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