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- 2025-12-24 05:42:10
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- HIV drug Pifeltro may be prescribed at hub hospitals in Kore
- by Eo, Yun-Ho Jan 10, 2023 05:35am
- ‘Pifeltro,’ a single-ingredient drug used for HIV, can be prescribed at general hospitals in Korea. According to industry sources, MSD Korea’s HIV treatment Pifeltro (dovavirine) passed the Drug committees of tertiary hospitals such as the Seoul National University Hospital and Sinchon Severance Hospital as well as local hub hospitals (national and public hospitals) that are in charge of HIV treatment in Korea, including the Kyungpook National University Hospital, National Medical Center, Pusan National University Hospital, Soonchunhyang University Hospital, Ulsan University Hospital, Chonnam National University Hospital, and Hanyang University Hospital. MSD’s fixed-dose combination drug ‘Delstrigo (dovavirine, lamivudine, tenofovir disoproxil) also contains the main active ingredient in Pifeltro, dovavirine. Both Delstrigo and Pifeltro were listed for reimbursement in October 2021. The final listed price was set at KRW 7,975 per tablet for Pifeltro, and KRW 19,491 per tablet for Delstrigo. Delstrigo is already being prescribed at major medical institutions in Korea. Both drugs are indicated for the treatment of HIV-1 infection in patients without prior antiretroviral therapy (ART) treatment history in Korea. The efficacy of the drugs was identified through the DRIVE-AHEAD trial, in which Delstrigo demonstrated noninferiority to efavirenz·emtricitabine·tenofovir(EFV/FTC/TDF). In the trial, the proportion of patients who sustained viral suppression through 48 weeks (viral suppression of HIV-1 RNA
- 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.”
- 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.
- 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.
- 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%.
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- “I strongly recommend Retevmo as first-line treatment”
- by Jan 06, 2023 05:57am
- Reimbursement listing for Lilly’s ‘Retevmo(selpercatinib),’ which opened a new door to treating RET-targeted mutations, is gaining momentum in Korea. If approved for reimbursement, the scope of treatment for patients with RET mutations is expected to broaden significantly. In November this year, the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service set the reimbursement standards for Retevmo in non-small cell lung cancer (NSCLC) and thyroid cancer and is up for deliberation by the Drug Reimbursement Evaluation Committee (DREC). As HIRA announced it will reduce the reimbursement listing period by 30 days for drugs that treat life-threatening diseases like Retevmo, discussion on the drug’s reimbursement is expected to speed up further. Retevmo is the first targeted therapy that targets the RET mutation. The RET gene is in charge of the formation of normal organs as well as the maintenance of various tissues including neural, neuroendocrine, hematopoietic, and male reproductive cells. However, the abnormal activation of RET due to mutations in the RET gene, such as fusion or point mutation causes malignant tumors. The mutation is mostly found in NSCLC, thyroid cancer, and medullary thyroid cancer. In NSCLC, RET mutation occurs in 2 to 6 % of all cases. The drug is already being used actively in the field in Japan, where Retevmo was approved earlier and is being reimbursed. Dailypharm interviewed Professor Kaname Nosaki of the National Cancer Center Japan (Department of Thoracic Oncology) to seek insight into Japan’s treatment experience with Retevmo in RET fusion-positive NSCLC. Professor Kaname Nosaki, National Cancer Center Japan In the interview, Professor Nosaki stressed the need for Retevmo in patients with RET fusion-positive NSCLC. Prior to its introduction, patients had no other option but to use chemotherapy, which has high toxicity. Professor Nosaki said, “With no other targeted therapy available before Retevmo, patients who were identified with RET mutations had no other option but to receive chemotherapy. As expected, due to poor treatment prognosis and low rate of survival, a strong unmet need existed in the field. Retevmo is very necessary for these patients as it has demonstrated excellent clinical efficacy, duration in effect, and excellent safety.” The Japan Lung Cancer Society updated its clinical practice guidelines to strongly recommend the use of Retevmo in patients with RET fusion-positive NSCLC who have no prior treatment experience. The recommendation is based on the LIBRETTO-001 trial that was conducted on 702 patients with advanced or metastatic solid cancer with RET mutations. The objective response rate (ORR) of Retevmo was 85% in patients with no prior chemotherapy experience. Also, 79% of the Retevmo patients showed continued response during the follow-up period (median 7.4 months). The ORR was slightly lower in patients with previous treatment experience but was still 64%. The median duration of response (DoR) was 17.5 months. Professor Nosaki said, “The overall survival (OS) is yet to be reached in the Retevmo trial. We need to continue monitoring the data, but we are positive about the results as the 2-year survival rate of enrolled patients is near 70%. When the OS has not been reached, we evaluate results based on progression-free survival (PFS) or duration of response (DoR), and Retevmo showed good results in the criteria with an mPFS of 18.4 months and DoR of 20.4 months. He emphasized that the use of Retevmo in the first line should be considered after identifying RET mutations in the initial stages of diagnosis in patients with NSCLC. Due to differences in the diagnostic environment, the less common RET mutations are identified relatively later than other mutations. In other words, patients are first searched for major mutations such as EGFR·ALK·ROS1, and those without these mutations are prescribed cancer immunotherapies and then identified for minor mutations. Therefore, patients found with RET mutations at this time may only use Retevmo in the second line. On this, Professor Nosaki said, “Patients with a certain mutation may not respond well to immunotherapies, therefore, treatment sequence is all the more important in these patients. Unexpected toxicity problems may occur when using cancer immunotherapies first then using TKIs, which may lead to pneumonia or liver function deterioration.” He added, “Therefore, if available, it is more appropriate to use the targeted therapy first. Doctors should quickly identify major and minor mutations with next-generation sequencing (NGS) from the early stage of diagnosis to allow patients to be treated with good drugs early on."
- Company
- 2 CGRP Migraine New Drugs
- by Eo, Yun-Ho Jan 06, 2023 05:57am
- Teva-Handok's Calcitoninene-related peptide (CGRP) targeted migraine treatment Ajovy has been covered by insurance benefits since January, and it will fight for prescription leadership with Emgality of Lily Korea, which was listed in September last year. The two drugs are in the same family, but there are differences in usage dosage, so choices are being made according to the characteristics of patients with severe migraines. Emgality is a method of administering 240 mg (two consecutive subcutaneous injections of 120 mg each) once, and subcutaneous injections of 120 mg once a month after that. In the case of Ajovy, 225 mg once a month or 675 mg (3 consecutive 225 mg) once every three months is used by subcutaneous injection. The domestic migraine treatment market is smaller than that of patients. The annual prescription amount of Tryptane-based drugs remains at 15.5 billion won as of 2020. However, the prevalence of migraines in Korea is not small at around 6%. According to the 2020 HIRA statistics, 550,000 patients have been treated for migraine headaches, but it is estimated that about 2 million patients have not visited the hospital. As Ajovy and Emgality have been registered as salaries, the market size is expected to expand in the future. Much of the prescription environment has already been created. Currently, Emgality can be prescribed at Big 5 general hospitals such as Seoul National University Hospital and Sinchon Severance Hospital, as well as medical institutions nationwide such as Gangbuk Samsung Hospital, Dongtan Sacred Heart Hospital, and Nowon Eulji University Hospital. Ajovy is also settled in general hospitals such as Asan Medical Center in Seoul and Severance Hospital in Sinchon. Both drugs are carrying out promotional activities through partnerships with domestic pharmaceutical companies. Teva-Handok has signed a joint sales contract with Chong Kun Dang and Lilly with SK Chemicals.
