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- 2026-05-17 08:10:42
- Company
- Ultra-high-priced ‘Kymriah’ is up for DREC deliberations
- by Eo, Yun-Ho Jan 11, 2022 06:29am
- Whether the new CAR-T therapy ‘Kymriah’ will be applied insurance benefit is receiving wide attention. According to industry sources, the world’s first chimeric antigen receptor T-cell (CAR-T) therapy ‘Kymriah' will be deliberated as an agenda by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on the 13th of this month, 3 months after the agenda passed the Cancer Disease Deliberation Committee in October last year. Specifically, the drug is indicated for ▲ adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy, and ▲ patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse Reimbursement listing of Kymirah is currently the biggest and hottest issue in the industry as this ‘one-shot’ treatment may cure cancer with a single administration but costs up to 500 million won per shot. The company had been going through the reimbursement process for Kymriah since it was approved in March last year through the ‘approval-reimbursement review linkage system.’ Although it was first set an agenda for CDDC deliberation in September, the committee deferred their decision. Immediately upon the news of deferral, the Korea Leukemia Patients Organization strongly criticized the government and the pharmaceutical company. The KLPO had before criticized the authorities over the delay in Kymriah’s agenda being put up for deliberation by the CDDC. Despite overcoming the CDDC obstacle, whether Kymriah will be able to complete its reimbursement journey to the end remains unknown. The CDDC may have passed the Kymriah agenda to DREC pressured by the intense attention focus around the agenda. Therefore DREC’s role is expected to be an important observation point that will play a key role in the listing process. Meanwhile, the CDDC had set the reimbursement standards for Kymriah so that the following conditions should be met for its reimbursement: ▲the company should bear a higher-level risk in consideration of the price level in other countries, ▲a risk-sharing system based on a performance-based payment model that pays according to treatment performance of each patient for relapsed or refractory diffuse large B cell lymphoma (DLBCL) as it has a poorer clinical outcome compared to acute lymphoblastic leukemia, and ▲an expenditure cap should be set on the total expenditure allowed for Kymriah. In other words, the key to the reimbursement listing of Kymriah depends on the fiscal sharing plan submitted by Novartis’ Korean subsidiary and its determination in persuading its head office.
- Policy
- Lee wants to cover infertility, contraception, HPV vaccines
- by Lee, Jeong-Hwan Jan 11, 2022 06:29am
- With the rising heat over the insurance coverage of hair loss treatments that was mentioned by presidential candidate Jae-Myn Lee, other healthcare-related election pledges made by the presidential candidates are also being reilluminated. Lee, who is planning to publically announce his pledge promising the insurance coverage of hair loss treatments, had previously already pledged to expand insurance coverage for infertility couples, contraception and abortion, and HPV vaccines. On the 7th, Lee’s camp announced that its policy team was reviewing the hair loss treatment coverage plan to set a specific pledge. Lee said that hair loss is not a cosmetic issue but a disease, therefore, his camp is seriously reviewing its details such as health insurance coverage targets, proportion, and required finances. In particular, he said that covering hair loss treatments should be positively considered because the coverage could be provided at an annual cost of 100 billion won. In addition, Lee is also known to be considering applying health insurance to wigs and hair transplants. In addition to the pledge for hair loss treatments, Lee had also made a number of pledges to expand health insurance coverage to various other areas. More specifically, Lee had announced the reimbursement of infertility-related treatment cost, contraception and abortion, and HPV vaccination for adolescents as part of his ‘small but definite happiness pledges.’ In covering infertility treatments, Lee said he will simplify the complicated number and support amount set for various parts of the in-vitro fertilization procedure and expand insurance coverage to necessary pharmaceuticals including ovulation inducers. Also, basic tests to identify infertility status will be added to the regular health examination items and promised emotional and psychological support through the provision of counseling vouchers, etc. to infertility couples. The contraception and abortion pledge promises insurance coverage for modern contraceptive procedures and well medical practice for the termination of pregnancies. This pledge may not only benefit contraception and abortion treatment but lead to the reimbursement of the abortion pill ‘Mifegymiso’ that may soon be granted marketing authorization in Korea. Lee also pledged to expand the subject for free HPV vaccinations to all adolescents between the ages of 12 and 17, male and female. In addition, he said he will change the name of the vaccination project from ‘First step for women’s health clinic project’ that is currently being used to ‘HPV vaccine national inoculation project.’ HPV, which causes cervical cancer in women and anal cancer in both men and women, is infectious regardless of gender, so Lee believes that the government should bear the cost of its vaccination so that both men and women can get vaccinated in a timely manner. In addition, Lee is known to be reviewing covering dental implants in addition to hair loss treatments as his insurance coverage expansion pledge. Currently, people aged over 65 are applied insurance for dental implants, and the number of teeth covered is limited to 2 for each person. Lee is reviewing extending the coverage to 4 teeth per person. Lee had mentioned his position on MBC’s 100 Minute Debate on the 6th. Lee said, “ Implants are also one of the NHI coverage agendas I am considering. 2 are not enough to chew. We need to cover at least 4 teeth implants.” The ruling party's leading candidate’s series of health insurance benefit expansion pledges have led the presidential election stage to focus on each candidate’s healthcare pledges. In response to Lee’s hair loss treatment pledge, Cheol-soo Ahn, presidential candidate of the minor opposition People's Party, pledged to reduce the price of hair loss drug generics and said that Lee’s pledge would worsen the financial status of the current national health insurance. Members of the leading opposition party had also set out to criticize Lee’s pledge as populism that undermines the domestic health insurance application procedures and standards that were just made to attract votes. In response to the populism criticism, the Democratic Party plans to hold a meeting to comprehensively review the coverage of hair loss treatments including the possibility of expanding NHI finances and the establishment of medical standards, then announce it as an election pledge.
- Policy
- Alopecia belongs to the health sector, benefits are possible
- by Lee, Jeong-Hwan Jan 11, 2022 06:29am
- Democratic Party of Korea's presidential candidate Lee Jae-myung claimed that the application of health insurance for hair loss treatments is a health pledge to alleviate public pain, and said he is reviewing the targets, ratios, and amounts through experts in the camp. He said that if pain relief is possible at an annual cost of around 100 billion won, we should think positively, but that it is necessary to discuss to what extent we will apply health insurance and to what extent. He said in MBC's current affairs program "100 Minute Discussion" on the 6th, "It is said that health insurance finances will collapse over the application of hair loss health insurance, and if an additional 100 billion won is paid annually, the drug price will be cheaper." He said that people who do not suffer from hair loss can never understand the pain caused by hair loss, adding that the application of health insurance related to hair loss belongs to the health field related to diseases, not welfare at the beauty level. He also said that the application of health insurance for hair loss should be viewed positively. However, he expressed his position that analysis and discussion are needed to determine to what extent insurance should be applied. He said, "People who are worried about hair loss are really in pain and the cost of medicine is quite burdensome. If there is anything that the people are in pain, it is the role of the government to alleviate and resolve it." He said, "If health insurance coverage for hair loss belongs to beauty, it is close to welfare, but it is a health area because it relieves pain. In the past, the Park Geun Hye government covered scaling. "At that time, it is not understandable to say that it distributes health insurance for hair loss, which costs about 100 billion won a year, rather than distributing it recklessly," he stressed. Candidate Lee said, "We need to think positively about the application of hair loss health insurance. However, it is necessary to discuss to what extent and to what extent it will be done. Experts are reviewing health insurance targets, support, ratio, and amount. The policy is to find a compromise. We will try to adjust it appropriately so that the majority opinion is not excluded."
- Policy
- 22 companies' Dapagliflozin+Sitaglipin were approved
- by Lee, Tak-Sun Jan 11, 2022 06:28am
- DongKoo Bio has obtained a number of drugs that are the same as the new diabetes drug "Dapagliflozin+Sitagliptin" approved on the 23rd of last month. A large number of consignment items produced by Dongkoo Bio have entered. Dapagliflozin+Sitaglipin is a new combination complex that has never been released before, but competition has become inevitable as many pharmaceutical companies have secured it even before its launch. On the 4th, the MFDS approved 22 items combined with Dapagliflozin+Sitaglipin. Licensed pharmaceutical companies are Aprogen, Aju, PharmGen Science , NBK Pharm, Jin Yang, Dae Hwa, Myung Moon, GC Pharma, Dongkwang, Lite pharm tech, Binex, SCD Pharm, Daewoo, Kukje, Shinpoong, Ilyang, Reyonpharm, Ildong, Yungjin Pharm, Hana, Guju, and Sinil. All of these items are commissioned and produced by DongKoo Bio. DongKoo Bio is said to have shared the permit data with them. DongKoo and consignment companies signed contracts before July when the so-called "consignment biological equivalence limitation 1+3" system was implemented, so 22 companies were able to obtain permission this time. If the contract was made after the system was implemented, DongKoo could share product data with only three companies and produce consignment. Dapagliflozin (Forxiga) is an SGLT-2 inhibitory diabetes treatment and has recently grown rapidly in the diabetes treatment market. AZ's Forxiga, the original drug, recorded 18.3 billion won in outpatient prescriptions (based on UBIST) in the first half of last year. Sitagliptin (Januvia) is a DPP-4 inhibitory drug that has long been leading the market. MSD's Januvia recorded 21.2 billion won in outpatient prescriptions in the first half of the year. The domestic pharmaceutical industry expects that both ingredients will generate a lot of sales if they are developed as a complex because they are widely used in medical sites and frequently combined prescriptions. Both ingredients cannot be sold to the market before September 2023 because their material patents have not expired. In addition, domestic insurance authorities have not yet established a salary standard for a combination of SGLT-2 and DPP-4 components. However, it seems that many consignment companies have participated in the approval in advance because it is difficult to hold new products if there are expectations for success and the consignment biological equivalence restriction system is implemented. Two days before Dongkoo Bio's product was approved, Daewon Pharmaceutical received its first approval for Dapacombi (Dapagliflozin+Sitagliptin). It is said that Daewon is considering the exclusive launch.
- Policy
- Chong Kun Dang applied for combination of Januvia+Forxiga
- by Lee, Tak-Sun Jan 10, 2022 11:40am
- Chungjeong-ro Headquarters of Chong Kun DangA combination of diabetes treatments Januvia (Sitagliptin) and Forxiga (Dapagliflozin) is gaining popularity among domestic pharmaceutical companies. Although it can only be released after September next year due to patent rights issues, many domestic pharmaceutical companies are developing products. According to the pharmaceutical industry on the 6th, Chong Kun Dang recently applied for permission from the MFDS for a combination of Sitagliptin+Dapagliflozin. Combination of Sitagliptin+Dapagliflozin succeeded in commercialization for the first time in Korea on the 21st of last month when Dapacombi of Daewon Pharmaceutical obtained permission. Two days later, Dongkoo Bio's Sitaflozin, the same ingredient as Dapacombi, was approved. On the 4th, 22 items from other pharmaceutical companies entrusted by Dongkoo Bio were approved and the number of related items increased to 24. Pharmaceutical companies that started developing products for the purpose of product approval include Alvogen Korea, GL Pharm Tech, SK Chemical, and Theagen Etex. Alvogen was approved by the MFDS in October 2020, GL Pharm Tech in March last year, SK Chemical in September last year, and Theagen Etex in December last year. Chong Kun Dang seems to have applied for permission by completing the development ahead of them. However, even if commercialization is successful, it is expected to be after September 2023, when Januvia's material patent ends. The reason why many domestic companies are developing products is that commercial expectations are high. This is because the two components are the flagship items of SGLT-2 and DPP-4 inhibitors, which are currently leading the diabetes treatment market, and the proportion of prescriptions using both drugs in combination at the treatment site is high. Based on UBIST, Januvia's outpatient prescription amount in the first half of last year was 21.2 billion won, and Forxiga's outpatient prescription amount was 18.3 billion won, ranking at the top of the market. Combination of Januvia+Forxiga is the first product introduced by a domestic pharmaceutical company without an overseas original product, so expectations are high for market creation by domestic pharmaceutical company sales. However, more than 20 pharmaceutical companies have already been approved, so it is difficult for any one company to be exclusive, which is considered a limitation in generating profits. There are no overseas products with the same ingredients, but there are three overseas original products of the same category (DPP-4+SGLT-2) combination, so if they are reimbursed, there will be little market preoccupation effect. In the industry, it is highly observed that top companies with large-scale customers such as Chong Kun Dang will eventually take the lead over other companies in terms of market share.
- Company
- Keytruda's reimbursment to be deliberated at DREC meeting
- by Eo, Yun-Ho Jan 10, 2022 05:56am
- The immuno-oncology drug ‘Keytruda’ is finally on its next step to reimbursement after passing Cancer Disease Deliberation Committee's review. According to industry sources, reimbursement expansion of MSD Korea’s PD-1 inhibitor Keytruda (pembrolizumab) will be deliberated by the National Health Insurance Service’s Drug Reimbursement Evaluation Committee on the 13th of this month. Keytruda was able to finally reach the DREC doorsteps, six months after the agenda passed the CDDC meeting last July and four years after it first applied for the reimbursement expansion to its indications including as first-line treatment in non-small cell cancer (NSCLC) Since MSD failed to put the agenda up for deliberation at the DREC meeting that was held last November, the company had expressed its will to complete that and the pricing negotiations with NHIS within that year but was unable to make progress even in December of the same year. However, although the CDDC had passed the agenda, it had once again mentioned the need for equity with Tecentriq to MSD and requested additional revision to the company’s fiscal sharing plan. Therefore, the industry's eyes are on what the DREC results will be. At the time, MSD Korea’s Managing Director Kevin Peters had said, “The company is deeply aware of the urgency felt by the many lung cancer patients and HCPs during the past 4 years while awaiting reimbursement of Keytruda in first-line lung cancer. We are focusing all efforts on internal and external discussions so we could proceed with relevant procedures as quickly as possible after CDDC deliberations.” The biggest barrier to expanding reimbursement for Keytruda was the ‘pharmaceutical company taking the burden of the initial 3 cycles’ worth of administration cost’ requested by the government to companies with immunotherapy agents. Roche Korea, which owned the then-latecomer ‘Tecentriq (atezolizumab),’ was the only company to accept the government’s proposal, and 2 types of PD-1 inhibitors – Keytruda and ‘Opdivo(nivolumab)’ were unable to accept the offer and has not been approved for the reimbursement extensions until now.
- Policy
- Will companies be able to apply for EUA for COVID-19 tx?
- by Lee, Tak-Sun Jan 10, 2022 05:55am
- PfizerThe development of COVID-19 treatments is actively progressing at home and abroad. Pfizer's oral treatment Paxlovid received EUA from the MFDS in December last year and is expected to be used in Korea soon. Currently, pharmaceutical companies that develop COVID-19 treatments are in a position to introduce them quickly in Korea through EUA like Paxlovid. By the way, is EUA possible only with the will of pharmaceutical companies? Companies can apply for the EUA. However, the MFDS must first announce the scope of medical products subject to emergency. The EUA is a system introduced under the "Special Act for Promotion of Development and Emergency Supply of Medical Products Responding to Public Health Crisis" enacted in March last year. The EUA refers to the urgent introduction of drugs that have not been approved for domestic items. Even before this law, it was possible to introduce unlicensed imported items in Korea through special import system. In February last year, it was decided to introduce the Pfizer COVID-19 vaccine through special import. However, special import was only possible if the head of related organizations, such as the head of the KDCA, requested special cases. In other words, as a special import procedure, the developer could not request approval for the item. The newly established EUA system can introduce drugs not only at the request of the heads of related agencies, but also when the MFDS deems it necessary to adequately cope with public health crises. At this time, the MFDS must announce ▲ the scope of medical products subject to EUA, and ▲other matters determined by the Minister of Food and Drug Safety as necessary, such as EUA requirements and approval period, etc. Based on this announcement, pharmaceutical companies can apply for the EUA. The application documents include data that can prove the safety and effectiveness of medical products. Evidence such as▲ Clinical trial results of medical products studied until the date of announcement, ▲ current status of domestic and foreign permits, etc., ▲reason for applying for the EUA, ▲ the instructions for the medical product, ▲ Quality inspection results of overseas manufacturing plants, etc. should be submitted. The MFDS is in a position that at least a clinical second-phase report that can prove its validity should be secured. Under this EUA system, pharmaceutical companies that develop COVID-19 treatments have completed phase 2 clinical trials and quickly introduced products into Korea. However, It does not mean that the EUA system can be used according to the will of pharmaceutical companies. Only when the MFDS announces it first can it be applied to pharmaceutical companies. In the current COVID-19 situation, it is not easy for the MFDS to announce alone because the state oversees the purchase of vaccines and treatments. Therefore, like the existing special import system, it is highly likely that the MFDS will review EUA products by applying for KDCA. Pfizer's Paxlovid is also a case in which the EUA was decided by KDCA application. An official from the MFDS explained, "If EUA is needed, corporate applications can be received, but since COVID-19 tx and vaccines are purchased and managed under state control, it will be difficult to do EUA without KDCA applications." The recent plan that pharmaceutical companies that develop COVID-19 treatments will apply for EUA to the MFDS cannot be considered feasible. This is because the state must purchase the treatment.
- Policy
- Remdesivir has been officially granted over the age of 12
- by Lee, Tak-Sun Jan 10, 2022 05:55am
- The MFDS has approved the change to use Remdesivir, which was first approved as a treatment for COVID-19, only for those aged 12 or older. However, the EUA was decided for this age group to prevent gaps in pediatric treatment under the age of 12. This is the same as when the U.S. FDA officially approved Remdesivir in October 2020. The MFDS announced on the 7th that it has allowed administration range of Veklury, a treatment for COVID-19, to be changed to "inpatients with severe or pneumonia who are adults and 12 years old and need adjuvant oxygen treatment for children over 40kg." In July 2020, Veklury was conditionally approved to use the results of phase 3 clinical trials on the market for "severe inpatients who need 3.5kg or more of auxiliary oxygen treatment confirmed with COVID-19." As Gilead submitted the results of the global phase 3 clinical trial to implement the permit conditions this time, the results report was reviewed and the scope of administration was allowed to be changed. The MFDS decided to use Veklury for "inpatients with severe or pneumonia who need adjuvant oxygen treatment under the age of 12 or under 40kg (3.5kg or more) considering that there is no COVID-19 treatment available in Korea. Pfizer's oral treatment Paxlovid, which will be introduced soon, is also used only for those aged 12 or older. This measure reflects a comprehensive review of domestic and foreign cases for children and overseas approval cases such as the United States and Japan. When officially approved in October 2020, the United States took the same measures as in Korea, fearing a gap in pediatric treatment. In Japan, it has been used for children since approval. The EUA is a system that allows manufacturers and importers to manufacture and import medicines that have not been licensed in Korea or to supply them with different uses and capacities than those that have already been licensed.
- Policy
- PAGs request expedited new drug listing system to candidates
- by Kim, Jung-Ju Jan 10, 2022 05:55am
- With the presidential election two months ahead, patient groups have asked the presidential candidates to introduce an expedited listing system in the National Health Insurance for new drugs directly related to life. On the 7th, the Korea Alliance of Patients' Organizations had set out to propose and deliver ‘4 key patient policies’ for patients in the healthcare industry to the presidential candidates of each party. The 4 key patient policies that were delivered to the candidates were: ▲ Introduction of an expedited NHI listing system for new drugs that are directly related to life ▲Establishment of an integrated patient support platform ▲ Severe disease and patient-focused innovation to the integrated nursing care system ▲Enactment of a basic law for patients Among these, the introduction of an expedited NHI listing system on new drugs that are directly related to life is an agenda being frequently discussed with the advent of 'one-shot treatments’ that can cure a disease with a single dose, on to what extent society may cover such ultra-expensive new drugs. The new drug paradigm has shifted from the era of chemotherapy that had large side effects but less effect to the era of targeted therapies/immunotherapies/ and CAR-T therapies that are groundbreaking in terms of effectiveness and side effects. In line with such a trend, enhancing coverage of the ‘one-shot treatments’ has emerged as a key agenda. KAPO pointed to “the fact that the new drugs are extremely expensive and that it takes over a year for drugs that are directly related to life to be reimbursed after gaining approval due to the ‘pricing tug-of-war’ between the government and pharmaceutical companies” as a key issue, and reminded that these delays are life-threatening issue to those affected. Economically wealthy patients or patients with private insurance can purchase these new drugs to extend their lives, but low-income patients with less economic affordability or those who do not have private insurance are dying because they are unable to receive the benefits of these new drugs. Therefore, KAPO believes that Korea’s universal health insurance should address this life-related issue. For this, KAPO proposed to the candidates that an expedited NHI listing system should be established for new drugs that are used in life-threatening diseases. The expedited system allows rapid reimbursement of new drugs by allowing the company to concurrently apply for the marketing authorization and reimbursement listing to the MFDS (authorization) and HIRA (reimbursement listing) and concurrently review both applications. KAPO said, “The authorities can set a tentative drug price when a new drug is first sold in the market after MFDS approval so that patients could be saved using NHI finances. The difference between it and the final price should be settled after the reimbursement procedures are completed - going through the CDDC and DREC’s reimbursement procedure, pricing negotiations between the company and NHIS, and deliberation by the HIPDC. This way, the government could guarantee patients’ right to promptly access new drugs as stipulated in the Constitution.” However, on how to define and set the scope for ‘new drugs directly related to life,’ KAPO proposed that a ‘social consultative body’ should be established with participation by the government, experts, pharmaceutical companies, public, consumer, and patient groups. KAPO said, “We need to reinforce the patient-focused health insurance system by ensuring low-income patients’ access to new drugs to allow everyone who is ill to be treated and increase public and patient trust in health insurance to reduce dependence on private insurance. Also, the system enables the government to ensure access to new drugs that are directly related to life for all patients – the tax-paying public - regardless of their economic ability.”
- Company
- Heads of 4 MNCs were newly appointed last year… increase of
- by Eo, Yun-Ho Jan 07, 2022 06:06am
- (From the left) GMs Byungjae Yoo, Martin Corcoll, Cherry Huang, So Eun Kim Four multinational pharmaceutical companies have appointed new CEOs over the past year. According to Dailypharm’s update of CEOs in 32 major multinational pharmaceutical companies, including the Korean Research-based Pharmaceutical Industry Association, heads of 4 pharmaceutical companies were replaced or newly appointed last year. Most were regular personnel appointments mainly due to term of office expiry, with others due to CEO’s relocation or corporate spin-offs. ◆ Novartis·BI·Janssen’s appoints new head due to term expiry… New launch of Organon First, companies such as Novartis Korea, Boehringer Ingelheim, and Janssen Korea welcomed new heads to their office due to the expiration of the term of office of former CEOs or promotions. Novartis appointed Byungjae Yoo, former Managing Director of Johnson & Johnson Medical North Asia to succeed Joshi Venugopal who made a promotional transfer to Novartis headquarters. Boehringer Ingelheim Korea appointed Martín Coroll, former general manager of Boehringer Ingelheim Austria, to lead the office after Steven Walter’s term expiry. In Janssen’s case, Janssen Korea appointed Cherry Huang as the next CEO of Janssen Korea in June to take place after the former CEO Jenny Zhuang moved to head its Chinese subsidiary. Huang had previously served as the CFO of Janssen Asia Pacific. Just as Viatris Korea entered the industry in 2020, Organon Korea spun off from MSD Korea in 2021 and launched as a new and separate company. In line with its new establishment, the company appointed So Eun Kim as its first Managing Director. Since entering MSD Korea in 1998, Kim had served various roles in MSD Korea and abroad for 23 years. ◆17%, a record-high proportion of local CEOs…rate of women CEOs exceed 30% 2021 is also a significant year in that the proportion of women and Korean CEOs recorded the highest-ever within Korean subsidiaries of multinational pharmaceutical companies. In particular, this will be the second time since its establishment that a Korean subsidiary of Novartis will be managed by a local CEO. Since its establishment in 1997 and the first president Frans Hompe, the company had mostly appointed foreign heads to lead the Korean subsidiary. The only Korean national that had previously been appointed was Hak-sun Moon in 2015. In addition, Organon also appointed a Korean women head with its establishment. Moderna Korea, which entered the Korean market with the development of its COVID-19 vaccine, also added weight to the proportion of women CEOs by appointing Ji-Young Sohn as the new General Manager. Meanwhile, Sang Wook Kang, CEO of GSK Consumer Healthcare resigned. Due to Kang’s unexpected resignation, the company is currently being operated under an acting representative system.
