METHODOLOGICAL QUALITY ASSESSMENT OF EUROPEAN PHARMACOECONOMIC MODELS: A SYSTEMATIC EVALUATION USING AN INNOVATIVE ITALIAN CHECKLIST FOR ECONOMIC MODELS
Author(s)
Martina Bianco, MSc1, Martina Managò, MSc2, Beatrice Canali, MSc3, Isabella Neri, MSc4, Vito Luigi Orlando, MSc5, LUCA PICCOLI, MSc6, Martina PIPOLI, Jr., MA7, Salvatore Pirri, PhD8, Massimiliano Povero, PhD7, Andrea Marcellusi, PhD2.
1Menarini Stemline Italia S.r.l., Florence, Italy, 2University of Milan, Milan, Italy, 3IQVIA SOLUTIONS ITALY S.r.l., Milan, Italy, 4Roche S.p.A., Monza, Italy, 5Leo Pharma Italia S.p.A., Milan, Italy, 6Direzione Farmaceutico-Protesica Dispositivi Regione Veneto, Venice, Italy, 7AdRes HE&OR, Turin, Italy, 8Menarini Ricerche S.p.A., Florence, Italy.
1Menarini Stemline Italia S.r.l., Florence, Italy, 2University of Milan, Milan, Italy, 3IQVIA SOLUTIONS ITALY S.r.l., Milan, Italy, 4Roche S.p.A., Monza, Italy, 5Leo Pharma Italia S.p.A., Milan, Italy, 6Direzione Farmaceutico-Protesica Dispositivi Regione Veneto, Venice, Italy, 7AdRes HE&OR, Turin, Italy, 8Menarini Ricerche S.p.A., Florence, Italy.
OBJECTIVES: Economic evaluations are pivotal in HTA, but a historic lack of standardized requirements in Italy has introduced substantial qualitative variability among Price and Reimbursement submissions. To address this, the ISPOR Italy-Rome Chapter Working Group has developed a new checklist for economic models, which represents a context-specific innovation for the Italian HTA environment designed to foster transparency, improve analytical reliability and enhance review efficiency for the Italian Medicines Agency, academics and industry. To test the checklist, this study systematically evaluated the methodological quality of recent European economic models.
METHODS: A systematic literature review on PubMed identified 108 European economic evaluations of pharmacological treatments published between 2021 and 2025. The models were evaluated item-per-item across 6 domains: (1) General Settings, (2) Quality of Life, (3) Costs, (4) Direct Efficacy, (5) Indirect Efficacy and (6) Sensitivity Analysis. Quality was quantified on a 0-100 scale using three innovative indicators: a Penalty-based Score (penalizing flaws), a Linear Weighted Score (evaluating completeness a priori) and a data-driven PCA Score (empirically weighting items that statistically distinguish robust models).
RESULTS: Of the 108 models (78.7% cost-utility), the analysis revealed high compliance in General Settings (87.9% positive items) but critical gaps in Indirect Efficacy (34.5%). Synthetic indices averaged 68.0 for Linear Weighted, 74.6 for Penalty-based, and 68.7 for PCA-driven score. Using the empirical PCA score, 71.3% of models achieved "High" or "Good" quality, 25.0% were "Acceptable" and 3.7% were "Insufficient". Oncology and neurology models recorded the strongest methodological performance, while complex model structures (semi-Markov and partitioned survival) proved more robust than classic Markov models.
CONCLUSIONS: Methodological quality among European economic models remains highly heterogeneous, with notable weaknesses in handling uncertainty and indirect comparisons. This innovative checklist introduces a robust, standardized framework to mitigate these gaps, offering a shared methodological language to ensure coherence and uniform validation for future Italian HTA processes.
METHODS: A systematic literature review on PubMed identified 108 European economic evaluations of pharmacological treatments published between 2021 and 2025. The models were evaluated item-per-item across 6 domains: (1) General Settings, (2) Quality of Life, (3) Costs, (4) Direct Efficacy, (5) Indirect Efficacy and (6) Sensitivity Analysis. Quality was quantified on a 0-100 scale using three innovative indicators: a Penalty-based Score (penalizing flaws), a Linear Weighted Score (evaluating completeness a priori) and a data-driven PCA Score (empirically weighting items that statistically distinguish robust models).
RESULTS: Of the 108 models (78.7% cost-utility), the analysis revealed high compliance in General Settings (87.9% positive items) but critical gaps in Indirect Efficacy (34.5%). Synthetic indices averaged 68.0 for Linear Weighted, 74.6 for Penalty-based, and 68.7 for PCA-driven score. Using the empirical PCA score, 71.3% of models achieved "High" or "Good" quality, 25.0% were "Acceptable" and 3.7% were "Insufficient". Oncology and neurology models recorded the strongest methodological performance, while complex model structures (semi-Markov and partitioned survival) proved more robust than classic Markov models.
CONCLUSIONS: Methodological quality among European economic models remains highly heterogeneous, with notable weaknesses in handling uncertainty and indirect comparisons. This innovative checklist introduces a robust, standardized framework to mitigate these gaps, offering a shared methodological language to ensure coherence and uniform validation for future Italian HTA processes.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE194
Topic
Economic Evaluation, Health Technology Assessment
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), Infectious Disease (non-vaccine), Neurological Disorders, Oncology