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- 2026-04-11 18:25:00
- Company
- Novartis' application for voluntary retirement is closed
- by Sep 14, 2022 05:50am
- The application for ERP, which is underway by Novartis Korea, has ended. Attention is focusing on whether the relatively quiet voluntary retirement will be completed without any problems. According to the pharmaceutical industry on the 8th, the application for voluntary retirement, which was conducted by Novartis Korea for about two weeks, has recently been closed. The company announced the implementation of voluntary retirement on the 25th of last month. Novartis Korea is in the process of integrating and dividing its business units at the same time. The plan is to combine the Rx division and the anti-cancer drug division to unite innovative drugs into one and form a new division that collects patented drugs. New drugs such as Kymriah and Zolgensma are bound to be innovative drugs, and old drugs such as relatively low-cost chronic disease drugs are expected to be classified as patent expired drugs. ERP was also carried out in the process of integrating and dividing business units. The compensation condition is '2n+8' and additional compensation is given for each year. This means that an average salary of eight months is paid twice the number of years of service, and an additional six months' worth of employees for 10 to 15 years of service and 12 months' worth of employees for more than 15 years. It is reported that voluntary retirement is taking place in a relatively quiet atmosphere. It went through a meeting with the labor union before the announcement of his voluntary retirement, and it was found that it was not a coercive atmosphere because it did not specify the target. However, the key is how the company will respond if the applicant falls short of the desired retirement size the company thinks. The higher the number of years of service, the higher the desired retirement compensation. Last year, there was also a backlash against proceeding with voluntary retirement despite no management difficulties due to high profits. The NPU, which includes Novartis Korea, said at a meeting of National Assembly aides on the 7th, "Novartis is the world's most profitable pharmaceutical company last year, and this restructuring is also due to the unification of its business unit, not management reasons." The NPU said, "Novatis Korea also announced its voluntary retirement with a very passive attitude that it has no management difficulties, but has no choice but to follow global decisions." In the process, there is a concern about the risk of forced voluntary retirement, such as encouraging retirement, the NPU said. The union said, "There were some applicants for voluntary retirement, and the exact number of people is being determined. However, it remains to be seen how much the company thinks of voluntary retirement and whether it will make artificial adjustments beyond the legal part if they do not reach that level, he said. In response, the union said, "We have completed the application for voluntary retirement smoothly, and all procedures are conducted transparently and fairly in accordance with the law. The union said, "We will respect the will of our employees as much as possible and will not exercise compulsory pressure such as urging them to retire."
- Policy
- GOV·Pharma starts work to localize 57 essential medicines
- by Lee, Jeong-Hwan Sep 13, 2022 05:52am
- The government and the pharmaceutical industry have entered the final stages of localizing the finished drug products and active pharmaceutical ingredients that are essential for national disease control and prevention as well as the treatment of emergency patients. The supply of such products and ingredients has been mainly dependent on imports despite the evident need to be manufactured and produced in Korea due to low profitability. Among drugs that are imported from 3 or fewer countries and therefore are vulnerable supply-wise, those from highly export-dependent countries of China, Japan, and India will be finally confirmed, upon which the government and the pharmaceutical industry plan to cooperate in securing domestic production technologies. The movement bears significance as it is the first time the government and the pharmaceutical industry joined forces to fundamentally increase the self-sufficiency rate of rare or essential drugs that are subject to stable supply measures in Korea. On the 12th, the Korea Orphan & Essential Drug Center (KODC) announced that it has tentatively finalized the list of 21 finished drugs and 35 APIs that are deemed to be in need of domestic technology development after discussion with the Ministry of Food and Drug Safety (MFDS) and Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), and will be collecting opinions from the industry as its last step. After collecting and reviewing opinions submitted by pharmaceutical companies, the KODC will hold an expert advisory meeting and finalize the list. Indications for the 21 tentatively confirmed finished drugs that were chosen due to the diseases’ difficulty in treatment or rarity of their patient group were treatments for emergency hypertension, ulcerative colitis, multiple myeloma, phosphorus excretion, acute heart failure or bradycardia, iron deficiency in patients unable to take oral medications, parasitic infection, adrenogenital syndrome, malignant hyperthermia, iron intoxication, methanol intoxication, Dravet syndrome, etc. Subject products were: Nitroprusside injection, mesalamine suppository·powder, melphalan tablet, bromocriptine oral tablet, sevelamer powder, etomidate injection, amiodarone injection, imiquimod cream, isoproterenol injection, ferric carboxymaltose hydroxide Injections, clarithromycin injections, pentamidine injections, fludrocortisone tablets, nisoldipine tablets, amiodarone hydrochloride tablets, dantrolene sodium injections, deferoxamine injections, dehydrated ethanol injections, stiripentol capsules, anakinra injections, etc. The 36 active pharmaceutical ingredients that were imported from countries with high import-dependency such as China, India, and Japan, are used for Brucellosis tularemia plague, Wilms' tumor, anthrax·plague·tularemia, drug-induced dystonia, Parkinson's disease, acute and chronic diarrhea, hypothyroidism, invasive fungal infection, supraventricular tachycardia, sepsis, tuberculosis, patent ductus arteriosus in preterm infants, Cushing's syndrome, atrophic vaginitis kraurosis vulvae, etc., that pose a fatal threat due to terrorism risk or in disease control and prevention in the nation, or have a rare patient group. The subject ingredients are Levodopa/benserazide tablet, loperamide capsule, liothyronine tablet, lincomycin hydrochloride capsule, voriconazole injection, bisoprolol tablet, salbutamol inhalent, adenosine injection, amiodarone tablet, amikacin injection, Amphotericin B injection, edaravone injection, ethambutol tablet, captopril tablet, clindamycin injection·capsule, pyridoxine injection, albendazole tablet, ketoconazole tablet, etc. The KODC plans to finalize the selection of drugs in need of stable supply after holding an expert advisory meeting on their selection criteria and considering their individual need for development, etc. In addition, in consideration of the potential for domestic development, industry interest, and the international supply network status of drugs that are not on the candidate list, the KODC will be collecting opinions on finished drugs and APIS that the industry believes are in need of domestic manufacturing technologies. A KODC official said, “We ask pharmaceutical companies that have separate opinions on our drug list selection, such as addition or deletion of items or the need for priority development, to submit their reviewed opinions and reasons. We will also be identifying pharmaceutical companies that are willing to produce products that are not yet approved for the manufacture of finished pharmaceuticals on paper, such as APIs in the Drug Master File system that are only being imported in Korea.”. Meanwhile, KODC is in charge of the MFDS’s research project on establishing a stable supply system for products with concerns over unstable supply and demand, focusing on National essential medicines that are used in public health crises.
- Company
- Hanmi’s Rolontis receives US FDA marketing approval
- by Kim, Jin-Gu Sep 13, 2022 05:52am
- Hanmi Pharmaceutical’s neutropenia treatment ‘Rolontis (US product name: Rolvedon)' received approval from the US FDA. Hanmi Pharmaceutical and its partner Spectrum Pharmaceuticals announced on the 9th (local time) that it had received written notice of approval allowing for the marketing authorization of Rolontis from the FDA. This is the first new drug developed by Hanmi Pharmaceutical to be granted marketing authorization by the FDA. In terms of achievements made by the domestic biopharmaceutical industry, Hanmi Pharmaceutical’s approval this time marks the 6th new homegrown drug MA granted by the FDA and is the first among new anticancer drugs Hanmi Pharmaceutical and Spectrum Pharmaceuticals explained that they are ready to launch Rolontis in the US market. The companies expect to have the product available within the year based on the nationwide sales and marketing network they have established in the US. Se-Chang Kwon, President & CEO of Hanmi Pharmaceutical, said, “The approval holds significance as it is Hanmi’s first new drug to be granted approval and the first demonstration of the potential held by the company’s proprietary platform technology, LAPSCOVERY, The approval will be a decisive opportunity for the commercial success of Rolontis and the rise in the future value of new biologics based on LAPSCOVERY.
- Opinion
- [Reporter's view] PVA market should be actively reflected
- by Lee, Tak-Sun Sep 13, 2022 05:51am
- The pharmaceutical industry is in accordance with PVA didn't like being drug price cut. Excessive government intervention in the law according to the principle of supply and demand markets. Other goods has increased the use of demand than supply shortages, needs to be raised prices. But people pay health insurance run to fund health insurance system for the integrity of the principles that are not in arms. The COVID cold medicines such as drug case is a typical example of the increased trend in use. In an emergency due to infectious disease, without reflecting the system would drugs is lowered to in the pharmaceutical industry is concerned. But, but not the government through the correction amount of disadvantage companies contained in the target group cut drug price just worried. Sudden reflex to stop sales profit is a drug containing impurities need medication to take a closer look at the situation. The drugs increased by the use of existing drugs often cheaper than the sales suspension is true, but rather believed to have to reduce the drug price. Whenever these situations unfold, the pharmaceutical industry suggests the Ministry of Health and Welfare or the NHIS to exclude PVA. Each time, the government fully collects opinions from the pharmaceutical industry, but does not reflect all of the industry's claims by citing the purpose or principles of PVA. Some vendors in the end product price to appeal the cut is an injustice to happen happens. The NHIS is currently conducting research services for PVA improvement plans. That are currently fixed up to 10% will raise new standards will increase direct deposits. Most of them are intended to seek expansion and operation of the system for fiscal reduction. But the system of acceptability of the participants to build a broader view of the principles and detailed criteria with the situation and the environment should be reflected in the same time is also necessary. As such, detailed proposals such as national emergency situations caused by infectious diseases and increased use of drugs with reduced finances compared to alternative drugs should not be made to prevent unfair cases. If the system is operated as it is now, consumers will discuss the effectiveness of drug reduction, and on the contrary, suppliers will only highlight unreasonable aspects. We hope that PVA will come up with a more elaborately designed improvement plan.
- Policy
- Paxlovid is contraindicated with other concomitant meds
- by Lee, Tak-Sun Sep 13, 2022 05:51am
- PaxlovidPiroxicam was excluded from the list among drugs that should not be taken with Paxlovid, an oral COVID-19 treatment. As a result, the number of combination contraindications has decreased to 16, but there are many contraindications, making it difficult for patients with chronic diseases who take drugs every day to take Piroxicam. The HIRA announced on the 5th that it will delete the Piroxicam-containing drug among the concomitant of the drug Paxlovid (Nirmatrelvir+Ritonavi) and Pfizer Pharmaceutical, which were approved for emergency use in COVID-19. Piroxicam is a nonsteroidal anti-inflammatory drug and] is used to relieve inflammation such as arthritis. Until now, Piroxicam has been one of the 17 contraindicated drugs for Paxlovid. This drug should not be taken with Paxlovid due to severe respiratory inhibition or hematological abnormalities. The KDCA last week ordered related ministries to exclude Piroxicam from contraindicated drugs according to overseas safety information, which is believed to have been reflected by the Ministry of Food and Drug Safety and the HIRA in the DUR. Although Piroxicam is excluded, Paxlovid is contraindicated with drugs which are Amiodarone, Ergotamine, Pimozide, Sildenafil, Simvastatin, Flecainide, Lovastatin, Alfuzosin, Pethidine, Ranolazine, Dronedarone, Colchicine, Clozapine, Triazolam, Propafenone, Methylergonovine.
- InterView
- “Will rise independently as Organon in the industry”
- by Eo, Yun-Ho Sep 08, 2022 05:59am
- So Eun Kim, Managing Director of Organon Korea Spin-offs, which are made for various reasons in various circumstances, bring out various positive and negative issues in the process. Organon’s course of the spin-off was also quite eventful. However, the company quickly straightened its affairs after completing the spin-off and being reborn as an independent organization in June last year. Organon was established in 1923 in Netherland and had become part of MSD. In 10 years since then, the company again was separated from MSD and reborn as Organon. Utilizing the power of its existing legacy brand, the company heralded its new leap into a pharmaceutical company specializing in biosimilar and women’s health. Dailpharm met with So Eun Kim (51), the founding Managing Director of Organon Korea, to hear about the company’s vision and value. -A year has already passed since the establishment of Organon Korea. Has the company undergone many changes? During the past year, the company had made efforts -small and large – to lay the foundation to realize our women's health vision. Above all, we were able to achieve organizational stability, and in terms of business, Global Organon has earned the trust of its investors by making a stable start from the first year. Organon Korea made a 4% YoY growth in the first year of the spin-off, expanding its product influence. -There must have been difficulties as well. One of the things our employees had the most trouble with was meeting with various healthcare professionals who were unfamiliar with our name, ‘Organon.’ The heightened COVID-19 situation had further rendered sales activities and external meetings with partners and stakeholders difficult. Therefore, we focused on utilizing digital channels in communicating with healthcare professionals. One main example of this is ‘Organon Connect,’ a portal site we prepared for HCPs. Korea was the first among all Organon subsidiaries globally to launch the portal and had launched it upon the establishment of the company. Through the system, we have continued to hold symposiums during the pandemic. -In addition to your existing items, what other products are you preparing for your goal to become a women’s health pharmaceutical company? Organon has signed agreements for 6 solutions in the field of women’s health where unmet needs remain. In the case of our solution for postpartum hemorrhage, the solution has been approved by the FDA and is being sold in the US. XACIATO, the bacterial vaginosis treatment, has been granted accelerated approval by the FDA. We are preparing to introduce these treatments to Korea as soon as possible, through market analysis in Korea. Clinical trials or preclinical trials on solutions for premature birth, endometriosis, breast cancer, contraception, etc. are also being completed. We are preparing to launch the products in development according to their development stage. Also, the contraception, infertility, childbirth, and postmenstrual treatments that we already own have much potential in the Korean market. Although the company was unable to pay sufficient attention to these products but based on Organon Korea’s vision, we plan to make the most of the opportunities owned by each and every product. -With so many of your women's health products in development, it seems like not many products are readily available for introduction to Korea. In this sense, the company would have to focus on its chronic disease area. What kind of efforts and attempts have you made to increase your influence in women’s health in Korea? Well, we expect that Korea will be able to participate in various stages of applicable clinical trials of the various products in development, and is preparing plans for such trials. Also, for the FDA-approved products, we are working to quickly introduce them to Korea. The chronic disease business accounts for over 90% of Organon Korea’s business. This field will be our main business for the few years to come, during which we will be making efforts to expand our portfolio and share in women’s health. -has the labor-management issues that you experienced in the course of your spin-off been resolved? Many of the concerns and anxiety held by our executives and employees with regard to the spin-off have been resolved. At the time of the spin-off, we focused on listening and communicating with our executives and employees about their various concerns and received consent from each through discussion with the union. After the spin-off, we worked to relay the direction of the company and build solidarity among our executives and employees. We are regularly communicating with the union every week, and are holding a labor-management council to listen to the opinions and answer questions held by the employees, facilitating smooth communication between the union, executives & employees, and the company. For your reference, only a very few employees left the company due to the spin-off. -What are your future ambitions? Based on Organon’s global ESG reporting standards, we believe we need to find areas where Organon can contribute to Korean society and increase our influence in Korea. Building on the vision and confidence we have today, we plan to grow together with our executives and staff and strive to lay the foundation for bigger dreams, toward our vision of women's health.
- Company
- Unilateral voluntary retirement
- by Sep 08, 2022 05:59am
- The GSK labor union of Korea has taken legal action, insisting on the management's unilateral voluntary retirement. The company is not taking any action, but the inside is "like the calm before the storm" as legal battles are predicted. Novartis Korea, where voluntary retirement is being carried out relatively quietly, is also nervous until the end. According to the pharmaceutical industry on the 8th, NPU's GSK branch recently filed an application with the Seoul Western Office of the Ministry of Employment and Labor and the Seoul Regional Labor Committee to file a petition for violation of the collective agreement and relieve unfair labor practices. It is claimed that the management violated the collective agreement and unilaterally proceeded with voluntary retirement. The union said, "According to Article 21 of the Korea Unification Association, in principle, it is necessary to agree with the union when the reduction is carried out due to unavoidable management circumstances. However, without any prior discussion, the management notified the union 30 minutes before the decision to reduce the number of employees and abruptly announced the voluntary retirement." Since then, they have pushed ahead with one-on-one meetings with employees, and they are putting psychological pressure on early applicants within a week by applying additional payment conditions. A union official added, "The decision is to make a legal judgment on HR's unfair labor practices and violations." It is reported that the management has not taken any action since the deadline for applications for voluntary retirement at the end of last month. Although the applicant did not meet the company's standards, there was no pressure or encouragement to meet the number of people. It is reported that there is no special response to the legal lawsuit filed by the union. Novartis Korea is better than this situation, a day before the deadline for voluntary retirement. Unlike GSK Korea, it has been consulted with the union and is found not to be coercive. Novartis Korea, the applicant union official said, " voluntary retirement and to understand the accurate number of people are. But the company's voluntary retirement is to think, how much remains to be part of what to do " said it would not.
- Policy
- Approval of Boryung’s new SCLC drug Zepzelca imminent
- by Lee, Hye-Kyung Sep 08, 2022 05:58am
- Boryung Pharmaceutical’s new drug for small-cell lung cancer (SCLC), 'Zepzelca inj, (lurbinectedin) is soon to be granted marketing approval in Korea. Currently, Hycamtin inj (topotecan)’ and ‘Camtobell Inj (belotecan)’ are approved for second-line use in Korea. According to industry sources on the 7th, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Zepzelca recently. With the safety and efficacy review complete for the drug, it is highly likely that Zepzelca will be approved soon if no variables arise. Zepzelca is an anticancer drug for which Boryung owns exclusive rights to development and sales in Korea. After signing a technology introduction agreement with the Spanish pharmaceutical company Pharmamar in 2017, the company has been coordinating the period for its domestic introduction after the drug received FDA marketing approval on June 15th, 2020. The FDA approved Zepzelca for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Zepzelca 3.2 mg/m2 is administered as a 60-minute infusion every 21 days, and treatment is continued until disease progression or unacceptable toxicity. The drug may be administered in an outpatient setting when appropriate, and the 21-day administration schedule has the advantage of reducing the time required for treatment in the hospital compared to its other options.
- Company
- Sales of immuno-cancer drugs exceeded 200 billion won
- by Sep 08, 2022 05:58am
- In the first half of this year, the domestic immune anticancer drug market surpassed 200 billion won. In particular, Opdivo's performance, which showed his endurance, was remarkable. Opdivo sales increased 41% from the previous year, surpassing 50 billion won in half-year sales. According to IQVIA, a pharmaceutical market research firm, the size of the domestic immuno-cancer drug market in the first half of this year was 215.8 billion won, up 17.2% from 184.1 billion won a year earlier. The drug leading this market is MSD's Keytruda, which has the most indications. Keytruda posted 94.4 billion won in sales in the first half of this year, up 1.2% from the previous year. Sales seemed to be decreasing from the same period last year due to drug price cuts in the first quarter, but it turned upward again as benefits expanded in the second quarter, including primary treatment for non-small cell lung cancer. Currently, there are 15 cancers that can use Keytruda, including lung cancer, head and neck cancer, Hodgkin lymphoma, urinary epithelial cancer (Bladder cancer), esophageal cancer, melanoma, renal cell cancer, endometrial cancer, gastric cancer, small intestine cancer, ovarian cancer, pancreatic cancer, biliary cancer, colorectal cancer, and triple negative breast cancer. ◆Opdivo, which shows its endurance, surpasses 50 billion won in semi-annual prescriptions What stands out is Opdivo's rise. Opdivo sales in the first half of the year were 51.3 billion won, up 40.5% from 36.5 billion won a year earlier. The gap with Keytruda, which nearly tripled, has less than doubled. The market share of immuno-cancer drugs has also changed due to higher growth than Keytruda. Unlike last year, when Keytruda monopolized half of the total market, its share of Opdivo rose to 24% this year, reducing its share of Keytruda to 44%. Opdivo, developed by Ono and BMS, is an immuno-cancer drug licensed in Korea at the same time as Keytruda in 2015. It recorded sales similar to Keytruda until 2017, but the gap widened since 2018. This is because it has been relatively slow to expand indications and benefits compared to Keytruda, which aggressively increased indications. For this reason, Opdivo sales seemed to slow down between 2019 and 2020, but began to rise again from the end of last year. Opdivo, which stayed at 10 billion won for seven consecutive quarters from the fourth quarter of 2019, surpassed 20 billion won for the first time in the third quarter of last year. In the first and second quarters of this year, it settled in the mid-20 billion range with 25.1 billion won and 26.2 billion won, respectively. Opivo is expected to continue its upward trend as stomach cancer benefits are expected for the first time in an immuno-cancer drug. In June, the HIRA set Opdivo's standard for first-line gastric cancer treatment. Opdivo succeeded in re-challenging in about four months after suffering once in February. When the expansion process is completed, patients with HER2-negative stomach cancer will be able to use new drugs at low prices. HER2 negative gastric cancer patients account for nearly 90% of all patients, and there are no drugs other than Opdivo in the first treatment, so if it is expanded, it is expected to have a significant impact on sales. Yervoy, considered Opdivo's partner, also saw sales increase. Yervoy, which was only 1.3 billion won in the first half of last year, jumped to 6.1 billion won this year. Yervoy, the first immuno-cancer drug in Korea in the CTLA-4 family, is not well selected alone due to its limited effect and relatively high side effects. Instead, there is a combination therapy with Opdivo. Earlier this year, a combination therapy with Opdivo added a metastatic direct bowel cancer indication. ◆↑ 23% of Tecentriq & growth of Impinzi Roche Tecentriq and AstraZeneca Impinzi, generics of immuno-cancer drugs, are also steadily increasing their sales. It is Tecentriq which is showing greater performance. Tecentriq increased 22.6% year-on-year to 37.6 billion won in the first half of the year. During the same period, Impinzi increased 19.1% from 22.2 billion won to 26.4 billion won. Tecentriq succeeded in paying liver cancer for the first time among immuno-cancer drugs in April. The combination of Tecentriq and the targeted anticancer drug Avastin has become a standard treatment for liver cancer with excellent data beyond existing drugs. Analysts say that Tecentriq will gain momentum in expanding sales as it is prescribed for liver cancer in earnest. Impinzi is growing at a relatively slow pace this year with no special news. After surpassing 10 billion won for the first time in the first quarter of last year, quarterly sales remained in the early 10 billion range. Impinzi continues clinical trials in biliary tract cancer and liver cancer to expand further indications. Merck's Bavencio posted only 100 million won in sales in the first half of the year.
- Company
- Zolgensma, which is the same price as an apartment
- by Moon, sung-ho Sep 08, 2022 05:58am
- With ultra-high-priced treatments from global pharmaceutical companies newly entering the benefit range this year, human "risk management" is emerging as an issue at clinical sites. Since the treatment is so expensive, "risk" management issues such as damage and loss that may occur during administration are acting as a key issue. #Kymriah, the CAR-T treatment of Novartis Korea, which entered the benefit range this year, and Zolgensma, the treatment of Spinal Muscular Atrophy (SMA), are representative. According to the pharmaceutical industry and the medical community, Novartis Kymriah Korea has been applied as a health insurance benefit since April, and it has been confirmed that it has been administered not only at university hospitals in the Seoul metropolitan area but also at university hospitals in provincial areas. Zolgensma, who has newly entered the health insurance benefit zone since August, has passed the Drug Committee (DC) of major Big 5 hospitals, including Seoul National University Hospital and Seoul Asan Hospital, and is preparing to administer patients in earnest. As expensive treatments, which cost hundreds of millions of won alone, are administered in earnest at the clinical site, "risk management" that may occur is emerging as a key issue. For example, the question is who will be responsible for the damage or loss of the treatment in the process of handling patients with expensive treatments. This is because the price of the treatment is expensive, so both hospitals and pharmaceutical companies can be burdened depending on where they are responsible. Moreover, in Korea, it is recognized as a bigger problem because there is no insurance system that can be called a safety device in preparation for the human risk of such expensive treatments. However, there is a difference if Kymriah and Zolgensma are directly compared in terms of risk management. First of all, Kymriah, which entered the benefit range, is a pair due to the nature of the treatment, that is, a system that prepares two treatments in case of an emergency. An official from Novartis said, "In the case of Kymriah, due to the nature of the treatment, two treatments are prepared in case of an emergency." He explained the background, "As we make a treatment with T cells collected from the patient's blood, we can make two treatments with the same sauce." Kymriah reached up to 500 million won in the United States for a single administration, but in Korea, the patient's burden was lowered to up to 5.98 million won as it was set at 360.4 million won through drug price negotiations. Against this background, Um Ki-sung, a professor of blood medicine at Seoul St. Mary's Hospital, said, "In the process of introducing Kymriah, Novartis said that he would not receive drug costs if it was not actually administered, regardless of who did it wrong." Professor Um Ki-sung explained, "If a patient receives a lot of chemotherapy during the three-week administration, lymphocytes may not be extracted or cells may not come out." Professor Um said, "This means that pharmaceutical companies will not take issue with this and will only receive the drug price when the administration is completed." The problem is Zolgensma, which domestic drug price has been set at nearly 2 billion won. This is because the characteristics are different from Kymriah itself and there is no insurance system to prepare for risks that may occur during the administration process. In particular, in the case of Zolgensma, it is also worrisome that it differs from Kymriah in that the process is different, such as putting genes in vectors and transporting them so that they do not die. For this reason, there are opinions among large hospitals that are concerned about this. On top of that, Evrysdi, which is considering salaries as SMA treatments following Zolgensma, is also said to have to come up with a safety device for human risk. In this regard, the HIRA, which is considering benefits, reportedly asked pharmaceutical company Roche to come up with a plan. As Evrysdi is an oral drug, it means that safety devices should be prepared to prevent risk of patient loss. This is because Evrysdi will not have a high drug price compared to Zolgensma and Spinraza, but it is widely expected that it will be set as a burdensome drug price for patients. Novartis is in a position to discuss the plan with hospitals as it is scheduled to be administered in earnest according to the application of Zolgensma benefits. "Since it is an expensive treatment, it is not easy for hospitals and pharmaceutical companies to pay for it," a Novartis official said. "In the near future, Seoul National University Hospital is discussing how to manage risks and has been partially coordinated." "I think we will need to continue discussions in the future," he explained. He said, "I checked the insurance company in terms of human risk safety, but there is no insurance company that covers it." He added, "There is no internal determination of responsibility at the moment, but since it is the first time, we have to continue to discuss it in the future.".
