Pharmacoeconomic and Healthcare Aspects of the TDM-Guided Decisions on Biological Treatment of Inflammatory Diseases: Systematic Review of International Evidence
Author(s)
Przemyslaw Holko, PhD1, Katarzyna Sladowska, PhD2, Mehtap Cakmak Barsbay, PhD3, Sean P. Gavan, BA, MSc, PhD4, Olga Pitsillidou, MSc5, Pawel Mocko, PhD6, Petya Milushewa, PhD7, Guenka Ivanova Petrova, ScD, PharmD, PhD8, Pawel Kawalec, PhD, MD9.
1Jagiellonian University Medical College, Kraków, Poland, 2Jagiellonian University Medical College, Krakow, Poland, 3Ankara Haci Bayram Veli University/Turkey, Ankara, Turkey, 4The University of Manchester, Manchester, United Kingdom, 5Health Insurance Organisation, Nicosia, Cyprus, 6Jagiellonian University, Kraków, Poland, 7Medical University of Sofia, Sofia, Bulgaria, 8Medical University of Sofia, Faculty of Pharmacy, Sofia, Bulgaria, 9Professor, Jagiellonian University, Kraków, Poland.
1Jagiellonian University Medical College, Kraków, Poland, 2Jagiellonian University Medical College, Krakow, Poland, 3Ankara Haci Bayram Veli University/Turkey, Ankara, Turkey, 4The University of Manchester, Manchester, United Kingdom, 5Health Insurance Organisation, Nicosia, Cyprus, 6Jagiellonian University, Kraków, Poland, 7Medical University of Sofia, Sofia, Bulgaria, 8Medical University of Sofia, Faculty of Pharmacy, Sofia, Bulgaria, 9Professor, Jagiellonian University, Kraków, Poland.
OBJECTIVES: Therapeutic Drug Monitoring (TDM) of biologic agents is the clinical practice of measuring the concentration of specific drug levels and anti-drug antibodies in blood to adjust the dosage, decide on discontinuation of treatment, or use a different drug. A systematic review was performed to evaluate the pharmacoeconomic and healthcare-related consequences of the TDM-guided decisions on biologic treatment of inflammatory diseases
METHODS: : A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Model- and trial-based economic evaluations (EE), simulation studies, and observational studies with pharmacoeconomic and healthcare-related endpoints were identified in PubMed, EMBASE, and Google Scholar. Economic analyses were evaluated according to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 statement; other studies - to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement.
RESULTS: 32 studies (19 EE or simulation studies and 13 observational studies) were identified. All EE focused on biologic agents with available biosimilars, primarily concentrating on anti-TNF agents, with one study focusing on tocilizumab. All EE were carried out in high-income European countries (The Netherlands, n=5; UK, n=4; France, n=2; Spain, n=2; Denmark, n=1; Finland, n=1) or USA (n=5), mainly among patients with Crohn's disease (9) or rheumatoid arthritis (8). No EE was performed for patients with psoriasis, ulcerative colitis, juvenile idiopathic arthritis, or osteoarthritis. The quality of model-based EE was moderate to high (mean CHEERS score: 23 out of 28, range: 16-27) with low to moderate quality of clinical evidence used to inform the models.
CONCLUSIONS: There is a lack of comprehensive pharmacoeconomic evidence regarding TDM. The impact of TDM on the pharmacoeconomic consequences remains uncertain with the availability of low to moderate clinical evidence, and the potential to overestimate TDM-lead reductions in biologic drug consumption within EE.
METHODS: : A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Model- and trial-based economic evaluations (EE), simulation studies, and observational studies with pharmacoeconomic and healthcare-related endpoints were identified in PubMed, EMBASE, and Google Scholar. Economic analyses were evaluated according to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 statement; other studies - to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement.
RESULTS: 32 studies (19 EE or simulation studies and 13 observational studies) were identified. All EE focused on biologic agents with available biosimilars, primarily concentrating on anti-TNF agents, with one study focusing on tocilizumab. All EE were carried out in high-income European countries (The Netherlands, n=5; UK, n=4; France, n=2; Spain, n=2; Denmark, n=1; Finland, n=1) or USA (n=5), mainly among patients with Crohn's disease (9) or rheumatoid arthritis (8). No EE was performed for patients with psoriasis, ulcerative colitis, juvenile idiopathic arthritis, or osteoarthritis. The quality of model-based EE was moderate to high (mean CHEERS score: 23 out of 28, range: 16-27) with low to moderate quality of clinical evidence used to inform the models.
CONCLUSIONS: There is a lack of comprehensive pharmacoeconomic evidence regarding TDM. The impact of TDM on the pharmacoeconomic consequences remains uncertain with the availability of low to moderate clinical evidence, and the potential to overestimate TDM-lead reductions in biologic drug consumption within EE.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE608
Topic
Economic Evaluation, Health Policy & Regulatory, Real World Data & Information Systems
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies
Disease
Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)