A global evaluation of the economic impact of time to initiation of biologic treatment of severe asthma patients

Study type

• Study topic:
  Disease /health condition
• Study type:
  Not applicable
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Economic study
• Data collection methods:
  No individual level data collected for the purpose of the study

Study drug and medical condition

• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  The International Severe Asthma Registry (ISAR) contains severe asthma patient information from over 33,000 patients from 29 countries.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  30000

Study design details

• Study design:
  This study will proceed through a systematic two-step process: (i) identification of biologic initiation and its clinical implications using the ISAR database and (ii) development of economic models to understand the cost-effectiveness of early versus late or non-initiation.
• Main study objective:
  This study aims to:; 1. Evaluate global and national-level cost-effectiveness:; • Assess the cost-effectiveness of initiating biologic treatment early in severe asthma patients at both the global and national level.; • Compare this to delayed initiation, considering direct and indirect costs at a global / country-specific level.; 2. Explore cross-country variations:; • Investigate variations in early biologic initiation effectiveness across different countries.; • Identify factors contributing to these variations and potential implications for national healthcare strategies.; 3. Quantify cumulative national disease burden:; • Quantify and compare the cumulative disease burden in severe asthma patients at the national level with early biologic initiation versus later initiation.; • Explore long-term health outcomes, including exacerbation rates, hospitalizations, and quality-adjusted life years (QALYs), tailored to each country's context.
• Data analysis plan:
  1. Calculation of national-level estimates:; • Utilise retrospective ISAR and other published data to derive national-level estimates for model parameters and inputs.; 2. Development of cumulative national disease burden:; • Utilize a validated economic model22 to generate and estimate scenarios comparing earlier biologic initiation versus later initiation.; 3. Cross-country comparison; • Explore factors contributing to observed variation between countries, including differences in healthcare infrastructure, treatment accessibility, or patient demographics.