Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab

NCT ID: NCT04550780

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7938 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-03
• Study Completion Date: 2023-07-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

The study population

The study population will comport all beneficiaries in the national French SNDS database who were prescribed mepolizumab and for whom health resource use data is available for the 12 months preceding and following a first filled prescription for mepolizumab.

Mepolizumab

Intervention Type: DRUG

The first administration of mepolizumab.

Interventions

Mepolizumab

The first administration of mepolizumab.

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Molinari, PhD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

Uh Montpellier

Montpellier, , France

Countries

France

Related Links

https://osf.io/zg3us/

Resala on the Open Science Framework

Other Identifiers

RECHMPL20_0393

Identifier Type: -

Identifier Source: org_study_id