context: To support innovative drugs and address public concerns over nationally procured drugs, a notice soliciting research findings regarding medical insurance real-world data services for evaluating drugs and medical devices was released by National Healthcare Security Administration on 21 July. The measures to support the high-quality development of innovative drugs propose exploring scientifically sound real-world research methods. Subsequently, the administration convened its first symposium supporting innovative drugs and devices, where over 20 enterprise and expert representatives requested prompt introduction of new system standards and normative guidelines.
For conditionally approved drugs with insufficient evidence and significant budget impact, single clinical trial data cannot adequately support medical insurance decisions, urgently requiring comprehensive efficacy, safety and economic profiles, comments MedTrend.
Whether reimbursable drugs are effective and whether medical insurance expenditure provides value cannot rely solely on laboratory materials and data provided at listing (derived from standardised environments and standardised patients), but should focus on actual real-world effectiveness, says Zhu Yongfeng 朱永峰 NHSA (National Healthcare Security Administration) office director.
Behind rapid shortening of drug approval time into the medical insyrance directory lies the reality of insufficient clinical data accumulation. Particularly, some drugs approved through single-arm trials lack randomised controlled data, with indications concentrated in scenarios like advanced tumours without standard treatment protocols—real-world research can supplement actual clinical application drug efficacy.
The 2025 national medical insurance drug directory adjustment application guide (draft) encourages enterprises to provide compliant, traceable real-world data, especially for traditional Chinese medicines, rare disease drugs, paediatric medications and high-value oncology drugs. Whilst real-world data isn't currently mandatory, intentions to formally 'incorporate it into institutional frameworks' are clear, providing greater possibilities for enterprise differentiated competition. Institutionally, real-world data application construction is accelerating.
NHSA notes that medical insurance systems have established unified platforms collecting extensive information spanning long periods, covering all insured persons and designated medical institutions. These standardised data derive from actual medical service behaviours—genuine real-world clinical data. Next steps involves transforming the data into 'evidence'. NHSA proposes a 'three-step' approach
- establish real-world databases with technical guidance principles, promote data granularity refinement and structuring
- research technical pathways for real-world data transformation, form methodological systems applicable to drugs, devices, consumables, and service technologies
- construct comprehensive value evaluation standard systems for medical insurance products based on real-world data
Previously, PRC innovative drug enterprises invested minimally in real-world research, often viewing it as supplementary material or application 'bonus points'. Completing real-world research for single indications is costly, requiring initial investments of C¥300,000–C¥500,000.
This transformation represents medical insurance logical adjustments regarding 'value' recognition. Previously, 'innovation' emphasised molecular structure, mechanism and technical pathway breakthroughs, whilst current medical insurance focuses on genuine clinical benefits, coverage of unmet treatment needs and authentic health benefit improvements within affordable ranges.
The ambiguous boundaries of 'genuine innovation' are continuously contracting, with 'clinical value priority' becoming core medical insurance value judgement orientation. However, institutionally, the PRC lacks unified, quantitative, operationally robust innovative drug recognition systems, notes MedTrend.
Real-world research introduction will also become crucial tools for 'outcome risk sharing'. Especially for conditionally approved innovative drugs, early submitted efficacy and safety data often inadequately support long-term value judgements, requiring further exploration of 'value verification cycles', price reduction or exit mechanisms.
Similarly, NHSA's exploring commercial health insurance innovative drug directory systems represents pre-positioned institutional arrangements for outcome risk sharing pathways, ensuring patient medication access whilst providing important windows for accumulating real-world data.