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- 2026-04-13 14:48:09
- InterView
- Merck will “focus on specialty care capabilities"
- by Eo, Yun-Ho Oct 21, 2021 05:14am
- Javed Alam, General Manager of Merck Biopharma Korea The global chemical and pharmaceutical company Merck is working intently to strengthen its capabilities in the pharmaceutical sector. The company, whose main areas of expertise are liquid crystal and LED, has also been continuing its commitment to introduce new drugs, starting with the anticancer drug ‘Erbitux (cetuximanb),’ the immune-oncology PD-L1 inhibitor ‘Bavencio (avelumab)’ that was co-developed with Pfizer, to the recently approved multiple sclerosis treatment 'Mavenclad (cladribine).’ Dailypharm met with Javed Alam, the General Manager of Merck Biopharma Korea, who has celebrated his 2nd year at the company, to hear about Merck’s vision in the healthcare business. -You have spent most of your time here since your appointment in the COVID-19 pandemic. Could you tell us about your impressions and thoughts about your work here in Korea, and the achievements that were made?. I would have to say my time here was crisis after crisis due to the COVID-19 pandemic. However, despite the COVID-19 pandemic, we were able to protect our employee’s health and safety while continuing communication with our customers and ensuring a smooth supply of products for our patients, based on which we achieved business growth during the past 2 years. In the midst of the COVID-19 crisis, our company had focused on Specialty Care and efficiently reorganized the organization, and carried out our roles smoothly so that there were no disruptions in the supply of our products. In addition, we made various efforts such as actively embracing the use of digital channels to communicate with our customers to frequently update them on the company’s situation. Also, I take special pride in the fact that no Merck Biopharma Korea employee has had COVID-19. -- New changes have occurred in the Pharma business area, such as the launch of new products. Does this mean the company is seeking a change of tone? Merck’s goal in global healthcare is to become a Global Specialty Innovator, under which Merck Biopharma Korea aims to become the most innovative specialty care company in Korea. To achieve this goal, the company had to undergo various changes in its business model, company structure, organization, etc. While making such changes, we also changed our corporate culture to focus on restructuring the business model to focus on specialty care and digitalization. Through these efforts, we expanded our digital channel from 1 to 8, including webinars, websites, and web meetings. Also, the company made various changes structure-wise, and these various efforts have fortunately paid off to benefit the company. -I can see the company’s strong commitment to specialty care. The Specialty Care unit covers rare and incurable diseases that are difficult to diagnose or cure. The number of patients and specialists for such diseases is relatively small, and that is why it is also an area that has the highest unmet need from patients. Among various areas of specialty care, Merck is focusing on 4 areas - Immuno-oncology∙Oncology, Neurology∙Immunology, Infertility, and Endocrinology. Erbitux has been showing good performance in our existing Immuno-oncology unit. In the recent KSMO Annual Meeting, & Conference we have presented the results of OPTIM1SE that demonstrated the drug’s clinical safety and efficacy in Korean patients. In addition, we have also released the immuno-oncology drug ‘Bavencio (avelumab)’ that was co-developed with Pfizer in our efforts to become a specialty care leader. Bavencio is a treatment for Merkel cell carcinoma (MCC) which is a rare and aggressive type of cancer that has a 5-year survival rate of 0-20%. I believe we were able to provide new hope to these patients with Bavencio. In Neurology∙Immunology, we have the multiple sclerosis treatment Mavenclad (cladribine). Multiple sclerosis occurs most commonly in women in their prime - 20s to 30s - causing difficulty in their life and treatment. However, Mavenclad’s innovative dosing and administration allows patients to only take Mavenclad for up to 20 days over 2 years, and then be free from additional dosing requirements for the other 2 years. -What kind of efforts have Merck Biopharma Korea made to advance Korea’s healthcare industry? We have been actively participating in clinical programs and global trials to increase Korea’s level of contribution and influence. Korea is involved in all of the 20 global clinical programs at Merck including its key 7 programs. By actively participating in R&D and the clinical stage, we are increasing our contribution to Merck’s portfolio and ultimately increasing Korea’s influence in the global market. Also, we have been making efforts to increase Korea’s contribution in earlier stage innovation. For example, we help promising startup venture companies in Korea to connect with Merck’s innovation program. The ‘Merck Accelerator program’ has supported a total of 12 companies worldwide until now, and ‘Inhand Plus,’ a Korean startup, was the first in Korea to be selected to receive benefits from the program. -Could you briefly introduce the company’s pipeline products that you plan to introduce in Korea in the future? Merck Biopharma Korea is striving to showcase innovation in all areas of its involvement, therefore, you can continue to expect innovative changes and products from us in the future. In the past, the company had depended heavily on primary care products. However, now, as the Global Specialty Innovator, we hope to become an unrivaled company in specialty areas. Our first goal is to maximize our Korean patients’ accessibility to the company’s excellent pipeline products. Merck Global Is focusing on enriching its entire pipeline, and we will continue our efforts to promptly and broadly introduce all the innovative solutions, products, and technology that is and will be developed by Merck to our patients in Korea.
- Policy
- Vegzelma is the name of Celltrion's Avastin biosimilar
- by Lee, Tak-Sun Oct 21, 2021 05:14am
- Celltrion reported on the 1st that it had submitted an application for approval of the biosimilar "CT-P16" of Avastin (Bevacizumab), Roche's colorectal cancer treatment, to the MFDS and the U.S. FDA. According to the MFDS on the 19th, Celltrion's Avastin biosimilar, which was recently applied for permission, is Vegzelma. This is the first time that the brand name of the development project CT-P16 has been known. Celltrion also registered trademark rights for Vegzelma with the Korean Intellectual Property Office in November last year. Celltrion has conducted a global clinical trial on a total of 689 people in 20 countries in Europe, South America, and Asia since 2018 and applied for permission for Full Label approved for Avastin, including metastatic and non-small cell lung cancer. The company said it plans to launch it on the market sequentially from the second half of next year once it is approved by each national agency. Currently, two Avastin biosimilars have been approved in Korea. In March, Samsung Bioepis' Onbevezy was approved for the first time in Korea, and in May, Pfizer's Jairabeve was approved. In September, Boryung started selling Onbevezy in Korea. Another item was found to have applied for permission in August, which is expected to lead to fierce competition in the Avastin biosimilar market. Since Avastin is a mega-sized item with annual sales of about 120 billion won in Korea alone, Avastin biosimilars are looking for opportunities to increase their performance.
- Policy
- The status of clinical trials is reported annually
- by Lee, Tak-Sun Oct 21, 2021 05:14am
- The subject of conditional approval and Priority review will be more clarified, and follow-up management will be strengthened. Previously, conditional approval regulations were in the notice, but it is expected that management and operation will be strengthened, including related contents in the Pharmaceutical Affairs Act, and procedural justification will be secured. The MFDS announced on the 19th that it had announced some amendments to the rules on drug safety. The revision was prepared to stipulate detailed standards for matters delegated by the revised Pharmaceutical Affairs Act on July 20. The revised bill included ▲simplification of the sample collection procedure for drugs approved for shipment to the state in the event of a public health crisis,▲ regulations on the subject and procedure of conditional permission and priority examination, ▲ regulations on the subject and procedure of disclosure of the results of item permission and report examination, ▲adding the scope of raw materials and drugs subject to registration with overseas manufacturing companies, ▲ exemption from separate designation procedures for performing sample analysis work at a medical institution designated as a clinical trial institution, and ▲ the deletion of some exemption criteria for labeling and description of non-drugs such as sanitary pads and masks. Conditional approval and priority review targets are defined as treatments for severe diseases and rare drugs. ▲Those who have obtained conditional permission report the clinical trial status by the end of March every year, and submit a report on the clinical trial results after the clinical trial is completed. ▲Drugs subject to the Priority Review will be reviewed within 40 days. The subject of disclosure of the results of the product license and report review was defined as finished drugs, and the results of the review were disclosed within 180 days from the date of product license and report with the opinion of the product licensee. The revision included medical institutions designated as clinical trial institutions so that they can perform related tasks even if they are not designated as clinical trial sample analysis institutions. Currently, sanitary pads and masks were exempted from labeling such as efficacy, effectiveness, dosage, and consignment manufacturers, but in the future, they will be listed the same as other pharmaceutical products. National lot release-targeted drugs, such as biological agents, should be collected by MFDS officials and sealed the number of lot release applications, but companies will be able to collect samples needed for testing and submit them to the Minister of Food and Drug Safety. The MFDS said it expects the preparation of detailed regulations on conditional approval and priority review to help expand patient treatment opportunities and quickly supply medicines, and that it will actively review and improve the drug safety management system. Organizations or individuals with opinions on this amendment can submit their opinions to the MFDS or the National Participation Legislative Center by December 20, 2021. For more information on the amendment, visit Korea Ministry of Government Legislation (opnion.lawmaking.go.kr) or It can be found in the MFDS (mfds.go.kr) → statutes and data → legislative/administrative notices.
- Company
- Q3 exports of Biopharmas 'Good’ Diagnostic kits ‘Slow'
- by Kim, Jin-Gu Oct 21, 2021 05:13am
- While pharmaceutical exports in Q3 increased slightly compared to the same period of the previous year, the performance of biopharmaceuticals and chemical drugs have shown mixed results. Export of biopharmaceuticals increased 13% YOY and continued on its strong flow from last year, however, export of chemical drugs fell 13%. Also, diagnostic kits, which rose as an export ‘cash cow’ after the COVID-19 outbreak, saw a decline in export value amount despite the large increase in export volume. The analysis is that this may be due to the continued decline in its export unit price. ◆Earned ₩6.8 trillion in Q3 exports….will the industry exceed last year’s ‘largest ever’ record? According to Korea Customs Service on the 15th, the domestic export value of pharmaceuticals in Q3 was $1.86 billion (approx.. ₩2.2 trillion). This is a 6% YOY increase from the $1.76 billion (approx.. ₩2.07 billion) in Q3 last year. The cumulative amount of exports by Q3 has increased 26% from $4.60 billion (approx. ₩5.44 trillion) last year to $5.77 billion (approx. ₩6.82 trillion) this year. If this trend continues, the industry may break the all-time export record that it made last year. The total pharmaceutical exports last year amounted to $6.89 billion (approx. ₩8.15 trillion). However, exports last year were concentrated around Q4. In Q4 last year, the industry earned $2.30 billion (approx. ₩2.71 trillion), accounting for 33% of the total amount of exports of the whole year. ◆Biopharmaceuticals increase 13% · Chemical drugs decrease 13% … shows clear difference between areas In detail, the export between biopharmaceuticals and chemical drugs have shown mixed results. In Q3, export sales of biopharmaceuticals amounted to $1.4485 billion (approx. ₩1.71 trillion) and increased 13% YOY. The analysis is that the export of biopharmaceuticals is continuing to show good flow. The share of biopharmaceuticals contributing to the total pharmaceutical exports also rose 5%p from 73% in Q3 last year to 78% in Q3 this year. Export of biopharmaceuticals has soared over the past 2 years, mainly around biosimilars from Celltrion and Samsung Biologics. Biopharmaceutical exports doubled from $430.17 million (approx. ₩510 trillion) in Q1 2019 to $868.95 million (approx. ₩1.03 trillion) in Q1 2020 and doubled once more to $1.81 billion (approx. ₩2.14 trillion) in Q1 this year. On the other hand, the export of chemical drugs fell 13% from $467.81 million (approx. ₩550 billion) in Q3 last year to $408.8 million (approx. ₩480 billion) in Q3 this year. ◆Export volume of diagnostic kits the greatest-ever… however value earned falls 5% in one year Also, the export performance of diagnostic kits that soared after the COVID-19 outbreak has been slowing down recently. In Q3 this year, exports of domestic diagnostic kits amounted to $570.37 million (approx. ₩670 billion), which is 5% lower than the $600.41 million (approx. ₩710 billion) in Q3 of last year. By each quarter, sales of diagnostic kits increased steadily until Q4 last year, and then was showing signs of stagnation entering this year. This is due to the worldwide COVID-19 vaccinations that began earlier this year, and the falling unit price of the kits due to intensified competition between global diagnostic kit companies. By export volume, quarterly exports of diagnostic kits set a new record of 2,517 tons in Q3 this year. This is much larger than the export volume in Q3 last year - 1,467 tons. In other words, the export value fell 5% despite a 72% increase in exports export volume in the same period.
- Company
- Pfizer applies for reimbursement of 3rd-gen ALKi Lorviqua
- by Eo, Yun-Ho Oct 20, 2021 05:56am
- Pfizer is aiming to introduce a second ALK inhibitor after ‘Xalkori’ into Korea’s prescription market. According to industry sources, Pfizer Korea has recently submitted a reimbursement listing application for its anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI), ‘Lorviqua (lorlatinib),’ which is in progress. Pfizer received the orphan drug designation for Lorviqua last March, then in July, the drug was approved as monotherapy to treat adult patients with ALK-positive advanced non-small-cell lung cancer (NSCLC) whose disease has progressed after - Alecensa (alectinib) or Zykadia (ceritinib) as the first ALK tyrosine kinase inhibitor (TKI) therapy; or Xalkori (crizotinib) and at least one other ALK TKI. Lorviqua is a third-generation drug that arose as an alternative option in patients who developed resistance to the first-generation drug Xalkori and the second-generation drugs Zykadia, Alecensa, or Alunbrig. In other words, patients who used Xalkori first-line may use second-generation drugs as second-line, then use Lorviqua; patients who used second-generation drugs as first-line may use Lorviqua as second-line treatment. Until now, patients who developed resistance to the drugs in the second-line had no available targeted therapies and therefore had to opt for chemotherapy in later-line treatments. ALK G1202R solvent front mutation is the most common ALK resistance mutation after being treated with second-generation drugs, and other ALK mutations also occur by drug, such as F1174L(Zykadia), I1171T/N/S(Alecensa), E1210K(Alunbrig), etc. Lorviqua (lorlatinib) has shown to be effective against all known resistance mutations. With such strengths to resistance, Lorviqua is expected to quickly attract prescriptions if listed for reimbursement. Whether Pfizer, the pioneer of ALK targeted anticancer therapy, will be able to increase its share in the market remains to be seen. Meanwhile, the approval of Lorviqua was based on an open-label, single-arm, multinational, multicenter Phase II study that was conducted on various 275 NSCLC patients with ALK-positive and ROS1-positive advanced NSCLC, from treatment-naïve patients to those who had been treated with up to three ALK inhibitors. In the study, the ORR (Objective response rate) - the primary endpoint - of patients who have been previously treated with 1 or more ALK inhibitors including second-generation ALK inhibitors was 47%, and the patients’ intracranial objective response rate (IC-ORR) was 63%. The median duration of response was yet to be reached at the time of analysis, as 63 out of 93 patients with a confirmed response at the time of analysis showed a continued response. The lower bound of the 95% confidence interval for the response period was 11.1 months.
- Policy
- The gov. begins research on preferential tx
- by Lee, Jeong-Hwan Oct 20, 2021 05:56am
- The MOHW has launched a research service to prepare preferential measures for new drugs developed by innovative pharmaceutical companies in Korea. The policy is to innovate pharmaceutical companies and achieve health insurance fiscal consistency, such as giving incentives when adjusting drug prices and supporting drug prices linked to R&D investment scale. On the 19th, the MOHW completed an order to Korea Online EProcurement System for "Research on Pharmaceutical Price Support Policy of Innovative Pharmaceutical Companies in Conformity with International Trade Order" through the KHIDI. Regarding the background of research on drug preferential treatment for innovative pharmaceutical companies, the KHIDI predicted that the global pharmaceutical market will grow 4.7% annually over the past five years, recording about $1.3 trillion in 2019, and expand up to $1.4 trillion by 2026. As the pharmaceutical and bio markets are expected to be new growth engines in Korea in the future, it is necessary to actively promote support measures. The KHIDI said that although the revision of the Pharmaceutical Industry Promotion and Special Act in December 2018 provided a basis for preferential treatment for innovative pharmaceutical companies, there are no subordinate laws due to trade problems. In fact, Article 17-2 of the Pharmaceutical Industry Promotion Act stipulates that the Minister of Health and Welfare sets drugs manufactured by innovative pharmaceutical companies by Presidential Decree, including the addition of the upper limit on medical care benefits under the National Health Insurance Act. The problem is that the Presidential Decree and enforcement regulations, which are subordinate statutes of the provision, have not been created, making it ineffective. When domestic pharmaceutical companies and the National Assembly's Health and Welfare Committee said they needed improvement in this year's parliamentary audit, the MOHW said it would launch research through the KHIDI to find ways to preferential drug prices for innovative pharmaceutical companies. The KHIDI took follow-up measures through practical research orders. It seeks a policy to support new drug prices for innovative pharmaceutical companies without harming the international trade order, with a research period of six months from the date of the contract and a budget of 50 million won. After the research order in October, the agency plans to select successful candidates for the research in early November and receive a final result report in March next year after an interim report in January next year. The key point of the study is to investigate the current status of drug price policies in the domestic and foreign pharmaceutical industries and to collect opinions on drug support from innovative pharmaceutical companies. It reviews the need to support innovative pharmaceutical companies and prepares practical drug preferential policy measures that meet the international trade order. It will also investigate drug price support policies of major overseas pharmaceutical advanced countries for innovative new drugs, biovectors, IMDs, biosimilars, and generics. After COVID-19, major pharmaceutical industry support policies in major foreign countries in the vaccine and bio sectors will be studied with weight on drug price support policies. It will also investigate international trade disputes and settlement cases related to drug price support policies to prepare for international friction. Innovative pharmaceutical companies will prepare opinions from related organizations such as the HIRA and the Health Insurance Corporation and drug support measures based on the demand survey for drug support. It is also accompanied by external opinions such as academic experts and civic groups. It plans to form an advisory committee to collect related opinions and investigate opinions from various fields related to drug support through surveys and interviews. There is also a procedure to analyze the history or effectiveness of support policies for innovative pharmaceutical companies, and the limitations of the current support policy. In order to favor innovative new drugs that do not harm the international trade order, it will induce innovation of pharmaceutical companies, such as drug price support measures, incentives for drug price follow-up adjustment, and drug price support linked to R&D investment. Above all, research will also be conducted to identify in advance the factors that can actually be raised and resolve solutions to ordinary issues related to policy measures for supporting innovative pharmaceutical companies. It plans to provide international trade advice through trade experts such as academic experts and lawyers. The KHIDI said, "The research goal is to present risk factors and solutions when promoting drug support for innovative pharmaceutical companies." The KHIDI said, "We will also analyze data requested by the organizer related to policies to support innovative pharmaceutical companies." It added, "We will select a research institute in December, sign a contract, and receive a report on the results in March after an interim report next year." The MOHW and the KHIDI are currently certifying 45 innovative pharmaceutical companies to intensively foster the pharmaceutical and bio industries as national growth engines.
- Company
- Moderna Korea speeds up group organization
- by Oct 20, 2021 05:56am
- Moderna Korea, which had shown little activity for almost 6 months after establishing its Korean subsidiary, is busy recruiting members in secrecy. With the active hiring and imminent production of Moderna vaccines, officials predict that the company will be starting its official activity soon. According to industry sources on the 19th, Moderna Korea has completed hiring executives for some of its departments including those for Medical, Pharmacovigilance, and Regulatory Affairs. For the PV Head, an official with global CRO experience has moved to Moderna Korea in July, and a former BMS official has been serving as the Quality Head since last August. The company has been speeding up its organizational process, recruiting executives and employees for various departments including the Supply Chain, Customer Services and Logistics, and Commercial Legal. The General Manager (GM) for the Korean subsidiary has also been appointed, however, who the GM is remains unknown. Only rumors that the GM is a vaccine expert from a specific multinational pharmaceutical company are abound. A representative of a multinational pharmaceutical company who wished to remain anonymous said, “Under the premise that the GM was already hired, it is possible that the new head may have been recruited from a different country since so little is still known.” Over 60 candidates had applied for the position, and although most were residing in Korea some have applied from other regions such as Hong Kong, etc. Looking at Moderna Korea’s organization chart, the Korean subsidiary’s role is expected to be concentrated around the supply and quality control of its products. An industry official said, “Looking at the areas in hiring, I believe the company’s work will focus on drug-related tasks such as the side effects of its vaccines rather than drug development. However, as Moderna is one of the few companies that can implement mRNA products as a platform, what role the branch will play remains to be seen.” This adds strength to expectations that Moderna Korea will start its official activities in line with Samsung Biologics' consignment production of the Moderna vaccines. According to the remarks made by the Minister of Food and Drug Safety Gang-lip Kim at the NA’s Health and Welfare Committee audit, Samsung Biologics is expected to receive GMP certification within this month. Samsung Biologics has begun production of the Moderna COVID-19 vaccine in line with this. After Moderna Korea finishes organizing its group, the company is expected to be in charge of the regulatory procedures necessary to supply the Moderna products produced by Samsung Biologics to Korea and the Asia Pacifica region.
- Policy
- It will improve side effects caused by non-face-to-face tx
- by Lee, Jeong-Hwan Oct 20, 2021 05:56am
- Rep. Kang Byeongwon of the Democratic Party (left) and Rep. Choi Hye-young proposed amendments to the medical law, which officially introduces temporary non-face-to-face tx, respectively The National Assembly is trying to solve problems arising from the implementation of non-face-to-face treatment temporarily allowed due to COVID-19 for more than a year and reduce social concerns. Instead of allowing non-face-to-face treatment temporarily and extensively, the ruling party-centered National Assembly officially introduces it as a supplement to face-to-face treatment to eliminate side effects. On the 18th, the Democratic Party of Korea previously proposed a revision to the medical law, which focuses on legislation of non-face-to-face treatment, following Rep. Kang. Kang's proposal, which was proposed first, is to officially institutionalize "remote monitoring," which is part of non-face-to-face treatment between doctors and patients. Choi Hye-young's proposal is expected to have a significant impact on the medical community in that it specifies the concept of non-face-to-face treatment itself and clearly specifies the allowable patient group and disease group. For now, both bills limited non-face-to-face medical institutions to primary medical institutions at the clinic level, not at the hospital level. It also aims to comply with the principle of face-to-face treatment and prevent unnecessary diseases from allowing non-face-to-face treatment by allowing non-face-to-face treatment, focusing on patients suffering from chronic diseases such as high blood pressure and diabetes. In a detailed sense, Kang focused on the legislation of non-face-to-face treatment for chronically ill patients and remote monitoring of ECGs for hikers, which partially proved their effectiveness in the Gangwon Digital Healthcare Special Zone. Rep. Choi focused on enabling non-face-to-face treatment only for chronic diseases if access to medical institutions such as islands, mountains, remote areas, or military units is significantly low, or if movement is greatly inconvenient, such as disabled or patients after surgery. Given that the scope of non-face-to-face treatment is specified and the concept is clarified, the two lawmakers' views are that if the two bills are promoted, the side effects of non-face-to-face treatment pointed out so far will be greatly improved. The number of cases of unnecessarily over-prescribing hormone drugs such as psychotropic drugs, erectile dysfunction treatments, hair loss drugs, and acne through non-face-to-face treatment is also expected to decrease significantly if the bill is promoted. In particular, Choi's proposal was designed to address concerns related to non-face-to-face treatment, which the front-line medical community, led by the Korean Medical Association, strongly opposes. An official from Choi Hye-young's office said, "As non-face-to-face treatment is temporarily allowed only in the crisis of infectious diseases such as COVID-19, the need for non-face-to-face treatment in areas or patient groups with low medical access has been confirmed."
- Policy
- One-shot treatment Kymriah passed the cancer committee
- by Lee, Hye-Kyung Oct 20, 2021 05:55am
- Kymriah (Tisagenlecleucel) of Novartis Korea, a "one-shot treatment" with an ultra-high cost of 500 million won per dose, passed the Cancer Drugs Benefit Appraisal Committee. At the Cancer Drugs Benefit Appraisal Committee held last month, the gap between health authorities and pharmaceutical companies was barely narrowed at the second Cancer Drugs Benefit Appraisal Committee. The HIRA released the "7th Cancer Drugs Benefit Appraisal Committee Deliberation Results in 2021" on the afternoon of the 13th. The HIRA, like the Cancer Drugs Benefit Appraisal Committee and the Cancer Drugs Benefit Appraisal Committee this month, decided to disclose the results of the deliberation to the media after the meeting. According to the results of today's meeting, Kymriah's benefit criteria were set for both indications: adult diffuse giant B-cell lymphoma and B-cell acute lymphocytic leukemia (ALL) in children and young adults. After 60 days of drug price negotiations with the NHIS after being recognized by the Drug Reimbursement Evaluation Committee, it must pass the Health Insurance Policy Committee to be listed on the list in earnest. Kymriah used Drug Approval-Linkage Systems in March to register benefits with approval from the MFDS. At the Cancer Drugs Benefit Appraisal Committee with Kymriah, there was a discussion on the expansion of benefit standards, but all of them failed to pass the Cancer Drugs Benefit Appraisal Committee except for the Benetoclax combination therapy of AbbVie Korea. Drugs that have not been set based include FOLFOX (Folinic acid, Fluorouracil, and Oxaliplatin), chronic lymphocytic leukemia treatment Imbruvica(Ibrutinib) by Janssen Korea, and B-cell acute lymphocyte leukemia treatment Blincyto (Blinatumomab).
- Policy
- What's Kymriah's procedure after passing the Committee?
- by Lee, Hye-Kyung Oct 19, 2021 08:54pm
- It seems that it will take time for the ultra-high-priced one-shot treatment Kymriah (Tisagencleucel) to be registered. In particular, it is because the setting of additional financial sharing conditions for pharmaceutical companies, which was not easy in the Cancer Drugs Benefit Appraisal Committee, may pass the Drug Reimbursement Evaluation Committee evaluation. The HIRA (Director Kim Sun-min) conducted the second Kymriah's standard review at the 7th The Cancer Drugs Benefit Appraisal Committee held on the 13th. Kymriah's standard, which were not set at the 6th Cancer Drugs Benefit Appraisal Committee held on September 1, were set at the 7th Cancer Drugs Benefit Appraisal Committee. Kymriah, which entered Korea in March using Drug Approval-Linkage Systems, is a one-shot treatment, but it took about seven months to set the standard as an ultra-high-priced new drug with a single dose cost of 500 million won. Even so, it was said that the period was shortened even a little due to the influence of one-man protests and national petitions as well as the parliamentary audit of the National Assembly's Health and Welfare Committee on the 15th, urging patients to pay Kymriah. The standard set after about seven months of meeting requires additional financial sharing by Novartis Korea. Novartis applied for benefits for both indications, including "adult diffuse giant B-cell lymphoma" and "B-cell acute lymphocytic leukemia in children and young adults," approved by the MFDS. The Cancer Drugs Benefit Appraisal Committee was concerned with indications for adult diffuse giant B-cell lymphoma. This is why the setting of salary standards was put on hold at the 6th Cancer Drugs Benefit Appraisal Committee. Finally, the Cancer Drugs Benefit Appraisal Committee established standards under these provisions like ▲ higher level of risk-sharing by pharmaceutical companies considering overseas drug prices ▲ in the case of diffuse giant B-cell lymphoma with insufficient clinical performance compared to acute lymphocytic leukemia, addition of risk-sharing system according to treatment performance at a patient level ▲ benefit can be applied. After reviewing the risk-sharing plan for cancer screening in detail, making a final draft, putting the agenda on the committee for review and resolution, and then negotiating drug prices with the NHIS. It has also been conducting drug price negotiations with the MOHW and the HIRA for 60 days, and will come up with a plan to share finances between the government and pharmaceutical companies. Therefore, since it is applied after deliberation and notification by the Risk Sharing Subcommittee, the Drug Reimbursement Evaluation Committee, the NHIS negotiations, and the Health Insurance Policy Review Committee of the MOHW, it must be at least next year for actual patients to receive Kymriah benefits.
