Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab

Asthma Clinical Trial

— Resala  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04550780
• Other study ID #: RECHMPL20_0393
• Status: Completed
• Start date: December 3, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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").

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7938
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Mepolizumab
The first administration of mepolizumab.

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in drug consumption: mepolizumab	Drug consumption refers to the quantity of medication consumed.	-12 months versus +12 months
Secondary	Change in drug consumption: corticosteroids	Drug consumption refers to the quantity of medication consumed.	-12 months versus +12 months
Secondary	Change in drug consumption: asthma-specific medications	Drug consumption refers to the quantity of medication consumed.	-12 months versus +12 months
Secondary	Change in drug consumption: diabetes-related medications	Drug consumption refers to the quantity of medication consumed.	-12 months versus +12 months
Secondary	Change in the number of hospitalisations: all causes		-12 months versus +12 months
Secondary	Change in the number of hospitalisations: asthma-related		-12 months versus +12 months
Secondary	Change in the cumulative number of days of hospitalisation: all causes		-12 months versus +12 months
Secondary	Change in the cumulative number of days of hospitalisation: asthma-related		-12 months versus +12 months
Secondary	Change in the cumulative number of days of intensive care: all causes		-12 months versus +12 months
Secondary	Change in the cumulative number of days of intensive care: asthma-related		-12 months versus +12 months
Secondary	Change in the number of generalist consults	The cumulative numbers of consultations will be compared between the baseline and exposure period and differentiated according to type (general and specialist medical consults, nursing and other paramedical consults etc). Special attention will be given to pulmonology/allergology and metabolic/endocrine specialist consults, as well as nursing consults for injections.	-12 months versus +12 months
Secondary	Change in the number of specialist consults	The cumulative numbers of consultations will be compared between the baseline and exposure period and differentiated according to type (general and specialist medical consults, nursing and other paramedical consults etc). Special attention will be given to pulmonology/allergology and metabolic/endocrine specialist consults, as well as nursing consults for injections.	-12 months versus +12 months
Secondary	Change in the number of nursing consults	The cumulative numbers of consultations will be compared between the baseline and exposure period and differentiated according to type (general and specialist medical consults, nursing and other paramedical consults etc). Special attention will be given to pulmonology/allergology and metabolic/endocrine specialist consults, as well as nursing consults for injections.	-12 months versus +12 months
Secondary	Change in the number of other paramedical consults	The cumulative numbers of consultations will be compared between the baseline and exposure period and differentiated according to type (general and specialist medical consults, nursing and other paramedical consults etc). Special attention will be given to pulmonology/allergology and metabolic/endocrine specialist consults, as well as nursing consults for injections.	-12 months versus +12 months
Secondary	Change in the number of lung function assessments	Information concerning the laboratory and imaging assessments performed is available, but not their results. Special attention will be given to lung function, adrenal function, glycemia, and bone density assessments. The cumulative numbers of different assessments will be described and contrasted between the baseline and exposure periods.	-12 months versus +12 months
Secondary	Change in the number of adrenal function assessments	Information concerning the laboratory and imaging assessments performed is available, but not their results. Special attention will be given to lung function, adrenal function, glycemia, and bone density assessments. The cumulative numbers of different assessments will be described and contrasted between the baseline and exposure periods.	-12 months versus +12 months
Secondary	Change in the number of glycemia assessments	Information concerning the laboratory and imaging assessments performed is available, but not their results. Special attention will be given to lung function, adrenal function, glycemia, and bone density assessments. The cumulative numbers of different assessments will be described and contrasted between the baseline and exposure periods.	-12 months versus +12 months
Secondary	Change in the number of bone density assessments	Information concerning the laboratory and imaging assessments performed is available, but not their results. Special attention will be given to lung function, adrenal function, glycemia, and bone density assessments. The cumulative numbers of different assessments will be described and contrasted between the baseline and exposure periods.	-12 months versus +12 months
Secondary	The change in health care costs: mepolizumab	Cumulative per-beneficiary costs (including all health care resource uses and government benefits) will be described and contrasted between the baseline and exposure periods. This will be performed at several levels: (i) all costs regardless of source or potential link with diagnoses, (ii) costs due to mepolizumab, (iii) costs that can be associated with asthma-specific care, (iv) costs that can be associated with the monitoring and care for certain key comorbidities (diabetes, bone density/osteoporosis).	-12 months versus +12 months
Secondary	The change in health care costs: asthma-specific care	Cumulative per-beneficiary costs (including all health care resource uses and government benefits) will be described and contrasted between the baseline and exposure periods. This will be performed at several levels: (i) all costs regardless of source or potential link with diagnoses, (ii) costs due to mepolizumab, (iii) costs that can be associated with asthma-specific care, (iv) costs that can be associated with the monitoring and care for certain key comorbidities (diabetes, bone density/osteoporosis).	-12 months versus +12 months
Secondary	The change in health care costs: comorbidity care	Cumulative per-beneficiary costs (including all health care resource uses and government benefits) will be described and contrasted between the baseline and exposure periods. This will be performed at several levels: (i) all costs regardless of source or potential link with diagnoses, (ii) costs due to mepolizumab, (iii) costs that can be associated with asthma-specific care, (iv) costs that can be associated with the monitoring and care for certain key comorbidities (diabetes, bone density/osteoporosis).	-12 months versus +12 months

External Links

•   Resala on the Open Science Framework