Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab

NCT04550780 | Completed

• 1 other identifier: RECHMPL20_0393
• Study Type: observational
• Target: 7,938
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma

Keywords

Mepolizumab

Outcome Measures

Primary Outcomes (1)

• The change in total health care costs for the year preceding the initiation of mepolizumab versus for the year after.

  Cumulative per-beneficiary costs (including all health care resource uses and government benefits) will be described and contrasted between the baseline and exposure periods. Day 0 = the initiation of mepolizumab treatment.

  -12 months versus +12 months

Secondary Outcomes (21)

• Change in drug consumption: mepolizumab

  -12 months versus +12 months

• Change in drug consumption: corticosteroids

  -12 months versus +12 months

• Change in drug consumption: asthma-specific medications

  -12 months versus +12 months

• Change in drug consumption: diabetes-related medications

  -12 months versus +12 months

• Change in the number of hospitalisations: all causes

  -12 months versus +12 months

Study Arms (1)

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.

Drug: Mepolizumab

Interventions

Mepolizumab DRUG

The first administration of mepolizumab.

The study population

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Beneficiary in the anonymous French national SNDS database
• The beneficiary received mepolizumab

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uh Montpellier

Montpellier, 34280, France

Location

Related Links

• Resala on the Open Science Framework

MeSH Terms

Conditions

Asthma

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Nicolas Molinari, PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 16, 2020
• Study Start: December 3, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)