NCT04550780

Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab

Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab (Nucala): a French SNDS Database Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7,938 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Currently, no study has addressed real-life data describing changes in health resource consumption and related costs attributable to mepolizumab treatment. The aim of the current study is to fill this knowledge gap by performing an exhaustive extraction of data for patients receiving mepolizumab in the French single-payer health care system. The change in real-life health-resource usage and costs observed for these patients would provide the first evidence that mepolizumab is changing the care landscape for eligible severe asthma patients. The overall objectives of this study are: (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. These initial data will additionally serve as a basis for the design of longer-term studies. Primary objective: To estimate the change in associated costs for the first year of treatment

Detailed description

Secondary objectives: * To describe the initial one-year changes in health resource use before and after the initiation of mepolizumab treatment * To further characterize rates of change in health resource usage and/or costs in subpopulations of interest (sex, age groups, severe asthma, uncontrolled asthma, COPD, diabetes) This retrospective, non-interventional (not involving human subjects) database study will compare real-life patient health resource consumption before versus after a first injection of mepolizumab. Data concerning patients receiving mepolizumab will be collated for a 12-month period (the "baseline period") preceding a first index treatment (at "T0") and compared to a 12-month period occurring after the index treatment (the "exposure period").

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Mepolizumab	The first administration of mepolizumab.

Timeline

• Start date: 2021-12-03
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2020-09-16
• Last updated: 2023-10-23

Locations

1 site across 1 country: France