- LOGIN
- MemberShip
- 2026-05-13 03:53:00
- Company
- Yuhan’s Leclaza zooms through the NHI listing process
- by Eo, Yun-Ho Jan 26, 2021 06:00am
- Yuhan Corporation’s new drug Leclaza could break the record of receiving the National Health Insurance reimbursement the fastest as an anticancer treatment. After the South Korean health authority approved of the drug on Jan. 18, the company immediately entered a talk to list the drug. The pharmaceutical industry source reported the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee is to deliberate Leclaza (lazertinib), a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) like Tagrisso (osimertinib), from next month. Yuhan Corporation is rushing through the commercialization process by fully utilizing the conditional approval and the approval-reimbursement linkage system. Leclaza was cleared for marketing in South Korea on Jan. 18. If the Cancer Deliberation Committee reviews the drug in the February meeting, the drug would be taking only a month to reach a reimbursement review. Generally, a novel anticancer treatment takes about four to five months to be deliberated by the Cancer Deliberation Committee after applying for the reimbursement. Considering the typical speed of the listing procedure, the 31st Korean-made new drug Leclaza may set the historic record of passing the Drug Reimbursement Evaluation Committee after the Cancer Deliberation Committee, settling a drug pricing and listing itself for the reimbursement. The related academic society also seems to be supporting for the Leclaza coverage. The Korean Association for Lung Cancer submitted a statement to urge for the healthcare benefit on Leclaza. The society claimed, “The National Health Insurance reimbursement should be granted on lazertinib, as it has demonstrated acceptable level of safety and low cardiac toxicity, and also the treatment is highly demanded by the patients to fight against a severe disease.“ Leclaza was approved as a first-in-class second-line treatment in EGFR T790M mutation-positive patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), who has been treated with EGFR-TKI previously. The drug approval was cleared based on the Phase II clinical trial (therapeutic exploratory trial) outcomes conducted in South Korea, but with a condition to conduct a post-marketing Phase III trial (therapeutic confirmatory trial).
- Company
- Antidiabetic DPP-4 inhibitor breaks record of KRW 600 bn
- by Kim, Jin-Gu Jan 26, 2021 06:00am
- The outpatient prescription volume of antidiabetic dipeptidyl peptidase 4 (DPP-4) inhibitors exceeded over 600 billion won for the first time in the history. The market is steadfastly growing with about 6 percent surge from last year. The experts hint the oral antidiabetic drug market was the key to the growth. The sodium-glucose cotransporter-2 (SGLT2) inhibitor market is constantly and exponentially expanding with Forxiga and Jardiance. The last year’s prescription volume grew 29 percent from the year before and marked 121.4 billion won. ◆DPP-4 inhibitor market volume expands by 6 percent and hits 602.4 billion won According to a pharmaceutical market research firm UBIST on Jan. 21, total 602.4 billion won worth of DPP-4 inhibitor single and combination drugs were prescribed last year and surpassed the 600 billion won line for the first time. The DPP-4 inhibiting antidiabetics became the major player in the market since the MSD’s Januvia launched in 2007 as it rose above sulfonylurea (SU) and thiazolidinedione (TZD). Apparently, the drug group dominates more than half of the oral antidiabetics market. And the market is ceaselessly growing. In last six years, the market volume surged from 358 billion won in 2015 to 440.8 billion won in 2016, 493.4 billion won in 2017, 543.1 billion won in 2018, 568.7 billion won and 602.4 billion won in 2020 showing growth of 23 percent, 12 percent, 10 percent, 5 percent and 6 percent, respectively. ◆Januvia and Trajenta lead the market, while Zemiglo, Tenelia and Suganon leap Sorting by company, MSD and Boehringer Ingelheim are still leading the market. MSD’s Januvia series (Januvia and Janumet) grew 5 percent from 168.2 billion won in 2019 to 176.2 billion won last year. Boehringer Ingelheim’s Trajenta series grew by 4 percent and hit 128.9 billion won. Also, the prescription volume of LG Chem’s Zemiglo series (Zemiglo, Zemimet) soared. From 100.4 billion won in 2019, the volume skyrocketed to 115.8 billion won with a 15-percent jump. The gap with the market’s second best-selling Trajenta series was narrowed from 58.6 billion won in 2016 to 13.1 billion won last year. Besides the Zemiglo series, Handok’s Tenelia series (Tenelia, Tenelia M) and Dong-A ST’s Suganon series (Suganon, Sugamet) were prescribed significantly more last year. The Tenelia series generated 42.5 billion won with a 14-percent surge, whereas the Suganon series made 24.5 billion won with a 51-percent surge. On the contrary, the prescription volumes of Novartis’ Galvus series (Galvus, Galvus Met) and Takeda Pharmaceutical’s Nesina series (Nesina, Nesina Act, Nesina Met) and JW Pharmaceutical’s Guardlet series (Guardlet, Guardmet) dipped last year compared to the year before. The Galvus series made 44.5 billion won, the Nesina series made 32.1 billion won and the Guardlet series made 10.3 billion won with a 4-percent, 9-percent and 27-percent drop, respectively. ◆SGLT-2 inhibitors broke through 100 billion won, 29 percent growth propelled by Forxiga and Jardiance The SGLT-2 inhibitor market, for the first time in the history, exceeded the 100 billion won line. Since the launch of AstraZeneca’s Forxiga in 2014, Boehringer Ingelheim and MSD joined the race to drive the rapid growth in the market. The market volume at 12.2 billion won in 2015 grew to 24.5 billion won in 2016, 33.3 billion won in 2017, 42.8 billion won in 2018, 53.1 billion in 2019 and 121.4 billion won in 2020, showing the growth of 131 percent, 75 percent, 40 percent, 34 percent and 29 percent, respectively. The growth rate is decreasing as time passes, but it is still strong at almost 30 percent. The Forxiga series (Forxiga. Xigduo) and the Jardiance series (Jardiance, Jardiance Duo) are firmly leading the market. Forxiga made 64.8 billion won last year, marking a 22-percent growth from 53.1 billion won in 2019. In the mean time, the Jardiance series grew 40 percent from 36.6 billion won to 51.1 billion won. On the other hand, MSD and Astellas are demonstrating underwhelming performances. Astellas’ Suglat generated 3.3 billion won, when MSD’s Steglatro made 2.3 billion won. The two drugs combined do not even take up 5 percent of the market share. ◆Combination drug is ‘in,’ towering over single drug growths in both DPP-4 and SGLT-2 inhibitor markets When most of the drugs combined with metformin performed notably well, the single agent drugs’ growths were sluggish or brought down. The source reported the phenomenon was apparent in both DPP-4 inhibitor and SGLT-2 inhibitor markets. For instance, MSD’s Januvia series saw a single agent drug Januvia’s prescription volume increasing only by 1 percent from 46.5 billion won to 47 billion won. But a combination drug Janumet’s volume grew by 6 percent from 121.7 billion won to 129.1 billion won. Also Trajenta single agent drug’s prescription volume showed almost no growth, whereas the combination drug grew by 8 percent from 62.4 billion won to 67.2 billion won. The situations were similar with Zemiglo (5 percent) and Zemimet (21 percent), Tenelia (11 percent) and Tenelia M (16 percent), Suganon (43 percent) and Sugamet (57 percent) and Onglyza (0 percent) and Kombiglyze (4 percent). Meanwhile, Guardmet and Nesinamet’s prescription volume plummeted compared to their single drugs. But an external factor seems to have caused it. Apparently, the manufacturing and sales of Guardmet were shut off last year due to N-Nitrosodimethylamine (NDMA), suspected as a cancerous substance, found in metformin used in the drug. Nesinamet had an issue with the supply from February last year. SGLT-2 inhibitor market also witnessed prominent growth by combination drugs. When Forxiga’s prescription volume grew by 11 percent, a combination drug with metformin Xigduo grew by 39 percent. A single agent drug Jardiance grew by 21 percent, when a combination drug Jardiance Duo skyrocketed by 117 percent.
- Company
- KRW 15M incentive to employees assigned to Organon
- by Jan 25, 2021 06:21am
- MSD Korea has promised to pay out an incentive of 15 million won and maintain the employee benefits for those who were notified to be transferred to a new subsidiary, Organon Korea. A pharmaceutical industry source reported today that MSD Korea has signed an agreement with the labor union on Jan. 22 after a long negotiation. First, MSD Korea has decided to provide an incentive of 15 million won to employees reassigned to Organon as a token of acknowledgement of their contribution to the company so far and encouragement for their new beginning. Moreover, Organon Korea would adopt the same employment relationship and condition as MSD Korea’s and ensure the job security for the labor union members transitioning to the new subsidiary. And when the employment condition is to change, they have agreed to actively engagement in communication. Especially, if the condition were to be revised in more disadvantageous ways for the employees, the management would require a consensus from the labor union with a majority of employees. In case of Organon Korea offering an early retirement proposal (ERP), the management has clarified to not forcefully demand the employee to take the offer against the expression of intention by the union. And for employees signing a salary agreement for two years (2021-2022) before coming June, the raise would be applied not only for in MSD Korea, but also for in Organon Korea. The Organon Korea management would also have to notify the labor union 60 days prior and sincerely negotiation for settlement, if it intends to split or merge the company, or sell off a part of or the whole of a business. Taking an example of the previous Pfizer case, where it split and sold off a business to merge with another company, Organon has agreed to notify and negotiate with the labor union before the final action. Also, MSD Korea, Organon Korea and MSD Korea Labor Union swore to mutually cooperate during the process of corporate split-off or employment relations and condition settlement. And they clarified the labor union members would not be discriminated. The latest agreement would affect the remedy requested for the unfair transfer in last December. Resisting against the transfer ordered without consent, the MSD Korea Labor Union filed a remedy for unfair transfer to the Seoul Regional Labor Relations Commission. Meanwhile, Organon Korea is to kick off from next month with Senior Director Kim So-eun as the first CEO.
- Company
- Evenity can be prescribed at general hospitals
- by Eo, Yun-Ho Jan 25, 2021 06:21am
- According to related industries, Amgen's bone formation promotion and bone resorption inhibitor Evenity (Romosozumab) has so far been prescribed in Big 5 general hospitals such as SMC, SNUH, Seoul St. hospital, AMC, and Shinchon Severance Hospital, and has passed the drug commitee (DC) of about 30 medical institutions such as Gangnam Severance Hospital, Pusan National University Hospital, Bundang Seoul National University Hospital, and Hanyang University Hospital. Amgen submitted an application for registration about one year after Evenity's domestic approval in May 2019, and was recognized for the adequacy of benefits from the HIRA's Pharmaceutical Benefit Advisory Committee in September. The approved indications are ▲treatment of postmenopausal female osteoporosis patients at high risk of fracture, and ▲higher bone density of male osteoporosis patients at high fracture risk. However, the benefit was limited to patients who were unable to use or were unable to use one or more of the bisphophonate drugs (although new fractures occurred despite sufficient administration for more than 1 year). The duration of administration is limited to a total of 12 times at intervals of one month from a lifetime, and when the bone density test is performed after the administration of the drug and the same or improvement compared to the baseline value is confirmed, the administration to a bone resorption inhibitor is permitted. However, as the registration process for new osteoporosis drugs in Korea was not easy, the registration of Evenity is encouraging. In the case of Forsteo (Teriparatide)', it took 10 years to register after approval. Professor Deok-yoon Kim of the Department of Endocrinology at Kyung Hee University Hospital said, "It is important to lower the risk of fracture with powerful drugs such as Evenity from the beginning of treatment for the ultra-high risk group for osteoporosis fracture. The application of Evenity is expected to enable customized treatment for the ultra-high risk group." The effectiveness of Evenity was confirmed through a phase 3 study FRAME and ARCH study, and a phase 3 clinical BRIDGE study in men with osteoporosis. Through FRAME, a placebo-controlled phase 3 clinical trial, Evenity showed the effect of lowering the risk of vertebral fracture in postmenopausal female patients with a high risk of fracture from -2.5 to -3.5 in anterior hip or femoral neck bone density T-score. In ARCH, an Alendronate-controlled phase 3 clinical trial, Evenity demonstrated superior preventive effects in both vertebral and clinical fractures compared to Alendronate in postmenopausal female patients with osteoporosis and fragile fractures. In the group that switched to Alendronate after 1 year of Evenity treatment, the risk of new vertebral fractures was reduced by 50% at 24 months compared to the continuous Alendronate group.
- Company
- KanghanLaw scouted Adviser Jaehong Kwon from BMS Korea
- by Eo, Yun-Ho Jan 25, 2021 06:21am
- Advisor Jaehong KwonKanghanLaw hired Jaehong Kwon (60 yrs old), an advisor from BMS, a multinational pharmaceutical company. According to the industry, former chief executive Jaehong Kwon, who retired from Korea BMS in August last year, officially joined KanghanLaw on January 1st. Adviser Kwon is an industry veteran with 34 years of experience who joined JW Pharma in 1986 and has worked at BMS Korea since 1998. KanghanLaw is planning to strengthen his expertise in the healthcare field with the recruitment of Advisor Kwon. He has been in charge of registering insurance benefits for new drugs such as 'Plavix','Baraclude', and 'Sprycel' as an expert in the pharmaceutical industry policy (GA, Government Affairs) and drug price (MA, Market Access) work. KanghanLaw is a law firm specialized in the field of health and welfare. This law firm has experienced attorneys, professional groups from health insurance companies such as The HIRA, BMS Korea, and global pharmaceutical companies, and Jooseong Kang, former president of the Health Right Network.
- Company
- ↑sales of chronic disease drugs & ↓sales of antibiotics
- by Chon, Seung-Hyun Jan 22, 2021 06:28am
- Despite COVID-19 epidemic, the chronic disease treatment market continued to grow. The market for antibiotics and expectorants declined significantly due to the decrease in cold patients due to strengthening hygiene management. According to UBIST, a drug research institute on the 19th, the prescription amount of statin drugs used to treat dyslipidemia last year was ₩1 trillion, an increase of 3.4% from the previous year. The prescription amount in 2019 was ₩976.5 billion won, an increase of 2.9% from the previous year, but the growth rate was higher last year. Statin sales increase every year. In 2017 and 2018, prescriptions increased 4.1% and 6.1% respectively from the previous year. Last year, it surpassed ₩1 trillion for the first time, continuing the growth trend, even though external activities of people were greatly reduced due to the aftermath of COVID-19. In the major chronic disease treatment prescription market, which forms a large market, there was little impact on COVID-19. The combination of calcium channel blocker (CCB) and angiotensin II receptor blocker (ARB), which are the most commonly used treatments for hypertension, recorded ₩811.3 billion in prescriptions last year, up 10.1% from the previous year. In 2019, it recorded an even greater growth rate than the prescription price growth rate of 6.9%. ARB+CCB combination drug prescription performance also increased 11.8% and 13.2% in 2017 and 2018 compared to the previous year, respectively. Last year, even in COVID-19 situation throughout the year, it continued high growth. The Lipid-regulating drugs, which have recently been increasing in demand, remained strong. Last year, the prescription size of the lipid-regulator combination drug was ₩633.5 billion, an increase of 21.0% from the previous year. The prescription market for lipid-regulating drugs increased by 10.2% and 15.1%, respectively, compared to the previous year in 2018 and 2019, but last year the growth trend was even steeper. In recent years, Rosuvastatin or Atorvastatin combined with Ezetimibe has continued to rise as preference for drugs has increased. The sales for the combination of DPP-4·Metformin, which is used as an ARB single drug or diabetes treatment, also rose. Last year, the market size of ARB single drug was ₩401.2 billion, an increase of 3.9% from the previous year, and DPP-4·Metformin combination drug increased 1.2%. In the industry, the use of medicines continues to increase due to the increase in the elderly population and the number of chronic diseases, so it is diagnosed that the entire industry will not contract due to short-term issues such as infectious diseases. Unlike the tourism and cultural industries, which fell into extreme crises after COVID-19 outbreak, the pharmaceutical industry is unlikely to lead to a sudden downturn because it is affected by the demands of patients rather than the external environment. The entire prescription market last year maintained a growth trend, while the chronic disease treatment market, which has a large prescription, was not affected by COVID-19. Last year, the total outpatient prescription amount was ₩14.85 trillion, up 0.2% from the previous year. Compared to the previous year, the growth trend has slowed somewhat, but it is evaluated that it has made good progress considering the big bad news of COVID-19. The slowdown in the growth of the entire prescription market can be found in the decline in sales of infectious diseases treatments such as antibiotics and expectorants. The prescription performance of oral Cephalosporins last year was ₩209.9 billion, down 20.6% from 2018. For oral Cephalosporins, the prescription amount in 2019 fell 1.5% from the previous year, but last year the decline has expanded significantly. Sales of oral Penicillin recorded ₩116.9 billion last year, down 34.9% from the previous year. In 2019, it fell 4.5% from the previous year, but last year, the total prescription size decreased by about a third. The size of prescriptions for expectorant drugs, which are widely used in pediatric patients, has also decreased significantly. Last year, the prescription for expectorant drugs was ₩124.8 billion, a 29.6% decrease from the previous year. The slowdown in the prescription market for antibiotics and expectorants is evaluated to be closely related to the decline in the number of patients. It is analyzed that after the spread of COVID-19, external activities contracted and personal hygiene management such as hand washing and wearing of masks was strengthened, leading to a decline in the incidence of infectious diseases such as colds.
- Company
- The sales of flu treatment fell 99.6% due to COVID-19
- by Chon, Seung-Hyun Jan 22, 2021 06:26am
- Last year, sales of influenza drugs fell more than 60% from the previous year. The prescription of Tamiflu, the most commonly used, has dropped sharply. In the fourth quarter of last year, the season of full-fledged flu, prescriptions for Tamiflu and generics decreased by more than 99%. As the number of flu patients sharply declined due to reinforced hygiene management following the spread of the new COVID-19, the market for treatments also shrank. According to the drug research institute UBIST on the 21st, the amount of outpatient prescriptions for flu treatments last year was ₩8.4 billion, a 61.8% decrease from the previous year. It has shrunk from ₩44.7 billion in 2019 to one-fifth in two years. This is the change in the prescription market due to the spread of COVID-19. After the COVID-19 epidemic, external activities contracted, and personal hygiene management such as hand washing and wearing of masks strengthened, greatly reducing the number of flu patients, and the market for treatments decreased. Sales of Tamiflu, the most used flu treatment drug, declined significantly. Last year, the outpatient prescription amount of Oseltamivir was ₩6.7 billion, down 60.2% from the previous year. It decreased by more than 80% in two years from ₩33.8 billion in 2018. Oseltamivir is the active ingredient of Tamiflu. Influenza drugs, including Tamiflu, are usually prescribed in the first and fourth quarters of the flu epidemic. In the first quarter of last year, the prescription amount of Oseltamivir was ₩6.7 billion, an increase of 20.4% from the previous year. Although the first confirmed cases of COVID-19 occurred on January 20 of last year, the flu treatment market was not significantly affected in the first quarter as the epidemic began in earnest after February. However, even though the flu season began in earnest in the fourth quarter of last year, Oseltamivir prescriptions were less than ₩100 million. It decreased by 99.6% from ₩5.9 billion in the fourth quarter of 2019 to ₩20 million in the fourth quarter of last year. As COVID-19 pandemic continues throughout the year, the flu treatment market has virtually disappeared. According to the KCDA, the number of suspected flu patients per 1,000 outpatients in December last year (weeks 49 to 52) was 2. 2.8 people at week 49, 2.8 people at week 50, 2.8 people at week 51, and 2.5 people at week 52, never exceeding 3 people. Compared to 2019, 19.5 people at 49 weeks, 28.5 people at 50 weeks, 37.8 people at 51 weeks, 49.8 people at 52 weeks , the flu patients rarely occurred. The prescription cost for all Oseltamivir products decreased significantly. Tamiflu's prescription amount last year was ₩2.8 billion, down 56.0% from the previous year. Tamiflu's prescription performance in the fourth quarter of last year was ₩23 million, down to 1% of ₩2.3 billion a year earlier. Sales of Hanmi Flu amounted to ₩1.6 billion last year, down 68.0% from 2019. Hanmi Flu recorded a prescription amount of ₩1.7 billion in the fourth quarter of 2019, but was only around ₩1 million in the fourth quarter of last year.
- Company
- Pharmaceutical industry rushes to recruit new GA managers
- by Eo, Yun-Ho Jan 22, 2021 06:26am
- The pharmaceutical industry is hectic seeking for government affairs specialists to recruit. An industry source reported, many of pharmaceutical companies and Korean Research-based Pharmaceutical Industry Association (KRPIA) are in search of new government affairs or market access managers, as their previous members are transitioning to other places. As the current healthcare policy director at KRPIA, Kang Tae-wook, was offered to teach at Sungshin Women’s University as a professor, the organization is looking for a successor. Before joining KRPIA in 2019, Director Kang was a healthcare policy researcher at the National Health Insurance Service (NHIS). Bayer Korea is in process of recruiting a Market Access-Government Affair Head, as the previous senior director of the department, Park Hanra moved to Bristol Myers Squibb (BMS). Organon, split from MSD, has decided to introduce Pyo Jihyun, a previous Policy and Stakeholder Relations Team Lead at Pfizer, as their new Head of Market Access, Government Affairs and Public Relations department. Pyo is expected to officially join Organon from coming February. Losing the key player in the company, Pfizer is also expected to search for a new lead in the team. Fine-tuning the new organization, Organon is looking for two more personnel to take over the government affairs and PR. Manager Paik Hee-jeong, previously worked at MSD, is decided to join the Organon market access department. Boehringer Ingelheim is newly recruiting a healthcare policy manager. Initially the company’s market access and government affairs were jointly managed by Senior Director Kim Mi-kyung, but the company has decided to hire another staff to solely manage the government affairs. Handok is also seeking a new market access manager as its previous Market Access Team Lead Park Sun has moved to UCB Korea. A government affairs manager at a multinational pharmaceutical company commented, “Because the job requires a specific skill set and experience, the companies inevitably looks for the new personnel within the industry. And that is why there is a chain of recruits and personnel assignment. Sometimes, however, companies look for someone from the National Assembly or news media for the government affairs.”
- Company
- Viatris·Organon's prescription performance declined
- by Kim, Jin-Gu Jan 22, 2021 06:26am
- Sales of major items owned by Viatris and Organon, which were spun off from Pfizer and MSD, are declining in the domestic outpatient prescription market. As of last year, Viatris' outpatient prescriptions fell 4% and Organon's 6% YoY. The decline in prescription results for most major items, such as Viatris' Lipitor·Lyrica and Organon's Singulair·Cozaar, has not been avoided. The prescription performance of the headquarters of Pfizer and MSD, which spun off its business divisions centering on patent-expired drugs, was relatively insignificant. ◆Viatris'L ipitor· Lyrica, 4% reduction in prescription performance According to UBIST, a drug market research organization on the 19th, Pfizer's outpatient prescription last year was ₩539.2 billion. Compared to ₩565.4 billion in 2019, it decreased by 11%. In 2018, Pfizer decided to spin off Pfizer Upjohn, focusing on drugs whose patents expired. Pfizer Upzone was officially launched in November last year under the name Viatris. However, the transfer and acquisition of Pfizer and its items has not been completed. Pfizer decided to hand over ▲Lipitor ▲Norvasc ▲ Lyrica ▲Celebrex ▲Viagra ▲Caduet ▲Neurontin ▲Xalatan ▲Cardura XL ▲Zoloft ▲Xanax ▲EfexorXR ▲Detrusitol ▲Zeldox ▲Xalacom ▲Zyvox to Viatris. The total amount of prescriptions for these items decreased by 4% from ₩453.1 billion in 2019 to ₩434.2 billion last year. Lipitor, the flagship product, was the most sold drug in the domestic outpatient prescription market for three consecutive years until last year, but it has been stagnant. The prescription amount last year was ₩185.5 billion, a 3% decrease from the previous year (₩191.4 billion). During the same period, Lyrica was 4% (₩67.3 billion → ₩64.5 billion), Celebrex 8% (₩44.3 billion → ₩40.4 billion), Caduet 15% (₩26.4 billion → ₩22.4 billion), Neurontin 14% (₩22.4 billion → ₩19.3 billion), Xalatan decreased by 1% (₩14.7 billion → ₩14.6 billion), respectively. Among the major items, only Norvasc increased by 1% (₩66.7 billion → ₩67.2 billion). The amount of outpatient prescriptions for the remaining items at Pfizer decreased by 7% from ₩112.3 billion to ₩10.5 billion. Compared to simple comparisons, Pfizer's remaining items declined more, but given the fact that the recent growth of anticancer drugs such as Ibrance and Xalkori, which have a large proportion of inpatient prescriptions, and vaccines such as Prevenar13, the actual decrease in prescription performance is not significant. ◆Excluding Organon's Atojet, Singulair and Proscar sharply decreased by around 10% MSD also decided to spin off some of the patent expired drugs, women's health products, and biosimilars. The name of the spin-off company is Organon. The items passed from MSD to Organon are ▲Atozet ▲Singulair ▲Vytorin ▲Proscar ▲Cozaar ▲Fosamax ▲Nasonex. Among them, prescription performance for other items excluding Atozet decreased significantly: Cozaar series 3% (₩52.4 billion → ₩50.6 billion), Singulair 29% (₩38.1 billion → ₩26.8 billion), and Vytorin 18% (₩24.8 billion → ₩20.3 billion). , Proscar 10% (₩19.1 billion → ₩17.2 billion), Fosamax series 9% (₩16.7 billion → ₩15.2 billion), and Nasonex 13% (₩8.2 billion → ₩7.2 billion), respectively. Atozet rose 14% from ₩65.8 billion to ₩74.7 billion. However, it is unclear how long Atozet's uptrend will continue. Generics for Atozet are expected to be listed as early as next month. Currently, it is known that about 20 companies, mainly Chong Kun Dang, are developing generics. MSD has decided to leave the Januvia series the only drug that has expired. The Januvia series' prescription performance last year was ₩176.2 billion, a 5% increase from the previous year (₩168.2 billion). The total outpatient prescriptions for items remaining in MSD, including Januvia, increased by 2% from ₩207 billion in 2019 to ₩29.9 billion last year. MSD plans to close the spin-off process with Organon in February. Currently, some of the 700 employees of MSD Korea have been relocated.
- Company
- Takeda to retry expanding all-comer coverage on Zejula
- by Eo, Yun-Ho Jan 21, 2021 06:15am
- An all-comer targeting anticancer treatment Zejula is shooting yet again for the healthcare reimbursement expansion this year. The pharmaceutical industry insider reported the drug could not overcome the hurdle of the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee in last June, but the poly ADP-ribose polymerase (PPARP) inhibitor Zejula’s (niraparib), applied again in last August to expand the reimbursed indication. On Jan. 27, the Cancer Deliberation Committee would assess expanding the healthcare reimbursement on the drug’s indication as a monotherapy for the patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first-line platinum-based chemotherapy, regardless of BRCA mutation. In last June, the Cancer Deliberation Committee reviewed using the drug as a single-agent maintenance therapy in patients with gBRCA-negative high-grade serous relapsed ovarian cancer who showed complete or partial response in platinum-based chemotherapy, and as a monotherapy in patients with relapsed ovarian cancer who previously received fourth-line or later chemotherapy. Ultimately, only the fourth-line monotherapy indication was approved, while the gBRCA-negative indication failed. But the government is still cautious of expanding the reimbursement on all-comer indication. The indication approval was based on the PRIMA study that evaluated Zejula’s efficacy as a first-line maintenance therapy on 733 adult patients diagnosed with ovarian cancer. The primary endpoint was a progression-free survival (PFS) in homologous repair deficiency (HRD) and overall population groups, which was evaluated by the Blinded Independent Central Review (BICR) in the order. The clinical study found the HRD patient group demonstrated a median PFS of 21.9 months, almost doubling that of the placebo group, and reduced the risk of disease progression and death by 57 percent. The control group’s median PFS marked 10.4 months. The overall population’s median PFS was 13.8 months with Zejula and 8.2 months with the placebo. The risk of disease progression and death was lessened by 38 percent. Professor Kim Jae-weon at Seoul National University Hospital Depart of Obstetrics and Gynecology noted, “The maintenance therapies each in first-line and second-line show a significant difference. Obviously, the survival rate goes up when the treatment is used at an earlier stage. Personally speaking, the healthcare coverage on the first-line maintenance therapy should be expanded for all possible patients.” Originally, Zejula’s reimbursed price was set at 76,400 won per capsule. Compared to the alternative option, Lynparza (olaparib) by AstraZeneca, Takeda’s option was evaluated as more cost-effective. But because Lynparza was listed with a pharmacoeconomic-analysis exemption through the risk sharing agreement (RSA), Zejula was also applied with the expenditure cap type RSA.
