Clinical trial NCT04550780: Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab
Official title: Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab (Nucala): a French SNDS Database Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Mepolizumab
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 7938
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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").

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

Primary outcomes:
measure: The change in total health care costs for the year preceding the initiation of mepolizumab versus for the year after.
timeFrame: -12 months versus +12 months
Secondary outcomes:
measure: Change in drug consumption: mepolizumab
timeFrame: -12 months versus +12 months
measure: Change in drug consumption: corticosteroids
timeFrame: -12 months versus +12 months
measure: Change in drug consumption: asthma-specific medications
timeFrame: -12 months versus +12 months
measure: Change in drug consumption: diabetes-related medications
timeFrame: -12 months versus +12 months
measure: Change in the number of hospitalisations: all causes
timeFrame: -12 months versus +12 months
measure: Change in the number of hospitalisations: asthma-related
timeFrame: -12 months versus +12 months
measure: Change in the cumulative number of days of hospitalisation: all causes
timeFrame: -12 months versus +12 months
measure: Change in the cumulative number of days of hospitalisation: asthma-related
timeFrame: -12 months versus +12 months
measure: Change in the cumulative number of days of intensive care: all causes
timeFrame: -12 months versus +12 months
measure: Change in the cumulative number of days of intensive care: asthma-related
timeFrame: -12 months versus +12 months
measure: Change in the number of generalist consults
timeFrame: -12 months versus +12 months
measure: Change in the number of specialist consults
timeFrame: -12 months versus +12 months
measure: Change in the number of nursing consults
timeFrame: -12 months versus +12 months
measure: Change in the number of other paramedical consults
timeFrame: -12 months versus +12 months
measure: Change in the number of lung function assessments
timeFrame: -12 months versus +12 months
measure: Change in the number of adrenal function assessments
timeFrame: -12 months versus +12 months
measure: Change in the number of glycemia assessments
timeFrame: -12 months versus +12 months
measure: Change in the number of bone density assessments
timeFrame: -12 months versus +12 months
measure: The change in health care costs: mepolizumab
timeFrame: -12 months versus +12 months
measure: The change in health care costs: asthma-specific care
timeFrame: -12 months versus +12 months
measure: The change in health care costs: comorbidity care
timeFrame: -12 months versus +12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Nicolas Molinari, PhD
role: STUDY_DIRECTOR
References: