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- 2026-05-16 15:56:28
- Company
- Drug pricing negotiations for ‘Xospata’ complete
- by Eo, Yun-Ho Feb 15, 2022 05:54am
- The new leukemia drug ‘Xospata’ has crossed the final barrier to reimbursement in Korea. According to industry sources, Astellas Pharma Korea completed drug pricing negotiations for its acute myeloid leukemia (AML) treatment Xospata (gilteritinib) with the National Health Insurance Service. Accordingly, if the agenda passes the Health Insurance Policy Deliberative Committee meeting in February, Xospata may be reimbursed from the following month (March). Astellas has opted for the pharmacoeconomic evaluation exemption track to receive reimbursement for Xospata and therefore will be reimbursed under the Expenditure cap type of the Risk Sharing Agreement (RSA). The drug, which was approved in March 2020, has passed the National Health Insurance Service’s Drug Reimbursement Evaluation Committee in September last year and started negotiations with the NHIS in the same year. After failing to reach an agreement within the set negotiation period (60 days), the company was finally able to reach an agreement this time after extending the deadline once. Interest in Xospata’s reimbursement is high as such a treatment option has not existed before. The Korea Alliance of Patients' Organization had delivered its position requesting the rapid reimbursement of new drugs including Xospata at the meeting with the Ministry of Health and Welfare’s Division of Pharmaceutical Benefits. Hui-Jae Kim, Professor of Hematology at Seoul St.Mary’s Hospital said, “Xospata’s approval relieved AML patients of the specific anxiety of having to suffer their condition without a proper treatment available. Of course, its cost remains an issue, but I expect the drug to quickly settle as the standard of care after being listed for reimbursement.” Meanwhile, Xostapa is the first FLT inhibitor approved by the MFDS for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation (FLT3mut+). The drug targets both types of FLT3 mutations, FLT3-ITD and FLT3-TKD, and can be self-administered at home as a single oral tablet once daily without frequent hospital visits. Also, Xostapa has improved efficacy compared with existing chemotherapy. In addition, Xostapa has received a ‘Category 1’ recommendation for patients with relapsed or refractory AML with an FLT3 mutation in the latest NCCN Clinical Practice Guidelines.
- Company
- The next Saxenda? Companies race to occupy GLP-1 RA market
- by Feb 15, 2022 05:54am
- GLP-1 class drugs are taking over the obesity treatment market. With ‘Saxenda’ in the lead, pharmaceutical companies in Korea and abroad are racing to catch up with Novo Nordisk, while the company is working to bring another improved GLP-1 analogue into the market. According to industry sources on the 14th, pharmaceutical companies in Korea and abroad are busy developing obesity treatments using GLP-1 analogues. Lilly is spurring up the development of its product in the market currently occupied by Novo Nordisk, with Hanmi Pharmaceutical and Humedix in Korea also conducting research. ◆Novo Nordisk spurs up development of an improved product based on Saxenda’s success Novo Nordisk is conducting domestic clinical trials for the injection-type and oral-type formulation of its long-acting GLP-1 analogue, ‘semaglutide.’ For the semaglutide injection that was approved in September, a Phase IIIb clinical trial is being conducted on 150 Asians with the Body Max Index (BMI) standard set at ‘25㎏/㎡or higher’ in line with the local obesity standard. The semaglutide injection being studied is ‘Wegovy,’ which has been approved by the US FDA in June last year. Then in November of the same year, a Phase IIIa trial was approved for an oral formulation of the injected semaglutide on 198 overweight or obese East Asians. The oral semaglutide is the first modified GLP-1 analogue formulation made by Novo Nordisk. The drug was approved by the US FDA as ‘Rybelsus’ in September 2019 and is being reviewed for approval in Korea as a diabetes treatment. Previously, Novo Nordisk had made a breakthrough in the obesity treatment market with its GLP-1 analogue. The company had changed the dosage of its GLP-1 analogue ‘Victoza’ that is used to treat diabetes and transformed it into the obesity treatment ‘Saxenda.’ Immediately upon its release, Saxenda rose to the top in the domestic obesity treatment market in 2018. In only 2 years since the release, its sales exceeded 30 billion won. According to the pharmaceutical research institute IQVIA, Saxenda’s sales recorded 36.8 billion won in 2020. Before Saxenda, ‘Belviq (lorcaserin)' and phentermine and phendimetrazine class antipsychotics were commonly used to treat obesity. Among these drugs, Belviq withdrew from the market, and sales of ‘Qsymia’ that combined phentermine and topiramate have surged recently. The reason why Saxenda gained popularity despite being an injection was in its relatively less amount of side effects. Drugs that had previously led the obesity treatment market were banned due to safety issues. ‘Reductil (sibutramine)’ and ‘Belviq (lorcaserin)’ have both withdrawn from the market due to cardiovascular and carcinogen risk. Patients are also required to exercise caution in the long-term use of antipsychotics like phentermine and phendimetrazine due to the risk of CNS side effects such as depression and insomnia. A Novo Nordisk official said, “Developing an obesity treatment is more difficult than other chronic diseases because maintaining the lost weight is as difficult as losing the weight. Novo Nordisk aims to close the gap between anti-obesity drugs and metabolic surgery through long-acting, combination drugs, etc.” ◆Lilly fiercely chases Novo Nordisk… Hanmi attempts at a winning bid with 'efpeglenatide' Lilly, which had been at the forefront of the race in developing GLP-1 analogues in diabetes, is at the other end of the race and is chasing Novo Nordisk in the obesity treatment market. This is because Lilly’s long-acting once-weekly GLP-1 analogue ‘Trulicity’ has a stronghold over the diabetes treatment market but does not own an indication for treating obesity. As a result, Lilly is looking to overtake the obesity treatment market with its next-generation GLP-1 analogue, its dual GIP, and GLP-1 receptor agonist ‘tirzepatide.’ GIP is a hormone that stimulates insulin secretion that works with GLP-1 to increase the weight loss effect. Tirzepatide’s diabetes indication is anticipated to be approved within this year by the US FDA. The drug has ranked No.2 among most-marketable drugs this year that was selected by the global biopharmaceutical market research institution, Evaluate Vantage. Domestic pharmaceutical companies have also jumped into the competition. Hanmi Pharm intends to apply its once-weekly administered GLP-1 class 'efpeglenatide' to obesity as well as diabetes. Currently, the company completed a global phase III trial for efpeglenatide on patients with diabetes or cardiovascular disease. Although slow to enter the competition, Humedix also started developing its own GLP-1 analogue. Humedix has signed an agreement with HLD to jointly research and develop a long-lasting injection for obesity treatment in August last year. Yuhan Corp is also developing a GDF15 inhibitor to compete with GLP-1 analgogues. Its candidate drug YH34160 binds specifically the GDF15 receptor that is mainly present in the brain to induce weight loss through appetite suppression. The company plans to complete the preclinical toxicity test on YH34160 within the year.
- Company
- Takeda, Boehringer, & AZ were selected as the Best Companies
- by Eo, Yun-Ho Feb 15, 2022 05:53am
- .Three Korean subsidiaries have been selected as the 2022 Global Top Employment Company. Boeringer Ingelheim, and AstraZeneca Korea were selected as "the best hiring companies" by setting extraordinary efforts and examples for welfare and employee competency development. Among them, Takeda was listed by Korean subsidiaries for the sixth consecutive year, and Beringer Ingelheim and AstraZeneca for the third consecutive year. Takeda received positive reviews every year for supporting various programs for employee competency development, such as strength-based coaching culture and horizontal open communication. Boeringer Ingelheim's headquarters has also been selected as one of the world's top 11 employment companies this year for the second consecutive year, and has also been certified as the best employment company in the Asia-Pacific region (ASEAN, Korea, Australia, and New Zealand). In the case of AstraZeneca, it received high scores in terms of flexible performance evaluation and reward system, online and offline hybrid working environment designed to enable smooth two-way communication, and diversity and inclusive culture. Meanwhile, the world's best employment company is organized by "horizontal open communication," a world-class personnel management evaluation agency, and annually surveys employment status and discloses a list of companies. In order to be certified as the "global best employment company," it must be certified as a "top employee" at branches in more than 20 countries in four regions, including the company's global headquarters.
- Company
- Changes in sales and marketing of companies
- by Moon, sung-ho Feb 15, 2022 05:53am
- As the COVID-19 pandemic continues for more than three years, changes are also taking place in academic sales and marketing of pharmaceutical companies. Pharmaceutical companies are competitively holding events for doctors on a rich theme and scale comparable to academic conferences of medical associations. This is a self-rescue measure due to the decrease in promotional activities, such as the prolonged COVID-19 and the transition of academic conferences to online conferences. According to the medical and pharmaceutical industries on the 10th, it was confirmed that more and more domestic pharmaceutical companies are holding large-scale "online symposiums" reminiscent of major medical conferences. The first case of introducing this is Dong-A ST's Korea Disease Week (KDW). It looks like an academic conference held by major domestic academic societies, but it is an online symposium held by Dong-A ST itself. In terms of size, it is as good as the academic conferences of existing academic societies. The period lasted for a week, and in addition to existing chronic diseases such as high blood pressure and diabetes, various experts related to cardiovascular disease were invited to form a large-scale academic feast, which received great response last year. When the KDW was held last year, an average of 2,100 doctors per day and a total of 10,500 doctors participated in the event. It is said that it was much more than the number of people participating in the general academic conference event. Dong-A ST is pushing for its second hosting in June. Domestic pharmaceutical companies such as Daewoong Pharmaceutical and Daewon Pharmaceutical are also competitively striving to hold online symposiums for their own doctors. In the case of Daewon Pharmaceutical, an academic event was held under the name AGORA WEEK in a similar way to Dong-A ST's KDW, while Daewoong Pharmaceutical also decided to hold an academic event for doctors under the name of Dowong Medical Festival (DMF). Another common point is that they are trying to expand the area of "online platform" for their doctors by holding such large-scale academic events. In particular, Daewon Pharmaceutical has a strong purpose of promoting the operation of an online platform (D·Talks, Detox) for doctors earlier this year. Likewise, Mediflicks and Doctorville use their own operating online platforms in common. At the same time as the academic symposium is held, the video is provided so that doctors can check it at any time by using the platform themselves.
- Company
- The era of personalized healthcare has arrived
- by Eo, Yun-Ho Feb 14, 2022 05:54am
- Optimal treatment for each patient differs by one’s genetic mutation. With this discovery, anticancer therapies targeting individualized genes have emerged one after another, and the field of precision medicine is evolving from ‘disease-targeted’ to ‘gene-targeted’ prescriptions. In particular, anticipation in the field is rising with the nearing possibility of prescribing NTRK(Neurotrophic tyrosine receptor kinase) inhibitors and the introduction of RET-targeted therapies in Korea. ◆'Rozlytrek ' and 'Vitrakvi' Roche Korea’s 'Rozlytrek (entrectinib)’ and Bayer Korea’s ‘Vitrakvi (Larotrectinib)’ are undergoing processes to receive insurance benefits in Korea. These two drugs, which are aiming to receive reimbursement through the pharmacoeconomic evaluation exemption track, have passed deliberations by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee last year but are yet to reach an agreement with the NHIS in their drug pricing negotiations. The drugs are indicated for the treatment of adult and pediatric patients who have an NTRK gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; have either progressed following treatment or have no satisfactory alternative therapy. In other words, the drugs may be used in most NTRK gene fusion-positive solid tumors. Roche and Bayer are generating prescription codes for their drugs at major medical institutions to allow the drugs to be prescribed immediately upon reimbursement. ◆'Gavreto' and 'Retevmo' Rozlytrek’s developer Roche is also undergoing the approval process for its other tumor-agnostic therapy 'Gavreto (pralsetinib),’ and Lilly Korea for its 'Retevmo (selpercatinib).’ The two drugs are expected to be approved within the year. The drugs, which target RET(Rearranged during transfection) gene fusions, inhibit the primary as well as the secondary mutation that causes resistance to anticancer treatments and are expected to address the unmet needs in various cancers. Retevmo, which had been quicker, became the first-ever RET inhibitor to receive approval. Retevmo was approved in May 2020, and Gavreto in September of the same year by the US FDA. Retevmo was approved for the two indications of non-small cell lung cancer (NSCLC) and thyroid cancer. Gavreto was initially approved as a treatment for lung cancer, then added a thyroid cancer indication in December of the same year. Although the drugs were initially approved for lung cancer and thyroid cancer, the companies plan to further increase the scope of indications for their RET inhibitors. RET gene fusion is discovered rarely in colorectal cancer, breast cancer, pancreatic cancer, and EGFR-mutant NSCLC. Gavreto and Retevmo are also expected to take the PE exemption track to receive reimbursement listing in Korea. Kyong-Hwa Park, Professor of Hemato-Oncology at Korea University Anam Hospital said, “There needs to be a reimbursement track established for precision medicine in Korea. I can’t imagine the distress and deprivation the patients would feel if a precision medicine drug is available with NGS screening but cannot be accessed due to systemic issues."
- Opinion
- [Reporter's view]Predictability should be increased
- by Lee, Tak-Sun Feb 14, 2022 05:54am
- Starting with Choline Alfoscerate, a brain function improving agent, the benefit reassessment, which has been in full swing since last year, has risen again this year. On the 11th, HIRA's Drug Reimbursement Evaluation Committee confirmed the items subject to salary revaluation in 2022 and 2023. Detailed items will be released through the Health Insurance Policy Committee. However, despite the HIRA notice, the target item was released to the media a few hours later. Six drugs, including Godex, were included in 2022 and eight drugs, including Hyaluronic acid eye drops, in 2023. Since media reports, the HIRA has not made any opinions on this. Perhaps this is because the items subject to re-evaluation match. Rather, they seem to be more curious about how the target item was delivered to the media. The exposure of items is due to the constant intelligence activities of the pharmaceutical industry to know the subject of re-evaluation in advance. No matter how much the HIRA cracks down on subcommittees or groups of experts in the committee that deliberate on revaluation targets, it is interpreted that it has not overcome the pharmaceutical industry's desire to predict revaluation projects in advance. This is because the benefit revaluation project is piled up in the veil. When The HIRA announced its five-year revaluation plan last year, it said it would use ▲ 0.1% of claims, or more than 20 billion won ▲ less than one of A8 countries, ▲ policy and social demands, insufficient intellectual drugs ▲ other committees. On top of that, there is an opinion that the registration date may have been considered. However, it is difficult to predict target items based on these criteria. Rather, looking at the selected drugs, most of them have undergone clinical re-evaluation by the MFDS or controversy over their socially usefulness. In fact, it is difficult to predict the order of re-evaluation. From a pharmaceutical company's point of view, if they knew the order of re-evaluation of benefits a few years ago, they would decide whether to maintain the business of the item and develop a new business to replace it. However, if it is announced so suddenly, companies cannot afford to prepare. Therefore, it may be a natural choice for companies to continue lawsuits such as suspension of execution. In order to increase predictability, the HIRA plans to disclose items subject to re-evaluation not only this year but also next year. Accordingly, the items subject to next year's re-evaluation have gained time to prepare for now. However, there is a limit to enhancing the predictability of the business by disclosing only the target items for next year. For now, it is not known whether the project will continue in the long run or end up with five years. If it is carried out regularly, how about applying a renewal system like the MFDS to determine whether or not to reevaluate benefits according to the order of registration date? In addition, if it was a five-year temporary project, the predictability of pharmaceutical companies would have increased if it had been divided by disease in the first place. The revaluation in this way is much more unilateral. Rather, the predictability of the business should be increased, giving the company more time to prove the clinical usefulness of the drug. Although it is a burden on health insurance finances, it is still important that drugs necessary for patients are not expelled due to lack of data evidence. It is questionable whether this will be properly filtered out by a short-term re-evaluation.
- Policy
- High-dose ‘pyridoxine’ to be classified as an Rx drug
- by Lee, Hye-Kyung Feb 14, 2022 05:54am
- The high-dose Vitamin B6 ‘Pyridoxine Hydrochloride 300mg’ is likely to be classified as a prescription drug. Although pyridoxine doses up to 250mg are classified as a health functional food abroad, experts reached a consensus that the 300mg dose of the same drug should be classified as a prescription drug in consideration of the side effects that arise from the long-term use of the higher dose, and similar cases where a low-dose formulation of an approved drug had been classified as an OTC and the high-dose formulation as an ETC. The Ministry of Food and Drug Safety disclosed the minutes of the meeting held by the drug classification subcommittee of the pharmaceutical policy committee under the Central Pharmaceutical Affairs Council that was held on January 17th. In Korea, pyridoxine may be taken up to 100mg as an OTC, up to 250mg under the Korean manufacturing standard for medicine, and up to 67mg as a health functional food. The product that was under review this time is a high-dose formulation that contains 300mg of pyridoxine. Other than in Japan which classified the 300mg high-dose formulation as a prescription drug, other countries have classified the same drug as a health functional food or OTC. However, the subcommittee members were skeptical about the classification of high-dose pyridoxine as an OTC due to concerns over its side effects and duration of use. In particular, the members reached a consensus that it is reasonable to classify the high-dose formulation as a prescription drug as the high-dose pyridoxine is used for conditions that require diagnosis, such as to prevent deficiencies arising from the administration of Vitamin B6 antagonists and the treatment of B6 dependence, in addition to well as the side effects that may arise. Also, some raised the opinion that the 300mg needs to be classified as an ETC for the safe use of the drugs in consideration of cases where the lower dose was approved as an OTC and the higher dose was approved as ETC. Regarding its efficacy and effect, some members pointed out that although the 300mg formulation is not expected to be sold as a nutritional supplement the standard between the health functional food and OTC was unclear as the same ingredient is approved as a health functional food up to 67mg/day, and as OTC up to 100mg/ day. To the question where dosages other than the 300mg high-dose formulation that is under review may be reviewed for classification as OTC/ETC, the MFDS responded that such cases would require a separate application for review. As a result, the MFDS voted to classify pyridoxine 300mg as a prescription drug with consensus from the committee members.
- Company
- Saxenda is also effective for childhood obesity
- by Feb 14, 2022 05:54am
- Saxenda of Novonodisc, a drug that can be used in children and adolescents, has emerged as an option for the first time. Effective weight loss is expected to help treat obesity in children and adolescents, but the fact that there is little data on Koreans should be supplemented. Novonodisc held a " Saxenda expansion of Pediatric Adaptation Meeting" at the Shilla Hotel in Jung-gu, Seoul on the 10th and pointed out the meaning of treating obesity in children and adolescents. Saxenda (Liraglutide), a GLP-1 analog, obtained an indication for pediatric and adolescent administration from the MFDS in December last year. The targets are children and adolescents aged 12 or older who are obese with an initial body mass index (BMI) of 30 kg/㎡ or higher in adults and weigh more than 60 kg. In SCALE TEENS clinical trials conducted for 56 weeks on 251 obese children and adolescents worldwide, Saxenda showed a significant weight loss effect. 74% of the Saxenda-administered group showed weight loss (28% of the placebo group), and the proportion of pediatric and adolescent patients who lost weight by more than 5% was 43%, significantly higher than that of placebo countries. The proportion of patients with weight loss exceeding 10% was 26% (8% of placebo group). At week 56 after discontinuation of the drug, the Saxenda group gained some weight, but nevertheless maintained a significant difference from the placebo group. Professor Lee Young-joon of Pediatrics and Adolescents at Korea University Ansan Hospital (General Director of the Korean Pediatric Endocrine Society), who was in charge of the presentation, commented that Saxenda will be able to help effectively lose weight at a time when childhood obesity increases. This is because so far, the drug treatments available to children and adolescents have been limited. Unlike adults, children and adolescents could only use Xenical, Metformin or Phentermine for a short period of time for those over the age of 16. Professor Lee said, "In the case of children and adolescents, parallel therapy with drug treatment is considered if it does not improve even with the improvement of primary lifestyle improvement is considered. Surgery is strictly restricted, he said. "I think Saxenda can be used as a breakthrough treatment option because it guarantees a relatively safe 5% weight loss effect." Saxenda has the disadvantage of including only two Asians in clinical trials that served as the basis for approval as a treatment for obesity in children and adolescents. Considering that there are differences within BMI from race to race, it is questionable whether it can have the same effect in Koreans. Professor Lee also said, "Only two Asians were included. Research on new drugs in children and adolescents is limited. Previously, other drugs tried clinical trials for children and adolescents, but they were suspended because they were not recruited, he explained. He then advised, "We need to build up Real World Data while carefully using Saxenda in Korea."
- Policy
- The selection of benefit revaluation is approaching
- by Lee, Hye-Kyung Feb 14, 2022 05:54am
- The pharmaceutical industry has suggested that it is difficult to review and predict the criteria for selecting evaluation targets as the targets for benefit revaluation were disclosed in the current year during the pilot project of Choline alfoscerate and Bilberry Fruit Dried Ext, Avocado-Soya, Ginkgo Leaf Ext, Silymarin, and Vitis Vinifera. In response, The HIRA held a meeting with the pharmaceutical industry on December 23 last year to set standards for the ingredients subject to re-evaluation after discussing the ingredients and standards required for evaluation through expert advisory meetings since September last year. Jang Yong-myung, executive director of HIRA Development, said at the Korea Special Press Association briefing held on the 8th, "We will conduct a deliberation to select a target for benefit revaluation at the Drug Reimbursement Evaluation Committee held on the 10th. We plan to disclose the results of the selection of ingredients subject to re-evaluation in February and conduct a re-evaluation of appropriateness such as a basis-based practical review and expert advisory meeting from March." Specifically, the HIRA will present agenda items for the 2022 and 2023 benefit revaluation necessary components and standards discussed so far as a deliberation list at the Drug Reimbursement Evaluation Committee to be held on the afternoon of the 10th. If members of the Drug Reimbursement Evaluation Committee oppose the disclosure of ingredients subject to two years' revaluation during the deliberation process, the results discussed so far may come to nothing. If all committee members accept the results discussed by the HIRA, experts, and the pharmaceutical industry for three months last year, unlike the pilot project and the first main project, the pharmaceutical industry will be able to first check the ingredients subject to two years' benefit revaluation. Kim Ae-ryeon, head of the drug management office, said, "The Drug Reimbursement Evaluation Committee will deliberate on this year's revaluation target and next year's target." She said, "There have been demands from the pharmaceutical industry to talk about the following ingredients and standards in advance, so we have put them on the agenda for deliberation." Director Kim explained, "For ingredients this year, if we pass the Drug Reimbursement Evaluation Committee like the pilot project and the main project procedure, we will proceed quickly through deliberation of the Health Insurance Policy Committee and inquiry of opinions from the pharmaceutical industry." She added, "The list will be released next year, but if it is released in advance, pharmaceutical companies will have enough time to prepare."
- Company
- Successful renewal of RSA contract for Keytruda
- by Eo, Yun-Ho Feb 11, 2022 05:56am
- Keytruda, an immuno-cancer drug, succeeded in renewing its RSA contract for the first time in half a year. According to related industries, MSD Korea signed an RSA renewal with the NHIS last month for indications such as NSCLC therapy, which is currently covered by PD-1 low-release Keytruda. Keytruda, which contract expired in August last year, recently passed HIRA's Drug Reimbursement Evaluation Committee, coupled with the expansion of benefits for indications such as primary therapy for non-small cell lung cancer. As a result, Keytruda will remain covered for five years. If the benefit is successful, the corresponding indication will also be added. Meanwhile, Keytruda has been challenging the government for about five years to receive primary lung cancer therapy benefits. It passed the committee on the 13th of last month, and finally negotiated with the NHIS. Keytruda, released in 2015, is an Immune Checkpoint Inhibitor that inhibits "PD-1" protein on the surface of immune cell T cells to block binding with PD-L1 receptors and treats cancer through activation of immune cells. In Korea, 18 indications for Keytruda were approved for 14 carcinomas, including melanoma, lung cancer, and head and neck cancer. Keytruda's quarterly sales remained around 3 billion won immediately after its release, but sales have risen since August 2017 when insurance benefits were applied as a secondary treatment for non-small cell lung cancer. Sales are likely to surpass 200 billion won last year. Keytruda also posted $12.6 billion (15 trillion won) in cumulative sales in the third quarter of this year in the global market.
