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Completed

NCT Number: NCT04550780

Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab

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

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34280, France

About this study

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").

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mepolizumab

Drug

The first administration of mepolizumab.

Primary outcomes

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

    Time frame: -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.

Secondary outcomes

  1. Change in drug consumption: mepolizumab

    Time frame: -12 months versus +12 months

    Drug consumption refers to the quantity of medication consumed.

  2. Change in drug consumption: corticosteroids

    Time frame: -12 months versus +12 months

    Drug consumption refers to the quantity of medication consumed.

  3. Change in drug consumption: asthma-specific medications

    Time frame: -12 months versus +12 months

    Drug consumption refers to the quantity of medication consumed.

  4. Change in drug consumption: diabetes-related medications

    Time frame: -12 months versus +12 months

    Drug consumption refers to the quantity of medication consumed.

  5. Change in the number of hospitalisations: all causes

    Time frame: -12 months versus +12 months

  6. Change in the number of hospitalisations: asthma-related

    Time frame: -12 months versus +12 months

  7. Change in the cumulative number of days of hospitalisation: all causes

    Time frame: -12 months versus +12 months

  8. Change in the cumulative number of days of hospitalisation: asthma-related

    Time frame: -12 months versus +12 months

  9. Change in the cumulative number of days of intensive care: all causes

    Time frame: -12 months versus +12 months

  10. Change in the cumulative number of days of intensive care: asthma-related

    Time frame: -12 months versus +12 months

  11. Change in the number of generalist consults

    Time frame: -12 months versus +12 months

    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. Change in the number of specialist consults

    Time frame: -12 months versus +12 months

    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.

  13. Change in the number of nursing consults

    Time frame: -12 months versus +12 months

    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.

  14. Change in the number of other paramedical consults

    Time frame: -12 months versus +12 months

    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.

  15. Change in the number of lung function assessments

    Time frame: -12 months versus +12 months

    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.

  16. Change in the number of adrenal function assessments

    Time frame: -12 months versus +12 months

    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.

  17. Change in the number of glycemia assessments

    Time frame: -12 months versus +12 months

    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.

  18. Change in the number of bone density assessments

    Time frame: -12 months versus +12 months

    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.

  19. The change in health care costs: mepolizumab

    Time frame: -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. 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).

  20. The change in health care costs: asthma-specific care

    Time frame: -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. 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).

  21. The change in health care costs: comorbidity care

    Time frame: -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. 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: Resala

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2020
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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