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- 2026-04-10 15:36:51
- Policy
- Rinvoq also succeeded in expanding youth atopy benefits
- by Lee, Tak-Sun Mar 24, 2023 05:48am
- Rinvoq 15mg will be covered from April as an adolescent atopy treatment. On the same day as the biologic drug Dupixent, the youth atopic treatment benefit is applied. It is the first among JAK inhibitors to obtain reimbursement for the youth indication before Cibinqo, a competitor drug. According to the industry on the 22nd, Rinvoq SR 15mg will be reduced by 5.1% from 21,085 won to 20,100 won by voluntarily lowering the upper limit of the salary. In addition to the reduction in the upper limit, benefits are also applied to the treatment of atopic dermatitis in adolescents. This drug was covered only for the treatment of moderate to severe atopic dermatitis in adults. As a result, it is expected that the treatment accessibility of adolescent atopic dermatitis patients will be improved. It is known that Rinvoq SR 15mg sought to lower the drug price according to the expansion of the range of use for the application of youth benefits. Although the upper limit of the range of use is adjusted within 5%, it is interpreted that the drug price cut was widened voluntarily, and the youth benefit was applied earlier than Cibinqo, a competing drug. From April, Dupixent will also be covered for atopic dermatitis in children and adolescents. The insurance authorities decided to apply Dupixent PFS 200mg and Dupixent PFS 300mg not only to adults with severe atopic dermatitis but also to children and adolescents aged 6 years or older through refund-type, total-limit, and initial treatment cost-reimbursement contracts. Pfizer's Cibinqo, a similar drug to Rinvoq, is currently negotiating with the NHIS to receive coverage as a treatment for atopic dermatitis in adults and adolescents. As the pediatric and adolescent atopic dermatitis treatment market expands, competition among related drugs is expected to intensify.
- Opinion
- [Reporter's view]Vaccine self-sufficiency rate to 80%
- by Kim, Jin-Gu Mar 23, 2023 04:45am
- In 2013, 10 years ago, the Ministry of Health and Welfare distributed a press release. The plan is to foster the domestic vaccine industry and raise the self-sufficiency rate of the National Immunization Vaccine to 80% by 2020. At the time, among the 28 types of National Immunization Vaccines, only 8 types of vaccines were self-sufficient, but the government's plan was to expand this to 22 types within 7 years. Only two years later, the plan to achieve 80% vaccine self-sufficiency was partially modified. The Ministry of Food and Drug Safety secretly delayed the target achievement from 2020 to 2022 at the Biopharmaceutical Global Growth Policy Forum. Four years later, the plan changed once more. The Ministry of Food and Drug Safety has delayed the goal of achieving the goal by one more year, to 2023. At the same time, the self-sufficiency rate target was lowered from 80% to 75%. Then what about the current situation? According to the KPBMA, the domestic National Immunization Vaccine self-sufficiency rate is only 50% as of 2021. This means that only 14 out of 28 types can be produced domestically. This is because many of the vaccine stocks are dependent on foreign imports. There are only six vaccines that domestic pharmaceutical companies can manufacture and supply from raw solutions to finished products, including hepatitis B, influenza, chickenpox, and tetanus/diphtheria. The self-sufficiency rate is less than 30%. Vaccine self-sufficiency is a very old issue. However, progress toward resolving the problem has been slow. The order that the vaccine self-sufficiency rate should be increased is only repeated as an empty cry every year around the state audit. Over the past three years, while the corona crisis has been prolonged, we have realized how desperate it is to secure vaccine sovereignty. As SK Bioscience succeeded in developing its own COVID-19 vaccine, it also confirmed its development capabilities. All that remains now is the motivation to drive the development and production of the National Immunization Vaccine by private companies. The solution of affordable pricing for the National Immunization Vaccine has been around for a long time. However, the slogan of securing vaccine sovereignty burns for a very short time and then goes out. While more than 10 years have passed, the plan to achieve 80% self-sufficiency in essential vaccines remains only a lofty goal. The corona crisis is turning into an endemic. In other words, great momentum is passing by to achieve the ambitious goal of securing vaccine sovereignty. We must act now. It is difficult to achieve this goal with only the pure will and efforts of private companies. It is difficult to attract participation from private companies through indirect means such as supporting vaccine R&D or improving licensing and regulation. There is a quick and sure solution called 'reasonable compensation'. Unless this solution is introduced, it is clear that the lofty goal will be revised once again before the year is out.
- Policy
- Pharma industry makes a request to MOTIE and MOEF
- by Nho, Byung Chul Mar 23, 2023 04:45am
- Public opinion has been rising for the government to revoke the designation of botulinum toxin as a national core technology. The rise of this public opinion brings more meaning as the request was made by Korea Pharmaceutical and Bio-Pharma Manufacturers Association, which represents the industry. Breaking away from lesser movements that had been made by individual companies or internally within the Ministry of Trade, Industry, and Energy, KPBMA has taken entitative and requested the above for industry development and the future. According to industry sources, KPBMA sent an opinion statement last week requesting the MOTIE to revoke the national core technology designation it had set for the manufacturing technology of botulinum toxin strain and products. In addition, within this week, the association plans to deliver an improvement proposal to the Ministry of Economy and Finance’s Economic Regulatory Innovation TF that requests the revocation of the designation of the national core technology on toxins. KPBMA submitted the petition to MOEF to revoke the toxin national core technology destination request to MOEF because the ministry had organized an 'Economic Regulation Innovation TF' to foster and support the industry, which team listens to the voices of the field, and reflects them in actual policy and institutional improvement. The TF consists of 13 private members and 12 government members and is jointly led by the Deputy Prime Minister of Economy and Finance and a private expert. An industry official said, “Since a written opinion has already been submitted to MOEF, the agenda will be discussed at MOEF’s TF meeting. After setting the direction, official discussions will be made between the two ministries on the withdrawal of the national core technology designation to toxins.” The designation, maintenance, and cancellation of toxin as a national core technology is regarded a sensitive issue for which considerable debate has taken place even within MOEF. The MOTIE Minister can designate or drop the designation of a certain technology after deliberation with the Industrial Technology Protection Committee (which consists of less than 25 members including the chair) under Article 9 ① and ③ of relevant laws. However, the agenda is busy being discussed due to the strong difference in opinion among the 25 committee members, which is why the committee is having trouble setting the specific direction of modifications, and the technology is far from originality and lacks progressive superiority. The representative key core technology designations in Korea include the following technologies: ▲Semiconductor (DDI design technology for OLED to operate driving display panels); ▲Electricity and electronics (design, process, manufacturing, and evaluation technology of ultra-high-performance electrodes or solid electrolyte-based lithium secondary batteries); ▲Display (AMOLED panel design, process, manufacturing, and operating technology). The technologies above are widely accepted as advanced technologies, however, the prevailing opinion is that toxins do not require advanced technology as the toxin strains are more discovered and purchased than developed. As the safety of these toxins can be ensured with the existing management and supervision of the health authorities, the industry has been voicing that it is time for the government to actively prepare a blueprint (revocation of national core technology) on toxins to increase domestic demand and exports. In the absence of general knowledge and information, concerns about the threat of terrorism due to the chemical weaponization of toxins could be raised, but it is a consistent opinion in academia that it is virtually impossible to weaponize the toxins in general pharmaceutical/bio-pharmaceutical research institutes or the private sector. In this regard, another industry official said, "The national core technology designations are made to strengthen the competitiveness of domestic companies by preventing and protecting illegal leakage of industry technology and to contribute to national security and national economic development. However, such toxins are already being approved, manufactured, and sold in a consigned CDMO format among domestic biopharmaceutical companies after they sign joint sales contracts. Therefore, its value as a national core technology is lessening in value.” Meanwhile, KPBMA is taking active steps to revitalize the industry through cooperative governance, therefore, the specific direction on whether to maintain and revoke toxins as national core technology may be determined as early as this year.
- Policy
- Legislation requiring submission of botulinum strains
- by Lee, Jeong-Hwan Mar 23, 2023 04:45am
- A bill that makes it mandatory to submit genetic information of bioterrorism infectious diseases such as botulinum toxin to domestic quarantine authorities and cancels the possession permit if not submitted did not pass the Health and Welfare Committee of the National Assembly held on the 22nd. If the bill is passed, it may lead to excessive regulation of trade secrets and property values of pharmaceutical companies with botulinum toxin strains, and retroactive application of the submission obligation to pharmaceutical companies prior to the enforcement of the law may be intrusive or cause trust protection problems. This is the result of reflecting the opinion of the expert member's office of the Welfare Committee that a policy judgment on legislation is necessary. The members of the subcommittee on the bill sympathized with the expert's point out that corporate trade secrets and property values could be excessively regulated while acknowledging the necessity of the bill. The bill has emerged as a controversial bill in the pharmaceutical industry as it contains a retrospective application clause that imposes the obligation to submit genetic information such as strains and base sequences to licensees and pharmaceutical companies that have obtained domestic marketing permission and have botulinum toxin before implementation after passing the National Assembly. Pharmaceutical companies with botulinum toxin have mixed opinions about the passage of the bill, but the opposing pharmaceutical companies are in the position that the legislation, such as the source of the strain and the submission of the base sequence, is ineffective given that the botulinum toxin strain is a natural substance. It is pointed out that Medytox and Daewoong Pharmaceutical are in a dispute over whether to steal botulinum strains in Korea, so if the bill is passed, disputes between pharmaceutical companies may escalate. The amendment to the Infectious Disease Prevention and Management Act, proposed by Choi Jong-yoon, a member of the Democratic Party, requires those who possess a total of eight types of bioterrorism infectious disease pathogens, including botulinum bacillus, to submit the pathogens to the Director of the Korea Centers for Disease Control and Prevention within 30 days from the date of possession. It also contains a provision allowing the director of the Korea Centers for Disease Control and Prevention to cancel the permit to possess the pathogen of an infectious disease of bioterrorism, even though it must be submitted within 60 days from the date of request for resubmission. The Director of the Korea Centers for Disease Control and Prevention checked whether the submitted bioterror infectious disease pathogens and the bioterror infectious disease pathogens approved for possession matched and made it possible to build a database. The purpose is to strengthen the safety management system for bioterror infectious disease pathogens. While acknowledging the necessity of the bill, the expert pointed out that it is necessary to judge whether there is room for excessive regulation on companies and research activities if the state management of pathogens, which are corporate trade secrets and property values, is strengthened. In particular, it was considered that it was necessary to review whether there is room for less invasive means to be applied and whether there is a possibility of specifying a legitimate reason for the content that allows the cancellation of the possession permit rather than an administrative fine as a sanction in the case of non-submission of pathogens of biological infectious diseases. Regarding the clause imposing the obligation to submit bioterror infectious disease pathogens of previous holders, the expert committee's office believed that there should be a policy judgment on whether the database establishment would pose an additional burden or protection of trust in the related industry. “The bioterrorism database, in which the state analyzes and builds genetic information for the submitted pathogens, is planned to be used for the purpose of preparing for and responding to bioterrorism, which requires strict security management", the director stated. As the legislative subcommittees decided to continue the review, the bill requiring the submission of botulinum strains was a chance for future legislative review.
- Company
- Neurofibromatosis Tx Koselugo makes progress for reimb
- by Eo, Yun-Ho Mar 23, 2023 04:45am
- Finally, reimbursement discussions for the new neurofibromatosis drug ‘Koselugo’ has made some progress. Results showed that AstraZeneca Korea’s new neurofibromatosis drug has passed the review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Standard Subcommittee recently. Therefore, its reimbursement can now be deliberated by the Drug Reimbursement Evaluation Committee. After the drug received a non-reimbursement decision from DREC in March, the company worked promptly and prepared the supplementary data to restart listing discussions for the drug. As NF1 is a rare disease area with no available treatment option, whether Koselugao will be able to receive reimbursement approval this time remains to be seen. Until now, patients had to rely on symptomatic treatment for neurofibromatosis due to the lack of an appropriate treatment option. Neurofibromatosis is a rare disease, and 85% of the patients with neurofibromatosis have neurofibromatosis type 1 (NF1), which is caused by a mutation in the neurofibromin tumor suppressor gene located on chromosome 17. The incidence of NF1 is approximately 1 in 3,000. Its first symptom is café-au-lait spots 1 to 3 centimeters in diameter early in life. Since then, the patients experience Optic nerve gliomas (brain tumors) at age 6, and scoliosis around age 6-10. In adulthood, lisch nodules, or iris hamartomas, occur predominantly in patients with NF1. If possible, treatment includes surgical removal of affected sites or chemotherapy and radiation therapy. However, most recur even after surgery, and as the patient must undergo a major operation, its treatment puts an immense burden on both the medical staff and the patient. Recurrence is even more frequent among pediatric patients, which means the patients must live with painkillers and often suffer from speech and movement disorders even after receiving several operations. Meanwhile, Koselugo was jointly developed by AstraZeneca and MSD. The drug blocks the activation of MEK to inhibit the growth of cell lines. The Phase II SPRINT study that became the basis for Koselugo’s approval showed that Koselugo reduced tumor size by over 20% in 68% of the patients that received Koselugo, and achieved its primary endpoint of ORR. Also, 82% of the patients that showed a partial response had sustained responses lasting at least 12 months. In contrast to the non-treated patients, half of which experience disease progression 1.5 years after diagnosis, only 15% of patients using Koselugo showed disease progression at year 3.
- Company
- Promoting the extension of the term of drug patents
- by Kim, Jin-Gu Mar 23, 2023 04:45am
- Previously, patentees could legally extend the duration of a patent unlimitedly, but the government's plan is to promote it up to 'up to 14 years'. According to the pharmaceutical industry on the 21st, the Korean Intellectual Property Office recently prepared an amendment to the Patent Act to reform the system for the duration of drug patent rights. The amendment is expected to be submitted to the National Assembly through legislative acts. In the current drug patent term extension system, there is no separate upper limit (cap). In addition to the essential patent period of 20 years, it extends the time taken for clinical trials and approval and approval of drugs. In other words, the duration of drug patents can be 21 years, 27 years, or 37 years in the '20+α' method. However, the United States and Europe set an upper limit on the additionally recognized period. This means that even if it took a total of 23 years for clinical trials, licensing, etc., only 14 years (USA) or 15 years (Europe) are recognized. On the other hand, Korea and Japan do not have a separate upper limit for this period. As a result, criticism has been constantly raised in the pharmaceutical industry that the patent holder's patent term is excessively long. As part of the evergreening strategy, the original company takes a strategy of registering a new patent and extending the total duration before the patent expiration date. It is criticism.
- InterView
- The rebate effect is not just employee deviation
- by Kim JiEun Mar 22, 2023 05:47am
- The pharmaceutical company, which was suspended from sales due to the confirmation of the salesperson's suspicion of providing rebates, argued that there was no reason for the disposition, saying that it was only an employee's deviance, but the court did not accept it. The Suwon District Court recently dismissed a request for cancellation of a disposition to suspend sales of pharmaceuticals filed by a pharmaceutical company against the Gyeongin Food and Drug Administration. The reason for the disposition of pharmaceutical company A is as follows. Mr. B, who was a salesperson at this company, provided a total of 41 million won worth of economic benefits to the hospital administration manager several times from October 2013 to January 2016. As the charges were confirmed, Mr. B received a summary order of a fine of 10 million won for violating the Pharmaceutical Affairs Act around February 2017. The Gyeongin Food and Drug Administration issued a three-month suspension of drug sales to Pharmaceutical Company A in October 2021, four years after going through the prior notification procedure. The reason for the disposition was in accordance with Mr. B's summary order. Regarding this disposition, Pharmaceutical Company A argued that there was no reason for the disposition and that the KFDA's disposition violated and abused its discretion. First of all, the pharmaceutical company said the reason why there is no reason for disposition, "(Rebate) is only Mr. B's personal deviation, and the company has never been involved." "There is a legitimate reason for not being a person who provided economic benefits, or for not being able to blame for the neglect of duty." “It was difficult for the company to know Mr. B’s rebate act, and it was only after four years had elapsed since the summary order, in this case, was finalized,” he said. Considering that the education was conducted and Mr. B's act was an aberrant act, this disposition violates the principle of proportionality and responsibility, and is illegal as it deviates from and abuses discretion.” However, the court completely refuted the claim of pharmaceutical company A. First of all, it was emphasized that Mr. B's kickback behavior was not regarded as Mr. B's individual act and that the company was also responsible for it. The court said, “Mr. B, who was an employee of a pharmaceutical company A, committed an act in this case in which he provided economic benefits to medical personnel, etc. in the process of carrying out sales duties entrusted by the company.” is ultimately vested in the company. The responsibility for the violation of administrative obligations that occurred in the process is also acknowledged as partly attributable to the company.” The pharmaceutical company said that it did not fulfill its obligations even if it provided education related to fair trade self-compliance to its employees. While pointing out that the 3-month suspension of business was not excessive as the company claims, the court also effectively reviewed the precedent in which the company was previously suspended for 3 months due to illegal kickbacks. The court said, "It is acknowledged that the company conducted regular CP (Compliance Program) training for its salespersons, but the contents of the training only seem to be of a general level." It is difficult to admit a legitimate reason that cannot be blamed for neglect of duty based on circumstances alone.” The court continued, “Although all of the 35 million won in cash that Mr. B provided to the hospital administration manager does not appear to be a rebate to promote the drug sales of this pharmaceutical company, considering the purpose of the case that the standard, in this case, did not determine the degree of disposition in proportion to the amount of the rebate. If so, it is difficult to conclude that the disposition, in this case, is unfair.” Company A’s claim is dismissed without reason.”
- Company
- Forxiga's generics will be suspended until the 7th
- by Kim, Jin-Gu Mar 22, 2023 05:47am
- Manufacturing and sales of Dong-A ST's SGLT-2 inhibitor-type diabetes treatment Dapapro are expected to be suspended by early next month. According to the pharmaceutical industry on the 20th, the Seoul Central District Court recently cited AstraZeneca's request for an injunction to prohibit infringement of patent rights filed against Dong-A ST. As a result, Dong-A ST will not be able to manufacture and sell Dapapro until the 7th of next month, when Forxiga's patent expires. Dapapro is a follow-on drug to Forxiga. Among the SGLT-2 inhibitors of Dapagliflozin, the original diabetes treatment, it is currently the only one listed as reimbursement, except Forxiga. In November of last year, Dong-A ST succeeded in avoiding part of the duration of the material patent for Forsyga alone in the first trial by using a 'prodrug' strategy. With this decision, Dong-A ST obtained the right to release a follow-on drug before the patent expiration of Forxiga. In December, Forxiga released Dapapro, a follow-up drug, for reimbursement. It was five months before the expiration of the Forxiga patent. AstraZeneca appealed to the Patent Court immediately after the first trial. At the same time, it filed an application for a provisional injunction requesting a ban on infringement of Dong-A ST's patent rights, including the manufacture and sale of Dapapro, until the second trial verdict. The Seoul Central District Court cited AstraZeneca's application for a provisional injunction. An official from AstraZeneca Korea said, "We welcome the decision of the Seoul Central District Court. Substance patents for active ingredients must be respected for the development of the pharmaceutical industry in Korea." We will work hard to do so,” he said.
- Company
- 10 years of the global launch of K-biosimilars
- by Chon, Seung-Hyun Mar 22, 2023 05:47am
- The cumulative exports of biosimilar products developed by Celltrion and Samsung Bioepis recorded 13 trillion won. Celltrion's Remsima is rapidly expanding its territory 10 years after entering the European market. Celltrion's biosimilars posted cumulative exports of 9 trillion won, and Samsung Bioepis' overseas sales of more than 4 trillion won. ◆Celltrion Health, accumulated exports of 9 trillion won by selling 4 similar types since 2013 According to the Financial Supervisory Service on the 22nd, Celltrion Healthcare's four biosimilars, Remsima, Remsima SC, Truxima, and Herzuma, posted a total of 1.71 trillion won in exports. It increased by 9.2% from the previous year and broke the record for the largest export. Celltrion Healthcare is an affiliate of Celltrion, and Celltrion Healthcare Holdings is the largest shareholder (24.3% stake). Celltrion Healthcare receives antibody biosimilar products from Celltrion and sells them to global distributors. Celltree Healthcare is selling four biosimilars in overseas markets: Remsima, Remsima SC, Truxima, and Herzuma. Remsima is a biosimilar product of Remicade. Remsima SC is a subcutaneous formulation of Remsima. Truxima and Herzuma are biosimilar products of anticancer drugs Mabthera and Herceptin, respectively. Last year, Remsima recorded the largest export of 859.3 billion won. It increased by 6.1% from 809.6 billion won in 2021 and produced the most exports since obtaining European permission in 2013. Despite intensifying competition in biosimilars, Remsima continues to increase exports as more than 100 countries obtained item approval last year. Remsima recorded exports of 145.3 billion won in 2013, and the cumulative amount of exports for 10 years until last year totaled 5,163.1 billion won. Remsima SC exported 236.9 billion won last year, more than double the previous year's 89.6 billion won. With only two products, Remsima and Remsima SC, the joint venture achieved 1.96 trillion won in exports last year. Remsima SC made its first export of 34.8 billion won in 2020 and recorded a cumulative export performance of 361.4 billion won over the past three years. Truxima showed exports of 436.5 billion won last year, down 4.9% from the previous year. It is the second consecutive year of decline since recording 786.8 billion won in 2020. It is analyzed that the growth rate has slowed somewhat as the competition for biosimilars intensified. Truxima posted its first export of 383.2 billion won in 2017 and achieved a total of 2.6148 trillion won in overseas sales over the six years until last year. Herzuma's export volume last year was 181.7 billion won, down 13.9% from the previous year. After posting overseas sales of 211 billion won in 2021, the growth trend has slowed down. Herzuma recorded a cumulative export performance of 865.6 billion won from 2017 to last year. Celltrion's four biosimilars jointly exported a total of 9.49 trillion won for 10 years from 2013 to last year. Samsung Bioepis is also breaking new records every year. Samsung Bioepis' operating profit was 231.5 billion won, up 20.1% from the previous year, and sales were 946.3 billion won, up 11.7% from the previous year. Both operating profit and sales are the highest since its launch in 2012. Sales increased by 21.7% in two years from 777.4 billion won in 2020, and operating profit increased by 59.6% during the same period. The operating profit to sales ratio last year was 24.5%, the highest ever. Starting with the Enbrel biosimilar in January 2016, Samsung Bioepis received approval for six and five biosimilars in Europe and the US, respectively. Biosimilars of five biosimilars of Samsung Bioepis, Enbrel, Remicade, Humira, Herceptin, and Lucentis, have been approved in Europe and the United States. In Europe, it has additionally obtained approval for the sale of Avastin biosimilars. Samsung Bioepis is selling five biosimilars in Europe and three biosimilars in the US. Samsung Bioepis started selling Enbrel and Remicade biosimilars in Europe in 2016. In 2018, it introduced biosimilars to Herceptin and Humira markets and started selling Avastin biosimilar AYBINTIO in Europe in 2021. In the US, among the five licensed products, Remicade biosimilar RENFLEXIS was launched in the US market in 2017, and Herceptin biosimilar Ontruzant was launched in the US in 2020. Last year, it started selling Lucentis biosimilar BYOOVIZ in the US. Established in 2012, Samsung Bioepis generated sales of 43.7 billion won for the first time in 2013. In 2016, when the biosimilar overseas targeting began in earnest, it recorded sales of 147.5 billion won, and has continued to grow every year since. Since its launch in 2012, Samsung Bioepis has recorded cumulative sales of 4,311.2 billion won. Most of Samsung Bioepis' sales come from overseas sales of biosimilars or royalties. Domestic sales volume is negligible. According to IQVIA, a pharmaceutical research institute, Samsung Bioepis' five biosimilars sold a total of 42.5 billion won last year. In other words, the biosimilars of Celltrion and Samsung Bioepis have exported more than 13 trillion won in total over the past 10 years.
- Company
- Dupixent likely to expand reimb to pediatrics from April
- by Eo, Yun-Ho Mar 22, 2023 05:46am
- Reimbursement of the atopic dermatitis treatment ‘Dupixent’ is expected to be expanded for pediatric and adolescent patients from April. According to sources from related industries, Sanofi-Aventis Korea recently concluded a drug price negotiation with the National Health Insurance Service for the low dose (200mg) of Dupixent (dupilumab). Thus, Dupixent will be presented to the Health Insurance Policy Deliberation Committee tomorrow (23rd). On the 23rd, JAK inhibitors such as Abbvie Korea’s ‘Rinvoq (upadacitinib)’ and Pfizer Korea’s ‘Cibinqo (abrocitinib)’ will also be discussed. Unless otherwise, treatment options for pediatric atopic dermatitis patients will be drastically expanded in April. Dupixent's journey to expand reimbursement has seem many twists and turns. Being an RSA (Risk Sharing Agreement) drug, and having added a separate dose of 200mg, Dupixent had to go through an additional cost-effectiveness review procedure with the Health Insurance Review and Assessment Service, and complete drug price negotiation with the National Health Insurance Service. If approved, Dupixent will finally see results after two years since applying for an expansion of reimbursement in April 2021. Although the specific indications may differ, the difference in speed of progress is evident when compared to JAK inhibitors such as Rinvoq and Cibinqo, which also have applied for expansion of reimbursement in atopic dermatitis. The price of JAK inhibitors are relatively lower than that of Dupixent. Rinvoq and Cibinqo were both listed for reimbursement in May last year and Rinvoq is also attempting to expand its reimbursement to pediatric adolescent patients. Meanwhile, Dupixent is the first and only biologic to specifically target and inhibit the signaling of IL-4 and IL-13, which is the fundamental cause of atopic dermatitis. As Dupixent does not have a black box warning from the US FDA, which addresses the most severe side effects, and does not require monitoring for organ toxicity during administration, it was approved without any requirement for testing when starting treatment or regular safety monitoring during treatment.
