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- 2026-04-03 10:38:09
- Policy
- Reimb of comb cancer therapies w/o detailed criteria
- by Lee, Tak-Sun May 14, 2025 06:09am
- The reimbursement policy for combination cancer therapies, announced this month, has been implemented without detailed criteria, causing further confusion in medical practices. This was contributed by the Ministry of Health and Welfare (MOHW) and the Health Insurance Review and Assessment Service (HIRA), which had differing schedules for revision. Accordingly, the HIRA will convene a Cancer Drug Review Committee (CDRC) meeting, notify of detailed criteria, and implement it in June. As of May 1, the MOHW approved that 'when combining a reimbursed chemotherapy regimen with another anticancer drug, the existing co-payment for the previously initiated chemotherapy shall continue to apply to that regimen.' Previously, all combination therapies not approved by insurance reimbursement were entirely non-reimbursed. However, with the establishment of this clause, one anticancer agent now recognized for reimbursement is expected to alleviate patients' financial burden and improve treatment accessibility. Patient organizations and foreign pharmaceutical companies have welcomed such notification. The problem is that no detailed criteria for reimbursement eligibility have been issued, confusing the field. An industry professional explained, "Even hospitals don't know whether the combination therapy will be covered when prescribing it, so they ask the sales representatives, but the pharmaceutical companies themselves cannot provide a clear answer." There have also been repeated inquiries about which of the two drugs in an approved combination regimen is eligible for reimbursement. The MOHW's revision containing the principles for partial reimbursement of combination cancer therapies (Detailed Criteria and Methods for Applying Reimbursement-Drugs) was announced on April 28. It took effect on May 1. Meanwhile, the CDRC, which was to discuss the HIRA's detailed notice on 'Detailed Criteria and Methods for Applying Reimbursement (of Medications Prescribed·Administered to Cancer Patients),' convened on April 30. In other words, the CDRC met to discuss the details just two days after the notice was announced, and reportedly did not have enough time for proper deliberation. In its administrative notice explaining the reasons for the revision, the MOHW stated that, since the dosing criteria for agents used in anticancer regimens are scheduled to change in the 'Detailed Criteria and Methods for Applying Reimbursement (of Medications Prescribed·Administered to Cancer Patients),' (the HIRA announcement), it would simultaneously revise the cost-sharing regulations; however, it pushed the notice through before HIRA's detailed announcement was issued. This suggests that the MOHW and HIRA did not adequately coordinate on the timing of implementation. It is reported that the two sides had differing views on preparing the list of partially reimbursable drugs. Critics argue that the MOHW rushed a policy that will require massive additional spending. Because setting reimbursement criteria for anticancer drugs falls under both HIRA and the MOHW, issuing the notice without consultation with the NHIS, which administers reimbursements, has been controversial. Some suggest that the MOHW bowed to pressure from the National Assembly, patient groups, and pharmaceutical companies without adequately debating fiscal savings. Notably, a policy forum on improving patient access to combination therapies was hosted by Rep. Lee Joo-young's office in March, during which government representatives expressed caution. Yet, barely two months later, the notice was issued. An unintended side effect of partial reimbursement for combination therapies is that if new drugs are used in first-line treatment, there may be no reimbursable options for second-line therapy after failure. To reduce confusion and unintended outcomes, HIRA plans to convene an unscheduled CDRC meeting this month to finalize the details. In a letter sent to relevant organizations on the 7th, HIRA stated that it will "discuss as soon as possible at the CDRC meeting the approved indications and academic society opinions to reduce confusion in practices when applying the detailed notice to existing anticancer regimens and combination therapies," and that it intends to implement the 'Detailed Criteria and Methods for Applying Reimbursement (of Medications Prescribed·Administered to Cancer Patients)' on June 1.
- Company
- Vyloy quickly lands in general hospitals in Korea
- by Eo, Yun-Ho May 13, 2025 06:07am
- Vyloy, a targeted anticancer drug for gastric cancer, may be prescribed at general hospitals in Korea. According to industry sources, Vyloy (zolbetuximab), a Claudin 18.2-positive gastric cancer targeted therapy developed by Astellas Korea, is now available for prescription at the Big 5 tertiary hospitals in Korea, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medcial Center, and Sinchon Severance Hospital. The drug has passed the regular or emergency drug committees (DCs) at each hospital. Additionally, prescription codes have been generated at other medical institutions such as Ajou University Hospital, Chilgok Kyungpook National University Hospital, and Hwasun Chonnam National University Hospital. Approved in Korea last September, Vyloy is the world's first claudin 18.2-targeted therapy, an immunoglobulin (IgG) monoclonal antibody that binds to Claudin 18.2, a protein expressed on the surface of cancer cells in gastric epithelial cells. The SPOTLIGHT study, which became the basis of Vyloy’s approval, showed that Vyloy+ mFOLFOX6 (fluorouracil, leucovorin, oxaliplatin) combination therapy’s progression-free survival (PFS) was 10.6 months, compared with the 8.67 months in the placebo arm. Also, the median overall survival (OS) was 18.23 months, compared with the 15.54 months in the placebo arm. Additionally, in the GLOW study, the combination therapy group of Vyloy and CAPOX (capecitabine and oxaliplatin) achieved a median progression-free survival (mPFS) of 8.21 months, reducing the risk of disease progression or death by approximately 31%. However, Vyloy has not yet been reimbursed by health insurance. The drug was submitted to the Health Insurance Review and Assessment Service's Cancer Disease Review Committee in February, but failed to set the reimbursement criteria. Additionally, due to companion diagnostic issues last year, Vyloy was only officially launched in Korea in March. To use Vyloy, patients must be diagnosed as Claudin 18.2 positive, and the companion diagnostic (CDx) device used for Claudin 18.2 diagnosis was considered for evaluation as a new health technology in the reimbursement review process. In response, Astellas has been conducting an EAP program even before Vyloy’s approval to allow sooner access to the treatment, and currently, 51 patients are enrolled across 10 institutions. SunYoung Rha, a professor of medical oncology at Yonsei Cancer Center, stated, “Approximately 90% of metastatic gastric cancer patients are HER2-negative, rendering a dire need for treatment options targeting this biomarker. Given that about 40% of HER2-negative patients are reported to be Claudin 18.2-positive, the release of Vyloy, which selectively binds to Claudin 18.2, presents a new treatment possibility.”
- Company
- Mounjaro provides more weight loss than Wegovy
- by Eo, Yun-Ho May 13, 2025 06:06am
- Research results found Mounjaro brings more weight loss than its competitor Wegovy. On the 12th, Lilly announced the detailed results of the SURMOUNT-5 Phase IIIb open-label clinical trial directly comparing Mounjaro (tirzepatide), a dual GIP/GLP-1 receptor agonist, and Wegovy (semaglutide), a GLP-1 receptor agonist. The study, which compared the weight loss effects of the two drugs that have garnered global attention as obesity treatments, was simultaneously presented at the 32nd European Congress on Obesity (ECO) and published in the international academic journal The New England Journal of Medicine (NEJM). The study enrolled adult patients with a body mass index (BMI) of 30 kg/m² or higher, or overweight patients (BMI 27 kg/m² or higher but less than 30 kg/m²) with at least one weight-related comorbidity, excluding diabetes. In the trial, Mounjaro demonstrated superiority over Wegovy, meeting all the primary endpoints and five key secondary endpoints at week 72. The primary endpoint, the mean percent change in weight from baseline to week 72 in the Mounjaro group (10 mg or 15 mg), was 20.2%, compared to 13.7% in the Wegovy group (1.7 mg or 2.4 mg), representing a 47% relative weight loss improvement. Based on treatment regimen estimands, the mean weight loss was 22.8 kg in the Mounjaro group and 15.0 kg in the semaglutide group. Mounjaro also outperformed Wegovy in all key secondary endpoints of weight loss. In key secondary endpoints, Mounjaro was superior across all weight reduction targets, with 64.6% of patients in the Mounjaro group achieving at least 15.0% weight loss compared to 40.1% in the Wegovy group. Additionally, patients in the Mounjaro group achieved a superior average waist circumference reduction of 7.2 in (18.4 cm), while in the Wegovy group saw an average reduction of 5.1 in (13.0 cm). Min-Seon Kim, President of the Korean Society for the Study of Obesity and Professor of Endocrinology at Asan Medical Center, stated, “In the head-to-head trial (SURMOUNT-5), Mounjaro demonstrated a superior weight loss effect compared to Wegovy. I expect the introduction of this medication to contribute to obesity treatment in Korea.”
- Policy
- CDRC to talk partial reimb details for comb cancer therapy
- by Lee, Tak-Sun May 13, 2025 06:06am
- An additional date has been set to discuss detailed criteria regarding partial reimbursement of combination cancer therapy, as announced this month. The Health Insurance Review and Assessment Service (HIRA) has decided to convene another Cancer Drug Review Committee (CDRC) meeting, which was not scheduled. According to industry sources on May 12, the HIRA will convene the 4th CDRC of 2025 on May 14, 4PM at Kukje Electronics Center. During the meeting, detailed criteria related to partial reimbursement of combination cancer therapy, notified by the Ministry of Health and Welfare (MOHW) this month, will be discussed. Based on the discussion during the meeting, the HIRA will revise the 'Detailed Criteria and Methods for Applying Reimbursement (of Medications Prescribed·Administered to Cancer Patients),' then implement it from June. The upcoming CDRC meeting had not been scheduled. The 4th CDRC meeting was initially planned to convene on June 11, but it has been moved up a month. In other words, it is the major issue in medical practices. This month, the Ministry of Health and Welfare (MOHW) newly established a partial reimbursement of combination cancer therapy through partial revision to the 'Detailed Criteria and Methods for Applying Reimbursement (Drugs).' In detail, a new clause states, 'when combining a reimbursed chemotherapy regimen with another anticancer drug, the existing co-payment for the previously initiated chemotherapy shall continue to apply to that regimen.' Previously, all combination therapies not approved by insurance reimbursement were entirely non-reimbursed. However, with the establishment of this clause, one anticancer agent now recognized for reimbursement is expected to alleviate patients' financial burden and improve treatment accessibility. However, confusion persists in medical practices due to a lack of details, such as which drugs are eligible for reimbursement. Pharmaceutical companies have also been asked whether the drug in question is eligible for reimbursement, but they have also been unable to provide clear answers. At the CDRC meeting held on April 30, there was consensus on the need for detailed criteria. Still, they failed to prepare a revision with only a few days left before the MOHW's notification takes effect. Recently, the HIRA sent an official letter to relevant organizations stating that it would promptly discuss at the CDRC meeting the comprehensive consideration of the approved indications and academic society opinions to reduce confusion in medical practice when applying the detailed criteria to existing anticancer therapies and combination therapies with other anticancer agents. The HIRA plans to revise the 'Detailed Criteria and Methods for Applying Reimbursement (of Medications Prescribed·Administered to Cancer Patients),' including eligibility criteria, and implement it on June 1. Accordingly, at the CDRC meeting scheduled for May 14, they are expected to establish the reimbursable drugs and detailed criteria for partial reimbursement for combination cancer therapies and include them in the announcement of cancer drug reimbursement criteria set to take effect in June.
- Product
- Indiscriminate in-hospital prescriptions of Wegovy
- by Jung, Heung-Jun May 13, 2025 06:06am
- Criticism arose regarding the indiscriminate in-hospital prescriptions of Wegovy, which is currently allowed with an exception. According to the Korean Pharmaceutical Affairs Act, in-hospital prescription is allowed only when an 'injectable is injected.' However, it has been pointed out that Wegovy is being sold without a single act of injection. According to a local pharmacy, more hospitals have begun in-hospital prescriptions after Wegovy's non-face-to-face prescription was restricted as of December 2024. Pharmacists complain that "out-of-hospital prescriptions are being made only when hospitals run out of stock." In fact, it has been pointed out that proper monitoring has not been done despite frequent in-hospital prescriptions without meeting the requirement of 'when injected.' A Pharmacist 'A' in Seoul said, "Prescriptions are being made only when hospitals run out of stock and until restocked. We heard from patients coming to pharmacies that hospitals are selling the medication without giving injections," and added, "We are aware that in-hospital prescriptions are being restricted and doing so raises problem." A Pharmacist 'A' added, "Based on the guideline's recommendation, dosage must be initiated from Level 1, but there are cases where Level 2-3 are prescribed." Proper monitoring is deemed necessary because indiscriminate and misuse cases of in-hospital prescriptions were also found in hospitals and clinics that give injections. At a Wegovy online community with over ten thousand members, information on 'shared injection' cases in hospitals where a needle part of a single Wegovy is swapped and injected into multiple patients. Furthermore, supply price may differ, so when hospitals offer in-hospital prescriptions at a lower price, nearby pharmacies' selling prices are heavily affected. A Pharmacist 'B' in Seoul said, "Although we are seeing lower prescriptions compared to the early period of the launch, a few patients still visit. Due to the non-face-to-face platform, checking the Wegovy price got easier, and patients are sharing information online, so we have lowered the price at the pharmacy." Since Zuellig Pharma Korea does not directly transact with pharmacies, pharmacists purchase Wegovy through collaborative wholesale merchants, such as Kyungdongsa and Geo-young. Zuellig Pharma Korea reported that they have not changed the distribution price since the first domestic distribution in October 2024. It has been reported that there is a difference of about KRW 20,000 between the distributing price and that purchased through the collaborative wholesale merchants. Consequently, if pharmacies were to lower the selling price, adjusting to several hospitals that offer extremely low-priced in-hospital prescriptions, they must sell Wegovy at the buying cost.
- Company
- U.S. pharmaceutical imports rise twofold amid tariff concern
- by Kim, Jin-Gu May 13, 2025 06:05am
- U.S. drug imports have nearly doubled in a year. This is believed to be the result of frontline pharmaceutical and biotech companies focusing on securing inventory in expectation of U.S. President Donald Trump's drug tariff imposition. According to Korea Biotechnology Industry Organization (KoreaBIO) on the 12th, the U.S. The United States Census Bureau and the U.S. Bureau of Economic Analysis recently announced the results of U.S. trade in goods and services. According to the data, U.S. imports of goods in the first quarter totaled USD 997.8 billion. This is a 26.6% (USD 209.8 billion) increase from the USD 788 billion in the first quarter of last year. In particular, imports of pharmaceuticals increased significantly. In the first quarter, U.S. imports of pharmaceuticals amounted to USD 108.2 billion, a 97.2% (or USD 53.3 billion) increase from the USD 54.9 billion in the same period last year. Pharmaceutical imports surged in March during the first quarter. This coincides with the spread of concerns over President Trump's pharmaceutical tariffs. In fact, U.S. pharmaceutical imports, which stood at USD 29.5 billion in February, rose to USD 50.4 billion in March, an increase of 70.9% in just one month. Considering that total imports increased by 5.5% (from USD 326.5 billion to USD 344.3 billion) during the same period, the increase in pharmaceutical imports was particularly notable. The share of pharmaceuticals in total U.S. imports rose from 9.0% in February to 14.6% in March, an increase of 5.6 percentage points in a single month. KoreaBIO explained that the increase in U.S. pharmaceutical imports was due to the proactive response of local pharmaceutical and biotech companies to concerns over President Trump's import tariffs. KoreaBIO analyzed that “local pharmaceutical and biotech companies appear to be focusing more on securing inventory in the U.S. this year as a short-term response.” Domestic companies are also focusing on securing inventory in the U.S. As of the 7th of this month, Celltrion has completed the transfer of approximately 15 months' worth of inventory for products scheduled for sale in the U.S. Celltrion expects that this will minimize the impact of tariffs not only this year but also in the first half of next year. Celltrion plans to minimize risk in the mid- to long-term by producing finished drug products (DP) through local contract manufacturing organizations (CMOs) in the US. The company explained that it has completed negotiations to secure additional quantities in preparation for the possibility of increased tariff burdens after next year. At the same time, it is pushing ahead with securing active pharmaceutical ingredient (API) manufacturing facilities in the US. It has completed preliminary reviews and has entered the stage of detailed reviews. A Celltrion official said, “We have been devising various strategies in advance to respond to the possibility of changes in President Trump's tariff policy,” adding, “Once the policy is finalized, we will promptly share a comprehensive response plan with our shareholders.” The U.S. government plans to make a separate announcement on whether to impose tariffs on pharmaceuticals. Although it was not included in the mutual tariffs announced on the 2nd of last month, expectations are growing that separate tariffs on specific items will be imposed in May. Prior to this, the U.S. Department of Commerce has been assessing the impact of imports of pharmaceuticals and pharmaceutical raw materials on national security under Section 232 of the Trade Expansion Act, and requested public comments from interested parties from the 16th of last month to the 7th of this month. It is reported that a total of 957 companies and institutions worldwide, including the United States, submitted public comments. South Korea also submitted comments through the government, KoreaBIO, and the Korea International Trade Association(KITA). U.S. companies and institutions, including the Pharmaceutical Research and Manufacturers' Association, are said to have submitted comments stating that “imposing tariffs on pharmaceuticals is not the answer.”
- Company
- 'Retevmo' also seeks thyroid cancer reimbursement
- by Eo, Yun-Ho May 12, 2025 05:59am
- Product photo of Retevmo The RET-targeted cancer therapy 'Retevmo' seeks insurance reimbursement listing of its medullary thyroid cancer indication. According to sources, Lilly Korea recently submitted reimbursement applications simultaneously for the non–small cell lung cancer indication and medullary thyroid cancer indication of the RET (REarranged during Transfection) inhibitor Retevmo (selpercatinib). Having failed in its previous two attempts to secure reimbursement listing for lung cancer, the company is now showing its determination to gain listing by adding a new indication. The prevalence of medullary thyroid cancer is only 1–2% of all thyroid cancers worldwide and just 0.6% in South Korea. However, 60% of cases harbor RET gene mutations. In other words, RET-targeted therapies can be used to treat medullary thyroid cancer. First-line treatments for medullary thyroid cancer currently consist of multitargeted kinase inhibitors such as vandetanib and cabozantinib, which inhibit multiple kinases non-selectively and can therefore be associated with higher rates of adverse events. In contrast, Retevmo is a highly selective RET inhibitor. Retevmo demonstrated efficacy in medullary thyroid cancer in the Phase 3 LIBRETTO-531 study. The LIBRETTO-531 study is a Phase 3 open-label trial comparing Retevmo against the approved first-line multikinase inhibitors (cabozantinib or vandetanib) in patients with progressive or metastatic RET-mutant medullary thyroid cancer. A total of 291 medullary thyroid cancer patients with no prior multikinase inhibitor therapy were randomized (193 Retevmo treatment group, 98 control group). At the investigators' discretion, patients in the control group received cabozantinib in 73 cases and vandetanib in 25 cases. The progression-free survival (PFS) comparison yielded positive data in the interim analysis. At a median follow-up of approximately 12 months, the Retevmo treatment group had not yet reached median PFS by blinded independent central review (BICR), while the control group had a median PFS of 16.8 months. The hazard ratio was 0.280. In preplanned subgroup analyses, BICR-assessed and investigator-assessed PFS were longer with Retevmo than with the control. Meanwhile, although Retevmo was approved in South Korea in March 2022, it failed to pass the National Health Insurance Service (NHIS) Cancer Disease Review Committee (CDRC) in May of the same year. Still, it cleared the CDRC in November and passed the Drug Reimbursement Evaluation Committee (DREC) in May 2023. After passing the reimbursement committee, negotiations with the NHIS on pricing began in June, raising hopes for listing, but ultimately, no agreement was reached. The case was the only failed price negotiation of that year. A Lilly representative said, "The company has been continuously preparing for the reapplication process and has submitted all required documents to the NHIS. The government is currently reviewing the application. We will do our best to ensure that more patients can benefit as soon as possible."
- Policy
- Reimb expansion for Benlysta in negotiations with NHIS
- by Lee, Tak-Sun May 12, 2025 05:59am
- Negotiations are underway to expand reimbursement for Benlysta (belimumab, GSK), a treatment for active systemic lupus erythematosus in adults. The drug was added to the reimbursement list in 2021 through the risk-sharing agreement (RSA), 8 years after its approval in Korea in 2013. According to industry sources on the 9th, the National Health Insurance Service added Benlysta to the list of drugs subject to price negotiations in May that was disclosed on its website. The proposal to expand Benlysta's scope of use was approved by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service in March. Benlysta is currently reimbursed for the treatment of adults patients with active, antibody-positive systemic lupus erythematosus who are being treated for 3 or more months with the standard of care (corticosteroids, antimalarial drugs, immunosuppressants alone or in combination) who satisfy all the following conditions: ▲ has a disease activity SELENA-SLEDAI score ≥ 10, ▲ anti‐dsDNA–positive, and ▲hypocomplementemic (C3/C4 level). The drug is currently covered at a coinsurance rate of 10% through the special calculation exemption system for rare diseases. However, the drug’s indication is broader. In addition to adult patients, it is also indicated for the treatment of patients aged 5 years or older with active systemic lupus erythematosus and adult patients with active lupus nephritis undergoing standard therapy. The proposed reimbursement expansion application sought to expand the scope of its covered use in adult patients. Lupus is an autoimmune disease that causes an inflammatory response throughout the body. In particular, when it affects major organs such as the heart, lungs, kidneys, and brain, it can cause irreversible damage and lead to death. Most patients are women of childbearing age, and 19% of pregnant women may experience fetal death, intrauterine growth restriction, low birth weight, or premature birth. Benlysta 's 2023 IQVIA sales are estimated at KRW 1.9 billion. Currently, three risk-sharing agreements have been signed for this drug, including a refund-type agreement, an initial treatment refund-type agreement, and an expenditure cap agreement. If the negotiations proceed smoothly, the drug is expected to be listed for reimbursement in the second half of this year.
- Company
- Pemazyre lands in major hospitals in Korea
- by Eo, Yun-Ho May 12, 2025 05:59am
- Pemazyre, a treatment for intrahepatic bile duct cancer(cholangiocarcinoma), may now be prescribed at tertiary hospitals in Korea. According to industry sources, Handok's Pemazyre (pemigatinib) has passed the drug committee (DC) of the Big 5 general hospitals in Korea, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Sinchon Severance Hospital. As the drug has been listed for reimbursement starting this May, the stage has now been set for its full-scale prescription in Korea. The drug is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. Pemazyre is the first drug in Korea to be approved for this patient population. In March 2022, Handok signed an agreement with the global biopharmaceutical company Incyte Corp for the registration and supply of Pemazyre in Korea. Pemazyre was designated as an orphan drug by the Ministry of Food and Drug Safety in November 2021. A dire need existed in the field of cholangiocarcinoma due to the lack of a standardized second-line therapy for patients who fail first-line therapy. Surgery is the best treatment for bile duct cancer, but typically only 20-30% of patients are eligible for surgery at the time of diagnosis. Even after surgery, bile duct cancer has a high recurrence rate of 60-70% and a reported 5-year survival rate of less than 20%. Specifically, fusions or other rearrangements of the FGFR2 gene, for which Pemazyre is indicated, occur in approximately 10-16% of patients with intrahepatic cholangiocarcinoma. The approval of Pemazyre is based on the Phase II FIGHT-202 study. The open-label, single-arm Phase II FIGHT-202 study enrolled 107 adult patients (mean age 56 years) who had received at least one prior therapy for locally advanced or metastatic cholangiocarcinoma with a fusion or rearrangement of the FGFR2 gene. The results showed that the primary efficacy endpoint, objective response rate (ORR), was 35.5%, and the secondary endpoint, median duration of response (DOR), was 7.5 months in the Pemazyre arm. In addition, the reported median progression-free survival (PFS) was 6.9 months, and the median overall survival (OS) was 21.1 months. The most commonly reported treatment-related adverse event was hyperphosphatemia, which was of the lowest severity (Grade 1 or 2) and manageable.
- Company
- Generic market share 13% after 'Trajenta' patent expiration
- by Kim, Jin-Gu May 12, 2025 05:59am
- Generic products have expanded their market share to 13% just nine months after the patent expiration of Trajenta (linagliptin), a DPP-4 inhibitor for diabetes treatment. Compared to previous cases of diabetes treatments in the same drug class that patents expired before Trajenta, generic products are analyzed to have slower market penetration. Analysis suggests that the entry of generic products was blocked until early this year because they failed to receive priority marketing authorization, leading to passive product launches due to the original manufacturer’s active resistance. Original prescription sales KRW 29.3 billion→KRW 21.6 billion in one year… and generics totaled KRW 3.1 billion According to UBIST, a pharmaceutical market research firm, on the 9th, the outpatient prescription market size for linagliptin-based diabetes treatments in the first quarter was KRW 24.7 billion. It decreased by 16% year-over-year (YoY). Prescription sales of the original products, Trajenta and Trajenta Duo, dropped. Trajenta monotherapy sales dropped from KRW 14.7 billion to KRW 9.7 billion, a 34% decline, while the metformin combination therapy decreased from KRW 14.6 billion to KRW 11.8 billion, a 19% decline. The combined prescription amount shrank from KRW 29.3 billion to KRW 21.6 billion, a 26% decrease. Such an outcome is attributed to the expiration of the compound patent, the entry of generics, and the resulting price reductions. The substance patent for Trajenta expired in June of last year. Since then, generic products have been listed for reimbursement, leading to price cuts for the original products. Trajenta price fell by 30% and Trajenta Duo by 11%. Quarterly prescription sales of Trajenta original drug (dark green) & generics (light green). (unit: KRW 100 million, source: UBIST) The generics that entered the market immediately after patent expiration have gradually increased their market influence. The combined prescription value of Trajenta and Trajenta Duo generics rose from KRW 1.8 billion in Q3 of last year to KRW 2.7 billion in Q4, and KRW 3.1 billion in Q1 of this year. By company, as of Q1 of this year, KyungDong Pharmaceutical had the highest combined generic prescriptions for the single and combination products at KRW 600 million, followed by Daewon Pharmaceutical at KRW 500 million, Kyungbo Pharmaceutical at KRW 400 million, Yuhan and Hanmi Pharmaceutical each at KRW 300 million, and Boryung at KRW 200 million. Except for one company, all generic manufacturers recorded less than KRW 500 million prescriptions in Q1. The average prescription value per generic-launching company was just over KRW 100 million. Penetration rate↓ compared to previous cases of patent expiry… Did the original company's defensive strategy work? Analysis suggests that generic market penetration has been somewhat slow, even with other diabetes drugs of the same class whose patents expired earlier. For example, generics for 'Galvus (vildagliptin),' which lost patent protection before Trajenta, achieved a 39% market share three quarters after expiration. Generics for 'Tenelia (teneligliptin)' reached a 48% market share nine months after patent expiry. Generics for 'Januvia (sitagliptin),' whose patent expired in September 2023, had a 15% share three quarters after launch, two percentage points higher than Trajenta generics at the same period (13%). Trajenta's generics have shown the slowest market penetration among DPP-4 inhibitor diabetes drugs. The pharmaceutical industry suggests several analysis. First, the lock on priority marketing authorization for Trajenta generics was lifted earlier this year. After Trajenta's compound patent expired in May last year, 26 companies obtained priority marketing authorization and launched products. Their priority marketing periods ended in March of this year. Companies without those priority marketing authorization approvals were barred from launching generics for about ten months. Only after those periods expired in March were an additional 12 companies, including Hanmi Pharmaceutical·Genuone Sciences, able to enter the market. In addition, the original company, Boehringer Ingelheim Korea, actively defended its position by enforcing so-called 'unlisted patents' on Trajenta to defend generic launches. Generic manufacturers faced the choice of launching products without entirely circumventing or invalidating those unlisted patents, risking patent infringement findings and damages in future litigation. For these reasons, some companies reportedly held back on generic launches. Only 15 firms listed the Trajenta monotherapy generic for reimbursement, whereas 39 listed the combination therapies, because reformulating the combination can partially avoid unlisted patent risks. Indeed, of the 40 firms that listed a Trajenta Duo generic, 27 secured approval by changing the formulation to an extended-release tablet. Strong brand loyalty to the original product in clinical practice may have also contributed. Trajenta held the number 2 spot in the market for DPP-4 inhibitors for a long time after Januvia before its patent expiry, and despite generic entry, it maintains high loyalty in prescribing.
