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Early Market Access Guidance

  • The Early Pricing Guidance is being used at the following stages of a lifecycle
  • Investment Decision Phase I study
  • Investment Decision Phase II study
  • Investment Decision for licensing-in products
  • Key questions being answered in an Early Pricing Guidance
  • What achievable pricing and reimbursement strategy will support an investment decision?
  • What is the unmet need/Burden of Illness in the target indication(s)?
  • To what degree is clinical, humanistic, and economic differentiation required to compete with the Standard of Care at launch?
  • What hypothesized measures of benefit and magnitude of benefit should be considered for market entry to satisfy payer unmet need and achieve reimbursement  at targeted price?
  • What could put the proposed strategy at risk?
  • Key content in the Early Pricing Guidance
  • Pricing strategy and projected reimbursement level
  • Probability of Access Success (green, yellow, red) for each key market and coverage/reimbursement assumption in these markets
  • Key planning assumptions, risks and uncertainties (inc. monitoring plan if required)
  • Perceived Unmet Needs
  • Value Proposition
  • Pricing and Reimbursement Potential
  • Risk Assessment and Recommendations
  • Payer Specific Changes to the Target Product Profile
  • Summary Key Product and Standard of Care Assumptions
  • Summary of Treatment Costs (relevant unit of measurement will depend on the disease/indication)