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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
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)
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