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The company of specialists.
2Copyright © 2009 i3 | CONFIDENTIAL
Economic Analyses of Niaspan® in Latin Americafor Abbott Laboratories
Project Initiation Meeting
Rio de Janeiro, Brazil
9 September 2009
3Copyright © 2009 i3 | CONFIDENTIAL
Agenda
Introductions Project Overview & Abbott Expectations i3 Innovus Review of Project Scope Role of Latin American Research Consortium Overview of Niaspan® Global Models Project Roles Project Deliverables & Timelines Final Questions
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Introductions:Abbott
Abbott Global HEOR Bob Simko *Silky Webb
Abbott Latin America Diego Cortina; Abbott Mexico Gena Laranjeira; Abbott Brazil Paulo Vega Mateus; Abbott Colombia
* Abbott point-of-contact
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Introductions:i3 Innovus Project Team
David Thompson; Project Director *Joanna Campbell; Senior Manager Hemangi Parekh; Research Analyst Kevin Leahy; Research Associate
* i3 Innovus point-of-contact
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Introductions:i3 Innovus Latin American Research Partners
AxiaBio (Brazil) Gabriella Tannus de Araujo; Health Economics Director
Guia Mark (Mexico) Leon Zapata; Director General
HEORT (Colombia) Alejandro Bryon; Project Manager Ximena Burbano; Research Director
IECS (Argentina) Federico Augustovski; Director, Health Economic Evaluation
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Project Overview & Abbott Expectations
Silky Webb; Abbott
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i3 Innovus Review of Project Scope:Study Objectives
The specific objectives for this project are to:
Evaluate current Abbott global economic models of Niaspan® for suitability of adaptation to Latin America– Identify local-area data requirements
Identify, evaluate & collect local secondary data in six countries– Argentina, Brazil, Colombia, Mexico, Peru & Venezuela
Propose appropriate methods of supplementary primary data collection, where necessary
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i3 Innovus Review of Project Scope:Develop Research Plan
i3 Innovus to work with Abbott to develop a written research plan for the project
Specify project objectives
Describe specific research tasks– Search strategy– Data evaluation guidelines– Data analysis plan for Brazil & Colombia– Criteria for assessing primary data collection strategies
Specify content & format of project deliverables – Data abstraction template– Study report outline
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i3 Innovus Review of Project Scope:Evaluation of Niaspan® Global Economic Models
Conduct a thorough review of existing global Niaspan® models
Inventory the data requirements for each model
– Assess need for Latin American data inputs, target search for appropriate local-area data
Evaluate model flexibility in incorporating new treatment comparators – Treatments for hypercholesterolemia/mixed dyslipidemia– Treatments for disease-related complications
Document identified deficiencies and collaborate with Abbott to develop recommendations
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i3 Innovus Review of Project Scope:Identification, Evaluation & Collection of Local-Area Data
Work with consortium of research partners in the Latin American region to
Identify sources for required local-area estimates:– disease epidemiology (prevalence & incidence)– clinical endpoints in model (e.g. plasma cholesterol, HDL-C, LDL-C,
triglycerides)– treatment patterns – costs of treatments for disease & disease-related complications
Evaluate quality of data sources
Abstract readily acquired data into excel spreadsheets– Where available, collect separate data for public & private payers
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i3 Innovus Review of Project Scope:Identification, Evaluation & Collection of Local Data (cont’d)
Data searches will be conducted using English-, Portuguese-, and Spanish-language sources:– General: PubMed and Google Scholar
– Region-specific: LILACS, SciELO, Compumedicina
– PAHO publications
Review of publications by national statistical agencies– Epidemiology
– Healthcare resource use
– Healthcare costs
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i3 Innovus Review of Project Scope:Identification, Evaluation & Collection of Local Data (cont’d)
Gaps likely in local secondary data sources
– Especially healthcare utilization (& costs)
High-quality electronic data resources in Brazil and Colombia already identified
– Data analysis plans to be reviewed by Abbott prior to implementation
Document remaining gaps in secondary sources– Evaluate alternative methods of supplementary primary data
collection for likely validity, cost, ease of acquisition• Advisory boards • Analysis of local hospital or payer databases • Chart reviews • Surveys of local providers and/or prayer representatives
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i3 Innovus Review of Project Scope:Prepare Study Report
i3 Innovus will prepare a study report describing in detail the study’s objectives, methods, findings, and implications
Study report to center on:– Model evaluations– Results of search for local data– Recommendations for supplemental primary data collection
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i3 Innovus Latin American Research PartnersGabriella Tannus de Araujo; AxiaBio
Ximena Burbano; HEORT
Federico Augustovski; IECS
Leon Zapata; Guia Mark
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Overview of Niaspan® Global Models
Silky Webb; Abbott
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Project Roles & Responsibilities:
Abbott Project Lead– Silky Webb;
Tel: 847.938.0200
email: [email protected]
i3 Innovus Project Manager
– Joanna Campbell;
Tel: 781.518.4017
email: [email protected]
Abbott – i3 Innovus Business Development Liaison– Kevin Kelly
Tel: 317.564.2913
email: [email protected]
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Project Deliverables
Agenda & meeting summary for initial kick-off meeting Research plan: draft & final Study report w/ data appendices: draft & final
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Project Timelines
*Dates & times of update calls to be confirmed
Task
ISPOR Latin America Meeting
1. Develop Research Plan
2. Evaluate Current Niaspan Global Economic Models
3. Identify, Evaluate & Collect Local Data on Disease Epidemiology & Clinical Endpoints in Six Latin American CountriesClinical Endpoints in Six Latin American Countries
4. Identify, Evaluate & Collect Local Data on Treatment Patterns & Local Pharmacoeconomic Data in Six Latin American CountriesPharmacoeconomic Data in Six Latin American Countries
5. Prepare Study Report & Presentation
Project Management
Bi-weekly update conference calls*
9 10 11 125 6 7 85-Oct
1 2 3 414-Sep 21-Sep 21-Sep 28-Sep 16-Nov
Project Gantt Chart:
Economic Analyses of Niaspan® in Latin America
12-Oct 19-Oct 2-Nov 9-Nov
Project Weeks
26-Oct7-Sep
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Additional Questions
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The company of specialists.