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- 2026-06-28 21:20:01
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- Keytruda leads the market for 3 consecutive years
- by Chon, Seung-Hyun Feb 22, 2023 05:54am
- The immuno-oncology drug Keytruda has topped the rank in pharmaceutical sales for 3 consecutive years. Also, new drugs from multinational pharmaceutical companies, such as Gardasil 9, Prolia, Opdivo, and Dupixent showed strong growth and joined the KRW 100 billion club after exceeding KRW 100 billion in sales last year. On the 22nd, according to the pharmaceutical research institution IQVIA, MDSD's Keytruda's sales topped the market by recordeingKRW 239.6 billion last year. This is a 19.7% YoY increase from the previous year. This is the third consecutive year the drug has held the lead after taking the top spot for the first time in 2020 with sales of KRW 155.7 billion. Also, Keytruda’s sales exceeded 200 billion won for 2 consecutive years since 2021. Keytruda is an immune checkpoint inhibitor that inhibits PD-1 proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 and activating the immune system to treat cancer. The drug is currently approved for 16 cancers: ▲Lung cancer, ▲head, and neck cancer, ▲ Hodgkin lymphoma, ▲urothelial carcinoma (bladder cancer), ▲esophageal cancer, ▲ melanoma, ▲renal cell cancer (kidney cancer), ▲endometrial cancer, ▲stomach cancer, ▲small intestine cancer, ▲ovarian cancer, ▲pancreatic cancer, ▲biliary tract cancer, ▲colorectal cancer ▲triple negative breast cancer, and ▲cervical cancer. It is indicated for the largest number of cancer types among cancer immunotherapies approved in Korea. In the early years of its release, in 2016 and 2017, its sales had only been KRW 100 billion and KRW 12.2 billion. However, its sales started to surge with reimbursement approval. After reimbursement was applied for non-small-cell lung cancer (NSCLC) in August 2017, its sales soared over fivefold to KRW 70.3 billion in 2018, and then exceeded KRW 100 billion by 2019. In 2020, the drug outsold the then-lead Lipitor and rose to the lead. Last year, Keytruda continued strong growth amid favorable and unfavorable events. Keytruda’s insurance ceiling price had fallen 25.6% with its reimbursement extension to first-line treatment of NSCLC in March this year. Its sales in Q1 last year had fallen 8.4% compared to the same quarter the previous year due to the price cut – to KRW 40.4 billion – but it recovered its momentum after the benefits from its first line reimbursement were applied in earnest. When considering the price cut that was applied to Keytruda, its sales volume has increased by over 60%. New drugs from multinational pharmaceutical companies showed strong sales and made the ranks last year. MSD’s HPV vaccine Gardasil 9 ranked third last year with sales of KRW 117 billion, rising 61.2% from the previous year. Gardasil 9 is an improved version of the company’s Gardasil, which offers protection for four serotypes (6, 11, 16, and 18). Gardasil 9 offers protection for five more serotypes (31, 33, 45, 52, 58) than Gardasil. Also, It contains the most HPV types among cervical cancer vaccines. Vaccinations among males for Gardasil 9, which was released at the end of 2016, have also been rising every year with the news spreading that Gardasil 9 offers protection for HPV-related diseases other than cervical cancer, such as anal cancer, genital warts, and precancerous lesions. Also, the revaccination rate has also risen greatly among adults who already received vaccination after the recommended age was expanded from 9-26 to 27-45 in July 2020. Sales of Gardasil 9 had increased over twofold in 2 years from KRW 42.5 billion in 2020 to exceed KRW 100 billion for the first time last year. Amgen’s Prolia ranked fourth raising KRW 115.7 billion YoY last year. Prolia, a biological osteoporosis treatment that targets the RANKL protein essential for the formation, activation, and survival of osteoclasts that destroy the bone, was released in November 2016 in Korea. Its sales started to rise after it was applied reimbursement as a second-line treatment in 2017. After additionally being approved for reimbursement in the first line from April 2019, Prolia’s sales rose explosively and its annual sales exceeded KRW 100 billion for the first time. Prolia is copromoted by Chong Kun Dang in Korea. Sales of Ono Pharmaceutical’s cancer immunotherapy Opdivo increased 29.3% YoY to record ₩109.9 billion this year. Opdivo, which was approved in 2015, recorded a high growth rate of 64.7% in two years from the 66.7 billion it had earned in 2020, and its annual sales exceeded 100 billion for the first time last year. Sales of Sanofi’s atopic dermatitis treatment Dupixent rose 36.3% YoY to record ₩105.2 billion last year. Dupixent is the first targeted biologic for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with prescription topical therapies or who cannot use topical therapies. Sales of Dupixent, which was approved in March 2018, increased rapidly after it was approved for reimbursement for severe atopic dermatitis in January 2020, and exceeded KRW 100 billion last year. Roche’s Perjeta’s annual sales rose 9.4% YoY to record KRW 102.7 billion last year. Perjeta is approved for use in combination with docetaxel and trastuzumab in patients with metastatic or unresectable locally advanced HER2-positive breast cancer who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer. The drug was approved for reimbursement to treat patients with metastatic or unresectable locally advanced HER2-positive breast cancer who have not received anti-HER2 therapy in 2017. After the drug was granted selective reimbursement in May 2019, trastuzumab and combination therapy settled as the standard adjuvant therapy and its sales exceeded KRW 100 billion. Among new drugs developed by domestic pharmaceutical companies, HK.Inno.N’s K-CAB’s sales rose 16.0% YoY to record KRW 104.8 billion and ranked eighth last year. K-CAB, which was released in March 2019. It has a new mechanism of action that inhibits gastric acid secretion by competitively binding to the proton pump and potassium ion located in the final stage of acid secretion.
- Company
- GC Biopharma receives WHO Pre-Qualification for Barycela
- by Kim, Jin-Gu Feb 21, 2023 05:52am
- Pic. of Barycela GC Biopharma announced that the World Health Organization (WHO) has granted prequalification (PQ) for its varicella vaccine, Barycela. Vaccines that receive the WHO prequalification decision after a review of their safety and efficacy become eligible for procurement by the United Nations agencies to be used in national immunization programs. With the approval of its varicella vaccine, the company now owns 3 PQ vaccines along with its H1N1 pandemic and seasonal influenza vaccines. Barycela is a live attenuated varicella virus vaccine that contains the MAV/06 strain, a virus exclusively attenuated by GC Biopharma. The product has improved stability while containing a higher amount of virus compared to its previous product. In a global trial, the company demonstrated Barycela’s noninferiority in terms of immunogenicity and an equivalent level of safety compared with Varivax, an existing prequalified vaccine in the market. The vaccine is produced in a state-of-the-art aseptic system through cell culture, virus infection, and purification. It has the characteristic of being the only varicella vaccine produced without antibiotics. With the WHO's PQ decision, the company believes that there is a rising possibility that its ‘MAV/06 strain’ will be registered in the WHO Technical Report Series (TRS) in addition to the previously listed OKA strain. Also, GC Biopharma plans to actively target the global market with Barycela by utilizing the global supply network it had previously established supplying its existing varicella vaccine. Eun Chul Huh, President of GC Biopharma, said, “We hope to continue contributing to reducing the world's social and economic cost incurred by varicella outbreaks with Barycela.” In 1993, GC Biopharma received approval for ‘Suduvax,’ the first varicella vaccine in Korea and the world's second varicella vaccine. Over 28 million doses of Suduvax have been sold worldwide over the past 3 decades through PAHO and others.
- Company
- 3rd PARPi Talzenna may be prescribed at hospitals in Korea
- by Eo, Yun-Ho Feb 21, 2023 05:52am
- Korea’s third PARP inhibitor, ‘Talzenna’ can now be prescribed at general hospitals in Korea. According to industry sources, Pfizer Korea’s breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) treatment ‘Talzenna (talazoparib)' passed the drug committee reviews of various medical institutions in Korea, including the National Cancer Center St. Mary’s Hospital and Yeouido St. Mary's Hospital. Talzenna was approved in Korea in July 2020 as monotherapy for the treatment of adult patients with germline BRCA mutations who have HER2-negative locally advanced or metastatic breast cancer with previous treatment experience. Afterward, the company applied for reimbursement, and the agenda was selected for review by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in November of the same year but was unable to pass CDDC deliberations, and no progress had been made since. The health authorities are known to have been expressing concerns about reimbursing PARP inhibitors like Talzenna in breast cancer due to their broad indication in the disease. AstraZeneca’s Lynparza was the first PARP inhibitor to receive reimbursement in Korea. Lynparza was listed for reimbursement in October 2017 and was applied the Expenditure Cap type of the Risk Sharing Agreement (RSA) through the pharmacoeconomic evaluation exemption system. Listing of Takeda’s ‘Zejula’ followed in December 2019. The drug may be prescribed as maintenance monotherapy for adult patients with platinum-sensitive recurrent ovarian cancer who are in complete or partial response to platinum-based chemotherapy. However, its first reimbursement was only approved for approved the BRCA-positive indication. However, both drugs are experiencing difficulty extending reimbursement to breast cancer. Meanwhile, Talzenna’s efficacy was demonstrated through the large-scale, open-label, randomized, international Phase III trial, EMBRACA. The trial compared the efficacy of Talzenna monotherapy versus chemotherapy of the investigator’s choice in patients with gBRCA-mutated HER2-negative locally advanced or metastatic breast cancer who received no more than 3 prior cytotoxic chemotherapy regimens for their metastatic or locally advanced disease. Results showed that the median progression-free survival (mPFS), the primary efficacy endpoint, was 8.6 months for the Talzenna monotherapy arm, which was a significant improvement compared with the 5.6 months in the chemotherapy arm. Also, the risk of disease progression or death was 46% lower in the Talzenna monotherapy arm compared to the chemotherapy arm. Such significant improvement in PFS in patients treated with Talzenna was consistently observed across major patient subgroups, which were defined by the number of prior cytotoxic regimens, hormone receptor status (HR+ or TNBC), and history of CNS metastases. Also, the secondary endpoint, objective response rate (ORR), was 62.6% for the Talzenna monotherapy arm, which was more than double the 27.2% achieved in the chemotherapy arm.
- Policy
- Severe Cancer Drug Benefits, covered by the National Budget
- by Lee, Jeong-Hwan Feb 20, 2023 05:53am
- The legislation will be promoted in which the state is responsible for the cost of applying health insurance benefits for new drugs for the treatment of severe diseases and cancer. It also included a provision to include a new technology support project for cancer treatment in the scope of the National Health Insurance Service's work and to raise the funding rate used for new technologies for cancer treatment. On the 14th, Kang Sun-woo, a member of the Democratic Party of Korea, announced that he proposed three amendments to the Cancer Management Act, the National Health Insurance Act, and the National Health Promotion Act. Lawmaker Kang plans to name the three package bills proposed this time as the "Three Acts of State Responsibility for Severe Diseases" and push for legislation. The current law stipulates that cancer treatment and medical expenses should be subsidized according to income level to ease the economic burden of severely ill patients and cancer patients. However, it has been pointed out that in the current medical expenses support system, the limit of support is limited. Cancer patients are in financial difficulties and lose their lives due to the lack of rapid health insurance benefits after the approval of the Ministry of Food and Drug Safety. In response, Kang proposed a new support project to support new non-paid cancer treatment and new medical technology from the budget of the National Health Promotion Fund and included new cancer treatment technology support projects within the scope of the National Health Insurance Corporation's work. It also specified legal grounds for raising the National Health Insurance Service fund support rate (partial amendment to the National Health Promotion Act) used for related support projects such as new cancer treatment technologies. Lawmaker Kang said, "We proposed the bill in the sense that strengthening the coverage of drugs for severe diseases directly related to the lives of the people should be carried out more actively with government support."
- Policy
- The Minister's willingness to innovate regulations
- by Lee, Hye-Kyung Feb 20, 2023 05:53am
- A full view of Hanmi Pharmaceutical Oh Yoo-kyung, head of the Ministry of Food and Drug Safety, met with representatives of pharmaceutical companies and expressed his willingness to innovate regulations. At 2 p.m. today (15th), Director Oh met with representatives of pharmaceutical industries such as Hanmi Pharmaceutical, Dasan Pharmaceutical, Daewoong Pharmaceutical, Amgen Korea, Inist, Pfizer Korea, Huons, and Hugel at the Hanmi Pharmaceutical Research Center. The meeting was held in the name of the New Year's meeting, and the reason why Hanmi Pharmaceutical Research Center was selected as a venue is to encourage executives and employees of Hanmi Pharmaceutical, which has been approved for marketing by the U.S. FDA, for the first time in Korea. In September last year, Hanmi Pharmaceutical received FDA approval for the treatment of neutropenia, "Rolontis." "We are grateful for the hard work of the company officials who are striving to develop the domestic pharmaceutical industry and improve their international status," Oh said. "The Ministry of Food and Drug Safety will also do its best to improve the drug system and provide administrative support." It announced its plan to boldly change Korean drug regulations to global standards so that domestic companies can enter and compete in overseas markets. "The Ministry of Food and Drug Safety will work closely with the industry and related organizations to promote regulatory innovation so that Korean drug regulations can lead the international standards," Oh said. "Please continue to develop high-quality new drugs to open new treatment opportunities for our people." The meeting was held to introduce major policy directions and core brand businesses of the Ministry of Food and Drug Safety in 2023 and to discuss future development and regulatory innovation measures of the Ministry of Food and Drug Safety with related industry officials. The Global Leader, Partner, Supporter (GPS) project was introduced as a major policy in the pharmaceutical sector, which means accelerating entry into the international market through global leadership to strengthen export support, partners in pharmaceutical production using advanced digital technology, and customized support for global innovative products. The Ministry of Food and Drug Safety plans to support the virtuous cycle of the pharmaceutical industry by enhancing Korea's international status and becoming a leading regulatory country through international harmonization of pharmaceutical regulations. Previously, it operated a Global Innovative Products on Fast Track (GIFT) program to help global innovative medical products become quickly commercialized and dominate the global market. It said it would implement customized regulatory support projects to quickly enter the next-generation biopharmaceutical market. The plan is to establish a preemptive item classification system for new concept drugs as the development of new concept products that transcends the classification and concept of existing drugs is expanded. If a biopharmaceutical company applies for and discovers next-generation biopharmaceuticals, it will support regulations through internal communication, classification standards, customized regulatory support, internal review committee, external consultation, notification and objection, procedures, and information provision. To secure vaccine sovereignty, it also announced plans to operate a national cell bank, test and analysis of vaccines at an international level, comprehensive technology consulting from vaccine development to licensing, overseas licensing strategy consulting, and expand the foundation for future-oriented policy and system development. The Ministry of Food and Drug Safety said it will continue to play the role of a regulatory agency that protects public safety based on regulatory science expertise, push for export GPS strategies to enter the global market beyond global technical regulations, and play a role as a partner in organically communicating and cooperating with industries and organizations.
- Company
- Organon ‘Samsung’s Humira biosimilar to make KRW 100 billi
- by Jung, Sae-Im Feb 20, 2023 05:53am
- Samsung Bioepeis’ U.S partner Organon projected that the sales of the company’s Humira biosimilar will reach a maximum of KRW 123.5 billion in the first year of its release. On the 16th (local time), Organon projected so while presenting its full-year 2022 financial results, announcing that the company “will be launching the Humira biosimilar ‘Hadlima’ in the U.S. July this year.” Hadlima is a Humira biosimilar that was developed by Samsung Bioepis. Humira is a blockbuster drug that held the ranks as the most-sold drug worldwide for a decade. Its global sales recorded USD 21.24 billion (approximately KRW 27 trillion) last year, of which sales in the U.S. accounted for USD 18.62 billion (approximately KRW 24 trillion). Starting with Amgen, various companies including Samsung Bioepis, Boehringer Ingelheim, Pfizer, and Coherus are set to release Humira biosimilars this year. Amgen’s ‘Amjevita’ has already been released to the market. In particular, up to 8 companies including Samsung Bioepis are expected to competitively release their biosimilar products in July this year. Building on their successful launch of Hadlima in Canada and Australia, the company expects the experience to positively impact the launch in the U.S. market. Also, it pointed to Hadlima’s equal product composition and pen device technology as what differentiates its biosimilar from other products. Organon said, “We have launched Hadlima in Canada and Australia in 2021 and achieved good results. The data we collected from the launches will support our launch of the same in the U.S. Both the citrate-free, high-concentration formulation and the low-concentration formulation will be released then. The design of the pen that contains the drug can also be a differentiating factor. As a device design and manufacturing expert, the company designed the pen to ensure a smooth transition for the patients switching from Humira to Hadlima.” Organon expects Hadlima to make sales of up to USD 96.75 million (KRW 123.5 billion) this year, the first year of its launch in the US. This amount was derived based on the expectation that Hadlima sales will not exceed 1.5% of the estimated total sales of USD 92.25-96.75 million (KRW 117.8-123.5 billion), which roughly amounts to USD 92.25-96.75 million (KRW 117.8-123.5 billion). This will be around fivefold of what Hadlima made last year (USD 19 million, KRW 24.2 billion). Organon said, “We expect sales of Hadlima to rise gradually with competition among biosimilars to be officially listed by major Pharmacy Benefit Managers (PBMs) in the U.S. From the next year after the biosimilar market is formed in earnest, Hadlima will grow into Organon's second largest grossing product.” The ‘interchangeable biosimilar’ designation sought by Samsung Bioepis was expected to be achieved in Q2 to Q3 of 2024. The interchangeable biosimilar designation is made by the U.S. Food and Drug Administration for biosimilars that are very similar to and have no clinically meaningful differences from the original drug. Drugs that are approved as interchangeable biosimilars may be substituted at the pharmacy without a separate order for switching by the prescribing health care provider. Organon said, “We expect to be able to receive the interchangeable biosimilar designation around one year after Hadlima’s release in July. Our other Humira biosimilar competitors will also be able to receive designation by then. For the first 1-2 years after a drug is launched, whether the drug received the interchangeable biosimilar designation does not become a key point of differentiation for biosimilars during discussions with PBMs. As long as give convince them that we can receive the designation within a reasonable period of time, it will not be a major point for discussion at the negotiation table."
- Policy
- Will there be progress in introducing a checkup for Hep C?
- by Jung, Sae-Im Feb 20, 2023 05:52am
- Attention is focusing on whether the introduction of national screening for hepatitis C, which has been idle for eight years, will be able to make progress this year. At APASL 2023, which was held in Taipei, Taiwan for five days from the 15th, in-depth discussions were held on preparing national policies to combat hepatitis C. The forum examined the situation in Korea, where hepatitis C was still not included in the national examination. The WHO declared the eradication of hepatitis C by 2030 and called for international efforts. As hepatitis C has opened the era of cure due to the development of treatments, the most important goal is to find patients who have not been diagnosed. Several countries around the world, including Germany, Japan, and Taiwan, are reducing the number of patients through active diagnosis and treatment, including hepatitis C, in national checkups. Discussions on hepatitis C, which began in 2016, are still "in progress." Although cost-effectiveness has been consistently proven through feasibility studies and pilot projects centered on the Korean Liver Association, the government has not responded positively. Korean health officials who attended the forum made an optimistic prediction that "If positive results are obtained from this year's expert review, hepatitis C could be included in the national examination as early as next year." Kwak Jin, head of the infectious disease management department of the Korea Centers for Disease Control and Prevention, said, "The first expert review conducted in 2018 judged that there was not enough evidence to meet the qualifications for national screening." "If we pass the review successfully, we predict that national screening of hepatitis C could be possible next year or the year after next," he said. He also suggested other aspects to consider to combat hepatitis C. This means that a system from diagnosis to treatment and management, such as post-diagnosis treatment and high-risk group management, should be established organically. Manager Kwak said, "If a public or private examination confirms the infection, a system should be established that can be performed as treatment." It is also important to establish management and screening systems for high-risk groups of infection, such as correctional facility inmates, refugees, and injection drug users, and to establish a comprehensive public-private cooperation system including the hepatitis Policy Advisory Committee. Park Ji-min, a health promotion officer at the Ministry of Health and Welfare, said, "Since the Korean government is well aware of the importance of eradicating hepatitis C, two large-scale pilot studies have been conducted. However, Park took a cautious stance, saying, "Korea has a national health examination system, which is a program for all Korean citizens, and the inclusion of hepatitis C in the national examination has a great impact. Therefore, the careful and conservative application is needed according to the principles mentioned by Kwak." This is seen as a remark in consideration of whether it is right to include hepatitis C, which has a domestic prevalence of only 0.8%, in the screening system for all citizens. The prevalence of hepatitis C, which has met cost-effectiveness through various pilot projects, has been mentioned as the reason for failing to enter the national examination. The Korean Liver Association has reaffirmed the validity of the hepatitis C screening test through further research. According to the report on the study's final results on the feasibility analysis of hepatitis C screening and follow-up management of screening among the national health screening items released by the Korea Centers for Disease Control and Prevention, hepatitis C met all five conditions for introducing national screening items. The five conditions will be important health problems, diseases that can be detected and treated early, acceptable to the screening method, more profitable than loss, and effective against cost. The report relates to prevalence. In 2020, medical expenses due to hepatitis and related diseases were confirmed to be 11.5% of the total annual medical expenses," it stressed. At the forum, domestic specialists reiterated the need to introduce a rapid national screening of hepatitis C. Jang Jae-young, a professor of gastroenterology at Soonchunhyang University Seoul Hospital, said, "As a result of the study, the incidence of major liver diseases was significantly reduced when all people aged 40 to 65 were examined for hepatitis C through national checkups and was cost-effective at all ages. In particular, screening in the 60s is the most cost-effective, and when conducting hepatitis C screening tests at the age of 56 to 65, the savings have been greater than the input cost since 12 years ago. After 20 years, 20 billion won can be saved, and 30 billion won can be saved after 30 years."
- Company
- Novartis’s Jakavi makes a step towards reimb for GvHD
- by Eo, Yun-Ho Feb 20, 2023 05:52am
- ‘Jakavi’ is now one step closer to extending reimbursement to Graft versus Host Disease (GvHD) in Korea. According to industry sources, Novartis Kroea’s Jakavi (ruxolitinib) recently passed deliberation by the Drug Reimbursement Evaluation Standard Subcommittee. The next step is for the drug to be reviewed by the Drug Reimbursement Evaluation Committee. Novartis Korea submitted an application to extend reimbursement for Jakavi (ruxolitinib) to Graft-versus-Host Disease (GvHD), immediately after receiving approval for the indication in May 2022. The application passed review after being pending at this stage for 8 months. GvHD is a potentially serious complication that may occur after allogeneic stem cell transplantation. When the donor’s T cells (the graft) view the patient’s healthy cells (the host) as foreign and attack and damages them, affecting various organs including the skin, the gastrointestinal tract, the liver, and the lungs. As symptoms can appear throughout the body, GvHD poses another challenge to patients who have survived allogeneic hematopoietic stem cell transplantations by affecting the patient’s quality of life. Steroids are used as standard first-line therapy, but unmet needs exist as no standard-line therapy exists in the second-line for the 50% of patients that fail treatment in the first-line. In this area, Jakavi arose as an option that can be used to treat patients aged 12 years and older with acute or chronic GvHD who have an inadequate response to corticosteroids or other systemic therapies. Hee-Jae Kim, the Chief Chair of the Korean Society of Blood and Marrow Transplantation (Professor of Hematology at the Catholic University of Korea), said, “Jakavi demonstrated superior effect in treating acute and chronic GvHD patients in clinical studies and has shown similar results in the field, and opened up new possibilities for patients suffering from the lack of an appropriate treatment option” Meanwhile, Jakavi has demonstrated its efficacy in the Phase III REACH2 trial. Results showed that the overall response rate with Jakavi at Day 28 was 62% (96/154), compared to the 39% that was achieved with the best available therapy (61/155) Also, the durable overall response was found to be twice higher in the Jakavi group at Day 56 at 22% (34/155) compared with 40% (61/154) in the control group.
- Policy
- Skyrizi benefit will be expanded from next month
- by Lee, Jeong-Hwan Feb 17, 2023 05:50am
- Expanded standards for oral hepatitis B drugs. From March 1, the scope of recognition of drug care benefits by Skyrizi PFS is expected to expand from existing psoriasis to active and progressive psoriatic arthritis. Reva-K and Reba-eye 2% are listed as new benefits, and medical benefits are recognized when administered to "improve corneal epithelial disorders in adult ocular anterior patients." The criteria for recognition of medical care benefits for oral chronic hepatitis B treatment will also be expanded compared to the previous one. The phrase of the Argatroban component injection is changed so that the detailed recognition criteria for medical care benefits are administered within the scope of permits for each drug. The hemostatic oxidative regenerative cellulose benefit item is changed from Equtamp to Surgicel. On the 15th, the Ministry of Health and Welfare will announce the administrative notice of "partial revision of the criteria and methods for applying for medical care benefits" and conduct a related opinion inquiry until the 24th. First, the standard of the AbbVie interleukin (IL)-23 inhibitor Skyrizi PFS will be expanded. Skyrizi, which is an indication of plate psoriasis and psoriatic arthritis, is currently only reimbursed for psoriasis. The Ministry of Health and Welfare adds 'active and progressive psoriatic arthritis' to the Skyrizi standard. Skyrich will also be added to the replacement pay standard for Tremfya, Taltz PFS, Cosentyx, and Stelara. 2% Reva-K and Reba-ye, are newly registered and a new standard will be established. Nursing benefits are recognized if administered within the scope of the permit, "Improvement of corneal epithelial disorders in adult dry eye patients." However, benefits are not recognized when administered in combination with mucin secretion promoters such as Diquasol Eye drops. Oral chronic hepatitis B drugs expand the liver enzyme (AST/ALT) numerical standard that recognizes drug benefits. The HBV-DNA numerical standard, which recognizes benefits even in chronic hepatitis B patients accompanied by targeted cirrhosis, is expanded. Specifically, "Patients with 40-80 units of AST or ALT and showing stages of liver biopsy or fibrosis of illiterate periphery" will be added to the initial treatment benefit standard. Patients with chronic active hepatitis B with cirrhosis and hepatocellular carcinoma are recognized for benefits if they are HBV-DNA positive. The standard item of Agastroban injection, an antithrombotic component used to treat chronic arterial obstruction, will be revised from "Argaron Inj" to "Argaron Inj, etc." Considering that each drug has different permits, the statement of the administration discussion will be changed within the scope of each drug. The standard item for hemostatic oxidatively regenerated cellulose is changed from Equtamp to Surgicel. This is to make it current as an item on the list of drug benefits.
- Company
- Leclza’s partner ‘Rybrevant’ lands in Big 5 hospitals
- by Eo, Yun-Ho Feb 17, 2023 05:50am
- The anticancer drug Rybrevant which targets a small number of lung cancer patients has landed at general hospitals in Korea. According to industry sources, Janssen Korea’s Rybrevant (amivantamab), which is used to treat EGFR exon 20 insertion non-small-cell lung cancer (NSCLC) that is insensitive to currently available EGFR tyrosine kinase inhibitors (TKIs), has passed the drug committees of 18 medical institutions in Korea including tertiary hospitals such as the Samsung Medical Center, Seoul National University Hospital, Seoul St.Mary’s Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital, as well as other institutions nationwide, such as Gangnam Severance Hospital, National Cancer Center, Konyang University Hospital, Kyungpook National University Hospital, Ajou University Hospital, Incehon St.Mary’s Hospital, Jeonbuk National University Hospital, Chungnam National University Hospital, Kyungpook National University Chilgok Hospital, and Chonnam National University Hwasun Hospital. The drug has landed relatively quickly for prescriptions after being approved in Korea in February last year. However, Rybrevant is currently a non-reimbursed drug. Janssen applied for reimbursement but was unable to pass deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. The company is known to be preparing to reapply for reimbursement. EGFR exon 20 insertion mutations in NSCLC are so rare that it is found in only 2% of all NSCLC patients harboring EGFR mutations in Korea. With no suitable treatment available for the specific condition, even the NCCN guidelines have only been recommending platinum-based chemotherapy for the patients. And even this is subject to expenditure cuts. Although lung cancer in itself is not a rare disease, NSCLC with EGFR exon 20 insertions can be classified as a rare condition. Unlike other common EGFR mutations, NSCLC patients with EGFR exon 20 insertion mutations have a 75% higher risk of death, a 5-year survival rate of 8%, and a life expectancy of less than 2 years. Rybrevant, which is well known for its combined use with ‘lasertinib (Leclaza),’ was the first targeted therapy approved in Korea for the treatment of NSCLC with EGFR exon 20 insertion mutations in February this year. The approval for the drug was based on the results from the CHRYSALIS study, where the drug demonstrated an overall response rate (ORR) of 40%, a 4% complete response (CR), and 36% partial response (PR) rate. The U.S. Food and Drug Administration (FDA) granted accelerated approval for the drug based on Phase I trial results in recognition of its value as a treatment for a rare type of cancer. Following the approval in the U.S., the drug also was designated for expedited review and approved in Korea. However, the issue lies in whether its value will be accepted during the reimbursement review. As the drug was approved based on data from a single-arm clinical trial that was conducted without a control group, Rybrevant needs to take the pharmacoeconomic evaluation exemption track for reimbursement. Therefore, the key issue lies in whether Rybrevant’s value as a treatment for a rare cancer, not just lung cancer, will be acknowledged during the reimbursement review. Byoung-Chul Cho, Chief of the Lung Cancer Center at Yonsei Cancer Center, said “EGFR exon 20 insertion presents in various subtypes, and the sub-analysis of the CHRYSALIS study showed that Rybrevant showed an even response rate across several subtypes. In addition to its target inhibition effect, Rybrevant shows more promise due to its immune cell-directing activity.”
