By Fineline Cube China’s National Healthcare Security Administration (NHSA) this week released the Series of Guidelines for Real‑World Comprehensive NRDL‑based Value Assessment of Drugs (Trial), establishing a systematic framework for evaluating drug value using real‑world evidence. The guidelines prioritize eight categories of drugs for assessment and outline how findings will inform National Reimbursement Drug List (NRDL) negotiations and volume‑based procurement (VBP) decisions.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | National Healthcare Security Administration (NHSA) |
| Document | Series of Guidelines for Real‑World Comprehensive NRDL‑based Value Assessment of Drugs (Trial) |
| Release Date | 13 Jan 2026 |
| Status | Trial guidelines open for implementation |
| Key Feature | Prioritizes 8 drug categories for real‑world comprehensive value assessment |
| Purpose | Inform NRDL payment standard adjustments and catalog management |
Priority Drug Categories for Assessment
The guidelines identify eight circumstances where real‑world comprehensive value assessment is prioritized:
- Conditionally Approved Drugs: Single‑arm trial or surrogate endpoint approvals; encourage OS‑based assessments
- Generic Drugs Post‑Consistency Evaluation: Assess using clinical/pharmacodynamic endpoints and key safety indicators
- Drug Combinations/Sequences: Evaluate advantages in effectiveness, safety, economy, and appropriateness vs. existing treatments
- High‑Cost/High‑Utilization Drugs: Focus on whether patient outcomes meet expected benefit levels
- Data Integrity Concerns: Drugs questioned by authorities for manipulation or failing to complete confirmatory trials on time
- Off‑Label Uses: Therapies used for indications or dosages not in approved labeling or guidelines
- High‑Priced Reimbursement List Drugs: Those lacking cost‑effectiveness vs. similar drugs
- Other Concerns: Drugs with inappropriate use, major dosage changes per guidelines, or significant public debate on value
Assessment Outcomes & Incentives
Research findings will be incorporated into NHSA’s real‑world comprehensive value assessment database and serve as basis for:
- New Drugs with Expected Results: Successful NRDL negotiation may receive flexible incentives without disrupting price balance among similar drugs
- Drugs with Insufficient Evidence: Manufacturers can commit to completing assessment; pre‑set evidence strength temporarily accepted with flexible incentives, but must submit complete evidence by first renewal or face re‑negotiation
- NRDL‑Listed Drugs: Encouraged for high‑expenditure, rapid‑growth, or conditionally approved drugs to proactively conduct assessments alongside post‑marketing trials
- Commercial Insurance Drugs: Those seeking NRDL inclusion encouraged to conduct assessments to verify cost‑effectiveness
- VBP Candidates: Assessment results can serve as reference for comprehensive scoring, sequencing, and price risk management in procurement rounds
Market Impact & Strategic Implications
- Innovation Incentive: Conditional approvals can access NRDL with provisional incentives, but must deliver robust real‑world evidence
- Cost‑Effectiveness Pressure: High‑priced drugs must demonstrate value vs. alternatives or face pricing pressure or delisting
- Generic Differentiation: Post‑consistency evaluation generics must prove clinical equivalence or superiority to maintain pricing
- VBP Integration: Value assessments will directly influence VBP scoring and sequencing, moving beyond simple price cuts to holistic value evaluation
- Timeline Acceleration: Guidelines enable pre‑communication on reference drugs (released Jan 2026), streamlining evidence generation
Competitive Landscape
| Region | Value Assessment Framework | Key Feature |
|---|---|---|
| China | Real‑World Comprehensive NRDL Assessment (2026) | Integrates real‑world evidence into reimbursement decisions |
| Germany | AMNOG (2011) | Early benefit assessment with price negotiations |
| France | HAS (2020) | Real‑world studies for innovative drugs |
| UK | NICE (2017) | Patient access schemes and real‑world data |
| US | ICER Reports (2020) | Used by payers but not mandatory |
China’s framework is the first to mandate real‑world assessment for conditional approvals and high‑expenditure drugs, positioning it as a global leader in evidence‑based reimbursement.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding guideline implementation timelines, market impact, and drug pricing outcomes. Actual results may differ due to manufacturer compliance, data quality issues, and evolving healthcare policy priorities.-Fineline Info & Tech