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Stefano Capri Scuola di Economia e Management Università LIUC, Castellanza (VA) Milano, 17 gennaio 2017
Stefano CapriScuola di Economia e Management
Università LIUC, Castellanza (VA)
Milano, 17 gennaio 2017
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2001
2009
Comparative Effectiveness Research Methods Economic Evaluation Methods Modeling Methods Observational Study Methods-Database Methods Observational Study Methods-Medication
Adherence Methods Patient Reported & Clinician Reported Outcomes
Methods Preference-Based Methods Risk Benefits Methods Use of Outcomes Research in Health Care Decisions
Budget Impact Analysis Good Practices Cost Effectiveness Analysis with Clinical Trials Cost-Effectiveness Analysis alongside Clinical Trials Good
Practices II (in development)
Health Economic Evaluation Publication Guidelines – CHEERS Measuring Drug Costs in CEA: Issues and Recommendations Measuring Drug Costs in CEA: A Societal Perspective Measuring Drug Costs in CEA: A Managed Care Perspective Measuring Drug Costs in CEA: Medicare/Medicaid Perspective Measuring Drug Costs in CEA: An Industry Perspective Measuring Drug Costs in CEA: An International Perspective Nutrition Economics (in development) Quality Improvement of Cost Effectiveness Research Transferability of Economic Evaluations Across Jurisdictions
Conceptualizing a Model: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force Working Group-2
Dynamic Transmission Modeling: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force Working Group-5
Modeling Good Research Practices - Overview: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-1
Modeling Studies Modeling using Discrete Event Simulation: A Report of the ISPOR-SMDM
Modeling Good Research Practices Task Force Working Group-4 Model Parameter Estimation and Uncertainty: A Report of the ISPOR-
SMDM Modeling Good Research Practices Task Force Working Group-6 Model Transparency and Validation: A Report of the ISPOR-SMDM
Modeling Good Research Practices Task Force Working Group-7 Simulation Modeling Applications in Health Care Delivery Research -
Emerging Good Practices Task Force State-Transition Modeling: A Report of the ISPOR-SMDM Modeling Good
Research Practices Task Force Working Group-3
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COUNTRY-SPECIFIC PHARMACOECONOMIC GUIDELINES
Published PE Recommendations PE Guidelines Submission
GuidelinesAfrica South Africa Egypt
America-Latin
BrazilColombia
CubaMéxico
America-North United States Canada
Asia China MainlandTaiwan
South KoreaMalaysia
IsraelThailand
Europe
AustriaDenmarkHungary
ItalyRussian Federation
SpainCroatia
Baltic (Latvia, Lithuania, Estonia)BelgiumFrance
GermanyIreland
The NetherlandsNorwayPortugal
Slovak RepublicSloveniaSweden
Switzerland
England & WalesFinlandPoland
ScotlandSpain - Catalonia
Region
Oceania New Zealand AustraliaI
Da tempo le “buone pratiche” sono standardizzate(sebbene con differenti livelli di approfondimento-analisi statistica, modelli)◦ Possibili evoluzioni/miglioramenti
Come accade per le sperimentazioni cliniche: un bravo biostatistico ed un bravo clinico insiemesono in grado di disegnare e/o valutare uno studio di qualità.
Le linee guida che servono sono quelle “normative”, quelle richieste per l’ottenimento del P&R (NICE,…)
Studi di di qualità, ma soprattutto pratiche di HTA per l’utiizzo di tali studi:◦ Pricing & reimbursement◦ Budget impact◦ Incremento utilizzo nuove terapie◦ Abbandono di terapie esistenti◦ Inserimento della farmaoeconomia nel sistema di
incentivi (positivi/negativi) per le strutture di offerta e per gli operatori
IL VALORE DEL TRATTAMENTOUn differente modo di attribuire valore ad un trattamento oncologico:American Society of Clinical Oncology Value Framework
Schnipper et al. JCO 2016
Schnipper et al. JCO 2016
Schnipper et al. JCO 2016
NET HEALTH BENEFITNHB score it is derived from:• overall survival (OS), • progression-free survival (PFS), • response rate (RR), • symptom palliation, • time off• treatment, • QoL, along with the comparative toxicity of the
regimen
Clinical benefit, toxicity, net health benefit (NHB), and cost of ipilimumab versus placebo as derived from the prospective randomized trial comparing ipilimumab against placebo after primary treatment of stage III melanoma.
Schnipper et al. JCO 2016
Schnipper et al. JCO 2016
Net health benefit (NHB) scores for doxorubicin plus cyclophosphamide followed by paclitaxel plus trastuzumab versus doxorubicin, cyclophosphamide, and paclitaxel (control) in the adjuvant treatment of human epidermal growth factor receptor 2–positive breast cancer
NHB(Net Health Benefit) non permette confronti con le altre aree terapeutiche
NHB non contiene alcun elemento di teoriaeconomica (e.g. l’utilità)
NHB è ancora in evoluzioneProposte
Elaborare un algoritmo per tradurre NHB in QALYs
Approfondire il peso della OS; utilizzo delleproxies (PFS, ORR, ecc.)
creare una scala di preferenze utilizzare il NHB attraverso un processo di
MCDA (Multiple Criteria Decision Analysis)
