Abstract
OBJECTIVES: This study aimed to analyze the impact of China's centralized volume-based procurement policy on the procurement and utilization of coronary stents in Tianjin from 2019 to 2021. METHODS: An interrupted time-series design was used to assess monthly procurement data of coronary stents and balloons in Tianjin from January 2019 to December 2021. RESULTS: The volume-based procurement policy significantly reduced coronary stents prices, with an average price reduction of 92.67% for ten selected stents, and the lowest price dropped to 469 CNY. Following policy implementation, annual procurement in Tianjin increased by 59.55%, and tertiary hospitals demonstrated a significant monthly level increase of 1,473.53 units (p = 0.027; 95% CI: 181.69-2,765.36). Imported stents procurement showed a significant level increase of 703.85 units (p < 0.0001), while domestic stents exhibited no significant monthly variation (p = 0.154). Structural upgrades accelerated: stainless steel stents decreased by 30.94% in usage share (p < 0.001; 95% CI: 17.36-44.52) and were rapidly phased out post-policy, whereas permanent-coated stents increased by 23.00% (p < 0.001; 95% CI: 18.46-27.54). Procurement expenditure decreased by 73.03% compared to the 2019 baseline. Drug-eluting balloons as an alternative technology remained unaffected (p = 0.32). CONCLUSION: The study shows that Tianjin's centralized volume-based procurement policy for coronary stents significantly improved stent supply and clinical utilization quality, while substantially reducing medical insurance expenditures-indicating that such policies can optimize healthcare resource allocation and enhance the cost-effectiveness of medical device procurement.