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- 2026-04-10 08:38:09
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- Will the leukemia ADC Mylotarg be reimb this time?
- by Eo, Yun-Ho Apr 17, 2023 05:58am
- whether the new drug for acute myeloid leukemia (AML), ‘Mylotarg’ will be reimbursed in its second attempt is gaining attention. Mylotarg (gemtuzumab ozogamicin), which submitted an application for reimbursement listing earlier this year, is likely to be presented to the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service this month. Also, another ADC drug, Enhertu (trastuzumab deluxtecanis also expected to be presented for review at the CDDC meeting. Mylotarg was deliberated by the HIRA’s CDDC in May last year but was unable to pass review and set reimbursement standards at the time. Therefore, whether Mylotarg will be able to pass CDDC this time and start on its journey to receiving reimbursement in Korea remains to be seen. The drug is an antibody-drug conjugate (ADC) approved as a first-line treatment for patients with newly-diagnosed CD33-positive AML. The drug, which received marketing authorization in Korea in December 2021, is an ADC composed of a CD33-targeting monoclonal antibody linked to calicheamicin, a potent cytotoxic agent. The drug works on cells that express the CD33 antigen, which is expressed on more than 90% of AML patients. This blocks cancer cell growth and induces apoptosis. Mylotarg’s approval was based on a clinical trial (ALFA-0701) conducted on 271 patients aged between 50 to 70 with newly-diagnosed AML with no prior treatment experience. The ALFA-0701 trial was an open-label, randomly assigned, multicenter Phase III study that compared the existing standard front-line chemotherapy, daunorubicin+cytarabine combination therapy, with Mylotarg+ daunorubicin+ cytarabine combination therapy. Results showed that the median event-free survival (EFS) in the Mylotarg+daunorubicin+cytarabine combination arm was 17.3 months, a 7.8-month extension compared to the 9.5 months in the daunorubicin+cytarabine combination arm. Also, the Mylotarg combination therapy reduced the risk of induction failure, relapse, or death by 44% compared to chemotherapy alone. Also, the median relapse-free survival (RFS) was 28.0 months in the Mylotarg+daunorubicin+cytarabine combination arm and 11.4 months in the daunorubicin+cytarabine combination arm, showing a significant difference of 16.6 months. In the case of median overall survival (OS), the median OS was 27.5 months in the Mylotarg+daunorubicin+cytarabine combination arm and 21.8 months in the daunorubicin+cytarabine combination arm, and the difference was not statistically significant.
- Company
- Sales of cepha antibiotics make a rebound
- by Kim, Jin-Gu Apr 14, 2023 05:49am
- Biopharmaceutical companies that produce the so-called ‘cepha antibiotics' have taken a breather with the increased demand for related products due to the rapid increase in confirmed COVID-19 cases last year. This is in stark contrast to the situation of the previous year when many companies were contemplating whether to withdraw their cepha businesses. However, the dominant opinion is that the sales increase last year was a temporary phenomenon due to the rapid increase in confirmed COVID-19 patients. The frontline companies unanimously agree that they are still contemplating whether to reduce or discontinue their cepha business amid the recent trend of a steady decline in antibiotic prescription rates and a steady rise in production costs. ◆Sales of cepha antibiotics make a rebound...influenced by the surge in confirmed COVID-19 patients According to the Financial Supervisory Service on the 13th, Yungjin Pharm's antibiotic-related sales increased 15% in one year from KRW 59.6 billion in 2021 to KRW 68.6 billion last year. Sales of products it directly produces and sells such as Clamonex, Cefaclor, and Ceftazidime have increased 40% from KRW 30.6 billion to KRW 42.7 billion. In the same period, special sales of Cepha antibiotic APIs soared from KRW 200 million to KRW 1.8 billion. However, exports of cefcapen, cefditoren, and ceftazidime fell 16% from KRW 28.9 billion to KRW 24.2 billion. Yungjin Pharm's antibiotic-related sales have steadily declined until 2021. Its related sales, which reached KRW 102.2 billion in 2019, decreased 42% in two years to KRW 85.6 billion in 2020, then to KRW 59.6 billion in 2021. However, sales made a successful rebounded last year. It is analyzed that this is due to the increase in prescriptions to relieve COVID-19-related symptoms in line with the surge in confirmed COVID-19 patients in Korea. According to the market research institution UBIST, prescriptions of oral cephalosporins last year were KRW 259.6 billion, up 33.4% from the previous year. The ‘cepha antibiotics,’ or cephalosporins are widely used antibiotics for pneumonia, laryngopharyngitis, tonsillitis, and bronchitis. The situation has turned drastically from the first and second years of COVID-19. The cephalosporin antibiotic prescription market, which was worth KRW 271.1 billion in 2019, shrank to KRW 211.5 billion in 2020, then to KRW 194.6 billion in 2021. In the early phases of COVID-19, the market shrank greatly with the plummeting number of cold and flu patients, but last year, along with cough and cold preparations, their use for the purpose of relieving COVID-19 symptoms increased explosively. ◆Presciptions rise 33% in 1 year...companies that pondered market withdrawal breathe a sigh of relief Other cepha antibiotic manufacturers also experienced a similar situation. In particular, companies that had been considering withdrawing their businesses due to a steady decline in sales until the previous year were able to take a breath of relief. Boryeong's sales related to cepha antibiotics shrank from KRW 25.3 billion in 2019 to KRW 20.4 billion in 2020. However, sales rebounded to KRW 21.7 billion last year. Korus Pharm has been manufacturing cepha-class antibiotics such as Korus Cefaclor, Korus Ceftriaxone, K Axone, Cefozol, etc. The company’s combined antibiotic sales decreased 24% in 2 years from KRW 6 billion in 2019 to KRW 4.5 billion in 2021, but rebound to 5.3 billion last year. Withus Pharm’s Withus Cefaclor Cap’s sales fell to KRW 0.6 billion in 2020 from KRW 1.5 billion in 2019, then increased over threefold in 2 years to reach KRW 2.1 billion last year. Withus Pharm’s antibiotic sales, including Cefaclor Cap, increased 2.5 times in 2 years from KRW 2 billion in 2020 to KRW 5 billion last year. Daewoong Bio also saw its cepha antibiotic Ceclor’s sales increase 32% from KRW 7.4 billion in 2021 to KRW 9.8 billion last year. In addition, finished cepha antibiotic products from Kyungbo Pharmaceuticals, Kukje Pharm, and Jeil Pharm increased last year. However, Kyungbo’s sales of cepha-class antibiotic APIs decreased 4% from KRW 37.6 billion in 2021 to KRW 36.3 billion. ◆”Rise in cepha-class drugs temporary...still not profitable” This is in contrast to the years 2020 and 2021 when many companies were contemplating whether to withdraw their cepha antibiotic business. In 2020, a large pharmaceutical company A decided to discontinue consignment production of cephalosporin antibiotics. Company A has stopped manufacturing products contracted by other pharmaceutical companies and is only currently producing only its products. Another large pharmaceutical company, B, put up its cephalosporin antibiotic manufacturing plant for sale last year. A few companies considered taking over, but pharmaceutical company B withdrew its intention to sell. Company C, a mid-sized pharmaceutical company, also contemplated withdrawing from the cepha antibiotics business last year. On the surface, the company pointed to the decrease in prescriptions of cephalosporin antibiotics in the process of prolonged COVID-19, but the analysis was that the chronic deterioration of profitability caused them to consider withdrawing from the business. In line with the trend, the industry anticipates the companies’ withdrawal from the cepha antibiotics business will be repeated this year. Front-line companies all agree that the deteriorating profitability of antibiotics will not improve due to the rising cost of APIs day by day, while supply prices are unchanged under Korea’s health insurance. The price of APIs of cephalosporin antibiotics imported from China and India has risen by 10-20% during the past 2 years. On the other hand, the reimbursed product prices have stayed the same for a long period of time. The fact that the government is constantly trying to reduce antibiotic prescriptions is also cited as a reason for the deteriorating profitability. The antibiotic prescription rate for acute upper respiratory infections has decreased from 52% in 2010 to 36% in 2020. An official from a pharmaceutical company that produces cepha antibiotics said, “We have almost no profit gain from the manufacture of 1st and 2nd generation cephalosporin antibiotics. Labor costs have also risen significantly, so it is difficult to make any profit.”
- Policy
- Obesity treatment Mounjaro, soon to launch in Korea
- by Lee, Hye-Kyung Apr 14, 2023 05:49am
- Eli Lilly's Mounjaro, called a 'game changer' for obesity treatment, is imminent in Korea. Maunjaro GLP-1 agonists act on GLP-1, a hormone that makes patients feel full by acting on the hypothalamus of the brain, activates incretin, an intestinal hormone, and promotes insulin production to lower blood sugar levels. In this process, it slows down the movement of food from the stomach to the small intestine, increases satiety, and has been proven to be effective, becoming a 'hot' obesity treatment in the United States. According to the pharmaceutical industry on the 14th, the Ministry of Food and Drug Safety completed a safety and efficacy review of Maunjaro. Completing this review means that sooner or later, the product approval process will begin. Mounjaro is a successor to Lilly's blockbuster diabetes treatment 'Trulicity,' and was approved by the US FDA in May of last year as a dietary and exercise supplement to improve blood sugar control in patients with type 2 diabetes. The dosage includes 5mg, 10mg, and 15mg, and it can be used as monotherapy or combination therapy with 'Metformin', 'SGLT2 inhibitor', 'Sulfonylurea', and 'Insulin Glargine'. Last year, Lilly conducted a phase 3 clinical trial to study the effect of reducing morbidity and mortality in obese adults, including in Korea. The phase 3 clinical trial was a randomized, double-blind, placebo-controlled trial involving 15,000 participants worldwide and 60 obese and overweight patients in Korea. Meanwhile, representative drugs such as GLP-1 agonists include Novo Nordisk's 'Saxenda' and 'Wegovy'.
- Policy
- SGLT2+DPP4 combinations are to be released next month
- by Lee, Tak-Sun Apr 14, 2023 05:49am
- Domestic DPP-4·SGLT-2 diabetes complex ZemidapaAs the three-drug regimen of diabetes treatment Metformin + SGLT2i + DPP4i is also covered from this month, the SGLT2i + DPP4i complex is expected to be released next month. A total of five items are expected to hit the market in May. However, according to the reimbursement standard, these drugs are reimbursed only when used in combination with Metformin. According to the industry on the 13th, MSD Stegluzan, Boehringer Ingelheim Esglito, AstraZeneca Qtern, LG Chem Zemidapa, and Dong-A ST Sugadapa are expected to release benefits in May. Since April, regardless of ingredients, the three-drug regimen of Metformin + SGLT2i + DPP4i has been applied, allowing these items to enter the market. However, these combinations are difficult to use as monotherapy. This is because the three-drug regimen, including metformin, in the clinical trial for approval proved the blood sugar-enhancing effect, and the SGLT2i + DPP4i two-drug regimen is not covered under the reimbursement standard. The competitiveness of the combination drug, which contains two ingredients in one pill and enhances the convenience of taking it, has not been revealed due to the additional intake of metformin. This is because benefits are applied even if a DPP-4 single drug is added to the commercially available Metformin + SGLT2 complex. Metformin + SGLT2 combinations have been pouring out in droves due to the expiry of Dapagliflozin's patent on the 8th. Perhaps conscious of this, some SGLT2i+DPP4i combinations, such as Qtern and Zemidapa, all of a sudden went on non-reimbursement sales this month. Discussions on the two-drug regimen of SGLT2i + DPP4i are highly likely to resurface starting in September when Januvia's patent expires. This is because many domestic pharmaceutical companies have received approval for the combination of Dapagliflozin + Sitagliptin and are aiming to release a benefit when the patent expires. This is because the two-drug regimen of Dapagliflozin + Sitagliptin can still be used according to the approval. However, the full co-payment is applied to one of the two drugs. It is expected that there will be many reimbursement inquiries about the two-drug therapy in the field, conscious of confusion, and it is expected that the insurance authorities will somehow sort it out. Meanwhile, the domestic SGLT-2i new drug Envlo, developed by Daewoong Pharmaceutical, recently concluded negotiations with the NHIS. By accepting 90% of the price of this drug compared to alternative drugs, only the expected billing amount is negotiated without negotiation of the upper limit, and the reimbursement list is expected to be accelerated.
- Company
- “Reimb standard for hemophilia should align with approvals"
- by Jung, Sae-Im Apr 14, 2023 05:49am
- Young-Sil Park, Treasurer of KSH The Korean Society of Hematology has set out to narrow the gap between the approved indication and reimbursement standards for hemophilia treatments. Through the amendment, KSH aims to apply the optimal dose and dosing schedule for each patient as personalized treatment strategies have settled as the standard for maintenance and prevention therapies. Therefore, whether the government will accept the new reimbursement standard plan proposed by the KSH remains the focus of attention. Young-Sil Park, Treasurer of KSH (Department of Pediatrics, Kyung Hee University School of Medicine), met with reporters on the 13th and said “We have submitted a proposal for the amendment of the reimbursement standards for hemophilia drugs in the Fall last year and is awaiting results. Although there are several steps left to final reimbursement extensions, I heard that HIRA has shown a positive response." The amendment to the reimbursement standards that KSH proposed can largely be divided into two parts. Increasing dose amount and frequency of administration. Currently, the reimbursement standard is set narrower than the approved maximum dose and number of administrations. For this reason, it has been pointed out that the treatment effect may be reduced due to insufficient single dosage amount depending on the patient. Therefore, KSH’s argument is that the maximum level in the reimbursement standard should be set at the same level as each drug’s indication. Drug reimbursement standard improvement plan, reconstituted by Dailypharm Specifically, KSH requested the dosage allowed for administration with each reimbursement to be increased from the current 20-25 (IU/kg) to a maximum of 50. The amendment would allow the dose to be increased flexibly according to the patient's condition, with the dose for standard half-life formulations to range from 20 to 40 (20 to 50 for children under 6 years of age) and extended half-life formulations to range from 40 to 50. These are the scope of dosages specified in the label for each formulation. The KSH also suggested the reimbursed number of monthly administrations allowed for patients should be expanded. According to the current reimbursement standard, patients can visit the hospital once or twice a month and receive a total of 10 doses of standard half-life treatments. Severely ill patients are allowed up to 12 doses. A total of 7 doses (8 doses for severely ill patients) are reimbursed for extended half-life drugs during the 1-2 visits per month. Drug reimbursement standard improvement plan, reconstituted by Dailypharm This means that standard half-life drugs can be administered three times a week for severe patients. However, experts pointed out that it is often necessary to adjust the frequency of administration depending on the patient's condition. Accordingly, the proposed amendment stipulates that 'if the trough concentration level cannot be maintained at 1% or higher 48 hours after setting and administering the maximum dose allowed according to the individual pharmacokinetic test result, administration of an additional dose up to the maximum dose permitted in the label may be accepted.’ Treasurer Park said, “Currently, patients are administered treatments three times every 7 days, on Day 2, Day 4, and Day 7. In some cases, almost no clotting factors remain in the body on the third day for some patients. Our proposed improvement to the plan offers an increased number of administrations so that the optimal effect can be achieved for those whose minimum coagulation factor level is not maintained on the second day.” The KSH is requesting another revision 4 years after the reimbursement standards for hemophilia treatment were revised because the hemophilia treatment has now been expanded to maintenance and preventive therapies. In the past, treatment of hemophilia was centered around ‘replacment therapy', in which clotting factors were administered when bleeding occurred. In recent years, the treatment paradigm has evolved to 'maintenance and prevention therapy', which prevents bleeding in advance by regularly administering clotting factors even without bleeding events. Furthermore, ‘personalized treatment', where a patient’s administration cycle and dose are customized in consideration of the patient's symptoms, living environment, and pharmacokinetics, has emerged as a trend. Currently, the treatment goals for patients with severe hemophilia consist of maintenance and prophylaxis therapies. Also, the introduction of drugs with extended half-life has reduced the required number of regular administrations, and an application that allows patients to determine their pharmacokinetic levels has been introduced, customized maintenance and prevention therapy have settled as the standard of care. However, the reimbursement standards that have been set in the past are narrower than the scope approved, which limits the realization of customized maintenance and prevention therapy. Park added, “The reimbursement standards for hemophilia have improved a lot compared to the past. I believe that a change in the reimbursement standard is necessary to achieve the optimal effect for patients in line with the changes made to the domestic treatment environment and the hemophilia treatment environment. I look forward to the government's positive decision that can allow personalized treatment for each individual in consideration of each patient’s factors."
- Company
- “Olumiant rises as a new option for alopecia areata”
- by Jung, Sae-Im Apr 13, 2023 05:46am
- A new treatment option has emerged in the field of severe alopecia, an area where no option other than local steroid therapy had existed until now. The drug gained attention from patients with severe circular hair loss due to its safe and high therapeutic effect. However, it remains unclear whether the indication for circular hair loss will be able to rise to the right to benefit. Lilly Korea held a press conference at The Plaza Hotel in Jung-gu, Seoul on the 12th and explained the meaning of expanding the indication for severe circular hair loss of the JAK inhibitor 'Olumiant (ingredient: baricitinib)'. Oh-sang Kwon, professor of Dermatology at Seoul National University Hospital, and Bark-Lynn Lew, Professor of dermatology at Kangdong Kyunghee University Hospital, explained the current state of alopecia areata in Korea, the disease burden, and the effects of Olumient. Professor Kwon served as the vice president of the Korean Hair Research Society and Professor Lew serves as the Academic Director of her academic society. Professor Oh-sang Kwon (left) Professor Bark-Lynn Lew (right) According to Professor Lew, as of 2021, about 170,000 patients visit the hospital with alopecia areata a year in Korea. Young patients in their 20s to 40s account for about 60% of the AA population. Unlike general hair loss caused by hormones, alopecia areata is classified as one of the symptoms of an autoimmune disease. The immune system mistakenly recognizes part of one’s hair as a foreign substance, and the hair falls out. Unlike general hair loss, in which the hair gradually thins, the forehead widens in the shape of an M, and the hair loss expands, in alopecia areata, one or several circular bald areas with clear boundaries occur on the scalp. Bald spots can occur not only on the scalp, but also anywhere on the hair, such as eyebrows, beard, armpit hair, and pubic hair. Professor Lew added, “Most hair loss is naturally cured and responds well to treatment, but about 40% of patients experience recurrence within a year, and in severe cases, all hair on one’s scalp or body falls out and progresses to widespread alopecia. Alopecia areata is a chronic autoimmune disease, which has a high risk of autoimmune disease complications such as atopic dermatitis at the same time and can have a significant impact on the quality of life of patients. Its lifetime prevalence of the psychiatric disorder is up to 74%." he explained.” Before Olumiant, there was no treatment approved for severe alopecia areata. Instead, topical steroids were used off-label for patients with mild symptoms. However, the efficacy evidence was limited on its use while the risk of side effects was high from long-term steroid use. The efficacy of Olumiant was demonstrated through the Phase III BRAVE-AA1 and BRAVE-AA2 trials that were conducted on a total of 1,200 patients with severe alopecia areata. Koreans participated in both studies. The trials’ primary efficacy endpoint was a SALT score of 20 or less. SALT stands for Severity of Alopecia Tool score. 41%, and 37% in the group treated with Olumiant for 52 weeks in AA1 and AA2, respectively, achieved the primary efficacy endpoint. At the time, improvements in eyebrow and eyelash coverage were also observed. The company plans to further confirm the effectiveness and safety of Olumiant treatment for up to 200 weeks. Professor Kwon said, "What is noteworthy in the 52-week extension study is that the regrowth effect of scalp, eyebrows, and eyelashes continued to improve for up to 52 weeks when treated with Olumient 4mg. This shows that long-term treatment may be required to achieve maximum benefit in AA patients." Patients’ responses were also positive. Professor Lew said, "Although it is reimbursed yet, about 60% of patients were willing to use Olumiant when it was recommended. This is twice more than my expectations, indicating the high willingness to treat among the patients.” However, it is expected that the AA indication will not be covered for the time being. Lilly Korea said, "It's only been a month since the indication was added, so nothing has been decided or progressed related to reimbursement yet. We will make efforts to expand access to Olumiant in AA patients with high unmet needs.”
- Policy
- Domestic approval of Pemazyre is imminent
- by Lee, Hye-Kyung Apr 13, 2023 05:45am
- Domestic approval of Pemazyre, a treatment for advanced or metastatic cholangiocarcinoma, is imminent. According to the pharmaceutical industry on the 13th, the Ministry of Food and Drug Safety recently completed a safety and efficacy review of Pemazyre. Completing the safety and efficacy means that sooner or later, the product approval process will begin. Pemazyre is approved in the United States, Europe, and Japan for treating adult patients diagnosed with locally advanced or metastatic cholangiocarcinoma with a fusion or rearrangement of the FGFR2 gene who have received at least one prior systemic therapy. In Korea, after being designated as an orphan drug in November 2021, it has been designated as a treatment for life-threatening or serious diseases since December. Previously, the US FDA designated Pemazyre as a breakthrough therapy for the treatment of previously treated patients with advanced, metastatic, or unresectable FGFR2 translocation cholangiocarcinoma, and designated it as an orphan drug, conducting an expedited review through a priority review program. Cholangiocarcinoma is a rare type of cancer and is classified according to its anatomical origin into intrahepatic cholangiocarcinoma (iCCA) arising from the bile duct existing inside the liver and extrahepatic cholangiocarcinoma arising from the bile duct outside the liver. Cholangiocarcinoma is often diagnosed at an advanced or advanced stage with a poor prognosis. FGFR2 fusions or rearrangements are found in 10-16% of patients with intrahepatic cholangiocarcinoma. FGFRs play important roles in the proliferation, survival, migration, and angiogenesis of tumor cells. FGFR fusion, rearrangement, translocation, and gene amplification activities are closely related to the development of various cancers. Pemazyre is an oral FGFR inhibitor and is the first and only treatment approved by the FDA for this indication. After the domestic approval of Pemazyre, Handok will exclusively take charge of domestic distribution and supply.
- Policy
- Decreased commitment to production/sales/new generics
- by Lee, Jeong-Hwan Apr 13, 2023 05:45am
- "Financial expenses for health insurance drugs are calculated by multiplying volume and price. The government has been engrossed in finding reasons for reducing drug prices and establishing policies for decades while neglecting efforts to reduce usage." "(To the government), it seems that the price adjustment of generic drugs is always recognized as the easiest and easiest way. For pharmaceutical companies that are constantly striving to create new drugs, generics are the driving force. Only pharmaceutical companies that do not directly produce drugs or do research and development Please consider the hard way to regulate tweezers." Domestic pharmaceutical companies are becoming more concerned as the Ministry of Health and Welfare is preparing a policy for preferential drug prices for innovative pharmaceutical companies and moving to reduce the price of generic drugs at the same time. It is a reality that generic drugs are already cut as soon as they are cut and it is difficult to go down further, and they are playing a role as a cash generator for pharmaceutical companies that are keen on R&D. Appeals from pharmaceutical companies come out. In particular, as the 2nd Vice Minister of Health and Welfare Park Min-soo is personally leading the policy for this move to adjust generic drug prices, there are even burdensome observations that the price-cutting policy equivalent to the past batch drug price cuts and cascading drug price systems will be triggered. According to pharmaceutical industry sources on the 9th, the Ministry of Health and Welfare is in the midst of preparing and announcing a policy for price adjustment of generic drugs as well as a policy for giving preferential prices to medicines and essential medicines made by innovative pharmaceutical companies in the near future. The Ministry of Health and Welfare has held five public-private consultative body meetings since last February to reflect the appropriate value of innovative new drugs, which were completed last month. The Ministry of Health and Welfare is expected to disclose a policy proposal based on the results of the council meeting at the end of April at the earliest and begin collecting opinions from the pharmaceutical industry. In addition, the public-private consultative body to prepare measures to adjust or lower generic drug prices is expected to quickly begin seeking specific policies from this month, starting with a kick-off meeting at the end of last month, right after the innovative new drug consultative body meeting. The domestic pharmaceutical industry sees this move by the Ministry of Health and Welfare as a full-fledged commitment to the 'trade-off' drug price policy. It is the opinion that the Ministry of Health and Welfare chose the policy goal of sacrificing generics for preferential prices for innovative new drugs. Ironically, the Ministry of Health and Welfare's drug price trade-off was initiated by the National Assembly's request to resolve the fact that sub-statutes for preferential drug prices for innovative new drugs within the 'Special Act on Promotion and Support of the Pharmaceutical Industry' had not been made for several years. The National Assembly pressed the Ministry of Health and Welfare by repeatedly emphasizing the legitimacy and necessity of converting the sub-statute on preferential drug prices for innovative new drugs from the current voluntary regulation to mandatory regulation, and the Ministry of Health and Welfare promised to create a sub-statute as soon as possible instead of amending the law. At the same time, the Ministry of Health and Welfare made clear its will to "lower generic drug prices." On top of that, starting on the 8th, 170 generics for single and combination drugs of Forxiga, which have prescriptions exceeding 90 billion won per year, were released to the market all at once. As a result, the Ministry of Health and Welfare entered the process of materializing the willingness to cut drug prices, which was revealed in an inquiry about generic drug prices by Rep. Choi Jae-hyeong of People’s Power in a parliamentary audit in October last year. In response to this move by the Ministry of Health and Welfare, the domestic pharmaceutical industry is evaluating that it has chosen an easy way to secure health insurance finances by reducing generic drug prices. Some are criticizing that the drug price was cut from the two pillars of health insurance finance, 'Volume' and 'Drug Price', to secure financial soundness and secure financial resources for innovative new drugs. In particular, rather than blindly lowering the price of generic drugs, pharmaceutical companies should look closely at each company's management to make generics that contribute to health insurance finances or exclude companies that do not neglect R&D investment to discover new drugs from the reduction targets. They are also requesting consideration of delicate administration. “In order to create a preferential drug price system for innovative new drugs as soon as possible, we did not stop at operating a public-private consultative body to collect opinions from pharmaceutical companies, but also pulled out a generic drug price cut card,” said a drug price manager at domestic pharmaceutical company A. It is not true, but it is very regrettable that the Ministry of Health and Welfare blindly chooses an easy way to touch the price of generic drugs.” An official from Company A said, "Even if the price of generic drugs is reduced, we have to think about reducing the amount of usage together with drug prices, such as reducing unnecessary prescriptions by analyzing the prescription patterns of domestic drugs, but the Ministry of Health and Welfare shows no signs of doing so. There are many cases where prescriptions are not necessary or for a longer period of time than necessary. It is easy to price a drug with a pharmaceutical company, and it is difficult to adjust the prescription amount with a doctor. A person in charge of drug prices at domestic pharmaceutical company B also said, “Regulate pharmaceutical companies that are only making temporary money through CSO sales without having a production plant or new drug R&D efforts, and pharmaceutical companies that make and sell generics themselves and use them as cash cows for new drug development can lower drug prices. “I hope the government will think about a delicate policy that does not cut prices,” he said. A person in charge of company B said, "I don't expect much from the enactment of sub-statutes for drug price preferential treatment. Prior to preferential treatment, we need to select pharmaceutical companies that are making generics and new drugs properly, and create an environment in which the pharmaceutical company's drugs can be properly sold in the market."
- Company
- Supreme Court dismissed again
- by Chon, Seung-Hyun Apr 13, 2023 05:44am
- Pharmaceutical companies won a complete victory in the 2nd round suspension of execution of the lawsuit to cancel the reduction of benefits for the brain function improving Choline alfoscerate. Following Daewoong Bio Group, Chong Kun Dang Group also issued a ruling in the Supreme Court to suspend the implementation of wage reduction until the main lawsuit in the second trial is over. According to the industry on the 7th, the 3rd Special Division of the Supreme Court dismissed the decision of the Ministry of Health and Welfare to suspend the enforcement of choline drug benefit reduction. It is a decision to suspend the effect until the 30th day from the date of adjudication of the cancellation case of the ‘Announcement of Partial Revision of Details on the Application Criteria and Methods of Medical Care Benefit’, which contains the reduction of health insurance benefits for choline preparations. This means that 26 pharmaceutical companies including Chong Kun Dang and 8 individuals will not be able to reduce benefits until the end of the second trial in progress with the Ministry of Health and Welfare to cancel benefit reduction for choline drugs. This means that the benefit reduction will not be implemented until the end of the second trial of the ongoing lawsuit against the Ministry of Health and Welfare between 24 pharmaceutical companies such as Daewoong Bio and one individual to cancel the benefit reduction of choline drugs. In August 2020, the Ministry of Health and Welfare issued a partial revision notice of ‘Details on the Application Criteria and Methods of Medical Care Benefits’, which contains the content of reducing the scope of benefits for choline preparations. It is content that increases the cost burden rate from 30% to 80% when patients who have not been diagnosed with dementia use cholinergic drugs. After the Ministry of Health and Welfare issued a notice, a lawsuit began all at once. Pharmaceutical companies filed a lawsuit to cancel the notice of reduction in benefits. The lawsuit was filed in two groups according to the legal representative. Law firm Shin & Kim filed a lawsuit on behalf of 39 companies, including Chong Kun Dang, and eight individuals, while Lee & Ko, a law firm, took on the lawsuit for 39 companies, including Daewoong Bio, and one person. However, the Chong Kun Dang Group lost in July of last year, and Daewoong Bio also received a ruling in November of last year. The pharmaceutical companies filed an appeal and also requested a suspension of execution of the reduction in benefits. The suspension of execution requested by Daewoong Bio Group was cited in December of last year. The Ministry of Health and Welfare requested an appeal for suspension of execution, but the Supreme Court also sided with the pharmaceutical companies last month. The Chong Kun Dang Group’s request for suspension of execution also received a ruling in November of last year, “Suspend the enforcement of the public notice until the 30th day from the date of the second trial judge.” Pharmaceutical companies have all led to the suspension of execution in the first trial of the lawsuit for cancellation of benefit reduction. Pharmaceutical companies filed a lawsuit to cancel the reduction in benefits in 2020 and requested suspension of execution to suspend the implementation of the reduction notice until the main lawsuit. The lawsuit for suspension of execution was also filed in two groups according to the legal representative. The suspension of payroll reduction enforcement requested by Chong Kun Dang and others was completed until the Supreme Court ruling in April 2021. In September 2020, the Seoul Administrative Court made a decision to suspend execution, and in the appeal trial in December of the same year, the court sided with the pharmaceutical companies. The Supreme Court upheld the decision of the lower court even in the appeal of the suspension of execution. The suspension of execution of choline drugs, which was raised by Daewoong Bio and others, was cited in October 2020, and nine months after the Ministry of Health and Welfare appealed, the second trial also issued a decision citing the suspension of execution. In October of last year, a ruling was dismissed in an appeal filed by the Ministry of Health and Welfare. From the pharmaceutical company's point of view, it means that they have won all 10 cases of suspension of execution of choline drug benefit reduction. Looking at the ruling in the case of suspension of execution, the court judged that "there is no reason to admit that there is a concern that the suspension of choline drugs may have a significant impact on public welfare." The court pointed out that due to the reduced reimbursement for cholinergic drugs, patients may find themselves in a situation where they have to continue to be prescribed the drug or give up taking it while bearing a considerably higher co-payment than before. The court judged that if benefits were reduced because the clinical usefulness of choline preparations was not proven, the trust and reputation of choline preparations and the reputation of pharmaceutical companies could be damaged, and the related market could suffer a major blow.
- Company
- SK Bioscience declares its vision
- by Kim, Jin-Gu Apr 13, 2023 05:43am
- SK Bioscience announced on the 12th that it held a vision proclamation ceremony at Andong L House on the 11th and pledged to become a 'global bio hub' through 'One Goal, One Team'. About 450 executives and employees attended the vision proclamation ceremony, including Ahn Jae-yong, CEO of SK Bioscience, Kim Hoon, CEO of Global R&BD, and Lee Sang-gyun, plant manager (vice president) of L House. The vision proclamation ceremony consists of a time to look back on the achievements and major milestones that L House has achieved during the COVID-19 pandemic and to share future strategies and goals at the time of transition to the endemic era. SK Bioscience shared the future strategy of 'SKBS 3.0', which consists of specific action tasks and action plans to grow into a global company in the endemic era, and a 'digital establishment plan'. In addition, to achieve the One Goal of 'Global Innovative Partner of Vaccine and Biotech', the members of L House were asked to join forces as one team in the future. In particular, the acquisition of cGMP (Current Good Manufacturing Practice) from the U.S. Food and Drug Administration (FDA) was selected as a key task for L House to achieve SK Bioscience's vision. Along with this, SK Bioscience plans to solidify its position as a global vaccine production hub by expanding facilities of about 1,067,616 sqft in L House. In addition, it plans to build a global top-tier R&D network through the 325.7 billion won Global R&PD Center being established in Songdo, Incheon with the goal of completion in 2025. Ahn Jae-yong, CEO of SK Bioscience, said, "Today's vision proclamation ceremony is a place where the members of House L announce their will to achieve 'One Goal' by gathering strength through the 'One Team' culture." We will secure a vaccine portfolio and promote sustainable growth.” Lee Sang-gyun, Plant Manager, said, “SK bioscience has been able to stand at the center of the response to the COVID-19 pandemic over the past three years because of the valuable efforts of L House members.” I am grateful to the staff," he said.
