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- 2025-12-20 23:09:05
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- 1st drug to win 2nd concurrent approval·pricing program
- by Eo, Yun-Ho Jul 28, 2025 06:08am
- As the first drug has been approved under the 2nd concurrent approval·drug pricing program, the process for insurance reimbursement is garnering attention. MSD Korea's 'Winrevair (sotatercept),' a new drug for pulmonary arterial hypertension (PAH), recently obtained final approval from the Ministry of Food and Drug Safety. As it has been selected for the concurrent approval-evaluation-negotiation pilot program, Winrevair will soon be subjected to reimbursement review. The Ministry of Health and Welfare has been running the 'Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations' since 2023 to improve treatment access for life-threatening severe and rare diseases. The project conducts approval, reimbursement evaluation, and drug price negotiations concurrently, aiming to shorten the time required for new drugs to be included in the National Health Insurance list. The first pilot project is in its final stage, showing accomplishments. The Ministry of Health and Welfare recently completed selecting items, and three drugs were chosen. Three drugs chosen for the second pilot project are 'Winrevair (sotatercept),' a pulmonary hypertension treatment from MSD Korea; 'Fintepla (fenfluramine),' a Dravet syndrome treatment from UCB Pharma Korea; and 'Limcato,' a large B-cell lymphoma treatment from the Korean company Curocell. Winrevair is a first-in-class innovative new drug with a novel mechanism of action, emerging 20 years after 'Sildenafil,' which targeted the NO-sGC-cGMP pathway in 2005. As of 2023, the number of pulmonary hypertension patients in Korea was approximately 3,600. The average age of these patients is in their 40s, a demographic that plays a crucial role in society and families. Although the 5-year survival rate has significantly improved compared to the past, 3 out of 10 Korean pulmonary hypertension patients still die within 5 years. Furthermore, most patients experience significant difficulties performing daily activities such as housework, childcare, and light outings. Pulmonary hypertension is a rare, intractable, and progressive disease, delaying the worsening of the condition directly impacts patients' quality of life and survival. To date, no cure through drug treatment has been discovered, and the mechanism of existing drugs primarily aims to alleviate symptoms by relaxing thickened pulmonary arteries. It remains to be seen how quickly drugs undergoing the concurrent approval-evaluation process, including Winrevair, will be included to the list. Meanwhile, the approval of Winrevair was based on the 'STELLAR' clinical study. This study evaluated the efficacy and safety of Winrevair in 323 adult patients with pulmonary hypertension (WHO-FC II or III). During the 24-week study period, patients received either Winrevair or a placebo in combination with their existing therapy, administered once every three weeks. As a result, Winrevair increased the 6-minute walk distance by 40.8m (Hodges–Lehmann estimate) compared to placebo at the 24-week mark and reduced the risk of clinical worsening or death by 84%. Additionally, significant improvements were confirmed compared to the placebo in eight secondary efficacy endpoints, including the WHO-FC, pulmonary vascular resistance (PVR), and NT-proBNP levels, a biomarker for heart failure. Wook-Jin Chung, President of the Korean Society of Pulmonary Hypertension (Professor of Cardiology at Gachon University Gil Hospital), stated, "Winrevair is a new mechanism treatment that normalizes modified pulmonary vascular structures. It's also presented as a combination therapy option for use in early treatment stages, as outlined in updated global clinical guidelines, based on the latest evidence. This approval has widened the range of treatment options for pulmonary hypertension patients in Korea."
- Opinion
- [Reporter’s View] AI-assisted diagnosis and its hurdles
- by Whang, byung-woo Jul 28, 2025 06:08am
- Advanced technologies such as AI-assisted diagnosis and robotic surgery are being actively introduced into the domestic medical field more than ever before. Robotic surgery, which was first introduced 20 years ago, has now become the standard treatment in many fields. For example, the Da Vinci Robotic Surgical System, introduced in 2005, has since performed a cumulative total of approximately 370,000 robot-assisted surgeries in Korea, and currently, more than 200 systems are in operation in Korea. This quantitative growth is the result of the efforts of medical professionals and their willingness to embrace innovation. In fact, robotic surgery has demonstrated clinically significant benefits, such as a 75% reduction in blood transfusions during surgery, a 44% reduction in postoperative complications, and a 46% reduction in mortality, and is recognized as one of the global standards for minimally invasive treatment. AI-assisted diagnostic technologies are also being developed, with domestic medical AI startups such as Lunit, Vuno, and Neurophet gaining prominence. The global medical AI market is rapidly expanding, with the market size expected to grow from approximately USD 1.3 billion in 2023 to USD 3.7 billion by 2028. In Korea, innovative medical devices such as AI software for early cancer diagnosis are garnering attention as a potential next-generation industry. Although resistance to innovative technology has decreased compared to the past, conservative views still remain in the medical community. In other words, the view is that advanced technology should only play a supporting role rather than a leading role. In fact, at a briefing held by a global medical device company that this reporter attended, while emphasizing the company's achievements, the company was cautious in answering questions about the possibility of such devices completely replacing doctors. In particular, the word “assistant” was mentioned in the press material, highlighting how robots would play an “assistant role” rather than replacing doctors. "Even with cutting-edge technologies, the company’s approach reflects the industry’s cautious stance, which emphasizes that technology should not overtake the role of physicians, given the unique nature of medicine." Behind this cautious attitude in the medical field lie concerns about safety and reliability. In fact, when AI is applied to actual clinical practice, there are cases where its accuracy falls short of expectations. For example, there is a domestic report that an AI diagnostic solution, which was evaluated with an “excellent” rating with a sensitivity of 91.7% and a specificity of 88.6%, had a sensitivity of only 54.9% in actual field diagnosis. In addition, the possibility of AI misdiagnosis, vague anxiety about the replacement of medical personnel, and the unclear accountability in the event of a malfunction are some of the key concerns raised by the medical community. Such discrepancies between laboratory performance and actual clinical outcomes inevitably lead to a lack of trust among medical staff, which explains why a degree of skepticism remains. However, there are also opinions that we should not miss opportunities for innovation due to vague fears about technology. Although concerns about AI doctors replacing human doctors have been raised since the beginning, AI introduced into clinical practice has been proven to improve the quality of medical care and benefit more patients as an auxiliary tool. By serving as an extension of doctors' hands and eyes, AI is bringing about better outcomes for patients. Ultimately, the key lies not in the technology itself, but in the attitude and approach toward accepting it. Innovation and conservatism are always in a tense balance, even more so in the field of medicine, where human lives are at stake. However, for the sake of a better future for patients, it is sometimes necessary to take bold steps toward change. It is this reporter’s hope to see a future where innovation is embraced, but only with the wisdom to thoroughly evaluate and mitigate its risks."
- Policy
- Eun-kyung Jeong “will review limited INN prescriptions”
- by Lee, Jeong-Hwan Jul 28, 2025 06:08am
- Minister of Health and Welfare Eun-Kyung Jeong plans to review a plan to allow limited adoption of international nonproprietary name prescriptions for essential medicines with unstable supply. However, she drew a line on the full introduction of INN prescriptions in place of brand-name prescriptions as a measure to address issues such as the proliferation of generic drugs and illegal rebates, saying that it would constitute a violation of the agreement on the prescription-dispensing separation system. As this is one of President Jae-Myung Lee’s campaign pledges, it will be interesting to see how the MOHW will partially introduce INN prescriptions in the future. Minister Jeong responded to an inquiry from Democratic Party of Korea lawmaker Rep Young-seok Seo on INN prescriptions on the 25th. Minister Jeong said, “I believe it is necessary to consider introducing INN prescriptions for essential medicines with unstable supply in order to protect the health of the people,” adding, “However, as there are differing opinions within the medical community, sufficient discussion would be necessary during the implementation process.” She further noted, “Issues such as the proliferation of generic drugs and widespread rebates stem from various causes, including distribution structures, corporate ethics, competitive environments, and drug prices, so a comprehensive approach is necessary to resolve such issues. The full implementation of INN prescriptions would involve changing the consensus reached during the separation of pharmaceuticals and medical services, so sufficient consultation with medical and pharmaceutical associations, experts, and others is necessary regarding the necessity and effectiveness of such a measure.”
- Company
- Alopecia areata drug Litfulo lands in the Big 5 hospitals
- by Eo, Yun-Ho Jul 28, 2025 06:07am
- Litfulo, a new drug for alopecia areata, may now be prescribed at tertiary hospitals in Korea.. According to industry sources, Pfizer Korea's new Janus kinase (JAK) inhibitor Litfulo (ritlecitinib) has passed review of Drug Committees (DCs) at major medical institutions, including Samsung Medical Center, Seoul National University Hospital, Seoul Asan Medical Center, Sinchon Severance Hospital, Pusan National University Hospital, Seoul National University Bundang Hospital, and Pusan National University Yangsan Hospital. Jeonbuk National University Hospital and Chungnam National University Hospital. Since the drug’s launch in March, its prescription area has been steadily expanding. Approved in Korea in September last year, Litfulo is the first drug approved for the treatment of alopecia areata in adolescents in Korea. Alopecia areata is an autoimmune condition that causes patchy or complete hair loss on the scalp, face, or other parts of the body. It occurs when the immune system attacks the hair follicles, causing hair loss. The number of patients diagnosed with alopecia areata in Korea has increased over the past decade, from 154,380 in 2013 to 178,009 in 2023. In general, most cases of alopecia areata with mild symptoms tend to recover naturally or respond well to treatment, but also recur frequently, with approximately 40–80% of patients experiencing recurrence within one year. Professor Chong-Hyun Won of the Department of Dermatology at Asan Medical Center Seoul, said, “The launch of this new treatment option brings new hope for patients who have long suffered from alopecia areata and have unmet needs. It is also significant for us medical professionals as it provides a new and safe option.” Meanwhile, Litfulo has demonstrated its efficacy through the global ALLEGRO IIb/III trial. Its primary endpoint, which evaluated the proportion of patients with a Severity of Alopecia Tool (SALT) score of 20 or below, 23% of the treatment group achieved a SALT score of 20 or below at Week 24, compared to 2% in the placebo group, demonstrating statistically significant treatment efficacy. At Week 48, the proportion of patients in the Litfulo 50 mg treatment group with a SALT score of 20 or below was 43%, compared to 10% in the placebo group, confirming significant efficacy. This suggests that the efficacy of Litfulo increases over time. The incidence of adverse events in these patients was similar to that in the placebo group, with no deaths.
- Policy
- Measures to ban imports of psychotic dietary supplements
- by Lee, Hye-Kyung Jul 28, 2025 06:07am
- The Ministry of Food and Drug Safety (MFDS; Minister, Yu-Kyoung Oh) announced on July 25 that the Ministry is designating '7-Hydroxymitragynine,' an ingredient that is narcotic (antipsychotic), as a prohibited material and ingredient for import into South Korea. This measure was implemented to ban overseas direct purchase of dietary supplements, gummies, or drink mixes containing '7-Hydroxymitragynine.' The newly designated 7-hydroxymitragynine is an ingredient classified as a psychotropic substance under 'The Narcotics Control Act.' It is an alkaloid component present in small amounts in the Southeast Asian plant Mitragyna speciosa (scientific name), commonly known as Kratom. It is known to pose a serious risk to human health if misused or abused. The Ministry of Food and Drug Safety is strengthening the safety management of overseas direct-purchase foods. To this end, it designates ingredients and raw materials (such as narcotics, medicinal and traditional Korean medicine ingredients) in overseas direct-purchase foods that pose a risk to public health and need to be blocked from domestic entry, as raw materials/ingredients subject to domestic import blockage. Furthermore, considering that consumers find it difficult to identify harmful ingredients/raw materials, MFDS also provides an easily understandable list of products containing harmful ingredients (3,800 items). Therefore, it is vital for consumers first to check the 'Overseas Direct Purchase Foods' section on the 'FoodSafetyKorea' website before purchasing overseas direct-purchase foods. MFDS stated, "We plan to continue providing consumers with information on precautions and harmful substances when purchasing overseas direct purchase foods."
- Company
- Mounjaro launch set for August in Korea
- by Whang, byung-woo Jul 25, 2025 06:11am
- The launch date for Mounjaro (tirzepatide), a dual GIP/GLP-1 receptor agonist, has been set, signaling the start of full-fledged competition in the obesity treatment market in Korea. Lilly Korea announced on the 23rd that it will launch Mounjaro 2.5mg and 5mg/0.5mL in mid-August for patients with type 2 diabetes and obesity in Korea. Mounjaro is the first and currently only dual GIP (glucose-dependent insulinotropic polypeptide)/GLP-1 (glucagon-like peptide-1) receptor agonist. It is a single-molecule injection designed to selectively bind to and activate the GIP receptor and GLP-1 receptor with once-weekly administration. It helps lower blood glucose levels by promoting insulin secretion, improving insulin sensitivity, and reducing glucagon levels, as well as reducing food intake and body weight through delayed gastric emptying. Domestic and international clinical guidelines, as well as the World Health Organization (WHO), classify Mounjaro as a distinct class of therapy apart from existing GLP-1 receptor agonists based on its mechanism of action and the results of the Phase III SURPASS and SURMOUNT clinical trials. Mounjaro is currently indicated in Korea as an adjunct to diet and exercise (monotherapy or combination therapy) for improving blood sugar control in adult patients with type 2 diabetes, and for chronic weight management in adults with obesity (initial BMI ≥ 30 kg/m2) or overweight (initial BMI 27 kg/m2 ≤ BMI) with at least one weight-related comorbidity.
- Company
- Verzenio fails to pass third CDDC review for reimb in KOR
- by Eo, Yun-Ho Jul 25, 2025 06:10am
- Unfortunately, the third time was not the charm. The breast cancer treatment Verzenio is facing difficulties in expanding insurance reimbursement for early breast cancer in Korea. On the 23rd, Lilly Korea’s CDK4/6 inhibitor Verzenio (abemaciclib), which sought to secure reimbursement for its early breast cancer indications, failed to pass the Health Insurance Review and Assessment Service's Cancer Disease Review Committee (CDRC). This is already the company’s third failed attempt.. The reason for the committee not establishing Verzenio's reimbursement criteria is believed to be the lack of overall survival (OS) data. However, OS data is difficult to obtain for drugs with early-stage cancer indications such as Verzenio. In fact, overall survival (OS) has been the main reason many drugs fail to pass the CDRC review. This has become one of the biggest points of contention among pharmaceutical companies with oncology portfolios regarding the committee’s evaluation criteria. Verzenio faced difficulties in being reviewed by the CDRC in its first attempt for early breast cancer. After a long wait of 6 months after submitting the reimbursement application, it was finally reviewed by CDRC in May 2023, but the result was “reimbursement criteria not set.” Five months later, in October, Lilly resubmitted the reimbursement application to HIRA, and in March last year, it was submitted to CDRC for review, facing the same results. The reimbursement of Verzenio for early breast cancer has been a long-standing hope among patients. In fact, a national petition calling for the expansion of reimbursement for Verzenio has garnered more than 50,000 signatures. The 5-year monarchE data that was presented at the 2023 European Society for Medical Oncology (ESMO) Congress reaffirmed the drug’s clinical efficacy for early breast cancer. This was a follow-up study to the 4-year data presented at the Annual San Antonio Breast Cancer Symposium and Lancet Oncology in December 2022. Results showed that the gap between the Verzenio arm and the control arm (endocrine therapy alone) in the primary clinical endpoints of invasive disease-free survival (IDFS) and distant recurrence-free survival (DRFS) widened further in year 5 compared to year 4. At year 5, the primary endpoint, the difference in invasive disease-free survival (IDFS), was approximately 8% between the two arms. This data suggested that even for those who received treatment with Verzenio for the limited period of 2 years after surgery, the treatment benefit persisted on to year 5. Other than the letrozole generic that is used as endocrine therapy, it is the only new drug available for HR+/HER2- type early breast cancer. The drug’s indication was expanded on November 18th, 2022, as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence in combination with endocrine therapy. More specifically, the drug is indicated for a very limited range of patients at high-risk of relapse: ▲ patients with 4 or more positive axillary lymph nodes, ▲ 1-3 positive axillary lymph nodes and a tumor size of 5 cm or larger, or ▲histological grade 3 disease. Professor Keun Seok Lee from the Breast Cancer Center of the National Cancer Center said, “The Verzenio+endocrine therapy combination is recommended with a high level of evidence in major national and international practice guidelines as adjuvant therapy for patients at high risk of recurrence. With various clinical studies and major academic society reviews confirming its clinical utility, we need to enable rapid access to the treatment through prompt reimbursement to improve the survival of patients at high risk of recurrence.”
- Opinion
- [Reporter's View] Denmark's corporate model, Wegovy success
- by Jul 25, 2025 06:10am
- I recently had the opportunity to visit the biotech industry in Denmark. I toured facilities like Novo Nordisk, which rose to stardom with its GLP-1-based obesity treatment Wegovy, as well as LEO Pharma, with its 117-year history, and Lundbeck, a powerhouse in the central nervous system field. What struck me was that all these companies, without exception, cited their 'foundation-owned governance structure' as the secret to Denmark's biotech industry competitiveness. Denmark has Europe's most structured foundation-owned model. Approximately 1,300 companies in Denmark operate under a foundation-owned structure. Pharmaceutical companies like Novo Nordisk, LEO Pharma, and Lundbeck, as well as the toy company Lego, brewery Carlsberg, and shipping giant Maersk, all adopt governance structures where a foundation is the largest shareholder. Examining the governance structure of these companies reveals that non-profit foundations run them. A foundation controls an intermediate holding company, which is also a professional investment firm. This holding company, in turn, oversees various operating companies. It can be summarized as 'Foundation → Holding Company → Operating Company,' where the foundation indirectly controls its subsidiaries through a holding company-style investment firm. Foundations support the life sciences field in all-in efforts. The Novo Nordisk Foundation boasts one of the largest asset sizes globally, with Assets Under Management (AUM) reaching approximately $140 billion (KRW 194 trillion). Thisfigure is more than twice the AUM of the Bill & Melinda Gates Foundation, North America's largest private foundation, which stands at $69 billion. Such investment strengthens Denmark's scientific foundation nationwide and effectively attracts top talent from around the world to Denmark. A unique aspect of the Danish foundation-owned model is that the founding family does not serve as the largest shareholder of the operating company, nor do they directly hold equity. While some foundations may have founding family members play a symbolic role on the board, they do not exercise substantial control over the organization. Denmark has thus created a corporate ecosystem that perpetuates the founder's philosophy through a foundation while separating equity ownership from operational management. Due to this clear separation of ownership and management, companies can consistently pursue long-term strategies without being influenced by short-term performance. Being free from the pressures of short-term profits from external investors or shareholders creates an environment where companies can concentrate on long-term research and development (R&D) while delivering public value. Unlike private equity funds, which seek short-term returns based on profit, foundations can respond flexibly regarding equity maintenance or exit timing. In my opnion, this Danish case could offer significant implications for the direction the Korean pharmaceutical industry should take as it faces a transition in its governance structure. With the succession to the 3rd or 4th generation of founders gaining momentum, many Korean pharmaceutical companies are seeking solutions that simultaneously satisfy transparency in governance and continuity in management. Listed pharmaceutical companies find themselves in a situation where they must find a 'sustainable governance' middle ground between companies seeking to continue family management and succession, and shareholders demanding accountability and transparency. It doesn't imply that owner-management or professional management is better, or that the Danish model is superior. Korean companies cannot simply replicate the Danish model. Denmark has a highly sophisticated legal framework for foundation-owned companies, whereas South Korea lacks clear public interest foundation laws or a tax incentive structure. In Korea's case, a strong perception exists that public interest foundations are often a means for illegal succession, due to past instances of irregular successions by some companies. However, the Danish model can serve as a meaningful reference point for the Korean pharmaceutical industry when redesigning its governance structure. The key is to reinterpret the Danish model and integrate it into a feasible structure that aligns with Korean culture, institutions, and management realities. In the pharmaceutical industry, where a long-term vision is essential, the sustainability of the entire industry could be jeopardized without careful consideration of governance. New ideas and discussions about new structures are urgently needed for the development of "K-made Wegovy."
- Policy
- Daewoong, Kolon enter Ofev generic market at the same price
- by Lee, Tak-Sun Jul 25, 2025 06:09am
- Daewoong Pharmaceutical and Kolon Pharma will additionally enter the generic market for “Ofev Soft Cap (Nintedanib Esylate),” a treatment for chronic fibrotic interstitial lung disease. Competition is expected to intensify in the market with two more generic versions entering the market following Yungjin and Ildong Pharmaceutical’s entry with their respective generic versions in July. Except for the Ildong Pharmaceutical product, the prices of the generic drugs were all set the same. According to industry sources on the 24th, Daewoong Pharmaceutical's Ofild Tab 100 mg and 150 mg and Kolon Pharma’s Effidanib Tab 100 mg and 150 mg will be reimbursed from August in Korea. These generic versions contain the same active ingredient as Ofev Soft Cap (nintedanib esilate), but differ in formulation — the original is a soft capsule, while the generics are in tablet form. Ofev was listed for reimbursement in May as a treatment for chronic fibrotic interstitial lung disease. It took nine years for the company to obtain reimbursement after receiving marketing authorization from the MFDS. There are currently no alternative therapeutic options recognized for chronic fibrosing interstitial lung diseases in Korea. However, the reimbursement came too late, as it came even after the drug’s substance patent expiry on January 25, 2025. Two months after Ofev was listed for reimbursement, its generic versions started to appear on the market. Youngjin Pharmaceutical's Nintebro Tab 100 mg and 150 mg, and Ildong Pharmaceutical's Cuninta Tab 150 mg were the first generics to be listed for reimbursement. A month later, Daewoong Pharmaceutical and Kolon Pharma also entered the generic market. Although all generic drugs are designated as orphan drugs and could have been priced the same as the original Ofev, all the companies decided to lower their prices. Coincidentally, except for Ildong Pharmaceutical, all other pharmaceutical companies set the same prices for their respective products. The companies’ 100mg dose version is priced at KRW 9,000, and the 150mg at KRW 15,000. Ildong Pharmaceutical's Cuninta Tab 150 mg is the cheapest at KRW 13,500. The original Ofev soft Cap cost KRW 29,600 for the 100 mg dose and KRW 26,220 for the 150 mg dose, which is about twice the price of the generic drugs. The generic drugmakers sought to quickly enter the market with low prices. In particular, with only a 2-3 month difference in release dates compared to the original, industry observers believe that the generic companies stand a chance of gaining an equal market share. The estimated annual national health insurance financial expenditure for listing Ofev was KRW 6.3 billion. This calculation is based on the assumption that approximately 329 patients will be prescribed 2 capsules per day. Although the claim amount is not large, at less than KRW 10 billion, pharmaceutical companies have entered competition because the market is essentially untapped. Latecomers are particularly expecting synergistic effects with pirfenidone, which is already used for idiopathic pulmonary fibrosis. This is because nintedanib is already being used without reimbursement for idiopathic pulmonary fibrosis, and the hospitals treating these patients tend to be the same institutions that prescribe pirfenidone. In a market where the original and generic drugs are launched almost simultaneously, all eyes are on who will emerge as the ultimate winner.
- Policy
- Reimb criteria established for Roche's DLBCL drug 'Polivy'
- by Lee, Tak-Sun Jul 25, 2025 06:08am
- The reimbursement criteria for Roche Korea's Polivy (polatuzumab vedotin), a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), have been successfully established by the Health Insurance Review & Assessment Service's (HIRA) Cancer Disease Review Committee (CDRC). This drug, which is garnering attention as the first DLBCL first-line treatment in 20 years, passed the CDRC on its third attempt. HIRA announced that reimbursement criteria were established for drugs, including Polivy, at the 6th CDRC meeting held on July 23, 2025. For Polivy, the reimbursement criteria were set for "combination therapy with rituximab, cyclophosphamide, doxorubicin, and prednisone/prednisolone (R-CHP) in adult patients with previously untreated diffuse large B-Cell lymphoma (DLBCL)." Meanwhile, the reimbursement criteria have not been established for Polivy in combination with bendamustine and rituximab in adult patients with relapsed or refractory DLBCL who are not eligible for hematopoietic stem cell transplantation and have failed one or more prior therapies. Along with Polivy, reimbursement criteria were established for the new drug Darzalex SC (daratumumab) for "combination therapy with bortezomib, cyclophosphamide, and dexamethasone in newly diagnosed light chain (AL) amyloidosis patients." Reimbursement criteria have been established for Polivy (polatuzumab vedotin) and Darzalex SC (daratumumab). Expanded reimbursement criteria were approved for Neulasta Prefilled Syringe, Tecentriq, and Blincyto. Drugs that failed to receive the reimbursement criteria include Verzenio (abemaciclib). Expanded reimbursement criteria were approved for Neulasta Prefilled Syringe, Tecentriq, and Blincyto. For Neulasta, the reimbursement criteria were set for "reduction in the incidence of febrile neutropenia and the duration of neutropenia in patients receiving cytotoxic chemotherapy for malignant neoplasms." For Tecentriq, reimbursement criteria were established for "post-operative adjuvant therapy after resection and platinum-based chemotherapy in patients with Stage II-IIIA non-small cell lung cancer (NSCLC) where PD-L1 is expressed in ≥ 50% of tumor cells (TC)." For Blincyto, reimbursement criteria were set for "consolidation therapy for Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (ALL) in adults and children." The anticancer drugs for which reimbursement criteria have now been established will undergo final review for reimbursement coverage through negotiation with HIRA's Drug Reimbursement Evaluation Committee (DREC) and the National Health Insurance Service.
