Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab (Resala)

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

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Mepolizumab

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").

• Study Type: Observational
• Enrollment (Actual): 7938

Contacts and Locations

• Study Contact: Name: Nicolas Molinari, PhD; Phone Number: +33(0)4.67.33.63.03; Email: nicolas.molinari@inserm.fr

Study Locations

• France
  • Montpellier, France, 34280
    • UH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The first administration of mepolizumab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in drug consumption: mepolizumab	Drug consumption refers to the quantity of medication consumed.	-12 months versus +12 months
Change in drug consumption: corticosteroids	Drug consumption refers to the quantity of medication consumed.	-12 months versus +12 months
Change in drug consumption: asthma-specific medications	Drug consumption refers to the quantity of medication consumed.	-12 months versus +12 months
Change in drug consumption: diabetes-related medications	Drug consumption refers to the quantity of medication consumed.	-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 hospitalisation: asthma-related		-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 cumulative number of days of intensive care: asthma-related		-12 months versus +12 months
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Nicolas Molinari, PhD, University Hospital, Montpellier

Publications and helpful links

Helpful Links

• Resala on the Open Science Framework

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Mepolizumab
• Other Study ID Numbers: RECHMPL20_0393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: SNDS data are accessible only by specially trained and qualified individuals. Due to regulatory constraints, they cannot be made available to the public.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No