Programme

  • The program consists of 5 mandatory modules plus one optional module on Health Economics
    The program has been revised from now and module lectures expanded to 28 hours per module:
  • Each module will contain one case study and one workshop
  • Practical applications for each main topic
  • Multiple examples from the public domain and lecturers experience
  • An optional module of 3 days on health economics
  • The full development of a Market Access Plan including strategy, gap analysis, activity prioritization

EMAUD 2019/2020

Module 1 – 28h: Market Access Environment
(30 September – 4 October 2019)

Objective
  • Set the scene: health environment, health policies, market access regulations across a broad range of countries. Country-specific policies are presented by Public Agency Representatives.
Activities
  • Introduction to market access definition, concept, and principles
    • National stakeholders
    • Regional stakeholders
    • Local stakeholders
    • Why has market access emerged? Decision-making chain
    • Market access strategies
      • Adapting the strategy for each market access stakeholder
  • Market access policies in Europe
  • Market access policies outside Europe (USA, Canada, Australia, Japan and China)
  • Market access perspectives and drug development
  • Key activities, outputs and benefits from Phase I to LCM: what should you do and when should you do it?
Workshop & Case study

Module 2 – 28h: Market Access Activities in Early Preparation Phase I/II
(2-6 December 2019)

Objectives
  • Market Access landscape, and strategy
  • Gap Analysis and activity prioritization
  • Market access planning, budgeting and execution
  • Support to development decision making
  • Drivers and barriers for access
  • Incorporate market access issues in clinical development (P&R, HTA and Market Access Plan)
Activities
  •  Landscape analysis
    • Desk Research
      • Disease understanding
      • Mapping
      • Literature Review (PRO, competitors, disease management, policy review, Guidelines, HTA assessment)
  • Pricing
    • Payer research
    • Price anchoring studies
    • Reimbursement evaluation
  • Market Access Agreement
  • Early HTA advices
  • Value story development and Gap Analysis
Workshop & Case study

Module 3 – 28h: Market Access Activities in Early Phase III/Pre Launch
(10-14 Feb 2020)

Objectives
  • Monitor Changes
  • Advocacy
  • Managing uncertainty
  • Pricing studies
  • Market Access focus on specific products
Activities
  • Pricing
    • P&R environment
    • Price sensitivity
    • Payer research
    • External reference pricing
    • Pricing sequence
    • Price strategy
    • P&R risk evaluation
  • Building an effective advocacy strategy to support market access
  • Market access specificities in emerging countries
  • Market access of specific products
    • Orphan drugs
    • Oncology products
    • Cell therapies
    • Mature products
    • Value added medicine
    • Combined products (fix combination and device drugs combination)
    • Biosimilars
Workshop & Case study

Module 4 – 28h: Market Access Activities in Launch/Post Launch/LCM
(6-10 April 2020)

Objectives
  • Achieve P&R, HTA recommendations, and Formulary inclusion at optimal prices/restrictions
Activities
  • Final Pricing Strategy
  • Launch
    • Negotiation guide
    • Core Value Dossier
    • Adaptation Core Value Dossier to Local Needs
    • Strategic advice
  • Negotiation Skills and Strategy
  • Life Cycle
    • Price database; Coordination sequence; Price Erosion
    • HEOR/Epidemiology
      • Launch
        • FDA/EMEA PRO submission dossier
        • Publication HEOR evidence (Cost-effectiveness, comparative effectiveness, clinical relevance, Phase III HEOR results)
        • Standard HTA dossier
        • Local Adaptation (Cost-effectiveness and local HTA Dossier)
        • HE studies
        • Post-hoc analyses
        • Publications
      • Life Cycle
        • IITs; real life effectiveness
        • Scientific Lobbying
        • Anticipate re-evaluation and update HTA dossier
        • Monitor New entrants/Environment
  • Interaction Affiliates Region and corporate functions for successful market access
Workshop & Case study

Module 4bis – 18h: Health Economics and Outcome Research (25-27 May 2020)

Objectives
  • Understand the concept of HEOR and realize basic exercise including:
    • Develop specification of a model
    • Develop a model
    • Develop a utility instrument
    • Develop a protocol for micro-costing
    • Critical review of a model
  • Morning lectures are centered around theory, while the afternoon session is dedicated to practical exercises
Activities
  • Health Economics and Outcome research
    • Conceptual Model
    • Pro Development
    • COI Studies
    • Ballpark Modelling/Value Based Pricing
    • Early cost-effectiveness evaluation
    • Different types of models

Module 5 – 28h: Market Access for Vaccines, Medical Device and Diagnostics
(15-19 June 2020)

Objectives
  • Understand the specificities of Market Access for Vaccines, Medical Devices and Diagnostics.
Activities
  • Overview of the market and strategy
  • Mapping of the access process in Europe and outside Europe
  • Definition, regulation, classification, certification
  • HTA and NITAG
  • Vaccines in emerging countries: a worldwide paradigm
  • Specificities for health economics assessment and value demonstration
  • Innovation and future challenges
  • Value based pricing for diagnostics and devices
Workshop & Case study
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