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- 2026-04-09 09:45:00
- Policy
- Celltrion receives approval for Nesina Met SR
- by Lee, Hye-Kyung Sep 15, 2023 05:33am
- Celltrion, which acquired the Asia-Pacific distribution rights for Takeda Pharmaceutical products, used them to create an improved new drug. One of the acquired products, Nesina Met SR, a type 2 diabetes treatment, received approval from the Ministry of Food and Drug Safety. The Ministry of Food and Drug Safety announced on the 14th that it had approved Celltrion's type 2 diabetes treatment Alogliptin Met SR. This is the first time that Celltrion has received domestic approval for a chronic disease treatment. Alogliptin Met SR appears similar to Nesina Met, which Celltrion acquired from Takeda in 2020 and has domestic licensing rights but is a domestically developed product with a different formulation and dosage. First of all, the dosage form of Nesina Met is a rectangular film-coated tablet, but Alogliptin Met SR is approved as an oval-shaped SR film-coated tablet. SR has the advantage of reducing the number of medications taken because the efficacy lasts for a long time with a single dose. Nesina Met was released with Alogliptin and Metformin doses of 12.5/500 mg, 12.5/800 mg, and 12.5/1000 mg, respectively, but the two Alogliptin Met extended-release tablets have the same dosage and are released at 25/1000 mg instead of 12.5/1000 mg. In the case of Nesina Met or Alogliptin Met SR, the maximum recommended daily dose of each ingredient should not exceed Alogliptin 25mg and Metformin 2000mg. When taking Alogliptin Met SR, taking 2 tablets of the existing Nesina Met once a day becomes easier by taking 1 tablet at a time. Celltrion acquired the Asia Pacific rights to 18 Rx and OTC items, including Nesina Met, from Takeda for $278.3 million in December 2020. Currently, the domestic sales rights for Nesina Met are held by Celltrion Pharmaceuticals. Attention is focused on whether Celltrion will enter the domestic chronic disease treatment market as it has developed Alogliptin Met SR, conducted clinical trials, and obtained product approval.
- Policy
- Which P-CAB generic will come first, K-CAB or Vocinti?
- by Lee, Tak-Sun Sep 15, 2023 05:33am
- Companies have started developing generic versions of the P-CAB (potassium-competitive acid blocker) class gastroesophageal reflux disease (GERD) treatments K-CAB (tegoprazan, HK Inno.N) and Vocinti (vonoprazan, Takeda Pharmaceuticals Korea). The post-marketing surveillance (PMS) period for the original drugs, which are being targeted by the generic companies, is set to end in 2024 and 2025, respectively. The release of their generic versions will then depend on whether they can avoid the originals’ patents. According to industry sources on the 14th, approvals for bioequivalence tests using K-CAB and Vocinti as reference drugs have been continuing this year. In the case of bioequivalence tests filed for the approval of K-CAB generics, starting with SamChunDang Pharm in May, Kukje Pharm, Jinyang Pharm, and Hutecs Korea have been approved to conduct bioequivalence tests with K-CAB. Hanlim Pharm was first to receive approval to conduct a bioequivalence test for its Vocinti generic on September 12th. In terms of the expiry of the PMS term, K-CAB's generics will likely be approved first. K-CAB’s PMS term expires on July 4, 2024, and Vocinti on March 28, 2025. The PMS system also serves a data protection function, therefore generic can only be approved after the end of the PMS period. However, the market release date may be delayed much further as the patent term for the original drug is in effect until 2036. K-CAB and Vocinti In the case of K-CAB, its substance patent expires on August 25, 2031, and its crystalline patent on March 12, 2036. Over 70 generic companies have filed for trial to avoid the two patents. If the companies succeed in avoiding both patents, the release date of K-CAB generics may be pulled forward. Patent challengers are focusing on avoiding the extended term of K-CAB’s substance patent. If they succeed, they may launch their generic versions after December 6, 2026, the expiration date that had been set before HK Inno.N filed to extend their patent term. On the other hand, if the companies fail, the first generic may only be launched in 2036 after the crystalline patent expires, or in 2031 if the companies only succeed in avoiding the crystalline patent. In the case of Vocinti, one patent expires on December 20, 2027, and the other patent expires on November 17, 2028. No pharmaceutical companies have filed patent challenges yet. But in terms of patent duration, Vocinti ‘s generic can hit the market sooner. However, unlike K-CAB, Vocinti has not been released yet and is non-reimbursed in Korea. If Vocinti is not released in the Korean market before the end of the PMS period, its marketing authorization may be revoked. In this case, there is a possibility that the generic will have difficulty procuring the control drug needed for the bioequivalence test. Also, if Vocinti remains non-reimbursed, the latecomer will have to go through the process of reimbursement listing as a drug subject to pricing negotiations, so it may be reimbursed later than K-CAB generics which will receive a set reimbursement price. Therefore, the launch of the generic drugs will ultimately depend on whether or not the companies succeed in avoiding their patent. An industry official said, "K-CAB had posted sales of KRW 100 billion, so generic companies are very eager to release their generic versions of the drug as soon as possible as its commercial viability has been proven. However, if the companies do not succeed in avoiding the patents, their launch date may be delayed, therefore, releasing a Vocinti generic can also be a good alternative.”
- Company
- nAMD tx Vabysmo can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 15, 2023 05:33am
- Vabysmo, a treatment for macular degeneration, can be prescribed at general hospitals. According to related industries, Vabysmo, Roche Korea's first bispecific antibody treatment for eye diseases, passed the drug committee of medical institutions such as Konyang University Hospital, Kim Eye Clinic, Nune Eye Clinic, Inje University Busan Paik Hospital, and Chung-Ang University Hospital. Roche is also conducting landing procedures at medical institutions across the country. As Vabysmo is currently negotiating drug prices with NHIS, it is expected to be linked to actual prescriptions if it is listed on the insurance benefit list. Vabysmo, approved for the treatment of neovascular or wet age-related macular degeneration and vision damage caused by diabetic macular edema, is a new drug with a differentiated mechanism that targets both VEGF-A and Ang-2, the main disease pathogenesis. It is the first intraocular injection that enables administration at 4-month (16-week) intervals through approved clinical research based on a new mechanism, which can reduce the treatment burden on patients by administering a small number of injections. Vabysmo is administered by intravitreal injection once a month (4 weeks) at the recommended dose of 6mg (0.05ml) for the first 4 doses. Afterward, nAMD patients without disease activity are administered once every 4 months (16 weeks). In patients with DME, the dosing interval can be increased in 4-week increments up to a maximum of 4 months (16 weeks) at the discretion of the medical staff. Meanwhile, Vabysmo has proven its effectiveness through a total of four phase 3 studies, including clinical studies of TENAYA and LUCERNE related to nAMD treatment and YOSEMITE and RHINE related to DME treatment. Among them, the TENAYA and LUCERNE studies are non-inferiority trials compared to Vabysmo and Eylea in the treatment of nAMD. As a result of the study, Vabysmo treatment at intervals of up to 4 months (16 weeks) in the first year of treatment showed a non-inferior level of visual acuity improvement compared to Eylea treatment at 2-month (8 weeks) intervals. In particular, in the first year of treatment, approximately 80% of the Vabysmo treatment group maintained a dosing interval of more than 3 months (12 weeks). The recently announced results of the second year of treatment showed that more than 60% of patients maintained a dosing interval of 4 months (16 weeks), raising expectations that it would provide continued clinical benefits to patients.
- Company
- Gilead Sciences Korea appoints Jae-Yeon Choi as new head
- by Eo, Yun-Ho Sep 15, 2023 05:33am
- Gilead Sciences Korea announced it has appointed Jae-Yeon Choi as its new General Manager as of October this year. The position had remained vacant for the past 6 months. At Gilead Sciences Korea, the new GM Choi will oversee Gilead's business operations in Korea, and promote businesses in the fields of HIV, viral hepatitis, COVID-19, antifungal, and oncology. After acquiring an MBA from Kellogg School of Management at Northwestern University, Choi accumulated over 20 years of experience in Eli Lilly and MSD, holding leadership roles in various functions including commercial, human resources, drug pricing, and policy, in various regions including the United States, China, and Taiwan. Before joining Gilead, Choi had served as the Managing Director of MSD Taiwan, where she achieved remarkable business growth for 2 consecutive years. She joined MSD Korea in 2017 as an Executive Director of External Affairs, where she achieved excellent results in the field of immune-oncology drugs. Before entering MSD, she had worked at Eli Lilly for 11 years, serving various positions including as a Marketing Director at the company. Choi said, “I am pleased to be able to join Gilead Sciences Korea and carry on the company’s mission of improving and saving the lives of patients in Asia. In addition to our team, I will work with Gilead executives and employees in Asia to provide better treatment solutions for patients suffering from HIV, viral hepatitis, fungal infections, and cancer.”
- Policy
- Imfinzi recieves RSA reevals and seeks to extend reimb
- by Lee, Tak-Sun Sep 15, 2023 05:32am
- The Risk-Sharing Agreement (RSA) reevaluations for term renewal are underway for Imfinzi Inj (durvalumab, AZ), which applied for reimbursement extensions to its biliary tract cancer indication. The reevaluations are being conducted in preparation for the RSA contract renewal set for March next year. According to industry sources on the 14th, AstraZeneca Korea recently submitted the pharmacoeconomic evaluation data for Imfinzi to the Health Insurance Review and Assessment Service for RSA renewals. Korea's RSA system requires companies to submit PE evaluation data for reevaluation within 1 year of RSA term expiry. The company signed an RSA for Imfinzi, and the drug was listed for reimbursement in April 2020 for patients with locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based concurrent chemoradiation therapy (CRT). The drug was reimbursed through two types of RSA: Refund-type and Expenditure cap-type RSA. The RSA term expires on March 31st. The company refunds a certain proportion of the claims amount back to NHIS, and if the claims amount exceeds the expected amount, a certain proportion of the exceeded amount is also returned to the NHIS. The expected claims amount at the time was KRW 22 billion. Imfinzi’s sales last year, based on IQVIA, amounted to KRW 52.4 billion. The company has recently been working to extend reimbursement to biliary tract cancer. Imfinzi’s biliary tract cancer indication was approved by the Ministry of Food and Drug Safety in November last year, as a first-line treatment for locally advanced or metastatic biliary tract cancer in combination with gemcitabine and cisplatin. With the approval, Imfinzi became the first new standard therapy introduced to the field of biliary tract cancer in 12 years. Imfinzi’s effect as a combination therapy was demonstrated through Phase III TOPAZ-1 which was conducted on 685 treatment-naïve patients with unresectable locally advanced or metastatic biliary tract cancer. Results showed that the Imfinzi arm (Imfinzi+gemcitabine+cisplatin) showed a 20% improvement in overall survival (OS) versus the placebo arm (placebo+gemcitabine+cisplatin). At 2 years, the survival rate in the Imfinzi arm was 24.9% compared with the 10.4% in the placebo arm. The median progression-free survival (PFS) was 7.2 months for the Imfinzi arm, which was a 25% improvement compared to. the 5.7 months in the placebo arm. Whether AstraZeneca will be able to kill two birds with one stone and renew its RSA and extend reimbursement to the biliary tract cancer indications remain the focus of industry interest.
- Policy
- Reevaluation difficult for Ildong and Abbott’s Lypsta
- by Lee, Tak-Sun Sep 14, 2023 06:40am
- There are slightly ambiguous aspects to Abbott Korea's ‘Lypsta Plus Tab,’ whose drug price was lowered on the 5th after the insurance price ceiling reevaluations. This drug was jointly developed between Abbott Kore and Ildong Pharmaceutical, and the bioequivalence test data among the clinical trial data was submitted by Abbott. Perhaps for this reason, Abbott opposed the price cut and filed for a stay of execution, due to which the drug price will be maintained as is the 28th. According to industry sources on the 13th, The price of Lypsta Plus Tab’s 10/5mg formulation had been lowered from KRW 895 to KRW 761; the 10/10mg formulation from KRW 1,251 to KRW 1,063; and the 10/20mg formulation from KRW 1,263 to KRW 1,074. However, the execution of the price cut is set to be suspended until the 28th due to Abbott’s application for a stay of execution. The drug is a combination drug for hyperlipidemia that combines rosuvastatin and ezetimibe. Lypsta and 'Droptop Tab’ were jointly developed by Ildong and Abbott. During the reevaluations conducted this time, a price reduction could only be avoided if the company proves that it has conducted its own bioequivalence test or clinical trial, even for jointly developed products, In a Q&A session before the reevaluation, HIRA said, “Even for drugs that were developed through joint clinical trials, in-house bioequivalence test or an in-house clinical trial must be conducted, and data of such proof be submitted to meet the standard requirements. In the case of products approved through clinical trials, the clinical trial has to be conducted under the supervision of the marketing authorization holder (pharmaceutical company).’ However, HIRA added that the standard requirements do not apply if the product that was approved through joint clinical trials is the first product to be listed for reimbursement in Korea. However, Lypsta is not the first product reimbursed in its class. Rosuzet is the first product that was ever listed, and Lypsta was released two years after Rosuzet’s reimbursement. However, HIRA’s self-bioequivalence test verification requirements are a little ambiguous. This is because the two companies divided the clinical trials and shared the results with each other. For example, Ildong Pharmaceutical submitted drug interaction test and therapeutic confirmatory clinical trial data among quality assessment data, non-clinical trial data, and clinical trial data, and Abbott submitted the biopharmaceutics test data among clinical trial data. Excerpt from Lypsta In other words, Abbott conducted the Phase I bioequivalence test, and Ildong conducted the Phase III therapeutic confirmation trial. The two items were shared between the companies and the drug was approved in December 2017. This aspect is indicated in the approval report disclosed by the Ministry of Food and Drug Safety. It is understood that health authorities concluded that although there was a bioequivalence test submitted by Abbott, the core clinical trial was conducted by Ildong Pharmaceutical, its joint development partner, therefore the data did not meet the standard requirements. During reevaluations, Ildong Pharmaceutical's 'Droptop’ was excluded from receiving drug price cuts for meeting the standard requirements. With an administrative suit in place, whether Lypsta Plus Tab meets the standard requirements is expected to depend on the court's judgment in the future.
- Company
- Wellysis receives FDA approval for electrocardiograph
- by Nho, Byung Chul Sep 14, 2023 06:40am
- Access Bio (CEO Choi Young-ho), a global in vitro diagnostic company, announced on the 13th that Wellysis' patch-type electrocardiograph S-Patch Ex, with which it formed a strategic partnership last year, has received approval from the U.S. Food and Drug Administration (FDA). Access Bio previously made an investment by acquiring redeemable convertible preferred stock issued by Wellysis through Mason Healthcare New Technology Investment Association No. 2. The market expects that the solid global distribution network of Access Bio, headquartered in the United States, will play a significant role in Wellysis' entry into the United States through this approval. In the future, Access Bio plans to expand its business model to enable real-time monitoring, analysis, tracking, and remote patient management by combining Wellysis' platform technology with its diagnostic products. Through this, we plan to leap forward as a digital healthcare platform service company by maximizing IT convergence synergy in ‘field-centered diagnosis’. An Access Bio official said, “Many domestic healthcare startups are trying to enter the United States, the largest market, but in reality, it is not easy due to the high entry barrier,” adding, “On the other hand, Access Bio, headquartered in the United States, has advanced technology and global supply capabilities during the COVID-19 pandemic. “It has already been recognized through the pandemic,” he said confidently. Wellysis is a digital healthcare company that spun off from Samsung SDS in 2019 and currently provides S-Patch-EX to 14 countries. S-Patch, which weighs only 9g, is a small and lightweight cable-shaped patch design that collects accurate ECG waveforms while minimizing noise. Continuous measurement is possible for up to 100 hours without battery replacement, so the arrhythmia detection rate is high. Inside the device, Samsung Semiconductor's Bio-Processor, a chip specializing in biosignal collection, is installed, allowing the electrocardiogram to be collected and processed effectively. The global wearable electrocardiogram test market is estimated to be worth more than 1.5 trillion won by 2022, of which the US market accounts for about 55%. Access Bio has also recently invested in CuraPatient, a US digital healthcare company, and is looking forward to further accelerating its digital healthcare business with Access Bio's US FDA approval. Access Bio is a KOSDAQ-listed American company in which PharmGen Science acquired the majority stake and has been recognized for its high technology, including being recently selected as a research company for the development of next-generation diagnostic kits by the National Institutes of Health.
- Policy
- [Reporter's view] Focus on non-face-to-face contraceptives
- by Lee, Jeong-Hwan Sep 14, 2023 06:37am
- The Ministry of Health and Welfare will hold a public hearing to prepare a reform plan for the non-face-to-face medical treatment pilot project from 2 p.m. today (14th). After disclosing the status of the pilot project, the plan is to hold a panel discussion to hear opinions from the medical community, pharmaceutical industry, platform app industry, and patient and consumer groups. The Ministry of Health and Welfare has not officially commented on the direction of the pilot project reform. Some media outlets only 'leaked' a statement that they are considering a reform plan to expand the scope of non-face-to-face first visitation. For this reason, some criticize that “the Ministry of Health and Welfare is busy using the media to gauge public opinion in order to expand the implementation of the non-face-to-face medical treatment pilot project.” Some even point out that rather than starting administration based on specific policy implementation grounds, they are belatedly formulating policies that suit their tastes after being conscious of public opinion. Non-face-to-face medical treatment is a policy that Minister of Health and Welfare Cho Gyu-hong and Second Vice Minister Park Min-soo have repeatedly emphasized over the years as to the need for institutionalization, but I wonder why they are so unsure about it. First of all, the Ministry of Health and Welfare plans to prepare a reform plan after holding a public hearing on the non-face-to-face medical treatment pilot project, but there are already media reports that there is a strong direction to expand the permitted time zone for the non-face-to-face first treatment to nights, late at nights and public holidays, and to expand the permitted area to areas with a shortage of medical institutions. The purpose is to enable residents in vulnerable areas who are not guaranteed access to medical care in the current pilot project to benefit from non-face-to-face medical treatment. There is some criticism of the direction of the Ministry of Health and Welfare's reorganization that it is trying to allow unlimited non-face-to-face first visits by modifying the 'time zone' regulations, but if evidence is presented that the truly unreasonable reality of pilot projects can be improved, there is some sympathy with the direction of the Ministry of Health and Welfare's reorganization. It can be expressed. This means that the Ministry of Health and Welfare should specifically present cases where non-face-to-face treatment is not available due to a lack of medical institutions nearby, even though the area is not remote, such as islands or mountainous regions. The Ministry of Health and Welfare has not made a single comment on how to manage the side effects that are concentrated in non-covered high-risk prescription drugs such as morning-after contraceptives, isotretinoin-based acne treatments, and finasteride-based hair loss treatments, which have been pointed out several times as representative side effects of non-face-to-face therapy. The Ministry of Health and Welfare only reiterated its position that it would discuss expanding the scope of prescription-restricted drugs through a pilot project advisory group meeting but did not present any measures or blueprints on how to manage the concentration of prescriptions for high-risk medications. Even after the implementation of the pilot project, non-face-to-face treatment prescription patterns or statistics are not disclosed. Due to this situation, pharmacist professional organizations such as the Seoul Pharmaceutical Association and the Korean Pharmaceutical Association are individually calculating and publicizing their own statistics. The justification for implementing and institutionalizing the non-face-to-face medical treatment pilot project announced by the Ministry of Health and Welfare is ‘strengthening medical access for medically vulnerable groups and residents.’ It is questionable whether the concentration of non-covered prescriptions for morning-after contraceptives, acne medicines, and hair loss medicines is in line with the Ministry of Health and Welfare's goal of strengthening the medical rights of the medically vulnerable. Even in this situation, the Ministry of Health and Welfare is considering improvement measures to expand the scope of initial and repeat visits for non-face-to-face medical treatment, and it is highly likely that the Ministry of Health and Welfare will continue to mention the need to expand the scope at the public hearing to be held today. The fact that the Ministry of Health and Welfare has not made any comments regarding regulatory measures for non-covered prescription drugs influenced Democratic Party lawmaker Jeon Hye-sook to come to the conclusion that she suspected 'collusion between platform operators and the government.' The National Assembly and medical groups have been calling for several years since the COVID-19 pandemic to address the side effects of unnecessary medications being excessively prescribed through non-face-to-face treatment and platforms, but the Ministry of Health and Welfare has not made any specific comments. Vice Minister Park Min-soo strongly opposed Rep. Jeon Hye-sook's point that the Ministry of Health and Welfare is pushing for non-face-to-face medical treatment to save the platform. Rather than protesting, the first priority is to create an alternative that can solve the problem of wasting health insurance funds through excessive treatment and overprescription and increasing the risk of side effects from medicines for patients. Platforms have gained too much power and have grown into 'super apps', standing over medical institutions and pharmacies to gather opinions on how to address side effects that could damage the healthcare delivery system. The public hearing for the non-face-to-face medical treatment pilot project should be held in a format where the Ministry of Health and Welfare directly discloses the prescription statistics and patterns that occurred during the guidance period over the past three months, while also collecting opinions on solutions that will erode concerns about the concentration of prescriptions for high-risk non-reimbursed drugs and concerns about platform side effects. It should not just be a formality and a basis-building effort to expand the scope of non-face-to-face first and return visits. The slogan that face-to-face treatment is the principle and non-face-to-face treatment is an auxiliary means was put forward every time the Ministry of Health and Welfare insisted on the need to implement pilot projects and legislate. The Ministry of Health and Welfare is breaking the principles of face-to-face treatment by discussing a pilot project reform plan that blindly expands the scope of first and repeat visits without any valid basis.
- Company
- Hanmi will focus on anti-obesity drugs... from GLP-1 to DTx
- by Kim, Jin-Gu Sep 14, 2023 06:37am
- Hanmi Pharm Hanmi Science has pointed to obesity management as a future growth engine for the Hanmi Group. Hanmi Science plans to select 5 types of pipelines, including a new GLP-1 obesity treatment, and operate the project under the name, 'H.O.P (Hanmi Obesity Pipeline)'. The H.O.P project includes 5 types of treatment that include ▲'efpeglenatide', which is being developed as an economical GLP-1 obesity treatment customized for Koreans, and ▲ a 'next-generation triple agonist (LA-GLP/GIP/GCG)' that simultaneously activates GLP-1, glucagon, and GIP. In particular, Hanmi’s LA-GLP/GIP/GCG is a candidate substance that uses the company’s next-generation independent platform technology rather than the existing biodrug platform ‘LAPSCOVERY,’ Hanmi Science explained that it is a different substance from the ‘efocipegtrutide (LAPSTripleagonist)’ that is currently undergoing global Phase IIB clinical trials as a treatment for NASH. Based on the effects confirmed through preclinical studies, Hanmi Science expects that its LA-GLP/GIP/GCG substance will be able to demonstrate strong efficacy comparable to the weight loss effect (about 25%) of surgical therapy. In addition, the company is also developing a new biodrug that can prevent the loss of muscle mass that may occur from the use of GLP-1 agents, improving the quality of weight loss, while helping to suppress the weight rebound. In addition, the company has also identified candidate substances that can improve eating disorders like binge eating. In addition, the company has started to develop oral peptide platform technology plans and saw its potential for commercialization and will start development of an oral GLP-1 agent as soon as possible. Hanmi Science also added that it plans to start working on developing digital therapeutics. Hanmi Science believes that digital therapeutics can further increase the weight loss effect of the treatments administered and taken by patients, strengthen the safety of drugs, and help correct the patients' lifestyles. Furthermore, the company plans to sequentially introduce a series of ‘personalized treatments' that can support the patient’s obesity treatment cycle that covers the whole range of treatments from obesity treatment to weight gain prevention and post-weight-loss management. Hanmi Science explained that a large number of researchers from Hanmi Pharmaceutical’s R&D Center, New Product Development Headquarters, Strategic Marketing Team, Pyeongtaek Bio Plant, Paltan Pharmaceutical Research Center, and Hanmi Fine Chemical (raw material company), are all participating in this H.O.P project. In particular, the company emphasized that company-wide efforts are underway to establish the H.O.P. project as Hanmi’s next-generation core growth engine based on the leadership of the recently appointed Director of Strategic Planning, Ju-Hyun Lim. An official from Hanmi Science said, “We expect the H.O.P project to become a new growth engine for Hanmi as it prepares to make another leap forward in celebration of its 50th anniversary.”
- Company
- SMA drugs Spinraza and Evrysdi complete pricing negotiations
- by Eo, Yun-Ho Sep 14, 2023 06:36am
- The spinal muscular atrophy (SMA) treatment ‘Evrysdi (risdiplam)’ finally passed the final hurdle to its reimbursement in Korea According to industry sources, both SMA treatments, Biogen Korea’s ‘Spinraza (nusinersen)’ and Roche Korea’s treatment ‘Evrysdi (risdiplam),’ reached a final agreement with the National Health Insurance Service after drug pricing negotiation. The discussions were being made for Spinraza's reimbursement extension and the new listing of Evrysdi. As a result, the two drugs are expected to be listed for reimbursement starting next month (October) if no unexpected events arise. The current reimbursement standard for Spinraza is 5q which satisfies all of the following criteria: ▲genetic diagnosis of deletion or mutation of the 5q SMN-1 gene ▲appearance of SMA-related clinical symptoms and signs at age 3 or younger ▲case not using a permanent ventilator He is a patient with spinal muscular atrophy. Spinraza is currently reimbursed for the treatment of 5q Spinal Muscular Atrophy in patients that satisfy all of the following conditions: ▲received genetic diagnosis of 5q SMN-1 deficiency or mutation; ▲had onset of SMA-related clinical symptoms and signs at the age of 3 or less; and ▲ are not using permanent ventilators. In other words, only patients whose symptoms have been found before the age of 3 were allowed reimbursement until now. The reimbursement extensions discussed this time aimed to expand that age limit to ‘the age of 18 or less.’ In the case of the oral SMA drug Evrysdi, the drug will be also listed for reimbursement under the same reimbursement standards set for Spinraza. Discussions on the reimbursement and reimbursement extension of SMA treatments had seemingly started to make rapid progress due to rising demand for the abolition of Spinraza’s treatment discontinuation standards, however, the discussions became prolonged as the requested range of reimbursement was broader than what the government and pharmaceutical companies had expected. At the time, the government had planned to proceed with discussions on the reimbursement listing of Evrysdi after making an agreement on the scope of extended reimbursement for Spinraza, but both drugs have entered the final negotiations stage. The decision for the two drugs had been delayed once.
