UNCOVERING THE HIDDEN COSTS OF AUTOMATIC BIOSIMILAR SUBSTITUTION THROUGH BESPOKE ECONOMIC MODELING APPROACH
Author(s)
Yuvraj Sharma, MSc1, Ana Lisica2, Jomol Jose, BA, MSc3, Yash Choudhary, BTech3, Alex Geddes, PhD1, Temis Vasili, MSc1, Björn Vandewalle, PhD4, Joshua K. Porter, MSc5, Paul Stuart, PhD5, james richard laubner, BBA5, Joe Robinson, BA5.
1IQVIA, London, United Kingdom, 2Manager, IQVIA, London, United Kingdom, 3IQVIA, Bengaluru, India, 4IQVIA Portugal, Oeiras, Portugal, 5Amgen Inc., Thousand Oaks, CA, USA.
1IQVIA, London, United Kingdom, 2Manager, IQVIA, London, United Kingdom, 3IQVIA, Bengaluru, India, 4IQVIA Portugal, Oeiras, Portugal, 5Amgen Inc., Thousand Oaks, CA, USA.
OBJECTIVES: Automatic substitution refers to policy requiring or incentivizing pharmacists to substitute the least costly biological medicine, typically a biosimilar, in place of the prescribed biologic, without prescriber authorisation. The policy is proposed as a strategy to increase biosimilar uptake and generate healthcare system savings. However, evidence on operational implications is scarce. This study outlines an innovative approach to identify operational complexity and quantify costs associated with implementing automatic substitution.
METHODS: An economic model was developed to quantify changes in healthcare resource utilization (HCRU) and associated costs across the care pathway. Inputs were derived from targeted literature review, public databases, IQVIA proprietary data, and a quantitative stakeholder survey with pharmacists, physicians, and procurement leads. Inputs were structured across four domains: (i) staff HCRU (pharmacists, physicians, nurses, procurement leads), (ii) non-staff HCRU (e.g., follow-up tests, replacement therapies), (iii) unit costs (e.g., salaries, treatment costs, legal liabilities), and (iv) healthcare system capacity (e.g., hospital, pharmacies, and staff availability). Automatic substitution costs were estimated for three care delivery settings: self-administered chronic subcutaneous (SC), hospital-administered chronic intravenous (IV), and outpatient-administered acute (IV or SC). Unit costs were combined with population size and healthcare resource counts, to estimate the overall population-level impact.
RESULTS: The model identified costs of implementing automatic substitution using Germany (DE) and France (FR) as examples. Costs were highest in the retail settings (DE: €269M; FR: €216M over 3 years) driven by a larger pool of eligible self-administered chronic SC therapies. Substantial recurring maintenance costs were observed irrespective of substitution volume, including pharmacy system setup and pharmacist training. Pharmacists (DE: 43%) and the healthcare system (DE: 32%) bore the majority of costs.
CONCLUSIONS: Economic modelling provides a structured framework to quantify costs of implementing new healthcare policies and contextualize them against reported healthcare system savings, supporting more informed policy decision-making.
METHODS: An economic model was developed to quantify changes in healthcare resource utilization (HCRU) and associated costs across the care pathway. Inputs were derived from targeted literature review, public databases, IQVIA proprietary data, and a quantitative stakeholder survey with pharmacists, physicians, and procurement leads. Inputs were structured across four domains: (i) staff HCRU (pharmacists, physicians, nurses, procurement leads), (ii) non-staff HCRU (e.g., follow-up tests, replacement therapies), (iii) unit costs (e.g., salaries, treatment costs, legal liabilities), and (iv) healthcare system capacity (e.g., hospital, pharmacies, and staff availability). Automatic substitution costs were estimated for three care delivery settings: self-administered chronic subcutaneous (SC), hospital-administered chronic intravenous (IV), and outpatient-administered acute (IV or SC). Unit costs were combined with population size and healthcare resource counts, to estimate the overall population-level impact.
RESULTS: The model identified costs of implementing automatic substitution using Germany (DE) and France (FR) as examples. Costs were highest in the retail settings (DE: €269M; FR: €216M over 3 years) driven by a larger pool of eligible self-administered chronic SC therapies. Substantial recurring maintenance costs were observed irrespective of substitution volume, including pharmacy system setup and pharmacist training. Pharmacists (DE: 43%) and the healthcare system (DE: 32%) bore the majority of costs.
CONCLUSIONS: Economic modelling provides a structured framework to quantify costs of implementing new healthcare policies and contextualize them against reported healthcare system savings, supporting more informed policy decision-making.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE308
Topic
Economic Evaluation, Health Policy & Regulatory, Methodological & Statistical Research
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies
Disease
Biologics & Biosimilars, No Additional Disease & Conditions/Specialized Treatment Areas