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First Edition of Commercial Health Insurance Innovative Drug Catalog Officially Established
Date:2025-12-09count:
The 2025 High-Quality Development Conference on Innovative Drugs was held in Guangzhou on December 7, 2025. At the event, the National Healthcare Security Administration (NHSA) officially launched the inaugural edition of the *Commercial Health Insurance Innovative Drug Catalog*, which includes 19 cutting-edge therapies—among them five CAR-T products with annual treatment costs reaching the RMB 5-million level. This milestone signifies the formal establishment of a dual-tiered payment mechanism for innovative drugs in China: while basic medical insurance provides foundational coverage, commercial health insurance now serves as a structured, value-based supplementary layer—marking a strategic shift from isolated “single breakthroughs” to coordinated “dual-wheel drive” protection for high-cost, high-value therapeutics.
Policy Evolution: From “Basic Coverage” to “Multi-Tiered Protection”
Historically, highly innovative therapies—such as CAR-T cell treatments, with annual costs often exceeding tens of millions of RMB—have remained outside the National Reimbursement Drug List (NRDL), primarily due to sustainability constraints on the basic medical insurance fund. To address this systemic gap, the NHSA and the National Health Commission jointly issued the *Several Measures to Support the High-Quality Development of Innovative Drugs* on June 30, 2025. A cornerstone of this policy is the institutionalization of a dedicated Commercial Health Insurance Innovative Drug Catalog—a complementary, evidence-informed framework designed specifically for therapies that demonstrate exceptional innovation, robust clinical utility, and meaningful patient benefit, yet fall beyond the scope of basic insurance reimbursement.
In parallel, the national healthcare drug directory was expanded by 114 entries—including 50 first-class innovative drugs—thereby reinforcing the foundation of public coverage. The Commercial Health Insurance Innovative Drug Catalog functions as a targeted “supplementary tier,” ensuring continuity and coherence across the broader health financing architecture.
Inaugural Catalog Highlights: 19 Therapies Selected, CAR-T Therapies at the Forefront
Of the 121 candidate drugs undergoing initial evaluation, 19 were selected for inclusion in the first edition of the catalog—representing 18 pharmaceutical enterprises (6 multinational and 12 domestic innovators). Nine of the listed agents are classified as first-class new drugs under China’s regulatory framework. The catalog spans three priority therapeutic areas:
• Oncology: All five approved CAR-T cell therapies are included—namely, Acrisys Injection (Fosun Pharma) and Regiocel Injection (Wu Ming Ju Nuo)—indicated for relapsed or refractory leukemia, lymphoma, and multiple myeloma;
• Neurological Disorders: Two novel disease-modifying therapies for Alzheimer’s disease, offering tangible hope to millions of affected individuals and their families;
• Rare Diseases: Targeted treatments for pediatric rare conditions—including neuroblastoma and Gaucher disease—further strengthening China’s comprehensive rare disease protection system.
“Three Exclusions” Policy: Removing Systemic Barriers to Clinical Access
To ensure timely and equitable patient access, the NHSA introduced an unprecedented “Three Exclusions” support mechanism:
• Exclusion from the self-payment ratio assessment applied to designated medical institutions under basic medical insurance;
• Exclusion from the monitoring scope governing substitute product selection in national volume-based procurement programs;
• Exemption from diagnosis-related group (DRG) or diagnosis-intervention packet (DIP) payment assessments for cases covered exclusively by commercial health insurance.
Collectively, these measures alleviate institutional disincentives for hospitals to adopt high-cost innovative drugs—effectively resolving the longstanding “admission bottleneck.” Furthermore, pricing for catalog-listed drugs follows a confidential negotiation mechanism between pharmaceutical manufacturers and commercial insurers, safeguarding enterprise innovation incentives and supporting sustainable global pricing strategies.
Policy Evolution: From “Basic Coverage” to “Multi-Tiered Protection”
Historically, highly innovative therapies—such as CAR-T cell treatments, with annual costs often exceeding tens of millions of RMB—have remained outside the National Reimbursement Drug List (NRDL), primarily due to sustainability constraints on the basic medical insurance fund. To address this systemic gap, the NHSA and the National Health Commission jointly issued the *Several Measures to Support the High-Quality Development of Innovative Drugs* on June 30, 2025. A cornerstone of this policy is the institutionalization of a dedicated Commercial Health Insurance Innovative Drug Catalog—a complementary, evidence-informed framework designed specifically for therapies that demonstrate exceptional innovation, robust clinical utility, and meaningful patient benefit, yet fall beyond the scope of basic insurance reimbursement.
In parallel, the national healthcare drug directory was expanded by 114 entries—including 50 first-class innovative drugs—thereby reinforcing the foundation of public coverage. The Commercial Health Insurance Innovative Drug Catalog functions as a targeted “supplementary tier,” ensuring continuity and coherence across the broader health financing architecture.
Inaugural Catalog Highlights: 19 Therapies Selected, CAR-T Therapies at the Forefront
Of the 121 candidate drugs undergoing initial evaluation, 19 were selected for inclusion in the first edition of the catalog—representing 18 pharmaceutical enterprises (6 multinational and 12 domestic innovators). Nine of the listed agents are classified as first-class new drugs under China’s regulatory framework. The catalog spans three priority therapeutic areas:
• Oncology: All five approved CAR-T cell therapies are included—namely, Acrisys Injection (Fosun Pharma) and Regiocel Injection (Wu Ming Ju Nuo)—indicated for relapsed or refractory leukemia, lymphoma, and multiple myeloma;
• Neurological Disorders: Two novel disease-modifying therapies for Alzheimer’s disease, offering tangible hope to millions of affected individuals and their families;
• Rare Diseases: Targeted treatments for pediatric rare conditions—including neuroblastoma and Gaucher disease—further strengthening China’s comprehensive rare disease protection system.
“Three Exclusions” Policy: Removing Systemic Barriers to Clinical Access
To ensure timely and equitable patient access, the NHSA introduced an unprecedented “Three Exclusions” support mechanism:
• Exclusion from the self-payment ratio assessment applied to designated medical institutions under basic medical insurance;
• Exclusion from the monitoring scope governing substitute product selection in national volume-based procurement programs;
• Exemption from diagnosis-related group (DRG) or diagnosis-intervention packet (DIP) payment assessments for cases covered exclusively by commercial health insurance.
Collectively, these measures alleviate institutional disincentives for hospitals to adopt high-cost innovative drugs—effectively resolving the longstanding “admission bottleneck.” Furthermore, pricing for catalog-listed drugs follows a confidential negotiation mechanism between pharmaceutical manufacturers and commercial insurers, safeguarding enterprise innovation incentives and supporting sustainable global pricing strategies.