Identification



Read newsletter # 7 !


Past Issues

PROGRAMME

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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 Acces Landscape, and strategy
  • Gap Analysis and activity prioritization
  • Market access planning, budgeting and execution
  • Support to Development decision making
  • Drivers and barriers for acces
  • 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
    • 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

 

 

 

 

Module 1: Market Access Environment – 24h

 

Objective

  • Set the scene: health environment, health policies, market access regulations

 

Activities

  • Introduction to the concept of market access
  • Why market access has 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 New-Zealand)
  • Market access perspectives and drug development
    • Key activities, outputs and benefits from Phase I to LCM: when to do what?

 

Module 2: Market Access Activities in Early Preparation Phase I/II – 24h

Objectives

  • Market Access Gap Analysis
  • Support to portfolio decision making
  • Drivers and barriers
  • Incorporate Market Access issues in clinical development (P&R, HTA and Market Access Plan)

Activities

  • Disease Environment/Management
    • Desk Research
      • Mapping
      • Literature Review (PRO, competitors, disease mgt, policy review, Guidelines, HTA
        assessment)
    • Observational studies (cohort, database)
  • Pricing
    • Payer landscape research
    • Price anchoring studies
    • Reimbursability evaluation
  • Health Economics Outcome Research
    • Conceptual Model
    • PRO development
    • COI studies
    • Ballpark Modelling/Value Based Pricing
    • Early cost-effectiveness evaluation
    • Early HTA advices

 

Module 3: Market Access Activities in Phase III/Pre Launch - 24h

Objectives

  • Monitor Changes
  • Support to Portfolio decision making
  • Incorporate Market Access Issues in Clinical Development
  • Create Value Story

Activities

  • Disease Environment/Management
    • Desk Research
      • Mapping
      • Literature Review (PRO, competitors, disease mgt, policy review, Guidelines,
        HTA assessment)
    • Observational Studies (cohort, database)
  • Pricing
    • P&R environment
    • Price sensitivity
    • Payer research
    • Pricing sequence
    • Price strategy
    • P&R risk evaluation
  • HEOR
    • Endpoint Model, FDA/EMEA document (labeling claims)
    • PRO development
    • HEOR analyses of Clinical Studies
    • Publication cost-effectiveness evaluation
    • Clinical Relevance, indirect comparison
    • Preparation HTA sequence
  • Affiliates Responsibilities
    • Alert local issues
    • Scientific stakeholder management
    • Local studies

 

Module 4: Market Access Activities in Launch/Post Launch/LCM – 24h

Objective

  • Achieve P&R, HTA recommendation and Formulary inclusion at optimal prices/restrictions

Activities

  • Pricing
    • Launch
      • Negotiation guide
      • Core Value Dossier
      • Adaptation Core Value Dossier to Local Needs
      • Strategic advice
    • 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
        • Local HTA dossier
      • HE studies
      • Post-hoc analyses
      • Publications
    • Life Cycle
      • IITs
      • Observational studies to demonstrate real life effectiveness (cohort, databases)
      • Scientific Lobbying
      • Anticipate re-evaluation and update HTA dossier
      • Monitor New entrants/Environment
  • Affiliates Responsibilities
    • Alert local issues/Policy management
    • Scientific stakeholder management & Patient advocacy
    • Local studies
    • Adaptation, Submission and Negotiations
    • Communication/ Management of HTA decisions

Module 5: Risk Management and Decision Science – 24h


Objectives

  • Enhance managerial understanding of decision making processes
  • Address the many complex phenomena of the decision making process

 

Activities

  • Decision science theory
  • Risk management concepts and applications
  • Insurance theory and risk management applied to market access
  • Portfolio management : integration of market access constraints
  • Decision science and risk management as tool for tomorrow market access
  • Risk sharing applied to market access

 

Workshop: Strategic Planning - time to be confirmed

 

Objective

  • Application for strategic planning

 

Activities

  • Establish Core Team who develop
    • Global Master Plan
    • Core Value / HTA dossier
  • Insert real example presented by external speakers

 

 

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