Use of Real-World Evidence to Support Regulatory Clearance of a Labeling Revision for Robotic-Assisted Radical Prostatectomy in the United States

OBJECTIVES: Use real-world evidence (RWE) to support regulatory clearance for a labeling revision for a robotic-assisted surgical device (RASD) for radical prostatectomy (RP) by evaluating its non-inferiority relative to non-RASD RP with respect to long-term overall survival (OS).

METHODS: This work was as part of the implementation process for developing the National Evaluation System for health Technology Mark (the “NEST Mark”), an initiative of a cooperative agreement with the US Food and Drug Administration (FDA) and Medical Device Innovation Consortium through the NEST to advance the innovative use of RWE. Males aged ≥35 years with treatment-naive prostate cancer and a RASD or open (non-RASD) RP procedure code between 7/1/2007 and 12/31/2014 were selected from Optum’s de-identified Clinformatics® Data Mart Database of claims with linked mortality data. OS was defined as the absence of a reported death evaluated from the day after RP until the end of the follow-up period (e.g., 5 years for 5-year OS) or 12/31/2019 (end of study period) using a Kaplan-Meier approach after propensity score stratification in quintiles. Non-inferiority was assessed with a margin of 2% and test size of 2.5%.

RESULTS: Among the patients undergoing RP via RASD (N=18,949) versus non-RASD (N=5,401) approach, unadjusted OS was not worse at 5 (96.13% vs. 95.65%) through 10 years (89.18% vs. 87.31%). Adjusted differences were 0.20% (95% CI: -0.46%, 0.86%) for 5-year and 0.88% (95% CI: -0.35%, 2.11%) for 10-year OS probabilities, demonstrating non-inferiority for both (p < 0.0001).

CONCLUSIONS: In this collaborative demonstration case, RWE was successful in supporting United States regulatory clearance for a labeling revision for the da Vinci Xi/X Ⓡ Surgical System to modify a precaution statement about a lack of FDA’s evaluation of overall survival after RP for the treatment of prostate cancer.