- LOGIN
- MemberShip
- 2026-04-09 09:45:01
- Policy
- Hanmi is the first to release Zytiga generic at half price
- by Lee, Tak-Sun Sep 25, 2023 05:35am
- Hanmi Pharm has become the first to launch the first generic of Janssen's prostate cancer treatment ‘Zytiga (abiraterone acetate).’ In particular, the drug is expected to greatly reduce the financial burden borne by patients as it is sold at a much lower price than the original Zytiga. According to industry sources on the 22nd, Hanmi Pharm’s 'Abiteron Tab 500mg' will be listed for reimbursement on the 1st of next month. The drug is a generic that contains the same ingredients as Zytiga and is the first generic to be listed for reimbursement. Its insurance price ceiling is KRW 8,537 per tablet, which is almost half of that of Zytiga, which is KRW 16,780. It is even lower than 53.55% of the original price, which is the standard used to calculate the price of generics. The company said that it set a low price to reduce the financial burden on patients and improve accessibility. There are no patents registered on MFDS’s green list for Zytig. Nevertheless, the reason no other generic version has been approved so far is due to the difficulty in conducting bioequivalence tests. However, Hanmi succeeded in completing the bioequivalence test and won the first generic title. Abiteron has the same indications as Zytiga. The drug is indicated for ▲the treatment of asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer, ▲treatment of f metastatic castration-resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen, and ▲ treatment of newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT). Among these, Janssen, which owns the original Zytiga, is taking steps to convert the selective reimbursement (30% copayment rate) status of the third indication to essential reimbursement (5% copayment rate). If the company succeeds in expanding reimbursement of its drug, Abiteron is also expected to benefit and receive expanded coverage. Based on IQVIA sales, Zytiga recorded sales of KRW 21.8 billion in Korea last year.
- Company
- Roche’s Rozlytrek lands in tertiary hospitals in Korea
- by Eo, Yun-Ho Sep 25, 2023 05:34am
- The tumor-agnostic anticancer drug ‘Rozlytrek’ may now be prescribed in 5 tertiary hospitals in Korea. According to industry sources, Roche Korea’s NTRK(Neurotrophic tyrosine receptor kinase) inhibitor Rozlytrek (entrectinib)’ has passed review of drug committees (DCs) at the Big 5 tertiary hospitals in Korea, - Samsung Medical Center, Seoul National University Hospital, Seoul, Asan Medical Center, Seoul St.Mary’s Hospital, and Sinchon Severance Hospital – and its prescription code has been inserted in medical institutions nationwide. Rozlytrek was listed for reimbursement this April. It is currently reimbursed for first-line or higher treatment of adult and pediatric patients 12 years of age and older with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, whose cancer type is classified as Type 2A or higher under the NCCN guidelines and are locally advanced, metastatic or have high risk of severe morbidity upon surgical resection, and have progressed following the use of existing treatments (or therapies) and have no other available treatment options. The drug was approved in April 2020 as a treatment for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation and for adult patients with locally advanced ROS1-positive or metastatic NSCLC. Rozlytrek was approved based on the Phase I/II STARTRK-NG trial on pediatric patients, as well as the pivotal Phase II STARTRK-2 and Phase I STARTRK-1 and ALKA-372-001 trials. In the Phase II STARTRK-2 study, Rozlytrek shrank tumors in more than half (objective response rate [ORR] = 56.9%) of people with NTRK fusion-positive solid tumors. Objective responses to Rozlytrek were seen across 10 different solid tumor types with a median duration of response [DoR] = 10.4 months. Treatment of CNS metastatic conditions in patients with NTRK gene fusion-positive cancer had been limited until now because most anticancer drugs have not been able to pass through the blood-brain barrier (BBB), rendering it difficult for the drugs to be exposed to the central nervous system (CNS) to an appropriate level However, Rozlytrek showed an ORR of 62.5% even in the 16 patients with CNS metastasis at baseline, showing a consistent response rate regardless of CNS metastasis. This is because Rozlytrek is designed to permeate the BBB partially remain within the CNS and act on primary brain tumors and brain metastases.
- Policy
- Mifegyne, inadequate national essential drug system
- by Lee, Jeong-Hwan Sep 25, 2023 05:34am
- Rep. Nam In-soon applies as a reference to the Pharmaceutical Society for a Healthy Society Anticipation of questions such as transparency of essential medicines. Problems with the national essential drug designation system and the issue of the miscarriage inducer Mifegyne not being designated as a national essential drug are expected to be discussed at this year's Ministry of Food and Drug Safety inspection. On the 22nd, after examining the final list of applications for witnesses and references for the National Assembly's Health and Welfare Committee of the National Assembly, Nam In-soon, a member of the Democratic Party of Korea, applied for Lee Dong-Geun, secretary general of the Pharmaceutical Association for a Healthy Society, as a reference. Rep. Nam's reason for applying as a reference is to inquire about problems with the national essential drug system. The Pharmaceutical Association for a Healthy Society has been pointing out problems with the Ministry of Food and Drug Safety's national essential drug designation system for several years now. The biggest problem that the Pharmaceutical Association for a Healthy Society is looking at is that the purpose and standards for reorganizing the national list of essential drugs are unclear, and that “miscarriage-inducing drugs,” which civil society has been continuously demanding, are not designated as essential drugs. Due to the decision in 2019 to make the abortion law unconstitutional, many women are receiving abortion procedures at medical institutions starting in 2021, but abortion through medication is still not performed in Korea, and the reason for this is the non-designation of Mifegyne as an essential drug. The Ministry of Food and Drug Safety has not designated Mifegyne as a national essential drug. Although the Ministry of Food and Drug Safety's failure to designate Mifegyne as an essential drug cannot necessarily be viewed as faulty administration, it has been pointed out that the national essential drug designation system must be disclosed more transparently in order to examine whether it is proper administration. This is also the reason why the Pharmaceutical Association for a Healthy Society is demanding that the Ministry of Food and Drug Safety reveal the standards for designating nationally essential drugs. In addition, the Pharmaceutical Association for a Healthy Society pointed out that it was a problem that nine items for the treatment of acquired immunodeficiency syndrome (HIV) were included in the list of drugs that can be de-designated as essential drugs. Acquired immunodeficiency requires a variety of medicines due to the nature of the disease, and it is unreasonable for the Ministry of Food and Drug Safety to consider lifting the designation even though there is a precedent in the past where multinational pharmaceutical companies unilaterally stopped supply for economic reasons. An official from the Pharmaceutical Society for a Healthy Society explained, “We plan to respond to questions from the National Inspector General regarding the non-designation of miscarriage inducers such as Mifegyne as essential drugs and urge that the standards for designation as national essential drugs be disclosed more transparently than they are now.” He explained, “Even if a lactic acid inducing drug is not approved for domestic marketing, it is possible to designate it as an essential drug, but the Ministry of Food and Drug Safety is holding on by refusing to respond.”
- Policy
- Vabysmo·Evrysdi will be reimbursed in October
- by Lee, Jeong-Hwan Sep 25, 2023 05:34am
- New reimbursement standards for Vabysmo, SMA treatment Evrysdi, and hemophilia A treatment Jivi (Damoctocog Alfa Pegol) will be established from the 1st of next month. The scope of reimbursement for Spinraza, a cure for spinal muscular atrophy, will be expanded, and the reimbursement standard for the emergency introduction drug Ivexproglycem Suspension will be established within the range recognized by the Minister of Food and Drug Safety. The Ministry of Health and Welfare recently announced some revisions to the details of the standards and methods for applying such nursing care benefits. We plan to implement it from the 1st of next month after collecting opinions on the 25th. ◆Vabysmo=Vabysmo, an ophthalmic medication, is newly approved for neovascular (wet) age-related macular degeneration and diabetic macular edema. If the medication is replaced with Vabysmo with an administration opinion attached, and the treatment effect does not appear after 3 administrations, subsequent administration will not be reimbursed. In addition, for diabetic macular edema, reimbursement is recognized up to 14 times in total, including the number of administrations of Aflibercept and Ranibizumab. ◆Evrysdi=Evrysdi is newly reimbursed when administered to patients with 5q spinal muscular atrophy with a confirmed genetic diagnosis of deletion or mutation of the 5q SMN-1 gene. ▲If the SMN2 gene copy number is 3 or less even before the onset of symptoms and the start of treatment is less than 6 months old, or ▲Patients who have developed SMA-related clinical symptoms and signs and are Type 1 to Type 3 and are not using a permanent ventilator are eligible for the benefit. Reimbursement is not recognized for replacement or co-administration between Evrysdi and spinal muscular atrophy treatment. However, if improvement is confirmed during Spinraza administration and does not meet the discontinuation criteria, but the committee determines that there are clinical reasons for replacement with Evrysdi, one replacement administration is permitted. In addition, in-hospital prescriptions are the principle, but for long-term prescriptions, the dosage per prescription is limited to 2 bottles for discharge and outpatient use. ◆Jivi = Hemophilia A treatment Jivi is approved for reimbursement when administered to adult and adolescent (age 12 or older) hemophilia A patients with a previous treatment history (exposure for more than 150 days). The single administration dose (one serving) is 20-25 IU/kg. However, in case of moderate or higher bleeding, up to 30 IU/kg is allowed depending on the doctor's medical judgment. ◆Spinraza = Spinraza's benefits range is expanded based on the same standards as Evrysdi. Patients with 5q Spinal Muscular Atrophy (SMA) with a confirmed genetic diagnosis of deletion or mutation of the 5q SMN-1 gene are eligible for administration. Eligibility for coverage is ▲ SMN2 gene copy number of 3 or less even before symptom onset and less than 6 months of age at the start of treatment, or ▲ Type 1 to Type 3 with SMA-related clinical symptoms and signs and not using a permanent respirator. In addition, both Spinraza and Evrysdi will be added to the list of expensive drugs. The management period is 1 year, and those eligible for management are those who are over 18 years old at the time of first administration and have an HFMSE score of less than 5 points. ◆Other= Ivexproglycem Suspension is within the scope recognized by the Minister of Food and Drug Safety, that is, inoperable pancreatic islet cell adenoma, pancreatic islet cell carcinoma, or extrapancreatic malignant tumor in adults, leucine sensitivity, pancreatic islet cell hyperplasia, extrapancreatic malignant tumor, and islet cell in infants and children. Reimbursement is recognized for the treatment of hyperinsulinemia related to adenoma or pancreatic islet adenomatosis. It can be used not only as a temporary measure before surgery but also when hypoglycemia persists after surgery. Preda and Progynova, which are estradiol preparations, are approved for use not only within the scope of approval, such as prevention of menopausal disorders and postmenopausal osteoporosis, but also for hypoestrogenism (for women over 11 years of age) due to decreased gonadal function and ovarian dysfunction, and assisted reproductive technology.
- Company
- RET-targeted anticancer drugs fail reimb…no promise
- by Eo, Yun-Ho Sep 25, 2023 05:34am
- With RET-targeted anticancer drugs failing to receive reimbursement, patients are now left to wait indefinitely for coverage of their drugs. Lilly Korea's RET inhibitor Retevmo (selpercatinib) failed to be listed for reimbursement last month due to the final breakdown in drug price negotiations with the National Health Insurance Service. This drug was the first treatment option for patients with RET gene mutated non-small cell lung cancer and thyroid cancer and was the only drug that continued on evaluations for reimbursement in Korea. Only two RET-targeted therapies – Retevmo and Gavreto – are currently approved in Korea. In the case of Gavreto, the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee and the Drug Reimbursement Evaluation Committee determined the drug inadequate for reimbursement and made a final ‘non-reimbursement’ decision. Only Retevmo passed the DREC meeting Before Retevmo, no other option had been available for RET-mutated NSCLC or thyroid cancer in Korea. This is why the Ministry of Food and Drug Safety had approved Retevmo for the treatment of: ▲adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); ▲adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; and ▲ adult patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or lenvatinib treatment, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy. The company had attempted to receive reimbursement for the thyroid cancer and NSCLC indications. In other words, Retevmo was accepted as a drug that requires urgent introduction in recognition of its innovation and clinical value in Korea. In fact, among the A7 countries that are used as Korea’s drug price reference countries, Retevmo is covered and used in 6 countries (US, Germany, Italy, UK, Switzerland, Japan) other than France. This was why Retevmo had applied for expedited reimbursement listing through the approval-evaluation linkage system and engaged in discussions with the relevant authorities for a year and a half but to no avail. Although the authorities acknowledged the innovativeness of the drug, they deemed that there remained uncertainty about the efficacy of the specific gene-targeting drug as it was approved through a single-arm study without a comparator rather than a Phase II trial. The MFDS has been operating an expedited review system to promptly launch and supply highly innovative drugs for life-threatening or serious conditions to the market and patients. However, only 1 out of 23 approved through the fast track is currently being covered by insurance. This means that even after the drugs receive approval quickly through fast-track review, it is difficult for cancer patients to receive treatment benefits without reimbursement. This is why non-small cell lung cancer and thyroid cancer specialists who have been longing for Retevmo’s listing are expressing the most disappointment. Se-Hoon Lee, Professor of Hematology-Oncology at Samsung Medical Center, said, “Retevmo is recommended as a first-line treatment for patients with RET fusion-positive NSCLC in the NCCN guidelines. It is very unfortunate that our patients have no opportunity to receive the proven therapeutic benefits of Retevmo.” Dong-Jun Lim, Professor of Endocrinology and Metabolism at the Catholic University of Korea Seoul St.Mary’s Hospital, said, “Although thyroid cancer is generally known to be an easy-to-treat cancer with a high survival rate, patients with medullary thyroid cancer with RET mutations have a poor prognosis and low survival rate. It is a very difficult situation for both the patients and doctors, being unable to use treatments with proven, significant clinical results on patients with RET-mutated medullary thyroid cancer due to the lack of treatment access, or in other words, coverage.”
- Company
- Boryung develops 4-drug kanarb combo… increases lineup
- by Chon, Seung-Hyun Sep 22, 2023 05:42am
- Pic of Kanarb Family On the 20th, Boryung Pharmaceutical announced that the Ministry of Food and Drug Safety has approved the Phase III clinical trial plan (investigational new drug, IND) for ‘BR1018,’ its incrementally modified drug candidate for hypertension and dyslipidemia. BR1018 is a four-drug combination that combined amlodipine, atorvastatin, and ezetimibe with fimasartan. Fimasartan is the main active ingredient of Kanarb, a new hypertension drug developed by Boryung. Kanarb was released in 2011 as a new drug for high blood pressure in the angiotensin II receptor blocker (ARB) class and was developed by Boryung with its proprietary technology. Amlodipine is a calcium channel blocker (CCB) type hypertension treatment drug. Atorvastatin and ezetimibe are treatments for hyperlipidemia. The clinical trial for BR1018 will test the drug’s efficacy on 156 patients with essential hypertension and primary hypercholesterolemia for 2 years. The company explained, “As the drug contains 4 ingredients in a single pill, we expect it may improve the patient’s medication compliance.” By releasing a series of combination drugs that use its Kanarb, Boryung has provided various treatment options in the field. In 2013, the company released LaCor, which was a combination of Kanarb and the diuretic hydrochlorothiazide. In 2016, the company introduced Tuvero, a combination of Dukarb (Kanarb+calcium channel blocker (CCB) drug amlodipine) and rosuvastatin, a hyperlipidemia treatment drug. In 2019, the company launched Dukaro, a 3-drug combination drug that combined rosuvastatin with Dukarb, and Akarb, a combination of Kanarb and atorvastatin, for hypertension and hyperlipidemia. In June last year, it released Dukarb Plus, a combination of Kanarb with amlodipine and hydrochlorothiazide. Last year, the Kanarb family recorded prescription sales of KRW 141.8 billion. Its sales have continued to grow at an average rate of more than 23% over the past 5 years. Boryung secured 131 papers and over 72,000 clinical cases related to Kanarb, added an indication for reducing proteinuria, and expanded the age of use. It also demonstrated its effect in controlling blood pressure in stroke patients and reducing stroke recurrence. Boryung plans to continue launching combination drugs and expand clinical research to achieve annual sales of KRW 200 billion by 2026 through the ‘Great Kanarb’ strategy. Currently, Boryung is developing additional Kanarb fixed-dose combinations including BR1015, a combination drug for high blood pressure, and BR1017, a combination drug for hypertension and dyslipidemia. The company had also applied for IND for BR1019, a combination drug that can simultaneously treat high blood pressure and diabetes. Jong-Rae Lim, Head of R&D at Boryung said, “We aim to provide various treatment options to prescribing doctors through continuous development of Kanarb combinations while improving patients’ medication compliance. We will enhance the clinical excellence of our Kanarb family by continuing to add indications through continuous research and investment.”
- Policy
- How Samsung’s biosimilar became covered in the US
- by Lee, Hye-Kyung Sep 22, 2023 05:41am
- Language barriers, insufficient handling of administrative issues related to regulations and visas, difficulties in recruiting and managing local personnel, and lack of a network infrastructure were pointed to as barriers to the Korean pharmaceutical companies’ entry into the U.S. Entry into the U.S. market holds significance in the industry as it is the world's largest pharmaceutical market that leads global technological standards. However, due to the various risk factors that exist, thorough preliminary research and simulation are necessary before making an attempt. The '2023 Global Pharmaceutical-Bio Market Export Support Report' that was issued by the Korea Health Industry Development Institute on the 21st published the difficulties and entry strategies for domestic companies seeking to enter the US market. First, the report said that companies should consider a strategy of being listed in the private insurance market through pricing, like Celltrion Healthcare and Samsung Bioepis. Celltrion Healthcare's Humira biosimilar’ Yuflyma’ was listed on the formulary of OptumRx, which is a subsidiary of one of the top 3 PBMs in the US, United Healthcare. The company pursued a high price strategy of setting the price at USD 6,576, which is only 5% cheaper than the original Humira. It is said that the high drug price allows room for much margin, increasing rebate resources and being advantageous in negotiations with PBMs. Samsung Bioepis’s Humira biosimilar ‘Hadlima’ was listed as a preferred drug in the formulary of Cigna Healthcare, a major private insurance company. The company had set the Wholesale Acquisition Cost (WAC) of its drug at USD 1,038, which was the lowest among all Humira biosimilars in competition in Korea, and 85% lower than that of the original. On the other hand, SK Biopharmaceuticals had prepared a direct sales approach due to a lack of network infrastructure. When using a direct sales system, profitability increases as the number of products sold increases, but initially, it imposes a huge fixed cost burden as the company needs to establish a local corporate body and hire professional sales and marketing personnel. SK Biopharmaceuticals explained that its SG&A expenses have continued to rise for the company since 2019 when it began preparing for a direct sales system. According to KAPAL (Korean-American Professional Association in Life Sciences), difficulties faced by Korean companies entering the US include language barriers, poor administrative management related to regulations/visas, difficulties in recruiting and managing local personnel, and lack of a network infrastructure. It also advised that preliminary research, thorough simulation, and advice from local experts and the experienced should be used to address the difficulties. In other words, companies need to understand and overcome local environmental and cultural differences, including by thorough localization of personnel and business operations, understanding and accepting the high wages and flexible working conditions, and taking a long-term approach based on an understanding of the relatively slow business progress and invest the time for information collection and networking to continuously develop its technology and intelligence property to successfully enter the US market. Although the CDMO infrastructure in the US is saturated, the government announced a policy to strengthen manufacturing. This is expected to expand medical and pharmaceutical production facilities and bases in the US, and the situation could be used in favor of the Korean companies as it would allow the companies to receive incentives and secure leadership in local production. New investment in the field of new drug development and clinical trials has been increasing in the US, and the government has been investing particularly in cancer treatment. Anticancer drug development and clinical trials account for 40% of all clinical trials conducted in the US, therefore, companies can seek entry into relevant fields through licensing out, technology transfers, and M&A with companies related to anticancer drug development.
- Product
- Will Insulin being sold out persist for a long time?
- by Kim JiEun Sep 22, 2023 05:41am
- There are signs that the sell-out of insulin preparations will continue for a long time. Some pharmaceutical companies have announced the timing of the resumption of supply, but the wholesale industry predicts that the current crisis will not be resolved in the near future. Novo Nordisk Pharmaceuticals recently announced the schedule for the resumption of the supply of Xultophy FlexTouch and Novorephid to pharmaceutical wholesalers. According to the information provided this time, the expected supply resumption date for Xultophy FlexTouch Injection 100U/ml, 3.6mg/ml is the first week of November, and for Novorephid 100U/ml is the fourth week of September. The company said, “We are continuously working to normalize the supply of Xultophy Flextouch Injection products.” The company explained, “We will secure supply so that patients who have been prescribed Xultophy FlexTouch Injection can continue treatment and provide information on the expected supply resumption date.” A company official added, “We deeply apologize for any inconvenience caused to patient care or work due to the instability of product supply due to the global imbalance in supply and demand.” According to the industry, Novo Nordisk had previously announced the resumption of Xultophy supply in September, but this announcement announced that it would resume supply in November, effectively delaying the restart by about two months. As of September 21, products such as Tresiba and Trulicity were still unable to be ordered from online malls, and it was confirmed that product supply and shipment were not smooth in the wholesale industry. Local pharmacies and the industry predict that if patients with long-term prescriptions flock to hospitals and clinics ahead of the long Chuseok holiday next week, the difficulties faced by front-line pharmacies due to shortages of insulin preparations may double. An official from the wholesale industry said, “Items such as Tresiba and Trulicity have been stocked and shipped in small quantities since August, but it is difficult to meet all the demand. In the case of Xultophy, it has not been seen in the market for several months even though there is considerable demand.” “As the resumption of supply has been postponed again to November, difficulties will inevitably arise at pharmacies where prescriptions for the product are delivered,” he said. This official said, “As this Chuseok holiday is so long, the number of visits to hospitals and pharmacies by patients with long-term prescriptions may increase next week.” He said, “If this happens, there could be another shortage of insulin products.”
- Company
- Next-gen asthma drug Tezspire to soon be introduced to KOR
- by Eo, Yun-Ho Sep 22, 2023 05:41am
- The next-generation drug for severe asthma, ‘Tezpire' is soon expected to enter the Korean market. According to industry sources, AstraZeneca Korea has submitted an application for the approval of ‘Tezspire (tezepelumab)’ in H2 to the Ministry of Food and Drug Safety and is receiving its final review. Whether AstraZeneca will be able to continue on its lineage in the field of asthma with Tezspire after failing to list its ‘Fasenra (benralizumab)’ for reimbursement remains to be seen. As a viable competitor to Sanofi’s ‘Dupixent (dupilumab),’ Tezspire inhibits the action of the thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades, to block the inflammatory chain reaction. The drug was approved by the US FDA in 2021 as a treatment for adult and pediatric patients aged 12 years and older with severe asthma., and added a self-injection formulation to its approval in February this year. Tezspire demonstrated a consistent and significant reduction in asthma exacerbation in the Phase II PATHWAY trial and Phase III NAVIGATOR trial, which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status, and fractional exhaled nitric oxide (FeNO). In the study, the most common adverse reactions shown in patients who received Tezspire were pharyngitis, rash, arthralgia, and injection site reactions. The findings from the NAVIGATOR study were published in The New England Journal of Medicine in May 2021. The Korea National Enterprise for Clinical Trials had designated Tezspire as the No.1 drug in need of urgent introduction to Korea in its report on the ‘List of foreign new unintroduced drugs that should be promptly Introduced to Korea.’
- Policy
- Vabysmo·Evrysdi, listed as reimbursement
- by Lee, Tak-Sun Sep 22, 2023 05:41am
- It is reported that Vabysmo and Spinal Muscular Atrophy Evrysdi Dry Syrup 0.75mg/mL will be listed on the benefit in October. Additionally, the upper limit for 2 Jardiance items and 2 Ninlaro items is expected to be reduced due to PVA. It is reported that the upper limit price of pseudoephedrine ingredient preparations that have completed negotiations will be adjusted to 29 to 32 won as a condition of supply expansion. According to the industry on the 21st, the government is pushing for such revisions to the drug list. It is expected to take effect as early as September 1. Vabysmo passed the HIRA Pharmaceutical Reimbursement Evaluation Committee last July. It is said that at the time of passage, the upper limit of the drug price negotiation standard was accepted and the NHIS only negotiated the estimated billing amount. This drug is used to treat nAMD and vision impairment caused by DME. In particular, it is attracting attention because it is a new drug that targets both VEGF-A and Ang-2, which are major disease pathogenesis. Evrysdi is used for symptomatic SMA patients under the age of 18. Along with the listing of Evrysdi, the existing SMA treatment Spinraza will also have expanded coverage. Only patients under the age of 3 with symptoms could be administered, but with the expansion of coverage, it is expected that patients under the age of 18 with symptoms, like Evrysdi, will also be able to use it. The upper limit for SGLT-2 inhibitory diabetes drugs Jardiance 10mg and Jardiance 25mg will be adjusted due to increased usage. PVA type Na standard was applied. The upper limit price for Takeda's multiple myeloma treatments Ninlaro 2.3mg, Ninlaro 3mg, and Ninlaro 4mg will be reduced based on the type price standard. Pfizer's acute lymphoblastic leukemia treatment Besponsa and Takeda's ovarian cancer treatment Zejula 100mg successfully renewed their RSA contracts. For the four single-drug pseudoephedrine products (Samil Pseudoephedrine Tablets, SamA Schdafen, Kolon Cosue, and Shinil Shinil Pseudoephedrine Tablets) for which price increases have been confirmed due to supply shortages, the upper limit price will range from 29 won to 32 won depending on the amount of supply expansion stipulated as a condition. It is applied differentially. Currently, one item is 20 won and the remaining three items are 23 won.
