Phase 1
Phase 2
Phase 3
Phase 4
  • Define broad strategy
  • Define value and communication story
  • Differentiation of pricing strategy
  • Conduct early payer engagement studies
  • Medical needs gap analysis
  • Finalize launch timelines and pricing strategy
  • Implement the value dossiers and health economics model by local affiliates
  • Prepare dossiers and apply for pricing and reimbursement
  • Conduct projects for societal support

The market access strategy needs to start as early as early access programs!

Review:

  • Product profile
  • Competitive environment
  • Market dynamics
  • Pricing & reimbursement of competitors
  • Target Population

Secondary research:

  • Literature search
  • Treatment guidelines

Market Access Processes:

  • P&R process
  • HTA Review
  • Mapping and understanding of country-specific pricing and reimbursement processes requirements
  • MA current trends in each country
  • Define critical success factors to achieve successful market access

Payer research: 

  • Interview guide
  • KOLs & payers interviews
  • Analysis & consolidation of findings

Assessment:

  • Achievable / optimal price per country
  • Possible scenarios
  • Launch sequence
  • International price referencing
  • National price referencing

Value dossier preparation including:

  • Systematic literature researches, meta analysis, etc.
  • Modeling, cost-effectiveness, cost-utility analysis
  • Budget impact analysis

Recommendations:

  • Price strategy
  • Actions & data to support pricing & market access
  • Poster & article preparation
  • Application assessment