Revisiting the Willingness-to-Pay Threshold in the Czech Republic: Integrating QALY Shortfall to Reflect Disease Severity and Unmet Medical Need
Author(s)
Jiri Klimes, PhD, Tomas Mlcoch, MSc., Balint Pasztor, MSc., Štepán Uherek, MS, Milan Vocelka, MSc, Klara Lamblova, MSc, Martina Mazalova, MSc, Monika Danielisová, PharmDr., Jessica Vydrova, MSc., Lenka Pribylova, MSc., Lukas Pisek, PhD, Jan Dolezel, PhD, Matej Bizub, PharmDr., Michaela Tauchmanova, MSc., Filip Dostal, MD, MA, Robert Chlád, MSc., Ivana Kubatova, PhD, David Suchanek, PharmDr., Martin Kolek, MSc., Michal Kostern, PhD, Eliska Simunkova, MSc., Apolena Koklarova, PharmDr., Martin Kubes, MSc., Aneta Schimmerova, PharmDr., Martina Krejcova, PharmDr., Katerina Chadimova, MA, Barbora Decker, PhD.
Czech ISPOR Chapter, Prague, Czech Republic.
Czech ISPOR Chapter, Prague, Czech Republic.
OBJECTIVES: This study aims to critically reassess the current Willingness-to-Pay Threshold (WTP-T) applied in the health technology assessment (HTA) of medicines in Czechia. Specifically, this study explores whether incorporating QALY shortfall metrics—absolute shortfall (AS), proportional shortfall (PS), and the ratio of incremental QALYs to AS (ΔQALY/AS)—can better reflect disease severity, unmet medical need, and societal preferences in reimbursement decisions.
METHODS: A retrospective analysis was conducted on 73 reimbursement decisions issued between 2022 and 2024. A standardized QALY shortfall calculator was developed by the Czech Pharmacoeconomic Society (ČFES), utilizing relevant data sources to calculate AS, PS, and ΔQALY/AS for each individual case. These metrics were evaluated across different types of reimbursement procedures recognized by the Czech law—standard, highly innovative medicines (VILP), and orphan drugs (EMA designated)—and stratified by therapeutic area. International practices from NICE (UK), ZIN (Netherlands), and NOMA (Norway) were also reviewed for comparison.
RESULTS: The median ICER across all cases was approximately €72,000/QALY considering official list prices (note, 80% of medicines were reimbursed under managed entry agreements), with 37% of cases falling below the informal WTP-T of approximately €48,000/QALY. Median AS, PS and ΔQALY/AS were 8.9, 71% and 9%, respectively. Orphans exhibited the highest median AS (12.5 QALYs) and VILPs (primarily oncologics) showed the highest PS (87%). Orphans also had the highest ΔQALY/AS ratios, indicating substantial innovation and unmet need. Despite smaller patient populations, orphan and VILP submissions contributed disproportionately to total QALY gains, highlighting their potential value. In contrast, standard submissions showed lower shortfalls and innovation ratios.
CONCLUSIONS: QALY shortfall metrics provide a robust approach for quantifying disease burden, unmet medical need and level of innovation—within the current framework and without additional administrative burden. ČFES recommends initiating a broad stakeholder dialogue to explore potential for threshold differentiation or QALY weighting based on shortfall indicators.
METHODS: A retrospective analysis was conducted on 73 reimbursement decisions issued between 2022 and 2024. A standardized QALY shortfall calculator was developed by the Czech Pharmacoeconomic Society (ČFES), utilizing relevant data sources to calculate AS, PS, and ΔQALY/AS for each individual case. These metrics were evaluated across different types of reimbursement procedures recognized by the Czech law—standard, highly innovative medicines (VILP), and orphan drugs (EMA designated)—and stratified by therapeutic area. International practices from NICE (UK), ZIN (Netherlands), and NOMA (Norway) were also reviewed for comparison.
RESULTS: The median ICER across all cases was approximately €72,000/QALY considering official list prices (note, 80% of medicines were reimbursed under managed entry agreements), with 37% of cases falling below the informal WTP-T of approximately €48,000/QALY. Median AS, PS and ΔQALY/AS were 8.9, 71% and 9%, respectively. Orphans exhibited the highest median AS (12.5 QALYs) and VILPs (primarily oncologics) showed the highest PS (87%). Orphans also had the highest ΔQALY/AS ratios, indicating substantial innovation and unmet need. Despite smaller patient populations, orphan and VILP submissions contributed disproportionately to total QALY gains, highlighting their potential value. In contrast, standard submissions showed lower shortfalls and innovation ratios.
CONCLUSIONS: QALY shortfall metrics provide a robust approach for quantifying disease burden, unmet medical need and level of innovation—within the current framework and without additional administrative burden. ČFES recommends initiating a broad stakeholder dialogue to explore potential for threshold differentiation or QALY weighting based on shortfall indicators.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR178
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Reimbursement & Access Policy
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), Diabetes/Endocrine/Metabolic Disorders (including obesity), Oncology, Rare & Orphan Diseases, Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)