- LOGIN
- MemberShip
- 2026-07-22 03:12:19
- Company
- Public petition for 'Imdelltra' reimbursement surpasses 50,000
- by Eo, Yun-Ho Jun 21, 2026 02:49pm
- Interest in health insurance reimbursement listing of the bispecific antibody anticancer drug 'Imdelltra' has been rising.According to industry sources, a public petition for reimbursement of Amgen Korea's Imdelltra (tarlatamab), a treatment for relapsed or refractory extensive-stage small cell lung cancer (SCLC), recently surpassed 50,000 signatures, satisfying the requirement for a National Assembly petition.The speaker of the National Assembly will report the agenda to the parliamentary Health and Welfare Committee, where it will be formally selected. The Health and Welfare Committee will review the petition and, if necessary, can request the Ministry of Health and Welfare (MOHW) and Health Insurance Review and Assessment Service (HIRA) to examine or implement corresponding institutional improvements.However, given precedent, even if a petition satisfies the submission criteria, it often remains in the National Assembly or fails to lead to reimbursement determinations. Amgen resubmitted its reimbursement application for Imdelltra at the end of February, immediately after receiving a non-reimbursement determination from the HIRA's Cancer Disease Review Committee in January, which failed to establish initial reimbursement criteria. Despite the resubmission, a definitive schedule for this drug’s re-evaluation on the committee's schedule has not yet been confirmed.Given the relatively small patient population associated with small-cell lung cancer, which is classified as a rare malignancy, almost 50,000 petition signatures represents an exceptionally rare demonstration of collective advocacy compared to other disease groups. It remains to be seen whether this public petition will inject renewed momentum into the ongoing reimbursement discussions for Imdelltra. Meanwhile, Imdelltra was approved in South Korea in May of last year. This drug is a bispecific antibody therapeutic targeting delta-like ligand 3 (DLL3), an antigen expressed in 85% to 96% of patients with small cell lung cancer. While the DLL3 antigen is typically intracellular in healthy cells, it is aberrantly expressed on the surface of malignant cells in neuroendocrine tumors, including small cell lung cancer.Imdelltra demonstrated clinical efficacy in the DeLLphi-301 clinical study. The DeLLphi-301 trial was a Phase II clinical study evaluating adult patients presenting with extensive-stage small cell lung cancer whose disease had progressed following at least two or more prior lines of therapy, including a platinum-based chemotherapy regimen.According to the study results, Imdelltra demonstrated a meaningful objective response rate. Among 100 patients treated with Imdelltra 10 mg, the confirmed objective response rate reached 40%, with 58% of responding patients (n=23/40) maintaining a durable response lasting six months or longer. Furthermore, the median overall survival in the 10 mg group was 14.3 months, while the median progression-free survival (PFS) was 4.9 months. Treatment-related adverse events documented in the 10 mg treatment group were predominantly low-grade, with Grade 3 or higher events observed in 29% of participants across Parts 1 and 2 of the clinical program and in 15% of patients enrolled in Part 3.
- Company
- Hepatitis B clinical practice guidelines revised in Korea
- by Son, Hyung Min Jun 18, 2026 03:36pm
- The Korean Association for the Study of the Liver (KASL) has recently revised its hepatitis B clinical practice guidelines, signaling a potential shift in the treatment paradigm for chronic hepatitis B in Korea.The key change in the revised guidelines is a reorganization of the treatment framework away from the traditional alanine aminotransferase (ALT)-based approach toward expanding treatment eligibility based on disease risk assessment that uses HBV DNA levels.In particular, attention is rising on early intervention strategies for liver cancer prevention, as treatment recommendations have been strengthened for so-called ‘gray-zone’ patients who previously required treatment but often did not receive appropriate intervention under existing criteria.On the 16th, Gilead Sciences Korea hosted the ‘2026 Hepatitis Academy,’ where experts discussed the significance and clinical evidence behind KASL’s revised hepatitis B treatment guidelines.From the left: Young-suk Lim (Gastroenterology, Asan Medical Center), Gi-Ae Kim (Gastroenterology, Kyunghee University Hospital)The most significant change in the revised guidelines is the reclassification of the natural history of chronic hepatitis B based primarily on hepatitis B virus (HBV) DNA levels.Previous Korean guidelines recommended antiviral treatment for patients with ALT levels persistently exceeding twice the upper limit of normal or in cases where liver fibrosis had been confirmed. Under the guidelines, patients with high HBV DNA levels but normal ALT levels were often excluded from treatment, creating a persistent unmet need in clinical practice.According to Korean studies, 64% of all liver cancer cases occurred outside the current National Health Insurance reimbursement criteria. Also, patients with moderate viremia, defined as HBV DNA levels of 4–8 log10 IU/mL, were reported to have the highest risk of developing liver cancer.Reflecting these findings, KASL reclassified the natural history of chronic hepatitis B into four categories: ▲high viremia (HBV DNA >8 log10, ▲HBeAg-positive moderate viremia, ▲low viremia (HBV DNA <2000 IU/mL), and ▲HBeAg-negative moderate viremia.In particular, the treatment recommendations were expanded to include antiviral therapy for patients with moderate viremia regardless of ALT levels.ATTENTION study provides evidence for a previously underserved treatment populationThe revised guideline was largely supported by findings from the ATTENTION study, led by Korean investigators.The ATTENTION study was a multicenter, randomized, clinical trial involving 734 chronic hepatitis B patients without cirrhosis and with HBV DNA levels of 4–8 log10 IU/mL. Patients were assigned either to treatment with Vemlidy (tenofovir alafenamide, TAF) or to an untreated observation group.Professor Young-suk Lim (Gastroenterology, Asan Medical Center)After a median follow-up of 17.7 months, major clinical events, such as hepatocellular carcinoma (HCC), liver function deterioration, liver transplantation, and death, occurred in 2 patients in the TAF group (both HCC), 9 patients in the observation group (7 HCC, 1 liver function deterioration, and 1 death).Treatment benefits were also confirmed across secondary endpoints. The proportion of patients achieving HBV DNA suppression below 10 IU/mL was 91% in the TAF group and 31% in the observation group. ALT normalization rates were 80% in the TAF group and 62% in the observation group. Among patients who had elevated ALT levels at baseline, ALT normalization rates were 73% in the TAF group and 50% in the observation group.Professor Young-suk Lim of the Department of Gastroenterology at Asan Medical Center (President of KASL) stated, “Liver cancer is one of the leading causes of cancer-related death in Korea, and a substantial proportion of cases are associated with chronic hepatitis B. Although liver cancer risk is closely linked to HBV DNA levels, which reflect the degree of viral replication, previous treatment criteria have relied heavily on whether ALT levels were elevated.”Professor Lim added, “The ATTENTION study provides evidence supporting the clinical value of early antiviral treatment in patients who were previously left in a treatment blind spot. We expect these findings to play an important role in shaping future clinical guidelines and treatment practices.Professor Gi-Ae Kim (Gastroenterology, Kyunghee University Hospital)Experts emphasized that this revision is not merely an adjustment of criteria, but a shift in the treatment paradigm, while also noting that further discussion on improving reimbursement criteria is necessary for its practical implementation in clinical settings.Professor Gi-Ae Kim of Kyung Hee University Hospital (Secretary of the KASL Publications Committee) stated, “The core of this revision is the shift toward evaluating disease progression and establishing treatment strategies based on HBV DNA levels rather than ALT levels. This change is consistent with the direction of global clinical guidelines.”Professor Kim added, “Patients with moderate viremia have been shown to carry the highest risk of hepatocellular carcinoma, so we revised the guideline to recommend treatment regardless of ALT levels. This represents a fundamental change from the previous treatment paradigm.”Kim also noted, “For these newly proposed recommendations to translate into actual patient care, discussions regarding expanded treatment access and revisions to reimbursement criteria will be necessary. Managing healthcare expenditures associated with the broader treatment population and improving long-term treatment adherence will also be important challenges moving forward.”
- Company
- Yescarta shifts focus to second-line reimbursement
- by Eo, Yun-Ho Jun 18, 2026 03:35pm
- Gilead Sciences Korea has decided to take one step back in order to move two steps forward with its CAR-T therapy, ‘Yescarta.’According to Dailypharm coverage, Gilead Sciences Korea has decided not to accept the condition proposed by the Drug Reimbursement Evaluation Committee (DREC) in May, requiring acceptance of a reimbursement price below the committee’s assessed value for Yescarta (axicabtagene ciloleucel) in the third-line treatment setting for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).Instead, the company plans to pursue reimbursement for the drug’s second-line indication rather than the third-line setting. Industry observers believe the application could be submitted as early as July.DLBCL is known to have rapidly worsening outcomes with each successive line of treatment, and the second-line stage is considered a critical period where a cure can be expected.Currently, reimbursed second-line treatment options for relapsed or refractory DLBCL in Korea primarily consist of older salvage cytotoxic chemotherapy regimens. Patients who fail first-line therapy or relapse within one year have a two-year survival rate of only around 20%, even with aggressive second-line treatment.For patients who are unlikely to achieve sufficient benefit from existing therapies, it is important to create an environment in which treatment options with the potential to improve long-term survival can be used at the right time.Yescarta is indicated for adult patients with DLBCL that is refractory to or relapses within 12 months after first-line chemoimmunotherapy, and adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy.A Gilead official stated, “We aim to provide patients in the second-line setting, who have the highest unmet need, with access to innovative treatment at the time when it can deliver the greatest benefit. We will continue to work closely with stakeholders to ensure that second-line reimbursement is realized in a sustainable manner.”
- Company
- How to address the growing backlog of non-reimbursed therapies
- by Son, Hyung Min Jun 17, 2026 04:30pm
- So, is there a solution? The reality that the number of non-reimbursable anticancer drugs is piling up as advanced new drugs increase is causing frustration for patients.However, the regulatory authorities also have their woes, as the faster innovative cancer therapies are developed, the greater the burden placed on Korea's National Health Insurance system.With the introduction of new classes of oncology treatments, including immunotherapies, antibody-drug conjugates (ADCs), bispecific antibodies, radiopharmaceuticals, and gene therapies, cancer survival outcomes have steadily improved. In some cancers, discussions have progressed beyond long-term survival to the possibility of a cure. For the National Health Insurance Service, however, the advances have come with rapidly increasing financial pressure as treatment costs often reach hundreds of thousands of dollars per patient.The core problem is that Korea's reimbursement system has struggled to keep pace with the speed of drug development and regulatory approval. Even therapies that have become global standards of care often require years to obtain reimbursement, leaving patients waiting long after approval until they can actually benefit from treatment.According to the Korea Alliance of Patients Organization, the average time from regulatory approval to reimbursement listing for 32 oncology drugs listed between 2021 and 2025 was 659 days, which is approximately 1 year and 10 months.Against this backdrop, attention is rising on whether the government's ongoing drug-pricing reform could provide part of the solution. The government ultimately plans to improve patient access to innovative medicines through the generic drug pricing reform, which includes measures to improve financial efficiency, accelerate reimbursement for rare-disease and severe-disease treatments, introduce flexible pricing agreements, and expand risk-sharing agreements."It's not just about money, it's about value"…Consensus forms on the need to change the reimbursement evaluation systemThe medical community criticized that reimbursement decisions for cancer drugs should not be viewed solely as financial issues. However, clinicians continue to believe that budget impact remains one of the most influential variables in reimbursement decisions.One medical oncologist commented, “In many recent reimbursement reviews, projected claims amount seems to carry more weight than treatment effectiveness. Particularly in cancers that affect many patients, reimbursement discussions can drag on simply because of the anticipated financial burden, regardless of how strong the clinical benefit may be.""Paradoxically, the more patients who could benefit from a treatment, the harder it sometimes becomes to obtain reimbursement. Even therapies with proven survival benefits may face access barriers because of financial concerns."One expert involved in CDRC discussions described the reimbursement process as “not a process of calculating costs, but a process of putting a price tag on value."According to the expert, "Cost-effectiveness is not simply about whether a drug is expensive or inexpensive. It is about determining how much society is willing to pay for extended survival, improved quality of life, and the possibility of a cure. Although discussions are made using Korea’s per-capita GDP of approximately USD 36,000 as a benchmark, for severe diseases and oncology treatments, society may need to consider doubled thresholds, those exceeding USD 70,000.“Below USD 36,000, treatments are generally viewed as more acceptable, and the burden becomes much greater when the threshold exceeds USD 70,000. Between those levels, the question is ultimately about which values society chooses to prioritize. That is less a scientific judgment than a social choice."There are also growing calls for improving the predictability and transparency of the current reimbursement evaluation system. At present, the results of the Cancer Disease Deliberation Committee (CDDC) are disclosed in forms such as reimbursement criteria established, reimbursement criteria not established, or reconsideration. However, it is not possible to determine which specific factors influenced the decision.One pharmaceutical industry official said, “Only the result -- ‘reimbursement criteria not established’ -- is disclosed, so it is difficult to determine whether the decision was due to insufficient clinical evidence, cost-effectiveness issues, or budget impact. From a company’s perspective, it is not easy to predict what needs to be supplemented in order to expect a positive outcome at the next review.”The official continued, “We agree that reimbursement evaluation is a process of finding a balance between financial sustainability and patient access. If there is insufficient explanation of the decision-making process, acceptance of the outcome may also be reduced. There is also a need for discussions on sharing evaluation criteria and the rationale behind making decisions more transparently.”Generic drug pricing reform… Whether the cost savings are reinvested in innovative drugs is keyThe drug pricing system reform being pursued by the government can also be viewed as part of the search for an answer to the same question. If the financial resources secured through generic drug price cuts lead to improved access to innovative medicines, and if the reimbursement system becomes able to reflect treatment value more flexibly, this reform could become not merely a cost-saving policy but the starting point of a patient-centered system reform.Recently, the Ministry of Health and Welfare finalized a plan to lower the price calculation rate for generics and off-patent medicines from 53.55% to 45%. At the same time, it established a structure that provides pricing incentives for innovative and quasi-innovative pharmaceutical companies with high levels of R&D investment.Through this, the government aims to improve the generic-centered market structure and encourage a transition toward an R&D-driven industry.One industry official explained, “This reform has more of the character of industrial restructuring than a simple drug price reduction policy. The expectation is that companies with insufficient R&D investment will naturally lose competitiveness, while the industry is reorganized around companies with strong innovative drug development capabilities.”Another industry official said, “It is important to create a virtuous cycle in which the financial resources secured through price reductions are reinvested into innovative medicines and R&D. If only the cost-saving effect is emphasized but does not lead to actual improvements in access, the justification for the reform could weaken.”In other words, the financial resources secured through drug price reductions should not merely remain as industry support but should be directed toward areas that the public can directly benefit from, such as improved access to innovative medicines and strengthened stability of essential medicine supply.RSA Expansion and flexible pricing agreements… Can they improve patient access?Experts are turning their attention to the expansion of risk-sharing agreements (RSA) and more flexible drug pricing contracts.A risk-sharing agreement allows the government and pharmaceutical companies to share the financial burden associated with high-cost innovative drugs. In Korea, many oncology drugs and rare disease treatments have already entered the reimbursement system through this mechanism.However, experts believe that the current refund-based RSA model alone has limitations.One industry official said, “The current structure tries to complete almost all evaluations before a drug enters the reimbursement system. As a result, patients wait longer, and the system spends a great deal of time trying to reduce uncertainty.”The official continued, “A more realistic approach may be to embrace a certain level of uncertainty, secure patient access first, and then evaluate effectiveness using real-world data before adjusting the drug price. Going forward, post-listing management is likely to become more important than pre-listing review.”Discussions are also continuing regarding evaluation criteria in terms of clinical usefulness. In the past, overall survival (OS) was considered the most important clinical endpoint. More recently, however, there have been increasing calls to consider a broader range of values, including long-term survival, recurrence prevention, and improvements in quality of life.In fact, many innovative new drugs have demonstrated the potential for long-term survival benefits even before mature OS data become available, through improvements in progression-free survival (PFS), positive trends in PFS2, and invasive disease-free survival (iDFS).One medical oncologist said, “OS remains an important endpoint in solid tumors, but in the current oncology treatment environment, it is often difficult to explain all of a therapy’s value using OS alone. As the number of long-term survivors increases and subsequent treatment options become more diverse, interpreting OS itself has become more complex than in the past.”The physician continued, “Difficult-to-treat cancers and rare cancers have small patient populations and poor prognoses, rendering generating OS data difficult. If OS is applied as an absolute standard without considering disease characteristics and unmet medical needs, patients may have to wait even longer before gaining access to new treatment opportunities.”Recently, there have also been calls for greater flexibility in the existing reimbursement system, particularly for immuno-oncology drugs and antibody-drug conjugates (ADCs), where indication expansion is occurring rapidly. For example, Keytruda currently has 35 approved indications in Korea alone. In effect, a single product is functioning as dozens of different therapies.The problem is that reimbursement reviews are repeated every time a new indication is added. If one indication remains under discussion at the CDDC or DREC stage for an extended period, subsequent indications must wait their turn for review. As the gap between the pace of innovative new drug development and the pace of reimbursement review widens, patient access issues are likely to persist.This is also why the Korean Research-based Pharmaceutical Industry Association (KRPIA) has advocated the introduction of Indication-Based Pricing (IBP). Under the current system, a drug is reimbursed at the same price regardless of how many indications it has. In practice, however, treatment effectiveness, patient population size, and cost-effectiveness of a single drug can vary significantly by indication.Recently, there have also been calls to expand beyond simple refund-based agreements and adopt outcome-based risk-sharing agreements. At present, most RSA arrangements in Korea are based on claims refunds or expenditure caps. Overseas, however, outcome-based agreements, in which pharmaceutical companies bear part of the cost if real-world treatment outcomes fail to meet expectations, are becoming the trend.Ultimately, discussions surrounding reimbursement for innovative oncology drugs are not simply about adjusting drug prices. The key challenge going forward will be whether the system can adequately reflect emerging treatment values, including extended survival, the possibility of cure, and improved patient access.One industry official emphasized, “In the past, the most important issue was whether a new drug received regulatory approval. Today, the more important question is how quickly patients can actually benefit from treatment. The reimbursement system also needs to evolve in a direction that improves flexibility and predictability in line with changes in the treatment environment.”
- Company
- Will generics be reimbursed before the original drug?
- by Kim, Jin-Gu Jun 16, 2026 08:33am
- Competition to launch generic versions of the neuropathic pain treatment Taleaje (mirogabalin) appears to be intensifying in Korea.Because the original product remains non-reimbursed, if generic drugs successfully launch their drugs early, their companies may obtain reimbursement independently and effectively take control of a largely untapped market for mirogabalin-based neuropathic pain treatments.According to industry sources on June 15, the Intellectual Property Trial and Appeal Board recently ruled in favor of Daewoong Pharmaceutical, Samjin Pharmaceutical, and Kyungdong Pharmaceutical in passive scope confirmation trials against Daiichi Sankyo Korea regarding Taleaje’s salt and formulation patent.Last month, Dong-A ST, JW Pharmaceutical, and Huons also succeeded in circumventing the same patent. Excluding HK Inno.N, Dongwha Pharmaceutical, and BC World Pharmaceutical, which voluntarily withdrew their challenges last year, every company that pursued patent litigation has now secured a first-instance victory.Taleaje is protected by three listed patents. It has been protected by the salt/formulation patent (expires April 2034) that the 6 companies had succeeded in circumventing this time, as well as a compound patent (expires June 2031), and a formulation patent (expires March 2036)Among these, generic manufacturers have already cleared the salt/formulation patent hurdle and are now expected to target the remaining formulation patent, with the goal of launching products immediately upon expiration of the compound patent in 2031.One particularly noteworthy aspect of the case is that the original Taleaje product still lacks reimbursement coverage. Daiichi Sankyo obtained approval for four strengths (2.5 mg, 5 mg, 10 mg, and 15 mg) in January 2020. However, the reimbursement listing failed after price negotiations with health authorities broke down. The company has been selling the drug as a non-reimbursed therapy ever since.If domestic companies succeed in launching generics before reimbursement is secured for the original product, they could potentially establish a market led by generic products rather than the original brand.Generic manufacturers have already satisfied key requirements for first generic exclusivity, including being among the first to challenge the patent and successfully prevailing in those challenges. In January this year, the Ministry of Food and Drug Safety received 19 generic applications for mirogabalin products, including one application for the 2.5 mg strength and six applications each for the 5 mg, 10 mg, and 15 mg strengths. Industry observers believe the 6 patent challengers likely filed their applications simultaneously, with only 1 company seeking approval for the lowest-dose product.If these companies also succeed in overcoming the remaining formulation patent and launch in 2031, analysts believe the situation could mirror the case of Otezla (apremilast).In 2021, Korean generic manufacturers successfully challenged patents covering Amgen’s Otezla, which had never been launched in Korea. After reimbursement negotiations failed, Amgen withdrew the original product from the Korean market in June 2022.Generic manufacturers subsequently obtained approvals in 2024 and independently pursued reimbursement listing, eventually launching products into what was effectively an uncontested market. Currently, Dong-A ST, Daewoong Pharmaceutical, and DongKoo Bio & Pharma market apremilast products in Korea.Industry experts believe Taleaje generics may have even greater commercial potential than Otezla generics. Unlike the psoriasis market, which has seen numerous new therapies emerge following Otezla, the neuropathic pain market has seen few innovative treatments introduced in recent years.The Korean neuropathic pain market is currently estimated at approximately KRW 200 billion annually. Current treatment is dominated by reimbursed products containing ‘pregabalin (Lyrica)’ and ‘gabapentin (Neurontin).’ Taleaje could also compete with COX-2 inhibitors such as celecoxib (Celebrex) and SNRI antidepressants such as duloxetine (Cymbalta).One of Taleaje’s key advantages is its lower incidence of drowsiness and dizziness compared with existing therapies, rendering it a positive option for physicians treating neuropathic pain. The drug has also demonstrated favorable pain-reduction outcomes in patients with diabetic peripheral neuropathic pain (DPNP).As a result, Taleaje generated approximately KRW 3.7 billion in sales (as of 2024) without reimbursement. Given that level of commercial performance without reimbursement coverage, industry observers believe patent challenges and first-generic exclusivity rights remain highly valuable opportunities for generic manufacturers.
- Company
- The OS barrier to CDDC review and reimbursement in Korea
- by Eo, Yun-Ho Jun 16, 2026 08:33am
- Beyond its roughly 50% approval rate, there is little dispute that the Cancer Disease Deliberation Committee (CDDC) has become the highest hurdle in Korea's oncology reimbursement process.Originally established as a committee of prescribing physicians tasked with evaluating the clinical usefulness of cancer drugs seeking reimbursement, the CDDC became the center of controversy after 2020 when it began formally considering budget impact in addition to clinical value.The fact that a committee that used to review a drug’s usefulness began reviewing fiscal impact became an issue, as budget considerations are already addressed later in the reimbursement process by bodies such as the Pharmacoeconomic Evaluation Subcommittee and the Drug Reimbursement Evaluation Committee (DREC). Criticism intensified when physician members of the CDDC began opposing reimbursement for certain therapies based not only on medical judgment but also on pharmacoeconomic considerations.From a clinical perspective, it can appear counterintuitive for physicians who treat patients to oppose the reimbursement of new therapies. For physicians who prescribe the drugs, the more treatment options there are, the better. As a result, CDDC members have become a top priority for pharmaceutical companies seeking reimbursement approval.Don't expect to pass CDDC review without OS dataControversies surrounding the CDDC have included issues such as the composition of committee members, transparency, and fairness. Among them, one factor has increasingly been viewed as almost a guaranteed predictor of failure: the absence of overall survival (OS) data.OS measures the time from the start of treatment until death from any cause. Because patient outcomes vary widely, OS is generally reported as a median rather than an average. Patients who remain alive at the time of analysis are censored at their longest observed follow-up. Naturally, demonstrating an OS benefit requires lengthy follow-up periods.For this reason, oncology drugs are often approved initially based on progression-free survival (PFS) data, with OS evidence submitted later.PFS measures the length of time during which a patient remains alive without disease progression. Historically, PFS was widely accepted as a meaningful clinical endpoint. Many physicians continue to argue that “neither OS nor PFS should be viewed as inherently superior to the other.” However, under the growing influence of CDDC, some believe PFS has effectively become insufficient on its own.According to DailyPharm’s coverage, among solid-tumor therapies that underwent pharmacoeconomic evaluation and sought new reimbursement listings or reimbursement expansions over the past three and a half years, only a handful of products, including Lecluza, successfully passed the CDDC without OS data. While some hematologic malignancy treatments have obtained reimbursement without demonstrating OS benefits, in the field of solid tumors, the absence of OS data effectively leads to failure.Even in the adjuvant treatment setting, which is often regarded as one of the most challenging areas for reimbursement approval, therapies that successfully secured reimbursement generally did so only after obtaining OS data.However, officials from both the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service (HIRA) emphasized, “We do not look solely at OS. The CDDC evaluates clinical usefulness, social need, budget impact, and other factors to make fair and balanced decisions."Two drugs that were simultaneously reviewed at the CDDC levelA recent case illustrates the issue. At last month's CDDC meeting, two drugs with the same mechanism of action were reviewed simultaneously for similar reimbursement expansions, to meet contrasting results. The drugs were the CDK4/6 inhibitors ‘Verzenio’ and ‘Kisqali.’Both sought reimbursement expansion for adjuvant treatment of early breast cancer, but only Verzenio passed review. The key difference was that Verzenio had generated OS data, while Kisqali had not yet done so.The simultaneous review of the two drugs attracted significant attention. Verzenio itself had previously failed 3 separate CDDC reviews before obtaining OS data. First submitted in May 2023, the product remained more than 3 years without reimbursement coverage.The fact that a drug repeatedly rejected due to lack of OS evidence was later reviewed alongside a same-class competitor that also lacked OS data sparked intense interest. Industry and academic observers argued over whether the committee would apply a class effect approach or continue to place primary emphasis on demonstrated OS benefits.One medical oncology professor who previously served on the CDDC said, “It is very difficult for a solid tumor drug to pass CDDC review without OS data. There is even a growing sentiment among committee members that 3-year OS data may not be enough. If the current trend continues, companies may eventually need even longer-term OS evidence to secure CDDC approval."
- Company
- Mounjaro and Wegovy generate KRW 427 billion in 3 months
- by Chon, Seung-Hyun Jun 15, 2026 09:19am
- The new obesity treatments Mounjaro and Wegovy have taken over the Korean market. Mounjaro generated over KRW 323.2 billion in sales in just 3 months, while Wegovy surpassed KRW 100 billion in quarterly sales for the fourth consecutive quarter. Mounjaro patients showed a stronger demand for lower-dose products, whereas Wegovy patients recorded a higher share of high-dose prescriptions. Meanwhile, Saxenda, once the dominant obesity treatment, has seen its market influence decline dramatically.According to IQVIA data released on June 11, Eli Lilly's Mounjaro recorded KRW 323.2 billion in sales during the first quarter, making it the top-selling obesity treatment in Korea. This figure was more than three times higher than that of Wegovy, which was KRW 104 billion, firmly establishing Mounjaro as the market leader.AI-generated imageMounjaro, which was released in Korea in August last year, is a dual agonist targeting both the glucose-dependent insulinotropic polypeptide (GIP) receptor and the glucagon-like peptide-1 (GLP-1) receptor. The drug lowers blood glucose levels before and after meals by stimulating insulin secretion, improving insulin resistance, and reducing glucagon secretion.Mounjaro was first approved in Korea in June 2023 as a diabetes treatment. It was approved for the treatment of type 2 diabetes as an adjunct to diet and exercise for glycemic control. In August 2024, it gained an additional indication for chronic weight management in adults, to be used alongside a reduced-calorie diet and exercise regimen.The drug generated its first sales of KRW 29.4 billion in the third quarter of last year and surged to KRW 191.6 billion in the fourth quarter, becoming the market leader in obesity treatment sales. Over the nine-month period from Q3 2025 through Q1 2026, cumulative sales reached KRW 544.1 billion, rapidly reshaping the obesity treatment landscape.Mounjaro has also overtaken Wegovy and risen to the lead in the global obesity drug market. Last year, Mounjaro recorded worldwide sales of USD 23.07 billion (approximately KRW 33 trillion), significantly exceeding Wegovy's sales of DKK 79.1 billion (approximately KRW 18 trillion).Industry analysis shows that obese patients in Korea have an increased demand for Mounjaro due to its superior weight-loss efficacy.GLP-1 suppresses appetite by stimulating satiety centers in the brain and slows gastric emptying. GIP not only enhances insulin secretion but also promotes fat metabolism and synergistically helps reduce gastrointestinal side effects commonly associated with GLP-1 therapies.Mounjaro demonstrated significant weight-loss benefits in the Phase 3 SURMOUNT-1 trial involving overweight adults without diabetes who had a BMI of at least 30 kg/m² or at least one weight-related comorbidity. In the trial, patients receiving Mounjaro experienced an average weight reduction exceeding 15% at Week 72, while those receiving the highest dose achieved weight loss of approximately 21% of body weight.Mounjaro also outperformed Wegovy in the head-to-head SURMOUNT-5 study. Results showed that patients receiving Mounjaro (10 mg or 15 mg) achieved an average weight reduction of 20.2% at Week 72, compared with 13.7% among patients receiving Wegovy (1.7 mg or 2.4 mg).Novo Nordisk's Wegovy may have lost its leadership position, but it continues to post quarterly sales exceeding KRW 100 billion.Wegovy generated KRW 104 billion in Q1 sales, representing a 26.6% increase from the same period a year earlier. The drug contains semaglutide, a GLP-1 receptor agonist. Novo Nordisk developed Wegovy after observing substantial weight-loss effects during clinical trials of GLP-1-based diabetes treatments.Following its launch in Korea in October 2024, Wegovy quickly became a commercial success. The drug generated KRW 62.3 billion in sales during the fourth quarter of 2024 and immediately became the market leader in obesity treatment sales.By Q2 2025, Wegovy had achieved KRW 138.5 billion in quarterly sales, surpassing the KRW 100 billion milestone within just nine months of launch. It has now maintained quarterly sales above KRW 100 billion for four consecutive quarters. Even before entering Korea, Wegovy gained global notoriety as a weight-loss aid favored by celebrities, contributing to worldwide supply shortages. Novo Nordisk strengthened its commercial presence by signing a co-promotion agreement with Chong Kun Dang in September last year.However, Wegovy's sales have declined for two consecutive quarters since peaking at KRW 142 billion in Q3 last year. Analysts attribute the slowdown to competition from Mounjaro and the impact of price reductions. After Mounjaro entered the Korean market in August last year, Wegovy reduced its supply price by approximately 40%. Since Q4 2024, Wegovy has generated cumulative sales of KRW 649.6 billion over an 18-month period. Combined cumulative sales of Mounjaro and Wegovy have now exceeded KRW 1 trillion.Mounjaro and Wegovy showed contrasting prescribing patterns by dose strength. Mounjaro had higher sales volumes in lower dosages, while Wegovy had a higher market share in higher-dosage products.Mounjaro is currently sold in four different strengths: 2.5mg, 5mg, 7.5mg, and 10mg. In the first quarter, a total of 3,868,149 units were sold, with 5mg and 2.5mg being the most popular, at 1,551,910 units and 1,474,823 units, respectively. The market shares for 5mg and 2.5mg were 40% and 38%, respectively, accounting for a total of 78%. In comparison, the higher-dose 7.5 mg and 10 mg products accounted for only 12% and 10% of Wegovy’s sales, respectively.Wegovy is approved in five strengths: 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg. Each pen contains enough medication for four administrations. For instance, the 0.25mg product contains a total of 1mg, which can be administered four times using a single pen. In the first quarter, the 2.4mg dosage held the highest sales volume share at 34%, followed by 1mg at 22% and 1.7mg at 15%. The lowest dosage, 0.25mg, had the smallest share at 12%.It is analyzed that Mounjaro has a high share of low-dosage products intended for initial treatment due to its relatively late entry into the domestic market, whereas Wegovy, having been on the market for over a year, has a higher proportion of patients in follow-up treatment stages.Some industry observers suggest that the growing trend of ‘dose splitting’ with Wegovy may be contributing to the strong preference for higher-dose products. Unlike Mounjaro, which is supplied as a single-use prefilled pen, Wegovy is a multi-dose injection pen that allows users to select and adjust the dose before administration. As a result, many patients reportedly receive higher-dose prescriptions and divide them into multiple lower-dose injections. In fact, supply shortages have risen for Wegovy's higher-dose products. The proportion of the 2.4 mg dose among total Wegovy sales volume increased 15 percentage points from 19% in the first quarter of last year.The market positions of Saxenda and Qsymia, which dominated the obesity treatment market before the emergence of Wegovy, have shrunk significantly.Novo Nordisk's Saxenda generated only KRW 900 million in first-quarter sales. Before the launch of Wegovy, Saxenda recorded KRW 15.1 billion in first-quarter sales in 2024, but more than 90% of that revenue disappeared within 2 years. Launched in Korea in 2018, Saxenda was the world's first obesity treatment approved as a GLP-1 analogue. It contains the same active ingredient, liraglutide, as the diabetes treatment Victoza, differing only in dosage and administration. Following its launch, Saxenda became the leading obesity treatment in Korea, recording KRW 42.6 billion in sales in 2019 and maintaining the top position for five consecutive years through 2023. However, the introduction of Wegovy and Mounjaro has reduced its market presence to a minimal level. Industry observers believe that Wegovy, another GLP-1-based therapy, has effectively absorbed most of Saxenda's market.Meanwhile, Alvogen Korea's Qsymia posted KRW 7.1 billion in first-quarter sales, down 18.5% year-on-year. Launched in Korea at the end of 2019, Qsymia is a fixed-dose combination product containing phentermine and topiramate.’ Alvogen Korea acquired the domestic marketing rights from U.S.-based Vivus in 2017. Although Qsymia experienced a smaller sales decline than Saxenda, it remains far behind Wegovy and Mounjaro. Combined first-quarter sales of Saxenda and Qsymia totaled just KRW 7.9 billion, representing less than 2% of the combined KRW 427.2 billion generated by the newer obesity treatments Wegovy and Mounjaro during the same period.
- Company
- K-onocology drug Leclaza posts KRW 25.4B in sales in 3 mths
- by Chon, Seung-Hyun Jun 15, 2026 09:19am
- The domestically developed cancer drug Leclaza (lazertinib) continues to perform strongly in the prescription market. The drug generated over KRW 25 billion in sales during the first quarter alone, putting it on track to exceed KRW 100 billion in annual sales. Following reimbursement expansion as a first-line lung cancer treatment, Leclaza has maintained strong momentum and emerged as one of Korea's most successful homegrown oncology drugs. Being an oral medication, the unusual phenomenon of approximately 80% of total sales being generated through outpatient prescriptions has also emerged, as the patients may take the drug at home.According to IQVIA data released on June 13, Yuhan Corp’s Leclaza recorded KRW 25.4 billion in Q1 sales, representing an 8.0% increase YoY.AI-generated imageLeclaza was approved in January 2021 as Korea's 31st domestically developed new drug for the treatment of non-small cell lung cancer (NSCLC). It officially entered the prescription market in July 2021 following inclusion in the national reimbursement list.The product's growth grew steeply after its reimbursement coverage was expanded to first-line treatment.Leclaza was first approved as a second-line therapy for patients with locally advanced or metastatic NSCLC who developed the EGFR T790M resistance mutation after treatment with first- or second-generation EGFR tyrosine kinase inhibitors (TKIs). In June 2023, the Ministry of Food and Drug Safety allowed its indication expansion to include first-line treatment of NSCLC.Beginning in January 2024, the Ministry of Health and Welfare extended reimbursement coverage to first-line use. As a result, patients with EGFR mutation-positive locally advanced or metastatic NSCLC became eligible for reimbursement when receiving Leclaza as initial therapy. At the time, the ministry estimated that the reimbursement expansion would require an additional KRW 88.1 billion in healthcare spending.Leclaza generated KRW 6.2 billion in sales during Q4 2023, but sales surged to KRW 18.9 billion in the first quarter of 2024 following the expansion of reimbursement. This is almost a threefold increase in sales from the first-line reimbursement expansion. In effect, the reimbursement decision added more than KRW 10 billion in quarterly first-line treatment sales in just 3 months.Sales exceeded KRW 20 billion in the second quarter of 2024 and have continued to grow thereafter. Leclaza generated KRW 99.6 billion in sales last year and will potentially surpass the KRW 100 billion annual sales milestone for the first time this year.A defining feature of Leclaza is its overwhelming reliance on outpatient prescriptions.During Q1, outpatient prescriptions accounted for KRW 20.3 billion, representing 79.8% of total sales. The drug’s outpatient share has never fallen below 70% ever since it exceeded the mark in Q4 2022. In the fourth quarter of last year, outpatient prescriptions totaled KRW 19.5 billion, representing 80.4% of total quarterly sales of KRW 24.2 billion.Leclaza is setting a new sales record among domestically developed Korean anticancer drugs. Other domestically developed anticancer drugs approved in Korea before Leclaza include Il-Yang Pharm's Supect, Dong-wha Pharm's Milican, Chong Kun Dang's Camtobell, Samsung Pharm’s Riavax, and Hanmi Pharm's Olita. None of these products has achieved annual sales exceeding 100 billion won.
- Company
- A numbers-driven look into Korea's reimbursement system
- by Son, Hyung Min Jun 15, 2026 09:18am
- It is no exaggeration to say that today's pharmaceutical market is defined by ‘reimbursement,’ no matter how strong the momentum behind new obesity drugs may be.Reimbursement listing and how quickly it is obtained ultimately determines the commercial success of a new medicine. Amid a flood of high-cost drugs with multiple indications, pharmaceutical market access (MA) professionals have become some of the industry's most sought-after specialists.Oncology drugs sit at the center of this trend. Cancer drug development is increasingly moving beyond single-cancer indications, with therapies expanding into multiple tumor types and treatment settings. Immuno-oncology drugs initially developed for lung cancer, for example, are now being used in gastric cancer, esophageal cancer, triple-negative breast cancer (TNBC), endometrial cancer, and renal cell carcinoma.Cancer treatment, which has been focused on end-stage disease management, has evolved to be used in neoadjuvant and adjuvant settings, for recurrence prevention, and as maintenance therapy, fundamentally reshaping treatment strategies.The challenge, however, is their reimbursement. A new oncology drug must pass through multiple stages before obtaining reimbursement coverage, including review by the Cancer Disease Deliberation Committee (CDDC), the Drug Reimbursement Evaluation Committee (DREC), price negotiations with the National Health Insurance Service (NHIS), and final approval by the Health Insurance Policy Deliberation Committee (HIPDC).Among these, the Cancer Disease Deliberation Committee serves as the first gateway to reimbursement. As it is the first and most critical gateway that determines reimbursement potential, the committee is often referred to as a "wall of lamentation" by companies with oncology products.Only half of approved oncology drugs passed final review during the past 3.5 yearsEven among drugs that received positive CDDC reviews, only 65.2% ultimately reached reimbursement listing after completing NHIS price negotiations and HIPDC review.An analysis conducted by DailyPharm on the Cancer Disease Deliberation Committee and Drug Reimbursement Evaluation Committee decisions between January 2023 and June 2026 found that only 65.2% of indications that passed reimbursement evaluation ultimately succeeded in obtaining reimbursement listing.During the same period, the Cancer Disease Deliberation Committee reviewed a total of 244 oncology drug indications. Of these, 124 indications (50.6%) received reimbursement criteria. On the other hand, 86 indications (35.2%) were denied reimbursement criteria, and 34 indications (13.9%) were sent back for reconsideration.In other words, only 1 out of every 2 oncology indications successfully cleared the first committee.By contrast, approval rates at the DREC level were considerably higher. Over the past 3 years, the committee reviewed 81 oncology indications, of which 59 received reimbursement adequacy approvals, resulting in an approval rate of 75.6%. Meanwhile, 9 indications (11.1%) were reconsidered, and 13 indications (16.0%) were deemed not appropriate for reimbursement. Ultimately, 65.2% eventually completed NHIS negotiations and secured reimbursement listing (excluding results from the 6th meeting of 2026).The time required to complete the reimbursement process also remains a significant issue. According to the Korea Alliance of Patient Organizations, the average period from regulatory approval to reimbursement listing for 32 oncology drugs listed between 2021 and 2025 was 659 days. This means patients waited an average of 1 year and 10 months after approval before gaining access to reimbursement benefits.Experts attribute these delays to redundant reviews of clinical value and budget impact that occur throughout the reimbursement process, from CDDC and DREC review, price negotiations, to HIPDC review.MSD makes the most attempt at reimbursement… Multi-indication development acceleratesAmong pharmaceutical companies, MSD was the most active in pursuing reimbursement expansion. Over the past three years, 44 MSD-related oncology indications were reviewed, the highest number among all companies. Most of these reviews involved expanding reimbursement for its immuno-oncology drug Keytruda (pembrolizumab).MSD was followed by Janssen (28), Roche (17), Pfizer and Lilly (10 each), Astellas (9), and AstraZeneca (8).Blockbuster oncology products such as ‘Darzalex (daratumumab),’ ‘Rybrevant (amivantamab),’ ‘Enhertu (trastuzumab deruxtecan),’ and ‘Tevimbra (tislelizumab)’ have repeatedly appeared before both the CDDC and DREC as their indications expanded across multiple cancer types and treatment settings.This trend reflects more than simply an increase in the number of reimbursement applications submitted by individual companies. It demonstrates a broader shift in the oncology drug development paradigm toward a multi-indication model.Rather than remaining confined to a single cancer type, new oncology drugs are increasingly expanding into early-stage and metastatic settings, combination regimens, and biomarker-defined patient populations. As a result, repetitive and ongoing reimbursement reviews have been ongoing for a single new drug.Among individual products, Keytruda was the most active. Over the past 3 years, Keytruda has pursued reimbursement expansion across 11 solid tumor indications, including lung cancer, gastric cancer, esophageal cancer, triple-negative breast cancer (TNBC), cervical cancer, endometrial cancer, and renal cell carcinoma. More specifically, the drug underwent review for a total of 41 indications.This reflects the rapid expansion of immuno-oncology therapies from an initial focus on metastatic cancers into neoadjuvant and adjuvant settings, biomarker-based populations, and combination therapies.Following Keytruda, the products with the highest number of reviews were Darzalex (11 indications), Rybrevant (9), Enhertu and Tevimbra (7 each), Verzenio (abemaciclib, 5), Columvi (glofitamab), 4), Polivy (polatuzumab vedotin, 4), Padcev (enfortumab vedotin, 4), and Opdivo (nivolumab) (4)Efforts to expand reimbursement coverage also continued in rare cancers. ‘Welireg (belzutifan)’ sought reimbursement for indications including Von Hippel-Lindau (VHL) disease-associated renal cell carcinoma and metastatic renal cell carcinoma (mRCC). However, discussions were prolonged because of the limited patient population and cost-effectiveness concerns.In particular, immuno-oncology therapies are considered the fastest-growing category in terms of indication expansion. Products such as Keytruda, Opdivo, and Tevimbra are extending beyond metastatic disease into earlier treatment settings and combination regimens, leading to broader reimbursement discussions. On the other hand, expanding patient populations and the potential for longer treatment durations have made reimbursement decisions increasingly complex for both the CDDC and DREC.Rybrevant, Verzenio, and Welireg…still await review at CDDC stageA considerable number of products repeatedly faced either the non-establishment of reimbursement criteria or requests for reconsideration.The product with the highest number of such cases was Keytruda. Over the past 3 years, Keytruda accumulated 30 indications that were either denied reimbursement criteria or sent back for reconsideration. Given the rapid pace of indication expansion, reimbursement discussions were repeatedly revisited.Rybrevant and Darzalex each experienced 8 indications that were either reconsidered or denied reimbursement criteria. Rybrevant repeatedly sought reimbursement expansion in areas of high unmet need, including EGFR exon 20 insertion-mutated non-small cell lung cancer and first-line combination therapy settings. However, many of these indications failed to advance to the reimbursement-criteria establishment stage.Enhertu and Verzenio each recorded 4 indications, and Welireg, Opdivo, Yervoy (ipilimumab), and Polivy each had 3 indications that failed to secure reimbursement criteria or were sent back for further review.For Verzenio, repeated reimbursement discussions centered on adjuvant treatment for HR-positive/HER2-negative early breast cancer, where the balance between recurrence prevention benefits and cost-effectiveness became a major issue. For Welireg, discussions were prolonged because of the combination of a small patient population, limited clinical evidence, and cost-effectiveness concerns.Ultimately, the results of the past 3 years suggest that Korea's oncology reimbursement system has struggled to keep pace with the rapid expansion of approved indications.With more therapies quickly expanding into multiple indications, like immunotherapies and antibody-drug conjugates (ADCs), reimbursement decisions are becoming increasingly complex. Finding the appropriate balance between patient access and the long-term sustainability of the National Health Insurance system is expected to remain a central challenge for future discussions within both the CDDC and DREC.A 50% pass rate: the gap between regulatory approval and reimbursementLooking solely at recent figures, the CDDC has emerged as the highest hurdle within Korea's oncology reimbursement framework.The committee does not merely assess whether a drug has received regulatory approval. Rather, it determines the actual scope of reimbursement criteria and conditions of use, taking into account clinical need, availability of alternative treatments, target patient populations, and budget impact. By contrast, DREC primarily reviews indications that have already passed CDDC review and focuses on cost-effectiveness, budget impact, and the potential applicability of risk-sharing agreements (RSAs).As a result, many observers argue that reimbursement outcomes for oncology drugs are largely determined at the CDDC stage. On-site, there has been criticism that considerations such as budget impact and cost-effectiveness exert substantial influence during the reimbursement-criteria setting process, limiting early patient access even to therapies that have become the global standard of care.The increasing use of adjuvant therapy in early-stage cancer has further complicated reimbursement discussions. As immunotherapies, targeted therapies, and CDK4/6 inhibitors are increasingly used after surgery to reduce recurrence risk, the question, “To what extent should recurrence prevention be recognized as a reimbursable clinical benefit?” has arisen as the new point of concern.Opinions remain divided regarding the CDDC’s relatively low approval rate. Some healthcare professionals argue that as oncology drugs expand into new indications at an accelerating pace, financial and cost-effectiveness considerations are being introduced too early in the reimbursement process. However, committee experts contend that prioritization is unavoidable given the constraints of a limited national health insurance budget.One committee member explained that reimbursement decisions for oncology drugs cannot be based solely on efficacy. Rather, they require a complex assessment that incorporates treatment outcomes, quality of life, and long-term financial sustainability.The member explained, "Patients would naturally want access to effective treatments as quickly as possible. However, because the national health insurance system is funded by public resources, cost-effectiveness is a must. As high-cost oncology drugs become more expensive and expand into more indications, we inevitably apply stricter standards when assessing which patient populations derive meaningful value from treatment."Even when differences in survival are modest, treatments that reduce toxicity and preserve quality of life can still provide meaningful benefits. Nevertheless, priorities must ultimately be established within budget constraints. The reimbursement process for oncology drugs is fundamentally about finding a balance between clinical value and financial sustainability."Many clinicians, however, see the situation differently. They argue that reimbursement discussions are failing to keep pace with the speed of clinical innovation.One medical oncologist noted, “Patients who experience recurrence often require longer treatment durations and sequential use of multiple therapies, which ultimately increases socioeconomic costs. Reducing the risk of recurrence early and maintaining patients in a healthy state for longer periods has value not only for individual patients but also from a long-term healthcare financing perspective."“Rather than granting reimbursement to all therapies, the more important task is identifying which patient populations derive the greatest clinical value. Ultimately, oncology reimbursement policy is about balancing short-term costs against long-term treatment value. Adjusting the current 5% patient co-insurance rate could also be one possible approach."
- Company
- "Prep for CSO regulations"… solution platform mkt
- by Kim, Jin-Gu Jun 14, 2026 12:13pm
- As the government reviews stringent regulations on contract sales organizations (CSOs), the market for related management platforms is expanding. With growing demands for sub-consignment structure monitoring, expense reporting, and compliance management, specialized solution providers supporting these needs are significantly increasing their market presence.According to pharmaceutical industry sources on the 9th, the Ministry of Health and Welfare (MOHW) recently initiated a comprehensive CSO field survey in collaboration with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA). Industry analysis suggests that, based on this investigation, additional regulatory measures, such as tightening sub-consignment management and increasing the transparency of commission fee frameworks, are highly likely to be reviewed.The government is reportedly focused not only on investigating the primary consignment contracts between pharmaceutical companies and CSOs but also on the sub-consignment structures established among CSOs. The intent of this investigation is to verify the actual commercial operators and commision fee payout structures, thereby preemptively eliminating potential pathways for illegal rebates.These policy shifts are leading to an increased administrative burden for both pharmaceutical companies and CSOs. The industry explains that as sub-consignment architectures gain complexity, the compliance tracking burden grows exponentially heavier. Currently, a substantial number of pharmaceutical firms manage sub-consignment agreements and official notices through disparate emails or decentralized digital folders, with document storage and submission formats varying widely across PDFs, scanned copies, and Excel spreadsheets.Under these circumstances, relying solely on basic contract document storage presents a significant operational bottleneck, making it difficult to establish a management system that meets the rigorous standards mandated by the government. Beyond maintaining contract records ▲pharmaceutical companies must continuously monitor and manage business registration status ▲official CSO declaration compliance, initial and continuing education training status ▲sub-consignment contract and notification histories ▲ commission rates.CSO structure monitoring by specialized solution providers involves contract management, expense reporting, education, and compliance management.A pharmaceutical industry official said, "When sub-consignment structures are complex, it is not easy to track exactly which CSOs a specific item passes through or which field representative is executing the actual sales promotion," and added, "Many companies are experiencing significant difficulties during the government's current field audit, simply collecting and consolidating the necessary documentation."The official stated, "Moving forward, the compliance environment will demand that companies be able to explain exactly who delegated to whom and who ultimately executed the promotional activity. There are clear limitations to manually managing an interconnected structure that links primary to n-th tier CSOs down to the actual sales representatives."From sub-consignment management to expense reporting…CSO compliance platforms 'rises'In response to these shifts, tech solution vendors are actively targeting the CSO regulatory compliance market by introducing specialized software platforms engineered to fully digitize CSO-related workflows.For instance, CP-LINK, a platform operated by IlDong Group, focuses its capabilities on expense report compilation and comprehensive compliance program (CP) support. Following the enforcement of the mandatory CSO declaration system, the platform ensures that detailed expenditures regarding the provision of economic benefits, which CSOs are statutorily required to report to the MOHW, are accurately logged and submitted in full compliance with current regulations. Alongside these features, it delivers highly specialized regulatory updates, on-site corporate compliance training, and real-time advisory counseling services.Furthermore, the platform provides services related to CSO business operations, such as ▲a specialized promotional marketplace designed specifically for pharmaceutical marketing ▲partnerships with legal and tax accounting firms. In particular, the integration of a 'corporate ADMIN function' allows pharmaceutical corporations utilizing CSO networks, as well as large-scale corporate CSOs managing extensive internal agent rosters, to govern individual independent CSO operators in a highly structured and efficient manner.CSO24 offers an integrated management platform that unifies sub-consignment contracts, notification status tracking, electronic signatures, commission fees, and educational completion records. It is designed to transform the entire sub-consignment chain (from the originating pharmaceutical sponsor through primary, secondary, and n-th tier CSOs down to the individual medical representative) into structured, traceable data. Using this technology, the developer recently secured a proprietary patent for an enterprise resource planning (ERP) system designed specifically for managing pharmaceutical sub-consignment sales contracts.In addition, ProMR is capturing market share by offering robust consignment contract management, financial settlement accounting, and commercial sales performance tracking features. CORE CSO Solution delivers an all-in-one suite combining regulatory compliance, expense reporting, and tax accounting mechanisms. Medilink operates as a strategic commercial network platform designed to bridge pharmaceutical sponsors seeking qualified CSOs. Market analysts forecast that as regulatory pressure on CSOs intensifies, the landscape of specialized technical solutions will become increasingly diverse.Industry observers anticipate that if the MOHW further tightens its administrative oversight and supervisory framework governing sub-consignments in the future, the corresponding management platform market will experience parallel growth.An official from CSO24 said, "What the government intends to verify is not merely whether a company holds physical paperwork, but the sales structure and financial settlement flows. We are continuously upgrading our sub-consignment management data tracking and automation functions to aid pharmaceutical companies and CSOs to adapt seamlessly to the fluid regulatory climate."A representative from CP-LINK said, "We are actively contributing to cultivating an ethical operating culture and increasing compliance awareness across the CSO sector to align closely with the guidelines and policy intents of the health authorities. We plan to continuously upgrade our related systems and services to reflect evolving policy changes and market demands."
