Assessment of Price Reduction Prediction Based on the Lasted Reimbursement Drug Renewal Rules in China

OBJECTIVES: In context of the latest reimbursement drug price renewal rules, the NRDL (National Reimbursement Drug List)-listed medicines will be faced with a price adjustment biannually. This study explore strategies for stakeholders to balance the market share and drug prices via an innovative toolkit.

METHODS: We focused on NRDL-listed medicines with agreements expiring by December 31, 2026. Drug A, which indicates for type 2 diabetes (T2D) patients with BMI ≥ 25 and poorly controlled on oral hypoglycemics or insulin, was selected as an example. Firstly, the target population size was calculated with parameter obtained from published literature. The market share data was collected from public data. The annual usage was then estimated based on the package insert. Current payment criteria were retrieved and the annual amount of the NRDL reimbursement for drug A was predicted. Lastly, based on drug price renewal rules, estimate the maximum annual sales volume for Drug A at various price reduction points.

RESULTS: The target population size in 2025 and 2026 is 707,610 and 710,369 respectively, corresponding to 18,996,298 and 19,070,384 units usage of drug A. With the current NRDL price of CNY 110 and the reimbursement rate of 65%, the potential price reduction is predicted to range between 0-21% in the next renewal cycle. The annual sales volume should be controlled within 20,936,676 units if no price reduction is expected.

CONCLUSIONS: The price reduction in the next renewal cycle hinge on the target population size and the current reimbursement criteria. For products with large patient size, significant discrepancies between predicted and actual sales can lead to substantial price reductions or renewal failure. Stakeholders must carefully forecast market dynamics to effectively manage expectations and regulatory compliance.