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- 2026-05-01 14:44:59
- Policy
- Dupixent receives the green light for reimb extensions
- by Lee, Tak-Sun Oct 30, 2023 05:30am
- The insurance authorities showed a positive stance on expanding coverage of Dupixent (dupilumab, Sanofi), which is available for patients with severe atopic dermatitis from 6 years of age, to critically ill infants and toddlers from 6 months to 5 years of age. Depending on the cost-effective review results, the reimbursement process may gain momentum in the future. In addition, it appears that the authorities are also reviewing reimbursing the drug for another indication, asthma. The Health Insurance Review and Assessment Service recently revealed so in response to a written inquiry they received at the NA audit. Last April, Sanofi applied HIRA to expand reimbursement so that infants and young children with symptomatic atopic dermatitis from 6 months to 5 years of age can also receive reimbursement for the drug.”. Dupixent obtained the relevant indication from the Ministry of Food and Drug Safety on November 3 last year. The indication was approved based on the results of a Phase III clinical trial (LIBERTY AD PRESCHOOL) that was conducted on atopic dermatitis patients aged 6 months to 5 years of age, which confirmed a significant improvement in AD lesions compared to the placebo group. HIRA subsequently held an expert advisory meeting and reported the review plan to the Ministry of Health and Welfare to secure the feasibility of expanding Duppixent’s reimbursement to infants and toddlers. A full-scale cost-effectiveness evaluation will be conducted accordingly. Regarding the application of reimbursement for the asthma indication, the agenda is also expected to enter the cost-effectiveness evaluation stage soon. It is said that the reimbursement standards were set after two expert advisory meetings held to prepare the reimbursement standards. Dupixent is indicated for severe eosinophilic asthma and oral corticosteroid-dependent severe asthma in adults (aged 18 and older) and adolescents (aged 12 to 17). At the expert advisory committee that took place last July, the members decided that the reimbursement standards should be set, but undergo additional expert advice on the unification of terminology and detailed standards with other drugs in the process of being listed for reimbursement for the same indication. Additional expert advice and opinion collection were conducted thereafter. Based on this, if a reimbursement standard plan is prepared and reported to the Ministry of Health and Welfare, a cost-effectiveness evaluation for the indication will also begin, similar to the case of AD in infants and toddlers. As Cinqair Inj and Nucala Inj, which are biological asthma drugs, have recently succeeded in being reimbursed, the possibility of Dupixent's successful reimbursement expansion has also been increasing. Of course, it takes a considerable amount of time to evaluate cost-effectiveness and it is not easy to pass, so it is currently impossible to predict when the reimbursement expansion will take place. Nevertheless, as the feasibility of expanding the salary standard has been recognized, it is expected that the reimbursement process can accelerate if pharmaceutical companies are willing to present appropriate cost-sharing plans. In addition to the reimbursement extension, Dupixent is also in the process of renewing its risk-sharing contract. After the first round of RSA renewal negotiations broke down, it seems highly likely that a contract renewal will be agreed upon in the second round of negotiations. Attention is being paid to whether Dupixent's Sanofi will be able to kill two birds with one stone, by expanding reimbursement and renewing the risk-sharing agreement, remains to be seen. Based on IQVIA, Dupixent posted sales of KRW 105.2 billion in 2022. As claims are expected to increase further this year due to reimbursement extension to children and adolescents, there is a possibility that the pharmaceutical company's share of the burden will increase with the renewal of the risk-sharing system.
- Policy
- NA criticizes HIRA's low prior approval of specific drug
- by Lee, Tak-Sun Oct 30, 2023 05:29am
- In response to the criticism that the prior review approval rate of certain drugs is low, the Health Insurance Review and Assessment Service said that the low rate is due to a lack of understanding of the reimbursement standards and that it will maintain the current standards. The response was made regarding the low approval rate of Soliris for aHUS (atypical hemolytic uremic syndrome) disease. On the 18th, Rep. Sun-Woo Kang of the Democratic Party of Korea made a written inquiry about the low prior approval rate of certain drugs used for aHUS during the NA audit of the Health Insurance Review and Assessment Service. aHUS is a severe and rare hereditary disease in which 79% of patients die or require dialysis within 3 years of onset and suffer permanent renal failure. Also, patents with aHUS experience 'thrombotic microangiopathies (TMA)' (a condition in which blood clots and inflammation damage small blood vessels throughout the body), and major organs such as the kidneys, heart, and brain become damaged, bringing about various complications such as acute renal failure, heart failure, and stroke. In acute cases, the disease can tear internal organs within 1 week, especially the walls of the kidneys, which severe cases lead to death. The prior approval system was implemented in 1992 as a system that allows a prior review subcommittee, which consists of several experts, to decide whether or not to allow reimbursement for each case before treatment to allow patients in dire need of treatment with high-priced rare disease treatments. The system has been applied to pharmaceuticals since 2007. This is not the first time Soliris' low approval rate for aHUS has been raised as an issue. According to the data presented by Yong Kyun Won, Professor of Radiation Oncology at Soonchunhyang Univ. Cheonan Hospital, Soliris’s prior approval rate for aHUS was only 21.6%. None of the 6 new applications filed in July that were disclosed by the HIRA passed expert review. This is why experts in the field have expressed concerns saying, "If the prior review approval rate is low, the prescribing doctor may give up use of the drug in advance, impeding patient access to treatment." However, HIRA has been arguing that the low approval rate is not a concern, rather, it is due to a lack of understanding of the reimbursement standards. In a response to Rep Kang’s written inquiry, HIRA stated, "The approval rate for aHUS is low because medical institutions have been filing many applications to receive help from experts in the prior review subcommittee on determining the reimbursement adequacy of their patients or apply with a lack of knowledge about the reimbursement standards, rather than clearly determining the eligibility and exclusion criteria themselves based on each patient’s medical records. In addition, regarding the criticism about the strict reimbursement standards, HIRA answered, “A reimbursement t expansion request has been filed recently, asking for ‘'ease of the TMA requirements in the aHUS salary standards.’” After discussing the request at an advisory meeting, including experts from related societies such as the Korean Society of Nephrology, they concluded that the current standards should be maintained, as no new clinical evidence has been generated to warrant a change, and the prior review subcommittee has been reviewing the situation of each patient in consideration of the comprehensive situation of each patient for cases that require medical judgment.” Despite so, concerns have continued to rise in the field. In a survey conducted on relevant societies in the ‘Current Status and Improvement Plan for Medical Benefit Prior Approval System (2022)’ that was conducted by HIRA, the relevant societies said that the criteria for selecting target drugs for the prior review system have not been specified, and the varying composition of the expert committee members that discuss each reimbursement can bring different results. Related academic societies said, “Although the prior review application process in itself is complicated, there is a lack of sufficient explanation regarding the progress or reasons for disapproval. Patients miss out on the appropriate treatment period due to the prior review meeting schedule, which is held once or twice a month. Therefore, flexible operation may be necessary to review cases that arise by case." In addition to Rep Kang, Rep Chounsook Jung from the same party had also raised the issue of the prior review approval rate of a specific drug. Jung made a written inquiry to the health authorities regarding the cases of disapproval of Spinraza, which is used to treat spinal muscular atrophy (SMA), and the need for their improvement. Spinraza’s scope of administration has been expanded starting in October. Its subjects have been expanded from those under the age of 3 to those under the age of 18 who show onset of symptoms. Rep. Jung pointed out that measures are needed for patients who were not approved before the change of the standards. Regarding this, HIRA said, "Patients who were previously disapproved because they did not meet the existing age requirements may be able to receive reimbursement if they meet all the reimbursement requirements after evaluation through the prial approval process in line with to the expansion of the age requirement. However, patients who were disapproved while receiving other drugs after review would need to consider that their decision was made based on the expert opinion that ‘after a close and careful review of the medical records (progress record, test results, video, etc.), the members of the ‘prior review subcommittee’ that consist of many experts made the professional medical judgment that ‘it cannot be determined whether the motor function can be maintained or improved with administration of the medication.” HIRA added, “We also have a relief procedure that allows patients and caregivers to file an appeal to the prior review results, and committee members rediscuss the rejected cases based on the submitted explanatory material. If the patient or institution has an objection to the appealed results, they may seek relief for the patient’s rights through administrative adjudication by the Health Insurance Dispute Mediation Committee." HIRA added that 10 administrative adjudications have been filed, 8 of which were rejected, and 2 are under review.
- Policy
- New dug price reeval standards will be set within the year
- by Lee, Jeong-Hwan Oct 27, 2023 05:33am
- The Health Insurance Review and Assessment Service said, “We will prepare a final plan within this year” to an inquiry on the progress made on the reevaluation of off-patent drugs through a comparison of overseas drug prices. In particular, based on the established reevaluation standards, HIRA also expressed their intention to sequentially carry out reevaluations starting next year and reduce the prices of drugs listed at higher prices compared to overseas to secure the financial sustainability of Korea’s national health insurance. Such will were found in the response submitted to answer People Power Party Rep. Young-Hee Choi’s written inquiry during the NA audit on the 25th. Regarding the comparison of overseas drug prices, HIRA explained that it had improved the foreign drug price reference standard (foreign drug price conversion formula) through the operation of a working group with the pharmaceutical industry last year. HIRA is currently working with the Ministry of Health and Welfare to prepare a plan to compare and reevaluate overseas drug prices of listed drugs and announced that it will prepare a final plan within this year after gathering opinions through meetings with the pharmaceutical industry. HIRA said, “We plan to carry out the revaluations sequentially on an annual basis starting next year. We will secure the sustainability of health insurance finances by managing the expenditures spent on drugs listed at a higher price compared to foreign countries.”
- Policy
- Galvusmet generics released in all dosage forms in KOR
- by Lee, Tak-Sun Oct 27, 2023 05:33am
- Novartis Korea The second round of competitions is now on with the entry of Galvusmet generics. If the first round was held between generics before and after Galvusmet’s substance patent expiry, the second round this time expected this time is set to start with the release of Galvusmet generics that come in all dosage forms. According to the industry on the 26th, Daewoong Bio, Mothers Pharmaceutical, and Korea Hutex Pharmaceutical, led by the contracted CDMO Genuone Science, will launch all dosage forms of Galvusmet generics. Galvusmet is a combination of the DPP-4 inhibitor vildagliptin and metformin hydrochloride. Novartis Korea received approval for the drugs in 2008 in Korea. It had been offered in three doses, Galvusmet Tab 50/500mg, Galvusmet Tab 50/850mg, and Galvusmet Tab 50/1000mg. Five companies (United Pharma Korea, Shinpoong, Ahn-gook, Ahn-gook New Pharm, Samjin) had previously released a 50/500mg dosage of the same-ingredient generic. Only Hanmi Pharmaceutical’s Vildaglmet Tab and KyungBo Pharma’s Vildamet Tab offered all the dosage forms offered by Galvusmet, and were self-modified drugs. So this is the first time 50/850mg, and 50/1000mg same-ingredient generics are being released in Korea. Last year, Galvus (including single and combination drugs) posted outpatient prescription sales of KRW 14.5 billion (UBIST data). Among the amount, the original Galvus series posted KRW 32.4 billion in prescriptions, down 30% YoY due to the release of generics. Among the latecomers, Hanmi’s Vildagle series showed the highest performance of KRW 3.9 billion. The analysis is that the company succeeded in preoccupying the market by launching a variety of dosage options. The competition is expected to intensify further with the release of the generic versions in all dosages. In particular, these Galvus generics were released after the enforcement of patent avoidance and bioequivalence t sharing regulations 1 (consignee) + 3 (consignor) and therefore will have fewer competitors than Forxiga or Januvia, which will work in favor of the generic companies in terms of sales and marketing. Also, the fact that the market size for the combination drug Galvusmet is 5 times larger than that of its single-agent drug Galvus is also a factor that the generic companies are looking forward to. Last year, Galvus recorded outpatient prescriptions of KRW 5.4 billion, while Galvusmet recorded KRW 26.9 billion.
- Policy
- Final PVA improvement plan to be prepared soon
- by Lee, Tak-Sun Oct 27, 2023 05:33am
- The final plan to improve the price-volume linkage system is expected to be prepared soon. Most of the improvement plans are expected to reflect the research service results that were released last April. According to industry sources on the 26th, the National Health Insurance Service will complete the public-private working group activities that have been held since June will be completed with the last meeting held on improving the usage-drug price linkage system in early November The NHIS plans to prepare a final draft after the completion of working group activities and aims to revise the internal guidelines with the goal of implementing it on January 1 next year. Accordingly, the final draft is expected to be released at the end of the year. The revision to the internal guidelines is likely to raise the claims amount standard for drugs subject to PVA price cut negotiations from KRW 2 billion to KRW 3-4 billion. If this happens, lower-performing products will likely be relieved of the burden of relieving drug price cuts. However, the other measures that require notification will be implemented later. Industry experts expect the changes such as increasing the maximum reduction rate currently restricted to 10% and including items with an increase in claims amount of more than 10% and KRW 5 billion to be subject to PVA negotiations, to be made by the first half of next year. Meanwhile, changes to the PVA system as a preferential measure for innovative new drugs that had been discussed may also likely be included in the final draft. The price reduction rate for innovative new drugs that are subject to PVA will be reduced if the same drug is subject to PVA three times in a row. Last year, the NHIS carried out an external research service on practical measures to improve Korea’s drug expenditure management system, and its result report was released in April. Results of the ‘A study on the performance of the Price-Volume Agreement System and measures on its improvement’ that Professor SeungJin Bae from Ewha Womans University's College of Pharmacy participated as the principal investigator, showed that the selection and management of drugs with large financial impact should be identified and that a more efficient operation of the system is necessary.
- Policy
- Minister Cho will work to address shingles vaccine issue
- by Lee, Hye-Kyung Oct 26, 2023 06:06am
- The government responded that it would seek ways to ease the public burden in response to the request that shingles vaccines should be included in Korea’s National Immunization Program (NIP). Rep Young-Joo Kim of the Democratic Party of Korea pointed at the audit of the NA Health and Welfare Committee that was held on the 25th. She said, “There are medical institutions that charge up to KRW 400,000 for shingles prevention vaccine, whose supply price starts at KRW 8,400. In addition to adding the vaccines to NIP, we need to take measures such as a price disclosure system for suppliers.” According to the data Rep Kim received from the KDCA and HIRA, the average price of Zostavax Inj in 2022 was KRW 165,471, ranging from KRW 90,000 to up to KRW 400,000. In 2021, the average price of vaccination in SKYZoster was KRW 146,358. Its price ranged from KRW 40,000 to KRW 230,000, which is a sixfold difference. From 2021 to August of this year, the average supply price of SKYZoster was around KRW 77,000 every year. The places that received the vaccines at the highest price during this period were found to have received them at KRW 341,000, KRW 161,000, and KRW 150,000 in 2021, 2022, and 2023, respectively. Rep Kim said, “People are receiving shingle vaccinations like a lottery. The ex-factory price is being set randomly, and those who lack information are left to receive the vaccination for KRW 400,000,” requesting countermeasures. In relation to this, Minister of Health and Welfare Minister Kyoo-Hong Cho said, "We have been disclosing the price of non-reimbursed items first because it is difficult to control their price. We will investigate the cause of the sharp drop in price and the price difference. The issue of its reimbursement through NIP needs to be reviewed on its medical necessity and financial efficiency. It is difficult to say no, so we will seek ways to alleviate the public burden." HIRA President Jung-Gu Kang, said, “We have been disclosing the non-reimbursed prices of drugs, and will expand the disclosed items to more than 1,000 in the future. We will try to find other means (to disclose ex-factory prices).” Commissioner Young-Mee Jee of the Korea Disease Control and Prevention Agency said, “We are currently evaluating introducing shingles vaccine to NIP. We will apply it as soon as the results are available. If it is listed as an NIP drug, the method of purchasing the vaccine will also be improved and be priced appropriately.”
- Policy
- Prostate cancer tx Xtandi·Zytiga, 5% pt copayment applied
- by Lee, Tak-Sun Oct 26, 2023 06:06am
- Mandatory coverage is applied to some treatments for prostate cancer treatments Xtandi soft capsule 40mg and Zytiga, which is expected to reduce the financial burden on patients. This is a measure of fairness as Erleada is subject to mandatory benefit as it was previously listed. The HIRA announced that it will revise the anticancer drug reimbursement standards including this information starting in November. Xtandi's pt copayment will be lowered from 30% to 5% due to expanded coverage for ADT combination therapy (first-line palliative treatment) for metastatic hormone-sensitive prostate cancer. Zytiga also lowers the pt copayment of prednisolone + ADT combination therapy (first-line, palliative treatment) from 30% to 5% for metastatic hormone-sensitive prostate cancer. HIRA said, "As Erleada, a drug in the ARTA (androgen receptor targeting agent) class, was recently applied for the same indication with a pt copayment of 5/100, issues such as confusion in actual clinical settings and patient equity were raised, so textbooks and guidelines were revised. · Referring to academic opinions, etc., it was judged to be a drug that needed expanded coverage, so the pt copayment was changed from 30% to 5%,” he explained. The upper limit amount was also adjusted according to the expansion of benefits. Zytiga has applied an ex officio adjusted upper limit amount as Hanmi Pharmaceutical's 'Abiteron 500mg', a generic drug, was listed starting this month. Accordingly, the upper limit will be reduced from 16,780 won per party, which is 70% of the previous highest price, to 11,746 won. After one year, it will drop to 8,986 won, which is 53.55%. For reference, Hanmi's first generic ‘Abiteron 500mg’ was listed at 8,537 won per tablet. The transition to mandatory coverage also greatly reduces the financial burden on patients. In the case of Xtandi, the cost per patient is reduced from about 5.84 million won to about 660,000 won per year, the NHIS said. Last year, based on IQVIA, domestic sales amounted to 29.1 billion won for Xtandi and 21.8 billion won for Zytiga.
- Policy
- Will restrictions be eased for vaccine clinical trials?
- by Lee, Jeong-Hwan Oct 26, 2023 06:06am
- Minister of Food and Drug Safety Yu-Kyung Oh promised to reduce or ease the mandatory participation rate of domestic clinical patients from the current 10% to 5% to strengthen sovereignty over domestically produced vaccines and increase self-sufficiency. The plan is to improve the current regulations by accepting the claims raised by domestic pharmaceutical companies that seek to develop domestic vaccines and agreeing with the National Assembly's suggestion to speed up development by lowering the domestic reference rate to reinforce actual vaccine self-sufficiency. On the 25th, Yu-Kyung Oh, Minister of Food and Drug Safety, responded as follows to an on-site inquiry made by Rep. Ki-Youn Kang of the People Power Party at the NA audit. Rep. Kang pointed out that vaccines to prevent diseases such as pertussis and cervical cancer are frequently sold out or out of stock domestically, thereby infringing on people's health and convenience. In particular, Rep. Kang pointed to the 10% domestic participation rate requirement set for clinical trials for vaccine development as the issue and urged it be lowered to 5%. Rep. Kang said, “South Korea, which ranks among the top 10 economies around the globe, is always low on vaccines. To secure sovereignty, the related R&D budget must be significantly increased. Also, the current 10% domestic participation rate required for vaccine clinical trials is very high compared to global standards. If this ratio is lowered to just 5%, the vaccine development period can be shortened by 2 to 3 years.” Rep. Kang added, “Please review the claim that the proportion of the Korean participants in the clinical trial should be lowered. The Ministry of Food and Drug Safety needs to ease regulations by actively listening to the pharmaceutical industry’s demands for vaccine development.” In response to Rep. Kang's criticism, MOHW Minister Kyoo-Hong Cho promised to secure the R&D budget necessary for vaccine development, and MFDS Minister Oh promised to push down the domestic participation rate requirement to 5% for vaccine clinical trials. Minister Cho said, “We will be able to better support vaccine sovereignty by introducing a new project called Korean ARPA-H in the 2024 budget. We will proceed according to plan.” Minister Oh said, “The 10% rate is not mandatory, but recommended. If the developer provides statistically valid evidence, the Korean participation rate can be adjusted flexibly.” When Rep. Kang requested easing of the regulation to 5%, Oh replied, “I will do so.”
- Policy
- Severe asthma txs Nucala and Cinqair are to be reimbursed
- by Lee, Jeong-Hwan Oct 24, 2023 05:22am
- Reimbursement treatment options for the treatment of severe eosinophilic asthma are expanded. GSK Korea's Nucala and Handok Teva Cinqair will be listed on the payroll simultaneously next month. Eisai's JAK inhibitor Jyseleca will also have new insurance coverage standards, and Novartis' JAK1/JAK2 inhibitor Jakavi will have coverage standards for Graft-versus-host reaction or disease (GVHD) added. Recently, the Ministry of Health and Welfare announced the details of the standards and methods for applying such nursing care benefits. We will begin collecting opinions until the 29th for implementation on the 1st of next month. Nucala and Cinqair are used in adult patients with severe eosinophilic asthma who are not adequately controlled despite high-dose inhaled corticosteroids - long-acting inhaled β2 agonists (ICS-LABA) and long-acting muscarinic antagonists (LAMA). In this case, salary is recognized. Benefits are recognized only when ▲the blood eosinophil level is more than 300 cells/㎕ within 12 months before starting treatment, ▲ four or more acute exacerbations of asthma requiring systemic corticosteroids within 12 months prior to starting treatment, or ▲if oral corticosteroids equivalent to 5 mg/day of prednisone have been administered continuously for 6 months prior to starting treatment or, only when the blood eosinophil level is 400 cells/㎕ or more within 12 months before starting treatment and when there have been three or more acute exacerbations of asthma requiring systemic corticosteroids within 12 months before starting treatment. Continued administration is recognized upon evaluating before and every year after drug administration to ensure that the frequency of acute exacerbations of poly asthma has decreased by more than 50% compared to before starting treatment, ▲for patients who require continuous oral corticosteroid treatment, the oral corticosteroid dose is reduced by more than 50% compared to before starting treatment while improving or maintaining asthma symptom control. Nucala is registered with RSA applied, and Cinqair is registered as a general salary. Accordingly, Nucala's sticker price (maximum price) is much higher, but the actual price is known to be similar. If Cinqair had previously been listed as general, it would have been difficult to apply the RSA for Nucala, but with the two drugs being listed at the same time, they were able to be listed under a different reimbursement procedure track. Jyseleca has a new reimbursement standard for rheumatoid arthritis and moderate-to-severe active ulceritis in adults. The standard for benefits is when the patient does not respond appropriately to or is intolerant to common medications for each disease. For those over 65 years of age, benefits may be recognized if the patient does not respond appropriately to or is intolerant to TNF-α inhibitors. Novartis' JAK1/JAK2 inhibitor Jakavi has additional coverage criteria for steroid-refractory GVHD for those aged 12 years or older. Reimbursement is recognized for acute patients for whom a response is confirmed in a monthly evaluation 2, 4, 6, or 8 weeks after the start of Jakavi administration, and for chronic patients for whom a response is confirmed for a monthly evaluation 3 months after the start of Jakavi treatment. do. However, only chronic patients who show a more than adequate response to a daily dose of 10 mg or less can be evaluated at a maximum of 3 months, and re-administration is permitted for patients who stopped after improving. The maximum administration period is up to 6 months for acute administration and up to 3 years for chronic administration. Chronic administration after completion of acute administration, cases where acute and chronic symptoms overlap, and cases where a patient who stopped treatment after improvement relapses and administration exceeds the maximum administration period are case-by-case. In addition, if GVHD progresses during administration (symptoms worsen or new symptoms appear), adverse reactions that prevent administration occur, or systemic treatments other than steroids and calcineurin inhibitors are used, supplementation will be discontinued. Meanwhile, a new reimbursement standard for Celebrex and Layla was also established. Reimbursement is permitted within the scope of approval, but concurrent use of other digestive tract medications to prevent symptoms such as gastritis is not permitted.
- Policy
- TZD combined DPP4i-SGLT2i complex
- by Lee, Tak-Sun Oct 24, 2023 05:21am
- Due to the expansion of the reimbursement standards for combination diabetes drugs, combination drugs combining TZD-based ingredients with DPP4i or SGLT2i are expected to be released in November. Most of these products are combination drugs combining the DPP4i series Sitagliptin. According to the industry on the 23rd, TZD combination drugs such as Mothers Pharmaceuticals Sitadion, Hyundai Pharmaceuticals Sitapio, Samik Pharmaceuticals Piosita, Medica Korea Pioglsita, Hutex Pharmaceuticals Piovia, Daewoo Pharmaceuticals Sita-Act, Jinyang Pharmaceuticals Januacto, and Daewon Pharmaceuticals Janupio will be listed on the payroll next month. These products are a combination of DPP4i-type Sitagliptin and TZD-type Pioglitazone. Boryung Trubuddy is also listed on the payroll. This drug is a combination of the SGLT2i series Dapagliflozin and Pioglitazone. The sudden emergence of Pioglitazone combination drugs is due to the expanded diabetes drug combination reimbursement standards last April and the impact of Sitagliptin with the patent expired in September. Last April, the combination of metformin + SGLT2i + TZD was approved for reimbursement. Accordingly, in the case of Boryung Trubuddy, which will be released in November, reimbursement is recognized when used together with metformin. The substance patent for Forxiga, the original product of dapagliflozin contained in Trubuddy, also expired on April 8. As the substance patent for Januvia expired on September 1, not only single drugs but also combination drugs are being released one after another. The Sitagliptin + Pioglitazone combination, which is being newly introduced this time, is the first combination drug developed quickly by domestic companies. These combination drugs have the advantage of reducing the risk of side effects and maximizing efficacy because each single drug has a different mechanism.
