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5款CAR-T产品通过商保创新药目录专家评审 一针百万元的“抗癌神药”有望飞入寻常百姓家?
Mei Ri Jing Ji Xin Wen· 2025-09-23 15:36
Core Viewpoint - The National Healthcare Security Administration (NHSA) has completed the expert review for the 2025 National Basic Medical Insurance (BMI) catalog and the commercial insurance innovative drug catalog, marking the eighth adjustment since its establishment and the first inclusion of a commercial insurance innovative drug catalog [1][2]. Group 1: CAR-T Products Approval - Five CAR-T products have successfully passed the expert review and will be included in both the basic medical insurance and commercial insurance innovative drug catalogs, laying the groundwork for future negotiations and access [1][2]. - The approval of these CAR-T products is seen as a positive signal, indicating the regulatory body's commitment to improving access to cutting-edge therapies [1][3]. - The review process emphasized the innovation level, efficacy, and the ability to fill treatment gaps, with CAR-T therapies receiving unanimous approval [2][5]. Group 2: Impact on Patients and Companies - The introduction of the commercial insurance innovative drug catalog is expected to significantly reduce out-of-pocket expenses for patients, making high-cost CAR-T treatments more accessible [3][4]. - Companies view the catalog as a "second channel" for innovative drugs, alleviating pricing pressure during negotiations with basic medical insurance and potentially expanding market share [4][5]. - The collaboration between pharmaceutical companies and insurance providers is anticipated to evolve towards deeper cooperation, exploring mechanisms like outcome-based payments and risk-sharing [4][5]. Group 3: Future Outlook - Companies express cautious optimism regarding the inclusion of CAR-T products in the commercial insurance innovative drug catalog, supported by policy direction, clinical value, and practical experience [5][6]. - The ongoing expansion and optimization of the commercial insurance catalog are expected to further benefit patients in need of CAR-T therapies [6].
国产CAR-T突破复发绝境 22岁白血病患者获完全缓解
Nan Fang Du Shi Bao· 2025-05-09 08:21
Core Insights - The article highlights the revolutionary impact of CAR-T therapy in treating adult relapsed acute B lymphoblastic leukemia (B-ALL), showcasing a successful case where a patient achieved complete remission after treatment [1][4][7] Group 1: CAR-T Therapy Development - The first CAR-T therapy for adult relapsed B-ALL in China, "Nakiolun", was approved in 2023, filling a significant gap in immunotherapy options for this patient population [2][4] - CAR-T therapy has shown high efficacy, with a reported objective response rate (ORR) of 82.1% and a minimal residual disease (MRD) negative rate of 100% within three months of treatment [4][6] Group 2: Patient Outcomes and Survival Rates - Adult patients with relapsed B-ALL have a median overall survival of only 2-6 months, with a 5-year survival rate below 10% [3][6] - CAR-T therapy offers a promising alternative, as evidenced by a patient who, after traditional treatments failed, achieved long-term remission through CAR-T, highlighting its potential to improve survival outcomes significantly [3][7] Group 3: Challenges and Future Directions - Despite its effectiveness, CAR-T therapy faces challenges such as being used only as a last resort after exhausting other treatment options and its high cost, approximately 1.2 million yuan (around 120,000 USD) [6][7] - There is a clinical ambition to reposition CAR-T therapy from a last-line treatment to an earlier intervention for patients with first relapse or MRD positivity, which could potentially replace traditional stem cell transplants [7]