The Da Vinci surgical system is classified as a type “A” medical device in China; the procurement plan of which is regulated by the National Health and Family Planning Commission (NHFP). Between 2010 to 2015, there were thirty-four Da Vinci surgical robots purchased, and installed in thirty tertiary public hospitals across the country. In order to generate context-specific evidence and support further capital funding decisions, the NHFP commissioned a Health Technology Assessment (HTA) of Da Vinci surgical robots, with a focus on real use of the technology in those tertiary public hospitals.
Nine hospitals were selected to collect real word data between 2013 to 2015. Using a cross-sectional survey, data of all robotic surgical cases were collected and described. The unit costs of the robotic surgery were estimated from activity based costing. We also collected cases of prostatectomy (427 versus 421) and hysterectomy (247 versus 105) using the robotic system and laparoscope respectively, and then compared hospital fees and effectiveness during hospitalization. Simulation of the budget impact on health insurance in Shanghai City over the next 5 years was also performed.
A full HTA was conducted based on real data from nine public hospitals in the central and eastern region. Based on a systematic review methodology, we appraised evidence on safety, effectiveness and cost-effectiveness of the Da Vinci surgical robot. Data on technology use, clinical management, and pricing and payment were collected through a cross-sectional survey and interviews of hospital managers, surgeons and nurses. We designed a cohort study on cost-effectiveness of Da Vinci-assisted prostatectomy and hysterectomy, comparing Da Vinci-assisted and laparoscopic prostatectomy (427 vs 421) and Da Vinci-assisted and laparoscopic hysterectomy (247 versus 105). Ethics and inequity issues were discussed based on patient interviews. A budget impact analysis was performed based on scenario mapping of promoting Da Vinci-assisted prostatectomy in Shanghai City over a 5-year timeline.
Due to a lack of evidence on long-term clinical effectiveness and high impact on public finances, the Da Vinci robotic robot should not be procured in large numbers in China. For equipment purchasing the government should strengthen regulations and require the public hospitals to collect more evidence.
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