type 2 diabetes patients for whom the concomitant administration of lobeglitazone and empagliflozin is appropriate.For Chong Kun Dang, the strategy is to maximize synergy in the prescription market by presenting new treatment alternatives to medical staff and patients through the introduction of various combination drugs centered on Duvie.Annual outpatient prescriptions for Suganon family (unit: KRW 100 million, source: UBIST)The market situation for Duvie is also not easy. Last year, outpatient prescription costs for the four types in the Duvie family totaled KRW 20.3 billion, a 3.9% decrease from the previous year. Duvie's prescription volume was KRW 18.3 billion, accounting for about 90%, while the remaining products were not significantly prominent. In 2022, Duvie and Duviemet combined for KRW 25.4 billion. Last year, the combined prescription amount of the four products decreased by 20.2% compared to three years ago.As with Suganon, it is a difficult environment for Duvie to sustain growth as pharmaceutical companies indiscriminately release generics for diabetes drugs like SGLT-2 inhibitors. However, the company is moving to equip itself with additional growth engines by steadily releasing combination drugs developed through its R&D capabilities. It is viewed that combination drugs developed by a pharmaceutical company's proprietary new drugs can become a driving force for future profitability, especially as the government continues its attempts to lower generic drug prices.In November last year, the Ministry of Health and Welfare (MOHW) reported to the Health Insurance Policy Deliberation Committee a plan to improve the drug pricing system, which includes lowering the price calculation rate for generics and off-patent drugs from 53.55% to the 40% range. It is reported that on the 11th, the MOHW held a sub-committee of the Health Insurance Policy Deliberation Committee and suggested a generic drug price calculation rate in the low-to-mid 40% range. If the generic drug price standard is lowered from 53.55% to 43%, the calculation shows the maximum generic price will be reduced by 19.7%.In the reorganization plan reported by the MOHW last November, it was specified that, while maintaining the maximum price requirements applied since 2020, the reduction rate for unmet requirements would be expanded from 15% to 20%. This means that the prices of generics that do not meet the maximum price requirements will drop even further.Under the drug pricing system reform since July 2020, a generic product can receive the maximum price only if it meets both requirements: performing a bioequivalence study and using registered drug master file ingredients. Every time one requirement is not met, the upper limit price drops by 15%. If both requirements are not met, the structure results in a 27.75% reduction. Applying a 15% reduction rate, the generic maximum price calculation standard of 53.55% drops to 45.52% if one requirement is unmet, and to 38.69% if two requirements are unmet.If the generic calculation standard is set at 43%, a generic that fails to meet one maximum price requirement will be lowered to 34.40%, and a generic that fails to meet two requirements will be lowered to 27.52%. In this case, the price of a generic failing to meet one requirement is reduced by 24.4% compared to the current level, and the reduction rate for failing two requirements is 28.9%. It is mathematically possible to calculate that the reduction in generic drug prices will approach 30%.This is the background for which pharmaceutical companies are complaining that performance pressure could intensify due to the generic drug price cuts. An industry official stated, "Due to the government's policy on lowering drug prices, the market may find it difficult to expect profits from generics in the future. Equipping new drugs or IMDs that can receive high drug prices will greatly help future performance strength."
- Company
- Evolving HIV treatment strategies… new treatment options emerge
- by Son, Hyung Min Mar 16, 2026 09:25am
- The paradigm of HIV treatment is expanding beyond simple viral suppression toward a “lifecycle management” strategy that considers the entire lifespan of people living with HIV.Within the current HIV treatment landscape, a variety of options have emerged, ranging from oral dual-drug regimens that reduce the medication burden during the initial treatment phase to long-acting injectables that prioritize quality of life during long-term treatment. Consequently, treatment strategies are becoming increasingly multifaceted.HIV had long been perceived as a fatal infectious disease characterized by rapid disease progression and high mortality. However, with advances in antiretroviral therapy (ART), the life expectancy of people living with HIV has increased to approximately 78 years, reaching a level not significantly different from that of the general population.At the same time, the U=U (Undetectable = Untransmittable) concept—which states that the virus cannot be transmitted to others once the viral load in the blood becomes undetectable— has positioned HIV treatment as a core pillar of public health strategy, moving beyond individual care.Accordingly, HIV treatment is shifting from a question of survival to ‘how to manage the disease for a long time and in good health.’ In actual clinical practice, the number of patients newly diagnosed in their 20s and 30s is increasing, alongside those in their 60s and 70s who have been on treatment for decades, underscoring the growing importance of long-term treatment management strategies.Amid these changes, there is an emphasis on an approach that considers the entire treatment journey, from the initial treatment phase through long-term management. Among the leading treatment options are GSK’s oral two-drug regimen ‘Dovato (dolutegravir and lamivudine)’ and the combination therapy of the long-acting injectable combination therapy ‘Vocabria (cabotegravir) + Rekambys (rilpivirine).’Two-drug regimen ‘Dovato’ emerges as an initial treatment strategy…effective viral suppression with minimal drug burdenHIV treatment drug ’Dovato.’More than half (approximately 66.7%) of newly diagnosed HIV infections in Korea are diagnosed in people in their 20s and 30s. Since lifelong treatment is required from the time of diagnosis, the importance of strategies to minimize the medication burden during the initial treatment stage is increasing.Dovato, a two-drug oral regimen, is characterized by its ability to reduce drug exposure while demonstrating viral suppression efficacy non-inferior to existing three-drug regimens.In the GEMINI I and II studies, Dovato demonstrated non-inferiority in viral suppression compared with the dolutegravir (DTG) + tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)-based three-drug regimen, and the TANGO study reported positive results regarding bone and renal biomarkers and lipid changes compared to TAF-based therapy. The risk of weight gain was also found to be relatively lower.Thermore, the PASO-DOBLE study, which directly compared the regimen to the existing three-drug regimen of bictegravir (BIC), FTC, and TAF, confirmed non-inferiority in viral suppression rates at week 48, and reported relatively lower risks of weight gain and metabolic side effects.The DOLCE study, conducted in a high-risk group of treatment-naïve HIV-infected individuals with low CD4 counts and high viral loads, and the ATTEND study, which focused on late-diagnosed individuals, also confirmed similar viral suppression effects compared to triple therapy.Based on these study results, guidelines from the Spanish AIDS Research Group GeSIDA (Grupo de Estudio de SIDA), as well as those in Norway, Sweden, and other countries, recommend Dovato as an initial treatment option regardless of baseline viral load.Every 2 month injectable better utilized for HIV in the long term…offers greater utilization in long-term treatment stagesHIV treatment drugs ‘Vocabria’ and ‘Rekambys’As HIV treatment enters the long-term management phase, the focus of treatment has naturally shifted toward quality-of-life management.Amid this trend, the long-acting injectable combination therapy ‘Vocabria + Rekambys,’ administered once every two months, is also establishing itself as a major treatment option.In the Phase III SOLAR study, the therapy demonstrated non-inferiority in both virologic failure rates and viral suppression rates compared with the standard three-drug oral regimen (BIC/FTC/TAF).Treatment satisfaction was also high. The study found that approximately 90% of patients who switched to the long-acting injectable regimen preferred it over the existing oral regimen, citing the following main reasons: ▲ the absence of the need to take medication daily, ▲ treatment convenience, and ▲ reduced psychological burden from being repeatedly reminded of their HIV status through daily medication.The U.S. Department of Health and Human Services (DHHS) guidelines also state that switching to long-acting injectable therapies can improve treatment convenience and reduce medication-related fatigue and the burden of social stigma.In the CARES study, which reflects real-world clinical practice, the virologic success rate of the long-acting injectable therapy reached 96.9%, showing similar efficacy to the oral medication group. Treatment adherence was also found to be high, with 96% of scheduled doses administered within ±7 days.Based on these study results, the 2025 European AIDS Clinical Society (EACS) removed HIV Subtype A1, which had previously been identified as a risk factor for virologic failure and resistance in certain ethnic groups when switching to the Vocabria + Rekambys combination therapy.Currently, the Vocabria + Rekambys combination therapy is the only long-acting HIV injectable treatment available in Korea. It is being used as a switch therapy option to improve treatment convenience and quality of life in adult patients whose viral load has been stably suppressed through existing treatments.This treatment has reportedly accumulated more than 1,000 treatment cases within about one year since its launch in Korea last April.
- Policy
- Pace of expanding low-priced purchase incentive has been adjusted
- by Jung, Heung-Jun Mar 16, 2026 09:25am
- The government is expected to adjust the schedule of its implementation policy, considering the potential side effects of expanding low-priced purchase incentives for medical institutions.While the original plan was to increase the incentive for low-priced purchases from 20% to 50%, officials are now reviewing a plan to lower the target to 35%.According to industry sources on the 16th, the government's fundamental policy direction of transitioning market price reductions into a 'market-linked, transaction-based price system' remains unchanged.However, given the potential negative consequences of a rapid expansion of incentives, the Health Insurance Policy Deliberation Committee is expected to lower the planned increase rate at its meeting this month.The low-price purchase incentive is a system that provides a portion of the savings as a grant to medical institutions when they purchase medicines at a transaction price below the maximum reimbursement limit. Under the current standards notified by the Ministry of Health and Welfare (MOHW), approximately 20% to 30% of the price difference is paid to these institutions.The reform plan released last November included a proposal to expand the incentive payout rate to a maximum of 50%. It is intended to lower actual transaction prices through market competition without relying on government-mandated price cuts.Since the announcement, there have been persistent concerns about overheated price competition and chaos in the distribution order. Critics have pointed out that the side effects of damaging the industry ecosystem could outweigh the benefits of reduced pharmaceutical expenditures.During a recent National Assembly debate on the drug pricing system, specific concerns were raised regarding the potential for rebates following the expansion of these incentives.Hong Seok-hwan, the Policy Director of the Korean Confederation of Trade Unions, criticized the move by stating that rather than the government directly removing the price bubble, the policy induces pharmaceutical companies and hospitals to enter into side agreements at prices lower than the officially notified price, effectively legalizing rebates by guaranteeing the price difference as profit.The government is adjusting the rate of increase in incentives downward to address these concerns. The proposed 35% rate is currently under discussion, and the final payout rate will be decided at this month's Health Insurance Policy Deliberation Committee meeting.Meanwhile, this expansion of low-price purchase incentives applies only to private tertiary general hospitals, general hospitals, clinics, and pharmacies. National and public hospitals are expected to maintain the current 20% rate.
