Developing a Value Assessment Framework for Modified New Drugs In China
Author(s)
Chengaxin Duan, Master1, Binyan Sui, PhD1, Qian Xu, Master2, Dandan Ai, Master1, Monica Yu, PhD3, Kun Zhao, PhD1.
1CNHDRC, Beijing, China, 2Fudan University, Shanghai, China, 3Imperial College London, London, United Kingdom.
1CNHDRC, Beijing, China, 2Fudan University, Shanghai, China, 3Imperial College London, London, United Kingdom.
Presentation Documents
OBJECTIVES: Modified new drugs, particularly dosage form innovations, are a key focus in pharmaceutical development. In China, all new drugs follow a unified reimbursement access pathway, regardless of innovation level. Due to reliance on non-inferiority or bioequivalence trials, cost-effectiveness analysis (CEA) is often unsuitable, and cost-minimization analysis (CMA) risks undervaluing clinical and innovative aspects. This study aims to establish a tailored value assessment framework for modified new drugs to inform pricing and reimbursement.
METHODS: Based on China’s 2023 National Reimbursement Drug List (NRDL), we analyzed multi-dosage-form drugs by therapeutic areas and dosage form types. Pricing data for modified dosage form drugs included in the NRDL in 2022-2023 were reviewed to identify key value dimensions and factors. Statistical analysis and expert consultation were used to finalize dimensions and scoring criteria.
RESULTS: The top three therapeutic areas with multi-dosage-form drugs are gastrointestinal and metabolic drugs, systemic anti-infectives, and neurological drugs, with oral formulations being the most common type of modification. In 2022-2023, 46% of modified dosage form drugs secured premium pricing in NRDL negotiations compared to existing dosage forms in the reimbursement list. Key factors for premium pricing included targeting severe disease subgroups, recommendation in authoritative clinical guidelines, and alignment with national innovation priorities. Therapeutic areas and types of modifications were also associated with pricing. The proposed framework evaluates pharmaceutical value, clinical value, and evidence-based support, covering dimensions such as modification type, disease severity, treatment improvements, regulatory priorities, pediatric formulations, and clinical guidelines. Case testing demonstrated the framework's practicality, objective scoring, and rational outcomes.
CONCLUSIONS: This framework quantifies the value of modified new drugs, addressing CMA limitations and offering a more comprehensive and objective evaluation. It supports improved pricing and reimbursement decisions, highlighting the clinical and innovative contributions of modified new drugs.
METHODS: Based on China’s 2023 National Reimbursement Drug List (NRDL), we analyzed multi-dosage-form drugs by therapeutic areas and dosage form types. Pricing data for modified dosage form drugs included in the NRDL in 2022-2023 were reviewed to identify key value dimensions and factors. Statistical analysis and expert consultation were used to finalize dimensions and scoring criteria.
RESULTS: The top three therapeutic areas with multi-dosage-form drugs are gastrointestinal and metabolic drugs, systemic anti-infectives, and neurological drugs, with oral formulations being the most common type of modification. In 2022-2023, 46% of modified dosage form drugs secured premium pricing in NRDL negotiations compared to existing dosage forms in the reimbursement list. Key factors for premium pricing included targeting severe disease subgroups, recommendation in authoritative clinical guidelines, and alignment with national innovation priorities. Therapeutic areas and types of modifications were also associated with pricing. The proposed framework evaluates pharmaceutical value, clinical value, and evidence-based support, covering dimensions such as modification type, disease severity, treatment improvements, regulatory priorities, pediatric formulations, and clinical guidelines. Case testing demonstrated the framework's practicality, objective scoring, and rational outcomes.
CONCLUSIONS: This framework quantifies the value of modified new drugs, addressing CMA limitations and offering a more comprehensive and objective evaluation. It supports improved pricing and reimbursement decisions, highlighting the clinical and innovative contributions of modified new drugs.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HTA85
Topic
Health Technology Assessment
Topic Subcategory
Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas