Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab (Nucala): a French SNDS Database Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,938
- 试验地点
- 1
- 主要终点
- The change in total health care costs for the year preceding the initiation of mepolizumab versus for the year after.
研究概览
简要总结
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
详细描述
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").
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Beneficiary in the anonymous French national SNDS database
- •The beneficiary received mepolizumab
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Mepolizumab (Drug)
结局指标
主要结局
The change in total health care costs for the year preceding the initiation of mepolizumab versus for the year after.
时间窗: -12 months versus +12 months
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.
次要结局
- Change in drug consumption: corticosteroids(-12 months versus +12 months)
- Change in the number of hospitalisations: all causes(-12 months versus +12 months)
- Change in the number of hospitalisations: asthma-related(-12 months versus +12 months)
- Change in the cumulative number of days of hospitalisation: all causes(-12 months versus +12 months)
- Change in the cumulative number of days of intensive care: asthma-related(-12 months versus +12 months)
- Change in the number of generalist consults(-12 months versus +12 months)
- Change in the number of glycemia assessments(-12 months versus +12 months)
- Change in drug consumption: mepolizumab(-12 months versus +12 months)
- Change in drug consumption: asthma-specific medications(-12 months versus +12 months)
- Change in the cumulative number of days of intensive care: all causes(-12 months versus +12 months)
- Change in the number of nursing consults(-12 months versus +12 months)
- Change in the number of other paramedical consults(-12 months versus +12 months)
- Change in drug consumption: diabetes-related medications(-12 months versus +12 months)
- Change in the cumulative number of days of hospitalisation: asthma-related(-12 months versus +12 months)
- Change in the number of specialist consults(-12 months versus +12 months)
- Change in the number of lung function assessments(-12 months versus +12 months)
- Change in the number of adrenal function assessments(-12 months versus +12 months)
- Change in the number of bone density assessments(-12 months versus +12 months)
- The change in health care costs: mepolizumab(-12 months versus +12 months)
- The change in health care costs: asthma-specific care(-12 months versus +12 months)
- The change in health care costs: comorbidity care(-12 months versus +12 months)