Programme

>>PDF<<

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

Module 1 – 28h: Market Access Environment
(08-12 October 2018)
Objective

  • Set the scene: health environment, health policies, market access regulations in a broad range of countries. Countries specific policies will be presented by Public Agencies representatives.

Activities

  • Introduction to market access definition, concept, and principles
  • Why has market access emerged? Decision-making chain
    • National stakeholders
    • Regional stakeholders
    • Local stakeholders
    • 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: when to do what?

Workshop & Case study

Module 2 – 28h: Market Access Activities in Early Preparation Phase I/II
(10-14 December 2018)
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
    • Reimbursability 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
(4-8 Feb 2019)
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 3bis – 18h: Health Economics and Outcome Research
(11-13 March 2019)
Objectives

  • Understand the concept of HEOR and realize basic exercise including:
    • Develop specification of a model
    • Develop a model
    • Develop an utility instrument
    • Develop a protocol for micro-costing

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 4 – 28h: Market Access Activities in Launch/Post Launch/LCM
(1-5 April 2018)
Objectives

  • Achieve P&R, HTA recommendation 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 5 – 28h: Market Access for Vaccines, Medical Device and Diagnostics
(3-7 June 2019)
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
  • Dealing with innovation and future challenges
  • Toward a value based pricing for diagnostics and devices

Workshop & Case study