Development of a Comprehensive List of Immunosuppressive Therapies to Enable a Multi-Data Source Global Real-World Effectiveness (RWE) Program of Immunocompromised Patients

Speaker(s)

Kamauu AW1, Parker CG2, Shields A3, Glaser L4, DuVall S5, Haidar G6, Lynch J5, Kamauu AG2, Taylor S7, Talarico C8
1Navidence LLC, Bountiful, UT, USA, 2Navidence LLC, Salt Lake City, UT, USA, 3Navidence LLC, Chapel Hill, NC, USA, 4Medical Affairs, Vaccines & Immune Therapies, BioPharmaceuticals Medical, AstraZeneca, Wilmington, DE, USA, 5VA Informatics and Computing Infrastructure, VA Salt Lake City Health Care System, Salt Lake City, UT, USA, 6UPMC and University of Pittsburgh, Pittsburgh, PA, USA, 7AstraZeneca, Cambridge, Cambridgeshire, UK, 8Epidemiology, Vaccines & Immune Therapies, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA

OBJECTIVES: Patients who are immunocompromised (IC) form a heterogeneous population in which evaluation of effectiveness and safety of medicines and vaccines is challenging — partly due to a lack of concordance on which medications are considered immunosuppressive. In 2021, AZD7442 (two monoclonal antibodies, tixagevimab/cilgavimab) received emergency use authorization to prevent COVID-19 in IC patients, including those treated with immunosuppressive therapies. To enable AZD7442 effectiveness studies conducted globally across IC patients, multiple sources and clinical input were used to define a comprehensive list of immunosuppressive therapies.

METHODS: A rigorous process was used to develop the comprehensive list.

  1. Immunosuppressive medications collected from 5 source lists:
    • NLM Value Set Authority Center
    • Master Protocol, COVID-19 Natural History, Sentinel Initiative 2020
    • Two health systems within the AZD7442 RWE program: US Department of Veterans Affairs and University of Pittsburgh Medical Center
    • Medication classes from SUPERNOVA (AZD3152 trial); all medications per class in use worldwide were included
  2. Medications on ≥3 source lists preliminarily accepted for comprehensive list
  3. Medications on 1-2 source lists further evaluated:
    • Use at health systems or in SUPERNOVA deemed relevant based on clinical judgment
    • Others received additional review, including determining approved indications and mechanisms of action
  4. Medical review of the comprehensive list by authors, with adjudication of select medications by SUPERNOVA investigators
  5. RxNorm (ingredient-level) and anatomical therapeutic chemical (ATC)-5 codes determined for each medication on comprehensive list

RESULTS: The five source lists each contained 71-110 medications, with the comprehensive list including 157 distinct medications across 21 classes. In the comprehensive list, 143 medications had RxNorm codes and 148 had ATC-5 codes; 4 medications without codes were only approved in countries not using those coding systems.

CONCLUSIONS: A comprehensive list of immunosuppressive medications (with associated medication codes) was defined that can be used globally to increase consistency across studies of IC patients.

Supported by AstraZeneca.

Code

RWD29

Topic

Real World Data & Information Systems

Topic Subcategory

Reproducibility & Replicability

Disease

Drugs, No Additional Disease & Conditions/Specialized Treatment Areas