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- 2026-05-11 17:34:30
- Company
- Braftovi can be prescribed at tertiary hospitals
- by Eo, Yun-Ho Jan 10, 2023 05:34am
- The new colorectal cancer drug Braftovi has settled in tertiary hospitals. According to related industries, Ono's BRAF-inhibitory ELECTRIC CANCER (colorectal cancer) treatment Braftovi passed the Drug Commission (DC) of Korea University Anam Hospital, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Asan Medical Center. Braftovi is still a non-reimbursed drug. It was approved in August 2021 and passed the Cancer Disease Review Committee in January of the following year. It quickly passed the HIRA Cancer Disease Deliberation Committee, the highest level in anticancer drug benefits, but failed to present the agenda of the Drug Benefit Evaluation Committee. If it succeeds in registering this year, it is expected to lead to actual prescriptions quickly. Braftovi can be used as a combination therapy with Erbitux of Merck Korea for adult patients with direct bowel cancer with previous treatment experience and confirmed BRAF V600E mutation. Braftovi combination therapy confirmed efficiency through a three-phase clinical BEACON CRC study in patients with unstoppable progressive or recurrent direct bowel cancer with BRAF V600E mutation after primary or secondary treatment. Braftovi -Cetuximab combination therapy showed statistically significant elongation (HR 0.60, p=0.0003) in OS compared to the control Irinotecan-Cetuximab-based combination therapy. The median OS value was 8.4 months in the Braftovi group and 5.4 months in the control group. In ORR according to BICR, Braftovi-Cetuximab combination therapy was 20%, showing statistically significant improvement compared to 2% of the control group. The median PFS value was 4.2 months for Braftovi-Cetuximab combination therapy and 1.5 months for the control group. In this study, there was no unexpected toxicity of Braftovi-Cetuximab combination therapy. In Korea, BRAF V600E gene mutation is positive in 4.7% of patients with direct bowel cancer. It is known that if there is a BRAF V600E mutation, the prognosis is worse than that of patients who do not. There were no approved drugs based on efficacy and effectiveness in direct bowel cancer with BRAF gene mutation, so a new treatment option was needed.
- Company
- Obesity drug Saxenda’s sales surge with expanded indication
- by Moon, sung-ho Jan 10, 2023 05:33am
- Saxenda (liraglutide) has been recording dominant sales in the growing obesity treatment market in Korea. Therefore, the drug is expected to monopolize the obesity treatment market until other new obesity treatments such as ‘Wegovy (semaglutide, Novo Nordisk)’ and ‘Mounjaro (tirzepatide, Lilly)’ are released in Korea. #According to the market investigation institution IQVIA on the 25th, Novo Nordisk’s Saxenda showed a surge in quarterly prescription sales recently. More specifically, Saxenda’s sales recorded KRW 10.4 billion in Q1 last year, then increased to KRW 15.4 billion in Q2, then recorded a quarterly best record of KRW 16.6 in Q3 last year. In other words, the company succeeded in bringing in more than KRW 40 billion in only three quarters last year. Compared to the same three quarters of the previous year, the drug recorded a 70% growth in its sales and solidified its lead in the domestic obesity treatment market. Sales of its competitor Qsymia((phentermine / topiramate ER) have been pushed back by Saxenda's rapid growth, and the sales gap between the two drugs seems to be rather widening despite Qsymia’s sales increase. Alvogen Korea’s Qsymia recorded prescription sales of KRW 8.2 billion in Q3 last year, which is over twice the difference in quarterly sales compared to Saxenda. Qsymia is currently sold by Chong Kun Dang in Korea. Then why has Saxenda been able to enjoy such rapid growth in sales? The medical and pharmaceutical industry pointed to how the drug’s indication was expanded to treat children and adolescents this year. In December 2021, the indication for Saxenda had been expanded to treat adolescents aged 12 to 18 with obesity in Korea with a body weight above 60 kg and an initial BMI corresponding to ≥30 kg/m2 for adults. Novo Nordisk had implemented active sales and marketing activities, such as opening a 'Saxenda portal' exclusively for doctors and launching a digital weight management application to support weight control for patients who have been prescribed Saxenda. A PM that requested anonymity, said, “In the case of Saxenda, its indication expansion to adolescents was the key driver of its sales growth. The number of obesity patients has surged with the COVID-19 pandemic, and the timely indication expansion to pediatric and adolescent patients brought a synergistic effect.” Also, the industry saw that the lowered price and MFDS’s ‘warning’ in addition to the COVID-19 pandemic was behind the rise in sales of Saxenda in local clinics. Since last year, the MFDS has been strengthening control over antipsychotics that contain ▲ phentermine, ▲ phendimetrazine, ▲diethylpropion, and ▲mazindol to address concerns over the misuse and abuse of drugs. A doctor from an internal clinical in Seoul who requested anonymity said, “The obesity treatment market is one representative non-reimbursed treatment market. Its average price had been up to KRW 150,000 at the highest, but its price has now fallen to the KRW 70,000-80,000 range in some areas. In the case of Qsymia, no dumping sales of the product are being made yet as the drug is still new to the market.” “Qsymia costs KRW 4,000 per tablet, therefore, a 30-day prescription of the drug will cost KRW 120,000. Saxenda’s lowered price has therefore led to the increase in sales as well.” Professor Hee-Jin Hwang of the International St. Mary’s Hospital (Department of Family Medicine) who also serves as an executive member of the Korean Society for the Study of Obesity, said, “The MFDS had issued a warning disposition to some doctors in the course of reinforcing management of antipsychotic drugs. As some obesity treatments contain controlled substances, this would inevitably affect the prescription behavior of doctors.”
- Policy
- ↑63% of the average annual SA bill
- by Lee, Tak-Sun Jan 10, 2023 05:33am
- Among ultra-high-priced drugs with an annual drug cost of more than 10 million won per patient, RSA contract drugs have increased significantly. It was confirmed that the claims for RSA drugs increased by an average of 62.6% per year. This fact was found in the "Research on the Performance Evaluation and Development Direction of RSA" conducted by the Industrial-Academic Cooperation Group of Seoul National University (Professor Lee Tae-jin), at the request of the NHIS. The results of this study were partially released on the 2nd through the management information disclosure system (Alio) of public institutions. The research team surveyed the cost of claiming risk-sharing drugs among high-priced drugs exceeding 10 million won per year from 2010 to 2021, and the number of RSA drugs increased from 31.9 billion won in 2014 to 959 billion won in 2021. The amount is equivalent to an average annual increase of 62.6%. RSA drugs accounted for 57% of the total 1.6927 trillion won in claims for expensive drugs in 2021. RSA emergency high-priced drugs increased only 4.9% annually from 50.8 billion won in 2014 to 65.8 billion won in 2021. The research team evaluated, "The RSA system seems to have provided new opportunities for high-priced drugs." In the meantime, he suggested financial management measures for expensive drugs that need to check the RSA system and evaluate the performance of the financial-based types, Refund type, and Expenditure Cap type. However, the research team added, "One-shot treatments, which have recently received great attention, are not included in this analysis, so we propose additional analysis including one-shot treatments in the future, and in the long run, it is necessary to establish a high-priced financial monitoring system based on this data extraction and analysis." The research team also said that it is necessary to prepare financial management measures for RSA non-emergency drugs. The research team explained, "Among non-RSA drugs, anti-cancer drugs are not expensive, and hemophilia drugs and enzyme drugs are high," adding, "Hemophilia drugs are worth 200 billion won in 2021, and enzyme drugs are worth 100 billion won, which has steadily increased." "Unlike RSA drugs, where financial uncertainty is managed, non-RSA drugs have no financial management plan other than price cuts at the expiration of patents," he said. "It is necessary to review re-evaluation or renegotiation considering environmental changes such as changes in foreign prices and listing alternative treatments." The research team said, "To reduce the uncertainty of ultra-low benefit, different approaches are needed depending on the type of uncertainty, the prospect of resolving uncertainty, and decision-making uncertainty. If the primary goal is to apply the CED method, it is better to apply the refund or Expenditure Cap type." As of July 2022, a total of 60 drugs were found to have signed RSA contracts. Anti-cancer drugs and rare disease treatments have increased their registration rates since the introduction of risk-sharing systems, and from 2015 to 2021, the drug cost of risk-sharing drugs increased by 50.9% annually, and RSA drugs averaged about 1.8 million won. RSA is an anticancer drug or rare disease treatment without an alternative and can be applied to serious diseases, omitted drugs submitted by PE, or phase 3 conditionally licensed drugs. When the NHIS RSA contract is signed, pharmaceutical companies will refund a certain percentage to the corporation based on their finances and performance.
- Company
- Mylotarg can be prescribed at general hospitals
- by Eo, Yun-Ho Jan 09, 2023 06:11am
- Mylotarg, a new drug for acute myelogenous leukemia, can be prescribed at general hospitals. According to related industries, Mylotarg, Pfizer's Acute myeloid leukemia (AML) treatment, passed the Drug Commission (DC) of medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Sinchon Severance Hospital. Mylotarg can be used in the primary treatment of adult AML patients who are CD33 positive, and newly diagnosed with Antibody-Drug Conjugate (ADC). Mylotarg has not yet been applied to insurance benefits. The drug was introduced to the HIRA in May last year, but it was judged that the benefit standard was not set. Mylotarg, approved in Korea in December 2021, is an ADC composed of CD33 target monoclonal antibodies and a cytotoxic drug Calicheamicin, which acts on cells expressing CD33 antigens that appear in 90% of all AML patients. This blocks cancer cell growth and induces apoptosis. The Mylotarg permit was based on a clinical study conducted on 271 newly diagnosed AML patients with no treatment experience before the age 50 to 70. The clinical trial was ALFA-0701 clinical trial, which was conducted with open-label, random assignment, and multi-organ phase 3. The existing chemotherapy, Downorubicin or Citarabin combination therapy, Mylotarg, Daunorubicin, and Cytarabine combination therapy were compared and evaluated. As a result, the Mylotarg+Daunorubicin+Cytarabine combination group showed an effect of extending about 7.8 months compared to 9.5 months of the Event-free survival median value of 17.3 months. The risk of induction failure, recurrence, or death was reduced by about 44%. The median value of Relapse-free survival was 28.0 months in the Mylotarg+Daunorubicin+Cytarabine bottle administration group and 11.4 months in the Daunorubicin+Cytarabine combination administration group, showing a significant difference of about 16.6 months. In the case of the median value of Overall survival, there was no statistically significant difference between the Mylotarg+Daunorubicin+Cytarabine combination administration group for 27.5 months and the Daunorubicin+Cytarabine combination administration group for 21.8 months.
- Opinion
- [Reporter’s View] Decide whether to reimb diabetes combos
- by Lee, Tak-Sun Jan 09, 2023 06:11am
- Once again, discussions on expanding reimbursement to combination therapies to treat diabetes are at a standstill. The Ministry of Health and Welfare was unimpressed with the price reduction plans submitted by relevant companies under the assumption that reimbursements are expanded. This discussion, which had shown small progress only recently after being deliberated since 2016, has now again come to a standstill. Some have questioned whether the authorities intend to push back reimbursement of combination therapies for two more years until the patent expires for the original drugs. However, the issue cannot be ignored any longer. The combinations being discussed for reimbursement are triple-drug-combinations including metformin+SGLT-2+DPP-4, metformin+SGLT-2+TZD, as well as some SGLT-2 inhbitors+sulfonylurea or insulin combinations. The voices are strong in the field on the urgent need for their reimbursement due to wide use. The health authorities will not be able to dismiss the doctors’ claim that the combination therapies above are the best options available for the treatment of 6 million diabetes patients in Korea. On the pharmaceutical companies' part, they have also waited enough. Many companies have received approval for their combination therapies in anticipation of reimbursement expansions. The first new combination drug that had been approved is subject to reevaluations this year and is on the verge of being canceled. Domestic companies have invested immensely in the development of combination therapies, and many have already received approvals for the drugs. If the discussions are delayed or come to a full stop, the companies may incur significant losses in their investment. The biggest issue is the fiscal scale. If reimbursement is extended to combination therapies, its fiscal expenditure is expected to reach nearly KRW 100 billion. Therefore, the MOHW is seeking to minimize fiscal expenditure by lowering the insurance price ceiling of listed diabetes treatments. Now is the time to come to a conclusion. If expanding reimbursement to the combination of all classes cannot be made, the authorities should now seriously consider applying reimbursement to at least some substances at a level that will minimally affect the state’s fiscal expenditures. There is no time left. To reduce patient burden and industry damage, this is now the time for the government to derive an optimal plan and come to a conclusion.
- Company
- Reinforced drug regulations change generic drug approvals
- by Chon, Seung-Hyun Jan 09, 2023 06:10am
- The number of generic drugs approved per every bioequivalence test fell greatly. Affected by the reform made in Korea's drug pricing policy, the proportion of generic drugs approved per bioequivalence test dropped significantly. According to the Food & Drug Statistical Year Book published by the Ministry of Food and Drug Safety on the 6th, 648 items were approved after being recognized as bioequivalent to their alternative in 2021. This was a 58.8% decrease from the 1,573 approved in 2020. Compared to the 2,358 in 2019, this was a 72.5% decrease in 2 years. Drugs recognized as bioequivalent are products recognized as being equivalent to their original drug, and are mostly granted for newly approved generic drugs. No. of bioequivalent items (left) and No. of items approved per bioequivalence test (right) (Unit: items, Data: MFDS) The drastic reduction in the number of bioequivalent drugs in 2021 is considered to have been directly influenced by the reform of the drug pricing system. The main change that had been made with the reform of the drug pricing system that had been implemented in July 2020 was that only generic drugs that meet both requirements – those that directly perform bioequivalence tests and those that use registered APIs – are allowed to maintain a price level that is at 53.55% of the original drug price prior to patent expiry. The reformed system also contained a stepped drug pricing system that lowers the price ceiling of drugs by order of listing and reducing the price of those that are listed later. If 20 or more generic drugs are listed for a certain ingredient, the price ceiling set for the newly listed drugs afterward is set at 85% of the existing lowest price. As companies cannot receive a high drug price without directly performing bioequivalence tests, this reduced the companies’ attempts to receive approval for generic drugs after consigning the whole manufacturing process. Therefore, the number of generic drugs approved per bioequivalence tests has been reduced greatly. Among the 648 bioequivalent drug items approved in 2021, 75 performed a direct bioequivalence test. This roughly translates to 8.6 generics being approved for each test. In 2019 and 2020, the number has been 29 and 9.4 drugs per bioequivalent test each. The proportion of consigned generics among bioequivalent drug items reached 96.6% in 2019 but was reduced to 88.4% by 2021. By year, the number of bioequivalent drug items increased exceptionally in 2019 and 2020. The number, which had been 625 and 789, suddenly rose threefold in just a year to 2,358 in 2019. This explosive increase is analyzed to be caused by the government's move to tighten regulations on generic drugs. A total of 175 valsartan-containing hypertension drugs were suspended sales due to excess detection of impurities. At the time, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety prepared measures to inhibit the flooding of generic drugs by organizing a ‘Consultative Body to Improve the Generic Drug System.’ In response to the government’s move to reinforce regulations, pharmaceutical companies have worked to receive approval for their generic drugs in advance, which greatly increased the number of generic approvals for a short period of time. In other words, the government’s work to reinforce regulations had caused an increase in generic approvals, and the level only returned to the previous level after the system reform. As the regulations for the approval of generics have also been strengthened, the proportion of approved consigned generics is expected to be further reduced. According to the amended Pharmaceutical Affairs Act, which took effect in July last year, the number of consigned generics that can be approved for each bioequivalence test has been limited to a maximum of three. Therefore, the proportion of consigned generics among generic approvals will not be able to exceed 75%.
- Company
- Sanofi consumer healthcare appoints Chung Kyung-hee as CEO
- by Eo, Yun-Ho Jan 09, 2023 06:10am
- Sanofi's Korean subsidiary Consumer Healthcare (Sanofi CHC) division announced on the 5th that it had appointed Chung Kyung-hee as its new CEO. Chung Kyung-hee, the new CEO, has been intensively building his capabilities in various global companies' marketing and digital fields over the past 26 years. From 2020 to May last year, he served as CEO of Pierre Fabre Dermocosmetics Korea, leading in-house cultural innovation to improve the group's overall performance and organizational efficiency. From 2015 to 2020, he led the successful sales growth of major brands such as Aveda, Clinique, and Lab series as a brand general at ELCA Korea. "Based on our past experience, we will do our best to bring out the potential and balanced growth of the CHC division," said new CEO Chung Kyung-hee.
- Policy
- nAMD & DME tx Vabysmo is about to be approved in Korea
- by Lee, Hye-Kyung Jan 09, 2023 06:10am
- The domestic approval of Vabysmo, the first and only dual-specific antibody biological drug related to eye diseases developed by Roche, is imminent. Vabysmo has been approved as an nAMD treatment and DME treatment in more than 40 countries around the world, including the United States, Japan, the United Kingdom, and the European Union, and was approved by the U.S. FDA in January last year. According to industries on the 5th, the Ministry of Food and Drug Safety recently completed a safety and effectiveness review of Vabysmo. If the review is completed without any problems, product approval is expected to take place soon. Vabysmo is the first and only ophthalmic injection approved by the FDA for nAMD and DME simultaneously. Depending on the patient's anatomical evaluation and vision results, vision can be improved and maintained by administering it every one to four months after the first four monthly administrations. It is estimated that more than 40 million patients suffer from one of the neovascular age-related nAMD treatments and DMEs worldwide, and the number of patients is gradually increasing as the population ages and the prevalence of diabetes increases. Until now, the standard therapy for the two diseases had to be administered every one to two months. However, in phase 3 of the Vabysmo global clinical trial, the patient group receiving Vabysmo at intervals of up to 4 months was found to have achieved a non-mean level of vision improvement compared to the patient group receiving Eylea every 2 months. It is evaluated that the convenience of patients has been improved by improving the administration cycle for up to four months. The international journal Nature Review Drug Discovery expects Babysmo's estimated sales to reach $1.129 billion within five years. Currently, four new nAMD drugs licensed in Korea are Avastin, Lucentis, Eylea, and Beovu.
- Company
- Diabetes combination benefits
- by Nho, Byung Chul Jan 06, 2023 05:57am
- SGLT-2 inhibitory diabetes medication (from left to right, Forxiga, Jardiance, Xigduo, Jardiance Duo)As health authorities officially announced the suspension of financial impact analysis on drugs subject to expanding the scope of use, discussions on expanding the benefit standard for diabetes solvents are likely to be postponed up to three years later. According to the industry, the HIRA recently stopped evaluating financial impact analysis reports submitted by individual pharmaceutical companies based on a request to temporarily suspend economic impact analysis on drugs subject to the expansion of the scope of use of insurance drugs by the Ministry of Health and Welfare. The plan to expand the salary standard has a structure in which the HIRA Drug Standards Department listens to related academic societies and internal opinions and confirms the contents. After that, the Ministry of Drug Safety and Standards reports this to the Ministry of Health and Welfare, and the Ministry of Health and Welfare will review whether to lower the drug price based on additional financial needs to the HIRA drug price calculation government. However, the expansion of the standard for diabetes solvents has been conducted by first requesting opinions from pharmaceutical companies and self-reviewing them over the past year, and notified of the request to temporarily revise the financial impact analysis review in mid-December 2022. The industry is taking this as an exception because a financial impact review is an essential administrative requirement for drugs that expand their salary standards. This is because some pharmaceutical companies' confirmation of the HIRA has been set to proceed with the voluntary cut conducted in November, not the financial impact analysis. The future outlook following the aftermath cannot rule out the possibility that the expansion of the combined benefit standard will go to a zero source base if sufficient financial savings due to voluntary cuts are not reflected. In addition, there seems to be room to review the combined benefits once again from 2025 when SGLT-2 and DPP-4 diabetes treatment generic enter in earnest. Considering that the additional finances required for this combined benefit are a banding width of 30 to 50 billion won, the most efficient way to realize this without any separate financial requirements may be to voluntarily cut 5% of the existing drug costs, mainly from the original company. It is not easy to enforce such a method in the face of the patent of the original diabetes treatment, and it is believed that few foreign subsidiaries have submitted such doctors to the Ministry of Health and Welfare so far. Therefore, it is analyzed that the health authorities are more likely to use the compensated amount by waiting for the expiration of the original drug patent within one to three years rather than spending additional finances to expand the combined benefits of diabetes drugs. If the original drug price is reduced by 30% due to ex officio adjustment, the budget will be reduced by about 30 billion to 50 billion, which is interpreted as an intention to turn it into a share of combined benefits. The expansion of salary standards for the combination of diabetes treatment SGLT-2 inhibitor drugs and DPP-4 inhibitor drugs was expected to be applied by the end of this year as it was discussed in 2022 after the diabetes association requested it to the health authorities in 2016. Since then, the HIRA has conducted a financial impact analysis in June by reviewing the pay standards for three-drug therapy such as metformin+SGLT-2+DPP-4, metformin+SGLT-2+TZD, and SGLT-2+sulfonylurea or insulin combination therapy.
- Company
- Rare RCC drug Welireg may be commercialized in Korea this yr
- by Eo, Yun-Ho Jan 06, 2023 05:57am
- The new rare anticancer drug ‘Welireg’ is expected to be commercialized in Korea within the year. According to industry sources, the Ministry of Food and Drug Safety is currently reviewing approval of MSD Korea’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, ‘Welireg (belzutifan).’ The drug had been designated as an orphan drug in January last year for the treatment of Von Hippel-Lindau disease, and the company applied to receive approval for the indication the same year. In the US, the drug was granted priority review in 2021 and approved. The indication the company applied for in Korea is also for the treatment of adult patients with VHL disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET) that do not require immediate surgery. As a HIF-2α inhibitor, Welireg reduces transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis, and tumor growth. The drug’s efficacy was demonstrated through the open-label Study 004 trial which investigated 61 patients with VHL-associated RCC that were diagnosed with at least one measurable solid tumor localized to the kidney. Patients enrolled in the trial had other VHL-associated tumors including CNS hemangioblastomas and pNET. The major efficacy endpoint of the clinical trial was the overall response rate (ORR) in patients with VHL-associated RCC as measured by radiology assessment using RECIST v1.1 as assessed by an independent review committee (IRC). Additional efficacy endpoints included duration of response (DoR) and time to response (TTR). In the study, Welireg showed an ORR of 49% in patients with VHL-associated RCC. All responses were partial responses. The median DoR had not yet been reached, and the DoR among responders that were still responding after at least 12 months was 56%. Median TTR was 8 months. In patients with VHL-associated CNS hemangioblastomas, Welireg showed an ORR of 63%, with a complete response rate of 4% and a partial response rate of 58%.
