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- 2026-05-16 03:41:29
- Company
- Emgality passes DREC review… what about Ajovy?
- by Eo, Yun-Ho Jun 07, 2022 06:04am
- With Emgality nearing insurance reimbursement in Korea, what path Ajovy will walk is also gaining attention. Teva-Handok Pharma had applied for the reimbursement of its calcitonin gene-related peptide (CGRP) targeting migraine drug Ajovy (fremanezumab) earlier this year. However, Ajovy’s reimbursement was not deliberated as an agenda at the DREC meeting that was held in May this year, the same meeting at which Emgality (galcanezumab) passed deliberations. The gap could be reasonable when considering Emgality applied for reimbursement in March last year, but as the reimbursement discussion period for the two drugs had coincided somewhat, the industry had predicted that the two agendas will be deliberated at the same time, but saw different results. As a result, the company is awaiting DREC deliberation on the reimbursement of Ajovy and is in discussion with the HIRA. Both drugs are currently prescribed without reimbursement. Although Emgality and Ajovy are same class drugs, they differ in dosage and administration, allowing patients to be prescribed the drugs according to their individual characteristics. Emgality is administered in a loading dose of 240mg (two consecutive subcutaneous injections of 120 mg each) followed by monthly doses of 120mg injected subcutaneously. Ajovy is administered in a monthly dosage of one 225 mg subcutaneous injection each month or a quarterly dosage of 675mg subcutaneous injection (three consecutive 225mg injections) every 3 months. Ajovy demonstrated its efficacy at the HALO EM/CM clinical trial that was conducted for 12 weeks on 2,000 episodic migraine (EM) and chronic migraine (CM) patients. In the HALO EM study that was conducted to verify the efficacy and safety of Ajovy in comparison to placebo, Ajovy met the primary endpoint by significantly reducing the monthly number of migraine days in both the monthly and quarterly dosed groups. The proportion of patients with a 50% reduction in migraine days was also higher for the Ajovy administered group than the placebo group. The proportion of subjects that showed a 50% or more reduction in migraine days was 47.7% in the monthly Ajovy and 44.4% in the quarterly Ajovy group, compared to the 27.9% in the placebo group. In the HALO CM study, the monthly average reduction in migraine days in the monthly dosing Ajovy group was 4.6±0.3 days, and the quarterly dosing Ajovy group was 4.3±03 days, a significant reduction compared to the placebo group’s 2.5±0.3 days. WonGu Lee, Professor of Neurology at Kosin University Hospital, said, “Unlike existing preventive drugs that required daily dosage, patients may manage their migraines with once-a-month injection with CGRP-targeted antibody drugs. The treatment cost remains an issue, however, we neurologists have high expectations for these drugs because the more the patient receives the targeted therapy, the easier it is to treat.”
- Policy
- Price Negotiation for One-shot Treatment Zolgensma
- by Lee, Tak-Sun Jun 07, 2022 06:04am
- Zolgensma of Novartis, which passed the Drug Reimbursment Evaluation Committee of the HIRA on the 12th of last month, began negotiations on drug prices to register health insurance benefits. Given that Kymriah of the same company, which has attracted attention as a once-in-a-lifetime drug, succeeded in being reimbursed two months after passing the Drug Reimbursment Evaluation Committee, attention is being paid to whether Kymriah will be able to proceed quickly. According to the industry on the 3rd, the NHIS and Korea Novartis will start negotiations on the drug price for the SMA treatment Zolgensma on the 25th of last month and proceed for two months until the 25th of next month. Earlier on the 12th of last month, Zolgensma was recognized as a condition for pre-approval of medical care benefits and application of RSA and caps based on patient performance at the Drug Reimbursement Evaluation Committee. Zolgensma is an ultra-high-priced drug sold in the U.S. for about 2.5 billion won, and it is urgent to register health insurance benefits for patients to relieve their economic burden and receive medication. There are many opinions asking for registration in that most of the patients with SMA, a rare disease, are children. The political community has welcomed the passage of the Drug Reimbursment Evaluation Committee. Choi Hye-young, a member of the Democratic Party of Korea, posted an SNS post titled "We are happy that it passed the Drug Reimbursment Evaluation Committee for SMA treatment," and Lee Jong-sung also said, "The adequacy of health insurance benefits for Zolgensma was recognized at the first review of the Yoon Seok-yeol government." "It is a decision that fits the policy philosophy of the Yoon Seok-yeol government to further protect the people in need," he welcomed. Zolgensma is compared to Kymriah, which previously succeeded in reimbursement for it, in that it is administered once in a lifetime and sold by Novartis. With the registration of Kymriah health insurance, it can be administered at up to 5.98 million won. As political circles and patient groups are paying keen attention, attention is being reimbursed to whether Zolgensma will succeed in making reimbursement as fast as Kymriah. If the drug price is settled within the negotiation period, health insurance benefits will also be available from August 1. As ultra-high-priced drugs appear one after another, health insurance finances are expected to be burdened by rising drug costs. Therefore, it is highly likely to affect the pharmaceutical industry depending on what position the Yoon Seok-yeol administration, which has just started, takes on the issue of drug cost management. Some analysts say that there is a possibility that generic drugs may be considered to be lowered due to the influence of the ultra-high-priced new drug registration.
- Company
- Cumulative sales of Spinraza in 3yrs is ₩200 billion
- by Chon, Seung-Hyun Jun 07, 2022 06:03am
- Spinraza, a rare disease treatment, posted 200 billion won in sales over the past three years after registering health insurance benefits. Although there is not much demand, it has achieved high performance in a short period of time due to the nature of expensive treatments worth nearly 100 million won per bottle. According to IQVIA, a pharmaceutical research firm, on the 3rd, Biogen's Spinraza sold 17.4 billion won in the first quarter, up 18.3% from the same period last year. Although it is less than 20.2 billion won posted in the first quarter of 2020, it has recorded 10 billion won in quarterly sales for three years since the second quarter of 2019. Quarterly Spinraza Revenue (Unit: 100 million won, Data: IQVIA) Spinraza is a rare disease treatment called SMA that treats neuromuscular genetic diseases in which muscles contract due to damage to spinal cord and brainstem motor neurons. SMA is a disease that has normal cognitive functions, but it is difficult to live a normal life, such as low muscle tension and contraction of tongue muscles. Spinraza, which received domestic permission in December 2017, was listed at an upper limit of 92.35 million won per bottle (5 ml) in April 2019 after negotiating the price of drugs with the NHIS. Spinraza made 10.2 billion won in sales in the second quarter of 2019 when it was listed on the health insurance benefit list. It recorded sales of 20.4 billion won and 15.9 billion won in the third and fourth quarters of 2019, respectively, and sold 46.4 billion won in the first year of the registration. Spinraza recorded sales of 10 billion won to 20 billion won in the quarter, showing sales of 72 billion won and 61.3 billion won in 2020 and last year, respectively. The cumulative sales raised after the registration totaled 7.1 billion won. Based on the high price of nearly 100 million won per bottle, it made a lot of sales in a short period of time. The size of the market has not expanded significantly because the number of patients is not large and a difficult procedure that requires prior review before administration.
- Company
- Bio USA to be held offline for the first time in 3 years
- by Kim, Jin-Gu Jun 03, 2022 06:37am
- The Bio International Convention (BIO USA),’ which is known as one of the largest global events in the biotechnology industry, is set to be held in San Diego USA from the 13th to the 16th of this month. Twenty or more pharma and bio companies in Korea including Samsung Biologics, Celltrion, SK Pharmteco, and Lotte Biologics are planning to attend this first offline event held in 3 years since 2019. According to industry sources on the 3rd, over 3,000 companies have registered to attend Bio USA online and offline. Bio USA is a global bio event that is being held for the 29th time this year. After 2019's event that was held in Philadelphia, the event was held online for two consecutive years. This year will mark the first event that will be held offline in 3 years. In particular, 20 domestic pharmaceutical companies have expressed their will to physically attend the event. Samsung Biologics, Celltrion, SK Pharmteco, and Lotte Biologics have prepared separate booths to interact with other pharma-bio companies around the world. Also, the Korean booth that will be jointly operated by Korea BIO and KOTRA will make known the names of 16 other domestic companies. One company that is receiving particular interest is Lotte Biologics. Lotte had announced its plan to enter the bio business at the group level. The company acquired BMS’s manufacturing facility which is located in Eastern New York for $160 million (approx. ₩200 billion). Also, the company had set the goal to grow Lotte Biologics into one of the Top 10 global CDMO companies by investing ₩2.5 trillion over the next 10 years. The Bio USA is expected to be Lotte Biologics’s official debut in the global market. Lotte Biologics has secured an exclusive booth in the 'Contract Services Zone.’ Based on the manufacturing capability secured with the BMS plant, the company plans to make its name known to pharma and bio companies around the world at the event. Locations of Korean companies/organizations at BIo USA this year SK Pharmteco plans to participate in the event Yposkesi that it acquired last year. The Korean investment firm SK Holdings acquired the French gene and cell therapy CMO Yposkesi in March last year. The financial terms of the deal were not disclosed under agreement by both parties. In June last year, the company had additionally invited €58 million (approx. ₩80 billion ) to build a second plant. The second plant is expected to be completed by 2023 at a 5,000㎡ scale. If completed, the company will own the largest manufacturing capacity in Europe at a 10,000㎡scale. SK had also acquired BMS’s Ireland Swords plant in 2017 and US AMPAC in 2018. In 2019, the company had then established SK Pharmteco as an integrated CMO corporation. Samsung Biologics and Celltrion, regulars at Bio USA had also secured exclusive booths at the event. As the first offline event to be held in three years, the two companies are known to have high expectations for the event. Samsung Biologics’ CEO John Rim is expected to personally attend the event. Samsung Biologics has been recognized for its CMO capability in the global market during the past two years in the prolonged COVID-19 crisis. Samsung Biologics had decided to operate its own booth at Bio USA. Pic: 2019 Bio USA Other bio companies have also shown high expectations for this year’s event. Vigencell plans to attend this year’s event to have partnering meetings with various global companies. During the conference, it had made plans to have meetings with various companies and promote its ▲ViMedier ™(VM), the world’s first cord blood-derived myeloid suppressor cell therapy, ▲ViRanger ™(VR), the “Off-the-Shelf” allogenic universal T cell gene therapy, and ▲ViTier ™(VT), an antigen-specific killer T cell therapy. Bridge Bio Therapeutics has received an opportunity to introduce its company face-to-face for 13 minutes in front of industry officials at the ‘Company Presentation Theater 3’ on the morning 16th (local time), the last day of the event. The company plans to introduce its main development projects such as its targeted therapy candidates in its anticancer pipeline, 'BBT-176', 'BBT-207,’ as well as its ulcerative colitis treatment candidate 'BBT-401,’ idiopathic pulmonary fibrosis treatment candidate ‘BBT-877.’ Korea Bio and KOTRA which are supporting this year’s event explained that global interest in Korean companies has increased compared to the past. An official from Korea Bio said, “We have been receiving continued requests for partnership with Korean companies. Some have specifically requested to meet with certain companies, and some have asked us for recommendations.” He added, “Overseas companies have been more actively making requests, especially on vaccines or treatments.”
- Company
- Pharmas succeed in additionally avoiding Entresto patent
- by Kim, Jin-Gu Jun 03, 2022 06:37am
- Domestic pharmaceutical companies have succeeded in additionally avoiding the patent of Novartis’s heart failure treatment ‘Entresto.’ According to industry sources on the 2nd, the Intellectual Property Trial and Appeal Board recently ruled that the claims were established in the trial to confirm the passive scope of rights on Entresto’s substance patent (10-1700062) that Hanmi Pharmaceuticals filed against Novartis. In May last year, 10 companies in addition to Hanmi Pharmaceutical – Chong Kun Dang, YooYoung Pharmaceutical, Hana Pharm, Hanlim Pharm, Ahn-Gook Pharmaceutical, Genuone Sciences, GenuPharma, Samjin Pharm, Yuyu Pharm, Elyson Pharm – filed the same claims on this patent that is set to expire in 2028. Among these, the decision on Hanmi Pharmaceutical’s trial was the first to be made, and the results of other companies are also expected to be released soon. The Intellectual Property Trial and Appeal Board had also ruled in favor of the generic companies in a trial to confirm the passive scope of rights filed on Entresto’s another substance patent(10-1589317) that is set to expire in 2029 that Hanmi Pharmaceutical and Daewoong Pharmaceuticals had filed. The 10 companies – Chong Kun Dang, YooYoung Pharmaceutical, Hana Pharm, Hanlim Pharm, Ahn-Gook Pharmaceutical, Genuone Sciences, GenuPharma, Samjin Pharm, Yuyu Pharm, and Elyson Pharm – are also challenging the patent, results of which are expected to come out soon. Generic companies have also succeeded in avoiding Entresto’s crystalline patent. At the time, 13 domestic companies including Hanmi Pharmaceuticals and Chong Kun Dang succeeded in avoiding this patent that is set to expire in 2027. Currently, the issue is being tried at the Patent Court of Korea after Novartis’ appeal. Entresto is protected with a total of 5 (including 1 non-listed) patents. The patents are ▲salt and hydrates patent that expires in November 2026, ▲use patent that expires in July 2027, ▲crystalline patent set to expire in September 2027, ▲composition patent set to expire in November 2028, and another ▲composition patent set to expire in January 2029. Among the 5 patents, generic companies have now overcome 3 patents, the ▲crystalline patent set to expire in September 2027, ▲the composition patent set to expire in November 2028, and another ▲composition patent set to expire in January 2029. Only two patents, ▲the salt and hydrates patent that expires in November 2026 and the ▲use patent that expires in July 2027 are now left to be challenged. If the generic companies succeed in overcoming the remaining patents, they will qualify for early generic release. Entresto's PMS already expired in April. The key is likely to be the use patent that is set to expire in July 2027. Entresto is a combination drug of valsartan and sacubitril and has no separate substance patent. Therefore, the two patents on the ingredients act as substance patents. Entresto is Novartis’ heart failure treatment that was launched in October 2017 in Korea. According to the market research institution UBIST, outpatient prescription sales of Entresto have been rapidly increasing in size after recording ₩6.3 billion in 2018. Its sales recorded ₩32.3 billion last year.
- Company
- 10 years since stem cell therapy was introduced
- by Chon, Seung-Hyun Jun 03, 2022 06:36am
- 4 types of domestic approved stem cell therapyTen years have passed since stem cell treatments appeared in Korea, but they have yet to produce commercial results. Medipost's CARTISTEM is recording annual sales of 10 billion won in Korea, but there is virtually no overseas sales. According to the Financial Supervisory Service on the 2nd, Medipost's sales of stem cell treatments in the first quarter were 4.5 billion won, up 3.5% from a year earlier. Medipost's stem cell therapy is the only treatment for osteoarthritis, CARTISTEM. CARTISTEM is a drug mainly composed of stem cells derived from cord blood of the same kind. Medipost succeeded in developing the world's first cord blood-derived stem cell therapy using cord blood stem cells from others, and received an item approval from the MFDS in January 2012. It is used for the treatment of knee cartilage defects in ICRS grade IV. After surpassing 10 billion won in sales for the first time in 2017, CARTISTEM posted 10 billion won in sales for five consecutive years until last year. Last year, CARTISTEM's sales reached 17.2 billion won. However, the recent growth has slowed down somewhat. CARTISTEM's sales grew 36.1% and 16.6% year-on-year in 2018 and 2019, respectively, but in 2020 and 2021, they increased only 3.2% and 3.8% year-on-year, respectively. Looking at sales in the first quarter, CARTISTEM increased 95.1% and 40.1% year-on-year in the first quarter of 2018 and 2019. However, CARTISTEM's sales in the first quarter of 2020 and 2021 grew less than 1% year-on-year and recorded 3% growth this year. Medipost is seeking to enter the global market of CARTISTEM, but no overseas sales have occurred yet. The sales performance of other stem cell treatments other than CARTISTEM is even lower than expected. Currently, there are a total of four types of stem cell treatments approved in Korea. After Pharmicell's acute myocardial infarction treatment Hearticellgram-AMI was approved in Korea as the world's first stem cell treatment in 2011, CARTISTEM and Antrogen's Crohnistem were approved for market in 2012, and CORESTEM's Lou Gehrig's fourth stem cell treatment in 2014. In the first quarter of last year, Pharmicell's bio business sales were only 572 million won. Pharmicell's bio business includes cosmetics along with Hearticellgram-AMI. Last year, Pharmicell's bio business sales were only 800 million won. Cupistem posted 700 million won in sales in 2020, including stem cell culture. It recorded 359 million won in sales in the first quarter of last year. Antrogen has not disclosed sales by business units since the second quarter of last year. Total sales of anthrogen in the first quarter were 1.7 billion won. CORESTEM's Neuronata recorded sales of 1.9 billion won and 1.2 billion won, respectively, in 2020 and last year. It made 300 million won in sales in the first quarter. Although it received great attention at the time of domestic approval, it is not in high demand due to the characteristics of rare diseases, and its preference is rarely increasing at the prescription site. Stem cell therapy was once in the spotlight as a next-generation growth engine, but news of the recent emergence of new products is also far from clear. Since Neuronata's approval in 2014, there are no stem cell treatments approved for eight years. In 2016, the Ministry of Food and Drug Safety revised the regulations for product licensing screening such as biological drugs, allowing cell therapy used for life-threatening diseases or severe irreversible diseases to receive conditional approval only with the results of phase 2 clinical trials. The intention is to shorten the time to enter the market for cell therapy products whose safety has been confirmed and treatment effects have been searched. A life-threatening disease is a disease that is likely to die if it is not accompanied by appropriate treatment and is defined as a disease in which there is no alternative to treatment. Serious irreversible disease refers to a disease or condition in which irreversible pathological conditions deteriorate for functions necessary for daily life if appropriate treatment is not accompanied. After easing regulations on cell therapy approval, bio companies such as Kang Stem Biotech, Naturecell, and Pharmicell attempted conditional approval of stem cell treatments, but all failed.
- Company
- Dukarb of Huons won the patent battle
- by Kim, Jin-Gu Jun 03, 2022 06:36am
- Given that Boryung won a series of previous referees, the pharmaceutical industry is paying keen attention to the decision, which is the opposite of the previous one. ◆Patent judge decides opposite to previous judgment According to the pharmaceutical industry on the 2nd, the Korean Intellectual Property Tribunal made a claim citation decision on the 31st of last month in a passive judgment on the scope of rights for patent of Dukarb filed by Huons against Boryung. For generic companies, including Huons, they won the Dukarb patent dispute for the first time. The Dukarb patent dispute began in March last year when 40 pharmaceutical companies filed a series of passive judgment on the scope of rights, starting with Arlico. The first decision was made in March this year. Arlico, Shinpoog, HLB, and Union Korea, Futechs Pharmaceutical lost after receiving a decision to dismiss the claim. In April, Hana, Whan In Pharm, and Union Korea also lost. The pharmaceutical industry judged that the rest of generic companies are likely to lose in the first trial. This is because the Patent Tribunal tends to cite the preceding trial as it is for cases with the same content. ◆ Huons wins first trial by changing target to non-core dose product Dukarb consists of a total of four items depending on the content. There are 30/5 mg, 30/10 mg, 60/5 mg, and 60/10 mg doses. Among them, patent of Dukarb protects only 30/5mg. Boryung has registered a patent only for its core dose of 30/5mg among the four Dukarb products. The generic companies requested a passive scope of rights confirmation trial targeting the core capacity of 30/5mg. However, Huons changed the target to 60/5mg. In the case of 60/5mg, non-infringement is clear because it is not protected by patents in the first place. For this reason, the Patent Tribunal made a decision citing Huons' claim. ◆Despite the victory of the first trial, patent avoidance of core capacity products failed However, since this trial decision is not about 30/5mg products, Huons cannot release 30/5mg generics even if it wins the first trial. 30/5 mg-related generic for exclusivity cannot be obtained. An official from the pharmaceutical industry said, "Huons met the requirement of winning the first trial, but the core capacity has not been avoided." "For Boryung, we are still protecting the Dukarb patent like the previous judges." Dukarb is a combination product that combines Amlodipine with Fimasartan, a hypertension treatment developed by Boryung. Among Kanarb-based combinations, the prescription performance is the highest. According to UBIST, a pharmaceutical market research firm, the prescription amount was 41.1 billion won last year. It increased by 14% compared to 36.1 billion won in 2020.
- Policy
- Zerbaxa passed evaluation committee after 4 yrs of challenge
- by Lee, Tak-Sun Jun 03, 2022 06:36am
- MSD Korea's antibiotic drug Zerbaxa has been recognized for its benefit adequacy by the HIRA Drug Reimbursment Evaluation Committee. As a result, it is likely to be listed on health insurance benefits through NHIS negotiations. The HIRA released the results of the 6th Drug Reimbursment Evaluation Committee review on the 2nd, and determined that Zerbaxa was appropriate for complex intra-abdominal infection, complex urinary tract infection, and hospital infection pneumonia. Zerbaxa is a super antibiotic approved in Korea in 2017, and is evaluated as a drug that can overcome antibiotic resistance. Dr. Low, who has challenged since 2018, succeeded in passing the Drug Reimbursment Evaluation Committee for the first time in four years. In 2019, the Drug Reimbursement Evaluation Committee recognized the clinical necessity but non-reimbursed because it was difficult to see that the clinical treatment rate was inferior. As the MOHW expanded the anti-bacterial system for treating symptomatic infections to PE in 2020, Zerbaxa also seems to have benefited.
- Policy
- Lioresal was newly listed
- by Kim, Jung-Ju Jun 02, 2022 05:59am
- With the new registration of 10mg/5mL of the skeletal muscle relaxant, the standard was newly established this month. Jakabi 5mg, which belongs to an anti-malignant tumor drug, has been clearly set in accordance with the change in permission from the MFDS. The MOHW announced that it partially revised the "details on the criteria and methods for benefits" as of the 1st. Looking at the change table, 10mg/5mL of Lioresal was newly registered, and the standard for this ingredient was newly established by applying the permission of the MFDS. According to the MFDS' recognition, this drug is used to treat severe, chronically increased muscle tension that has not been treated with standard drugs for progressive neurological diseases in the brain and spinal cord accompanied by physical and mental symptoms. The scope of benefit has been clarified as the MFDS' permission for Jakabi 5mg has been changed. The added indication is a non-antibiotic therapy. Benefits are expanded in the general principle of oral chronic hepatitis B treatment. The MOHW and the Korea Appraisal Board deleted the taboo and expanded the benefit, considering that the permission for "administration of patients with mild, moderate, and severe" of the drug was changed and that Besifovir was recommended as an initial treatment if there was a decrease in renal function. The MOHW and the HIRA made the decision in consideration of domestic and foreign permits, textbooks, clinical medical guidelines, clinical research documents, opinions of related academic societies, and approval for the use of non-reimbursement exceeding the permission of the MFDS. Looking at the newly established contents in detail, Voriconazole injections that exceed the permission can be recognized if they are administered according to the standard. Subject patients are only adult patients diagnosed with Fungal Endophthalmitis who are confirmed to have fungal infection in the blood or eyeball, and are recognized when administered in the anterior injection (50 μg/0.1ml) and in the vitreous cavity (50 μg/0.1ml~100 μg/0.1ml). Anti-inhibitor coagulant complex injection Faiva is paid more. The MOHW and the HIRA have a need for preventive therapy because antibody patients themselves have a very high tendency to bleed, and other hemophilia drugs have recently recognized preventive therapy for antibody hemophilia patients, so they decided to expand their benefits. Specifically, it is recognized up to six times per visit, and a total of 12 times per four weeks. However, if bleeding occurs after administering 12 doses every 4 weeks and visits the hospital, it can be recognized up to 2 times per visit, and a doctor's note must be attached. In the case of in-house administration, the in-house administration is included when calculating the number of administrations.
- Opinion
- [Reporter’s View] Differing indication and reimb standards
- by Eo, Yun-Ho Jun 02, 2022 05:58am
- There are some cases where the insurance reimbursement standards and the indication for a drug differs. This gap emerges as not all the uses of a drug approved by the regulatory authorities may be deemed appropriate by the insurance authorities to spend their limited insurance finances on. This is why voices of complaint often arise in the field. It is impossible for the authorities to address all the complaints, but there exist cases where the non-reimbursement measure seems unreasonable, no matter how ‘financial’ the reason may be. One representative example of this is the restrictions set on switching and the period of administration. Let us look at the reimbursement standards set for the acute myeloid leukemia (AML) treatment Xospata (gilteritinib) which was recently listed for insurance benefit. The reimbursement standards for Xospata state that patients who show partial remission or higher after 2 cycles of administration and have received prior approval to receive allogeneic hematopoietic stem cell transplantation (or have presented evidence equivalent to the condition above) are allowed to receive 2 additional cycles of treatment in consideration of the preparation period for allogeneic hematopoietic stem cell transplantation. In general, the restrictions on a drug’s dosing cycle are set based on the design of the drug’s clinical trial or guidelines set by overseas authorities. However, there is no reason to limit the period of administration for Xospata. The ADMIRAL study that was conducted on Xospata shows that the drug was designed without limitation in the administration period, and the NCCN guidelines also recommend the drug as ‘Category 1’ without restricting its period of administration. JAK inhibitors that receive attention as oral rheumatoid arthritis treatments are facing a switching issue. The JAK inhibitors approved in Korea are ' Xeljanz (tofacitinib)', ' Olumiant (baricitinib)', ' Rinvoq (upadacitinib),’ etc. However, if patients switch to a different drug while receiving another, the reimbursement for their first drug is not recognized, In other words, if the patient who had switched to a different drug expecting better treatment results wishes to reuse the previous drug after seeing poor results, they may not receive reimbursement. The anti-TNF agents that had first entered the autoimmune disease treatment market had also undergone the same process. With the issue continuously raised in the field, switching of drugs such as ‘Humira (adalimumab),’‘Remicade (infliximab),’ and ‘Enbrel (etanercept)’ were finally allowed reimbursement in 2013. In Korea, the reimbursement of drugs significantly affects prescription in the field. Most HCPs in Korea give up prescribing a drug even if it is deemed necessary for a patient if the drug is non-reimbursed. Restricting fiscal spending in areas where prescriptions are needed may be toxic. In this sense, a little more trust on the health authorities’ part in the judgment made in the field would be mutually beneficial.
