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- 2026-05-01 23:17:58
- Company
- J.P. Morgan selects ADC and obesity as big deal keywords
- by Moon, sung-ho Jan 08, 2025 05:53am
- With the opening of the 'J.P. Morgan Healthcare Conference', which attracted much attention last year with domestic pharmaceutical and biotech companies announcing the achievement of 'big deals,’ approaching, attention is gathering on what results will be announced this year. The keywords of this year's event are glucagon-like peptide-1 (GLP-1)--based obesity drugs and antibody-drug conjugates (ADCs), which have risen as hot topics in the global pharmaceutical and bio market. At the event, domestic pharmaceutical and biotech companies will be presenting their portfolios and holding face-to-face meetings. #According to industry sources on the 6th, the 43rd JP Morgan Healthcare Conference is scheduled to be held in San Francisco, U.S., from January 13 to 16 (local time). The event, which celebrates its 43rd event this year, has served as an opportunity for about 600 domestic and large multinational pharmaceutical companies to share their new R&D achievements and status and discuss the future development of the pharmaceutical and bio industry. Above all, it is an opportunity for domestic pharmaceutical and biotech companies to fulfill their main objectives of ”technology exports” and “forging partnerships.” In particular, at this year's event, in addition to the conference regular Samsung Biologics, Lotte Biologics, and Celltrion will unveil their contract development manufacturing Organization (CDMO) facilities and major business strategies. Among them, Samsung Biologics has always participated in the event since the 2020s and unveiled its major business strategies in the Main Track. This year, the company's CEO John Rim will be the main track presenter and will present its manufacturing facilities (5-8 plants) and antibody-drug conjugate (ADC) portfolio. Celltrion will also participate in the event to showcase its drug development achievements, including its ADC anti-cancer pipeline, as well as its CDMO vision. Celltrion is developing 3 ADC drugs and 3 multi-antibody drugs with the goal of commercializing its first product in 2029. Lotte Biologics, which has set its sights on becoming a CDMO specialist, is expected to announce its plans for the CDMO business and the expansion of its Syracuse ADC production facility under its newly appointed CEO James Park. Lotte Biologics previously announced that it will invest KRW 4.6 trillion by 2030 to own the capability as a global-level biopharmaceutical manufacturing competitor. At the same time, the Syracuse Bio Campus has disclosed plans to invest in ADC production facilities and begin full-scale production this year. Along with domestic CDMOs, bio companies that are challenging new drug development also registered and put their names on the event lineup. Among them, Onconic Therapeutics, a subsidiary of Jeil Pharmaceutical, which launched the P-CAB class gastroesophageal reflux disease drug Zaqbo (zastaprazan) last year, will also participate in the event. Onconic Therapeutics will use the JP Morgan Healthcare Conference to focus on strategic meetings with global pharmaceutical companies and investors. In particular, the company plans to accelerate the global market entry of its targeted anti-cancer drug Nesuparib with Zaqbo. “The JP Morgan Healthcare Conference will be an important opportunity to showcase our new drug pipeline and technology to the global market and create new collaboration opportunities,” said a representative from Onconic Therapeutics. “As we excluded the market value of Nesuparib from the public offering price during the KOSDAQ listing process, leaving new shareholders’ interests untouched, we look forward to a full-scale reassessment and valuation of the company through this event.” Bridge Biotherapeutics has been officially invited to make a corporate presentation. The presentation will highlight the company's growth strategy, including BBT-877, its lead candidate for idiopathic pulmonary fibrosis. BBT-877 is in the later stages of a global Phase 2 clinical trial, with top-line data expected next April. To date, 98 patients, representing more than 75% of the total patients, have completed the 24-week dosing process, and data from all patients in the trial will be finalized within the first quarter of next year. In addition, domestic companies that are developing not only anti-cancer drugs but also obesity drugs, a global drug development trend, will also participate in the event. D&D Pharmatech will present its glucagon-like peptide (GLP-1) based obesity treatment. In November last year, D&D Pharmatech started clinical trials for DD02, an oral GLP-1-based obesity treatment, through its U.S. partner Metsera. Also, Dx&Vx will also be participating in the event to share the progress of its own oral GLP-1 obesity drug currently in development. “As global pharmaceutical companies compete to develop oral GLP-1 therapeutics, interest in our technology is growing,” said a representative from Dx&Vx. ”We look forward to strengthening our global presence at the J.P. Morgan Healthcare Conference and collaborating with various partners to bring better treatment options to patients.”
- Company
- Expansion of NIP needed for 20-valent pneumococcal vaccine
- by Whang, byung-woo Jan 08, 2025 05:53am
- "Invasive pneumococcal disease remains the most common invasive infection and poses a significant burden. Pneumococcal diseases, such as pneumonia or ear infection, pose significant burden. The new vaccine must cover conventional serotypes as well as newly introduced serotypes to manage the invasive pneumococcal infection and expect an additional reduction." The introduction of the pneumococcal vaccine with the most serotypes in South Korea has brought attention to its preventive effects against pneumococcus and unmet needs for vaccines. Given the availability of vaccines in the National Immunization Program (NIP), there is a heightened interest in the preventive effects of added serotypes. Dr. Ki Wook Yun, Professor of the Department of Pediatrics and Adolescent Medicine at Seoul National University College of MedicineDr. Ki Wook Yun, Professor of the Department of Pediatrics and Adolescent Medicine at Seoul National University College of Medicine, emphasizes the importance of seeking ways to improve preventive effects in terms of society, given the additional effects of newly introduced drugs. According to Dr. Yun, unlike viral infection, bacterial infection cannot be recovered by relying on immunity, requiring antibiotic treatment. Mortality in children has decreased compared to the past, but bacterial infection still needs considerable attention. "Bacterial infection is one of the most burdening diseases in children. The prevalence decreased over time due to vaccine development and environmental improvement. Yet, the disease prevalence is higher than other diseases," Yun explained. "Not only children with immature immunity but seniors are prone to respiratory infections. Consequently, children and seniors are the primary patients for respiratory prevention and treatment." Dr. Yun comments that given these factors, it is crucial to prevent infection through vaccination and to stop it from transitioning to severe stages. Invasive pneumococcal disease remains the most common invasive infection and poses a high disease burden, so the importance of vaccination has been stressed. "Bacterial identification is challenging for infections related to pneumococcus, leading to frequent use of antibiotics. Consequently, patients may experience aftermaths of the treatment," Dr. Yun stated. "Vaccines can prevent these issues and may alleviate antibiotic tolerance by reducing the volume of antibiotic use." The government has included 13-valent and 15-valent pneumococcal vaccines in the NIP for children. From a different view, it remains to be seen what impact of Prevenar 20, a recently approved vaccine containing 20 serotypes, will have. Dr. Yun focuses on newly identified serotypes not included in the 13-valent vaccine as primary causes of infection. "13-valent vaccine alone cannot prevent all serotypes, so vaccines that contain new serotypes may be necessary," Dr. Yun said. "New vaccine must cover conventional serotypes as well as newly introduced serotypes to manage invasive pneumococcal infection and expect additional reduction." "Because Prevenar 20 also met non-inferiority to 13-valent vaccines, and it met immunogenicity requirements set by WHO at the fourth immunization, using the vaccine will likely be similar to the conventional vaccine," Dr. Yun added. "Additional serotypes can also offer disease prevention, so clinical benefits are expected." "The 20-valent pneumococcal vaccine has established sufficient validity for the NIP…establishing mass immunity must be considered" The remaining issue is whether the vaccine will be included in the NIP. While it offers broader prophylaxis than conventional vaccines, its introduction faces cost concerns due to the existing conventional vaccines already being part of the NIP. Dr. Yun analyzes that considering foreign cases, disease burden, and as drug price increases, Prevenar 20 has established sufficient validity for the NIP. "The 20-valent vaccine includes seven additional serotypes compared to conventional vaccines, potentially providing about 40-50% additional prevention against invasive pneumococcal infections. This suggests that the vaccine is more effective than existing ones," Dr. Yun said. "About 70-80% of non-vaccine serotypes causing infections in South Korea are not included in existing vaccines," Dr. Yun stated. "About half of these are serotypes included in the 20-valent vaccine. Consequently, it may be inadequate to keep using existing vaccines." Dr. Yun particularly emphasizes that to maximize the effects of the pneumococcal vaccine, increasing the vaccination rate for mass immunity must be considered. The 13-valent conjugate vaccine previously achieved high vaccination rates and demonstrative high effectiveness. However, a drop in vaccination rates due to new vaccines not being included in the NIP may lead to an increase in invasive infections and pneumonia. "Rather than expecting protection from individual vaccination, we must consider approaches generating society-wise preventive effects. Considering these views, there must be active measures to increase the vaccination rate with new vaccines such as Prevenar 20," Dr. Yun said. Finally, Dr. Yun remarked, "Despite the significant burden of pneumococcal diseases, such as pneumonia or ear infection, a surveillance system has not been established in South Korea." Adding, "The Korea Disease Control and Prevention Agency (KDCA) must address these aspects and implement systematic improvements so that invasive pneumococcal diseases are not overlooked."
- Opinion
- [Reporter's View] Pharma bio stocks shunned for good reason
- by Kim, Jin-Gu Jan 08, 2025 05:53am
- The sarcastic comment that “escaping from the KOSPI (Korean stock market) is a matter of intelligence” has become a trend for some time. Although the so-called “Korea discount” is not new, the distrust of the Korean stock market among individual investors has been rising recently. Pharmaceutical, biotech, and healthcare stocks are no exception. In fact, compared to other sectors, pharma bio, and healthcare stocks are even more shunned by these individual investors. According to the Korea Exchange, individual investors sold more than KRW 1.5 trillion worth of pharma bio and healthcare stocks last year. This leaves a bitter aftertaste, considering how these individual investors made net purchases of more than KRW 1 trillion in the overall securities market and the KOSDAQ market. Many of the largest stocks were shunned by individual investors. Individual investors sold more than KRW 1 trillion worth of Samsung Biologics shares alone. The same investors sold Alteogen and Celltrion stocks worth KRW 800 billion, and SK Biopharm, HLB, and GC Biopharma stocks worth KRW 100 billion. This is a large-scale disposal of stocks of pharma and biotech companies ranking 1-2 in market capitalization in the securities and KOSDAQ market. Various reasons have been pointed to as the cause of this massive sellout. Some analysts believe that the expanding global economic uncertainty has greatly dampened interest in pharma bio stocks that require long-term investment, while others say it is due to the lack of tangible results such as global drug approvals. In addition, the “Korea discount” has also been cited as a factor. Individual investors complain about insufficient shareholder returns, poor profitability and growth, weak corporate governance, and lack of transparency in accounting. While the Korea discount is not limited to pharma and biotech companies, it is argued that weak corporate governance leads to a lower valuation of pharma and biotech companies. In fact, domestic pharmaceutical bio companies are regarded to be more strongly influenced by their founders and owners. Major decisions are often made by the owners rather than their managers. Outside directors only act as yes-men, tending to the needs of owners. There are no checks and balances. Decisions are made against the interests of shareholders. Gimmicks abound. In the past year alone, dozens of pharma and biotech companies have engaged in so-called “owl disclosure”. They tried to divert investors' attention by disclosing bad information after the market closed. There were also cases of “trick block deals” by key executives. Seven executives and major shareholders of a medical AI company sold shares worth KRW 4.99 billion late last year. Controversy arose over the fact that they sold less than the KRW 5 billion per person limit to avoid disclosing block trades (large after-hours transactions) in advance. Disclosures and press releases that inflate or distort clinical results also continue to arise. Recently, as licensing-out deals were favorable, there have been many cases where the companies inflated the overall contract’s worth instead of disclosing the upfront payment amount. There are also many cases of accounting irregularities and “split listings” that violate the rights of existing shareholders. Such maneuvering and misbehavior of some companies have led to a loss of trust in the industry as a whole. Many pharma and biotech companies plan to pay cash and stock dividends this year as well. Many companies are expected to increase their dividends year-on-year. Many are reportedly planning dividends worth hundreds of billions of won. There are also more cases of free capital increase, stock buybacks, and stock burning. However, some companies' efforts to increase shareholder value are not enough. The entire pharma and biotech industry needs to rebuild trust from the ground up to win back the hearts of individual investors.
- Company
- New drug 'Truqap' for HER2- breast cancer Rx available
- by Son, Hyung Min Jan 08, 2025 05:53am
- Product photo of AstraZeneca Korea'Truqap,' an oral anticancer drug that targets AKT gene mutation, is now available for prescription at general hospitals. According to industry sources, AstraZeneca Korea's Truqap (capivasertib), a treatment for hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center and Seoul National University Hospital, and medical centers, including Gachon University Gil Medical center, Gangnam Severance Hospital, Korea University ANAM Hospital, Seoul National University Bundang Hospital, and Cha University Bungdang Medical Center. Domestically approved in March 2024, Truqap was launched as a non-reimbursable drug in September of the same year. This drug can be prescribed for combination therapy with fulvestrant following progression on or after an endocrine therapy or recurrence within 12 months after adjuvant therapy. The introduction of Truqap is significant because it offers more second-line treatment options following first-line treatment of HR-positive/HER2-negative breast cancer where there have been unmet needs. HR-positive/HER2-negative breast cancer accounts for 70% of the total breast cancer patients. This drug was demonstrated to be efficacious based on the CAPItello-291 Phase 3 study. The results showed that Truqap improved the median progression-free survival (mPFS) by approximately 2.5-fold compared to fulvestrant alone in patients who failed the first-line treatment following endocrine therapy (ET)±CDK4/6 inhibitor therapy. In detail, the Truqap+fulvestrant combination group had a mPFS of 7.3 months, which is more than double the 3.1 months with fulvestant alone. "Patients with PIK3CA/AKT1/PTEN mutations, accounting for about 50% of patients with HR-positive/HER2-negative breast cancer, may have faster disease progression; therefore, there has been a consistent need for second-line treatment for metastatic breast cancer targeting these mutations," Dr. Kywong Hwa Park, Professor of the Division of Oncology at Korea University ANAM Hospital, explained. "In metastatic breast cancer, patients who achieve complete recovery with a first-line treatment is rare, and most patients fail treatments, leading to the second-line treatments or more. The mutation targeted by Truqap commonly metastasizes to various organs, so we anticipate a positive outlook with this medication," Dr. Park said.
- Company
- Twice yearly HIV drug 'lenacapavir' receives ODD
- by Eo, Yun-Ho Jan 07, 2025 06:05am
- Product photo of Sunlenca Twice yearly injectable 'lenacapavir' for HIV prevention has been designated as an orphan drug in South Korea. The Ministry of Food and Drug Safety (MFDS) recently announced this through the new year's first orphan drug designation notification. The drug is indicated 'In combination with other antiretroviral therapy, for treatment of patients with multidrug-resistant HIV-1 infection for whom cannot be treated with antiretrovirals.' This drug, marketed under the product name as 'Sunlenca,' is a first-in-class long-acting HIV-1 capsid inhibitor that is subcutaneously administered every six months. It was approved in the United States and Europe in 2022 and has been prescribed. The current HIV treatment regimen requires daily oral administration of antiretrovirals. As long-acting agents become available, the treatment frequency has been extended to two or six months. Sunlenca offers not only HIV treatment but also 'prevention.' In September 2024, this drug's developer, Gilead Sciences, announced the second interim result of lenacapavir's Phase 3 PURPOSE2 trial. The result has shown that lenacapavir reduced HIV infection by 96% compared to baseline HIV prevalence (HIV). Only two cases occurred among 2180 study participants, suggesting that 99.9% of the participants in the lenacapavir-treated group had not been infected with HIV. The PURPOSE 2 study is the second key Phase 3 trial evaluating the efficacy of twice-yearly lenacapavir as a pre-exposure prophylaxis (PrEP) used to prevent HIV. In June 2024, Gilead Sciences concluded the double-blind trial conducted in Sub-Saharan Africa early after meeting the key endpoints. This PURPOSE1 clinical trial evaluated lenacapavir as a PrEP among cisgender women. Science, the academic journal and outlet for scientific news, has named lenacapavir as 'Breakthrough of the Year' based on these study results.
- Policy
- Dong-A ST first to pay the raised new drug approval fee?
- by Lee, Hye-Kyung Jan 07, 2025 06:05am
- With the new drug approval fee raised to KRW 410 million on Jan. 1 this year, the industry is eyeing whether Dong-A ST will become the first to apply for marketing authorization and pay the raised new drug approval fee. According to industry sources on the 7th, Dong-A ST applied for a prior consultation before applying for marketing authorization for its new drug cenobamate for epilepsy at the end of last year. Cenobamate is known under the brand name ‘Xcopri’ in the U.S. The prior consultation is a procedure introduced when the fee was increased as an ‘innovative measure for new drug approval,’ and is only available once for new drugs that are scheduled to apply for marketing authorization within 3 months. SK Biopharm and Dong-A ST signed an agreement in January for cenobamate Cenobamate is a new drug independently developed by SK Biopharm, which was approved by the U.S. Food and Drug Administration (FDA) in November 2019 and launched in the U.S. in May 2020. In Europe, the drug was granted marketing authorization through the company’s partner Angelini Pharma in March 2021 and has been launched sequentially since then, showing strong growth in the global market. Since licensing out cenobamate to the European market for the first time in 2019, the cumulative upfront payment for the drug is currently about KRW 600 billion, and the total amount of technology exports, including milestone payments, is reportedly 1.6 trillion. In the U.S. market, SK Biopharm has a direct sales system. Domestic marketing authorization, production, and sales are handled by Dong-A ST. In January last year, SK Biopharm signed a licensing agreement with Dong-A ST for its cenobamate. Under the agreement, Dong-A ST will receive cenobamate’s finished drug manufacturing technology from SK Biopharm and will be in charge of marketing authorization, production, and sales of the drug in 30 countries including Korea, Southeast Asia, Southwest Asia, Russia, Australia, New Zealand, and Turkey. Dong-A ST plans to launch the product in 2026 after completing preparations for cenobmate’s approval and reimbursement. With the increase in new drug approval fees this year, the company will receive benefits such as a dedicated review team and prioritized GMP surveys, so the company expects to be able to launch the product in 2026 as planned. Meanwhile, SK Biopharm is currently conducting Phase III clinical trials in Asia, including Korea, for adult partial-onset epilepsy. The trial is expected to be finalized around 2025. According to SK Biopharm, there are about 190,000 patients with epilepsy in Korea. Its relevant market is estimated to be worth KRW 130 billion.
- Company
- AstraZeneca Korea recertified Innovative Pharma Company
- by Whang, byung-woo Jan 07, 2025 06:05am
- AstraZeneca Korea announced today that it has successfully extended its certification as a 2024 Innovative Pharmaceutical Company by the Ministry of Health and Welfare. This marks the third consecutive recertification since the company was first certified in 2018, and recognizes the company's steady R&D investments and achievements made through global collaborations. With the extension, AstraZeneca Korea will be maintaining its status as an Innovative Pharmaceutical Company for another three years, until 2027. The Innovative Pharmaceutical Company certification system, which is organized by the Ministry of Health and Welfare, is based on the ‘Special Act on Fostering and Supporting the Pharmaceutical Industry,’ which reviews companies with high R&D investment ratios and excellent performance in developing new drugs. Certified companies can receive various support, including points for R&D support, preferential drug pricing, and tax benefits. Through its Open Innovation strategy, AstraZeneca Korea has been strengthening its collaboration with local researchers and companies to contribute to the development of the Korean pharmaceutical industry. In particular, the approval of durvalumab for the first-line treatment of biliary tract cancer in 2022 resulted from clinical trials led by local researchers and is considered a successful global collaboration model. Also, AstraZeneca Korea was recognized for its rapid response to the health crisis during the COVID-19 pandemic. The company invests around 20% of its annual revenue in clinical research, with more than 180 clinical studies underway in Korea. In addition, the company has continued to invest in R&D by conducting clinical trials on next-generation innovative drugs such as antibody-drug conjugates (ADCs), radioconjugates, and cell gene therapies in Korea. “The extension of the Innovative Pharmaceutical Company certification is an achievement of our long-standing collaboration with the Korean healthcare industry,” said Sehwan Chon, Country President of AstraZeneca Korea. ”We will continue to work closely with Korean research institutes and companies to create a patient-focused healthcare ecosystem and expand our innovative pipeline.” Chon added, “We look forward to further collaborating with the government, academia, and industry to raise the global profile of Korea's healthcare industry.”
- Product
- Will doctor-pharmacist conflict reignite?
- by Kim JiEun Jan 07, 2025 06:05am
- With candidate Joo Soo-ho, who advocates for the selective dispensing of drugs, advancing to the runoff election for the new president of the Korean Medical Association, a potential conflict between the medical community and the pharmaceutical association is expected. In the 43rd presidential election of the Korean Medical Association, which was held on Thursday, candidates Taek-woo Kim (No.1) and Soo-ho Joo (No.3) advanced to the runoff. As neither candidate received a majority of the votes, a runoff election will be held on the 7th and 8th to determine the final winner. The Korean Pharmacists Association is paying close attention to the outcome of this election. Depending on which candidate wins the election, the relationship between the medical association and the pharmacists’ association may change in the future. The current KPA executives, under Kwang-Hoon Choi, have not been at odds with the KMA. The previous KMA executives, led by Pil-Soo Lee, had also a relatively peaceful relationship with Choi’s KPA executives. When Lee stepped down earlier this year, the election of Hyun-Taek Lee, who had been at odds with KPA, created a tense atmosphere, but Lim, who focused on doctor-government conflicts, was eventually impeached and forced to leave his post early. With the KMA holding an early election due to the retirement of the previous president, the timing of the inauguration of the new KPA and KMA coincided, and attention was focused on the change in the tide between Young-hee Kwon’s executives and the new KMA executive. The medical community is wary of Kwon, who has been advocating for the introduction of International Nonproprietary Name prescription during her service as president of the Seoul Pharmaceutical Association. One after another, candidates for the presidency of the Korean Medical Association have voiced their opposition to Kwon's core campaign promise and long-awaited initiative. In particular, candidate Soo-ho Joo, who was selected as a runoff voter in the first round of the election, is noted for his stance against INN prescriptions and the need to introduce a selective dispensing system. “It is unfair for doctors to be held responsible for any accidents that may occur from the pharmacists’ choice of generic drugs from random pharmaceutical companies,” said Joo in a recent position paper, adding, ”The most effective way to minimize public inconvenience and reduce health insurance financial leakage by reducing dispensing fees is the selective dispensing system.” “We need to fix the wrong system and eliminate unsustainable systems. We already know what we need to change: the mandation of long-term care institutions, a single-payer insurance system, and the separation of prescribing and dispensing. We already know what we need to change. Now it's just a matter of taking action.” If Joo is ultimately elected president of the KMA, he is likely to be at odds with the Kwon and her KPA administration. It is also expected to have an impact on the bills currently in the National Assembly related to the activation of generic substitution and INN prescriptions. Currently, there is a bill introduced by Representative Yoon Kim to introduce INN prescribing for drugs with unstable supply and demand, as well as a bill to activate generic substitution by Representative Byung-Deok Min. “As Kwon has presented INN prescription as one of her key pledges for the presidential election, she will have no choice but to speak out and move to promote the policy,” said a pharmaceutical industry insider. ”INN prescriptions are unacceptable to the medical community. So if the militant candidate wins the KMA election, he may create a conflict with the KPA in the future. It will be important to see how Kwon can convince the government and the public despite the opposition from the medical community.”
- Opinion
- [Reporter's View] Switching of drugs reimbursable
- by Eo, Yun-Ho Jan 06, 2025 05:57am
- When a patient chooses one medication and switches to another, reimbursement does not cover the latter. Non-reimbursable drug switching has been a long-standing issue in South Korea. At the end of last year, a long-standing issue in one field was resolved. The Ministry of Health and Welfare (MOHW) granted approval for drug switching for patients with rheumatoid arthritis who discontinued treatment because of a lack of response to either tumor necrosis factor-alpha (TNF-α) inhibitors or JAK inhibitors. It is a victory. Until now, the government has been stating that reimbursement would be challenging because of the lack of clinical evidence relating to JAK inhibitor drug switching. However, organizations like the Korean College of Rheumatology have continuously submitted reports and evidence about prescription practices of drug switching. Ultimately, the government reconsidered the issue and reached a favorable decision. At that time, the MOHW stated, "The MOHW has decided to provide insurance coverage for drug switching between JAK inhibitors in the treatment of rheumatoid arthritis after referencing approval cases in both South Korea and overseas, textbooks, guidelines, clinical research articles, and academic (experts) consultations. However, an issue is still remaining. Concerns persist regarding drug switching between JAK inhibitors for atopic dermatitis. When a patient uses biological agents, such as interleukin-based agents, or oral agents, such as JAK inhibitors, and then switches to another medication, reimbursement is no longer provided. Even if a patient experiences side effects during the course of the initial treatment and does not benefit from the treatment, one cannot easily switch to another medication. Like drug switching for rheumatoid arthritis, drug switching for atopic dermatosis may lack direct clinical evidence. However, clinical practices have been suggesting opinions on this matter. The Korean Atopic Dermatitis Association submitted an opinion report to the MOHW requesting drug switching to be covered with reimbursement when treating atopic dermatitis. Furthermore, the association clarified that there are no differences in therapeutic status between biologic agents and oral medication through the guideline revision made in 9 years. Ultimately, at the end of last year, the government resumed reviewing reimbursement coverage for atopic dermatitis drug switching. The time is ticking. It is important that the government decide quickly on a result that the majority can agree to. If the government hesitates, it will take a long time. Furthermore, companies must put efforts into increasing the volume of use and finance.
- Policy
- Zolgensma shows 94% effect during post-evaluations
- by Lee, Tak-Sun Jan 06, 2025 05:56am
- The spinal muscular atrophy (SMA) treatment Zolgensma (onasemnogene abeparvovec) showed promising results suited to its high price. The use of the once-daily, one-shot treatment, which has an insurance cap set at KRW 2, requires a post-marketing evaluation to measure its cost-effectiveness. According to industry sources on the 5th, Zolgensma Inj was approved for reimbursement in August 2022 and was administered to 21 patients by November last year, 18 of whom have received outcome evaluations. 17 of the 18 patients showed significant improvement, with 1 patient failing to receive the drug due to death. The Health Reviews and Assessment Service recently released the results of the Zolgensma Inj performance evaluation that contained the results above. The performance evaluations for Zolgensma Inj are conducted before dosing and every 6 months following administration for up to five years. Failure was defined as: a) permanent ventilation or death; b) CHOP-INTEND score not improving by at least 4 points from pre-dose baseline; or c) a decrease in CHOP-INTEND of at least 4 points or HFMSE of at least 3 points on two consecutive response assessments, even if the b) improvement was achieved. However, a significant improvement after treatment was considered to have occurred if there was an increase in motor function test scores, even if the patient’s outcome falls within the criteria for treatment failure. Spinal muscular atrophy is a genetic disorder caused by problems in the part of the nervous system that controls the movement of the voluntary muscles. Zolgensma is designed to deliver a functional copy of the SMN1 (survival motor neuron 1) gene into cells via transfection. It promotes the survival and function of the transgenic motor neurons by alternatively expressing the SMN protein in the motor neurons. The majority of patients receiving Zolgensma are infants less than 24 months old. The 9 additional outcomes reported by the panel were also all infants at 24 months of age. Eight of these patients showed significant improvement from 12 to 24 months. One patient showed a decrease in HFMSE of more than 3 points at the 24-month evaluation and was required to confirm motor function via HFMSE at the next review, and if necessary, submit video evidence to confirm the HFMSE score. A total of 21 patients had received Zolgensma Inj by November of last year when the post-evaluation was conducted, the agency said. Of these, the results of 18 patients were disclosed because 3 are yet to receive the 6-month post-evaluations. One of the 18 patients showed treatment failure with death, and 17 showed significant improvement, rendering the effectiveness rate to 94.4%. As high as the drug’s price is, with an insurance price ceiling set at KRW19.817,269, the drug has been showing a clear effect. The patient’s out-of-pocket cost for the drug is KRW 5.98 million (10% coinsurance rate) for a single dose with health insurance.
