EMPIRICAL EVALUATION OF ACCESS-BASED PRICING USING A MULTI-COHORT STUDY OF EUROPEAN MEDICINAL PRODUCTS
Author(s)
Melanie Walter, PhD1, Nicolas Xander, MSc2, Anne Hendrickx, MSc3, Maximilian Salcher-Konrad, PhD1.
1WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department, Austrian National Public Health Institute, Vienna, Austria, 2Erasmus University Rotterdam, Rotterdam, Netherlands, 3International Association of Mutual Benefit Societies (AIM), Brussels, Belgium.
1WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department, Austrian National Public Health Institute, Vienna, Austria, 2Erasmus University Rotterdam, Rotterdam, Netherlands, 3International Association of Mutual Benefit Societies (AIM), Brussels, Belgium.
OBJECTIVES: High prices of newly authorised medicinal products (MPs) raise concerns regarding affordability and equitable access across Europe. Within the ASCERTAIN project, an access-based pricing model to support transparent and evidence-informed price setting was developed. This study aims to empirically evaluate the access-based price (ABP) of authorised MPs through a comparison to observed prices across Europe.
METHODS: We conducted a retrospective cohort study including three groups of MPs: (A) advanced therapeutic medicinal products (ATMPs), (B) precision cancer medicines and (C) high- budget-impact (high-BI) medicines. Eligible MPs were authorised by the European Medicines Agency between 2018 and 2022 for cohorts A and B and between 2015 and 2022 for cohort C. In total, 54 products were included (12 ATMPs, 27 precision cancer medicines, 15 high-BI medicines). Product-specific ABPs per treatment were calculated based on cost- and value-based determinants and subsequently compared to observed prices across six to ten European countries. Primary outcomes were percentage differences between ABP and observed prices. Deterministic sensitivity analyses (DSAs) assessed the impact of key model parameters, including R&D cost estimates, patient population, added therapeutic benefit (ATB) rating and treatment duration.
RESULTS: The cohort-based approach enabled systematic comparison of pricing patterns across heterogeneous product groups. Preliminary findings indicated variation between calculated ABPs and observed prices across cohorts and countries. The DSA revealed patient population size, R&D costs, and ATB rating as the most impactful price determinants on the calculated ABP. The standardisation to treatment costs allowed consistent cross-country comparison despite variation in packaging.
CONCLUSIONS: This cohort study provides an empirical assessment of access-based pricing across distinct groups of high-BI MPs in Europe. The findings highlight the relevance of key price determinants and support the use of transparent pricing models to inform price negotiations and policy discussions on improving affordability and access to innovative MPs in Europe.
METHODS: We conducted a retrospective cohort study including three groups of MPs: (A) advanced therapeutic medicinal products (ATMPs), (B) precision cancer medicines and (C) high- budget-impact (high-BI) medicines. Eligible MPs were authorised by the European Medicines Agency between 2018 and 2022 for cohorts A and B and between 2015 and 2022 for cohort C. In total, 54 products were included (12 ATMPs, 27 precision cancer medicines, 15 high-BI medicines). Product-specific ABPs per treatment were calculated based on cost- and value-based determinants and subsequently compared to observed prices across six to ten European countries. Primary outcomes were percentage differences between ABP and observed prices. Deterministic sensitivity analyses (DSAs) assessed the impact of key model parameters, including R&D cost estimates, patient population, added therapeutic benefit (ATB) rating and treatment duration.
RESULTS: The cohort-based approach enabled systematic comparison of pricing patterns across heterogeneous product groups. Preliminary findings indicated variation between calculated ABPs and observed prices across cohorts and countries. The DSA revealed patient population size, R&D costs, and ATB rating as the most impactful price determinants on the calculated ABP. The standardisation to treatment costs allowed consistent cross-country comparison despite variation in packaging.
CONCLUSIONS: This cohort study provides an empirical assessment of access-based pricing across distinct groups of high-BI MPs in Europe. The findings highlight the relevance of key price determinants and support the use of transparent pricing models to inform price negotiations and policy discussions on improving affordability and access to innovative MPs in Europe.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR44
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas