Clinical trial

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

Name
RECHMPL20_0393
Description
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
Trial arms
Trial start
2021-12-03
Estimated PCD
2023-07-31
Trial end
2023-07-31
Status
Completed
Treatment
Mepolizumab
The first administration of mepolizumab.
Arms:
The study population
Size
7938
Primary endpoint
The change in total health care costs for the year preceding the initiation of mepolizumab versus for the year after.
-12 months versus +12 months
Eligibility criteria
Inclusion Criteria: * Beneficiary in the anonymous French national SNDS database * The beneficiary received mepolizumab Exclusion Criteria: * Health resource use data covering the 12 months preceding the first filled prescription for mepolizumab are not available * Health resource use data covering the time period starting at the first filled prescription for mepolizumab and ending at subsequent death or at 12 months later are not available
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 7938, 'type': 'ACTUAL'}}
Updated at
2023-10-23

1 organization

1 product

1 indication

Indication
Asthma