Presentation (CTI)

OBJECTIVES: Models to estimate prices of newly authorized medicinal products (MPs) can assist healthcare decision-makers in ensuring equitable patient access while balancing incentives for innovation with healthcare system sustainability. The objective of this model is to provide an instrument to determine an access-based price of MPs to inform price negotiations and reimbursement decision-making. It aims to facilitate practical application by relevant stakeholder groups, while incorporating and reconciling their respective views and priorities.
METHODS: Findings from previous research involving a scoping literature review and semi-structured interviews with stakeholders informed a longlist of viable cost- and value-based price determinants. Subsequently, targeted literature reviews, stakeholder interviews, and a stakeholder survey were conducted to refine and operationalize the determinants ultimately included in the model.
RESULTS: Based on our findings from the literature and stakeholder elicitations, this pricing model incorporates a combination of cost- and value-based determinants. A cost-based base price is derived from costs for research and development (R&D), production, sales, and overhead costs, and incorporates a profit margin to cover operational costs. R&D costs can optionally be adjusted for cost of capital and return on public investment. Value-based determinants are computed as a multiplying factor of adjusted R&D costs, acting as an innovation reward. These determinants include the MP’s added therapeutic benefit over the standard of care, and also consider the quality of clinical evidence, unmet medical need fulfilment and societal value. To determine a price per patient, the output is divided by the product of relevant patient population size, treatment rate, and remaining market exclusivity period.
CONCLUSIONS: Through explicit and granular incorporation of cost- and value-based determinants, this access-based pricing model might provide valuable input for determining MP prices that contribute to improved patient access. Further research could test the cost-effectiveness of access-based prices for specific MP types and indications, and might facilitate further model refinement.