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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)

Grazie per l’attenzione

scapri@liuc.it