Nation-wide health resource consumption and costs associated with mepolizumab (Nucala): a French SNDS database study (Resala)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  MEPOLIZUMAB
• Medical condition to be studied:
  Asthma
• Additional medical condition(s):
  We will be extracting data for all persons prescribed Mepolizumab.

Population studied

• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • 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:
  2813

Study design details

• Main study objective:
  (i) using the SNDS French national database, to identify a representative, nation-wide population of patients treated with mepolizumab with a follow-up period of at least 12 months, (ii) to describe the initial one-year changes in health resource use before and after the initiation of mepolizumab treatment and (iii) to estimate the change in associated costs for the first year of treatment.
• Outcomes:
  • To estimate the change in associated costs for the first year of treatment Total health care costs for the year preceding the initiation of mepolizumab, as well as for the year after. • To describe the initial one-year changes in health resource use before and after the initiation of mepolizumab treatment Cumulative estimates for health resource use and associated costs for the year preceding the initiation of mepolizumab, as well as for the year after. • To further characterize rates of change in health resource usage and/or costs in subpopulations of interest
• Data analysis plan:
  Differences between the two study periods will be presented with their 95% confidence intervals, as well as significance testing for paired data. Changes in total costs with time will also be visually presented using mean cumulative function step curves. The cost rate curve (ie the slope of the mean cumulative cost curve) will be determined by a 28-day sliding window for the demonstration of changes in the speed of accumulating costs. Mean cumulative functions describing the difference between baseline and exposure periods can be computed. For the latter, the elapsed time at which the 95% confidence interval no longer contains zero indicates differences in cumulative costs. Similarly, mean cumulative functions for events of interest (specific health resource usages or associated costs found to differ before versus after T0) can be computed.