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- 2026-06-28 06:18:51
- MSD Korea’s sales rise 69% in 2 years
- by Jung, Sae-Im Apr 17, 2023 05:58am
- MSD Korea made its highest-ever sales last year, recording annual sales of KRW 820.4 billion last year. The strong sales of Keytruda and Gardasil 9 greatly contributed to the company’s external growth. However, the increase in sales costs and SG&A expenses cut the company’s operating profit by half. According to the Financial Supervisory Service on the 14th, MSD Korea recorded sales of KRW 820.4 billion last year. This is a 51% increase from last year's KRW 541.9 billion. MSD’s sales, which had been KRW 271.6 billion in 2019, then KRW 484.7 billion in 2020, had exceeded KRW 500 billion in 2021. Last year, sales surged by approximately KRW 280 billion to reach KRW 800 billion. Over the past 2 years, sales have increased by 69.3%. As a result, MSD Korea surpassed its pre-spinoff scale only 2 years after its Organon spinoff. According to MSD Korea's audit report in 2020, the company's sales before the spin-off were estimated to be around KRW 800 billion. Its flagship product, Keytruda, was the major contributor to this sales growth. The immuno-oncology drug Keytruda has been holding the highest sales among domestically marketed prescription drugs. According to IQVIA, a market research institute, Keytruda's annual sales exceeded KRW 100 billion in 2019 and KRW 200 billion in 2021. Sales last year were tallied at KRW 239.6 billion for Keytruda alone. Its growth has been accelerating recently. Quarterly sales had temporarily fallen in the aftermath of drug price cuts in Q1 last year but then rebound with the reimbursement expansion last year. In particular, higher growth is expected as its reimbursement was expanded to first-line treatment for non-small cell lung cancer, which has a large number of patients. In Q4 last year, Keytruda's quarterly sales increased to KRW 78 billion. Sales of the cervical cancer vaccine Gardasil9 had also contributed to the company’s increased sales. According to IQVIA, Gardasil 9 sold KRW 117 billion in sales last year and ranked third in domestic drug sales. This is a 61% increase over the previous year. The number of people looking to receive vaccinations with Gardasil 9 has been increasing with the recommended age for female vaccination expanded and the spreading perception that it is not a vaccine for only women. The supply price of Gardasil 9 also rose, and sales more than doubled from 2 years ago. Last year, the combined sales of Keytruda and Gardasil 9 in Korea reached KRW 356.6 billion. In addition, the COVID-19 treatment 'Lagevrio' that had been introduced last year is also analyzed to have contributed to the company's growth. The Korean government purchased 100,000 courses of Lagevrio earlier last year. The company’s operating profit, which turned into a profit in 2021, decreased by half last year. Last year's operating profit was KRW 28.6 billion. MSD Korea posted an operating loss of KRW 18.4 billion in 2019 and KRW 5.8 billion in 2020 and turned to a profit of 58 billion in 2021. This is because management costs such as severance pay due to the spin-off have now decreased. Last year, the company also made a profit, but the amount decreased by 51% compared to the previous year. The rising sales cost and higher SG&A expenses reduced the company’s operating profit. MSD Korea's sales cost had increased 76% from the previous year to record KRW 680.3 billion. This is greater than its sales growth rate. Last year's cost-of-sales ratio was 83%, up 12%p from the previous year. The amount of finished products that MSD Korea purchased from its headquarters last year amounted to KRW 715.9 billion. With the company spending more on sales, advertising, and R&D, its SG&A expenses rose 15% to reach KRW 111.5 last year.
- Policy
- Kyowa Kirin accepted the evaluation results for Nephoxil
- by Lee, Tak-Sun Apr 17, 2023 05:58am
- It is known that Kyowa Kirin Korea's hyperphosphatemia treatment 'Nephoxil 500mg' accepted the HIRA evaluation results. Accordingly, this drug is expected to move to the negotiation stage with the NHIS. Nephoxil is used for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis. Expectations are high because it is a product of Kyowa Kirin Korea, which stands out in the chronic kidney disease patient treatment market with Nesp·Regpara. Currently, non-calcium drugs such as Renvela are preferred in the hyperphosphatemia treatment market for hemodialysis patients, and the introduction of Nephoxil is expected to change the market structure. According to the industry on the 16th, Korea Kyowa Kirin of Nephoxil Capsule, which received conditional pass results at the Pharmaceutical Review Board meeting on the 6th, accepted the evaluation results. The HIRA judged that it was appropriate to receive reimbursement for this drug, which is used for hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis when it was accepted below the estimated amount. In other words, it is interpreted that the Korea Kyowa Kirin side accepted less than the estimated amount suggested by HIRA. The proposed valuation seems to have been based on the price of non-calcium-based drugs like Nephoxil. Calcium-based drugs and non-calcium-based drugs are used to treat hyperphosphatemia in dialysis patients. Although calcium-based drugs are relatively inexpensive, non-calcium-based drugs are increasing in use due to the risk of causing vascular calcification. Representative items of non-calcium-based drugs include Renvela, Invela (SK Chemicals), and Fosrenol (JW Pharmaceutical). As domestic drugs containing Sevelamer are released one after another, the price has become much cheaper. Accepting this evaluation result, Nephoxil will proceed with negotiations with NHIS in the future. When the negotiations are completed, they will go through a report to the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare and be listed on the list of benefits. In the market, as Kyowa Kirin Korea stands out in the domestic chronic renal failure drug market, Nephoxil is also expected to settle down early. Kyowa Kirin Korea is recording a high market share with Nesp, a treatment for anemia in patients with chronic kidney disease, and Regpara, a treatment for secondary hyperparathyroidism in patients with chronic kidney disease. Furthermore, Kyowa Kirin took the top spot in the hyperphosphatemia treatment market with Renagel before Renvela was launched in Korea. The domestic supply of Renagel was discontinued in 2015. Renagel and Renvela are drugs developed by Genzyme, and it is rumored that Renagel withdrew from the market after Renvela was supplied through Sanofi in Korea. From the perspective of Kyowa Kirin Korea, Nephoxil is expected to serve as an opportunity to further strengthen its position in the chronic renal failure patient treatment market. Meanwhile, Nephoxil received domestic approval in May last year.
- Company
- 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."
