Economic evaluation of robot-assisted laparoscopic radical prostatectomy vs conventional laparoscopic radical prostatectomy and open retropubic radical prostatectomy in prostate cancer: a real-life study based on the French National Healthcare Data System (SNDS). (ECOREPAR)

Study type

• Study topic:
  Medical procedure
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Prostate cancer

Population studied

• Short description of the study population:
  Men undergoing surgery for prostate cancer between 2012 and 2015.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  10400

Study design details

• Study design:
  Economic evaluation/ cost-effectiveness evaluation
• Main study objective:
  The main objective is to assess thereal-life incremental cost-effectiveness ratio at 5 years, of the robot-assisted laparoscopic radical prostatectomy compared with laparoscopic radical prostatectomy and open retropubic radical prostatectomy in the the French National Claims Database (SNDS).
• Setting:
  French nationwide claims database
• Comparators:
  Open radical prostatectomy (ORP).
• Outcomes:
  Incremental cost / progression-free (without additional treatment) life-year saved 5 years after initial surgery, 1)Incremental cost / life-year saved at 8 years. 2)Cost of robotic surgery.3)Outcomes measured at 5 and 8 years: Overall survival, Disease progression requiring a new treatment for prostate cancer,Continence disorders requiring treatment,Erectile dysfunction requiring treatment,Total healthcare consumptions.4)Urological hospitalizations within 90 days following the initial surgery.
• Data analysis plan:
  Following analyses will be done:1) Conditional probability of benefiting from the three surgical procedures using the high-dimensional propensity score (hdPS). Subjects from each group will be 1:1 matched on the score value.2) Progression-free survival at 5 and 8 years using Kaplan-Meier method. 3) Comparison of events rates between groups using proportional Cox models in total population with/without adjustment on hdPS, and in hdPS-matched populations. 4) None-adjusted estimation of cost-effectiveness ratios (95% CI estimated by boostrap).5) Net Monetary Benefit estimation of each surgical procedure (NMB = E x λ – C) with λ = differential cost-effectiveness threshold.6) hdPS-adjusted analysis using simple linear regression model, with BNM as dependent variable and type of surgery and hdPS as independent variables: one model to compare robot-assisted procedure with open procedure, and another to compare robot-assisted procedure with laparoscopic procedure.
• Summary results:
  5,677 men could be matched with a median follow-up of 6.7 years. PFS and OS were longer with RARP compared to ORP (HR = 0.85 [95%CI: 0.79-0.91, p < 0.001] and 0.79 [0.68-0.92, p = 0.003], respectively). Index hospitalisation duration was shorter for RARP (6.7 ± 4.0 days vs. 9.9 ± 5.0 days, p < 0.01). At follow-up, care for urinary incontinence and erectile dysfunction were less frequent with RARP (29.7% vs. 37.3%; p < 0.01 and 52.1% vs. 56.3%; p < 0.01, respectively). Results were similar with all patients after IPTW adjustment except no difference for erectile dysfunction care.